ADRIBLASTINA PFS
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Package(a):
VIALS (ready to use solution): 1 x 10 mg/5 ml.
Dosage(a):
I.V. route only. See prescribing information for full details.
Prescribing Restrictions:
Package(b):
VIALS (ready to use solution): 1 x 50 mg/25 ml.
Dosage(b):
I.V. route only. See prescribing information for full details.
Prescribing Restrictions:
Indications:
Neoplastic conditions.
Contra-Indications:
Hypersensitivity to doxorubicin or any other component of the product, other anthracyclines or anthracenediones. Persistent myelosuppression, severe hepatic impairment, severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias. Previous treatment with maximum cumulative doses of doxorubicin, daunorubicin, epirubicin, idarubicin, and/or other anthracyclines and anthracenediones.
Special Precautions:
Special attention must be given to the cardiotoxicity induced by doxorubicin. Cardiotoxicity may occur at lower doses in patients with prior mediastinal irradiation, concurrent cyclophosphamide therapy and advanced age. Cardiac function should be carefully monitored during treatment to minimize the risk of cardiac toxicity. Children are at increased risk for developing delayed cardiotoxicity following administration and therefore a follow-up cardiac evaluation is recommended periodically. There is a high incidence of bone marrow depression, primarily of leukocytes, requiring careful hematologic monitoring. Red blood cell and platelet levels should also be monitored. May potentiate the toxicity of other anticancer therapies. Prior to the individual dosing, evaluation of hepatic function is recommended. On I.V. administration, extravasation may occur with or without an accompanying stinging or burning sensation. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. Pregnancy and lactation: If used during pregnancy, or if the patient becomes pregnant during therapy, the patient should be appraised of the potential hazard to the fetus. Women of childbearing age should be advised to avoid becoming pregnant. Mothers should be advised to discontinue nursing during therapy. Doxorubicin is not an anti-microbial agent. Should be administered solely by intravenous injection or – in the case of local-regional treatment of tumors – by slow intra-arterial infusion. The dosage should be reduced in patients with impaired hepatic function.
Side Effects:
Myelosuppression and cardiotoxicity, reversible complete alopecia. Hyperpigmentation of nailbeds and dermal crease primarily in children. Acute nausea and vomiting, mucositis (stomatitis and esophagitis) may occur 5 to 10 days after administration, ulceration and necrosis of the colon, especially the cecum, anorexia and diarrhea. Phlebosclerosis. Severe cellulitis, vesication and tissue necrosis will occur if extravasation of doxorubicin occurs during the administration. Fever, chills, urticaria and anaphylaxis. Conjunctivitis and lacrimation occur rarely. See prescribing information.
Drug Interactions:
Cyclophosphamide, paclitaxel.
