Name: Oforta

What is the most important information i should know about fludarabine (oforta)?

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

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

If you need to have a blood transfusion, tell your caregivers ahead of time that you are being treated with fludarabine.

Fludarabine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection. Your blood may need to be tested often. Visit your doctor regularly.

Contact your doctor at once if you develop signs of infection such as fever, cough, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

Where can i get more information?

Your doctor or pharmacist can provide more information about fludarabine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Side Effects of Oforta

Oforta may cause side effects, some of which can be serious. See "Oforta Precautions" section. Tell your doctor if any side effect is severe or does not go away.

The most common side effects include:

  • bone marrow suppression which can cause low levels of red and white blood cells as well as low levels of platelets (increasing risk of infection, anemia, and blood clotting problems)
  • fever
  • chills
  • infection
  • nausea
  • vomiting

Other common side effects include:

  • general feeling of illness
  • unusual tiredness
  • decreased appetite
  • weakness
  • swelling of arms, hands, feet, ankles, or lower legs

This is not a complete list of Oforta side effects. Ask your doctor or pharmacist for more information.

Oforta Usage

Oforta is a liquid to be infused (slowly injected into a vein) by a healthcare provider in a medical facility. The infusion lasts approximately 30 minutes and is given once daily for five days in a row. This cycle may be repeated every 28 days.

Your doctor will order certain tests to check your body's response to Oforta.


Indications and Usage for Oforta

Oforta™ (fludarabine phosphate tablets) for oral use is indicated as a single agent for the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) whose disease has not responded to or has progressed during or after treatment with at least one standard alkylating-agent containing regimen. Studies demonstrating clinical benefit such as prolongation of survival or relief of symptoms have not been performed. Studies providing a direct comparison of the clinical efficacy and safety of Oforta™ relative to intravenously administered fludarabine phosphate have not been performed.

Oforta Dosage and Administration

Chronic Lymphocytic Leukemia (CLL)

The oral dose of Oforta™ is different than the intravenous fludarabine phosphate dose.

The recommended adult dose of Oforta™ is 40 mg/m2 administered by mouth daily for five consecutive days. Each 5-day course of treatment should commence every 28 days. Dosage may be decreased or delayed based on evidence of hematologic or nonhematologic toxicity. Physicians should consider delaying or discontinuing the drug if neurotoxicity occurs. Oforta™ can be taken either on an empty stomach or with food. The tablets have to be swallowed whole with water; they should not be chewed or broken.

The following table provides guidance for determining the number of tablets of Oforta™ to be administered based on body surface area (BSA):

Body Surface Area (BSA) Calculated Total Dose Equivalent to 40 mg/m2 BSA (rounded up or down to nearest 10 mg) Total Number of Tablets
0.75 – 0.88 30 mg 3
0.89 – 1.13 40 mg 4
1.14 – 1.38 50 mg 5
1.39 – 1.63 60 mg 6
1.64 – 1.88 70 mg 7
1.89 – 2.13 80 mg 8
2.14 – 2.38 90 mg 9
2.39 – 2.50 100 mg 10

A number of clinical settings may predispose to increased toxicity from Oforta™. These include advanced age, renal insufficiency, and bone marrow impairment. Such patients should be monitored closely for excessive toxicity and the dose modified accordingly. The optimal duration of treatment has not been clearly established. It is recommended that three additional cycles of Oforta™ be administered following the achievement of a maximal response and then the drug should be discontinued.

Renal Impairment

  • Reduce dose by 20% in patients with mild to moderate renal impairment (creatinine clearance 30 to 70 mL/min/1.73 m2). [See Warnings and Precautions (5.7)]
  • Reduce dose by 50% in patients with severe renal impairment (creatinine clearance < 30 mL/min/1.73 m2). [See Warnings and Precautions (5.7)]

What is Oforta?

Oforta (fludarabine) 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.

What happens if I overdose?

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