Lomustine Medac
Lomustine 40 mg hard capsules – Alkylating chemotherapy agent (Nitrosourea)
Lomustine Medac is a prescription chemotherapy medication belonging to the nitrosourea class of alkylating agents. It is primarily used to treat brain tumors (gliomas), malignant melanoma, and Hodgkin lymphoma. Because lomustine can cross the blood-brain barrier, it is particularly valuable in neuro-oncology. The drug is taken orally as a single dose every 6 to 8 weeks, with careful monitoring of blood counts required due to delayed and cumulative bone marrow suppression.
Quick Facts
Key Takeaways
- Lomustine Medac is an oral chemotherapy capsule used primarily for brain tumors, malignant melanoma, and Hodgkin lymphoma because it effectively crosses the blood-brain barrier.
- The standard dosing cycle is every 6 to 8 weeks, with doses individualized based on blood counts and body surface area. Typical single-agent dose is approximately 130 mg/m².
- Delayed bone marrow suppression is the most serious side effect, with blood count nadir occurring 4–6 weeks after each dose. Weekly blood monitoring is essential.
- Lomustine must not be used during pregnancy or while breastfeeding. Both men and women must use effective contraception during and after treatment.
- Long-term use carries risks of cumulative pulmonary fibrosis, renal toxicity, and secondary malignancies. Treatment requires close oncological supervision.
What Is Lomustine Medac and What Is It Used For?
Lomustine Medac is a chemotherapy capsule containing the active substance lomustine, a nitrosourea alkylating agent that disrupts cancer cell DNA. It is primarily used to treat brain tumors, malignant melanoma, and lymphoma.
Lomustine belongs to a group of anticancer medications known as nitrosourea compounds. These agents work by forming cross-links within DNA strands and by carbamylating cellular proteins, which interferes with the ability of cancer cells to replicate and repair themselves. This dual mechanism of action makes lomustine effective against a range of malignancies, particularly those involving rapidly dividing cells.
One of the most clinically significant properties of lomustine is its high lipophilicity, which allows it to readily cross the blood-brain barrier. This characteristic is crucial in neuro-oncology, where many chemotherapy agents cannot penetrate into the central nervous system. As a result, lomustine has become an important component of treatment protocols for primary brain tumors, including high-grade gliomas such as glioblastoma multiforme and anaplastic astrocytoma.
Approved Indications
Lomustine Medac is indicated for the treatment of several types of cancer:
- Brain tumors (gliomas): Lomustine is widely used as monotherapy or in combination regimens for both primary and recurrent high-grade gliomas. The PCV regimen (procarbazine, lomustine, vincristine) is a standard combination therapy for certain brain tumors, including anaplastic oligodendrogliomas and oligoastrocytomas with 1p/19q codeletion.
- Malignant melanoma: In cases of advanced or metastatic melanoma, lomustine may be used as part of combination chemotherapy, particularly when central nervous system involvement is present or suspected.
- Hodgkin lymphoma: Lomustine can be used in salvage regimens for relapsed or refractory Hodgkin disease, typically in combination with other chemotherapeutic agents.
The European Medicines Agency (EMA) and national regulatory authorities have approved lomustine for these indications based on decades of clinical experience and multiple randomized controlled trials. The landmark EORTC 26951 and RTOG 9402 trials demonstrated significant survival benefits when lomustine-containing regimens were combined with radiotherapy for anaplastic oligodendroglial tumors, with median overall survival exceeding 14 years in patients with 1p/19q codeletion.
Your prescribing oncologist may also consider lomustine for other cancer types not specifically listed here, based on clinical judgment and available evidence. Always follow your healthcare provider's specific recommendations regarding your treatment plan.
What Should You Know Before Taking Lomustine Medac?
Lomustine Medac has important contraindications including pregnancy, breastfeeding, severe kidney impairment, and allergy to wheat. Your oncologist must evaluate your blood counts, kidney, liver, and lung function before starting treatment.
Contraindications
You must not take Lomustine Medac if any of the following apply to you:
Do Not Take Lomustine Medac If:
- You are allergic to lomustine, to other nitrosourea-type alkylating agents, or to any of the other ingredients in this medicine
- Your tumor has previously not responded to other nitrosourea-type alkylating agents
- You do not have sufficient blood cells (blood tests are always taken before treatment to check your blood cell counts)
- You have impaired kidney function
- You are pregnant or breastfeeding
- You are allergic to wheat (note: this is different from celiac disease)
- You are scheduled to receive yellow fever vaccine or any other live vaccine during treatment
Warnings and Precautions
Talk to your doctor or pharmacist before taking Lomustine Medac. Several important precautions must be observed throughout treatment:
Bone Marrow Suppression
Lomustine can affect your bone marrow function, and this effect may appear after a delay of several weeks. This can increase your risk of bleeding or infection. The toxic effects of lomustine on your blood-forming system are cumulative and will increase over the course of treatment. Your doctor will check your blood values, typically once a week during treatment and for up to 6 weeks after treatment ends.
Always take Lomustine Medac exactly as prescribed by your doctor and do not repeat the prescribed dose any sooner than every 6 weeks. Due to the cumulative effect on bone marrow, your doctor may decide to reduce the dose of Lomustine Medac based on your blood values.
Before you begin taking Lomustine Medac, your doctor will check that your lungs, liver, and kidneys are functioning properly. These tests will be performed throughout the course of treatment. Long-term use of Lomustine Medac may potentially increase the risk of developing another cancer in the future, including acute leukemia and myelodysplastic syndrome.
Because lomustine is a cytotoxic agent, you should take care not to come into contact with the capsule contents. Wash your hands with soap and water after handling Lomustine Medac capsules. You must not receive live vaccines during treatment with Lomustine Medac and not until at least 3 months after completing treatment.
Pregnancy and Breastfeeding
Contraception: Women of childbearing potential must use effective contraception before treatment begins, during treatment, and for 7 months after the last dose. Men must use effective contraception before, during, and for 4 months after completing treatment.
Pregnancy: You must not use Lomustine Medac during pregnancy or if you are trying to become pregnant. Lomustine is known to be teratogenic and embryotoxic in animal studies, and the risk of harm to the developing fetus is considered significant. If you become pregnant during treatment or suspect that you may be pregnant, contact your doctor immediately. Genetic counseling is recommended for patients who wish to have children after treatment.
Breastfeeding: Do not take Lomustine Medac while breastfeeding, as lomustine may be excreted in breast milk. If treatment with Lomustine Medac is necessary, breastfeeding must be discontinued.
Fertility: Lomustine may have genotoxic effects. Men being treated with Lomustine Medac should not father children during treatment and for 4 months after the last dose. Patients should discuss precautionary measures with their doctor, such as sperm banking before starting treatment, as lomustine may impair fertility. Genetic counseling is recommended for patients who intend to have children after treatment.
Driving and Operating Machinery
This medicine can cause nausea, vomiting, and other effects that may impair your ability to drive or use machinery. You are responsible for assessing whether you are fit to drive or perform tasks requiring alertness. If in doubt, discuss with your doctor.
Important Information About Excipients
Lomustine Medac contains lactose and wheat starch. If you have been told by your doctor that you have an intolerance to certain sugars, consult your doctor before taking this medicine. The medicine contains only very small amounts of gluten (from wheat starch) and is considered "gluten-free." A single capsule contains no more than 4 micrograms of gluten. However, if you have a wheat allergy (which is different from celiac disease), you must not use this medicine.
How Does Lomustine Medac Interact with Other Drugs?
Lomustine can interact with theophylline, cimetidine, antiepileptics, other cytotoxic agents, and live vaccines. Always inform your oncologist about all medications you are taking.
Drug interactions with Lomustine Medac have not been extensively studied in formal clinical trials. However, based on pharmacological properties and clinical experience, several important interactions are recognized. Always inform your doctor about all medications you are currently taking, have recently taken, or plan to take.
Known Drug Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Theophylline | May alter theophylline metabolism and plasma levels | Monitor theophylline levels closely; dose adjustment may be needed |
| Cimetidine | May increase lomustine toxicity through inhibition of hepatic metabolism | Consider alternative H2-receptor antagonists; monitor for increased myelosuppression |
| Phenobarbital and other antiepileptics | Enzyme-inducing antiepileptics may alter lomustine metabolism | Dose adjustments may be necessary; discuss with your oncologist |
| Other cytotoxic agents / Radiation therapy | Increased risk of bone marrow toxicity (additive myelosuppression) | Dose reduction of lomustine typically required; close blood count monitoring |
| Live vaccines (e.g., yellow fever) | Risk of fatal systemic vaccine disease due to immunosuppression | Absolutely contraindicated during treatment and for 3 months after last dose |
Vaccines
You must not receive live vaccines during treatment with Lomustine Medac. This restriction applies to all live vaccines, including but not limited to yellow fever, measles-mumps-rubella (MMR), varicella, oral polio, and live influenza vaccine. The immunosuppressive effects of lomustine can lead to potentially fatal generalized vaccine disease if live vaccines are administered. Inactivated vaccines may be given, but the immune response may be diminished.
You should tell your doctor if you have been vaccinated recently. Wait at least 3 months after completing treatment with Lomustine Medac before receiving any live vaccine. Household contacts of the patient should also consult their healthcare provider regarding vaccination, as some live vaccines (such as oral polio) can potentially be transmitted to immunocompromised individuals.
What Is the Correct Dosage of Lomustine Medac?
The dose is individualized by your oncologist based on body surface area, blood counts, and whether other chemotherapy or radiation is being used. The typical single-agent dose is 130 mg/m² given as a single oral dose every 6–8 weeks.
Always take this medicine exactly as your doctor has prescribed. Do not adjust the dose on your own. The dose depends on your blood values, body surface area, and whether you are receiving other anticancer treatments. Your doctor will calculate the appropriate dose based on these factors.
Standard Dosing
Adults (Single-Agent Therapy)
The recommended dose for an average-sized adult is approximately 130 mg/m² body surface area (equivalent to roughly 200 mg for a typical adult), given as a single oral dose. This is repeated every 6 to 8 weeks, provided that blood counts have recovered sufficiently.
Combination Therapy
When lomustine is used in combination with other cytotoxic agents or radiation therapy, the dose is typically reduced. Your oncologist will determine the appropriate reduced dose based on the specific combination regimen and your individual response. In the PCV regimen, lomustine is typically dosed at 110 mg/m² on day 1 of each 6-week cycle.
Dose Adjustments Based on Blood Counts
Because of the cumulative effect on bone marrow, your doctor may need to reduce subsequent doses based on your blood values (nadir counts from the previous cycle):
- Leukocytes ≥ 3,000/µL and platelets ≥ 75,000/µL: 100% of previous dose
- Leukocytes 2,000–2,999/µL and platelets 25,000–74,999/µL: 70% of previous dose
- Leukocytes < 2,000/µL and platelets < 25,000/µL: 50% of previous dose
How to Take the Capsules
Swallow the capsules whole and unopened with at least half a glass of water. Do not break, crush, or open the Lomustine Medac capsules. If you accidentally get the capsule contents on your skin or in your mouth, rinse immediately with plenty of water. Taking lomustine on an empty stomach may help reduce nausea.
It is important to complete the treatment exactly as prescribed by your doctor. Do not stop treatment early without first consulting your doctor. Your doctor may adjust the dose and frequency based on your blood tests, general condition, other treatments, and the effect you experience from Lomustine Medac.
Missed Dose
If you have missed taking one or more doses, contact your doctor or pharmacist immediately for advice. Do not take a double dose to compensate for a missed capsule. Given the serious nature of this medication and its specific dosing schedule, any deviation from the prescribed regimen should be discussed with your oncologist promptly.
Overdose
Overdose Warning
If you have taken more Lomustine Medac than prescribed, contact your doctor or hospital immediately. Overdose cases, including fatal outcomes, have been reported.
Symptoms of overdose may include: severe bone marrow depression (unexplained bruising, bleeding, or susceptibility to infection), abdominal pain, diarrhea, nausea, vomiting, loss of appetite, lethargy, dizziness, signs of liver damage (yellowing of skin and eyes), cough, shortness of breath, and neurological symptoms. Multiple organ failure is a risk in very serious cases.
No specific antidote is available. Treatment is supportive and may include gastric lavage and appropriate supportive measures.
What Are the Side Effects of Lomustine Medac?
The most common side effects are bone marrow suppression (leading to low blood cell counts), nausea, and vomiting. Serious but less common effects include pulmonary fibrosis, liver and kidney damage, and secondary cancers.
Like all medicines, Lomustine Medac can cause side effects, although not everybody gets them. Contact your doctor immediately if you experience any of the following side effects. The frequency of side effects is classified according to international standards:
Very Common
May affect more than 1 in 10 people
- Bone marrow suppression – leading to decreased production of blood cells
- Thrombocytopenia – decreased platelets; may cause unusual bleeding and bruising
- Leukopenia – decreased white blood cells; increased susceptibility to infections
- Anemia – decreased red blood cells; weakness, fatigue, shortness of breath
- Nausea and/or vomiting – typically occurs 3–6 hours after dosing and lasts less than 24 hours
- Loss of appetite – may persist for 2–3 days after dosing
Common
May affect up to 1 in 10 people
- Infections, including infections in patients with weakened immune systems (e.g., shingles)
- Abnormal coordination (ataxia)
- Disorientation and difficulty with spatial awareness
- Inflammation of the mucous membranes in the mouth (stomatitis)
- Diarrhea
- Impaired liver function (usually reversible) and elevated liver enzymes
- Abnormal lack of energy, drowsiness, or lethargy
- Speech difficulties (dysarthria)
- Inability to coordinate muscle movements
Uncommon
May affect up to 1 in 100 people
- Apathy and loss of motivation
- Confusion
- Stammering or stuttering
- Severe impairment of kidney function and kidney damage (inability to function normally)
Rare
May affect up to 1 in 1,000 people
- Pulmonary fibrosis – scarring of lung tissue causing shortness of breath and dry cough
- Hair loss (alopecia)
- Obstructive jaundice (yellowing of skin and eyes from blocked bile flow)
- Abnormal sperm production (spermatogenesis disorders)
- Disruptions in egg production during the menstrual cycle
Very Rare
May affect up to 1 in 10,000 people
- Secondary cancers – including acute leukemia and myelodysplastic syndrome
- Persistent visual impairment (in combination with radiation therapy)
When to Contact Your Doctor Immediately
Seek immediate medical attention if you experience: unexplained bruising or bleeding, signs of infection (fever, chills, sore throat), yellowing of skin or eyes, significant shortness of breath or dry persistent cough, swelling of hands, ankles, or feet, decreased or absent urination, or any sudden neurological changes.
Managing Nausea and Vomiting
Nausea and vomiting are among the most common side effects and typically occur 3 to 6 hours after taking your dose. These symptoms usually subside within 24 hours, although loss of appetite may persist for 2 to 3 days. Your doctor may prescribe antiemetic medications (anti-nausea drugs) to take alongside your lomustine. Taking the capsules on an empty stomach may also help reduce the severity of nausea.
Monitoring During Treatment
Because of the delayed nature of bone marrow suppression, your doctor will monitor your complete blood count (CBC) weekly during treatment and for up to 6 weeks after each dose. Liver and kidney function tests will also be performed regularly. Pulmonary function testing may be conducted periodically, especially with cumulative dosing, to detect early signs of pulmonary fibrosis. The risk of pulmonary toxicity increases significantly with cumulative doses exceeding 1,100 mg/m².
How Should You Store Lomustine Medac?
Store below 25°C in the original packaging, protected from light and moisture. Keep out of the reach and sight of children.
Proper storage of Lomustine Medac is essential to maintain the efficacy and safety of this cytotoxic medication:
- Temperature: Store at no more than 25°C (77°F). Do not freeze.
- Light protection: Keep the capsules in the original packaging to protect from light.
- Moisture protection: The capsules are sensitive to moisture and should be stored in their original packaging.
- Child safety: Keep this medicine out of the sight and reach of children. Lomustine is a potent cytotoxic agent and accidental ingestion by a child could be life-threatening.
- Expiry date: Do not use this medicine after the expiry date stated on the carton and blister.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. These measures help protect the environment and prevent accidental exposure. As a cytotoxic agent, lomustine requires special disposal procedures in accordance with local regulations for hazardous pharmaceutical waste.
What Does Lomustine Medac Contain?
Each capsule contains 40 mg of lomustine as the active substance, along with inactive ingredients including anhydrous lactose, wheat starch, talc, and magnesium stearate.
Active Substance
The active substance is lomustine (also known as CCNU, or 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea). Each hard capsule contains 40 mg of lomustine.
Other Ingredients (Excipients)
- Anhydrous lactose
- Wheat starch
- Talc
- Magnesium stearate
Capsule shell: Gelatin, titanium dioxide (E 171), and indigotine (E 132).
Appearance and Pack Sizes
The capsules are blue and hard. Lomustine Medac is available in pack sizes of 5 capsules and 20 capsules. Not all pack sizes may be marketed in all countries.
Frequently Asked Questions
Lomustine Medac is a chemotherapy medication used to treat various types of cancer, primarily brain tumors (gliomas), malignant melanoma (a type of skin cancer), and Hodgkin lymphoma (cancer of the lymphatic system). It belongs to the nitrosourea class of alkylating agents and is particularly valuable for brain tumors because it can cross the blood-brain barrier.
Lomustine Medac is typically taken as a single oral dose every 6 to 8 weeks. The minimum interval between doses is 6 weeks, which is essential because the drug causes delayed bone marrow suppression. Your doctor will only prescribe the next dose after confirming that your blood counts have recovered sufficiently.
The most serious side effects include delayed and cumulative bone marrow suppression (myelosuppression), which can lead to severe infections, bleeding, and anemia. Other serious effects include pulmonary fibrosis (especially with cumulative doses exceeding 1,100 mg/m²), liver toxicity, kidney damage, and the development of secondary cancers including acute leukemia and myelodysplastic syndrome with long-term use.
Lomustine can interact with several medications. Known interactions include theophylline (asthma medication), cimetidine (ulcer medication), and antiepileptic drugs such as phenobarbital. Combining lomustine with other cytotoxic agents or radiation therapy increases the risk of bone marrow toxicity. Live vaccines must not be given during treatment or for at least 3 months after completing therapy. Always inform your oncologist about all medications you are taking.
No, lomustine must not be used during pregnancy as it can cause serious harm to the developing fetus. Women must use effective contraception during treatment and for 7 months after the last dose. Men must use effective contraception during treatment and for 4 months after. If pregnancy occurs during treatment, seek immediate medical advice. Genetic counseling is recommended for patients who wish to have children after completing treatment.
Lomustine Medac capsules should be swallowed whole and unopened with at least half a glass of water. Do not break, crush, or open the capsules. If the capsule contents accidentally come into contact with your skin or mouth, rinse immediately with plenty of water. Always wash your hands with soap and water after handling the capsules, as lomustine is a cytotoxic (cancer-fighting) agent that requires careful handling.
References
- European Medicines Agency (EMA). Lomustine – Summary of Product Characteristics. www.ema.europa.eu
- van den Bent MJ, et al. Adjuvant procarbazine, lomustine, and vincristine chemotherapy in newly diagnosed anaplastic oligodendroglioma: long-term follow-up of EORTC brain tumor group study 26951. J Clin Oncol. 2013;31(3):344-350. doi:10.1200/JCO.2012.43.2229
- Cairncross G, et al. Phase III trial of chemoradiotherapy for anaplastic oligodendroglioma: long-term results of RTOG 9402. J Clin Oncol. 2013;31(3):337-343. doi:10.1200/JCO.2012.43.2674
- National Comprehensive Cancer Network (NCCN). Clinical Practice Guidelines in Oncology: Central Nervous System Cancers. Version 2.2025. www.nccn.org
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd edition, 2023. www.who.int
- Herrlinger U, et al. Lomustine-temozolomide combination therapy versus standard temozolomide therapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter (CeTeG/NOA-09): a randomised, open-label, phase 3 trial. Lancet. 2019;393(10172):678-688. doi:10.1016/S0140-6736(18)31791-4
- British National Formulary (BNF). Lomustine monograph. National Institute for Health and Care Excellence (NICE). bnf.nice.org.uk
- U.S. Food and Drug Administration (FDA). Gleostine (lomustine) Prescribing Information. www.fda.gov
Editorial Team
This article was written by the iMedic Medical Editorial Team, comprising board-certified specialists in oncology and clinical pharmacology. All content is independently reviewed by the iMedic Medical Review Board to ensure accuracy, currency, and adherence to international clinical guidelines.
Our editorial process follows the GRADE evidence framework, with all medical claims supported by peer-reviewed research and international guidelines from the WHO, EMA, FDA, NCCN, and BNF. This content has no commercial funding and is free from pharmaceutical industry influence.