Oforta is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Oforta is used to treat B-cell chronic lymphocytic leukemia (CLL). It is usually given after other cancer medications have been tried without successful response to treatment.

Oforta may also be used for other purposes not listed in this medication guide.

Do not use Oforta if you are pregnant. It could harm the unborn baby. Use birth control to prevent pregnancy while you are taking this medicine, whether you are a man or a woman. Keep using birth control for at least 6 months after your treatment ends. Use of fludarabine by either parent may cause birth defects.

Before you take Oforta, tell your doctor if you have kidney disease, bone marrow problems, or a weak immune system.

Oforta can lower blood cells that help your body fight infections and help your blood to clot. Serious and sometimes fatal infections may occur during treatment. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, painful mouth sores, cold or flu symptoms, pale or yellowed skin, dark colored urine).

Oforta may also have harmful effects on your lungs. Call your doctor at once if you have a new or worsening cough, fever, and trouble breathing.

Oforta can affect your central nervous system during or just after treatment. Get emergency medical help if you have vision problems, confusion, agitation, changes in behavior, or a light-headed feeling (like you might pass out).

Before I take Oforta

You should not use Oforta if you are allergic to fludarabine, or if you are also being treated with pentostatin (Nipent).

To make sure Oforta is safe for you, tell your doctor if you have:

• kidney disease; or

• bleeding or blood clotting disorder.

FDA pregnancy category D. Do not use Oforta if you are pregnant. It could harm the unborn baby.

Use birth control to prevent pregnancy while you are taking Oforta, and for at least 6 months after your treatment ends whether you are a man or a woman. Oforta use by either parent may cause birth defects.

It is not known whether fludarabine passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking this medicine.

Oforta is usually taken daily for 5 days in a row every 28 days. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended. Your doctor will determine how long to treat you with Oforta.

Take this medicine with a full glass of water. You may take Oforta with or without food.

Do not crush or chew a tablet. Swallow it whole. The medicine from a crushed or broken pill can be dangerous if it gets in your eyes, mouth, or nose, or on your skin. If you accidentally touch a broken tablet, wash your skin with soap and water. Call your doctor if you develop a skin rash or severe irritation.

If the powder from a broken tablet gets in your eyes, rinse them with water for at least 15 minutes.

Oforta can lower blood cells that help your body fight infections and help your blood to clot. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Serious and sometimes fatal infections may occur during treatment. Your blood will need to be tested often. Your nerve function may also need to be checked.

If you need to have a blood transfusion, tell your caregivers ahead of time that you are taking Oforta.

Store at room temperature away from moisture and heat. Keep each tablet in the foil blister package until you are ready to take it.

Do not throw away unused or expired Oforta tablets in your household trash. Ask your pharmacist where to locate a community pharmaceutical take back disposal program.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using Oforta, or you could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection. Avoid activities that may increase your risk of bleeding or injury.

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Get emergency medical help if you have any of these signs of an allergic reaction to Oforta: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Oforta can affect your central nervous system during or just after treatment. Get emergency medical help if you have vision problems, confusion, agitation, changes in behavior, or a light-headed feeling (like you might pass out).

Call your doctor at once if you have:

• fever, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms;

• pale or yellowed skin, dark colored urine, unusual weakness;

• pain or burning when you urinate;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• a light-headed feeling, like you might pass out;

• new or worsening cough, trouble breathing, cough with yellow or green mucus, wheezing, stabbing chest pain;

• lower back pain, blood in your urine, little or no urinating;

• muscle weakness, tightness, or contraction, overactive reflexes;

• fast or slow heart rate, weak pulse, numbness or tingly feeling around your mouth; or

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Common Oforta side effects may include:

• vomiting, stomach pain, loss of appetite, diarrhea;

• swelling in your legs; or

• mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with Oforta, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.