IMPORTANT SAFETY
INFORMATION
What is the most important information I should know about
FILSPARI?
FILSPARI is only available through the FILSPARI Risk
Evaluation and Mitigation Strategy (REMS) Program because of
the
serious risk of liver problems and serious birth
defects.
Before you begin treatment with FILSPARI, you must read and agree to
all the instructions in the FILSPARI REMS Program.
FILSPARI can cause changes in liver tests.
Liver failure was not observed in people treated with FILSPARI in clinical studies, but some medicines that are like FILSPARI can cause liver failure. Your healthcare provider will do blood tests to check your liver before starting FILSPARI, monthly for the first 12 months, then every three months during treatment. Your healthcare provider may temporarily stop or permanently stop treatment with FILSPARI if you have changes in your liver tests.
Stop taking FILSPARI right
away if you develop any of the following signs of liver
problems during treatment with FILSPARI: nausea or vomiting,
pain on the upper right side of your stomach area,
tiredness, loss of appetite, yellowing of the skin or the
whites of your eyes (jaundice), dark “tea-colored” urine,
fever, or itching.
FILSPARI can cause serious birth defects if taken
during pregnancy. Patients must not be pregnant when
they start taking FILSPARI, become pregnant during
treatment, or for one month after stopping
treatment.
Patients who can become pregnant must have a negative
pregnancy test before starting FILSPARI, monthly during
treatment, and for one month after stopping FILSPARI.
Patients who can become pregnant must use effective birth control before starting treatment with FILSPARI, during treatment with FILSPARI, and for one month after stopping FILSPARI because the medicine may still be in your body.
- If you have had a tubal sterilization or have an IUD (intrauterine device) or progesterone implant, these methods may be used alone, and no other form of birth control is needed.
- Talk with your healthcare provider or gynecologist (a healthcare provider who specializes in reproduction) to find out about options for effective forms of birth control that you may use to prevent pregnancy during treatment with FILSPARI.
- If you decide that you want to change the form of birth control that you use, talk with your healthcare provider or gynecologist to be sure that you choose another effective form of birth control.
- Do not have unprotected sex. Talk to your healthcare provider or pharmacist right away if you have unprotected sex or if you think your birth control has failed. Your healthcare provider may talk with you about using emergency birth control.
- Tell your healthcare provider right away if you miss a menstrual period or think you may be pregnant.
Do not take FILSPARI if you:
- are pregnant, plan to become pregnant, or become pregnant during treatment with FILSPARI. FILSPARI can cause serious birth defects.
- are taking any of these medicines:
an angiotensin receptor blocker, an endothelin
receptor antagonist, or aliskiren. Ask your
healthcare provider or pharmacist if you are not sure if you take
one of these medicines.
Before taking FILSPARI, tell your healthcare provider
about all of your medical conditions, including if you
have
liver problems, are pregnant or plan to become pregnant during FILSPARI treatment, or are breastfeeding or plan to breastfeed as it is not known if FILSPARI passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during FILSPARI treatment.
Tell your healthcare provider about all the medicines
you take,
including prescription and over-the-counter medicines,
vitamins, herbal supplements, grapefruit, and antacid
medicines. FILSPARI and other medicines may affect how each
other works and cause side effects. Do not start any new
medicine until you check with your healthcare provider.
Especially tell your healthcare provider if you
take:
- nonsteroidal anti-inflammatory drugs (NSAIDs)
- potassium-containing medicines, potassium
supplements or salt substitutes containing
potassium
- blood pressure medicines
- H2 receptor blocker medicine or proton pump inhibitor (PPI) medicine
Ask your healthcare provider or pharmacist if you are not sure if you take one of these medicines.
What are the possible side effects of FILSPARI?
FILSPARI can cause serious side effects, including:
- Liver problems. See Medication Guide – What is the
most important information I should know about
FILSPARI?
- Serious birth defects. See Medication Guide – What
is the most important information I should know
about FILSPARI?
- Low blood pressure. This is common
during treatment with FILSPARI and can also be
serious. Tell your healthcare provider if you feel
dizzy, light-headed, or faint. Stay hydrated during
treatment with FILSPARI.
- Worsening of kidney function. Your
healthcare provider will check your kidney function
during treatment with FILSPARI.
- Increased potassium in your blood.
This is common during treatment with FILSPARI and
can also be serious. Your healthcare provider will
check your potassium blood level during treatment
with FILSPARI.
- Fluid retention. FILSPARI can
cause your body to hold too much water. Tell your
healthcare provider right away if you have any
unusual weight gain or swelling of your ankles or
legs.
The most common side effects of FILSPARI include: swelling
of the hands, legs, ankles, and feet (peripheral edema),
dizziness, and low red blood cells (anemia). These are not
all the possible side effects of FILSPARI. Call your doctor
for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Travere Therapeutics
at 1-877-659-5518.
For additional Important Safety Information, including serious side effects, please see the
Medication Guide.
