Nipent

Nipent is used to treat hairy cell leukemia (cancer of a certain type of white blood cell). Nipent is an antibiotic that is only used in cancer chemotherapy. It works by slowing or stopping the growth of cancer cells in your body.

Nipent comes as a powder to be mixed with liquid and injected into a vein by a healthcare professional. It is usually injected once every other week.

Common side effects include nausea, vomiting, and rash.

Nipent is used to treat hairy cell leukemia (cancer of a certain type of white blood cell).

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

• Hospira, Inc.

Common side effects of Nipent include the following:

• nausea
• vomiting
• diarrhea
• stomach pain
• constipation
• sores in the mouth and throat
• flatulence or large amounts of gas in the intestines or bowels
• hair loss
• muscle, back, or joint pain
• headache
• sweating
• difficulty falling asleep or staying asleep
• dry skin
• itching
• loss of strength or energy

This is not a complete list of this medication’s 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.

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

• allopurinol (Lopurin, Zyloprim, Aloprim)
• carmustine (Gliadel, BiCNU)
• etoposide (Etopophos)
• cyclophosphamide (Cytoxan)
• fludarabine
• vidarabine

This is not a complete list of all drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Nipent.

• Nipent can cause damage to the nervous system. If you experience any of the following symptoms, call your doctor immediately: seizures; confusion; drowsiness; loss of consciousness for a period of time; pain, burning, numbness, or tingling in the hands or feet; or weakness in the arms or leg or loss of ability to move your arms or legs.
• In a clinical study, people with chronic lymphocytic leukemia who used Nipent injection along with fludarabine (Fludara) were at a higher risk of developing serious lung damage. In some cases, this lung damage caused death. Therefore, your doctor will not prescribe Nipent injection to be given along with fludarabine (Fludara).

Do not take this medication if you are allergic to Nipent or to any of its ingredients.

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 this medication, there are no specific foods that you must exclude from your diet.

Before receiving Nipent,

• tell your doctor and pharmacist if you are allergic to Nipent, any other medications, or any of the ingredients in Nipent injection.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.
• tell your doctor if you have or have recently had an infection or if you have or have ever had kidney or liver disease.
• ell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding.

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. You should not become pregnant while you are receiving Nipent. If you become pregnant while receiving Nipent, call your doctor. Nipent may harm the fetus.

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

It is not known if this medication 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 this medication.

Nipent comes as a powder to be mixed with liquid and injected into a vein by a healthcare professional. It is usually injected once every other week.

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
• your gender

The recommended dosage of Nipent is 4 mg/m² every other week.

Because 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.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to Nipent.

Nipent should be administered under the supervision of a physician qualified and experienced in the use of cancer chemotherapeutic agents. The use of higher doses than those specified is not recommended. Dose-limiting severe renal, liver, pulmonary, and CNS toxicities occurred in Phase 1 studies that used Nipent at higher doses (20-50 mg/m2 in divided doses over 5 days) than recommended.

In a clinical investigation in patients with refractory chronic lymphocytic leukemia using Nipent at the recommended dose in combination with fludarabine phosphate, 4 of 6 patients entered in the study had severe or fatal pulmonary toxicity. The use of Nipent in combination with fludarabine phosphate is not recommended.