What is OFEV?
• OFEV is a prescription medicine used:
- to treat people with a lung disease called idiopathic pulmonary fibrosis
(IPF).
or
- to slow the rate of decline in lung function in people 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.
Important Safety Information
What is the most important information I should know about OFEV (nintedanib)?
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 during 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. Women
using hormonal birth control should add a barrier method of birth control (such as male condoms or
spermicide). 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.
• 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.
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-10881-800-FDA-1088.