Lomustine
Generic Name: lomustine
Brand Names:
Lomustine
11 DESCRIPTION Lomustine Capsules, USP (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 9 H 16 ClN 3 O 2 . The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL).
Overview
11 DESCRIPTION Lomustine Capsules, USP (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 9 H 16 ClN 3 O 2 . The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water (<0.05 mg per mL).
Uses
1 INDICATIONS AND USAGE 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. (1) Hodgkin’s lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. (1) 1.1 Brain Tumors Lomustine Capsules are indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. 1.2 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
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 5 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 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.
Side Effects
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 Lomustine Capsules 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.
Warnings
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. Cumulative myelosuppression from Lomustine Capsules is manifested by greater severity and longer duration of cytopenias. 5 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. (5.3) Secondary malignancies : Acute leukemia and myelodysplasia can occur with long-term use. (5.4) Hepatotoxicity : Increased levels of transaminases, alkaline phosphatase and bilirubin can occur with Lomustine Capsules. Monitor liver function. (5.5) Nephrotoxicity : Can cause renal failure. Monitor renal function. (5.6) 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. 4 CONTRAINDICATIONS None.
Pregnancy
8.1 Pregnancy Risk Summary Based on animal data and its mechanism of action, Lomustine Capsules can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. There are no available data on Lomustine Capsules exposure in pregnant women. Lomustine was teratogenic in rats and embryotoxic in rabbits at total dose levels approximately two to four times the total human dose of 130 mg/m 2 over 6 weeks (0.18 to 0.27 times the single human dose of 130 mg/m 2 ) based on BSA [see Data] . Advise pregnant women of the potential risk to a fetus. In the U.S.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 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 powder.
Frequently Asked Questions
What is Lomustine used for?▼
1 INDICATIONS AND USAGE 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. (1) Hodgkin’s lymphoma in combination with other chemotherapies, following disease progression with initial chemotherapy. (1) 1.1 Brain Tumors Lomustine Capsules are indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures. 1.2 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.
What are the side effects of Lomustine?▼
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 Lomustine Capsules 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.
Can I take Lomustine during pregnancy?▼
8.1 Pregnancy Risk Summary Based on animal data and its mechanism of action, Lomustine Capsules can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. There are no available data on Lomustine Capsules exposure in pregnant women. Lomustine was teratogenic in rats and embryotoxic in rabbits at total dose levels approximately two to four times the total human dose of 130 mg/m 2 over 6 weeks (0.18 to 0.27 times the single human dose of 130 mg/m 2 ) based on BSA [see Data] . Advise pregnant women of the potential risk to a fetus. In the U.S.
What are the important warnings for Lomustine?▼
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. Cumulative myelosuppression from Lomustine Capsules is manifested by greater severity and longer duration of cytopenias. 5 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. (5.3) Secondary malignancies : Acute leukemia and myelodysplasia can occur with long-term use. (5.4) Hepatotoxicity : Increased levels of transaminases, alkaline phosphatase and bilirubin can occur with Lomustine Capsules. Monitor liver function. (5.5) Nephrotoxicity : Can cause renal failure. Monitor renal function. (5.6) 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. 4 CONTRAINDICATIONS None.
Related Medications
Ragweed, Mixed Ambrosia
ragweed, mixed ambrosia
Dosage form: INJECTION, SOLUTION. Route: PERCUTANEOUS, SUBCUTANEOUS. Active ingredients: AMBROSIA ARTEMISIIFOLIA POLLEN (.05 g/mL); AMBROSIA TRIFIDA POLLEN (.05 g/mL). Category: BLA.
Classic
classic
Purpose Sunscreens
Onion, Apis Mellifera, Drosera Rotundifolia, Euphrasia Stricta, Urtica Urens
onion, apis mellifera, drosera rotundifolia, euphrasia stricta, urtica urens
Standardized Insect Venom Allergenic Extract [EPC]
Purpose: Temporarily relieves sneezing, coughing, runny nose, nasal congestion, itchy watery eyes and swelling.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.