"The U.S. Food and Drug Administration today approved Gazyva (obinutuzumab) for use in combination with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia (CLL).
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Busulfex Consumer (continued)
Nausea, vomiting, diarrhea, constipation, loss of appetite, mouth sores, stomach/abdominal pain, dizziness, swelling ankles/feet/hand, flushing, headache, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
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.
Many people using this medication develop 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. Careful monitoring by your doctor may decrease your risk.
Tell your doctor immediately if any of these unlikely but serious side effects occur: signs of liver disease (such as persistent nausea/vomiting, severe stomach/abdominal pain, yellowing skin/eyes, dark urine), mental/mood changes (such as depression, hallucinations, anxiety, confusion), muscle cramps, increased thirst/urination, fast/irregular heartbeat, coughing up blood, bloody urine, seizures, pain/redness/swelling at injection site.
Tell your doctor immediately if any of these rare but serious side effects occur: fainting, missed menstrual periods, shrinking testicles.
Busulfan has rarely caused very serious (possibly fatal) lung disease. Tell your doctor immediately if you develop symptoms of lung disease, including chest pain, shortness of breath, persistent cough.
Busulfan may cause other cancers (such as acute leukemia, tumors). Consult your doctor for more details. Tell your doctor immediately if you notice any symptoms of cancer, including unusual lumps, sudden weight loss.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: 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 Busulfex (busulfan) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before receiving busulfan, 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.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow disorders (such as bone marrow suppression, neutropenia, thrombocytopenia, anemia), brain disorders (such as seizures, head injury).
This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Busulfan can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.
Do not have immunizations/vaccinations without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).
To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This medication may make it harder for females to become pregnant or for males to father children. Discuss with your doctor for more details.
Busulfan is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the use of reliable forms of birth control with your doctor. If you become pregnant or think you may be pregnant, tell your doctor immediately.
It is unknown if 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 Busulfex Information
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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