Gleostine 100 mg/1
lomustine · CAPSULE, GELATIN COATED · Azurity Pharmaceuticals, Inc.
Gleostine is a capsule, gelatin coated containing lomustine at 100 mg/1, taken oral. Manufactured by Azurity Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Gleostine
- Generic Name
- lomustine
- NDC Code (Product)
24338-342- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Strength
- 100 mg/1
- Dosage Form
- CAPSULE, GELATIN COATED
- Route
- ORAL
- Marketing Status
- Application #
- NDA017588
- Drug Class
- Alkylating Drug [EPC]
- Marketing Start
- 10/24/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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 ) 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.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dose in adult and pediatric patients is 130 mg/m 2 orally every 6 weeks. ( 2.1 ) Round dose to nearest 10 mg. Give as a single oral dose and do not repeat for at least 6 weeks. 2.1 Important Prescribing and Dispensing Information PRESCRIBE 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 ( 5.2 ) and Overdosage ( 10 )] . 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 b…
Contraindications
4 CONTRAINDICATIONS None.
Adverse Reactions
6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Delayed myelosuppression [see Warnings and Precautions ( 5.1 )] Risks of overdosage [see Warnings and Precautions ( 5.2 )] Pulmonary toxicity [see Warnings and Precautions ( 5.3 )] Secondary malignancies [see Warnings and Precautions ( 5.4 )] Hepatotoxicity [see Warnings and Precautions ( 5.5 )] Nephrotoxicity [see Warnings and Precautions ( 5.6 )] 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 Common adverse reactions include delayed myelosupression, nausea, vomiting, stomatitis, and alopecia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc. at…
Frequently Asked Questions
What is Gleostine used for?
Gleostine contains lomustine. It is a capsule, gelatin coated taken oral. Consult your doctor for specific uses.
Is Gleostine a controlled substance?
Gleostine is not classified as a controlled substance by the DEA.
What is the generic name for Gleostine?
The generic name for Gleostine is lomustine. There are 6 other brand versions of lomustine.
What is the NDC code for Gleostine 100 mg/1?
The NDC (National Drug Code) for Gleostine 100 mg/1 is 24338-342, listed by Azurity Pharmaceuticals, Inc..