Pentostatin Injection

IMPORTANT WARNING:

Pentostatin injection must be given under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.

Pentostatin may cause serious side effects, including 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 pentostatin 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 pentostatin injection to be given along with fludarabine (Fludara).

WHY is this medicine prescribed?

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

Are there OTHER USES for this medicine?

Pentostatin is also sometimes used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells) and cutaneous T-cell lymphoma (a type of cancer that begins in a type of white blood cell that normally fights infection and that affects the skin). Talk to your doctor about the risks of using this medication for your condition.

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

HOW should this medicine be used?

Pentostatin comes as a powder to be mixed with liquid and injected intravenously (into a vein) over 5 minutes or infused intravenously over 20 to 30 minutes by a doctor or nurse in a medical facility. It is usually injected once every other week. The length of treatment depends on how well your body responds to treatment with pentostatin.

Your doctor may need to delay your treatment or change your dose if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with pentostatin injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving pentostatin,

• tell your doctor and pharmacist if you are allergic to pentostatin, any other medications, or any of the ingredients in pentostatin injection. Ask your pharmacist or a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medication listed in the IMPORTANT WARNING section or allopurinol (Zyloprim). Your doctor may need to monitor you carefully for side effects.

• 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 breast-feeding. You should not become pregnant while you are receiving pentostatin. If you become pregnant while receiving pentostatin, call your doctor. Pentostatin may harm the fetus.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

Pentostatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• 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

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

• difficulty breathing
• shortness of breath
• wheezing
• cough
• fever, sore throat, chills, or other signs of infection
• unusual bleeding or bruising
• black and tarry stools
• red blood in stools
• bloody vomit; vomited material that looks like coffee grounds
• fast, irregular, or pounding heartbeat
• chest pain
• dizziness
• fainting
• yellowing of the skin or eyes
• loss of appetite
• pain in the upper right part of the stomach
• dark colored urine
• decreased urination
• swelling of the face, arms, hands, feet, ankles, or lower legs
• unusual tiredness or weakness
• rash
• vision changes
• changes in hearing

Pentostatin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

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

Ask your pharmacist any questions you have about pentostatin.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.