Cosmegen

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PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Cosmegen Generic Name & Formulations

    Legal Class

    Rx

    General Description

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

    Pharmacological Class

    Actinomycin antibiotic.

    How Supplied

    Vials—1

    Manufacturer

    Recordati Rare Diseases, Inc.

    Cosmegen Indications

    Indications

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

    Cosmegen Dosage and Administration

    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.

    Cosmegen Contraindications

    Not Applicable

    Cosmegen Boxed Warnings

    Not Applicable

    Cosmegen Warnings/Precautions

    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).

    Cosmegen Pharmacokinetics

    See Literature

    Cosmegen Interactions

    Interactions

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

    Cosmegen Adverse Reactions

    Adverse Reactions

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

    Cosmegen Clinical Trials

    See Literature

    Cosmegen Note

    Not Applicable

    Cosmegen Patient Counseling

    See Literature

    Cosmegen Generic Name & Formulations

    Legal Class

    Rx

    General Description

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

    Pharmacological Class

    Actinomycin antibiotic.

    How Supplied

    Vials—1

    Manufacturer

    Recordati Rare Diseases, Inc.

    Cosmegen Indications

    Indications

    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.

    Cosmegen Dosage and Administration

    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.

    Cosmegen Contraindications

    Not Applicable

    Cosmegen Boxed Warnings

    Not Applicable

    Cosmegen Warnings/Precautions

    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).

    Cosmegen Pharmacokinetics

    See Literature

    Cosmegen Interactions

    Interactions

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

    Cosmegen Adverse Reactions

    Adverse Reactions

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

    Cosmegen Clinical Trials

    See Literature

    Cosmegen Note

    Not Applicable

    Cosmegen Patient Counseling

    See Literature

    Cosmegen Generic Name & Formulations

    Legal Class

    Rx

    General Description

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

    Pharmacological Class

    Actinomycin antibiotic.

    How Supplied

    Vials—1

    Manufacturer

    Recordati Rare Diseases, Inc.

    Cosmegen Indications

    Indications

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

    Cosmegen Dosage and Administration

    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.

    Cosmegen Contraindications

    Not Applicable

    Cosmegen Boxed Warnings

    Not Applicable

    Cosmegen Warnings/Precautions

    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).

    Cosmegen Pharmacokinetics

    See Literature

    Cosmegen Interactions

    Interactions

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

    Cosmegen Adverse Reactions

    Adverse Reactions

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

    Cosmegen Clinical Trials

    See Literature

    Cosmegen Note

    Not Applicable

    Cosmegen Patient Counseling

    See Literature

    Cosmegen Generic Name & Formulations

    Legal Class

    Rx

    General Description

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

    Pharmacological Class

    Actinomycin antibiotic.

    How Supplied

    Vials—1

    Manufacturer

    Recordati Rare Diseases, Inc.

    Cosmegen Indications

    Indications

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

    Cosmegen Dosage and Administration

    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.

    Cosmegen Contraindications

    Not Applicable

    Cosmegen Boxed Warnings

    Not Applicable

    Cosmegen Warnings/Precautions

    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).

    Cosmegen Pharmacokinetics

    See Literature

    Cosmegen Interactions

    Interactions

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

    Cosmegen Adverse Reactions

    Adverse Reactions

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

    Cosmegen Clinical Trials

    See Literature

    Cosmegen Note

    Not Applicable

    Cosmegen Patient Counseling

    See Literature

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