Biovinate Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Carboplatin

Indications/Uses

Initial treatment of advanced ovarian carcinoma of epithelial origin in established combinations w/ other approved chemotherapeutic agents. Palliative treatment of ovarian carcinoma of epithelial origin refractory to standard chemotherapy w/ or w/o cisplatin. Small cell lung carcinoma (SCLC).

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Dosage/Direction for Use

Previously untreated patient w/ normal renal function 400 mg/m² IV infusion over 15-60 min every 4 wk. Recurrent ovarian cancer Initially 360 mg/m² IV once every 4 wk. Advanced ovarian cancer (stage III & IV) 300 mg/m² carboplatin IV in combination w/ cyclophosphamide. Patient w/ renal impairment CrCl 41-59 mL/min Initial dose: 250 mg/m². 16-40 mL/min Initial dose: 200 mg/m².

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Contraindications

Hypersensitivity to carboplatin, cisplatin or other platinum-containing compd & mannitol. Preexisting severe renal impairment (CrCl <30 mL/min); severe myelosuppression, bleeding tumors, yellow fever vaccine. Pregnancy & lactation.

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Special Precautions

Perform blood counts, neurological, renal & hepatic function tests regularly. Do not administer more frequently than every 4 wk. Discontinue use if severe myelosuppression or abnormal renal or hepatic function occur. Risk of bone marrow suppression, myelosuppression, hematologic-, nephro- & neurotoxicity, ototoxicity, GI reactions, anaphylaxis, immunosuppressant effects/increased susceptibility to infections, loss of vision (high dose). Male patients should not father a child during & 6-mth post-treatment. May affect ability to drive or operate machinery. Childn. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Secondary acute malignancies, myeloid leukemia, myelodysplastic syndrome; infection; blood & lymphatic, immune system, metabolism & nutrition, nervous system, eye, ear & labyrinth, cardiac, vascular, resp thoracic & mediastinal. GI, skin & SC, musculoskeletal & connective tissue, renal & urinary effects; mucous membrane disorder, abnormal renal function, acute renal failure; mucous membrane disorder, asthenia, malaise, fever, mucositis, fatigue, pain, flu-like symptoms; decreased CrCl, increased BUN, blood alkaline phosphatase, aspartate aminotransferase; decreased blood Na, K, Ca, Mg; increased blood bilirubin, creatinine, uric acid; ototoxicity, inj site reaction, necrosis, extravasation, erythema.

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Drug Interactions

Al, anticoagulants. Potentiated hematologic toxicity w/ myelosuppressive agents or radiation therapy. Reduced digestive absorption of phenytoin/fosphenytoin. Increased nephro- or ototoxicity risks (w/ nephro- or ototoxic agents eg, aminoglycosides, vancomycin, capreomycin & diuretics); incidence of emesis w/ emetogenic agents. Live attenuated vaccines.

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MIMS Class

Cytotoxic Chemotherapy

ATC Classification

L01XA02 - carboplatin ; Belongs to the class of platinum-containing antineoplastic agents. Used in the treatment of cancer.

Regulatory Classification

Presentation/Packing

Form

Biovinate soln for infusion 150 mg/15 mL

Packing/Price

25 mL x 1's

Form

Biovinate soln for infusion 450 mg/45 mL

Packing/Price

50 mL x 1's (P6,427/vial)

Biovinate

carboplatin

Manufacturer:

UNILAB, Inc

Distributor:

UNILAB, Inc