Oforta

Generic Name: oral fludarabine phosphate tablets
Date of Approval: December 18, 2008
Company: sanofi-aventis U.S.

Treatment for: Chronic Lymphocytic Leukemia

Oforta Patient Information

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Read this Patient Information leaflet before you start taking Oforta and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What Is Oforta?

Oforta (oral fludarabine phosphate tablets) is a prescription anticancer medicine that slows or stops the growth of cancer cells in adults with chronic lymphocytic leukemia (CLL). Oforta also stops or slows the growth of some healthy cells. This can cause side effects that you should know about and report to your healthcare provider.

Oforta has not been studied in children.

What is the most important information I should know about Oforta?

On rare occasions people taking Oforta can have life-threatening symptoms. If you:

• have problems seeing
• feel very sleepy, tired, or confused
• have shortness of breath or have trouble breathing
• have yellow skin or dark urine

Tell your healthcare provider right away.

What should I tell my healthcare provider before taking Oforta?

Before taking Oforta, tell your healthcare provider about all of your medical conditions, including if you:

• have kidney problems
• have bleeding problems
• are pregnant or plan to become pregnant. It is not known if Oforta will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant. Women should not get pregnant during treatment with Oforta because the unborn baby may be harmed. Both men and women must take contraceptive measures during and for at least six months after cessation of therapy. Call your doctor right away if you become pregnant during or in the six months after treatment with Oforta.
• are breast- feeding or plan to breast-feed. It is not known if Oforta passes into your breast milk. You and your healthcare provider should decide if you will take Oforta or breast-feed. You should not do both.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements. Using Oforta with certain other medicines may affect each other. Using Oforta with other medicines may cause serious side effects. Know the medicines you take. Keep a list of them with you to show your healthcare provider.

How should I take Oforta?

• Take Oforta exactly as your healthcare provider tells you to take it.
• Your healthcare provider will tell you how much and when to take Oforta.
• Oforta can be taken with or without food.
• Push tablets through foil to open. Do not remove tablets from individual blisters until immediately prior to taking or administering each scheduled dose.
• Oforta tablets have to be swallowed whole with water; they should never be chewed, crushed, or broken. If you cannot swallow Oforta whole, ask your healthcare provider if you can take another form of fludarabine.
• If you miss a dose call your healthcare provider.
• If you take too much call your healthcare provider.

What should I avoid while taking Oforta?

• Do not allow other people or pets to touch or take Oforta.
• Avoid letting the tablets (whole or broken) touch your skin
• Do not chew tablets or hold them in your mouth. Swallow tablets right away.
• Do not breathe in any powder or residue from a broken tablet.
• If you touch a broken tablet, wash the area thoroughly with soap and water.
• If any Oforta gets in your eyes, wash your eyes right away with water for at least 15 minutes, and call your healthcare provider right away.
• Call your healthcare provider right away in case of a skin reaction.

What are the possible side effects of Oforta?

See "What is the most important information I should know about Oforta?"

Oforta may cause serious side effects, including:

• Low blood cell counts. Oforta lessens the number of blood cells that fight infection, help your blood to clot, and carry oxygen throughout your body. This can result in
  • Infection
  • Bleeding
  • Tiredness.
• Avoid activities that can raise your chances of these conditions. Your healthcare provider will check your blood counts so that you will know when you are most at risk for infection, bleeding, and tiredness.

Call your healthcare provider right away if you have a temperature of 100.5 F. or above or do not feel well. Do not take a fever medicine until you check with your healthcare provider.

Oforta may cause other side effects, including:

• nausea and vomiting
• loss of appetite
• skin rash
• swelling in your legs
• diarrhea
• redness and irritation inside your mouth (stomatitis)
• abdominal and muscle pain.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Oforta. For more information, ask your healthcare provider or pharmacist.

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

How should I store and throw away Oforta?

• Store Oforta at 59-86°F (15-30°C).
• Keep under normal light in a child-resistant container.
• Safely throw away medicine that is out of date or no longer needed.
• Do not put Oforta in your regular household trash.
• Ask your healthcare provider or pharmacist for directions about how to safely throw away and handle Oforta.

Keep Oforta and all medicines out of the reach of children.

General information about Oforta

Medicines are sometimes prescribed for conditions that are not mentioned in patient information. Do not use Oforta for a condition for which it was not prescribed. Do not give Oforta to other people, even if they have the same symptoms you have. It may harm them.

This patient information leaflet summarizes the most important information about Oforta. For more information about Oforta, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Oforta that is written for health professionals. For more information call 1-800-633-1610.

What are the ingredients in Oforta?

Active ingredients: fludarabine phosphate

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silicon dioxide, croscarmellose sodium and magnesium stearate. The film-coat contains hypromellose, talc, titanium dioxide (E171) and ferric oxide pigment (red/E172, yellow/E172).

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