"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"...
Purinethol Consumer (continued)
Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.
Tell your doctor immediately if any of these unlikely but serious side effects occur: easy bruising/bleeding, dizziness/fainting, joint pain/swelling, tongue/mouth sores or pain, unusual tiredness, symptoms of liver disease (such as persistent nausea/vomiting, stomach/abdominal pain, dark urine, yellowing eyes/skin).
Tell your doctor immediately if any of these rare but very serious side effects occur: symptoms of possible lymphoma (such as swollen or painful abdomen, persistent fever, night sweats, unexplained weight loss), change in amount of urine, pain in the lower back/side.
This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), 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 Purinethol (mercaptopurine) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking mercaptopurine, tell your doctor or pharmacist if you are allergic to it; or to azathioprine; 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.
This medication should not be used if you have a certain medical condition. Before taking this medicine, consult your doctor or pharmacist if a certain drug (thioguanine) did not work for you in the past. This may affect how well mercaptopurine works for you.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: other blood disorders (e.g., anemia, low blood cell counts), gout, kidney disease (including kidney stones), liver disease, pancreatitis, radiation treatment, history of cancer (such as lymphoma).
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.
To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
If you need to have surgery or a dental procedure, tell your doctor or dentist that you are using mercaptopurine.
Drinking alcohol may increase the risk of stomach/esophageal irritation or liver damage. Limit alcoholic beverages.
People with a certain inherited problem (lack of thiopurine methyltransferase-TPMT enzyme) may be at increased risk for serious side effects from this medication and may require dosage adjustment. Consult your doctor for details and to discuss whether you should be tested for this inherited problem.
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the liver and bone marrow effects.
This medication is not recommended for use during pregnancy. It may harm the unborn baby. It may be particularly harmful during the first 3 months of pregnancy. Consult your doctor for more details and to discuss reliable forms of birth control. If you become pregnant or think you may be pregnant, tell your doctor immediately.
It is not known whether this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
Additional Purinethol Information
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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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