Recommended Dosage for Wilms Tumor

​The recommended dose of COSMEGEN, as part of a multi-agent combination chemotherapy regimen, is 45 mcg/kg intravenously once every 3 to 6 weeks for up to 26 weeks.

Recommended Dosage for Rhabdomyosarcoma

The recommended dose of COSMEGEN, as part of a multi-agent combination chemotherapy regimen, is 15 mcg/kg intravenously once daily for 5 days every 3 to 9 weeks for up to 112 weeks.

Recommended Dosage for Ewing Sarcoma

​The recommended dose of COSMEGEN, as part of a multi-agent combination chemotherapy regimen, is 1250 mcg/m 2 intravenously once every 3 weeks for 51 weeks.

Recommended Dosage for Metastatic Nonseminomatous Testicular Cancer

The recommended dose of COSEMGEN, as part of a cisplatin-based, multi-agent combination chemotherapy regimen, is 1000 mcg/m 2 intravenously once every 3 weeks for 12 weeks.

Recommended Dosage for Gestational Trophoblastic Neoplasia

The recommended dose of COSEMEGEN for nonmetastatic and low-risk metastatic disease is 12 mcg/kg intravenously daily for five days as a single agent.

The recommended dose of COSEMEGEN, as part of a multi-agent combination chemotherapy regimen, for high-risk metastatic disease is 500 mcg intravenously on Days 1 and 2 every 2 weeks for up to 8 weeks.

Recommended Dosage for Regional Perfusion in Locally Recurrent and Locoregional Solid Malignancies

The recommended dose of COSMEGEN, in combination with melphalan, is 50 mcg/kg once for lower extremity or pelvis.

The recommended dose of COSMEGEN, in combination with melphalan, is 35 mcg/kg once for upper extremity.

Calculate the dose for obese or edematous patients based on ideal body weight.

Preparation and Administration

• COSMEGEN is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1
• Visually inspect the vials for particulate matter and discoloration, whenever solution and container permit.

Preparation

• Reconstitute each vial by adding 1.1 mL of Sterile Water for Injection without preservative using aseptic techniques.
• The reconstituted product should be a clear, gold-colored solution at a concentration of 500 mcg/mL.
• Further dilute the reconstituted product with 5% Dextrose Injection or 0.9% Sodium Chloride Injection to yield concentrations greater than 10 mcg/mL.
• Store at room temperature for no more than 4 hours from reconstitution to completion of injection or infusion. Discard after 4 hours.
• COSMEGEN does not contain a preservative. Discard any unused portions.

Administration

• Administer the diluted reconstituted product intravenously over 10 to 15 minutes.
• Do not use in-line filters with a cellulose ester membrane.

Management of Extravasation

• Discontinue COSMEGEN for burning or stinging sensation or other evidence indicating perivenous infiltration or extravasation.
• Manage confirmed or suspected extravasation as follows:
• Terminate the injection or infusion immediately and restart in another vein.
• Intermittent application of ice to the site for 15 minutes 4 times daily for 3 days [see Warnings and Precautions ( 5.3)].