Cosmegen

COSMEGEN- dactinomycin injection, powder, lyophilized, for solution
RECORDATI RARE DISEASES, INC.

1 INDICATIONS AND USAGE

1.1 Wilms Tumor

COSMEGEN is indicated for the treatment of adult and pediatric patients with Wilms tumor, as part of a multi-phase, combination chemotherapy regimen.

1.2 Rhabdomyosarcoma

COSMEGEN is indicated for the treatment of adult and pediatric patients with rhabdomyosarcoma, as part of a multi-phase, combination chemotherapy regimen.

1.3 Ewing Sarcoma

COSMEGEN is indicated for the treatment of adult and pediatric patients with Ewing sarcoma, as part of a multi-phase, combination chemotherapy regimen.

1.4 Metastatic Nonseminomatous Testicular Cancer

COSMEGEN is indicated for the treatment of adult and pediatric patients with metastatic, nonseminomatous testicular cancer, as part of a multi-phase, combination chemotherapy regimen.

1.5 Gestational Trophoblastic Neoplasia

COSMEGEN is indicated for the treatment of post-menarchal patients with gestational trophoblastic neoplasia, as a single agent or as part of a combination chemotherapy regimen.

1.6 Regional Perfusion in Locally Recurrent and Locoregional Solid Malignancies

COSMEGEN is indicated for the treatment of adult patients with locally recurrent or locoregional solid malignancies, as a component of palliative or adjunctive regional perfusion.

2 DOSAGE AND ADMINISTRATION

2.1 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.

2.2 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.

2.3 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.

2.4 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.

2.5 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.

2.6 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.

2.7 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)].

3 DOSAGE FORMS AND STRENGTHS

For injection: 500 mcg as a sterile, amorphous yellow to orange, lyophilized powder in a single-dose vial.

4 CONTRAINDICATIONS

None.

5 WARNINGS AND PRECAUTIONS

5.1 Secondary Malignancy or Leukemia

The risk of developing secondary malignancies, including leukemia, is increased following treatment with COSMEGEN.

5.2 Veno-occlusive Disease

Severe and fatal hepatic veno-occlusive disease (VOD) can occur with COSMEGEN. Risk factors for the development of VOD include age younger than 4 years or concomitant radiotherapy. After treatment with COSMEGEN, monitor frequently for signs and symptoms of VOD; these include elevations in AST, ALT, total bilirubin, hepatomegaly, weight gain, or ascites. If patients develop VOD, considering delaying next dose of COSMEGEN. Resume, reduce dose or permanently discontinue based on severity of reaction and disease being treated.

5.3 Extravasation

Extravasation of COSMEGEN can result in severe local tissue injury manifesting as blistering, ulcerations and persistent pain requiring wide excision surgery followed by split-thickness skin grafting. If any signs or symptoms of extravasation occur, immediately interrupt the injection or infusion. Apply ice to the site intermittently for 15 minutes, 4 times a day for 3 days [see Dosage and Administration ( 2.7)] . Observe closely and consult plastic surgery if necessary based on severity of reaction.

5.4 Myelosuppression

Severe and fatal myelosuppression, which may include neutropenia, thrombocytopenia and anemia, can occur with COSMEGEN. The nadir in neutrophil counts generally occurs 14 to 21 days after administration. Obtain complete blood counts prior to each treatment cycle. Delay next dose of COSMEGEN if severe myelosuppression has not improved. Consider dose reduction for patients with prolonged myelosuppression based on severity of reaction and disease being treated.

5.5 Immunizations

The safety with live viral vaccines following COSMEGEN has not been studied and vaccination with live virus vaccines is not recommended before or during treatment.

5.6 Severe Mucocutaneous Reactions

Severe mucocutaneous reactions, such as Steven-Johnson syndrome and Toxic Epidermal Necrolysis (TEN), can occur with COSMEGEN. Permanently discontinue COSMEGEN in patients who experience a severe mucocutaneous reaction.

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