Daratumumab – Uses, Dosage, Side Effects, Interaction

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Daratumumab - Uses, Dosage, Side Effects, Interaction
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Daratumumab is a CD38-directed cytolytic antibody used alone or as an adjunct drug in the treatment of multiple myeloma and light-chain amyloidosis. Daratumumab is an immunoglobulin G1 kappa monoclonal antibody developed by Janssen and Genmab.[rx] It was first described in the literature in 2010 as...

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Article Summary

Daratumumab is a CD38-directed cytolytic antibody used alone or as an adjunct drug in the treatment of multiple myeloma and light-chain amyloidosis. Daratumumab is an immunoglobulin G1 kappa monoclonal antibody developed by Janssen and Genmab.[rx] It was first described in the literature in 2010 as a monoclonal antibody that targets CD38+ multiple myeloma cells; the first of its kind.[rx] Daratumumab, sold under the brand name Darzalex,...

Key Takeaways

  • This article explains Mechanism of action in simple medical language.
  • This article explains Indications in simple medical language.
  • This article explains Contraindications in simple medical language.
  • This article explains Dosage in simple medical language.
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Definition

Daratumumab is a CD38-directed cytolytic antibody used alone or as an adjunct drug in the treatment of multiple myeloma and light-chain amyloidosis. Daratumumab is an immunoglobulin G1 kappa monoclonal antibody developed by Janssen and Genmab.[rx] It was first described in the literature in 2010 as a monoclonal antibody that targets CD38+ multiple myeloma cells; the first of its kind.[rx]

Daratumumab, sold under the brand name Darzalex, is an anti-cancer monoclonal antibody medication. It binds to CD38,[rx] which is overexpressed in multiple myeloma cells.[rx] Daratumumab was originally developed by Genmab, but it is now being jointly developed by Genmab along with the Johnson & Johnson subsidiary Janssen Biotech, which acquired worldwide commercialization rights to the drug from Genmab.[rx]

Daratumumab was granted FDA approval on 16 November 2015.[rx] It is approved for the treatment of multiple myeloma as monotherapy or combination therapy and light chain (AL) amyloidosis in combination with other drugs.[rx,rx]

Mechanism of action

CD38 is a glycoprotein present on the surface of hematopoietic cells and is responsible for a number of cell signaling functions. Daratumumab is an immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that targets CD38.[rx] Cancers like multiple myeloma overexpress CD38, allowing daratumumab to have a higher affinity for these cells.[rx] This binding allows daratumumab to induce apoptosis, antibody-dependent cellular phagocytosis, and antibody and complement-dependent cytotoxicity.[rx] Antibody-dependent cellular phagocytosis is mediated by the FC region of the antibody-inducing phagocytes such as macrophages, antibody-dependent cellular cytotoxicity is mediated by the FC region of the antibody-inducing effector cells such as natural killer cells, and complement dependent cytotoxicity is mediated by the FC region of the antibody binding to and inducing complement protein activity.[rx]

Daratumumab is a monoclonal antibody that targets and induces apoptosis in cells that highly express CD38, including multiple myeloma cells.[rx,rx] It has a long duration of action as it is given every 1-4 weeks.[rx,rx] Patients should be counseled regarding the risk of hypersensitivity, bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।" data-rx-term="neutrophil" data-rx-definition="Neutrophil is a white blood cell important for fighting bacterial infection. সহজ বাংলা: ব্যাকটেরিয়ার বিরুদ্ধে লড়াই করা শ্বেত রক্তকণিকা।">neutrophil count, which may increase infection risk. সহজ বাংলা: নিউট্রোফিল কম থাকা, সংক্রমণের ঝুঁকি বাড়তে পারে।" data-rx-term="neutropenia" data-rx-definition="Neutropenia means low neutrophil count, which may increase infection risk. সহজ বাংলা: নিউট্রোফিল কম থাকা, সংক্রমণের ঝুঁকি বাড়তে পারে।">neutropenia, platelet count, which can increase bleeding risk. সহজ বাংলা: প্লাটিলেট কম।" data-rx-term="thrombocytopenia" data-rx-definition="Thrombocytopenia means low platelet count, which can increase bleeding risk. সহজ বাংলা: প্লাটিলেট কম।">thrombocytopenia, embryo-fetal toxicity, and interferences with cross-matching and red blood cell antibody screening.[rx]

Indications

  • Daratumumab is indicated as an intravenous injection alone or in combination with other medications for the treatment of multiple myeloma.[rx] It is available as a combination product with hyaluronidase for the treatment of adults with multiple myeloma as monotherapy or combination therapy and light chain amyloidosis in combination with other drugs.[rx]
  • Light-Chain Amyloidosis
  • Multiple Myeloma (MM)
  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma

Use in Cancer

Daratumumab is approved to be used alone or with other drugs to treat:

  • Multiple myeloma. It is used:
    • In adults with newly diagnosed diseases. It is used:
    • In adults with relapsed or refractory disease. It is used:
      • With dexamethasone and bortezomib in patients who have received at least one therapy.
      • With dexamethasone and carfilzomib in patients who have received one to three other types of therapy.
      • With pomalidomide and dexamethasone in patients who have received at least two therapies that included lenalidomide and a proteasome inhibitor.
      • Alone in patients who have received at least three types of therapy that included a proteasome inhibitor and an immunomodulating agent or whose disease is refractory to both a proteasome inhibitor and an immunomodulatory agent.

Daratumumab is also available in a different form, combined with hyaluronidase. For more information, see the Drug Information Summary for Daratumumab and hyaluronidase-fihj.

Daratumumab is also being studied in the treatment of other types of cancer.

Contraindications

  • decreased blood platelets
  • low levels of a type of white blood cell called neutrophils
  • pregnancy
  • reactivation of hepatitis B infection

Dosage

Strengths: 20 mg/mL

Multiple Myeloma

DOSING SCHEDULE IN COMBINATION WITH LENALIDOMIDE OR POMALIDOMIDE (4-WEEK CYCLE) AND LOW-DOSE DEXAMETHASONE AND FOR MONOTHERAPY:

  • Weeks 1 to 8: 16 mg/kg IV weekly (total of 8 doses)
  • Weeks 9 to 24: 16 mg/kg IV every 2 weeks (total of 8 doses); the first dose of the every-2-week dosing schedule is given at Week 9
  • Week 25 and onwards until disease progression: 16 mg/kg IV every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 25

DOSING SCHEDULE IN COMBINATION WITH BORTEZOMIB, MELPHALAN, AND PREDNISONE 6-WEEK CYCLE:

  • Weeks 1 to 6: 16 mg/kg IV weekly (total of 6 doses)
  • Weeks 7 to 54: 16 mg/kg IV every 3 weeks (total of 16 doses); the first dose of the every-3-week dosing schedule is given at Week 7
  • Week 55 onwards until disease progression: 16 mg/kg IV every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 55

DOSING SCHEDULE IN COMBINATION WITH BORTEZOMIB, THALIDOMIDE, AND DEXAMETHASONE 4-WEEK CYCLE:
INDUCTION:

  • Weeks 1 to 8: 16 mg/kg IV weekly (total of 8 doses)
  • Weeks 9 to 16: 16 mg/kg IV every 2 weeks (total of 4 doses); the first dose of every-2-week dosing schedule is given at Week 9
  • Stop high-dose chemotherapy and ASCT.

CONSOLIDATION:

  • Weeks 1 to 8: 16 mg/kg IV every 2 weeks; the first dose of the every-2-week dosing schedule is given at Week 1 upon reinitiation of therapy following ASCT

DOSING SCHEDULE IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE 3-WEEK CYCLE:

  • Weeks 1 to 9: 16 mg/kg IV weekly (total of 9 doses)
  • Weeks 10 to 24: 16 mg/kg IV every 3 weeks (total of 5 doses); the first dose of every-3-week dosing schedule is given at Week 10
  • Week 25 onwards until disease progression: 16 mg/kg IV every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 25

DOSING SCHEDULE WITH CARFILZOMIB AND DEXAMETHASONE 4-WEEK CYCLE:

  • Week 1: 8 mg/kg IV on Days 1 and 2 (total of 2 doses)
  • Weeks 2 to 8: 16 mg/kg IV weekly (total of 7 doses)
  • Weeks 9 to 24: 16 mg/kg IV every 2 weeks (total of 8 doses); the first dose of the every-2-week dosing schedule is given at Week 9
  • Week 25 onwards until disease progression: 16 mg/kg every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 25
  • Dosing is based on actual body weight.
  • The first 16 mg/kg dose at Week 1 may be split over 2 consecutive days (i.e., 8 mg/kg on Day 1 and Day 2, respectively.
  • Pre-and post-infusion medications should be given prior to initiating therapy.

Manufacturer-recommended infusion rates and management of infusion-related reactions (IRRs):
OPTION 1 (SINGLE DOSE INFUSION):
Week 1 Day 1 (16 mg/kg):

  • Dilution volume: 1000 mL
  • Initial rate (first hour): 50 mL/hr
  • Rate increment: 50 mL/hr every hour
  • Maximum rate: 200 mL/hr

OPTION 2 (SPLIT DOSE INFUSION):
Week 1 Day 1 (8 mg/kg):

  • Dilution volume: 500 mL
  • Initial rate (first hour): 50 mL/hr
  • Rate increment: 50 mL/hr every hour
  • Maximum rate: 200 mL/hr

Week 1 Day 2 (8 mg/kg):

  • Dilution volume: 500 mL
  • Initial rate (first hour): 50 mL/hr
  • Rate increment: 50 mL/hr every hour
  • Maximum rate: 200 mL/hr

WEEK 2 (16 mg/kg):

  • Dilution volume: 500 mL
  • Initial rate (first hour): 50 mL/hr
  • Rate increment: 50 mL/hr every hour
  • Maximum rate: 200 mL/hr

WEEK 3 ONWARDS (16 MG/KG):

  • Dilution volume: 500 mL
  • Initial rate (first hour): 100 mL/hr
  • Rate increment: 50 mL/hr every hour
  • Maximum rate: 200 mL/hr
  • Consider incremental escalation of the infusion rate only in the absence of infusion reactions.
  • Use a dilution volume of 500 mL for the 16 mg/kg dose only if there were no infusion reactions the previous week; otherwise, continue to use a dilution volume of 1000 mL.
  • Use a modified initial rate (100 mL/hour) for subsequent infusions (i.e., Week 3 onwards) only if there were no infusion reactions during the previous infusion; otherwise, continue to use instructions indicated for the Week 2 infusion rate.

PREMEDICATIONS:
Premedicate approximately 1 to 3 hours prior to every infusion:
1) Corticosteroid (long- or intermediate-acting);

  • Monotherapy: Methylprednisolone (or equivalent) 100 mg IV; following the second infusion, consider reducing the dose to 60 mg (or equivalent) IV or orally.
  • Combination therapy: Administer 20 mg dexamethasone (or equivalent) IV or orally. When dexamethasone is the background regimen specific corticosteroid, the dexamethasone dose that is part of the background regimen will serve as premedication on daratumumab infusion days.
  • Do not administer background regimen-specific corticosteroids (e.g., prednisone) on daratumumab infusion day.
  • Daratumumab infusion days when patients have received dexamethasone (or equivalent) as a premedication.

2) Antipyretic: Acetaminophen 650 to 1000 mg orally
3) Antihistamine: Diphenhydramine (or equivalent) 25 to 50 mg IV or orally

POST-INFUSION MEDICATION:

  • MONOTHERAPY: Administer methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) orally for 2 days starting the day after the administration of daratumumab.
  • IN COMBINATION: Consider administering oral methylprednisolone at a dose of less than or equal to 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) beginning the day after the administration of daratumumab.
    If a background regimen-specific corticosteroid (e.g., dexamethasone, prednisone) is administered the day after the daratumumab infusion, additional corticosteroids may not be needed.
  • For patients with a history of chronic obstructive pulmonary disease, consider prescribing short and long-acting bronchodilators and inhaled corticosteroids. Following the first 4 daratumumab infusions, consider discontinuing these additional post-infusion medications if the patient does not experience a major infusion-related reaction.

PROPHYLAXIS FOR HERPES ZOSTER REACTIVATION:

  • Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting daratumumab and continue for 3 months after.
  • For dosing instructions of combination agents administered with this drug see the manufacturer product information.
  • In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant or with relapsed or refractory multiple myeloma who have received at least 1 prior therapy
  • In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT)
  • In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant
  • In combination with bortezomib and dexamethasone in patients who have received at least 1 prior therapy
  • In combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor
  • As monotherapy, in patients who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent

Dose Adjustments

  • No dose reductions of daratumumab are recommended. Consider withholding therapy to allow recovery of blood cell counts in the event of myelosuppression.

INFUSION-RELATED REACTIONS (IRRs):
For infusion-related reactions (IRRs) of any grade/severity, interrupt the infusion and manage symptoms (this may require further reduction in the rate of infusion or discontinuation of therapy):

  • Grade 1 to 2 (mild to moderate): After symptoms resolve, resume the infusion at no more than half the rate at which the IRR occurred; if the patient experiences no further IRRs, infusion rate escalation may resume at increments up to the maximum rate of 200 mL/hour.
  • Grade 3 (severe): After symptoms resolve, restart the infusion at no more than half the rate at which the IRR occurred; if the patient experiences no further IRRs, resume infusion rate escalation as outlined in the “Manufacturer recommended infusion rates and management of IRRs”. Repeat this procedure in the event of recurrence of Grade 3 symptoms. Permanently discontinue therapy upon the third occurrence of Grade 3 or greater IRR.
  • Grade 4 (life-threatening): Permanently discontinue therapy.

Administration advice:

  • This drug should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage IRRs.
  • Administer only as an IV infusion after dilution.
  • For dosing instructions of combination agents administered with this drug see the manufacturer product information.
  • If a dose is missed, administer as soon as possible and adjust the dosing schedule accordingly maintaining the treatment interval.

Side Effects

The Most Common

  • tiredness
  • constipation
  • diarrhea
  • back or joint pain
  • pain in your arms, legs, or chest
  • decreased appetite
  • pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">headache
  • swelling of the hands, ankles, or feet
  • pain, burning, or tingling in the hands or feet
  • muscle spasms
  • difficulty falling asleep or staying asleep
  • bruising or bleeding
  • fever
  • extreme tiredness
  • yellowing of the skin or eyes
  • cough with yellow or green mucus;
  • stabbing chest pain, wheezing, feeling short of breath;
  • numbness, tingling, burning pain; or
  • low blood cell counts–fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands, and feet, feeling light-headed or short of breath.
  • shortness of breath;
  • nerve problems causing tingling, numbness, or pain;
  • feeling tired or weak;
  • swelling in your hands, ankles, or feet; or
  • cold symptoms such as stuffy nose, sneezing, cough, sore throat.

More common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • body aches or pain
  • chest pain or tightness
  • chills
  • confusion
  • cough
  • difficulty swallowing
  • dizziness
  • ear congestion
  • facial swelling
  • fast heartbeat
  • fever
  • pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।" data-rx-term="headache" data-rx-definition="Headache means pain in the head or upper neck. সহজ বাংলা: মাথাব্যথা।">headache
  • hoarseness
  • loss of voice
  • nausea
  • nervousness
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, lips, or tongue
  • rapid, shallow breathing
  • skin rash, hives, or itching
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • stuffy or runny nose
  • tingling of the hands or feet
  • trouble breathing
  • unusual tiredness or weakness
  • unusual weight gain or loss
  • vomiting

Rare

  • Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • painful blisters on the trunk of body
  • sweating
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • constipation
  • coughing that sometimes produce a pink frothy sputum
  • darkened urine
  • lower back or side pain
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • swelling in the legs and ankles
  • ulcers, sores, or white spots in the mouth
  • unusual bleeding or bruising
  • yellow eyes or skin

Daratumumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Drug Interactions

Pregnancy and Lactation

AU TGA pregnancy category: C
US FDA pregnancy category: Not assigned

Pregnancy

Safety has not been established during pregnancy. IgG1 monoclonal antibodies cross the placenta after the first trimester of pregnancy; therefore, this drug should not be used during pregnancy unless the benefit of treatment to the woman is considered to outweigh the potential risks to the fetus. If the patient becomes pregnant while taking this medicine, the patient should be informed of the potential risk to the fetus. Women of reproductive potential should use effective contraception during therapy and for 3 months after cessation of therapy; however, when this drug is used in combination with lenalidomide and dexamethasone, patients should also follow advice about use in pregnancy of those products. Administration of live vaccines to neonates and infants exposed to this drug in utero should be deferred until a hematology evaluation is completed.

Lactation

The effects in the nursing infant are unknown. Human IgG is known to be present in human milk. Data suggest antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts.

No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. Until more data become available, this drug should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

How should this medicine be used?

Daratumumab comes as a liquid (solution) that is given intravenously (into a vein) by a doctor or nurse in a healthcare setting. Your doctor will decide how often you are to receive daratumumab based on other medications that may be given and your body’s response to this medication.

A doctor or nurse will watch you closely while you are receiving the infusion and afterward to be sure you are not having a serious reaction to the medication. You will be given other medications to help prevent and treat reactions to daratumumab prior to your infusion and for the first and second days after you receive your medication. Tell your doctor or nurse immediately if you experience any of the following symptoms: cough, wheezing, throat tightness and irritation, itchy, runny, or stuffy nose, headache, itching, nausea, vomiting, fever, chills, rash, hives, dizziness, lightheadedness, difficulty breathing, chest discomfort, or shortness of breath.

Your doctor may decrease your dose of daratumumab or temporarily or permanently stop your treatment. This depends on how well the medication works for you and the side effects you experience. Be sure to tell your doctor how you are feeling during your treatment with daratumumab. Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

What special precautions should I follow?

Before receiving a daratumumab injection,

  • tell your doctor and pharmacist if you are allergic to daratumumab, any other medications, or any of the ingredients in daratumumab injection. Ask your pharmacist or check the manufacturer’s patient information for a list of the ingredients.
  • tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor if you are receiving blood transfusions or if you have or have ever had shingles (a painful rash that occurs after infection with herpes zoster or chickenpox), breathing problems, hepatitis B (a virus that infects the liver and may cause severe liver damage), or a lung disease such as chronic obstructive pulmonary disease (COPD; a group of lung diseases, which includes chronic bronchitis and emphysema).
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. You should use birth control to prevent pregnancy during your treatment with daratumumab and for at least 3 months after your final dose. Talk to your doctor about the types of birth control that will work for you. If you become pregnant while receiving a daratumumab injection, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving a daratumumab injection.

References

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Which doctor may help?

Start with a registered doctor or the nearest qualified health center.

What to tell the doctor

  • Write when the problem started and how it changed.
  • Bring old prescriptions, investigation reports, and current medicines.
  • Write allergies, pregnancy status, diabetes, kidney/liver disease, and major past illnesses.
  • Bring one family member if the patient is weak, elderly, confused, or a child.

Questions to ask

  • What is the most likely cause of my symptoms?
  • Which danger signs mean I should go to hospital quickly?
  • Which tests are necessary now, and which can wait?
  • How should I take medicines safely and what side effects should I watch for?
  • When should I come for follow-up?

Tests to discuss

  • Vital signs: temperature, pulse, blood pressure, oxygen saturation
  • Basic physical examination by a clinician
  • CBC, urine test, blood sugar, or imaging only when clinically needed

Avoid these mistakes

  • Do not use antibiotics, steroid tablets/injections, or strong painkillers without proper medical advice.
  • Do not hide pregnancy, kidney disease, ulcer, allergy, or blood thinner use.
  • Do not delay emergency care when danger signs are present.

Medicine safety and first-aid guide

This section is for patient education only. It does not replace a doctor, pharmacist, or emergency care.

Safe first steps

  • Avoid heavy lifting, sudden bending, and prolonged bed rest.
  • Use comfortable posture and gentle movement as tolerated.
  • Discuss physiotherapy, X-ray, or MRI only when clinically needed.

OTC medicine safety

  • For mild back pain, pain-relief medicine may be discussed with a doctor or pharmacist.
  • Avoid repeated painkiller use if you have kidney disease, stomach ulcer, uncontrolled blood pressure, or are taking blood thinners.

Avoid these mistakes

  • Do not start antibiotics without a proper medical decision.
  • Do not use steroid tablets or injections casually for quick relief.
  • Do not delay emergency care because of home remedies.

Get urgent help if

  • Back pain with leg weakness, numbness around private area, loss of urine/stool control, fever, cancer history, or major injury needs urgent care.
Medicine names, dose, and timing must be decided by a qualified clinician or pharmacist after checking age, pregnancy, allergy, other diseases, and current medicines.

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Doctor to discuss: Medicine doctor / pediatrician for children / qualified clinician
Tests to discuss with doctor
  • Temperature chart and hydration assessment
  • CBC with platelet count if fever persists or dengue/other infection is possible
  • Urine test, malaria/dengue tests, chest evaluation, or blood culture only when clinically indicated
Questions to ask
  • What is the most likely cause of my symptoms?
  • Which warning signs mean I should go to emergency care?
  • Which tests are really needed now?
  • Which medicines are safe for my age, pregnancy status, allergy, kidney/liver/stomach condition, and current medicines?
  • Do I need antibiotics, or is this more likely viral?

Emergency warning signs such as chest pain, severe breathing difficulty, sudden weakness, confusion, severe dehydration, major injury, or loss of bladder/bowel control need urgent medical care. Do not wait for online information.

Safe pathway to proper treatment

Care roadmap for: Daratumumab – Uses, Dosage, Side Effects, Interaction

Use this simple roadmap to understand the next safe steps. It is educational and does not replace examination by a doctor.

Go to emergency care if you notice:
  • Severe or rapidly worsening symptoms
  • Breathing difficulty, chest pain, fainting, confusion, severe weakness, major injury, or severe dehydration
Doctor / service to discuss: Qualified healthcare provider; specialist depends on symptoms and examination.
  1. Step 1

    Check danger signs first

    If danger signs are present, seek emergency care and do not wait for online information.

  2. Step 2

    Record the symptom story

    Write when symptoms started, severity, medicines already taken, allergies, pregnancy status, and test results.

  3. Step 3

    Visit a qualified clinician

    A doctor, nurse, or qualified healthcare provider can examine you and decide which tests or treatment are needed.

  4. Step 4

    Do only useful tests

    Do tests after clinical assessment. Avoid unnecessary tests, random antibiotics, or repeated medicines without diagnosis.

  5. Step 5

    Follow up and return early if worse

    If symptoms worsen, new warning signs appear, or treatment is not helping, return for review quickly.

Rural patient practical tips
  • Take a written symptom diary and all previous prescriptions/test reports.
  • Do not hide medicines already taken, even herbal or over-the-counter medicines.
  • Ask which warning signs mean urgent referral to hospital.

This roadmap is for education. A real diagnosis and treatment plan requires history, examination, and clinical judgment.

RX Patient Help

Ask a health question safely

Write your symptom story. A health professional or site editor can review it before any answer is prepared. This box is not for emergency care.

Emergency first: Severe chest pain, breathing trouble, unconsciousness, stroke signs, severe injury, heavy bleeding, or rapidly worsening symptoms need urgent local medical care now.

Frequently Asked Questions

Mechanism of action CD38 is a glycoprotein present on the surface of hematopoietic cells and is responsible for a number of cell signaling functions. Daratumumab is an immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that targets CD38.[rx] Cancers like multiple myeloma overexpress CD38, allowing daratumumab to have a higher affinity for these cells.[rx] This binding allows daratumumab to induce apoptosis, antibody-dependent cellular phagocytosis, and antibody and complement-dependent cytotoxicity.[rx] Antibody-dependent cellular phagocytosis is mediated by the FC region of the antibody-inducing phagocytes such as macrophages, antibody-dependent cellular cytotoxicity is mediated by the FC region of the antibody-inducing effector cells such as natural killer cells, and complement dependent cytotoxicity is mediated by the FC region of the antibody binding to and inducing complement protein activity.[rx] Daratumumab is a monoclonal antibody that targets and induces apoptosis in cells that highly express CD38, including multiple myeloma cells.[rx,rx] It has a long duration of action as it is given every 1-4 weeks.[rx,rx] Patients should be counseled regarding the risk of hypersensitivity, neutropenia, thrombocytopenia, embryo-fetal toxicity, and interferences with cross-matching and red blood cell antibody screening.[rx] Indications Daratumumab is indicated as an intravenous injection alone or in combination with other medications for the treatment of multiple myeloma.[rx] It is available as a combination product with hyaluronidase for the treatment of adults with multiple myeloma as monotherapy or combination therapy and light chain amyloidosis in combination with other drugs.[rx] Light-Chain Amyloidosis Multiple Myeloma (MM) Refractory Multiple Myeloma Relapsed Multiple Myeloma Use in Cancer Daratumumab is approved to be used alone or with other drugs to treat: Multiple myeloma. It is used: In adults with newly diagnosed diseases. It is used: With lenalidomide and dexamethasone or with bortezomib, melphalan, and prednisone in patients who cannot receive an autologous stem cell transplant. With bortezomib, thalidomide, and dexamethasone in patients who can receive an autologous stem cell transplant. In adults with relapsed or refractory disease. It is used: With dexamethasone and bortezomib in patients who have received at least one therapy. With dexamethasone and carfilzomib in patients who have received one to three other types of therapy. With pomalidomide and dexamethasone in patients who have received at least two therapies that included lenalidomide and a proteasome inhibitor. Alone in patients who have received at least three types of therapy that included a proteasome inhibitor and an immunomodulating agent or whose disease is refractory to both a proteasome inhibitor and an immunomodulatory agent. Daratumumab is also available in a different form, combined with hyaluronidase. For more information, see the Drug Information Summary for Daratumumab and hyaluronidase-fihj. Daratumumab is also being studied in the treatment of other types of cancer. Contraindications decreased blood platelets low levels of a type of white blood cell called neutrophils pregnancy reactivation of hepatitis B infection Dosage Strengths: 20 mg/mL Multiple Myeloma DOSING SCHEDULE IN COMBINATION WITH LENALIDOMIDE OR POMALIDOMIDE (4-WEEK CYCLE) AND LOW-DOSE DEXAMETHASONE AND FOR MONOTHERAPY: Weeks 1 to 8: 16 mg/kg IV weekly (total of 8 doses) Weeks 9 to 24: 16 mg/kg IV every 2 weeks (total of 8 doses); the first dose of the every-2-week dosing schedule is given at Week 9 Week 25 and onwards until disease progression: 16 mg/kg IV every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 25 DOSING SCHEDULE IN COMBINATION WITH BORTEZOMIB, MELPHALAN, AND PREDNISONE 6-WEEK CYCLE: Weeks 1 to 6: 16 mg/kg IV weekly (total of 6 doses) Weeks 7 to 54: 16 mg/kg IV every 3 weeks (total of 16 doses); the first dose of the every-3-week dosing schedule is given at Week 7 Week 55 onwards until disease progression: 16 mg/kg IV every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 55 DOSING SCHEDULE IN COMBINATION WITH BORTEZOMIB, THALIDOMIDE, AND DEXAMETHASONE 4-WEEK CYCLE: INDUCTION: Weeks 1 to 8: 16 mg/kg IV weekly (total of 8 doses) Weeks 9 to 16: 16 mg/kg IV every 2 weeks (total of 4 doses); the first dose of every-2-week dosing schedule is given at Week 9 Stop high-dose chemotherapy and ASCT. CONSOLIDATION: Weeks 1 to 8: 16 mg/kg IV every 2 weeks; the first dose of the every-2-week dosing schedule is given at Week 1 upon reinitiation of therapy following ASCT DOSING SCHEDULE IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE 3-WEEK CYCLE: Weeks 1 to 9: 16 mg/kg IV weekly (total of 9 doses) Weeks 10 to 24: 16 mg/kg IV every 3 weeks (total of 5 doses); the first dose of every-3-week dosing schedule is given at Week 10 Week 25 onwards until disease progression: 16 mg/kg IV every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 25 DOSING SCHEDULE WITH CARFILZOMIB AND DEXAMETHASONE 4-WEEK CYCLE: Week 1: 8 mg/kg IV on Days 1 and 2 (total of 2 doses) Weeks 2 to 8: 16 mg/kg IV weekly (total of 7 doses) Weeks 9 to 24: 16 mg/kg IV every 2 weeks (total of 8 doses); the first dose of the every-2-week dosing schedule is given at Week 9 Week 25 onwards until disease progression: 16 mg/kg every 4 weeks; the first dose of the every-4-week dosing schedule is given at Week 25 Dosing is based on actual body weight. The first 16 mg/kg dose at Week 1 may be split over 2 consecutive days (i.e., 8 mg/kg on Day 1 and Day 2, respectively. Pre-and post-infusion medications should be given prior to initiating therapy. Manufacturer-recommended infusion rates and management of infusion-related reactions (IRRs): OPTION 1 (SINGLE DOSE INFUSION): Week 1 Day 1 (16 mg/kg): Dilution volume: 1000 mL Initial rate (first hour): 50 mL/hr Rate increment: 50 mL/hr every hour Maximum rate: 200 mL/hr OPTION 2 (SPLIT DOSE INFUSION): Week 1 Day 1 (8 mg/kg): Dilution volume: 500 mL Initial rate (first hour): 50 mL/hr Rate increment: 50 mL/hr every hour Maximum rate: 200 mL/hr Week 1 Day 2 (8 mg/kg): Dilution volume: 500 mL Initial rate (first hour): 50 mL/hr Rate increment: 50 mL/hr every hour Maximum rate: 200 mL/hr WEEK 2 (16 mg/kg): Dilution volume: 500 mL Initial rate (first hour): 50 mL/hr Rate increment: 50 mL/hr every hour Maximum rate: 200 mL/hr WEEK 3 ONWARDS (16 MG/KG): Dilution volume: 500 mL Initial rate (first hour): 100 mL/hr Rate increment: 50 mL/hr every hour Maximum rate: 200 mL/hr Consider incremental escalation of the infusion rate only in the absence of infusion reactions. Use a dilution volume of 500 mL for the 16 mg/kg dose only if there were no infusion reactions the previous week; otherwise, continue to use a dilution volume of 1000 mL. Use a modified initial rate (100 mL/hour) for subsequent infusions (i.e., Week 3 onwards) only if there were no infusion reactions during the previous infusion; otherwise, continue to use instructions indicated for the Week 2 infusion rate. PREMEDICATIONS: Premedicate approximately 1 to 3 hours prior to every infusion: 1) Corticosteroid (long- or intermediate-acting); Monotherapy: Methylprednisolone (or equivalent) 100 mg IV; following the second infusion, consider reducing the dose to 60 mg (or equivalent) IV or orally. Combination therapy: Administer 20 mg dexamethasone (or equivalent) IV or orally. When dexamethasone is the background regimen specific corticosteroid, the dexamethasone dose that is part of the background regimen will serve as premedication on daratumumab infusion days. Do not administer background regimen-specific corticosteroids (e.g., prednisone) on daratumumab infusion day. Daratumumab infusion days when patients have received dexamethasone (or equivalent) as a premedication. 2) Antipyretic: Acetaminophen 650 to 1000 mg orally 3) Antihistamine: Diphenhydramine (or equivalent) 25 to 50 mg IV or orally POST-INFUSION MEDICATION: MONOTHERAPY: Administer methylprednisolone 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) orally for 2 days starting the day after the administration of daratumumab. IN COMBINATION: Consider administering oral methylprednisolone at a dose of less than or equal to 20 mg (or an equivalent dose of an intermediate- or long-acting corticosteroid) beginning the day after the administration of daratumumab. If a background regimen-specific corticosteroid (e.g., dexamethasone, prednisone) is administered the day after the daratumumab infusion, additional corticosteroids may not be needed. For patients with a history of chronic obstructive pulmonary disease, consider prescribing short and long-acting bronchodilators and inhaled corticosteroids. Following the first 4 daratumumab infusions, consider discontinuing these additional post-infusion medications if the patient does not experience a major infusion-related reaction. PROPHYLAXIS FOR HERPES ZOSTER REACTIVATION: Initiate antiviral prophylaxis to prevent herpes zoster reactivation within 1 week after starting daratumumab and continue for 3 months after. For dosing instructions of combination agents administered with this drug see the manufacturer product information. In combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for autologous stem cell transplant or with relapsed or refractory multiple myeloma who have received at least 1 prior therapy In combination with bortezomib, melphalan, and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT) In combination with bortezomib, thalidomide, and dexamethasone in newly diagnosed patients who are eligible for autologous stem cell transplant In combination with bortezomib and dexamethasone in patients who have received at least 1 prior therapy In combination with pomalidomide and dexamethasone in patients who have received at least 2 prior therapies including lenalidomide and a proteasome inhibitor As monotherapy, in patients who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent Dose Adjustments No dose reductions of daratumumab are recommended. Consider withholding therapy to allow recovery of blood cell counts in the event of myelosuppression. INFUSION-RELATED REACTIONS (IRRs): For infusion-related reactions (IRRs) of any grade/severity, interrupt the infusion and manage symptoms (this may require further reduction in the rate of infusion or discontinuation of therapy): Grade 1 to 2 (mild to moderate): After symptoms resolve, resume the infusion at no more than half the rate at which the IRR occurred; if the patient experiences no further IRRs, infusion rate escalation may resume at increments up to the maximum rate of 200 mL/hour. Grade 3 (severe): After symptoms resolve, restart the infusion at no more than half the rate at which the IRR occurred; if the patient experiences no further IRRs, resume infusion rate escalation as outlined in the "Manufacturer recommended infusion rates and management of IRRs". Repeat this procedure in the event of recurrence of Grade 3 symptoms. Permanently discontinue therapy upon the third occurrence of Grade 3 or greater IRR. Grade 4 (life-threatening): Permanently discontinue therapy. Administration advice: This drug should be administered by a healthcare professional, with immediate access to emergency equipment and appropriate medical support to manage IRRs. Administer only as an IV infusion after dilution. For dosing instructions of combination agents administered with this drug see the manufacturer product information. If a dose is missed, administer as soon as possible and adjust the dosing schedule accordingly maintaining the treatment interval. Side Effects The Most Common tiredness constipation diarrhea back or joint pain pain in your arms, legs, or chest decreased appetite headache swelling of the hands, ankles, or feet pain, burning, or tingling in the hands or feet muscle spasms difficulty falling asleep or staying asleep bruising or bleeding fever extreme tiredness yellowing of the skin or eyes cough with yellow or green mucus; stabbing chest pain, wheezing, feeling short of breath; numbness, tingling, burning pain; or low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands, and feet, feeling light-headed or short of breath. shortness of breath; nerve problems causing tingling, numbness, or pain; feeling tired or weak; swelling in your hands, ankles, or feet; or cold symptoms such as stuffy nose, sneezing, cough, sore throat. More common Bloating or swelling of the face, arms, hands, lower legs, or feet blurred vision body aches or pain chest pain or tightness chills confusion cough difficulty swallowing dizziness ear congestion facial swelling fast heartbeat fever headache hoarseness loss of voice nausea nervousness pounding in the ears puffiness or swelling of the eyelids or around the eyes, lips, or tongue rapid, shallow breathing skin rash, hives, or itching slow or fast heartbeat sneezing sore throat stuffy or runny nose tingling of the hands or feet trouble breathing unusual tiredness or weakness unusual weight gain or loss vomiting Rare Dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position painful blisters on the trunk of body sweating Black, tarry stools bleeding gums blood in the urine or stools constipation coughing that sometimes produce a pink frothy sputum darkened urine lower back or side pain pains in the stomach, side, or abdomen, possibly radiating to the back painful or difficult urination pale skin pinpoint red spots on the skin swelling in the legs and ankles ulcers, sores, or white spots in the mouth unusual bleeding or bruising yellow eyes or skin Daratumumab injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088). Drug Interactions DRUG INTERACTION Abciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Daratumumab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Daratumumab. Aducanumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Aducanumab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Daratumumab. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Daratumumab. Amivantamab The risk or severity of adverse effects can be increased when Daratumumab is combined with Amivantamab. Anifrolumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Anifrolumab. Ansuvimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Ansuvimab. Anthrax i globulin The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Daratumumab. antilymphocyte The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Daratumumab. An immunoglobulin The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Daratumumab. Articaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Articaine. Asfotase alfa The risk or severity of adverse effects can be increased when Asfotase alfa is combined with Daratumumab. Atezolizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Atezolizumab. Atoltivimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Atoltivimab. Avelumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Avelumab. Bamlanivimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Bamlanivimab. Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Daratumumab. Bebtelovimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Bebtelovimab. Belantamab The risk or severity of adverse effects can be increased when Daratumumab is combined with Belantamab mafodotin. Belimumab The risk or severity of adverse effects can be increased when Belimumab is combined with Daratumumab. Benralizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Benralizumab. Benzocaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Benzocaine. Benzyl alcohol The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Benzyl alcohol. Besilesomab The risk or severity of adverse effects can be increased when Daratumumab is combined with Besilesomab. Bevacizumab The risk or severity of adverse effects can be increased when Bevacizumab is combined with Daratumumab. Bezlotoxumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Bezlotoxumab. Bimekizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Bimekizumab. Blinatumomab The risk or severity of adverse effects can be increased when Blinatumomab is combined with Daratumumab. Brentuximab vedotin The risk or severity of adverse effects can be increased when Brentuximab vedotin is combined with Daratumumab. Brodalumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Brodalumab. Brolucizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Brolucizumab. Bupivacaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Bupivacaine. Burosumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Burosumab. Butacaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Butacaine. Butamben The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Butamben. Canakinumab The risk or severity of adverse effects can be increased when Canakinumab is combined with Daratumumab. Caplacizumab The risk or severity of adverse effects can be increased when Caplacizumab is combined with Daratumumab. Capromab pendetide The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Daratumumab. Capsaicin The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Capsaicin. Casirivimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Casirivimab. Catumaxomab The risk or severity of adverse effects can be increased when Catumaxomab is combined with Daratumumab. Cemiplimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Cemiplimab. Certolizumab pegol The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Daratumumab. Cetuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Daratumumab. Chloroprocaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Chloroprocaine. Cilgavimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Cilgavimab. Cinchocaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Cinchocaine. Cocaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Cocaine. Conjugated estrogens Conjugated estrogens may increase the thrombogenic activities of Daratumumab. Darbepoetin alfa The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Daratumumab. Denosumab The risk or severity of adverse effects can be increased when Denosumab is combined with Daratumumab. Dienestrol Dienestrol may increase the thrombogenic activities of Daratumumab. Diethylstilbestrol Diethylstilbestrol may increase the thrombogenic activities of Daratumumab. Digoxin Immune The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Daratumumab. Dinutuximab The risk or severity of adverse effects can be increased when Dinutuximab is combined with Daratumumab. Diphenhydramine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Diphenhydramine. Dostarlimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Dostarlimab. Dulaglutide The risk or severity of adverse effects can be increased when Dulaglutide is combined with Daratumumab. Dupilumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Dupilumab. Durvalumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Durvalumab. Dyclonine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Dyclonine. Zaire vaccine The therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Daratumumab. Eculizumab The risk or severity of adverse effects can be increased when Eculizumab is combined with Daratumumab. Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Daratumumab. Eflapegrastim The risk or severity of adverse effects can be increased when Daratumumab is combined with Eflapegrastim. Eftrenonacog alfa The risk or severity of adverse effects can be increased when Daratumumab is combined with Eftrenonacog alfa. Elotuzumab The risk or severity of adverse effects can be increased when Elotuzumab is combined with Daratumumab. Emapalumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Emapalumab. Emicizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Emicizumab. Eptinezumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Eptinezumab. Erenumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Erenumab. Erythropoietin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Daratumumab. Esterified estrogens Esterified estrogens may increase the thrombogenic activities of Daratumumab. Estetrol Estetrol may increase the thrombogenic activities of Daratumumab. Estradiol Estradiol may increase the thrombogenic activities of Daratumumab. Estradiol acetate Estradiol acetate may increase the thrombogenic activities of Daratumumab. Estradiol benzoate Estradiol benzoate may increase the thrombogenic activities of Daratumumab. Estradiol cypionate Estradiol cypionate may increase the thrombogenic activities of Daratumumab. Estradiol valerate Estradiol valerate may increase the thrombogenic activities of Daratumumab. Estriol Estriol may increase the thrombogenic activities of Daratumumab. Estrone Estrone may increase the thrombogenic activities of Daratumumab. Estrone sulfate Estrone sulfate may increase the thrombogenic activities of Daratumumab. Ethinylestradiol Ethinylestradiol may increase the thrombogenic activities of Daratumumab. Ethyl chloride The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Ethyl chloride. Etidocaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Etidocaine. Evolocumab The risk or severity of adverse effects can be increased when Evolocumab is combined with Daratumumab. Fanolesomab The risk or severity of adverse effects can be increased when Daratumumab is combined with Fanolesomab. Fremanezumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Fremanezumab. Galcanezumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Galcanezumab. Gemtuzumab ozogamicin The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Daratumumab. Golimumab The risk or severity of adverse effects can be increased when Golimumab is combined with Daratumumab. Guselkumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Guselkumab. Idarucizumab The risk or severity of adverse effects can be increased when Idarucizumab is combined with Daratumumab. Imdevimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Imdevimab. Imlifidase The therapeutic efficacy of Daratumumab can be decreased when used in combination with Imlifidase. Inebilizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Inebilizumab. Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Daratumumab. Inotuzumab ozogamicin The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Daratumumab. Ipilimumab The risk or severity of adverse effects can be increased when Ipilimumab is combined with Daratumumab. Isatuximab The risk or severity of adverse effects can be increased when Daratumumab is combined with Isatuximab. Ixekizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Ixekizumab. Lanadelumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Lanadelumab. Levobupivacaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Levobupivacaine. Lidocaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Lidocaine. Loncastuximab The risk or severity of adverse effects can be increased when Daratumumab is combined with Loncastuximab tesirine. Maftivimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Maftivimab. Margetuximab The risk or severity of adverse effects can be increased when Daratumumab is combined with Margetuximab. Meloxicam The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Meloxicam. Mepivacaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Mepivacaine. Mepolizumab The risk or severity of adverse effects can be increased when Mepolizumab is combined with Daratumumab. Mestranol Mestranol may increase the thrombogenic activities of Daratumumab. Methoxy The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Daratumumab. Mirvetuximab The risk or severity of adverse effects can be increased when Daratumumab is combined with Mirvetuximab Soravtansine. Mogamulizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Mogamulizumab. Mosunetuzumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Mosunetuzumab. Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Daratumumab. Natalizumab The risk or severity of adverse effects can be increased when Natalizumab is combined with Daratumumab. Necitumumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Necitumumab. Nivolumab The risk or severity of adverse effects can be increased when Nivolumab is combined with Daratumumab. Obiltoxaximab The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Daratumumab. Obinutuzumab The risk or severity of adverse effects can be increased when Obinutuzumab is combined with Daratumumab. Ocrelizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Ocrelizumab. Odesivimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Odesivimab. Ofatumumab The risk or severity of adverse effects can be increased when Ofatumumab is combined with Daratumumab. Olaratumab The risk or severity of adverse effects can be increased when Olaratumab is combined with Daratumumab. Omalizumab The risk or severity of adverse effects can be increased when Omalizumab is combined with Daratumumab. Oxetacaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Oxetacaine. Oxybuprocaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Oxybuprocaine. Palivizumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Daratumumab. Panitumumab The risk or severity of adverse effects can be increased when Panitumumab is combined with Daratumumab. Peginesatide The risk or severity of Thrombosis can be increased when Peginesatide is combined with Daratumumab. Pembrolizumab The risk or severity of adverse effects can be increased when Pembrolizumab is combined with Daratumumab. Pertuzumab The risk or severity of adverse effects can be increased when Pertuzumab is combined with Daratumumab. Phenol The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Phenol. Polatuzumab vedotin The risk or severity of adverse effects can be increased when Daratumumab is combined with Polatuzumab vedotin. Polyestradiol phosphate Polyestradiol phosphate may increase the thrombogenic activities of Daratumumab. Pramocaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Pramocaine. Prilocaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Prilocaine. Procaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Procaine. Proparacaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Proparacaine. Propoxycaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Propoxycaine. Quinestrol Quinestrol may increase the thrombogenic activities of Daratumumab. Ramucirumab The risk or severity of adverse effects can be increased when Ramucirumab is combined with Daratumumab. Ranibizumab The risk or severity of adverse effects can be increased when Ranibizumab is combined with Daratumumab. Ravulizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Ravulizumab. Raxibacumab The risk or severity of adverse effects can be increased when Raxibacumab is combined with Daratumumab. Reslizumab The risk or severity of adverse effects can be increased when Reslizumab is combined with Daratumumab. Risankizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Risankizumab. Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Daratumumab. Romosozumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Romosozumab. Ropivacaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Ropivacaine. Sacituzumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Sacituzumab govitecan. Sarilumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Sarilumab. Secukinumab The risk or severity of adverse effects can be increased when Secukinumab is combined with Daratumumab. Siltuximab The risk or severity of adverse effects can be increased when Siltuximab is combined with Daratumumab. Sotrovimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Sotrovimab. Spesolimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Spesolimab. Sulesomab The risk or severity of adverse effects can be increased when Daratumumab is combined with Sulesomab. Sutimlimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Sutimlimab. S Estrogens, A Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Daratumumab. S Estrogens, B Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Daratumumab. Tafasitamab The risk or severity of adverse effects can be increased when Daratumumab is combined with Tafasitamab. Teplizumab The risk or severity of adverse effects can be increased when Teplizumab is combined with Daratumumab. Tetanus immune g The risk or severity of adverse effects can be increased when Daratumumab is combined with Tetanus immune globulin, human. Tetracaine The risk or severity of methemoglobinemia can be increased when Daratumumab is combined with Tetracaine. Tezepelumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Tezepelumab. Tibolone Tibolone may increase the thrombogenic activities of Daratumumab. Tildrakizumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Tildrakizumab. Tisotumab vedotin The risk or severity of adverse effects can be increased when Daratumumab is combined with Tisotumab vedotin. Tixagevimab The risk or severity of adverse effects can be increased when Daratumumab is combined with Tixagevimab. Tocilizumab The risk or severity of adverse effects can be increased when Tocilizumab is combined with Daratumumab. Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Daratumumab. Tralokinumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Tralokinumab. Trastuzumab The risk or severity of adverse effects can be increased when Trastuzumab is combined with Daratumumab. Trastuzumab deruxtecan The risk or severity of adverse effects can be increased when Daratumumab is combined with Trastuzumab deruxtecan. Trastuzumab The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Daratumumab. Tremelimumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Tremelimumab. Ustekinumab The risk or severity of adverse effects can be increased when Ustekinumab is combined with Daratumumab. Vedolizumab The risk or severity of adverse effects can be increased when Vedolizumab is combined with Daratumumab. Pregnancy and Lactation AU TGA pregnancy category: C US FDA pregnancy category: Not assigned Pregnancy Safety has not been established during pregnancy. IgG1 monoclonal antibodies cross the placenta after the first trimester of pregnancy; therefore, this drug should not be used during pregnancy unless the benefit of treatment to the woman is considered to outweigh the potential risks to the fetus. If the patient becomes pregnant while taking this medicine, the patient should be informed of the potential risk to the fetus. Women of reproductive potential should use effective contraception during therapy and for 3 months after cessation of therapy; however, when this drug is used in combination with lenalidomide and dexamethasone, patients should also follow advice about use in pregnancy of those products. Administration of live vaccines to neonates and infants exposed to this drug in utero should be deferred until a hematology evaluation is completed. Lactation The effects in the nursing infant are unknown. Human IgG is known to be present in human milk. Data suggest antibodies in breast milk do not enter the neonatal and infant circulations in substantial amounts. No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract. Until more data become available, this drug should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant. How should this medicine be used?

Daratumumab comes as a liquid (solution) that is given intravenously (into a vein) by a doctor or nurse in a healthcare setting. Your doctor will decide how often you are to receive daratumumab based on other medications that may be given and your body's response to this medication. A doctor or nurse will watch you closely while you are receiving the infusion and afterward to be sure you are not having a serious reaction to the medication. You will be…

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Foodborne Illness (also foodborne disease and colloquially referred to as food poisoning)[rx] is any illness resulting from the spoilage of contaminated food, pathogenic bacteria, viruses, or parasites that…