Pronunciation:

loe-MUS-teen

Brand Names:

• Ceenu
• Gleostine

Dosage Forms:

• Capsule

Warnings:

Lomustine causes delayed, dose-related, cumulative, fatal myelosuppression. Monitor blood counts for at least 6 weeks after each dose. Do not administer more than one dose every 6 weeks. Physician and pharmacist should emphasize to patient that overdosage can cause fatal toxicity .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Alkylating Agent

Chemical—

Nitrosourea

Uses of This Medicine:

Lomustine is used alone or in combination with other medicines to treat brain tumors, Hodgkin's disease, and other kinds of cancer. This medicine belongs to the group of medicines known as alkylating agents.

Lomustine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by lomustine, other effects may occur. Some of these may be serious and must be reported to your doctor. Other effects (e.g., hair loss) may not be serious, but may cause concern. Some effects may not occur for months or years after the medicine is used.

Before you begin treatment with lomustine, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies on the relationship of age to the effects of lomustine have not been performed in the pediatric population. However, pediatric-specific problems that would limit the usefulness of this medicine in children are not expected.

Older adults—

No information is available on the relationship of age to the effects of lomustine in geriatric patients. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving lomustine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine, Live
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Anemia (low red cells in the blood) or
• Bone marrow problems or
• Leukopenia (low white cells in the blood) or
• Lung disease or
• Thrombocytopenia (low platelets in the blood)—May make these conditions worse.

• Chickenpox, including recent exposure, or
• Herpes zoster (shingles) or
• Infection—May decrease the ability to fight an infection.

• Kidney disease—Effects may be increased because of slower removal from the body.

Proper Use of This Medicine:

Take this medicine only as directed by your doctor. Do not take more or less of it than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Taking too much may increase the chance of side effects, while taking too little may not improve your condition.

In order that you receive the proper dose of lomustine, there may be two or more different types of capsules in the container. This is not an error. It is important that you take all of the capsules in the container at the same time so you receive the right dose of the medicine.

Be careful while handling this medicine. Wear gloves when touching the capsules containing this medicine. Do not break, crush, or open the capsules. If any of this medicine gets on your skin or in your nose or mouth, wash the area with soap and water right away. If the medicine gets in your eyes, wash them with water right away and call your doctor.

This medicine is sometimes given together with other medicines. If you are using a combination of medicines, make sure that you take each one at the right time and do not mix them. Ask your doctor to help you plan a way to remember to take your medicines at the right time.

Nausea and vomiting often occur with lomustine, but usually last less than 24 hours. Loss of appetite may last for several days. This medicine is best taken on an empty stomach at bedtime, so it will cause less stomach upset. Ask your doctor for other ways to lessen these side effects.

If you vomit shortly after taking a dose of lomustine, check with your doctor. You may be told to take the dose again.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (capsules):
  • For brain tumors or Hodgkin's disease:
    • Adults and children—Dose is based on body surface area and must be determined by your doctor. The usual dose is 130 milligrams (mg) per square meter (m(2)) of body surface area, given as a single dose every 6 weeks. Your doctor may adjust your dose if needed.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

Check with your doctor right away if you have any of the following symptoms: fever, chills, dry cough, sore throat, confusion, shortness of breath, swelling of the feet or lower legs, unusual bleeding or bruising, or yellow eyes or skin.

While you are being treated with lomustine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Lomustine may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have recently taken oral polio vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Lomustine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in the urine or stools; or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

Side Effects of This Medicine:

Along with their needed effects, medicines like lomustine can sometimes cause unwanted effects such as blood problems, loss of hair, and other side effects; these are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bleeding gums

chest pain

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Awkwardness

black, tarry stools

blood in the urine or stools

confusion

cough or hoarseness

decrease in urination

fever or chills

lower back or side pain

painful or difficult urination

pale skin

pinpoint red spots on the skin

slurred speech

swelling of the feet or lower legs

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Abdominal or stomach pain or tenderness

bone pain

change in frequency of urination or amount of urine

clay colored stools

dark urine

decreased appetite

dizziness

drowsiness

dry mouth

headache

increased blood pressure

increased thirst

itching

loss of appetite

nausea or vomiting

skin rash

weight gain

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Darkening of the skin

diarrhea

Incidence not known

Blurred vision

changes in patterns and rhythms of speech

confusion about identity, place, and time

decreased vision

eye pain

hair loss or thinning of the hair

shakiness and unsteady walk

swelling or inflammation of the mouth

trouble with speaking

unsteadiness, trembling, or other problems with muscle control or coordination

unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.