Brand Name
Gleostine
Generic Name
Lomustine
View Brand Information FDA approval date: August 18, 2014
Classification: Alkylating Drug
Form: Capsule
What is Gleostine (Lomustine)?
Lomustine Capsules are 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. Brain Tumors Lomustine Capsules are indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. Hodgkin’s Lymphoma Lomustine Capsules are indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin’s lymphoma whose disease has progressed following initial chemotherapy.
Approved To Treat
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Brand Information
Gleostine (lomustine)
WARNING: 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 .
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 .
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 .
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 .
1DOSAGE FORMS AND STRENGTHS
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)
2CONTRAINDICATIONS
None.
3ADVERSE REACTIONS
The following serious adverse reactions are discussed in greater detail in other sections of the labeling:
- Delayed myelosuppression
- Risks of overdosage
- Pulmonary toxicity
- Secondary malignancies
- Hepatotoxicity
- Nephrotoxicity
The following adverse reactions associated with the use of Gleostine were identified in clinical trials or postmarketing reports. Because these reactions were reported from a population of uncertain size, it is not possible to estimate their frequency, reliability, or establish a causal relationship to drug exposure.
Gastrointestinal disorders: nausea, vomiting, and stomatitis
Ocular disorders: optic atrophy, visual disturbances, and blindness
Neurologic disorders: disorientation, lethargy, ataxia, and dysarthria
Other: alopecia
4OVERDOSAGE
Overdosage with Gleostine has occurred, including fatal cases
No antidotes exist for Gleostine overdosage.
5DESCRIPTION
Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2-chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C
The chemical structure is:
Gleostine is supplied as 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2.
6REFERENCES
OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
7PATIENT COUNSELING INFORMATION
Myelosuppression
Advise patients that periodic assessment of their blood counts are required. Advise patients to contact their healthcare provider for new onset of bleeding or fever or symptoms of infection [see Warnings and Precautions (
Overdosage
Advise patients that toxicity including fatal toxicity occurs with Gleostine overdosage [see Warnings and Precautions (.
Advise patients to take Gleostine as directed:
Advise patients that periodic assessment of their blood counts are required. Advise patients to contact their healthcare provider for new onset of bleeding or fever or symptoms of infection [see Warnings and Precautions (
Overdosage
Advise patients that toxicity including fatal toxicity occurs with Gleostine overdosage [see Warnings and Precautions (.
Advise patients to take Gleostine as directed:
- Gleostine is taken as a single oral dose that will not be repeated for at least 6 weeks.
- Use of the recommended dose at less than 6 week intervals leads to toxicities including fatal toxicities.
- Each dose may consist of 2 or more different strengths and colors of capsules.
Pulmonary Fibrosis
Advise patients to contact their healthcare provider for new or worsening cough, chest pain, or shortness of breath [see Warnings and Precautions (
Hepatotoxicity
Inform patients that Gleostine can cause hepatotoxicity and that liver function monitoring during treatment is necessary [see Warnings and Precautions (.
Nephrotoxicity
Inform patients that Gleostine can cause nephrotoxicity and that renal function and electrolyte monitoring during treatment is necessary [see Warnings and Precautions (.
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (.
Advise females of reproductive potential to use effective contraception during treatment with Gleostine and for at least 2 weeks after the final dose [see Use in Specific Populations (.
Advise male patients with female partners of reproductive potential to use condoms during treatment with Gleostine and for 3.5 months after the final dose [see Use in Specific Populations (
Lactation
Advise women not to breastfeed during treatment with Gleostine and for 2 weeks after the final dose [see Use in Specific Populations (
Infertility
Advise females and males of reproductive potential of the potential for reduced fertility from Gleostine [see Use in Specific Populations (.
Gleostine® is a registered trademark of Azurity Pharmaceuticals, Inc.
Manufactured by Latina Pharma S.p.A., Sermoneta (LT), Italy for:
Azurity Pharmaceuticals, Inc.
Woburn, MA 01801 USA
Rev.00 SEP2025
Advise patients to contact their healthcare provider for new or worsening cough, chest pain, or shortness of breath [see Warnings and Precautions (
Hepatotoxicity
Inform patients that Gleostine can cause hepatotoxicity and that liver function monitoring during treatment is necessary [see Warnings and Precautions (.
Nephrotoxicity
Inform patients that Gleostine can cause nephrotoxicity and that renal function and electrolyte monitoring during treatment is necessary [see Warnings and Precautions (.
Embryo-Fetal Toxicity
Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (.
Advise females of reproductive potential to use effective contraception during treatment with Gleostine and for at least 2 weeks after the final dose [see Use in Specific Populations (.
Advise male patients with female partners of reproductive potential to use condoms during treatment with Gleostine and for 3.5 months after the final dose [see Use in Specific Populations (
Lactation
Advise women not to breastfeed during treatment with Gleostine and for 2 weeks after the final dose [see Use in Specific Populations (
Infertility
Advise females and males of reproductive potential of the potential for reduced fertility from Gleostine [see Use in Specific Populations (.
Gleostine® is a registered trademark of Azurity Pharmaceuticals, Inc.
Manufactured by Latina Pharma S.p.A., Sermoneta (LT), Italy for:
Azurity Pharmaceuticals, Inc.
Woburn, MA 01801 USA
Rev.00 SEP2025