Important Safety
Information
What is the most important information
I should know about
OFEV?
OFEV can cause harm, birth defects, or death to an unborn baby. Women should not become pregnant
while taking OFEV. Women who are able to become pregnant should have a pregnancy test before
starting treatment and should use highly effective birth control at the start of treatment, during
treatment, and for at least 3 months after your last dose. Talk with your doctor about what birth
control method is right for you during this time. Birth control pills may not work as well in women
having vomiting, diarrhea, or other problems reducing the drug absorption. If you have any of these
problems, talk with your doctor about what highly effective birth control method is right for you.
If you become pregnant or think you are pregnant while taking OFEV, tell your doctor right away.
What should I tell my doctor before using OFEV?
Before you take OFEV, tell your doctor about all of your medical
conditions, including
if you have:
- liver problems.
- heart problems.
- a history of blood clots.
- a bleeding problem or a family history of a bleeding problem.
- had recent surgery in your stomach (abdominal) area.
Tell your doctor if you:
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if OFEV passes into your
breast milk.
You should not breastfeed while taking
OFEV.
- are a smoker. You should stop smoking prior to taking OFEV and avoid smoking during
treatment.
Tell your doctor about all the medicines you take, including
prescription and over-the-counter medicines, vitamins, and herbal supplements such as St. John’s
wort.
What are the possible side effects of OFEV?
OFEV may cause serious side effects.
TELL YOUR DOCTOR RIGHT AWAY if you are experiencing any side
effects, including:
Liver problems. Unexplained symptoms may
include yellowing of your skin or the white part of your eyes (jaundice), dark or brown
(tea-colored) urine, pain on the upper right side of your stomach area (abdomen), bleeding or
bruising more easily than normal, feeling tired, or loss of appetite. Your doctor will do blood
tests to check how well your liver is working before starting and during your treatment with OFEV.
Diarrhea, nausea, and vomiting. Your doctor may
recommend that you drink fluids
or take medicine to treat these side effects. Tell your doctor if you have these symptoms, if they
do not go away, or get worse, and if you are taking over-the-counter laxatives, stool softeners, and
other medicines or dietary supplements.
Heart attack. Symptoms of a heart problem may
include chest pain or pressure, pain in your arms, back, neck, or jaw, or shortness of breath.
Stroke. Symptoms of a stroke may include numbness
or weakness on one side of your body, trouble talking, headache, or dizziness.
Bleeding problems. OFEV may increase your chances
of having bleeding problems. Tell your doctor if you have unusual bleeding, bruising, wounds that do
not heal, and/or if you are taking a blood thinner, including prescription blood thinners and
over-the-counter aspirin.
Tear in your stomach or intestinal wall
(perforation). OFEV may increase your chances of having a tear in your stomach or
intestinal wall. Tell your doctor if you have pain or swelling in your stomach area.
Increased protein in your urine (proteinuria). OFEV may
increase your chances of having protein in your urine. Tell your doctor if you have any signs and
symptoms of protein in the urine such as foamy urine, swelling, including in your hands, arms, legs,
or feet, or sudden weight gain.
The most common side effects of OFEV are diarrhea, nausea, stomach pain, vomiting, liver
problems, decreased appetite, headache, weight loss, and high blood pressure.
These are not all the possible side effects of OFEV. For more information, ask
your doctor or pharmacist. You are encouraged to report negative side effects of
prescription drugs to
the FDA. Visit www.fda.gov/
medwatch
or call 1-800-FDA-1088.
OFEV is a prescription medicine used:
- to treat adults with a lung disease called idiopathic pulmonary
fibrosis (IPF).
- to treat adults with a long lasting (chronic) interstitial lung disease
in which lung fibrosis continues to worsen (progress).
- to slow the rate of decline in lung function in adults with systemic
sclerosis-associated
interstitial lung disease (SSc-ILD) (also known as scleroderma-associated ILD).
-
It is not known if OFEV is safe and effective in children.
CL-OF-100056 01.18.2022
Please click here for full Prescribing
Information,
including
Patient
Information.
