Fludara

DRUG DESCRIPTION

FLUDARA FOR INJECTION contains fludara (fludarabine) bine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-p-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Each vial of sterile lyophilized solid cake contains 50 mg of the active ingredient fludara (fludarabine) bine phosphate, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2-8.2. Reconstitution with 2 mL of Sterile Water for Injection, USP, results in a solution containing 25 mg/mL of fludara (fludarabine) bine phosphate intended for intravenous administration.

The chemical name for fludara (fludarabine) bine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0-phosphono- 0-D-arabino-furanosyl) (2-fluoro-ara-AMP). The molecular formula of fludara (fludarabine) bine phosphate is C10H13FN5O7P (MW 365.2) and the structure is:

Fludaraź
 (fludara (fludarabine) bine phosphate) Structural Formula Illustration

What are the possible side effects of fludarabine (Fludara)?

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

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness;
  • pale or yellowed skin, dark colored urine;
  • cough with yellow or green mucus,...

Read All Potential Side Effects and See Pictures of Fludara »

What are the precautions when taking fludarabine (Fludara)?

Before using fludarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell your doctor your medical history, especially of: current infections, certain virus illnesses (herpes, chickenpox), blood disorders (e.g., anemia, clotting problems), kidney problems.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others...

Read All Potential Precautions of Fludara »


Fludara Consumer (continued)

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, diarrhea, headache, muscle aches, tiredness, loss of appetite, and pain/redness at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication may have serious side effects. However, your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. To lower your risk of serious side effects, your doctor will follow your condition closely and order lab tests.

Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.

Tell your doctor right away if you have any serious side effects, including: fast/irregular heartbeat, swelling ankles/feet.

This medication affects your blood cells, reducing your ability to fight infections. Although fever and chills are common side effects of fludarabine, they may also be signs of an infection. Tell your doctor if you develop chills or fever.

Fludarabine sometimes causes side effects due to the rapid destruction of cancer cells (tumor lysis syndrome). To lower your risk, drink plenty of fluids unless your doctor directs you otherwise. Tell your doctor immediately if you experience symptoms such as low back/side pain (flank pain), red/pinkish urine, painful urination, or muscle spasms/weakness.

Get medical help right away if any of these rare but very serious side effects occur: bloody/black/tarry stool, persistent cough, coughing up blood, painful/difficult breathing, chest pain, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using fludarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell your doctor your medical history, especially of: current infections, certain virus illnesses (herpes, chickenpox), blood disorders (e.g., anemia, clotting problems), kidney problems.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others (e.g., flu, chickenpox).

To lower your chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, elderly people may be at greater risk for side effects (e.g., infection, bleeding) while using this drug.

This drug is not recommended for use during pregnancy. It may harm the unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment and for 6 months after treatment has ended. Consult your doctor for details and to discuss effective forms of birth control.

It is not known whether this medication passes into breast milk. However, it may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.


Fludara Patient Information Including Side Effects

Brand Names: Fludara

Generic Name: fludarabine (Pronunciation: floo DAYR a been)

  • What is fludarabine (Fludara)?
  • What are the possible side effects of fludarabine (Fludara)?
  • What is the most important information I should know about fludarabine (Fludara)?
  • What should I discuss with my healthcare provider before I receive fludarabine (Fludara)?
  • How is fludarabine given (Fludara)?
  • What happens if I miss a dose (Fludara)?
  • What happens if I overdose (Fludara)?
  • What should I avoid while receiving fludarabine (Fludara)?
  • What other drugs will affect fludarabine (Fludara)?
  • Where can I get more information?

What is fludarabine (Fludara)?

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

Fludarabine is used to treat B-cell chronic lymphocytic leukemia (CLL).

Fludarabine is usually given after other cancer medications have been tried without successful response to treatment.

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

What are the possible side effects of fludarabine (Fludara)?

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

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness;
  • pale or yellowed skin, dark colored urine;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of breath;
  • black, bloody, or tarry stools, coughing up blood;
  • lower back pain, blood in your urine;
  • urinating less than usual or not at all;
  • numbness or tingly feeling around your mouth, fast or slow heart rate, weak pulse, fainting;
  • muscle weakness, tightness, or contraction, overactive reflexes;
  • drowsiness, mood changes, increased thirst, swelling, rapid weight gain;
  • vision problems, headache or pain behind your eyes, changes in behavior, confusion, agitation, seizure (convulsions); or
  • severe blistering, peeling, and red skin rash.

Less serious side effects may include:

  • mild nausea, loss of appetite, diarrhea;
  • mild itching or skin rash;
  • headache;
  • muscle pain; or
  • tired feeling.

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.

What is the most important information I should know about fludarabine (Fludara)?

Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive fludarabine, tell your doctor if you have kidney disease, bone marrow problems or a weak immune system, any active infection, a history of skin cancer, or a history of a viral infection such as herpes zoster (shingles), Epstein-Barr, or a virus affecting the central nervous 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 have colds, the flu, or other contagious illnesses. Your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Do not receive a "live" vaccine while you are being treated with fludarabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you.

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

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