Lomoother 40mg Capsule

Lomustine 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. Brain Tumors Lomustine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. Hodgkin's Lymphoma Lomustine is indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Boxed warning. DELAYED MYELOSUPPRESSION AND RISK OF OVERDOSAGE DELAYED MYELOSUPPRESSION Lomustine 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 Lomustine is manifested by greater severity and longer duration of cytopenias. Monitor blood counts for at least 6 weeks after each dose. Do not give Lomustine 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 Lomustine. Both physician and pharmacist should emphasize to the patient that only one dose of Lomustine is taken every 6 weeks. WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE See full prescribing information for complete boxed warning. Delayed Myelosuppression Lomustine causes myelosuppression including fatal myelosuppression. Monitor blood counts and do not give Lomustine more frequently than every 6 weeks. Both physician and pharmacist should emphasize to patient that only one dose of Lomustine is taken every 6 weeks. Pulmonary toxicity: Pulmonary infiltrates and/or fibrosis occurs with Lomustine. Perform pulmonary function tests prior to treatment and repeat frequently. Permanently discontinue Lomustine 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. Monitor liver function. Nephrotoxicity: Can cause renal failure. Monitor renal function. Embryo-fetal toxicity: Can cause fetal harm. Advise males and females of reproductive potential of the potential risk to a fetus and to use effective contraception. Delayed Myelosuppression Lomustine causes myelosuppression that can result in fatal infections and bleeding. Myelosuppression from Lomustine is delayed, dose-related, and cumulative. It usually occurs 4 to 6 weeks after drug administration and persists for 1 to 2 weeks. Adjust dose based on nadir blood counts from prior dose. Risk of Overdosage Fatal toxicity occurs with overdosage of Lomustine. 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. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

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 Lomustine 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.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.