Gleostine

— THERAPEUTIC CATEGORIES —
  • Head and neck cancer
  • Leukemias, lymphomas, and other hematologic cancers

Gleostine Generic Name & Formulations

General Description

Lomustine 5mg, 10mg, 40mg, 100mg; caps.

Pharmacological Class

Alkylating agent.

How Supplied

Caps—5

Gleostine Indications

Indications

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

Gleostine Dosage and Administration

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).

Gleostine Contraindications

Not Applicable

Gleostine Boxed Warnings

Boxed Warning

Delayed myelosuppression. Risk of overdosage.

Gleostine Warnings/Precautions

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).

Gleostine Pharmacokinetics

See Literature

Gleostine Interactions

Not Applicable

Gleostine Adverse Reactions

Adverse Reactions

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

Gleostine Clinical Trials

See Literature

Gleostine Note

Notes

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

Gleostine Patient Counseling

See Literature

Gleostine Generic Name & Formulations

General Description

Lomustine 5mg, 10mg, 40mg, 100mg; caps.

Pharmacological Class

Alkylating agent.

How Supplied

Caps—5

Gleostine Indications

Indications

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

Gleostine Dosage and Administration

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).

Gleostine Contraindications

Not Applicable

Gleostine Boxed Warnings

Boxed Warning

Delayed myelosuppression. Risk of overdosage.

Gleostine Warnings/Precautions

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).

Gleostine Pharmacokinetics

See Literature

Gleostine Interactions

Not Applicable

Gleostine Adverse Reactions

Adverse Reactions

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

Gleostine Clinical Trials

See Literature

Gleostine Note

Notes

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

Gleostine Patient Counseling

See Literature