ADD THIS DRUG TO MY LIST

Select the drug indication to add to your list

COSMEGEN
Bladder, kidney, and other urologic cancers
Bone and connective tissue cancer
Gynecologic cancers
Prostate and other male cancers
Compare To Related Drugs
View/Edit/Compare Drugs In My List

Only 4 drugs may be compared at once

Drug Name:

COSMEGEN Rx

Generic Name and Formulations:
Dactinomycin 500mcg/vial; lyophilized pwd for IV inj or regional perfusion after reconstitution; contains mannitol; preservative-free.

Company:
Recordati Rare Diseases, Inc.

Therapeutic Use:

Indications for COSMEGEN:

In combination with other chemotherapy and/or multi-phase treatment regimen for Wilms' tumor.

Adult:

Give by IV infusion over 10–15mins. 45mcg/kg once every 3 to 6 weeks for up to 26 weeks.

Children:

See full labeling.

Warnings/Precautions:

Increased risk of secondary malignancies (including leukemia). Hepatic veno-occlusive disease (monitor). Avoid extravasation. Risk of myelosuppression; obtain CBCs prior to each cycle. Permanently discontinue if a severe mucocutaneous reaction develops. Potentiation of radiation toxicity/recall. Previous irradiation (esp. within 2 months of irradiation). Monitor renal and hepatic function. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Use effective contraception during therapy and for at least 6 months (females) and 3 months (males w. female partners) after final dose. Nursing mothers: not recommended (during and for 14 days after final dose).

Pharmacological Class:

Actinomycin antibiotic.

Interactions:

Avoid live vaccines. Concomitant radiotherapy: reduce dactinomycin dose by 50%.

Adverse Reactions:

Infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, hepatotoxicity.

How Supplied:

Vials—1

Indications for COSMEGEN:

In combination with other chemotherapy and/or multi-phase treatment regimen for childhood rhabdomyosarcoma, Ewing's sarcoma. As a component of regional perfusion, for palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.

Adult:

Give by IV infusion over 10–15mins. Childhood rhabdomyosarcoma: 15mcg/kg once daily for 5 days every 3 to 9 weeks for up to 112 weeks. Ewing's sarcoma: 1250mcg/m2 once every 3 weeks for 51 weeks. Regional perfusion (in combination with melphalan): 50mcg/kg once for lower extremity or pelvis; 35mcg/kg once for upper extremity. Calculate dose for obese or edematous patients based on ideal body weight.

Children:

See full labeling.

Warnings/Precautions:

Increased risk of secondary malignancies (including leukemia). Hepatic veno-occlusive disease (monitor). Avoid extravasation. Risk of myelosuppression; obtain CBCs prior to each cycle. Permanently discontinue if a severe mucocutaneous reaction develops. Potentiation of radiation toxicity/recall. Previous irradiation (esp. within 2 months of irradiation). Monitor renal and hepatic function. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Use effective contraception during therapy and for at least 6 months (females) and 3 months (males w. female partners) after final dose. Nursing mothers: not recommended (during and for 14 days after final dose).

Pharmacological Class:

Actinomycin antibiotic.

Interactions:

Avoid live vaccines. Concomitant radiotherapy: reduce dactinomycin dose by 50%.

Adverse Reactions:

Infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, hepatotoxicity.

How Supplied:

Vials—1

Indications for COSMEGEN:

As a single agent or as part of a combination chemotherapy regimen for post-menarchal patients with gestational trophoblastic neoplasia.

Adult:

Give by IV infusion over 10–15mins. As a single agent: 12mcg/kg daily for 5 days. As combination regimen: 500mcg on Days 1 and 2 every 2 weeks for up to 8 weeks.

Children:

See full labeling.

Warnings/Precautions:

Increased risk of secondary malignancies (including leukemia). Hepatic veno-occlusive disease (monitor). Avoid extravasation. Risk of myelosuppression; obtain CBCs prior to each cycle. Permanently discontinue if a severe mucocutaneous reaction develops. Potentiation of radiation toxicity/recall. Previous irradiation (esp. within 2 months of irradiation). Monitor renal and hepatic function. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Use effective contraception during therapy and for at least 6 months (females) and 3 months (males w. female partners) after final dose. Nursing mothers: not recommended (during and for 14 days after final dose).

Pharmacological Class:

Actinomycin antibiotic.

Interactions:

Avoid live vaccines. Concomitant radiotherapy: reduce dactinomycin dose by 50%.

Adverse Reactions:

Infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, hepatotoxicity.

How Supplied:

Vials—1

Indications for COSMEGEN:

In combination with other chemotherapy and/or multi-phase treatment regimen for metastatic, nonseminomatous testicular cancer.

Adult:

Give by IV infusion over 10–15mins. Metastatic nonseminomatous testicular cancer (in combination with cisplatin-based agents): 1000mcg/m2 once every 3 weeks for 12 weeks.

Children:

See full labeling.

Warnings/Precautions:

Increased risk of secondary malignancies (including leukemia). Hepatic veno-occlusive disease (monitor). Avoid extravasation. Risk of myelosuppression; obtain CBCs prior to each cycle. Permanently discontinue if a severe mucocutaneous reaction develops. Potentiation of radiation toxicity/recall. Previous irradiation (esp. within 2 months of irradiation). Monitor renal and hepatic function. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Use effective contraception during therapy and for at least 6 months (females) and 3 months (males w. female partners) after final dose. Nursing mothers: not recommended (during and for 14 days after final dose).

Pharmacological Class:

Actinomycin antibiotic.

Interactions:

Avoid live vaccines. Concomitant radiotherapy: reduce dactinomycin dose by 50%.

Adverse Reactions:

Infection, alopecia, rash, dysphagia, fatigue, fever, nausea, vomiting, anemia, neutropenia, thrombocytopenia, mucositis, hepatotoxicity.

How Supplied:

Vials—1

Sign Up for Free e-Newsletters