Ceenu (Oral)

Lomustine is used by itself or with other medicines to treat brain tumors, Hodgkin's disease, and other types of cancer. This medicine is part of a group called alkylating agents.

Lomustine works by stopping the growth of cancer cells, which are eventually destroyed. Because lomustine can also affect the growth of normal body cells, other side effects may happen. Some of these may be serious and should be reported to your doctor. Other side effects (like hair loss) may not be serious but can still be concerning. Some side effects may not appear for months or years after using the medicine.

Before starting treatment with lomustine, you and your doctor should discuss the benefits of this medicine as well as the risks of using it.

This medicine is available only with a prescription from your doctor.

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

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

Check with your doctor immediately 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. Additionally, other people living in your household should not take oral polio vaccine since they could pass the polio virus on to you. Also, avoid people 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, consider wearing a protective face mask that covers your 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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Additionally, let your health care professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Appropriate studies on the effects of lomustine in children have not been conducted. However, there are no expected pediatric-specific problems that would limit the usefulness of this medicine in children.

Geriatric

There is no information available on the effects of lomustine in older patients. However, elderly patients may be more likely to have age-related kidney problems, which could require a dose adjustment for those taking lomustine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before taking this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if an interaction could occur. In these situations, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is very important that your healthcare professional knows if you are using any of the following medicines. The interactions listed here have been chosen for their potential significance and may not include all possible interactions.

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

• 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 necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or frequency of one or both medicines.

• Adenovirus Vaccine
• Bacillus of Calmette and Guerin Vaccine, Live
• Cholera Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Influenza Virus Vaccine, Live
• Poliovirus Vaccine, Live
• Smallpox Vaccine
• Typhoid Vaccine, Live
• Yellow Fever Vaccine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food as interactions may occur. Using alcohol or tobacco with certain medicines can also lead to interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Be sure to inform your doctor if you have any other medical issues, especially:

• Anemia (low red blood cells) or
• Bone marrow problems or
• Leukopenia (low white blood cells) or
• Lung disease or
• Thrombocytopenia (low platelets)—These conditions may worsen.

• Chickenpox, including recent exposure, or
• Herpes zoster (shingles) or
• Infection—These may reduce your ability to fight an infection.

• Kidney disease—The effects may be stronger due to slower removal from the body.

Along with its helpful effects, medicines like lomustine can sometimes cause unwanted effects such as blood problems, hair loss, and other side effects; these are described below. Because of how these medicines work in the body, there is a chance they might cause other unwanted effects that may not happen until months or years after the medicine is used. These delayed effects may include certain types of cancer, such as leukemia. Talk to your doctor about these possible effects.

Along with its helpful effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, 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.

In the U.S.

• Ceenu
• Gleostine

Available Dosage Forms:

• Capsule

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Alkylating Agent

Chemical Class: Nitrosourea

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.