Prescription medicine
Lomustine Brand names: Gleostine
Lomustine (Gleostine) is a prescription medicine with an FDA approval on record since 1976. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the lomustine FDA label on DailyMed (effective September 25, 2025, Azurity Pharmaceuticals, Inc.); the NDA 17588 record on Drugs@FDA; every lomustine label on DailyMed.
Highlights of the record
FDA label of September 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
DELAYED MYELOSUPPRESSION AND RISK OF OVERDOSAGE DELAYED MYELOSUPPRESSION.
Gleostine causes myelosuppression including fatal myelosuppression. Myelosuppression is delayed, dose-related, and cumulative; occurring 4 to 6 weeks after drug administration and persisting 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 [see Warnings and Precautions ( 5.1 ), Dosage and Administration ( 2.2 , 2.3 )]. RISK OF OVERDOSAGE PRESCRIBE, DISPENSE, AND ADMINISTER ONLY ENOUGH CAPSULES FOR ONE DOSE. Fatal toxicity occurs with overdosage of Gleostine. Both physician and pharmacist should emphasize to the patient that only one dose of Gleostine is taken every 6 weeks [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.2 ), Overdosage ( 10 )]. WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE See full prescribing information for complete boxed warning. Delayed Myelosuppression Gleostine causes myelosuppression including fatal myelosuppression. Myelosuppression is delayed, dose-related, and cumulative. Thrombocytopenia is generally more severe than leukopenia. […]
Used for
From the label: 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.
Forms and strengths
- 10 mg
- 40 mg
- 100 mg
Gelatin-coated capsule; capsule.
On the market
- Earliest approval on file
- August 4, 1976 Gleostine, Azurity; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first October 27, 2025; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 4 of which 1 under generic applications, 3 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,533 through July 30, 2026
What is lomustine used for?
From the label: 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. ( 1 ) Hodgkin's lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. ( 1 ) 1.1 Brain Tumors Gleostine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. 1.2 Hodgkin's Lymphoma Gleostine is indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy.
FDA pharmacologic class: Alkylating Drug.
Source: FDA drug label (Gleostine), Azurity Pharmaceuticals, Inc., effective September 25, 2025 (SPL set 3529fe2f-3c23-4862-bb20-b48026957082), via openFDA; the full label on DailyMed
Is there a generic for lomustine (Gleostine)?
The FDA approved the first generic lomustine on October 27, 2025. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists lomustine from 1 labeler under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1976 earliest approval on file
- 2025 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for lomustine?
The FDA Adverse Event Reporting System holds 2,533 reports that list lomustine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 575 are coded as a death and 531 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other alkylating drugs
- the pharmacologic class, with prices and generics
- Lomustine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other