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TOPOKEBIR

TOPOTECAN · by ONCOGENE

ANTINEOPLASTICS Topoisomerase 1 inhibitor ONCOGENE

Composition

Inj Topotecan 4mg: powder in vial.

Indications & Dosage

Metastatic ovarian cancer when first-line or subsequent treatment has failed, Treatment of recurrent carcinoma of the cervix after radiotherapy and for patients with stage IV B disease (in combination with cisplatin): BY IV INF: Adults: 1-5mg/m2 daily by IV INF over 30 min for 5 consecutive days. Repeat every 3 week for minimum of 4 courses. Relapsed small-cell lung cancer when retreatment with the first-line regimen is considered inappropriate: BY IV INF: Adult: (consult product literature or local protocols).

Administration

Administer IVP Bolus over 30 min or by 24 hours continuous infusion. Reconstitute vials with 4 ml SWFI, D5W or NS: may be further diluted in 50-100ml D5w or NS for infusion.

Stability

Store intact vials at 20 C-25-C (68 F- 77 F), protect vials from direct sunlight. Single-used vials should be discarded after initial vial entry. Solution for infusion is stable for 24 hours at room temperature or up to 7 days under refrigeration after dilution in at least 50 ml D5W or NS.

Contraindications

Severe myelosuppression.

Precautions

Renal or hepatic impairment, mild to moderate renal impairment. Ensure baseline neutrophils as necessary prior to treatment. Monitor blood regularly.

Pregnancy

Contraindicated in pregnancy.

Lactation

Contraindicated. Discontinue breast-feeding

Side Effects

Alopecia, anorexia, asthenia, bone marrow suppression, extravasation, GI effects, hyperuricaemia, myelosuppression (dose limiting), nausea, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting.