Finished product reference
Lomustine
Capsule · Oral · 40 mg
- List code
- 769
- Pharmacologic class
- Alkylating Drug
WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE DELAYED MYELOSUPPRESSION Lomustine Capsules cause 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.
What it is and how it works
Mechanism of Action Lomustine alkylates DNA and RNA. As with other nitrosoureas, it may also inhibit several key enzymatic processes by carbamoylation of amino acids in proteins.
Mechanism class: Alkylating Activity
Indications
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. 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.
Dosage and administration (summary)
Recommended dose in adult and pediatric patients is 130 mg/m 2 orally every 6 weeks. Round dose to nearest 5 mg. Give as a single oral dose and do not repeat for at least 6 weeks. 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 Lomustine Capsules required for the administration of a single dose. The prescribed dose may consist of two or more different strengths and colors of capsules.
Contraindications
None.
Warnings and precautions
Pulmonary toxicity : Pulmonary infiltrates and/or fibrosis occurs with Lomustine Capsules. Perform pulmonary function tests prior to treatment and repeat frequently. Permanently discontinue Lomustine Capsules in patients diagnosed with pulmonary fibrosis. Secondary malignancies : Acute leukemia and myelodysplasia can occur with long-term use. Hepatotoxicity : Increased levels of transaminases, alkaline phosphatase and bilirubin can occur with Lomustine Capsules. Monitor liver function. Nephrotoxicity : Can cause renal failure. Monitor renal function.
Pregnancy
Pregnancy Risk Summary Based on animal data and its mechanism of action, Lomustine Capsules can cause fetal harm when administered to a pregnant woman . There are no available data on Lomustine Capsules exposure in pregnant women.
Storage and supply
How Supplied Lomustine Capsules, USP are available in three strengths, distinguishable by the color of the capsules, in individual bottles of 5 capsules each: Strength Capsule Description NDC Code 100 mg Hard gelatin capsule shell with light green opaque body and light green opaque cap, imprinted with black ink “CP116” on cap, containing white powd…
Source: Lomustine (Lomustine) — US FDA prescribing information, 2025-10-28, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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