IMPORTANT SAFETY INFORMATION
What is the most important information
I should know about TAVNEOS?
TAVNEOS can cause serious side effects, including:
Liver problems. People taking TAVNEOS may have serious liver problems.
Call your healthcare provider right away if you have
unexplained symptoms such as:
yellowing of your skin or the white part of your eyes (jaundice)
pain on the upper right side of your stomach area (abdomen)
dark or brown (tea colored) urine
bleeding or bruising more easily than normal
loss of appetite
Your healthcare provider will do blood tests to check how well your liver is working
before starting and during your treatment with TAVNEOS.
Do not take TAVNEOS if you are allergic to avacopan or any of the other ingredients
Get medical help right away if you experience swollen lips, tongue, throat,
trouble swallowing, or difficulty breathing. These
could be signs of an allergic reaction. Do not take more TAVNEOS until you have
consulted with your healthcare provider.
Before taking TAVNEOS, tell your healthcare provider about all your medical
conditions, including if you:
have or have had abnormal liver blood tests.
have or have had liver problems.
have or think you may have hepatitis B or C.
have an infection.
are pregnant or are planning to become pregnant. It is not known if TAVNEOS will
harm your unborn baby. Talk to your healthcare
provider if you are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed. It is not known if TAVNEOS can pass
into your breast milk. Talk to your healthcare provider about
the best way to feed your baby if you take TAVNEOS.
Tell your healthcare provider about all the other medicines you take,
including prescription and over-the-counter medicines, vitamins, and
herbal supplements. TAVNEOS and certain other medicines may affect each other
and cause side effects. Keep a list of the medicines you take and
show it to your healthcare provider and pharmacist.
Some medicines should not be taken with TAVNEOS.
Your healthcare provider may prescribe other medicines to treat your disease.
TAVNEOS may cause serious side effects, including:
Liver problems (see above).
Serious allergic reactions. Stop taking TAVNEOS and get emergency medical
help right away if you have any of the following
signs of a serious allergic reaction: shortness of breath or trouble breathing;
swollen lips, tongue, throat, or face; trouble
swallowing; chest pain; feeling dizzy or faint; moderate or severe abdominal
pain, or vomiting.
Hepatitis B virus (HBV) reactivation. If you have had HBV or are a
carrier of HBV, taking TAVNEOS could cause the virus to
become an active infection again. Tell your healthcare provider right away if
you get worsening tiredness or yellowing of your
skin or the white part of your eyes during treatment with TAVNEOS.
Serious infections. Serious infections can happen in people taking
TAVNEOS, and these infections can lead to death. The most
common serious infections with TAVNEOS were pneumonia and urinary tract
infections. People with serious infections should
not take TAVNEOS. Tell your healthcare provider right away if you have any
symptoms of infection: fever, cold symptoms that do
not go away, flu symptoms, pain during urination, or other signs of infection.
The most common side effects of TAVNEOS include:
nausea, headache, high blood pressure, diarrhea, vomiting, rash, tiredness,
stomach pain, dizziness, increase in blood creatinine, and
burning or prickling sensation.
What is TAVNEOS?
TAVNEOS is a prescription medicine that is used with other medicines (such as
glucocorticoids) to treat adults with severe active anti-neutrophil
cytoplasmic autoantibody (ANCA)-associated vasculitis (granulomatosis with
polyangiitis [GPA], formerly known as Wegener’s granulomatosis,
and microscopic polyangiitis [MPA]).
It is not known if TAVNEOS is safe and effective in children under the age of
These are not all the possible side effects of TAVNEOS. Call your doctor for
medical advice about side effects. Please see the
Full Prescribing Information and Medication
Guide for further details.
TAVNEOS is available as a 10 mg capsule.
You are encouraged to report negative side effects to Amgen at 1-833-828-6367 or to
the FDA by
visiting www.fda.gov/medwatch or calling 1-800-332-1088.