CeeNU

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.

CeeNU is a prescription medication used to treat certain types of brain tumors in patients who have already had surgery and/or radiation treatment. CeeNU is also used with other medications to treat Hodgkin's lymphoma (Hodgkin's disease) that has not improved or that has worsened after treatment with other medications.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• 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.

No drug interactions have been identified. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Becuase CeeNU reduces the function of the immune system, be sure to inform your physician if you are taking any other medications that also suppress your immune system, such as steroids or other cancer treatments.

Serious side effects have been reported with CeeNU including the following:

Lowered blood counts. CeeNU can reduce the number of blood cells in your bone marrow. This may increase the risk that you will develop a serious or life-threatening infection and/or have extended bleeding times. If you experience any of the following symptoms, call your doctor immediately:

• fever
• chills
• sore throat
• an ongoing cough and congestion
• signs of infection including fever and/or cough
• unusual bleeding or bruising
• bloody or black, tarry stools
• bloody vomit
• vomiting blood or brown material that resembles coffee grounds

Toxicity to bone marrow. To prevent toxicity to the bone marrow, your doctor will order lab tests and will adjust your CeeNU dose accordingly while you are taking CeeNU. 

Lung, liver, and kidney complications. Talk to your doctor about your risks for developing lung, liver, and/or kidney complications while taking CeeNU.

Development of new cancers. Talk to your doctor about your risks for developing new cancers while taking CeeNU.

Do not receive CeeNU if you are allergic to CeeNU or to any of its ingredients.

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

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.

Before receiving CeeNU, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to CeeNU or to any of its ingredients
• have bleeding disorders
• have any autoimmune disorders
• have liver or kidney problems
• have had a bone marrow transplant
• have heart or lung problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if CeeNU crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using CeeNU.

Take CeeNU exactly as prescribed.

• CeeNU comes in capsule form and is typically taken by mouth once every 6 weeks. Take CeeNU on an empty stomach.
• Your full dose of CeeNU may contain two or more different types and colors of capsules. Take all of the capsules given to you in the prescription bottle at the same time. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any parts you do not understand.
• Do not take more or less of it or take it more often than prescribed by your doctor.
• You should wear rubber or latex gloves when you handle the capsules so that your skin does not come into contact with the capsules. If contact occurs, wash skin immediately and thoroughly.
• Swallow CeeNU whole; do not split, chew, or crush the capsules.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Ceenu at the same time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age

The recommended dose of CeeNU for adults and children in previously untreated persons is 130 mg/m² as a single oral dose every 6 weeks.

The recommended dose of CeeNU for adults and children with existing bone marrow suppression is 100 mg/m² every 6 weeks.

Dose adjustments may be made based on other medications you are taking, blood counts, and other conditions you have.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

• Stored in a well-closed container at room temperature.
• Avoid excessive heat (over 40°C, 104°F).
• Keep this and all other medications out of the reach of children.
• Wear rubber or latex gloves when handling CeeNU capsules. If contact occurs, wash skin immediately and thoroughly.

CeeNU 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 immune-compromised person, is the most common and severe of the toxic effects of CeeNU.

Since the major toxicity of CeeNU is delayed bone marrow suppression, blood counts should be monitored weekly for at least 6 weeks after a dose. 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 lower blood counts from prior dose.