Monograph Details
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Neoplasms
> Cytotoxic antibiotics
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COSMEGEN |
| Manufacturer |
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Merck & Co., Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Actinomycin antibiotic. |
| Generic Name |
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Dactinomycin 500micrograms/vial; lyophilized pwd for IV inj or regional perfusion after reconstitution; contains mannitol; preservative-free. |
| Indications |
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In combination with other chemotherapy and/or multi-modality treatment regimen for Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma and metastatic, nonseminomatous testicular cancer. Gestational trophoblastic neoplasia. As a component of regional perfusion, for palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies. |
| Children |
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See literature. |
| Adults |
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Give by IV infusion. Wilms' tumor, childhood rhabdomyosarcoma, Ewing's sarcoma: 15micrograms/kg daily for 5 days. Metastatic nonseminomatous testicular cancer (in combination with cyclophosphamide, bleomycin, vinblastine, and cisplatin): 1000micrograms/m2 on Day 1. Gestational trophoblastic neoplasia: 12micrograms/kg daily for 5 days as a single agent; 500micrograms on Days 1 and 2 as combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide, and cisplatin. Regional perfusion: 50micrograms/kg for lower extremity or pelvis; 35micrograms/kg for upper extremity. Max 15micrograms/kg/day per 2-week cycle or 400–600micrograms/m2/day for five days. Use surface area to calculate dose for obese or edematous patients. |
| Contraindications |
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Current or recent chickenpox or herpes zoster. |
| Precautions |
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Myelosuppression; monitor bone marrow and hold treatment if platelets or WBCs decrease markedly. Extremely corrosive; avoid extravasation. Avoid skin, mucous membranes, eyes. Previous irradiation (esp. within 2 months of irradiation for treatment of right-sided Wilms' tumor), cytotoxic chemotherapy. Monitor renal and hepatic function. Obese. Elderly. Pregnancy (Cat.D); avoid use. Nursing mothers: not recommended. |
| Interactions |
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Avoid live vaccines. Concomitant radiotherapy in Wilms' tumor: not recommended. |
| Adverse Reactions |
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GI upset, stomatitis, bone marrow suppression (neutropenia, thrombocytopenia), liver toxicity, infusion site reactions, malaise, fatigue, alopecia, possible second primary tumors (including leukemia); for perfusion therapy: infection, impaired wound healing, superficial ulceration of gastric mucosa, edema, soft tissue damage, possible venous thrombosis. |
| How Supplied |
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Vials—1 |
| Additional Resources |
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• Related Prescribing Note |
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