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GLEOSTINE
Head and neck cancer
Leukemias, lymphomas, and other hematologic cancers
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Drug Name:

GLEOSTINE Rx

Generic Name and Formulations:
Lomustine 5mg, 10mg, 40mg, 100mg; caps.

Company:
NextSource Biotechnology, LLC

Therapeutic Use:

Indications for GLEOSTINE:

Treatment of patients with primary and metastatic brain tumors following appropriate surgery and/or radiotherapy.

Adults and Children:

Pretreat with antiemetics and give on empty stomach. Give one dose every 6 weeks. Previously untreated (as a single agent): 130mg/m2. Compromised bone marrow function: 100mg/m2. Combination with other myelosuppressive drugs: reduce dose accordingly. Subsequent doses: adjust according to hematologic response (see full labeling).

Warnings/Precautions:

Risk of delayed and cumulative myelosuppression leading to fatal infections and bleeding. Monitor CBCs weekly for at least 6 weeks after each dose; withhold each subsequent dose for >6 weeks if needed until platelets recover to ≥100,000/mm3 and leukocytes to ≥4000/mm3. Risk of overdosage (fatal toxicity); prescribe only 1 dose for every 6-week cycle. Monitor liver and renal function. Perform pulmonary function tests prior to and frequently during therapy; increased risk of pulmonary toxicity in patients with baseline <70% of the predicted Forced Vital Capacity or Carbon Monoxide Diffusing Capacity; permanently discontinue if pulmonary fibrosis occurs. Pregnancy. Use adequate contraception during therapy and for 2 weeks (females) or 3.5 months (males with female partners) after final dose. Nursing mothers: not recommended (during therapy and for 2 weeks after final dose).

Pharmacological Class:

Alkylating agent.

Adverse Reactions:

Delayed myelosuppression (thrombocytopenia, leukopenia), nausea, vomiting, stomatitis, alopecia; pulmonary toxicity, secondary malignancies, hepatotoxicity, nephrotoxicity.

Note:

Wear gloves when handling capsules. Formerly known under the brand name CeeNu.

How Supplied:

Caps—5

Indications for GLEOSTINE:

As a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy.

Adults and Children:

Pretreat with antiemetics and give on empty stomach. Give one dose every 6 weeks. Previously untreated (as a single agent): 130mg/m2. Compromised bone marrow function: 100mg/m2. Combination with other myelosuppressive drugs: reduce dose accordingly. Subsequent doses: adjust according to hematologic response (see full labeling).

Warnings/Precautions:

Risk of delayed and cumulative myelosuppression leading to fatal infections and bleeding. Monitor CBCs weekly for at least 6 weeks after each dose; withhold each subsequent dose for >6 weeks if needed until platelets recover to ≥100,000/mm3 and leukocytes to ≥4000/mm3. Risk of overdosage (fatal toxicity); prescribe only 1 dose for every 6-week cycle. Monitor liver and renal function. Perform pulmonary function tests prior to and frequently during therapy; increased risk of pulmonary toxicity in patients with baseline <70% of the predicted Forced Vital Capacity or Carbon Monoxide Diffusing Capacity; permanently discontinue if pulmonary fibrosis occurs. Pregnancy. Use adequate contraception during therapy and for 2 weeks (females) or 3.5 months (males with female partners) after final dose. Nursing mothers: not recommended (during therapy and for 2 weeks after final dose).

Pharmacological Class:

Alkylating agent.

Adverse Reactions:

Delayed myelosuppression (thrombocytopenia, leukopenia), nausea, vomiting, stomatitis, alopecia; pulmonary toxicity, secondary malignancies, hepatotoxicity, nephrotoxicity.

Note:

Wear gloves when handling capsules. Formerly known under the brand name CeeNu.

How Supplied:

Caps—5

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