Myocet Infusion

Doxorubicin Hydrochloride

50mg

GP-PHARM, S.A

Pack size	2 Vials (50mg Powder) + 2 Vials (NLT 1.9ml Liposomes) + 2 Vials (NLT 3ml Buffer)
Dispensing mode	POM
Source	SPAIN
Agent	CITY MEDICAL STORE
Retail Price	6381.00 AED

Indications

Myocet Infusion is used for: AIDS-related Kaposi's sarcoma, Ovarian carcinoma, Metastatic breast carcinoma, bladder carcinoma

Adult Dose

Intravenous As Doxorubicin liposomal Kaposi's Sarcoma Indicated for AIDS-related Kaposi’s sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy 20 mg/m² IV q3Weeks Ovarian Cancer Indicated for ovarian cancer in patients whose disease has progressed or recurred after platinum-based chemotherapy 50 mg/m² IV q4Weeks x 4 courses minimum Multiple Myeloma Indicated in combination with bortezomib for multiple myeloma in patients who have not previously received bortezomib and have received at least 1 prior therapy 30 mg/m² IV on day 4 following bortezomib 1.3 mg/m² on days 1, 4, 8 & 11 q3Weeks Metastatic breast cancer Adult: 60-75 mg/m2 BSA once every 3 wk in combination with cyclophosphamide given as an infusion over 1 hr diluted in 0.9% sodium chloride or 5% glucose. Irrigation Local malignant neoplasms in the bladder Adult: 50 ml of a 1 mg/ml solution instilled into the bladder for 1 hr once a mth. Hepatic Impairment Serum bilirubin <1.2 mg/dL: Dose adjustment not necessary Serum bilirubin 1.2-3 mg/dL [20.5-51.3 micromoles/L]: Give 50% dose Serum bilirubin: 3.1-5 mg/dL [53-85.5 micromoles/L]: Give 25% dose Severe hepatic impairment: Contraindicated

Child Dose

Safety and efficacy not established

Renal Dose

Renal Impairment Dose adjustment not necessary

Administration

Contra Indications

Cardiac disease, neonates, pregnancy and lactation, prior irradiation to mediastinum. IM/SC admin. Severe myelosuppression due to previous treatment with antitumour agents or radiotherapy.

Precautions

Elderly, children, hepatic impairment. Monitor blood counts and ECG. Lactation: Enters breast milk/not recommended

Pregnancy-Lactation

Pregnancy Category: D Lactation: Enters breast milk/not recommended

Interactions

Doxorubicin interacts with a number of other drugs e.g. antibiotics (aminoglycosides), steroids, aminophylline and propranolol. Potentially Fatal: Cholestasis induced by mercaptopurine may be potentiated by concurrent administration of the drug. Toxicity may be increased if streptozocin is given concurrently.

Adverse Effects

Side effects of Doxorubicin Hydrochloride : >10% Kaposi's Sarcoma Anemia (>50%), Thrombocytopenia (>50%), Neutropenia (10-50%), Anemia (18.2%), Nausea (17%) Ovarian cancer >25% Hand-foot syndrome (50%), Nausea (46%), Stomatitis (41%), Asthenia (40.2%), Vomiting (32.6%), Rash (28%), Constipation (>25%), Abdominal pain (>25%) Ovarian cancer 10-25% Fever (21.3%), Anorexia (20%), Diarrhea (20%), Peripheral edema, Dyspepsia, Pharyngitis, Dyspnea, Alopecia 1-10% Kaposi's Sarcoma 5-10% Asthenia (9.9%), Fever (9.1%), Diarrhea (7.8%), Vomiting (7.8%), Stomatitis (6.8%), Rash (1-5%), Alopecia (1-5%), Increased alkaline phosphatase Kaposi's Sarcoma 1-5% Hand-foot syndrome (3.4%), Hypotension, Tachycardia, Dyspnea, Hemolysis, Rash Ovarian cancer (selected) Neutropenia (13.3%), Anemia (0.4-5.4%), Thrombocytopenia (1.3%) <1% Abscess, Acute myeloid leukemia, Cardiomegaly, Cardiomyopathy, Erythema nodosum, Hyperkalemia, Hyperuricemia, Ketosis Potentially Fatal: Bone marrow suppression, cardiotoxicity.

Mechanism of Action

Doxorubicin is a cytotoxic anthracycline antibiotic. The cytotoxic action results from its binding to DNA and inhibition of nucleic acid synthesis. Doxorubicin has been shown to produce regression in a variety of disseminated malignancies.

Note

Myocet 50mg Infusion manufactured by GP-PHARM, S.A. Its generic name is Doxorubicin Hydrochloride. Myocet is availble in United Arab Emirates. Farmaco UAE drug index information on Myocet Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

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