Gleostine Generic Name & Formulations
Legal Class
Rx
General Description
Lomustine 5mg, 10mg, 40mg, 100mg; caps.
Pharmacological Class
Alkylating agent.
How Supplied
Caps—5
Manufacturer
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
Legal Class
Rx
General Description
Lomustine 5mg, 10mg, 40mg, 100mg; caps.
Pharmacological Class
Alkylating agent.
How Supplied
Caps—5
Manufacturer
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