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OXALIPLATIN AQ VIDA

OXALIPLATIN · by HIMMEL

ANTINEOPLASTICS Alkylating agent HIMMEL

Composition

Inf: Per ml: Oxaliplatin 5 mg; powder in vials; 50 mg (10 ml) & 100 mg (20 ml) vial.

Indications & Dosage

Treatment of metastatic colorectal cancer (in combination with fluorouracil and folinic acid): BY IV INF: Adults: 85 mg/m2every 2 wk over 2-6 hr prior to administration of 5-FU. Treatment of colon cancer after resection of the primary tumour (adjuvant treatment): BY IV INF: Adults: 85 mg/m2 every 2 wk for 12 cycles over 2-6 hr prior to administration of 5-FU. Children: Not recommended.

Administration

For administration by IV inf, the liquid concentrated injection must be diluted in 250 to 500 ml of D5W. Chloride containing solutions must not be used for dilution.

Compatibility

Incompatible with alkaline solutions (e.g. fluorouracil) and chloride-containing solutions. Flush infusion line with D5W prior to, and following, administration of concomitant medications via same IV line.

Stability

Store intact vials at room temperature of 25C (77F) and under normal lighting; excursions permitted to 15C-30C (59F-86F). Reconstituted solutions may be stored up to 24 hours at room under refrigeration at 2C-8C (36F-46F). Diluted solution is stable up to 6 hours at room temperature of 20C-25C (68F-77F) or up to 24 hours under refrigeration at 2C-8C (36F-46F).

Contraindications

Severe renal impairment, neutropenia, thrombocytopenia, peripheral sensory neuropathy.

Precautions

Moderate renal impairment; monitor renal function, reduce dose. History of sensitivity to platinum compounds; monitor for allergic reactions, discontinue immediately if anaphylactoid reactions develop, Grade 4 diarihoea, Warn patient of possibility of persistent sensory neuropathy following treatment. Perform a neurological ex-amination before each dose; discontinue or reduce dose if paraesthesia or dysaesthesia are present. Perform full blood count with white cell differential before each dose; delay or reduce dose if Grade 3-4 neutropenia or thrombocytopenia has occurred. Discontinue if unexplained respiratory symptoms occur, Mucositis/ stomatitis; delay next treatment until recovery to Grade 1 or less.

Pregnancy

Positive evidence of risk: Avoid

Lactation

Contraindicated. Discontinue breast-feeding

Side Effects

Alopecia, bone-marrow suppression, extravasation, GI disturbances, hyperuricaemia, myelosuppression, nausea, neurotoxicity (dose limiting), ototoxicity, posterior reversible encephalopathy syndrome (associated with oxaliplatin combination chemotherapy), sensory peripheral neuropathy (dose limiting), thromboembolism, transient vision loss (reversible on discontinuation), tumourlysis syndrome, vomiting, respiratory symptoms