Mogamulizumab – Uses, Dosage, Side Effects, Interaction

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Mogamulizumab - Uses, Dosage, Side Effects, Interaction
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Mogamulizumab is a CCR4-targeted immuno-oncology drug. It is intended to deplete CCR4-expressing Treg cells in the tumor microenvironment so as to release Teff cells from Treg-mediated suppression and facilitate tumor cell killing. However, it also targets intratumoral Treg cells that serve other vital immune cell...

For severe symptoms, danger signs, pregnancy, child illness, or sudden worsening, seek urgent medical care.

বাংলা রোগী নোট এখনো যোগ করা হয়নি। পোস্ট এডিটরে “RX Bangla Patient Mode” বক্স থেকে সহজ বাংলা সারাংশ যোগ করুন।

এই তথ্য শিক্ষা ও সচেতনতার জন্য। এটি ডাক্তারি পরীক্ষা, রোগ নির্ণয় বা প্রেসক্রিপশনের বিকল্প নয়।

Article Summary

Mogamulizumab is a CCR4-targeted immuno-oncology drug. It is intended to deplete CCR4-expressing Treg cells in the tumor microenvironment so as to release Teff cells from Treg-mediated suppression and facilitate tumor cell killing. However, it also targets intratumoral Treg cells that serve other vital immune cell functions and can induce serious side effects such as dermatologic toxicity and autoimmune issues. Mogamulizumab is a humanized monoclonal antibody...

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.
Educational health guideWritten for patient understanding and clinical awareness.
Reviewed content workflowUse writer and reviewer profiles for stronger trust.
Emergency safety firstUrgent warning signs are highlighted below.

Seek urgent medical care if you notice

These warning signs are general safety guidance. Local emergency numbers and clinical judgment should always come first.

  • Severe symptoms, breathing difficulty, fainting, confusion, or rapidly worsening illness.
  • New weakness, severe pain, high fever, or symptoms after a serious injury.
  • Any symptom that feels urgent, unusual, or unsafe for the patient.
1

Emergency now

Use emergency care for severe, sudden, rapidly worsening, or life-threatening symptoms.

2

See a doctor

Book a professional medical evaluation if symptoms persist, worsen, recur often, affect daily activities, or occur in a high-risk patient.

3

Learn safely

Use this article to understand possible causes, tests, treatment options, prevention, and questions to ask your clinician.

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Definition

Mogamulizumab is a CCR4-targeted immuno-oncology drug. It is intended to deplete CCR4-expressing Treg cells in the tumor microenvironment so as to release Teff cells from Treg-mediated suppression and facilitate tumor cell killing. However, it also targets intratumoral Treg cells that serve other vital immune cell functions and can induce serious side effects such as dermatologic toxicity and autoimmune issues.

Mogamulizumab is a humanized monoclonal antibody (mAb) directed against CC chemokine receptor 4 (CCR4) for the treatment of Mycosis fungoides (MF) and Sézary Syndrome (SS), the most common subtypes of cutaneous T-cell lymphoma. Cutaneous T-cell lymphomas occur when certain white blood cells, called T cells, become cancerous; these cancers typically affect the skin, causing various types of skin lesions.[rx]

On August 8, 2018, the U.S. Food and Drug Administration (FDA) approved mogamulizumab injection (also known as Poteligeo) for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoid (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.[rx] It was approved for the same indications in Canada in June 2022.[rx]

Mogamulizumab is derived from Kyowa Hakko Kirin’s INTELLIGENT (®) technology, which produces antibodies with enhanced antibody-dependent cell-mediated cytotoxicity (ADCC) activity. Approval in Japan was granted on April 30 2012 by the Japanese Ministry of Health, Labour, and Welfare for patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma.[rx]

Mechanism of action

Mogamulizumab selectively binds to and inhibits the activity of CCR4, which may block CCR4-mediated signal transduction pathways and, so, chemokine-mediated cellular migration and proliferation of T cells, as well as chemokine-mediated angiogenesis. Additionally, this agent may induce antibody-dependent cell-mediated cytotoxicity (ADCC) against CCR4-positive T cells. CCR4, a G-coupled-protein receptor for C-C chemokines such as MIP-1, RANTES, TARC, and MCP-1, is expressed on the surfaces of some types of T cells, endothelial cells, and certain types of neurons. CCR4, also known as CD194, may be overexpressed on adult T-cell lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) cells [rx]. In addition to directly targeting malignant T cells expressing CCR4, mogamulizumab depletes Treg cells, an important therapeutic target in many human cancers because of their role in suppressing host antitumor immunity [rx].

This drug is a CC chemokine receptor 4 (CCR4) antagonist. It is a monoclonal antibody that blocks T-cell proliferation, which leads to malignancy.[rx,rx] CCR4 is a chemokine receptor that is preferentially expressed by Th2 and regulatory T (Treg) cells. In response to its ligands, CCL17 (TARC) and CCL22 (MDC), CCR4 promotes T-cell migration to extranodal sites, including the skin

Indications

  • Mogamulizumab is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoid (MF) or Sézary syndrome (SS) after at least one prior systemic therapy.
  • Mogamulizumab is a monoclonal antibody used to treat relapsed or refractory mycosis fungoides or Sézary syndrome after attempting one other therapy.
  • Refractory Mycosis Fungoides and Sezary Syndrome
  • Relapsed Mycosis Fungoides/Sezary Syndrome

Use in Cancer

Mogamulizumab-kpkc is approved to treat:

Mogamulizumab-kpkc is also being studied in the treatment of other types of cancer.

Contraindications

  • a bad infection
  • infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation of the middle tissue heart muscle
  • a type of infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation of the lung called interstitial pneumonitis
  • infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation of the liver called hepatitis
  • glomerulonephritis, a condition that affects the kidneys
  • muscle infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।" data-rx-term="inflammation" data-rx-definition="Inflammation is the body’s response to injury, infection, or irritation, often causing pain, swelling, heat, or redness. সহজ বাংলা: শরীরের প্রদাহ; ব্যথা, ফোলা বা লালভাব হতে পারে।">inflammation

Dosage

Strengths: kpkc 4 mg/mL

Mycosis Fungoides

  • 1 mg/kg IV over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity
  • Administer premedication with diphenhydramine and acetaminophen for the first infusion.
  • For relapsed or refractory mycosis fungoid’s (MF) or Sezary syndrome (SS) after at least one prior systemic therapy

Dose Adjustments

Dose Modifications for Dermatologic Toxicity:

  • If mild (Grade 1) rash occurs, consider topical corticosteroids.
  • If a moderate or severe (Grade 2 or 3) rash occurs, interrupt therapy and administer at least 2 weeks of topical corticosteroids; if the rash improves to Grade 1 or less, therapy may be resumed.
  • Permanently discontinue therapy for life-threatening (Grade 4) rash or for Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). If SJS or TEN is suspected, discontinue therapy, and do not resume unless SJS or TEN has been excluded and the cutaneous reaction has resolved to Grade 1 or less.

Dose Modifications for Infusion Reactions:

  • If an infusion reaction occurs, administer premedication (i.e., diphenhydramine and acetaminophen) for subsequent infusions.
  • Temporarily interrupt the infusion for mild to severe (Grades 1 to 3) infusion reactions and treat symptoms. Reduce the infusion rate by at least 50% when restarting the infusion after symptoms resolve. If the reaction recurs and is unmanageable, discontinue infusion.
  • Permanently discontinue therapy for a life-threatening (Grade 4) infusion reaction.

Administration advice:

  • Premedicate patients with diphenhydramine and acetaminophen for the first infusion.
  • Administer within 2 days of the scheduled dose; if a dose is missed, administer the next dose as soon as possible and resume the dosing schedule.
  • Do not administer subcutaneously or by rapid IV administration.
  • Administer infusion solution over at least 60 minutes through an IV line containing a sterile, low protein binding, 0.22 micron (or equivalent) in-line filter.
  • Do not mix this drug with other drugs.
  • Do not coadminister other drugs through the same IV line

Reconstitution/preparation techniques:

  • Visually inspect drug product solution for particulate matter and discoloration prior to administration. The solution should be clear to slightly colorless opalescent. Discard the vial if cloudiness, discoloration, or particulates are observed.
  • Calculate the dose (mg/kg) and the number of vials needed to prepare the solution based on patient weight.
  • Aseptically withdraw the required dose into the syringe and transfer it into an IV bag containing 0.9% sodium chloride injection. The final concentration of the diluted solution should be between 0.1 mg/mL to 3 mg/mL.
  • Mix diluted solution by gentle inversion. Do not shake.
  • Discard any unused portion left in the vial.
  • The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags.

Side Effects

The Most Common

  • constipation
  • muscle spasms or pain
  • tiredness or fatigue
  • 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, feet, ankles, or lower legs
  • decreased appetite
  • changes in weight
  • difficulty falling asleep or staying asleep
  • depression
  • dry skin
  • hair loss
  • rash, skin pain, itching, blistering, or peeling
  • painful sores or ulcers in the mouth, nose, throat, or genital area
  • fever, cough, sore throat, chills, flu-like symptoms, or other signs of infection
  • nausea, diarrhea, or stomach pain
  • painful or frequent urination
  • easy bruising or bleeding

More common

  • Black, tarry stools
  • bladder pain
  • bleeding gums
  • blood in the urine or stools
  • cloudy urine
  • blurred vision
  • body aches or pain
  • burning, dry, or itching eyes
  • burning, itching, and pain in hairy areas, pus at the root of the hair
  • burning, numbness, tingling, or painful sensations
  • chest pain
  • chills
  • cough
  • cracked lips
  • decreased frequency or amount of urine
  • diarrhea
  • difficult or labored breathing
  • difficult, burning, or painful urination
  • difficulty in swallowing
  • discharge, excessive tearing
  • dizziness
  • drowsiness
  • dry mouth
  • ear congestion
  • fainting
  • fast, slow, or irregular heartbeat
  • fever
  • flushed, dry skin
  • frequent urge to urinate
  • fruit-like breath odor
  • headache
  • increased hunger
  • increased thirst
  • increased urination
  • itching, skin rash
  • joint pain, stiffness, or swelling
  • loss of appetite
  • loss of voice
  • lower back, side, or stomach pain
  • mood or mental changes
  • muscle and bone pain
  • muscle spasms (tetany) or twitching seizures
  • nasal congestion
  • nausea
  • nervousness
  • pale skin
  • pinpoint red spots on the skin
  • pounding in the ears
  • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
  • runny nose
  • skin blisters
  • sneezing
  • sore throat
  • sores, ulcers, or white spots on the lips, tongue, or inside the mouth
  • stomach pain
  • swelling of the face, fingers, lower legs, or feet
  • tenderness
  • tightness in the chest
  • trembling
  • troubled breathing with exertion
  • unexplained weight loss
  • unsteadiness or awkwardness
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • warmth on skin
  • weakness in the arms, hands, legs, or feet
  • weight gain

Rare

  • Burning or stinging of the skin
  • earache
  • painful cold sores or blisters on the lips, nose, eyes, or genitals
  • redness or swelling in the ear
  • Chest discomfort
  • dilated neck veins
  • extreme tiredness or weakness
  • irregular breathing
  • pain or discomfort in the arms, jaw, back, or neck
  • Dark urine
  • general tiredness and weakness
  • light-colored stools
  • upper right abdominal pain
  • yellow eyes and skin
  • Constipation
  • decreased appetite
  • discouragement
  • falls
  • feeling sad or empty
  • irritability
  • loss of interest or pleasure
  • thinning or loss of hair
  • trouble concentrating
  • trouble sleeping

Drug Interactions

Pregnancy and Lactation

FDA and TGA pregnancy category C

Pregnancy

There are no available data on POTELIGEO use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on AUC (see Data).

In general, IgG molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab-kpkc was detected in fetal plasma. Therefore, POTELIGEO has the potential to be transmitted from the mother to the developing fetus. POTELIGEO is not recommended during pregnancy or in women of childbearing potential not using contraception. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other
adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

Lactation

There is no information regarding the presence of POTELIGEO in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for POTELIGEO and any potential adverse effects on the breastfed child from POTELIGEO or from the underlying maternal condition.

Why is this medication prescribed?

Mogamulizumab-kpkc injection is used to treat mycosis fungoides and Sézary syndrome, two types of cutaneous T-cell lymphoma ([CTCL], a group of cancers of the immune system that first appear as skin rashes), in adults whose disease has not improved, has gotten worse or has come back after taking other medications. Mogamulizumab-kpkc injection is in a class of medications called monoclonal antibodies. It works by activating the immune system to attack cancer cells.

How should this medicine be used?

Mogamulizumab-kpkc injection comes as a solution (liquid) to be injected intravenously (into a vein) over at least 60 minutes by a doctor or nurse in a hospital or medical office. It is usually given once a week for the first four doses, and then once every other week for as long as your treatment continues. The length of treatment depends on how well your body responds to the medication and the side effects that you experience.

You may experience a serious or life-threatening reaction while you receive a dose of mogamulizumab-kpkc injection. These reactions are more common with the first dose of mogamulizumab-kpkc injection but may occur at any time during treatment. Your doctor may tell you to take certain medications before receiving your dose to prevent these reactions. Your doctor will monitor you carefully while you are receiving the medication. If you experience any of the following symptoms during or after your infusion, tell your doctor immediately: chills, shaking, nausea, vomiting, flushing, itching, rash, fast heartbeat, shortness of breath, coughing, wheezing, dizziness, feeling like passing out, tiredness, headache, or fever. If you experience any of these symptoms, your doctor will slow down or stop your infusion and treat the symptoms of the reaction. If your reaction is severe, your healthcare provider may decide not to give you any more infusions of mogamulizumab-kpkc.

Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving mogamulizumab-kpkc injection,

  • tell your doctor and pharmacist if you are allergic (such as a skin reaction or infusion reaction) to mogamulizumab-kpkc, any other medications, or any of the ingredients in mogamulizumab-kpkc injection. Ask your pharmacist 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 have had or plan to have a stem cell transplant using cells from a donor, and if you have or have ever had any type of autoimmune disease, liver disease including Hepatitis B virus infection, or any type of lung or breathing problems.
  • tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you are able to become pregnant, your doctor will do a pregnancy test before you start treatment with mogamulizumab-kpkc injection. You should use birth control to prevent pregnancy during your treatment with mogamulizumab-kpkc injection and for at least 3 months after your last dose of medication. Talk to your doctor about methods of birth control that will work for you. If you become pregnant while receiving mogamulizumab-kpkc injection, call your doctor.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving mogamulizumab-kpkc injection.

Doctor visit helper

Prepare before seeing a doctor

A simple rural-patient checklist to help you explain symptoms clearly, ask better questions, and avoid unsafe self-treatment.

Safety note: This is not a prescription or diagnosis. For severe symptoms, pregnancy danger signs, children with serious illness, chest pain, breathing difficulty, stroke-like weakness, or major injury, seek urgent care.

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.

For rural patients and family caregivers

Patient health record and symptom diary

Write your symptoms, medicines already taken, test results, and questions before visiting a doctor. This note stays on your device unless you print or copy it.

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: Mogamulizumab – 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 Mogamulizumab selectively binds to and inhibits the activity of CCR4, which may block CCR4-mediated signal transduction pathways and, so, chemokine-mediated cellular migration and proliferation of T cells, as well as chemokine-mediated angiogenesis. Additionally, this agent may induce antibody-dependent cell-mediated cytotoxicity (ADCC) against CCR4-positive T cells. CCR4, a G-coupled-protein receptor for C-C chemokines such as MIP-1, RANTES, TARC, and MCP-1, is expressed on the surfaces of some types of T cells, endothelial cells, and certain types of neurons. CCR4, also known as CD194, may be overexpressed on adult T-cell lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) cells [rx]. In addition to directly targeting malignant T cells expressing CCR4, mogamulizumab depletes Treg cells, an important therapeutic target in many human cancers because of their role in suppressing host antitumor immunity [rx]. This drug is a CC chemokine receptor 4 (CCR4) antagonist. It is a monoclonal antibody that blocks T-cell proliferation, which leads to malignancy.[rx,rx] CCR4 is a chemokine receptor that is preferentially expressed by Th2 and regulatory T (Treg) cells. In response to its ligands, CCL17 (TARC) and CCL22 (MDC), CCR4 promotes T-cell migration to extranodal sites, including the skin Indications Mogamulizumab is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoid (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. Mogamulizumab is a monoclonal antibody used to treat relapsed or refractory mycosis fungoides or Sézary syndrome after attempting one other therapy. Refractory Mycosis Fungoides and Sezary Syndrome Relapsed Mycosis Fungoides/Sezary Syndrome Use in Cancer Mogamulizumab-kpkc is approved to treat: Mycosis fungoides or Sezary syndrome (types of cutaneous T-cell lymphoma). It is used to treat the disease that has relapsed (come back) or is refractory (does not respond to treatment) in adult patients who have received at least one other type of systemic therapy. Mogamulizumab-kpkc is also being studied in the treatment of other types of cancer. Contraindications a bad infection inflammation of the middle tissue heart muscle a type of inflammation of the lung called interstitial pneumonitis inflammation of the liver called hepatitis glomerulonephritis, a condition that affects the kidneys muscle inflammation Dosage Strengths: kpkc 4 mg/mL Mycosis Fungoides 1 mg/kg IV over at least 60 minutes on days 1, 8, 15, and 22 of the first 28-day cycle, then on days 1 and 15 of each subsequent 28-day cycle until disease progression or unacceptable toxicity Administer premedication with diphenhydramine and acetaminophen for the first infusion. For relapsed or refractory mycosis fungoid's (MF) or Sezary syndrome (SS) after at least one prior systemic therapy Dose Adjustments Dose Modifications for Dermatologic Toxicity: If mild (Grade 1) rash occurs, consider topical corticosteroids. If a moderate or severe (Grade 2 or 3) rash occurs, interrupt therapy and administer at least 2 weeks of topical corticosteroids; if the rash improves to Grade 1 or less, therapy may be resumed. Permanently discontinue therapy for life-threatening (Grade 4) rash or for Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis (TEN). If SJS or TEN is suspected, discontinue therapy, and do not resume unless SJS or TEN has been excluded and the cutaneous reaction has resolved to Grade 1 or less. Dose Modifications for Infusion Reactions: If an infusion reaction occurs, administer premedication (i.e., diphenhydramine and acetaminophen) for subsequent infusions. Temporarily interrupt the infusion for mild to severe (Grades 1 to 3) infusion reactions and treat symptoms. Reduce the infusion rate by at least 50% when restarting the infusion after symptoms resolve. If the reaction recurs and is unmanageable, discontinue infusion. Permanently discontinue therapy for a life-threatening (Grade 4) infusion reaction. Administration advice: Premedicate patients with diphenhydramine and acetaminophen for the first infusion. Administer within 2 days of the scheduled dose; if a dose is missed, administer the next dose as soon as possible and resume the dosing schedule. Do not administer subcutaneously or by rapid IV administration. Administer infusion solution over at least 60 minutes through an IV line containing a sterile, low protein binding, 0.22 micron (or equivalent) in-line filter. Do not mix this drug with other drugs. Do not coadminister other drugs through the same IV line Reconstitution/preparation techniques: Visually inspect drug product solution for particulate matter and discoloration prior to administration. The solution should be clear to slightly colorless opalescent. Discard the vial if cloudiness, discoloration, or particulates are observed. Calculate the dose (mg/kg) and the number of vials needed to prepare the solution based on patient weight. Aseptically withdraw the required dose into the syringe and transfer it into an IV bag containing 0.9% sodium chloride injection. The final concentration of the diluted solution should be between 0.1 mg/mL to 3 mg/mL. Mix diluted solution by gentle inversion. Do not shake. Discard any unused portion left in the vial. The diluted solution is compatible with polyvinyl chloride (PVC) or polyolefin (PO) infusion bags. Side Effects The Most Common constipation muscle spasms or pain tiredness or fatigue headache swelling of the hands, feet, ankles, or lower legs decreased appetite changes in weight difficulty falling asleep or staying asleep depression dry skin hair loss rash, skin pain, itching, blistering, or peeling painful sores or ulcers in the mouth, nose, throat, or genital area fever, cough, sore throat, chills, flu-like symptoms, or other signs of infection nausea, diarrhea, or stomach pain painful or frequent urination easy bruising or bleeding More common Black, tarry stools bladder pain bleeding gums blood in the urine or stools cloudy urine blurred vision body aches or pain burning, dry, or itching eyes burning, itching, and pain in hairy areas, pus at the root of the hair burning, numbness, tingling, or painful sensations chest pain chills cough cracked lips decreased frequency or amount of urine diarrhea difficult or labored breathing difficult, burning, or painful urination difficulty in swallowing discharge, excessive tearing dizziness drowsiness dry mouth ear congestion fainting fast, slow, or irregular heartbeat fever flushed, dry skin frequent urge to urinate fruit-like breath odor headache increased hunger increased thirst increased urination itching, skin rash joint pain, stiffness, or swelling loss of appetite loss of voice lower back, side, or stomach pain mood or mental changes muscle and bone pain muscle spasms (tetany) or twitching seizures nasal congestion nausea nervousness pale skin pinpoint red spots on the skin pounding in the ears redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid runny nose skin blisters sneezing sore throat sores, ulcers, or white spots on the lips, tongue, or inside the mouth stomach pain swelling of the face, fingers, lower legs, or feet tenderness tightness in the chest trembling troubled breathing with exertion unexplained weight loss unsteadiness or awkwardness unusual bleeding or bruising unusual tiredness or weakness vomiting warmth on skin weakness in the arms, hands, legs, or feet weight gain Rare Burning or stinging of the skin earache painful cold sores or blisters on the lips, nose, eyes, or genitals redness or swelling in the ear Chest discomfort dilated neck veins extreme tiredness or weakness irregular breathing pain or discomfort in the arms, jaw, back, or neck Dark urine general tiredness and weakness light-colored stools upper right abdominal pain yellow eyes and skin Constipation decreased appetite discouragement falls feeling sad or empty irritability loss of interest or pleasure thinning or loss of hair trouble concentrating trouble sleeping Drug Interactions DRUG INTERACTION Abciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Mogamulizumab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Mogamulizumab. Aducanumab The risk or severity of adverse effects can be increased when Aducanumab is combined with Mogamulizumab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Mogamulizumab. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Mogamulizumab. Ambroxol The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Ambroxol. Amivantamab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Amivantamab. Anifrolumab The risk or severity of adverse effects can be increased when Anifrolumab is combined with Mogamulizumab. Ansuvimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Ansuvimab. Anthrax immune The risk or severity of adverse effects can be increased when Anthrax immune globulin human is combined with Mogamulizumab. Antilymphocyte immun The risk or severity of adverse effects can be increased when Antilymphocyte immunoglobulin (horse) is combined with Mogamulizumab. Antithymocyte immun The risk or severity of adverse effects can be increased when Antithymocyte immunoglobulin (rabbit) is combined with Mogamulizumab. Articaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Articaine. Asfotase alfa The risk or severity of adverse effects can be increased when Asfotase alfa is combined with Mogamulizumab. Atezolizumab The risk or severity of adverse effects can be increased when Atezolizumab is combined with Mogamulizumab. Atoltivimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Atoltivimab. Avelumab The risk or severity of adverse effects can be increased when Avelumab is combined with Mogamulizumab. Bamlanivimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Bamlanivimab. Basiliximab The risk or severity of adverse effects can be increased when Basiliximab is combined with Mogamulizumab. Belantamab mafodotin The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Belantamab mafodotin. Belimumab The risk or severity of adverse effects can be increased when Belimumab is combined with Mogamulizumab. Benralizumab The risk or severity of adverse effects can be increased when Benralizumab is combined with Mogamulizumab. Benzocaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Benzocaine. Benzyl alcohol The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Benzyl alcohol. Besilesomab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Besilesomab. Bevacizumab The risk or severity of adverse effects can be increased when Bevacizumab is combined with Mogamulizumab. Bezlotoxumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Bezlotoxumab. Bimekizumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Bimekizumab. Blinatumomab The risk or severity of adverse effects can be increased when Blinatumomab is combined with Mogamulizumab. Brentuximab vedotin The risk or severity of adverse effects can be increased when Brentuximab vedotin is combined with Mogamulizumab. Brodalumab The risk or severity of adverse effects can be increased when Brodalumab is combined with Mogamulizumab. Brolucizumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Brolucizumab. Bupivacaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Bupivacaine. Burosumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Burosumab. Butacaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Butacaine. Butamben The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Butamben. Canakinumab The risk or severity of adverse effects can be increased when Canakinumab is combined with Mogamulizumab. Caplacizumab The risk or severity of adverse effects can be increased when Caplacizumab is combined with Mogamulizumab. Capromab pendetide The risk or severity of adverse effects can be increased when Capromab pendetide is combined with Mogamulizumab. Capsaicin The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Capsaicin. Casirivimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Casirivimab. Catumaxomab The risk or severity of adverse effects can be increased when Catumaxomab is combined with Mogamulizumab. Cemiplimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Cemiplimab. Certolizumab pegol The risk or severity of adverse effects can be increased when Certolizumab pegol is combined with Mogamulizumab. Cetuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Mogamulizumab. Chloroprocaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Chloroprocaine. Cilgavimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Cilgavimab. Cinchocaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Cinchocaine. Cocaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Cocaine. Conjugated estrogens Conjugated estrogens may increase the thrombogenic activities of Mogamulizumab. Daratumumab The risk or severity of adverse effects can be increased when Daratumumab is combined with Mogamulizumab. Darbepoetin alfa The risk or severity of Thrombosis can be increased when Darbepoetin alfa is combined with Mogamulizumab. Denosumab The risk or severity of adverse effects can be increased when Denosumab is combined with Mogamulizumab. Dienestrol Dienestrol may increase the thrombogenic activities of Mogamulizumab. Diethylstilbestrol Diethylstilbestrol may increase the thrombogenic activities of Mogamulizumab. Digoxin Immune Fab The risk or severity of adverse effects can be increased when Digoxin Immune Fab (Ovine) is combined with Mogamulizumab. Dinutuximab The risk or severity of adverse effects can be increased when Dinutuximab is combined with Mogamulizumab. Diphenhydramine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Diphenhydramine. Dostarlimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Dostarlimab. Dulaglutide The risk or severity of adverse effects can be increased when Dulaglutide is combined with Mogamulizumab. Dupilumab The risk or severity of adverse effects can be increased when Dupilumab is combined with Mogamulizumab. Durvalumab The risk or severity of adverse effects can be increased when Durvalumab is combined with Mogamulizumab. Dyclonine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Dyclonine. Ebola Zaire vaccine The therapeutic efficacy of Ebola Zaire vaccine (live, attenuated) can be decreased when used in combination with Mogamulizumab. Eculizumab The risk or severity of adverse effects can be increased when Eculizumab is combined with Mogamulizumab. Efalizumab The risk or severity of adverse effects can be increased when Efalizumab is combined with Mogamulizumab. Eflapegrastim The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Eflapegrastim. Eftrenonacog alfa The risk or severity of adverse effects can be increased when Eftrenonacog alfa is combined with Mogamulizumab. Elotuzumab The risk or severity of adverse effects can be increased when Elotuzumab is combined with Mogamulizumab. Emapalumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Emapalumab. Emicizumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Emicizumab. Eptinezumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Eptinezumab. Erenumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Erenumab. Erythropoietin The risk or severity of Thrombosis can be increased when Erythropoietin is combined with Mogamulizumab. Esterified estrogens Esterified estrogens may increase the thrombogenic activities of Mogamulizumab. Estetrol Estetrol may increase the thrombogenic activities of Mogamulizumab. Estradiol Estradiol may increase the thrombogenic activities of Mogamulizumab. Estradiol acetate Estradiol acetate may increase the thrombogenic activities of Mogamulizumab. Estradiol benzoate Estradiol benzoate may increase the thrombogenic activities of Mogamulizumab. Estradiol cypionate Estradiol cypionate may increase the thrombogenic activities of Mogamulizumab. Estradiol valerate Estradiol valerate may increase the thrombogenic activities of Mogamulizumab. Estriol Estriol may increase the thrombogenic activities of Mogamulizumab. Estrone Estrone may increase the thrombogenic activities of Mogamulizumab. Estrone sulfate Estrone sulfate may increase the thrombogenic activities of Mogamulizumab. Ethinylestradiol Ethinylestradiol may increase the thrombogenic activities of Mogamulizumab. Ethyl chloride The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Ethyl chloride. Etidocaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Etidocaine. Evolocumab The risk or severity of adverse effects can be increased when Evolocumab is combined with Mogamulizumab. Fanolesomab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Fanolesomab. Fremanezumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Fremanezumab. Galcanezumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Galcanezumab. Gemtuzumab The risk or severity of adverse effects can be increased when Gemtuzumab ozogamicin is combined with Mogamulizumab. Glofitamab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Glofitamab. Golimumab The risk or severity of adverse effects can be increased when Golimumab is combined with Mogamulizumab. Guselkumab The risk or severity of adverse effects can be increased when Guselkumab is combined with Mogamulizumab. Hepatitis B immune The risk or severity of adverse effects can be increased when Hepatitis B immune globulin is combined with Mogamulizumab. Human cytomegalovirus The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Human cytomegalovirus immune globulin. Human immunoglobulin G The risk or severity of adverse effects can be increased when Human immunoglobulin G is combined with Mogamulizumab. Human Rho(D) The risk or severity of adverse effects can be increased when Human Rho(D) immune globulin is combined with Mogamulizumab. Human varicella-zoster The risk or severity of adverse effects can be increased when Human varicella-zoster immune globulin is combined with Mogamulizumab. Ibalizumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Ibalizumab. Ibritumomab tiuxetan The risk or severity of adverse effects can be increased when Ibritumomab tiuxetan is combined with Mogamulizumab. Idarucizumab The risk or severity of adverse effects can be increased when Idarucizumab is combined with Mogamulizumab. Imdevimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Imdevimab. Imlifidase The therapeutic efficacy of Mogamulizumab can be decreased when used in combination with Imlifidase. Inebilizumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Inebilizumab. Infliximab The risk or severity of adverse effects can be increased when Infliximab is combined with Mogamulizumab. Inotuzumab ozo The risk or severity of adverse effects can be increased when Inotuzumab ozogamicin is combined with Mogamulizumab. Ipilimumab The risk or severity of adverse effects can be increased when Ipilimumab is combined with Mogamulizumab. Isatuximab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Isatuximab. Ixekizumab The risk or severity of adverse effects can be increased when Ixekizumab is combined with Mogamulizumab. Lanadelumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Lanadelumab. Lecanemab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Lecanemab. Levobupivacaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Levobupivacaine. Lidocaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Lidocaine. Loncastuximab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Loncastuximab tesirine. Maftivimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Maftivimab. Margetuximab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Margetuximab. Meloxicam The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Meloxicam. Mepivacaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Mepivacaine. Mepolizumab The risk or severity of adverse effects can be increased when Mepolizumab is combined with Mogamulizumab. Mestranol Mestranol may increase the thrombogenic activities of Mogamulizumab. Methoxy epoetin beta The risk or severity of Thrombosis can be increased when Methoxy polyethylene glycol-epoetin beta is combined with Mogamulizumab. Mirvetuximab soravtansine The risk or severity of adverse effects can be increased when Mirvetuximab Soravtansine is combined with Mogamulizumab. Mosunetuzumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Mosunetuzumab. Muromonab The risk or severity of adverse effects can be increased when Muromonab is combined with Mogamulizumab. Natalizumab The risk or severity of adverse effects can be increased when Natalizumab is combined with Mogamulizumab. Necitumumab The risk or severity of adverse effects can be increased when Necitumumab is combined with Mogamulizumab. Nivolumab The risk or severity of adverse effects can be increased when Nivolumab is combined with Mogamulizumab. Obiltoxaximab The risk or severity of adverse effects can be increased when Obiltoxaximab is combined with Mogamulizumab. Obinutuzumab The risk or severity of adverse effects can be increased when Obinutuzumab is combined with Mogamulizumab. Ocrelizumab The risk or severity of adverse effects can be increased when Ocrelizumab is combined with Mogamulizumab. Odesivimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Odesivimab. Ofatumumab The risk or severity of adverse effects can be increased when Ofatumumab is combined with Mogamulizumab. Olaratumab The risk or severity of adverse effects can be increased when Olaratumab is combined with Mogamulizumab. Omalizumab The risk or severity of adverse effects can be increased when Omalizumab is combined with Mogamulizumab. Oxetacaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Oxetacaine. Oxybuprocaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Oxybuprocaine. Palivizumab The risk or severity of adverse effects can be increased when Palivizumab is combined with Mogamulizumab. Panitumumab The risk or severity of adverse effects can be increased when Panitumumab is combined with Mogamulizumab. Peginesatide The risk or severity of Thrombosis can be increased when Peginesatide is combined with Mogamulizumab. Pembrolizumab The risk or severity of adverse effects can be increased when Pembrolizumab is combined with Mogamulizumab. Pertuzumab The risk or severity of adverse effects can be increased when Pertuzumab is combined with Mogamulizumab. Phenol The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Phenol. Polatuzumab vedotin The risk or severity of adverse effects can be increased when Polatuzumab vedotin is combined with Mogamulizumab. Polyestradiol phosphate Polyestradiol phosphate may increase the thrombogenic activities of Mogamulizumab. Pramocaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Pramocaine. Prilocaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Prilocaine. Procaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Procaine. Proparacaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Proparacaine. Propoxycaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Propoxycaine. Quinestrol Quinestrol may increase the thrombogenic activities of Mogamulizumab. Ramucirumab The risk or severity of adverse effects can be increased when Ramucirumab is combined with Mogamulizumab. Ranibizumab The risk or severity of adverse effects can be increased when Ranibizumab is combined with Mogamulizumab. Ravulizumab The risk or severity of adverse effects can be increased when Ravulizumab is combined with Mogamulizumab. Raxibacumab The risk or severity of adverse effects can be increased when Raxibacumab is combined with Mogamulizumab. Relatlimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Relatlimab. Reslizumab The risk or severity of adverse effects can be increased when Reslizumab is combined with Mogamulizumab. Risankizumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Risankizumab. Rituximab The risk or severity of adverse effects can be increased when Rituximab is combined with Mogamulizumab. Romosozumab The risk or severity of adverse effects can be increased when Romosozumab is combined with Mogamulizumab. Ropivacaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Ropivacaine. Sacituzumab govitecan The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Sacituzumab govitecan. Sarilumab The risk or severity of adverse effects can be increased when Sarilumab is combined with Mogamulizumab. Secukinumab The risk or severity of adverse effects can be increased when Secukinumab is combined with Mogamulizumab. Siltuximab The risk or severity of adverse effects can be increased when Siltuximab is combined with Mogamulizumab. Sotrovimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Sotrovimab. Spesolimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Spesolimab. Sulesomab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Sulesomab. Sutimlimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Sutimlimab. Synthetic Estrogens, A Synthetic Conjugated Estrogens, A may increase the thrombogenic activities of Mogamulizumab. Synthetic Estrogens, B Synthetic Conjugated Estrogens, B may increase the thrombogenic activities of Mogamulizumab. Tafasitamab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tafasitamab. Teplizumab The risk or severity of adverse effects can be increased when Teplizumab is combined with Mogamulizumab. Tetanus immune globulin The risk or severity of adverse effects can be increased when Tetanus immune globulin, human is combined with Mogamulizumab. Tetracaine The risk or severity of methemoglobinemia can be increased when Mogamulizumab is combined with Tetracaine. Tezepelumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tezepelumab. Tibolone Tibolone may increase the thrombogenic activities of Mogamulizumab. Tildrakizumab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tildrakizumab. Tisotumab vedotin The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tisotumab vedotin. Tixagevimab The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Tixagevimab. Tocilizumab The risk or severity of adverse effects can be increased when Tocilizumab is combined with Mogamulizumab. Tositumomab The risk or severity of adverse effects can be increased when Tositumomab is combined with Mogamulizumab. Tralokinumab The risk or severity of adverse effects can be increased when Tralokinumab is combined with Mogamulizumab. Trastuzumab The risk or severity of adverse effects can be increased when Trastuzumab is combined with Mogamulizumab. Trastuzumab deruxtecan The risk or severity of adverse effects can be increased when Mogamulizumab is combined with Trastuzumab deruxtecan. Trastuzumab emtansine The risk or severity of adverse effects can be increased when Trastuzumab emtansine is combined with Mogamulizumab. Tremelimumab The risk or severity of adverse effects can be increased when Tremelimumab is combined with Mogamulizumab. Ublituximab The risk or severity of adverse effects can be increased when Ublituximab is combined with Mogamulizumab. Ustekinumab The risk or severity of adverse effects can be increased when Ustekinumab is combined with Mogamulizumab. Vedolizumab The risk or severity of adverse effects can be increased when Vedolizumab is combined with Mogamulizumab. Pregnancy and Lactation FDA and TGA pregnancy category C Pregnancy There are no available data on POTELIGEO use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. In an animal reproduction study, administration of mogamulizumab-kpkc to pregnant cynomolgus monkeys from the start of organogenesis through delivery did not show potential for adverse developmental outcomes at maternal systemic exposures 27 times the exposure in patients at the recommended dose, based on AUC (see Data). In general, IgG molecules are known to cross the placental barrier and in the monkey reproduction study mogamulizumab-kpkc was detected in fetal plasma. Therefore, POTELIGEO has the potential to be transmitted from the mother to the developing fetus. POTELIGEO is not recommended during pregnancy or in women of childbearing potential not using contraception. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. Lactation There is no information regarding the presence of POTELIGEO in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for POTELIGEO and any potential adverse effects on the breastfed child from POTELIGEO or from the underlying maternal condition. Why is this medication prescribed?

Mogamulizumab-kpkc injection is used to treat mycosis fungoides and Sézary syndrome, two types of cutaneous T-cell lymphoma (, a group of cancers of the immune system that first appear as skin rashes), in adults whose disease has not improved, has gotten worse or has come back after taking other medications. Mogamulizumab-kpkc injection is in a class of medications called monoclonal antibodies. It works by activating the immune system to attack cancer cells.

How should this medicine be used?

Mogamulizumab-kpkc injection comes as a solution (liquid) to be injected intravenously (into a vein) over at least 60 minutes by a doctor or nurse in a hospital or medical office. It is usually given once a week for the first four doses, and then once every other week for as long as your treatment continues. The length of treatment depends on how well your body responds to the medication and the side effects that you experience. You may experience a…

References

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