"The US Food and Drug Administration (FDA) has granted accelerated approval of obeticholic acid (Ocaliva, Intercept Pharmaceuticals, Inc) for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic (UDCA) in a"...
Tyzeka Consumer (continued)
Dizziness, tiredness, diarrhea, cough, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
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.
Tell your doctor immediately if any of these unlikely but serious side effects occur: unexplained muscle pain/tenderness/weakness.
Tell your doctor immediately if any of these rare but serious side effects occur: numbness/tingling/burning or weakness/pain of arms/legs, difficulty walking, signs of infection (such as fever, persistent sore throat), easy bruising/bleeding.
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 Tyzeka (telbivudine) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking telbivudine, 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: kidney problems, alcohol use.
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.
Avoid alcohol because it may worsen dizziness and liver problems.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
To decrease your risk of spreading hepatitis B to others, always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity. Consult your doctor or pharmacist for more details.
During pregnancy, this medication should be used only when clearly needed. It is not known if this medication helps to prevent the hepatitis B virus from passing from the mother to the baby. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. The manufacturer states that breast-feeding while using this drug 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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