Key facts
- Active ingredient
- Lomustine
- Drug class
- Alkylating Drug
- Form
- Capsule
- Strength
- Lomustine 100MG · Lomustine 10MG · Lomustine 40MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- brain neoplasms, colonic neoplasms, hodgkin disease
- Manufacturer
- Carnegie
- Half-life
- about 16 to 48 hours — but note this is the half-life of lomustine's metabolites, not the parent drug (how long it stays in your system)
- FDA application
- ANDA219265
- FDA boxed warning
- Yes — see the boxed warning
What is Lomustine?
From the FDA label: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). The chemical structure is: Lomustine Capsules, USP are supplied as 10 mg, 40 mg, and 100 mg capsules and contain the following inactive ingredients: magnesium stearate NF and mannitol USP. The 10 mg capsule shells are composed of gelatin and titanium dioxide. The 40 mg and 100 mg capsule shells are composed of FD&C blue #1, gelatin, iron oxide black, iron oxide yellow, and titanium dioxide. The capsules are printed with black ink composed of iron oxide black, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. FDA approved dissolution method is not listed in the USP Monograph for Lomustine Capsules, USP, 10 mg, 40 mg, and 100 mg. image description
How to use
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. Instruct patients that Lomustine Capsules are 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) ]. Lomustine Capsules 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 Lomustine Capsules. Do not break Lomustine Capsules; avoid exposure to broken capsules. If dermal contact occurs, wash areas of skin contact immediately and thoroughly. 2.2 Recommended Dose The recommended dose of Lomustine Capsules in adult…
Side effects
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. 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 Carnegie Pharmaceuticals LLC at 1-732-783-7010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
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. Monitor blood counts for at least 6 weeks after each dose. Do not give Lomustine Capsules more frequently than every 6 weeks [see Warnings and Precautions (5.1) , Dosage and Administration (2.2 , 2.3) ]. RISK OF OVERDOSAGE PRESCRIBE, DISPENSE, AND ADMINISTER ONLY ENOUGH CAPSULES FOR ONE DOSE. Fatal toxicity occurs with overdosage of Lomustine Capsules. Both physician and pharmacist should emphasize to the patient that only one dose of Lomustine Capsules is taken every 6 weeks [see Dosage and Administration (2.1) , Warnings and Precautions (5.2) , Overdosage (10) ]. WARNING: DELAYED MYELOSUPPRESSION and RISK OF OVERDOSAGE See full prescribing information for complete boxed warning. Delayed Myelosuppression Lomustine Capsules cause myelosuppression including fatal myelosuppression. Myelosuppression is delayed, dose-related, and cumulative. Thrombocytopenia is generally more severe than leukopenia. Monitor blood counts and do not give Lomustine Capsules more frequently than every 6 weeks. ( 2.2 , 2.3 , 5.1 ) Risk of Overdosage PRESCRIBE, DISPENSE, AND ADMINISTER ONLY ENOUGH CAPSULES FOR ONE DOSE. Fatal toxicity occurs with overdosage of Lomustine Capsules. Both physician and pharmacist should emphasize to patient that only one dose of Lomustine Capsules is taken every 6 weeks. ( 2.1 , 5.2 , 10 )
Warnings
Important safety information
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. (5.7 , 8.1 , 8.3) 5.1 Delayed Myelosuppression Lomustine Capsules cause myelosuppression that can result in fatal infections and bleeding. Myelosuppression from Lomustine Capsules is delayed, dose-related, and cumulative. It usually occurs 4 to 6 weeks after drug administration and persists 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. Monitor blood counts for at least 6 weeks after each dose. Do not give Lomustine Capsules more frequently than every 6 weeks. Adjust dose based on nadir blood counts from prior dose [see Dosage and Administration (2.3) ]. 5.2 Risk of Overdosage Fatal toxicity occurs with overdosage of Lomustine Capsules. 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. Both physician and pharmacist should emphasize to the patient that only one dose of Lomustine Capsules is taken every 6 weeks [see Dosage and Administration (2.1) and Overdosage (10) ]. 5.3 Pulmonary Toxicity Pulmonary toxicity characterized by pulmonary infiltrates and/or fibrosis occurs with Lomustine Capsules. Patients with a baseline below 70% of the predicted Forced Vital Capacity (FVC) or Carbon Monoxide Diffusing Capacity (DL CO ) are at increased risk. The onset of pulmonary toxicity occurs after an interval of 6 months or longer from the start of therapy, with cumulative doses of Lomustine Capsules usually greater than 1100 mg/m 2 . Obtain baseline pulmonary function tests prior to initiating treatment and repeat frequently during treatment. Permanently discontinue Lomustine Capsules in patients diagnosed with pulmonary fibrosis. 5.4 Secondary Malignancies Secondary malignancies, including acute leukemia and myelodysplasia, occur with long term use. 5.5 Hepatotoxicity Hepatic toxicity, manifested by increased levels of transaminases, alkaline phosphatase, and bilirubin occurs with Lomustine Capsules. Monitor liver function. 5.6 Nephrotoxicity Progressive renal failure with a decrease in kidney size occurs with Lomustine Capsules. Monitor renal function. 5.7 Embryo-Fetal Toxicity Based on animal data and its mechanism of action, Lomustine Capsules can cause fetal harm when administered to a pregnant woman. Embryo-fetal toxicity and teratogenicity occurred in rats and rabbits receiving lomustine daily during organogenesis at doses 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 body surface area (BSA). Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Lomustine Capsules and for 2 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Lomustine Capsules and for 3.5 months after the final dose [see Use in Specific Populations (8.1 , 8.3) ]. 5.1 Delayed Myelosuppression Lomustine Capsules cause myelosuppression that can result in fatal infections and bleeding. Myelosuppression from Lomustine Capsules is delayed, dose-related, and cumulative. It usually occurs 4 to 6 weeks after drug administration and persists 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. Monitor blood counts for at least 6 weeks after each dose. Do not give Lomustine Capsules more frequently than every 6 weeks. Adjust dose based on nadir blood counts from prior dose [see Dosage and Administration (2.3) ]. 5.2 Risk of Overdosage Fatal toxicity occurs with overdosage of Lomustine Capsules. 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. Both physician and pharmacist should emphasize to the patient that only one dose of Lomustine Capsules is taken every 6 weeks [see Dosage and Administration (2.1) and Overdosage (10) ]. 5.3 Pulmonary Toxicity Pulmonary toxicity characterized by pulmonary infiltrates and/or fibrosis occurs with Lomustine Capsules. Patients with a baseline below 70% of the predicted Forced Vital Capacity (FVC) or Carbon Monoxide Diffusing Capacity (DL CO ) are at increased risk. The onset of pulmonary toxicity occurs after an interval of 6 months or longer from the start of therapy, with cumulative doses of Lomustine Capsules usually greater than 1100 mg/m 2 . Obtain baseline pulmonary function tests prior to initiating treatment and repeat frequently during treatment. Permanently discontinue Lomustine Capsules in patients diagnosed with pulmonary fibrosis. 5.4 Secondary Malignancies Secondary malignancies, including acute leukemia and myelodysplasia, occur with long term use. 5.5 Hepatotoxicity Hepatic toxicity, manifested by increased levels of transaminases, alkaline phosphatase, and bilirubin occurs with Lomustine Capsules. Monitor liver function. 5.6 Nephrotoxicity Progressive renal failure with a decrease in kidney size occurs with Lomustine Capsules. Monitor renal function. 5.7 Embryo-Fetal Toxicity Based on animal data and its mechanism of action, Lomustine Capsules can cause fetal harm when administered to a pregnant woman. Embryo-fetal toxicity and teratogenicity occurred in rats and rabbits receiving lomustine daily during organogenesis at doses 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 body surface area (BSA). Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with Lomustine Capsules and for 2 weeks after the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with Lomustine Capsules and for 3.5 months after the final dose [see Use in Specific Populations (8.1 , 8.3) ].
Who should not take Lomustine
None.
Overdose — what happens if you take too much
Overdosage with Lomustine Capsules has occurred, including fatal cases [see Dosage and Administration (2.1) , Warnings and Precautions (5.2) ] . Overdosage causes severe myelosuppression, as well as abdominal pain, diarrhea, vomiting, anorexia, lethargy, dizziness, abnormal hepatic function, cough, and shortness of breath. No antidotes exist for Lomustine Capsules overdosage.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
How long does Lomustine stay in your body?
The elimination half-life of lomustine is about 16 to 48 hours — but note this is the half-life of lomustine's metabolites, not the parent drug — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. Important scope: the Gleostine (lomustine) FDA label does NOT report an elimination half-life for the parent drug. Its Pharmacokinetics section (12.3, "Elimination") states only that "the serum half-life of lomustine metabolites ranges from 16 hours to 48 hours." Lomustine (a nitrosourea) is rapidly and extensively metabolized after oral dosing — the parent is essentially not quantified, and its active metabolites are the pharmacologically and clinically relevant species, which is why the label tracks metabolite half-life rather than parent. The label does not resolve this into distribution vs. terminal phases; the 16–48 h is the single range given. Specific populations: the label explicitly says the impact of age, sex, race, renal impairment, and hepatic impairment on lomustine pharmacokinetics is UNKNOWN — no adjustment values are provided. This figure is not a drug-test detection window and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: Gleostine (lomustine) FDA label — DailyMed, §12.3 Pharmacokinetics.
Drug class
How this class works, per Cyclophosphamide — StatPearls, NCBI Bookshelf (NIH).
May treat (source: NIH RxClass)
See how Lomustine ranks — best-rated alkylating drug for:
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Lomustine treat?
- Lomustine (Lomustine) may be used to treat brain neoplasms, colonic neoplasms, hodgkin disease, kidney neoplasms, lung neoplasms, non-hodgkin lymphoma, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Lomustine work?
- Lomustine is a alkylating drug. Alkylating chemotherapy drugs attach chemical groups to a cell's DNA, forming cross-links that lock the two DNA strands together. This damage stops the cell from copying its DNA and dividing, which triggers it to die; because they are not limited to one phase of the cell cycle, they can act on cells whether or not they are actively dividing.
- Is there a coupon or discount for Lomustine?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lomustine. To pay less, Lomustine is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lomustine?
- Lomustine is marketed by Carnegie. You can see Carnegie's full profile, rating, and other products on pharmaranks.
- Is Lomustine a brand-name or generic drug?
- Lomustine is a generic medication; its active ingredient is Lomustine. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Lomustine available over the counter?
- No. Lomustine is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lomustine come in?
- Lomustine is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Lomustine?
- Lomustine is classified as alkylating drug, per the FDA's Established Pharmacologic Class.
- Is Lomustine FDA-registered?
- Lomustine is on record with the U.S. FDA under application number ANDA219265. You can verify this on its official FDA label.
- Is Lomustine safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Lomustine. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Lomustine?
- Lomustine's side effects are taken directly from its FDA label. From the label: 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 malig… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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