"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
Simulect Consumer (continued)
Remember that 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. Many people using this medication do not have serious side effects.
The use of medications that affect the immune system may lead to increased risk of infection or certain types of cancer. Tell your doctor right away if you have any serious side effects, including: fever, weakness, swollen glands, night sweats, unusual lumps, persistent cough/sore throat, sores around the mouth/genitals, pain with urination, vision changes, unexplained weight loss.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, unusually fast heartbeat, sneezing, 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 Simulect (basiliximab) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before using basiliximab, tell your doctor or pharmacist if you are allergic to it; or to mouse proteins; 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: certain infection (cytomegalovirus).
Previous treatment with basiliximab may increase your risk of a serious allergic reaction (see Side Effects section). Before using this medication, tell your doctor or pharmacist if you have received basiliximab in the past. If you must stop using this drug due to an allergic reaction, do not use the drug again. Consult your doctor or pharmacist for more details.
Before having surgery, tell your doctor or dentist that you are using this medication.
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.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Women who may become pregnant should use effective birth control before beginning treatment with this drug, during use, and for 4 months after finishing treatment. Consult your doctor or pharmacist for more information.
It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.
Additional Simulect 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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