"The US Food and Drug Administration (FDA) has approved a supplemental biologics license application (sBLA) for ofatumumab (Arzerra, Genmab/Novartis) for its use in combination with fludarabine and cyclophosphamide for the treatment of pati"...
Fludara Consumer (continued)
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. Also, your doctor may prescribe an additional medication. Tell your doctor right away if you have symptoms such as: low back/side pain (flank pain), pink/bloody urine, change in the amount of urine, painful urination, 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.
Read the Fludara (fludarabine) Side Effects Center for a complete guide to possible side effects
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.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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