doxorubicin hydrochloride

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doxorubicin hydrochloride

Adriamycin PFS, Adriamycin RDF, Rubex

Pharmacologic class: Anthracycline

Therapeutic class: Antibiotic antineoplastic

Pregnancy risk category D

FDA Box Warning

• Administer I.V. only-never I.M. or subcutaneously. Extravasation causes severe local tissue necrosis.

• Myocardial toxicity may occur during therapy or months to years afterward. Risk factors (cardiovascular disease, previous or concurrent radiotherapy to mediastinal or pericardial area, previous therapy with doxorubicin or other anthracyclines or anthracenediones, and concomitant use of other cardiotoxic drugs) may increase myocardial toxicity risk. Toxicity may occur at higher or lower cumulative doses even in patients without cardiac risk factors. Pediatric patients have increased risk of delayed cardiotoxicity.

• Secondary acute myelogenous leukemia (AML) may occur. Refractory secondary leukemia is more common when drug is given in combination with DNA-damaging antineoplastics, when patients have been heavily pretreated with cytotoxic drugs, and with dosage escalation. Pediatric patients also are at risk for secondary AML.

• Reduce dosage in hepatic impairment.

• Drug may cause severe myelosuppression.

• Give under supervision of physician experienced in cancer chemotherapy.


Unclear. Thought to inhibit DNA and RNA synthesis by forming complex with DNA. Also exerts immunosuppressive activity. Cell-cycle-S-phase specific.


Injection (preservative-free): 2 mg/ml

Powder for injection: 10 mg, 20 mg, 50 mg

Indications and dosages

Solid tumors, including bladder, breast, lung, stomach, and thyroid cancers; malignant lymphomas, including Hodgkin's disease; acute leukemia; chronic lymphocytic leukemia; multiple myeloma; Wilms' tumor; neuroblastoma

Adults: 60 to 75 mg/m2 I.V. as a single dose at 21-day cycles, or 30 mg/m2 I.V. as a single daily dose on first to third days of 4-week cycle, or 20 mg/m2 I.V. once weekly. Maximum cumulative dosage is 550 mg/m2.

Dosage adjustment

• Bone marrow depression
• Impaired cardiac or hepatic function

Off-label uses

• Endometrial carcinoma, islet cell carcinoma


• Hypersensitivity to drug
• Severe bone marrow depression
• Previous treatment with maximum cumulative doses of doxorubicin, other anthracyclines, or anthracenes


Use cautiously in:
• cardiac disease, hepatic impairment, depressed bone marrow reserve, CNS metastases, brain tumor, malignant melanoma, renal carcinoma
• elderly patients
• females of childbearing age
• pregnant or breastfeeding patients
• children.


• Follow facility policy for handling and preparing antineoplastics.

Don't dilute solution with bacteriostatic diluent. Don't mix with other drugs.
• Dilute as directed with normal saline solution to a final concentration of 2 mg/ml.
• Administer slowly over 3 to 5 minutes into tubing of free-flowing I.V. infusion of normal saline solution or dextrose 5% in water.
• Deliver into large vein using butterfly needle. Avoid veins over joints or extremities with compromised venous or lymphatic drainage.

Avoid rapid infusion, because this may increase risk of acute infusion-related reactions (back pain, chest tightness, flushing).

If extravasation occurs, stop infusion immediately, apply ice, and notify prescriber.

Adverse reactions

CNS: drowsiness, dizziness, asthenia, fatigue, malaise, paresthesia, headache, depression, insomnia, anxiety, emotional lability

CV: chest pain, hypotension, tachycardia, peripheral edema, cardiomyopathy, heart failure, arrhythmias, pericardial effusion

GI: nausea, vomiting, diarrhea, constipation, enlarged abdomen, abdominal pain, dyspepsia, oral candidiasis, moniliasis, stomatitis, glossitis, esophagitis, dysphagia

GU: albuminuria, hyperuricosuria, red urine

Hematologic: anemia, leukopenia, thrombocytopenia, neutropenia, bone marrow depression

Metabolic: hyperglycemia, hypocalcemia

Musculoskeletal: myalgia, back pain

Respiratory: dyspnea, increased cough, pneumonia

Skin: rash, dry skin, pruritus, skin discoloration, alopecia, diaphoresis, exfoliative dermatitis, palmar-plantar erythrodysesthesia

Other: abnormal taste, infection, chills, fever, herpes zoster, injection site reactions, allergic reactions including anaphylaxis, acute infusion-associated reactions


Drug-drug.Antineoplastics: additive bone marrow depression

Cyclophosphamide: increased risk of hemorrhagic cystitis, increased cardiotoxicity

Cyclosporine: profound and prolonged hematologic toxicity, increased risk of coma and seizures

Dactinomycin (in children): increased risk of pneumonitis

Live-virus vaccines: decreased antibody response to vaccine, increased risk of adverse reactions

Mercaptopurine: hepatitis

Paclitaxel (if given first): reduced doxorubicin clearance, increased incidence and severity of neutropenia and stomatitis

Phenobarbital: increased clearance and decreased effects of doxorubicin

Phenytoin: decreased phenytoin blood level

Progesterone: increased incidence and severity of neutropenia and thrombocytopenia

Streptozocin: increased doxorubicin half-life

Verapamil: increased doxorubicin blood level

Drug-diagnostic tests.Alkaline phosphatase, bilirubin, glucose, prothrombin time, serum and urine uric acid: increased levels

Calcium, hemoglobin, neutrophils, platelets, white blood cells (WBCs): decreased levels

Patient monitoring

Watch for acute life-threatening arrhythmias, which may occur during or within a few hours after administration.

Monitor for cardiomyopathy and subsequent heart failure with chronic overdose (more common in children).
• Stay alert for erythematous streaking along vein next to injection site, which may indicate too-rapid infusion.
• Watch for nausea and vomiting. Administer antiemetics as needed.

Check for superinfection or hemorrhage caused by persistent bone marrow depression (but expect WBC counts as low as 1,000/mm3 during therapy).

Watch closely for infusion-related reactions and anaphylaxis.
• Monitor CBC, hepatic profile, coagulation tests, ejection fraction, and glucose, uric acid, bilirubin, and calcium blood levels.

Patient teaching

Advise patient to promptly report irregular heartbeats, easy bruising or bleeding, or signs of hypersensitivity reaction, such as a rash.
• Caution patient to avoid people with colds, flu, or other contagious illnesses.
• Explain that drug may cause complete but reversible hair loss.
• Inform patient that drug may turn urine red for 1 or 2 days.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

DOXOrubicin hydrochloride

an anthracycline antibiotic.
indications It is prescribed in the treatment of a wide variety of malignant neoplastic diseases, including leukemias, lymphomas, sarcomas, germ cell tumors, and carcinomas (e.g., lung, breast, prostate, ovary).
contraindications Myelosuppression, heart disease, concurrent administration of DAUNOrubicin, or known hypersensitivity to this drug prohibits its use.
adverse effects Among the more serious adverse reactions are myelosuppression and cardiomyopathy. Stomatitis, GI disturbances, and alopecia commonly occur.

doxorubicin hydrochloride

A drug used in the treatment of breast cancer, esophageal cancers, sarcomas, and lymphomas. It has many side effects, one of which is cardiac muscle damage.
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In March 2012, to address the shortage of doxorubicin hydrochloride liposome injection, the FDA announced it would exercise enforcement discretion for temporary controlled importation of doxorubicin hydrochloride liposome injection generic, an alternative to Doxil(R) produced by Taj Phrama India under special authorised manufacturing to maximise the supply other than Janssen Biotech's Doxil(R); enforcement discretion was also used to release one lot of Janssen's Doxil(R) made under an unapproved manufacturing process.
Doxorubicin hydrochloride is approved by the US Food and Drug Administration (FDA) for use in the treatment of a number of metastatic human cancers including as breast, gastric, small cell lung and ovarian cancers.
Response data from the study entitled "A Multicenter, Phase I/II Trial of Hepatic Intra-Arterial Delivery of Doxorubicin Hydrochloride Adsorbed to Magnetic Targeted Carriers in Patients with Hepatocellular Carcinoma" showed that in 21 lesions (19 patients) treated at doses greater than or equal to 0.
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Contract awarded for listado140-2016 doxorubicin hydrochloride injectable solution or powder for parenteral use 10 mg vial or ampule code 668
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Contract awarded for 2728-2015 list doxorubicin hydrochloride injectable solution or powder for parenteral use 10 mg vial or ampule code 668
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Doxorubicin hydrochloride, pegylated liposomal suspension for injection 2 mg / ml, 10 ml vial
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DOX-SL is LTI's proprietary long-circulating Stealth(R) liposome formulation of the widely prescribed anti-cancer drug, doxorubicin hydrochloride, and the Company already has sufficient inventory of DOX-SL on hand to launch product at such time as FDA grants final product approval.