ADRIAMYCIN Solution for injection (2019)

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Hikma Pharmaceuticals USA Inc.

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BOXED WARNING SECTION

WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND TISSUE NECROSIS, and SEVERE MYELOSUPPRESSION Cardiomyopathy: Myocardial damage, including acute left ventricular failure can ...

1. Indications and Usage

1.1 Adjuvant Breast Cancer Adriamycin (DOXOrubicin HCl) Injection, USP and Adriamycin (DOXOrubicin HCl) for Injection, USP is indicated as a component of multi-agent adjuvant chemotherapy for treatment ...

2. Dosage and Administration

2.1 Recommended Dose Adjuvant Breast Cancer The recommended dose of doxorubicin is 60 mg/m² administered as an intravenous bolus on day 1 of each 21 day treatment cycle, in combination with cyclophosphamide, ...

3. Dosage Forms and Strengths

Adriamycin (DOXOrubicin HCl) Injection, USP: Vials contain 10 mg/5 mL, 20 mg/10 mL, 50 mg/25 mL, 150 mg/75 mL, and 200 mg/100 mL doxorubicin hydrochloride as a clear red solution.

4. Contraindications

Doxorubicin is contraindicated in patients with: Severe myocardial insufficiency [see Warnings and Precautions (5.1)] Recent (occurring within the past 4 to 6 weeks) myocardial infarction ...

5. Warnings and Precautions

5.1 Cardiomyopathy and Arrhythmias Cardiomyopathy Doxorubicin can result in myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy is generally proportional to the cumulative ...

6. Adverse Reactions

The following adverse reactions are discussed in more detail in other sections of the labeling. Cardiomyopathy and Arrhythmias [see Warnings and Precautions (5.1)] Secondary Malignancies ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of doxorubicin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible ...

7. Drug Interactions

7.1 Effect of CYP3A4 Inhibitors, Inducers and P-gp Doxorubicin is a major substrate of cytochrome P450 CYP3A4 and CYP2D6, and P-glycoprotein (P-gp). Clinically significant interactions have been reported ...

8.1. Pregnancy

Pregnancy Category D. Risk Summary Doxorubicin can cause fetal harm when administered to a pregnant woman. Doxorubicin was teratogenic and embryotoxic in rats and rabbits at doses approximately 0.07 times ...

8.3. Nursing Mothers

Doxorubicin has been detected in the milk of at least one lactating patient [see Clinical Pharmacology (12.3)]. Because of the potential for serious adverse reactions in nursing infants from doxorubicin, ...

8.4. Pediatric Use

Based on postmarketing reports, pediatric patients treated with doxorubicin are at risk for developing late cardiovascular dysfunction. Risk factors include young age at treatment (especially <5 years), ...

8.5. Geriatric Use

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

8.6. Females and Males of Reproductive Potential

Contraception Females Doxorubicin can cause fetal harm when administered during pregnancy. Advise female patients of reproductive potential to use highly effective contraception during treatment with doxorubicin ...

8.7. Hepatic Impairment

The clearance of doxorubicin was reduced in patients with elevated serum bilirubin levels. Reduce the dose of doxorubicin in patients with serum bilirubin levels greater than 1.2 mg/dL [See Dosage ...

10. Overdosage

Few cases of overdose have been described. A 58-year-old man with acute lymphoblastic leukemia received 10-fold overdose of doxorubicin (300 mg/m²) in one day. He was treated with charcoal filtration, ...

11. Description

Doxorubicin is a cytotoxic anthracycline antibiotic isolated from cultures of Streptomyces peucetius var.caesius. Doxorubicin consists of a naphthacenequinone nucleus linked through a ...

12.1. Mechanism of Action

The cytotoxic effect of doxorubicin on malignant cells and its toxic effects on various organs are thought to be related to nucleotide base intercalation and cell membrane lipid binding activities of doxorubicin. ...

12.3. Pharmacokinetics

Pharmacokinetic studies conducted in patients with various types of tumors have shown that doxorubicin follows multiphasic disposition after intravenous injection. The distribution half-life is approximately ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Doxorubicin treatment results in an increased risk of secondary malignancies based on postmarketing reports [see Warnings and Precautions (5.2)]. Doxorubicin was mutagenic in the in vitro ...

14. Clinical Studies

The clinical efficacy of doxorubicin containing regimens for the post-operative, adjuvant treatment of surgically resected breast cancer was evaluated in a meta-analysis conducted by the Early Breast Cancer ...

15. References

1. Hazardous Drugs. OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html

16.1. How Supplied

Adriamycin (DOXOrubicin HCI) Injection, USP is supplied in single-dose, flip-top vials, as a red-orange solution containing Doxorubicin Hydrochloride, USP 2 mg/mL in the following package strengths: ...

16.2. Storage and Handling

Adriamycin (DOXOrubicin HCI) Injection, USP / Single-dose vials: Store refrigerated, 2° to 8°C (36° to 46°F). Protect from light. Retain in carton until time of use. Discard unused portion. ...

17. Patient Counseling Information

See FDA-Approved Patient Labeling (Patient Information). Inform patients of the following: Doxorubicin can cause irreversible myocardial damage. Advise patients to contact a healthcare provider for symptoms ...