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COSMEGEN
Bladder, kidney, and other urologic cancers
Bone and connective tissue cancer
Gynecologic cancers
Prostate and other male cancers
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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-modality treatment regimen for Wilms' tumor. As a component of regional perfusion, for palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.

Adult:

Give by IV infusion. Wilms' tumor: 15mcg/kg daily for 5 days. Regional perfusion: 50mcg/kg for lower extremity or pelvis; 35mcg/kg for upper extremity. Max 15mcg/kg/day per 2-week cycle or 400–600mcg/m2/day for five days. Use surface area to calculate dose for obese or edematous patients.

Children:

See full labeling.

Contraindications:

Current or recent chickenpox or herpes zoster.

Warnings/Precautions:

Should be administered only under the supervision of an experienced healthcare provider. Extremely corrosive; avoid extravasation. Myelosuppression; monitor bone marrow and hold treatment if platelets or WBCs decrease markedly. 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:

Avoid live vaccines. Concomitant radiotherapy in Wilms' tumor: not recommended.

Pharmacological Class:

Actinomycin antibiotic.

Adverse Reactions:

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:

Vials—1

Indications for COSMEGEN:

In combination with other chemotherapy and/or multi-modality 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. Childhood rhabdomyosarcoma, Ewing's sarcoma: 15mcg/kg daily for 5 days. Regional perfusion: 50mcg/kg for lower extremity or pelvis; 35mcg/kg for upper extremity. Max 15mcg/kg/day per 2-week cycle or 400–600mcg/m2/day for five days. Use surface area to calculate dose for obese or edematous patients.

Children:

See full labeling.

Contraindications:

Current or recent chickenpox or herpes zoster.

Warnings/Precautions:

Should be administered only under the supervision of an experienced healthcare provider. Extremely corrosive; avoid extravasation. Myelosuppression; monitor bone marrow and hold treatment if platelets or WBCs decrease markedly. 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:

Avoid live vaccines. Concomitant radiotherapy in Wilms' tumor: not recommended.

Pharmacological Class:

Actinomycin antibiotic.

Adverse Reactions:

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:

Vials—1

Indications for COSMEGEN:

Gestational trophoblastic neoplasia.

Adult:

Give by IV infusion. 12mcg/kg daily for 5 days as a single agent; 500mcg on Days 1 and 2 as combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide, and cisplatin. Max 15mcg/kg/day per 2-week cycle or 400–600mcg/m2/day for five days. Use surface area to calculate dose for obese or edematous patients.

Children:

See full labeling.

Contraindications:

Current or recent chickenpox or herpes zoster.

Warnings/Precautions:

Should be administered only under the supervision of an experienced healthcare provider. Extremely corrosive; avoid extravasation. Myelosuppression; monitor bone marrow and hold treatment if platelets or WBCs decrease markedly. 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:

Avoid live vaccines. Concomitant radiotherapy in Wilms' tumor: not recommended.

Pharmacological Class:

Actinomycin antibiotic.

Adverse Reactions:

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:

Vials—1

Indications for COSMEGEN:

In combination with other chemotherapy and/or multi-modality treatment regimen for metastatic, nonseminomatous testicular cancer. As a component of regional perfusion, for palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies.

Adult:

Give by IV infusion. Metastatic nonseminomatous testicular cancer (in combination with cyclophosphamide, bleomycin, vinblastine, and cisplatin): 1000mcg/m2 on Day 1. Regional perfusion: 50mcg/kg for lower extremity or pelvis; 35mcg/kg for upper extremity. Max 15mcg/kg/day per 2-week cycle or 400–600mcg/m2/day for five days. Use surface area to calculate dose for obese or edematous patients.

Children:

See full labeling.

Contraindications:

Current or recent chickenpox or herpes zoster.

Warnings/Precautions:

Should be administered only under the supervision of an experienced healthcare provider. Extremely corrosive; avoid extravasation. Myelosuppression; monitor bone marrow and hold treatment if platelets or WBCs decrease markedly. 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:

Avoid live vaccines. Concomitant radiotherapy in Wilms' tumor: not recommended.

Pharmacological Class:

Actinomycin antibiotic.

Adverse Reactions:

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:

Vials—1

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