Ceenu

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Lomustine is taken in a single dose once every 6 weeks. Follow your doctor's dosing instructions very carefully.

Because an overdose of lomustine can be fatal, you will be given only enough of this medicine to take one dose every 6 weeks. To get the correct dose, you may need to take 2 or more capsules that are different types and colors.

Wear disposable rubber gloves when you handle a lomustine capsule. Throw the gloves away after one use.

Do not open the lomustine capsule. Do not use a broken pill. The medicine from a broken pill can be dangerous if it gets on your skin. If this occurs, wash with soap and water. Ask your doctor or pharmacist how to safely handle and dispose of a broken capsule.

Lomustine can cause nausea and vomiting for up to 24 hours after you take it. You may have loss of appetite that lasts for several days. Taking lomustine on an empty stomach may reduce nausea and vomiting. You may also be given anti-nausea medications. Call your doctor if you vomit right after taking a lomustine capsule.

Lomustine can have long lasting effects on your body. Your blood will need to be tested once per week for at least 6 weeks after each dose of this medicine.

Your lung function, kidney function, and liver function may also need to be checked.

Store at room temperature away from heat and moisture. Keep the bottle tightly closed until you are ready to take the medicine.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of lomustine can be fatal.

Overdose symptoms may include stomach pain, vomiting, diarrhea, loss of appetite, dizziness, cough, feeling short of breath, or signs of infection.

Call your doctor for instructions if you miss a dose of lomustine.

CeeNU is a prescription medication used to treat certain types of brain tumors. CeeNU is also used in combination with other medications to treat Hodgkin's lymphoma (Hodgkin's disease) that has not improved or has worsened after treatment with other medications. CeeNU belongs to a group of drugs called alkylating agents. These work by slowing or stopping the growth of cancer cells in your body.

This medication comes in capsule form and is taken by mouth as a single dose and is not repeated for at least 6 weeks. Take CeeNU on an empty stomach. Be sure to wear impervious (rubber or latex) gloves when handling CeeNU.

Common side effects of CeeNU include nausea, vomiting, and loss of appetite.

CeeNU can also cause dizziness. Do not drive or operate heavy machinery until you know how CeeNU affects you.

• E.R. Squibb & Sons, L.L.C.

Serious side effects have been reported with CeeNU. See the “CeeNU Precautions” section.

Common side effects of CeeNU include the following:

• nausea
• vomiting
• loss of appetite
• sores in the mouth and throat
• unusual tiredness or weakness
• pale skin
• fainting
• hair loss
• unsteady walk
• slurred speech

This is not a complete list of CeeNU side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of CeeNU, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. CeeNU may cause harm to your unborn baby. It is recommended to avoid becoming pregnant if taking this medication.

CeeNU (lomustine) should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents.

Bone marrow suppression, notably thrombocytopenia and leukopenia, which may contribute to bleeding and overwhelming infections in an already compromised patient, is the most common and severe of the toxic effects of CeeNU (see WARNINGS and ADVERSE REACTIONS).

Since the major toxicity is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose (see ADVERSE REACTIONS). At the recommended dosage, courses of CeeNU should not be given more frequently than every 6 weeks.

The bone marrow toxicity of CeeNU is cumulative and therefore dosage adjustment must be considered on the basis of nadir blood counts from prior dose (see dosage adjustment table under DOSAGE AND ADMINISTRATION).

CeeNU has been shown to be useful as a single agent in addition to other treatment modalities, or in established combination therapy with other approved chemotherapeutic agents in the following:

Brain tumorsboth primary and metastatic, in patients who have already received appropriate surgical and/or radiotherapeutic procedures.

Hodgkin’s diseasesecondary therapy in combination with other approved drugs in patients who relapse while being treated with primary therapy, or who fail to respond to primary therapy.

CeeNU should not be given to individuals who have demonstrated a previous hypersensitivity to it.

Applies to lomustine: oral capsule

Hematologic

Very common (10% or more): Decreased white blood counts (up to 65%), leukopenia
Frequency not reported: Myelosuppression/bone marrow suppression, thrombocytopenia, anemia, pancytopenia decreased hematocrit, bone marrow failure[Ref]

Gastrointestinal

Very common (10% or more): Nausea and vomiting (45% to 100%)
Very rare (less than 0.01%): Diarrhea
Frequency not reported: Stomatitis, anorexia, loss of appetite[Ref]

Hepatic

Rare (less than 0.1%): Cholestatic jaundice
Frequency not reported: Elevations in transaminases, alkaline phosphatase, and bilirubin levels[Ref]

Renal

Frequency not reported: Progressive azotemia, decreased kidney size, renal failure, kidney damage, elevated BUN levels, renal atrophy, renal injury[Ref]

Respiratory

Rare (less than 0.1%): Pulmonary toxicity, interstitial pneumonia, lung fibrosis
Frequency not reported: Lung infiltration[Ref]

Oncologic

Frequency not reported: Acute leukemia, bone marrow dysplasia, myelodysplastic syndrome[Ref]

Nervous system

Uncommon (0.1% to 1%): Apathy, disorientation, confusion, stuttering
Frequency not reported: Lethargy, ataxia, dysarthria, abnormal coordination[Ref]

Ocular

Frequency not reported: Optic atrophy, visual disturbances (e.g., blindness)[Ref]

Dermatologic

Frequency not reported: Alopecia[Ref]

Some side effects of CeeNU may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.