Usual Adult Dose for Squamous Cell Carcinoma

0.25 to 0.5 units/kg (10 to 20 units/m2) IV, IM, or subcutaneously 1 to 2 times a week

Comments:

• Squamous cell carcinoma sometimes requires 3 weeks before any improvement is noted.
• When this drug is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.

Uses: Squamous Cell Carcinoma: Head and neck (including mouth, tongue, tonsil, nasopharynx, oropharynx, sinus, palate, lip, buccal mucosa, gingivae, epiglottis, skin, larynx), penis, cervix, and vulva; the response to this drug is poorer in patients with previously irradiated head and neck cancer

Usual Adult Dose for non-Hodgkin's Lymphoma

NOTE: Because of the possibility of an anaphylactic reaction, the manufacturer recommends that lymphoma patients be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed.

0.25 to 0.5 units/kg (10 to 20 units/m2) IV, IM, or subcutaneously 1 to 2 times a week

Comments:

• When this drug is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.

Use: Non-Hodgkin's lymphoma

Usual Adult Dose for Testicular Cancer

0.25 to 0.5 units/kg (10 to 20 units/m2) IV, IM, or subcutaneously 1 to 2 times a week

Comments:

• Improvement in testicular tumors is prompt and noted within 2 weeks. If no improvement is seen at this time, improvement is unlikely.
• When this drug is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.

Uses: Testicular Carcinoma (embryonal cell, choriocarcinoma, and teratocarcinoma)

Usual Adult Dose for Hodgkin's Disease

NOTE: Because of the possibility of an anaphylactic reaction, the manufacturer recommends that lymphoma patients be treated with 2 units or less for the first 2 doses. If no acute reaction occurs, then the regular dosage schedule may be followed.

0.25 to 0.5 units/kg (10 to 20 units/m2) IV, IM, or subcutaneously 1 to 2 times a week; after a 50% response, a maintenance dose of 1 unit daily or 5 units weekly IV or IM should be given

Comments:

• Improvement in Hodgkin's Disease is prompt and noted within 2 weeks. If no improvement is seen at this time, improvement is unlikely.
• When this drug is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.

Use: Hodgkin's disease

Usual Adult Dose for Malignant Pleural Effusion

60 units administered as a single bolus intrapleural injection

Comments:

• When this drug is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.

Use: This drug is effective as a sclerosing agent for the treatment of malignant pleural effusion and prevention of recurrent pleural effusions

Renal Dose Adjustments

The manufacturer recommends the following dose adjustments in patients with renal impairment:
CrCl 50 mL/minute or greater: No adjustment recommended.
CrCl 40 to 50 mL/minute: Administer 70% of normal dose.
CrCl 30 to 40 mL/minute: Administer 60% of normal dose.
CrCl 20 to 30 mL/minute: Administer 55% of normal dose.
CrCl 10 to 20 mL/minute: Administer 45% of normal dose.
CrCl 5 to 10 mL/minute: Administer 40% of normal dose.

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:

• This drug should only be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents.
• Appropriate management of therapy and complications is possible only when adequate diagnostic and treatment facilities are readily available.
• Pulmonary fibrosis is the most severe toxicity associated with this drug. The most common presentation is pneumonitis which may progress to pulmonary fibrosis. Occurrence is higher in elderly patients and in those receiving greater than 400 units, but has been observed in young patients and those treated with low doses.
• A severe idiosyncratic reaction consisting of hypotension, mental confusion, fever, chills, and wheezing has been reported in approximately 1% of lymphoma patients treated with this drug.

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Procedures for proper handling and disposal of anticancer drugs should be utilized.
• To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing this drug.
• If this drug contacts the skin, immediately wash the skin thoroughly with soap and water.
• If contact with mucous membranes occurs, the membranes should be flushed immediately and thoroughly with water.
• Observe patients during and after therapy.
• This drug should be used with extreme caution in patients with compromised pulmonary function. Pulmonary toxicity appears to be dose related with a substantial increase when the total dose is over 400 units.
• When this drug is used in combination with other antineoplastic agents, pulmonary toxicities may occur at lower doses.

Storage requirements:

• The sterile powder is stable under refrigeration 2C to 8C (36F to 46F) and should not be used after the expiration date is reached.

Reconstitution/preparation techniques:

• The manufacturer product information should be consulted. Different routes of administration require different reconstitution technique.