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Lomustine

Lomustine is an oral chemotherapy drug (an alkylating drug) used to treat primary and metastatic brain tumors and, in combination with other chemotherapy, Hodgkin's lymphoma that has progressed after initial chemotherapy.

Brand name Gleostine
Drug class Alkylating Drug
Rx Form 1
Dr. Brian Staiger, PharmD, BCPS
Reviewed by Last reviewed Jul 10, 2026 Content updated Oct 2, 2026
🧬 Where this information comes from Click to expand

The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 4 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →

✓No current FDA shortage listed · checked Oct 5, 2026
Lomustine at a glance The quick version — the full detail is in the Patient Information Guide below.
Dr. Brian Staiger, PharmD, BCPS
The Pharmacist’s Take By · Clinical pharmacist · Written

Lomustine (Gleostine) is an older oral chemotherapy, an alkylating drug that damages cancer cells’ DNA and RNA and reaches into the brain, used by specialists for brain tumors after surgery or radiation and, with other chemotherapy, for Hodgkin's lymphoma that has progressed; it has been around since the 1970s and is available as a generic. Nausea and vomiting on dose day are the usual rough patch, with mouth sores or thinning hair possible. Its boxed warning covers fatal overdose from taking more than one dose and delayed, worsening drops in blood counts about 4 to 6 weeks later, so report fever, bleeding, bruising or new breathing trouble promptly.

Clinical pearls

  • Your dose may mix capsules of different colors and strengths, all swallowed together once, then none for at least 6 weeks.
  • Keep every blood test for at least 6 weeks after each dose, because counts drop late and platelets usually fall hardest.
  • This cell-killing drug should never be opened or broken; wash well if a broken capsule’s contents touch your skin.
  • Tell every prescriber you take lomustine, since other drugs that suppress bone marrow may mean your dose needs lowering.
How we write & review this content — our editorial policy →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾

Lomustine can cause serious, even fatal, drops in blood counts, and taking too many capsules can be fatal.

The drop in blood cells is delayed. It usually shows up 4 to 6 weeks after a dose and lasts 1 to 2 weeks. It gets worse with repeated doses. Platelets (which help blood clot) are usually hit harder than white blood cells. Your blood counts should be checked for at least 6 weeks after each dose, and doses should be no closer than every 6 weeks.

Only one dose is taken every 6 weeks. Your doctor and pharmacist should make this clear, and only enough capsules for one dose should be dispensed. Watch for fever, infection signs, and unusual bleeding or bruising, and get medical help promptly.

Read the full warning on DailyMed →
How you get itPrescription only
Comes asCapsule
Earliest FDA record1976
Companies listing it with the FDA4
FDA label last updatedSep 25, 2025
FDA’s strongest warning (boxed)Yes, read the warning

Patient information guide A plain-language walkthrough of Lomustine, written from its FDA label.

What Lomustine is used for

▾

Lomustine is an oral chemotherapy used for these conditions:

  • Primary and metastatic brain tumors, after appropriate surgery and/or radiation (Gleostine and Lomustine capsules).
  • Hodgkin's lymphoma, as part of combination chemotherapy, after the disease has progressed following initial chemotherapy (Gleostine and Lomustine capsules).

How Lomustine works

▾

Lomustine is an alkylating drug. It damages DNA and RNA in cells, which interferes with their ability to grow and divide. Like other drugs in its class (nitrosoureas), it may also block key enzyme processes by chemically modifying proteins.

Lomustine dosage

▾

Lomustine capsules (including Gleostine) are taken by mouth as one single dose. The dose is not repeated for at least 6 weeks.

  • Your dose may combine capsules of different strengths and colors.
  • Your prescriber may lower the dose if you have reduced bone marrow function, take other bone marrow-suppressing drugs, or had low blood counts after your last dose.
  • Your next dose may be delayed until blood counts recover.
  • Do not break the capsules. Anyone handling the bottle should wear impervious gloves.

Dosing details from the FDA-approved label

From the Lomustine prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.

  • Adult and pediatric patients (recommended dose)
    • 130 mg/m2 taken as a single oral dose every 6 weeks
    • Do not repeat for at least 6 weeks
    • Round dose to nearest 10 mg (Gleostine and gelatin coated lomustine labels) or nearest 5 mg (Lomustine Capsules label)
  • Patients with compromised bone marrow function
    • 100 mg/m2 every 6 weeks
    • Also reduce dose accordingly when using with other myelosuppressive drugs
  • Dose modification: nadir leukocytes 2000 - 2999/mm3 or platelets 25,000 - 74,999/mm3 after prior dose
    • Reduce dose by 30%
    • Perform weekly complete blood counts; withhold subsequent dose for more than 6 weeks if needed until platelets recover to 100,000/mm3 or greater and leukocytes recover to 4000/mm3 or greater
  • Dose modification: nadir leukocytes < 2000/mm3 or platelets < 25,000/mm3 after prior dose
    • Reduce dose by 50%
    • Perform weekly complete blood counts; withhold subsequent dose for more than 6 weeks if needed until platelets recover to 100,000/mm3 or greater and leukocytes recover to 4000/mm3 or greater
  • Dose modification: nadir leukocytes ≥ 4000/mm3 and platelets ≥ 100,000/mm3, or leukocytes 3000 - 3999/mm3 and platelets 75,000 - 99,999/mm3 after prior dose
    • No dose adjustment (None)
Read the label’s full dosing text

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. 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 and pediatric patients is 130 mg/m 2 taken as a single oral dose every 6 weeks. Round doses to the nearest 5 mg. Give as a single oral dose and do not repeat for at least 6 weeks. Reduce dose to 100 mg/m 2 every 6 weeks in patients with compromised bone marrow function. Also reduce dose accordingly when using with other myelosuppressive drugs. 2.3 Dose Modifications Perform weekly complete blood counts and withhold each subsequent dose for more than 6 weeks if needed until platelet counts recover to 100,000/mm 3 or greater and leukocytes recover to 4000/mm 3 or greater [see Warnings and Precautions (5.1) ]. Modify each dose of Lomustine Capsules according to the hematologic response of the preceding dose as described in Table 1: Table 1.

Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →

Lomustine side effects

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These are the most common side effects:

Common side effects

  • Delayed drop in blood cell counts (myelosuppression)
  • Nausea
  • Vomiting
  • Mouth sores (stomatitis)
  • Hair loss (alopecia)

When to get medical help

  • Call your doctor right away if you have signs of infection, such as fever, in the weeks after a dose. Low blood counts can lead to fatal infections.
  • Get help for unusual bleeding or bruising. Low platelets can cause serious bleeding.
  • Report new cough or shortness of breath. Lung scarring (pulmonary fibrosis) can occur.
  • Report vision changes, confusion, drowsiness, or trouble with balance or speech.
  • Tell your doctor about kidney or liver problems, such as changes in urination or yellowing of the skin or eyes.
  • If you think you took more than one dose, get emergency medical help immediately.

Other reported effects include vision problems, confusion, drowsiness, poor balance, and slurred speech. Call your doctor about fever, bleeding, breathing problems, or vision changes.

Lomustine warnings and precautions

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  • Delayed low blood counts: They can lead to fatal infections and bleeding, and they build up with repeated doses.
  • Overdose risk: Taking more than one dose can be fatal.
  • Lung toxicity: Scarring can develop after 6 months or longer. Risk is higher with low baseline lung test results. Treatment is permanently stopped if pulmonary fibrosis is diagnosed.
  • Secondary cancers: Acute leukemia and myelodysplasia can occur with long-term use.
  • Liver and kidney problems: Liver enzyme changes and progressive kidney failure can occur.
  • Pregnancy: It can cause fetal harm.

Lomustine interactions

▾

The label gives limited interaction information.

  • Other drugs that suppress bone marrow: the Lomustine dose should be reduced accordingly because blood counts may drop further.

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

🌿25 supplements and herbs with documented Lomustine interactions, ranked by severity Check Lomustine against a supplement or herb →

Before taking Lomustine

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  • Tell your doctor if you have reduced bone marrow function, lung disease, or liver or kidney problems.
  • Do not use if pregnant without discussing the risk to the baby with your doctor.
  • Use effective contraception: women during treatment and for 2 weeks after the last dose, and men for 3.5 months after the last dose.
  • Do not breastfeed during treatment and for 2 weeks after the final dose.
  • It may reduce fertility.
  • In children, use and dosing are not based on adequate, well-controlled studies.
  • In older adults, doses are chosen cautiously and kidney function is monitored.

Lomustine overdose

▾

Overdose has occurred, including fatal cases. It can cause severe drops in blood counts, abdominal pain, diarrhea, vomiting, loss of appetite, lethargy, dizziness, abnormal liver function, cough, and shortness of breath. There is no antidote, so seek emergency help right away if extra capsules are taken.

What Lomustine does in the body

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The specific pharmacodynamics (measurable effects on the body) of Lomustine are unknown.

How your body processes Lomustine

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Lomustine crosses the blood-brain barrier. Its metabolites have a serum half-life of 16 to 48 hours. About half of a radioactive oral dose was passed in the urine as breakdown products within 24 hours. How its metabolism works, and how age, sex, race, or kidney or liver problems affect it, is not known.

How to store Lomustine

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Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) .

Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

25

Supplements & herbs that interact with Lomustine

25 supplements and herbal products have documented interactions with Lomustine in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.

Severity mix
  • Major · 1
  • Moderate · 14
  • Minor · 10
ACTIVATED CHARCOAL Major ACEROLA Moderate ALPHA-LIPOIC ACID Moderate COENZYME Q10 Moderate COFFEE CHARCOAL Moderate EUROPEAN MANDRAKE Moderate GLUCOMANNAN Moderate GUAR GUM Moderate +17 more
Every supplement checked against Lomustine — ranked by severity The full interaction hub: 1 major · 14 moderate · 10 minor · every one linked to its full report. Check Lomustine against your exact supplements

Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.

1

Nutrient depletion considerations

Lomustine has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.

VITAMIN E Insufficient Evidence
See the full Lomustine nutrient depletion report

Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.

Lomustine: pharmacist answers to common questions

Quick, plain-English answers to the questions patients ask most about Lomustine — the kind of thing our pharmacy team would talk through with you at the counter.

What is Lomustine for?

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It's a chemotherapy capsule used for brain tumors, both ones that start in the brain and ones that spread there, usually after surgery or radiation. It's also used with other chemotherapy for Hodgkin's lymphoma that has gotten worse after first treatment.

How often do I take it?

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You take one single dose by mouth, and then you do not repeat it for at least 6 weeks. Your dose may be several capsules of different colors. Never take extra, since too much can be fatal.

What side effects should I expect?

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Nausea, vomiting, mouth sores, and hair loss are common. The most important effect is a drop in blood counts that shows up about 4 to 6 weeks after a dose, so you'll have regular blood tests.

When should I call my doctor?

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Call right away for fever or signs of infection, unusual bleeding or bruising, new cough or shortness of breath, vision changes, or confusion. These can be signs of serious effects on blood counts, lungs, or the nervous system.

How do I handle the capsules?

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Don't open or break them. If one breaks and touches your skin, wash the area right away and thoroughly. Caregivers handling the bottle should wear gloves.

What about pregnancy and breastfeeding?

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Lomustine can harm an unborn baby. Use effective birth control during treatment, for 2 weeks after the last dose if you could become pregnant, and for 3.5 months after if you're a man with a partner who could. Do not breastfeed during treatment or for 2 weeks after.

Is Lomustine available over the counter?

▾
No. Lomustine is a prescription medicine: every Lomustine product listed with the FDA is prescription only, so it is not sold over the counter. Your prescriber decides whether it is appropriate for you, and your pharmacist dispenses it.

When was Lomustine first available?

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The earliest FDA record we hold for Lomustine is from 1976: its first approval in Drugs@FDA or its earliest product listing in the NDC Directory, whichever is older. Many older medicines were in use before their first formal FDA approval, so this is the earliest date on record, not necessarily when Lomustine was first used.

Who makes Lomustine?

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4 companies currently list Lomustine products in the FDA's NDC Directory, including Azurity Pharmaceuticals, Inc., Carnegie Pharmaceuticals LLC, NextSource Biotechnology, LLC. That count includes repackagers and distributors as well as manufacturers (companies that sell only the raw ingredient are not counted), so fewer companies actually make it; the label on your bottle names the one that supplied yours.

Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →

More about Lomustine on HelloPharmacist

📊Lomustine supplement interactions25 checked — ranked by severity 🌿Drug & Supplement CheckerLomustine vs. vitamins & herbs 💬Ask a PharmacistFree answer, usually < 24h 🔎NDC & pricing lookupFind Lomustine NDCs & costs 🅰️Browse Drugs A–ZLook up any medication
Detailed data & references for Lomustine Forms & strengths, pricing, billing codes, manufacturers, safety reports and sourcing — the data behind the page. Most people can stop here. Each section below opens on a tap.

Lomustine forms and strengths (how it comes)

Lomustine is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.

Capsule

By mouth
Brands Gleostine
How this form is used
What it may be used for
  • Gleostine capsules are used for primary and metastatic brain tumors after surgery and/or radiation.
  • Gleostine capsules are used with other chemotherapy for Hodgkin's lymphoma that progressed after initial chemotherapy.
  • Lomustine capsules are used for the same brain tumor and Hodgkin's lymphoma indications.
Important instructions
  • Gleostine is taken as a single oral dose and not repeated for at least 6 weeks.
  • Lomustine capsules are taken as a single oral dose and not repeated for at least 6 weeks.
  • Do not break Gleostine or Lomustine capsules. Wash skin right away if it touches a broken capsule.
  • A single dose may include capsules of different strengths and colors.
Available strengths 3 strengths
10 mg 40 mg 100 mg
18 FDA-listed product records ⓘ

Lomustine on the U.S. market: products, makers and brands

How Lomustine appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.

4 companies list 12 Lomustine product records with the FDA, mostly as capsule; the earliest marketing or approval year on record is 1976. Brand names on the directory include Gleostine; the rest are generics.

1
Dose forms ⓘ
4
Labelers (makers, repackagers, distributors)
2
Brand names
12
FDA-listed product records ⓘ
1976
Earliest FDA record ⓘ

Also listed with the FDA, not a patient dose form: Powder (1) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.

Azurity Pharmaceuticals, Inc.25%
Carnegie Pharmaceuticals LLC25%
NextSource Biotechnology, LLC25%
Wilshire Pharmaceuticals, Inc.25%

Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.

Compare Lomustine products

A representative set of FDA-listed product records for Lomustine — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)

Strength Route Manufacturer / Labeler Category ⓘ Details
💊Capsule
10 mg Oral Azurity Pharmaceuticals, Inc. NDA View NDC →
40 mg Oral Azurity Pharmaceuticals, Inc. NDA View NDC →
100 mg Oral Azurity Pharmaceuticals, Inc. NDA View NDC →
10 mg Oral Carnegie Pharmaceuticals LLC ANDA View NDC →
40 mg Oral Carnegie Pharmaceuticals LLC ANDA View NDC →
100 mg Oral Carnegie Pharmaceuticals LLC ANDA View NDC →
10 mg Oral NextSource Biotechnology, LLC NDA View NDC →
40 mg Oral NextSource Biotechnology, LLC NDA View NDC →
100 mg Oral NextSource Biotechnology, LLC NDA View NDC →
10 mg Oral Wilshire Pharmaceuticals, Inc. NDA View NDC →
40 mg Oral Wilshire Pharmaceuticals, Inc. NDA View NDC →
100 mg Oral Wilshire Pharmaceuticals, Inc. NDA View NDC →

Showing 12 of 12 products — FDA National Drug Code Directory. See every product, package size and price: browse all 12 Lomustine NDCs →

Lomustine recall history

A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.

The FDA’s enforcement reports list no Lomustine recalls since July 2021.

✅No Lomustine recalls on record since July 2021

Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.

RxNorm Concept Web — From Ingredient to Every Form and Strength

This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.

Ingredient (IN) Lomustine RxCUI 6466 1 dose form · 4 strengths
  1. Dose form (SCDF) Oral Capsule RxCUI 372631 In current FDA listings
    Clinical drug / strength (SCD) 5 MG RxCUI 1720735 10 MG RxCUI 197894 40 MG RxCUI 197896 100 MG RxCUI 197895

Look up RxCUI 6466 in the RxCUI Atlas →

RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.

Lomustine brand names

Lomustine is sold under one brand name in the FDA directory — Gleostine. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.

Gleostine

Who makes Lomustine: manufacturers and labelers

4 companies list Lomustine products with the FDA. By number of product records, the largest are Azurity Pharmaceuticals, Inc., Carnegie Pharmaceuticals LLC, NextSource Biotechnology, LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.

Azurity Pharmaceuticals, Inc. 3 Carnegie Pharmaceuticals LLC 3 NextSource Biotechnology, LLC 3 Wilshire Pharmaceuticals, Inc. 3

Lomustine drug class (RxNorm)

Lomustine belongs to the Alkylating Drug class.

Pharmacologic class Alkylating Drug
Drug family (ATC) Nitrosoureas
How it works Alkylating Activity

Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.

Sources for this Lomustine page

Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.

📄
FDA-filed drug labels (SPL) Uses, dosing, warnings & side effects from SPL records retrieved through openFDA; the linked representative set can be verified on DailyMed. ✓ Linked label effective Sep 25, 2025
🏭
Forms, brands & labelersAggregated from ingredient-matched FDA National Drug Code Directory product records for Lomustine.
📈
Real-world reportsThe FDA Adverse Event Reporting System (FAERS), served through openFDA.
🚨
Recalls & shortagesopenFDA drug-enforcement reports and the FDA drug-shortage database.
🧾 Clinical label set — FDA-filed SPL labels retained for Lomustine after exact ingredient or ingredient-combination matching and applicable route/form matching
Clinical labels in scope
4
Finished products in the current FDA directory
12
Companies listing them (makers, repackagers, distributors)
4
FDA labeler codes behind them ⓘ
4
Linked representative label ⓘ
Azurity Pharmaceuticals, Inc.
Linked label effective
Sep 25, 2025
Composite sections available
22
Linked SPL Set ID
3529fe2f-3c23-4862-bb20-b48026957082
Linked SPL Document ID
3529fe2f-3c23-4862-bb20-b48026957082
Open the linked representative label on DailyMed ↗

How this page is built

HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Azurity Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →