Doxorubicin Hydrochloride – Uses, Dosage, Side Effects, Interaction

Indications

  • Doxorubicin is used to produce regression in disseminated neoplastic conditions like acute lymphoblastic leukemia, acute myeloblastic leukemia, Wilms’ tumor, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, ovarian carcinoma, transitional cell bladder carcinoma, thyroid carcinoma, gastric carcinoma, Hodgkin’s disease, malignant lymphoma and bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types. Doxorubicin is also indicated for use as a component of adjuvant therapy in women with evidence of axillary lymph node involvement following resection of primary breast cancer.
  • Myocet liposomal, in combination with cyclophosphamide, is indicated for the first-line treatment of metastatic breast cancer in adult women.
  • Caelyx pegylated liposomal is indicated:as monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk;for treatment of advanced ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen;in combination with bortezomib for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant;for treatment of AIDS-related Kaposi’s sarcoma (KS) in patients with low CD4 counts (
  • Treatment of breast and ovarian cancer.
  • Treatment of hepatocellular carcinoma
  • Zolsketil pegylated liposomal is a medicine used to treat the following types of cancer in adults:, , • breast cancer that has spread to other parts of the body in patients at risk of heart problems. Zolsketil pegylated liposomal is used on its own for this disease;, , • advanced ovarian cancer in women whose previous treatment including a platinum-based cancer medicine has stopped working;, , • multiple myeloma (a cancer of the white blood cells in the bone marrow), in patients with progressive disease who have received at least one other treatment in the past and have already had, or are unsuitable for, a bone marrow transplantation. Zolsketil pegylated liposomal is used in combination with bortezomib (another cancer medicine);, , • Kaposi’s sarcoma in patients with AIDS who have a very damaged immune system. Kaposi’s sarcoma is a cancer that causes abnormal tissue to grow under the skin, on moist body surfaces or on internal organs., , Zolsketil pegylated liposomal contains the active substance doxorubicin and is a ‘hybrid medicine’. This means that it is similar to a ‘reference medicine’ containing the same active substance called Adriamycin. However, in Zolsketil pegylated liposomal the active substance is enclosed in tiny fatty spheres called liposomes, whereas this is not the case for Adriamycin.,

Use in Cancer

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

  • Acute lymphoblastic leukemia (ALL).
  • Acute myeloid leukemia (AML).
  • Breast cancer. It is used:
    • After surgery to remove the primary tumor in women whose cancer has spread to the lymph nodes under the arm. It is used with other drugs.
    • In patients with metastatic breast cancer.
  • Gastric (stomach) cancer that is metastatic.
  • Hodgkin lymphoma.
  • Neuroblastoma is metastatic.
  • Non-Hodgkin lymphoma.
  • Non-small cell lung cancer that is metastatic.
  • Ovarian cancer that is metastatic.
  • Small cell lung cancer that is metastatic.
  • Soft tissue and bone sarcomas that are metastatic.
  • Thyroid cancer that is metastatic.
  • Transitional cell bladder cancer that is metastatic.
  • Wilms tumor that is metastatic.

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

Doxorubicin hydrochloride is also available in a different form called doxorubicin hydrochloride liposome.

FDA Approved Yes
Dru Use Doxorubicin hydrochloride is approved to be used alone or with other drugsto treat:

• Acute lymphoblastic leukemia(ALL).

• Acute myeloid leukemia(AML).

• Breast cancer.It is used:

• After surgeryto remove the primary tumorin women whose cancer has spread to the lymph nodesunder the arm. It is used with other drugs.

• In patients with metastaticbreast cancer.

• Gastric (stomach) cancerthat is metastatic.

• Hodgkin lymphoma.

• Neuroblastomathat is metastatic.

• Non-Hodgkin lymphoma.

• Non-small cell lung cancerthat is metastatic.

• Ovarian cancerthat is metastatic.

• Small cell lung cancerthat is metastatic.

• Soft tissueand bone sarcomasthat are metastatic.

• Thyroid cancerthat is metastatic.

• Transitional cellbladder cancerthat is metastatic.

• Wilms tumorthat is metastatic.

Doxorubicin hydrochloride is also being studied in the treatment of other types of cancer. Doxorubicin hydrochloride is also available in a different form called doxorubicin hydrochloride liposome.

Contraindications

Doxorubicin Hydrochloride Injection/for Injection is contraindicated in patients with:

  • Severe myocardial insufficiency
  • Recent (occurring within the past 4–6 weeks) myocardial infarction
  • Severe persistent drug-induced myelosuppression
  • Severe hepatic impairment (defined as Child-Pugh Class C or serum bilirubin level greater than 5 mg/dL)
  • Severe hypersensitivity reaction to doxorubicin hydrochloride, including anaphylaxis

Dosage

Strengths: 10 mg; 20 mg; 50 mg; 150 mg; 2 mg/mL; 75 mg; 100 mg

Breast Cancer – Adjuvant

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer-recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

  • 60 mg/m2 IV bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of 4 cycles

Usual Adult Dose for Breast Cancer

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer-recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Neuroblastoma

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer-recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Non-Hodgkin’s Lymphoma

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer-recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Hodgkin’s Disease

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer-recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Ovarian Cancer

NOTE: Several dosage regimens exist for this drug. The information presented here is manufacturer-recommended dosing. Some cancers are more responsive to this drug than others. Always consult institutional protocol.

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Wilms’ Tumor

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Stomach Cancer

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days
  • Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Acute Lymphoblastic Leukemia

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Bladder Cancer

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 day
  • Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Ewing’s Sarcoma

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Acute Myeloblastic Leukemia

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Thyroid Cancer

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Bronchogenic Carcinoma

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days
  • Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Soft Tissue Sarcoma

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days
  • Lifetime cumulative doses above 550 mg/m2 are associated with an increased risk of cardiomyopathy.

Neuroblastoma

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Pediatric Dose for Malignant Disease

  • As a single agent: 60 to 75 mg/m2 IV over 3 to 10 minutes every 21 days
  • In combination with other chemotherapy drugs: 40 to 75 mg/m2 IV every 21 to 28 days

Or

Adult dosing by indication:

Axillary node-positive breast cancer as an adjuvant:

  • 60 mg/m^2 IV once on the first day of a 21-day cycle. Use with cyclophosphamide. Patients should receive 4 cycles.

Leukemia monotherapy:

  • 60 to 75 mg/m^2 IV once on the first day of a 21-day cycle. The maximum cumulative dose is 550 mg/m^2. (ALL or AML)

Leukemia combination therapy:

  • 40 to 75 mg/m^2 IV once on the first day of a 21-day or 29-day cycle. The maximum cumulative dose is 550 mg/m^2. (ALL or AML)

Lymphoma monotherapy:

  • 60 to 75 mg/m^2 IV once on the first day of a 21-day cycle. The maximum cumulative dose is 550 mg/m^2. (Hodgkin and non-Hodgkin lymphoma)

Lymphoma combination therapy:

  • 40 to 75 mg/m^2 IV once on the first day of a 21-day or 29-day cycle. The maximum cumulative dose is 550 mg/m^2. (Hodgkin and non-Hodgkin lymphoma)

Solid tumors, monotherapy:

  • 60 to 75 mg/m^2 IV once on the first day of a 21-day cycle. The maximum cumulative dose is 550 mg/m^2.

Solid tumors, combination therapy:

  • 40 to 75 mg/m^2 IV once on the first day of a 21-day or 29-day cycle. The maximum cumulative dose is 550 mg/m^2.

Side Effects

The Most Common

  • Cardiac – Cardiogenic shock
  • Cutaneous – Skin and nail hyperpigmentation, oncolysis, rash, itching, photosensitivity, urticaria, acral erythema, palmar plantar erythrodysesthesia
  • Gastrointestinal – Nausea, mucositis, stomatitis, necrotizing colitis, typhlitis, gastric erosions, gastrointestinal tract bleeding, hematochezia, esophagitis, anorexia, abdominal pain, dehydration, diarrhea, hyperpigmentation of the oral mucosa
  • Hypersensitivity – Anaphylaxis
  • Laboratory Abnormalities – Increased ALT, increased AST
  • Neurological – Peripheral sensory and motor neuropathy, seizures, coma
  • Ocular – Conjunctivitis, keratitis, lacrimation
  • Vascular – Phlebosclerosis, phlebitis/thrombophlebitis, hot flashes, thromboembolism
  • Other – Malaise/asthenia, fever, chills, weight gain

More Common

  • nausea
  • vomiting
  • sores in the mouth and throat
  • loss of appetite (and weight loss)
  • weight gain
  • stomach pain
  • diarrhea
  • increased thirst
  • unusual tiredness or weakness
  • dizziness
  • hair loss
  • separation of fingernail or toenail from the nail bed
  • itchy, red, watery, or irritated eyes
  • eye pain
  • pain, burning, or tingling in the hands or feet
  • red discoloration of urine (for 1 to 2 days after dose)

Less Common

  • hives
  • skin rash
  • itching
  • difficulty breathing or swallowing
  • seizures

Drugs Interaction

 

Pregnancy and Lactation

Pregnancy

Based on findings in animals and its mechanism of action, Doxorubicin Hydrochloride Injection/for Injection can cause fetal harm when administered to a pregnant woman; avoid the use of Doxorubicin Hydrochloride Injection/for Injection during the 1st trimester. Available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2nd and 3rd trimesters. Doxorubicin hydrochloride was teratogenic and embryotoxic in rats and embryotoxic in rabbits when administered during organogenesis at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2 . Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

Lactation

Doxorubicin was measured in the milk of one lactating patient after therapy with 70 mg/m2 of doxorubicin hydrochloride given as a 15-minute intravenous infusion. The peak milk concentration at 24 hours after treatment was 4.4-fold greater than the corresponding plasma concentration. Doxorubicin was detectable in the milk up to 72 hours. There are no data on the effects of doxorubicin hydrochloride on the breastfed child or the effects on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with Doxorubicin Hydrochloride Injection/for Injection and for 10 days after the final dose.

What special precautions should I follow?

Before receiving a doxorubicin injection,

  • tell your doctor and pharmacist if you are allergic to doxorubicin, daunorubicin (Cerubidine, DaunoXome), epirubicin (Ellence), idarubicin (Idamycin), any other medications, or any of the ingredients in doxorubicin 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. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: certain chemotherapy medications such as cytarabine (DepoCyt), dexrazoxane (Zinecard), mercaptopurine (Purinethol), streptozocin (Zanosar); phenobarbital (Luminal Sodium); or phenytoin (Dilantin). Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Other medications may also interact with doxorubicin, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
  • tell your doctor if you have or have ever had any other medical conditions.
  • you should know that doxorubicin may interfere with the normal menstrual cycle (period) in women and may stop sperm production in men. However, you should not assume that you cannot get pregnant or that you cannot get someone else pregnant. Women who are pregnant or breastfeeding should tell their doctors before they begin receiving this drug. You should not become pregnant or breast-feed while you are receiving doxorubicin injection. If you become pregnant while receiving doxorubicin, call your doctor. Use a reliable method of birth control to prevent pregnancy. Doxorubicin may harm the fetus.
  • do not have any vaccinations without talking to your doctor.

Contraception

Females

Doxorubicin Hydrochloride Injection/for Injection can cause fetal harm when administered to pregnant women . Advise female patients of reproductive potential to use highly effective contraception during treatment with Doxorubicin Hydrochloride Injection/for Injection and for 6 months after treatment. .

Males

Doxorubicin hydrochloride may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. Due to the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with Doxorubicin Hydrochloride Injection/for Injection and for 3 months after treatment. Males with pregnant partners should use condoms during treatment and for at least 10 days after the final dose .Infertility

Females

In females of reproductive potential, Doxorubicin hydrochloride may cause infertility and result in amenorrhea. Premature menopause can occur. Recovery of menses and ovulation is related to age at treatment.

Males

Doxorubicin hydrochloride may result in oligospermia, azoospermia, and permanent loss of fertility. Sperm counts have been reported to return to normal levels in some men. This may occur several years after the end of therapy.

Pediatric Use

Based on postmarketing reports, pediatric patients treated with doxorubicin hydrochloride are at risk for developing late cardiovascular dysfunction. Risk factors include young age at treatment (especially < 5 years), high cumulative doses and receipt of combined modality therapy. Long-term periodic cardiovascular monitoring is recommended for all pediatric patients who have received doxorubicin hydrochloride. Doxorubicin hydrochloride, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure and may also contribute to gonadal impairment, which is usually temporary.

There are no recommended dose adjustments based on age. Doxorubicin clearance was increased in patients aged 2 years to 20 years as compared to adults, while doxorubicin clearance was similar in infants less than 2 years as compared to adults

Geriatric Use

Clinical experience in patients who were 65 years of age and older who received doxorubicin hydrochloride-based chemotherapy regimens for metastatic breast cancer showed no overall differences in safety and effectiveness compared with younger patients.

Hepatic Impairment

The clearance of doxorubicin was reduced in patients with elevated serum total bilirubin levels. Doxorubicin Hydrochloride Injection/for Injection is contraindicated in patients with severe hepatic impairment (defined as Child-Pugh Class C or serum bilirubin levels greater than 5 mg/dL). Reduce the dose of Doxorubicin Hydrochloride Injection/for Injection in patients with serum total bilirubin levels greater than 1.2 mg/dL.

Few cases of overdose have been described.

A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin hydrochloride (300 mg/m2) in one day. He was treated with charcoal filtration, hemopoietic growth factor (G-CSF), proton pump inhibitor and antimicrobial prophylaxis. The patient suffered sinus tachycardia, grade 4 neutropenia and thrombocytopenia for 11 days, severe mucositis and sepsis. The patient recovered completely 26 days after the overdose.

A 17-year-old girl with osteogenic sarcoma received 150 mg of doxorubicin hydrochloride daily for 2 days (intended dose was 50 mg per day for 3 days). The patient developed severe mucositis on days 4–7 after the overdose and chills and pyrexia on day 7. The patient was treated with antibiotics and platelets and recovered 18 days after the overdose.

References

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