DOXORUBICIN HYDROCHLORIDE- doxorubicin injection, powder, lyophilized, for solution DOXORUBICIN HYDROCHLORIDE injection, powder, lyophilized, for solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

DOXORUBICIN HYDROCHLORIDE (UNII: 82F2G7BL4E) (DOXORUBICIN - UNII:80168379AG)

متاح من:

Amneal Pharmaceuticals LLC

INN (الاسم الدولي):

DOXORUBICIN HYDROCHLORIDE

تركيب:

DOXORUBICIN HYDROCHLORIDE 2 mg in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Doxorubicin hydrochloride for injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer. Doxorubicin hydrochloride for injection is indicated for the treatment of - acute lymphoblastic leukemia - acute myeloblastic leukemia - Hodgkin lymphoma - non-Hodgkin lymphoma (NHL) - metastatic breast cancer - metastatic Wilms’ tumor - metastatic neuroblastoma - metastatic soft tissue sarcoma - metastatic bone sarcoma - metastatic ovarian carcinoma - metastatic transitional cell bladder carcinoma - metastatic thyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic carcinoma Doxorubicin hydrochloride for injection 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 [see Warnings and Precautions (5.1)] - Severe persistent drug-induced myelosuppression [see Warnings and Precautions (5.4)] - Severe hepatic impairment (defined as Child Pugh Class C or serum bilirubin level greater than 5 mg/dL) [see Warnings and Precautions (5.5)] - Severe hypersensitivity reaction to doxorubicin hydrochloride, including anaphylaxis [see Adverse Reactions (6.2)] Risk Summary Based on findings in animals and its mechanism of action, doxorubicin hydrochloride for injection can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride 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 (see Data) . 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. Data Animal Data Doxorubicin hydrochloride was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats. Teratogenicity and embryotoxicity were also seen using discrete periods of treatment. The most susceptible was the 6- to 9-day gestation period at doses of 1.25 mg/kg/day and greater. Characteristic malformations included esophageal and intestinal atresia, tracheo-esophageal fistula, hypoplasia of the urinary bladder, and cardiovascular anomalies. Doxorubicin hydrochloride was embryotoxic (increase in embryofetal deaths) and abortifacient at 0.4 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) in rabbits when administered during the period of organogenesis. Risk Summary 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 for injection and for 10 days after the final dose. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating doxorubicin hydrochloride for injection. Contraception Females Doxorubicin hydrochloride for injection can cause fetal harm when administered to pregnant women [see Use in Specific Populations (8.1)] . Advise female patients of reproductive potential to use highly effective contraception during treatment with doxorubicin hydrochloride for injection and for 6 months after treatment [see Use in Specific Populations (8.1)] . 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 for injection and for 3 months after treatment [see Nonclinical Toxicology (13.1)] . Males with pregnant partners should use condoms during treatment and for at least 10 days after the final dose [see Nonclinical Toxicology (13.1), Use in Specific Populations (8.1)] . 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 [see Nonclinical Toxicology (13.1)] . 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 [see Nonclinical Toxicology (13.1)] . 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 [see Clinical Pharmacology (12.3)] . 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. The clearance of doxorubicin was reduced in patients with elevated serum total bilirubin levels. Doxorubicin hydrochloride 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) [see Contraindications (4)] . Reduce the dose of doxorubicin hydrochloride for injection in patients with serum total bilirubin levels greater than 1.2 mg/dL [see Dosage and Administration (2.4), Warnings and Precautions (5.5)] .

ملخص المنتج:

Doxorubicin Hydrochloride for Injection, USP is supplied as a sterile red to orange red lyophilized cake or powder, available in single-dose vial packs or 10 vial packs as: 20 mg/vial : Single-Dose Vial in mono-carton                                NDC 70121-1218-1 10 mono-cartons in Outer Carton                               NDC 70121-1218-7 50 mg/vial: Single-Dose Vial in a Carton                                      NDC 70121-1219-1 Store all vials at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Retain in carton until time of use. Discard unused portion. Handling and Disposal Doxorubicin Hydrochloride for Injection, USP is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DOXORUBICIN HYDROCHLORIDE- DOXORUBICIN INJECTION, POWDER, LYOPHILIZED,
FOR SOLUTION
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXORUBICIN
HYDROCHLORIDE FOR INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR
DOXORUBICIN HYDROCHLORIDE FOR INJECTION.
DOXORUBICIN HYDROCHLORIDE FOR INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1974
WARNING: CARDIOMYOPATHY, SECONDARY MALIGNANCIES, EXTRAVASATION AND
TISSUE NECROSIS, AND SEVERE MYELOSUPPRESSION
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
CARDIOMYOPATHY: MYOCARDIAL DAMAGE CAN OCCUR WITH DOXORUBICIN
HYDROCHLORIDE WITH
INCIDENCES FROM 1% TO 20% FOR CUMULATIVE DOSES FROM 300 MG/M TO 500
MG/M
WHEN DOXORUBICIN HYDROCHLORIDE IS ADMINISTERED EVERY 3 WEEKS. 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. (5.1)
SECONDARY MALIGNANCIES: SECONDARY ACUTE MYELOGENOUS LEUKEMIA (AML) AND
MYELODYSPLASTIC SYNDROME (MDS) OCCUR AT A HIGHER INCIDENCE IN PATIENTS
TREATED
WITH ANTHRACYCLINES, INCLUDING DOXORUBICIN HYDROCHLORIDE. (5.2)
EXTRAVASATION AND TISSUE NECROSIS: 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. (5.3)
SEVERE MYELOSUPPRESSION RESULTING IN SERIOUS INFECTION, SEPTIC SHOCK,
REQUIREMENT
FOR TRANSFUSIONS, HOSPITALIZATION, AND DEATH MAY OCCUR. (5.4)
INDICATIONS AND USAGE
Doxorubicin hydrochloride for injection is an anthracycline
topoisomerase inhibitor indicated:
as a component of multiagent adjuvant chemotherapy for treatment of
women with axillary lymph node
involvement following resection of primary breast cancer (1.1).
for the treatment of: acute lymphoblastic leukemia, acute myeloblastic
leukemia, Hodgkin lymp