Doxorubicin Hydrochloride

What is Doxorubicin hydrochloride?

• Doxorubicin hydrochloride (Adriamycin) is an anthracycline topoisomerase inhibitor used is a chemotherapy medication used to treat cancer.

Doxorubicin

Doxorubicin mechanism

Doxorubicin-3D

What are the uses of this medicine?

Doxorubicin hydrochloride (Adriamycin) is 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 that 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.

How does this medicine work?

• Doxorubicin hydrochloride comes from the bacterium Streptomyces peucetius.
• Doxorubicin (dox” oh roo’ bi sin), epirubicin (ep” i roo’ bi sin), idarubicin (eye” da roo’ bi sin) and valrubicin (val roo' bi sin) are cytotoxic, anthracycline antibiotics which are believed to act by intercalating between DNA base pairs and uncoiling the DNA helix, which results in inhibition of DNA synthesis and the normal DNA breaking and resealing action of DNA toposiomerase II.
• These actions lead to apoptosis of rapidly dividing cells.
• These four agents are all semisynthetic derivatives of daunorubicin and share activities and toxicities.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• you have had a recent heart attack (within the past 4 to 6 weeks) or have severe heart problems.
• your blood cell counts (platelets, red blood cells, and white blood cells) are very low because of prior chemotherapy.
• you have severe liver problems.
• you have had a severe allergic reaction to Doxorubicin.

What drug interactions can this medicine cause?

• Avoid concomitant use of doxorubicin hydrochloride with inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp.
• Do not administer doxorubicin hydrochloride in combination with trastuzumab due to increased risk of cardiac dysfunction.

Is this medicine FDA approved?

• Doxorubicin was approved for use in the United States in 1974, and it remains an important agent in many cancer chemotherapeutic regimens.

How should this medicine be used?

Recommended dosage: Recommended Dosage for Adjuvant Breast Cancer:

• The recommended dosage of Doxorubicin Hydrochloride Injection/for Injection is 60 mg/m2 administered as an intravenous bolus on day 1 of each 21-day treatment cycle, in combination with cyclophosphamide, for a total of four cycles.

Recommended Dosage for Other Cancers:

• The recommended dosage of Doxorubicin Hydrochloride Injection/for Injection when used as a single agent is 60 mg/m2 to 75 mg/m2 intravenously every 21 days.
• The recommended dosage of Doxorubicin Hydrochloride Injection/for Injection, when administered in combination with other chemotherapy drugs, is 40 mg/m2 to 75 mg/m2 intravenously every 21 to 28 days.

• Discontinue Doxorubicin Hydrochloride Injection/for Injection in patients who develop signs or symptoms of cardiomyopathy.
• Reduce dose in patients with hepatic impairment.

Administration:

• Doxorubicin will be given to you into your vein through an intravenous (IV) line.
• Your healthcare provider will do blood tests to check for side effects during treatment with Doxorubicin.
• Your healthcare provider may stop your treatment, change the timing of your treatment, or change the dose of your treatment if you have certain side effects while receiving Doxorubicin.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: As Injection:

• 10 mg/5 mL, 20 mg/10 mL, 50 mg/25 mL in single-dose vial
• 150 mg/75 mL, and 200 mg/100 mL in multiple-dose vial
• Liposomal formulations are also available.

This medicine is available in fallowing brand namesː

• Adriamycin

What side effects can this medication cause?

The most common side effects of this medicine include:

• total hair loss (alopecia). Your hair may re-grow after your treatment.
• nausea
• vomiting

Other side effects:

• Red colored urine
• fertility problems in males
• fertility problems in females

Doxorubicin may cause serious side effects, including:

• Heart muscle problems
• Heart rhythm problems
• Risk of new cancers
• Skin damage at or near the vein where Doxorubicin is given
• Decreased blood cell counts

What special precautions should I follow?

• Doxorubicin hydrochloride can result in myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. Assess left ventricular ejection fraction (LVEF) before and regularly during and after treatment with doxorubicin hydrochloride.
• Secondary acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin hydrochloride.
• Extravasation of doxorubicin hydrochloride can result in severe local tissue injury and necrosis requiring wide excision and skin grafting. Immediately terminate the drug, and apply ice to the affected area.
• Severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur. Obtain complete blood counts prior to each treatment and carefully monitor patients during treatment for possible clinical complications due to myelosuppression. Delay next dose of Doxorubicin Hydrochloride Injection/for Injection if severe myelosuppression has not improved. Consider dose reduction for patients with prolonged myelosuppression based on severity of reaction.
• Reduce the dose of Doxorubicin Hydrochloride Injection/for Injection in patients with serum bilirubin levels of 1.2 to 5 mg/dL . Obtain liver tests including ALT, AST, alkaline phosphatase, and bilirubin prior to and during therapy.
• Doxorubicin hydrochloride can induce tumor lysis syndrome in patients with rapidly growing tumors. Evaluate blood uric acid levels, potassium, calcium, phosphate, and creatinine after initial treatment.
• Doxorubicin hydrochloride can increase radiation-induced toxicity to the myocardium, mucosa, skin, and liver. Radiation recall can occur in patients who receive Doxorubicin Hydrochloride Injection/for Injection after prior radiation therapy.
• Doxorubicin hydrochloride Can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus and on the use of effective contraception. Advise males with female partners of reproductive potential to use effective contraception. Advise males with pregnant partners to use condoms.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• sinus tachycardia
• neutropenia
• thrombocytopenia
• severe mucositis
• sepsis
• chills and pyrexia

Management of overdosage:

• Treatment with charcoal filtration, hemopoietic growth factor (G-CSF), proton pump inhibitor and antimicrobial prophylaxis may be useful.

Can this medicine be used in 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.

Can this medicine be used in children?

• Based on postmarketing reports, pediatric patients treated with doxorubicin hydrochloride are at risk for developing late cardiovascular dysfunction.
• Long-term periodic cardiovascular monitoring is recommended for all pediatric patients who have received doxorubicin hydrochloride.

What are the active and inactive ingredients in this medicine?

• Active ingredient: doxorubicin hydrochloride
• Inactive ingredients for Doxorubicin Hydrochloride Injection: sodium chloride, and hydrochloric acid, USP.

Who manufactures and distributes this medicine?

• Packager: Pfizer Laboratories Div Pfizer Inc

What should I know about storage and disposal of this medication?

• Store all vials at 2° to 8°C (36° to 46°F).
• Protect from light.
• Storage of Doxorubicin Hydrochloride Injection under refrigerated conditions can result in the formation of a gelled product.
• Place gelled product at room temperature [15° to 30°C (59° to 86°F)] for 2 to 4 hours to return the product to a slightly viscous, mobile solution.

Handling and Disposal

• Doxorubicin Hydrochloride Injection is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.

• Dailymed label info on Doxorubicin Hydrochloride
• FDA Doxorubicin Hydrochloride

Doxorubicin Hydrochloride Resources
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