Gleostine - Lomustine capsule, Gelatin Coated Prescribing Information
Gleostine causes myelosuppression that can result in fatal infections and bleeding. Myelosuppression from Gleostine is delayed, dose-related, and cumulative. It usually occurs 4 to 6 weeks after drug administration and persists for 1 to 2 weeks. Thrombocytopenia is generally more severe than leukopenia. Cumulative myelosuppression from Gleostine is manifested by greater severity and longer duration of cytopenias.
Monitor blood counts for at least 6 weeks after each dose. Do not give Gleostine more frequently than every 6 weeks. Adjust dose based on nadir blood counts from prior dose
The recommended dose of Gleostine in adult and pediatric patients is 130 mg/m2taken as a single oral dose every 6 weeks. Round doses to the nearest 10 mg. Give as a single oral dose and do not repeat for at least 6 weeks. Reduce dose to 100 mg/m2every 6 weeks in patients with compromised bone marrow function. Also reduce dose accordingly when using with other myelosuppressive drugs.
Perform weekly complete blood counts and withhold each subsequent dose for more than 6 weeks if needed until platelet counts recover to 100,000/mm3or greater and leukocytes recover to 4000/mm3or greater
Modify each dose of Gleostine according to the hematologic response of the preceding dose as described in Table 1:
Nadir After Prior Dose | Dose Adjustment | |
Leukocytes (/mm3) | Platelets (/mm3) | |
≥ 4000 | ≥ 100,000 | None |
3000 – 3999 | 75,000 – 99,999 | None |
2000 – 2999 | 25,000 – 74,999 | Reduce dose by 30% |
< 2000 | < 25,000 | Reduce dose by 50% |
Confirm the total dose prescribed by the physician and the appropriate combination of capsule strengths.
Dispense only the appropriate number of Gleostine capsules required for the administration of a single dose.
The prescribed dose may consist of two or more different strengths and colors of capsules.
Instruct patients that Gleostine is taken as a single oral dose and will not be repeated for at least 6 weeks. Taking more than the recommended dose causes toxicities, including fatal outcomes
Gleostine is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
To minimize the risk of dermal exposure, always wear impervious gloves when handling bottles containing Gleostine capsules. Do not break Gleostine capsules; avoid exposure to broken capsules. If dermal contact occurs, wash areas of skin contact immediately and thoroughly.
Fatal toxicity occurs with overdosage of Gleostine. Dispensing or administering more than one dose can lead to fatal toxicity.
Prescribe only one dose at a time. Dispense only enough capsules for one dose. Both physician and pharmacist should emphasize to the patient that only one dose of Gleostine is taken every 6 weeks
Overdosage with Gleostine has occurred, including fatal cases
No antidotes exist for Gleostine overdosage.
Gleostine is an alkylating drug indicated for the treatment of patients with:
- Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures. ()
1 INDICATIONS AND USAGEGleostine is an alkylating drug indicated for the treatment of patients with:
- Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures.
- Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy.
1.1 Brain TumorsGleostine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures.
1.2 Hodgkin's LymphomaGleostine is indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy.
- Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ()
1 INDICATIONS AND USAGEGleostine is an alkylating drug indicated for the treatment of patients with:
- Brain tumors, primary and metastatic, following appropriate surgical and/or radiotherapeutic procedures.
- Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy.
1.1 Brain TumorsGleostine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures.
1.2 Hodgkin's LymphomaGleostine is indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy.
- Recommended dose in adult and pediatric patients is 130 mg/m
2orally every 6 weeks. ()2.1 Important Prescribing and Dispensing InformationPRESCRIBE ONLY ONE DOSE FOR EACH TREATMENT CYCLE. DO NOT DISPENSE ENTIRE CONTAINER.Dispense only a sufficient number of capsules for one dose.Confirm the total dose prescribed by the physician and the appropriate combination of capsule strengths.
Dispense only the appropriate number of Gleostine capsules required for the administration of a single dose.
The prescribed dose may consist of two or more different strengths and colors of capsules.
Instruct patients that Gleostine is taken as a single oral dose and will not be repeated for at least 6 weeks. Taking more than the recommended dose causes toxicities, including fatal outcomes
[see Warnings and Precautions and Overdosage ].Gleostine is a cytotoxic drug. Follow applicable special handling and disposal procedures.1
To minimize the risk of dermal exposure, always wear impervious gloves when handling bottles containing Gleostine capsules. Do not break Gleostine capsules; avoid exposure to broken capsules. If dermal contact occurs, wash areas of skin contact immediately and thoroughly.
- Round dose to nearest 10 mg.
- Give as a single oral dose and do not repeat for at least 6 weeks.
Gleostine capsules are available in three strengths, distinguishable by the color of the capsules:
- 100 mg capsules (green/green)
- 40 mg capsules (white/green)
- 10 mg capsules (white/white)
Lactation: Do not breastfeed. (
There is no information on the presence of lomustine or its metabolites in human milk, its effects on the breastfed infant, or its effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from Gleostine, advise women not to breastfeed during treatment with Gleostine and for 2 weeks after the final dose.
None.