Select therapeutic use:

Bladder, kidney, and other urologic cancers:

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.

Boxed Warning:

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).

Pharmacologic 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

Bone and connective tissue cancer:

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.

Boxed Warning:

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).

Pharmacologic 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

Gynecologic cancers:

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.

Boxed Warning:

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).

Pharmacologic 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

Prostate and other male cancers:

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.

Boxed Warning:

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).

Pharmacologic 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