Ofev - Consumer Medicine Information
|Manufacture:||Boehringer Ingelheim Pharmaceuticals, Inc.|
|Condition:||Idiopathic Pulmonary Fibrosis|
|Ingredients:||nintedanib esilate, gelatin, glycerol, hard fat, iron oxide black, iron oxide red, iron oxide yellow, medium chain triglycerides, propylene glycol, shellac glaze, soya lecithin, titanium dioxide|
About this medication
What the medication is used for
Use OFEV to treat Idiopathic Pulmonary Fibrosis (IPF) in adults.
What it does
OFEV works to reduce the fibrosis in your lungs.
When it should not be used
- If you are allergic to nintedanib, peanut or soya, or any of the other ingredients in OFEV.
- If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking OFEV.
- Do not take OFEV during pregnancy. It can cause birth defects.
What the medicinal ingredient is
What the non-medicinal ingredients are
Gelatin, glycerol, hard fat, iron oxide black, iron oxide red, iron oxide yellow, medium chain triglycerides, propylene glycol, shellac glaze, soya lecithin, titanium dioxide
What dosage forms it comes in
Capsules: 100 and 150 mg
Warnings and precautions
BEFORE you use OFEV, talk to your doctor or pharmacist if you:
- have or had liver problems;
- have or had bleeding problems;
- have high blood pressure;
- take blood-thinning medicines to prevent blood clotting;
- have or had problems with your heart;
- recently had surgery or will be having surgery;
- are pregnant or planning to become pregnant.
Your doctor may do blood tests to determine if you may be treated with OFEV.
While taking OFEV, tell your doctor immediately if you:
- experience diarrhea. It is important to treat diarrhea early;
- vomit or have nausea;
- experience severe abdominal pain and swelling, nausea, vomiting, chills and fever as these could be symptoms of a hole in the wall of your gut (gastrointestinal perforation);
- experience swelling, redness and pain in one part of the body as these could be symptoms of a blood clot;
- experience chest pain, in the centre of the chest or spread over the shoulder or arm; a fast heartbeat; shortness of breath; nausea or vomiting; as these could be symptoms of a heart attack;
- have any bleeding that does not stop.
Birth control must be used while you are taking OFEV and for at least 3 months after your last dose. Use a second form of birth control, for example, a barrier method while taking OFEV. Tell your doctor or pharmacist right away if you become pregnant while taking OFEV.
Breastfeeding / Lactation
Do not breastfeed. OFEV may harm the infant.
Driving and using machines
Before doing tasks that require special attention, wait until you know how you respond to OFEV.
Interactions with this medication
As with most medicines, interactions with other drugs are possible. Tell your doctor, nurse, or pharmacist about all the medicines you take, including drugs prescribed by other doctors, vitamins, minerals, natural supplements, or alternative medicines.
Drugs that may interact with OFEV include:
- Ketoconazole used to treat fungal infections;
- Erythromycin used to treat bacterial infections;
- Rifampicin, an antibiotic used to treat tuberculosis;
- Carbamazepine or phenytoin used to treat seizures;
- St. John wort, a herbal medicine.
Proper use of this medication
OFEV should only be prescribed and monitored by physicians with the appropriate training and experience in the diagnosis and treatment of IPF.
Swallow the capsule whole with water. DO NOT chew or crush the capsule.
- exactly as prescribed;
- every day;
- every 12 hours, at about the same time every day;
- with food.
Usual Adult Dose
Recommended and Maximum daily dose: 150 mg twice a day
If you have side effects, your doctor may decrease the dose to 100 mg twice a day.
Do not take more than the maximum daily dose.
Do not reduce the dose or stop taking OFEV without consulting your doctor.
|In case of drug overdose, contact a healthcare practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
If you have forgotten to take your dose, carry on and take your next dose at the usual time. Do not double dose.
Side effects and what to do about them
Side effects may include:
- Diarrhea may lead to a loss of fluid and important electrolytes in your body. At the first signs of diarrhea, drink plenty of fluids and start anti-diarrheal treatment.
OFEV can cause abnormal blood test results. Your doctor will decide when to perform blood tests and will interpret the results.
If any of these affects you severely, tell your doctor, nurse or pharmacist.
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking|
|Uncommon||Jaundice: Increased blood bilirubin levels (liver test): yellowing of the skin or eyes, dark urine, abdominal pain, nausea, vomiting, loss of appetite||√|
|Hypertension(blood pressure increased): headache, vision disorders, nausea and vomiting||√|
|Gastrointestinal perforation: severe stomach pain, chills, fever, nausea and vomiting||√|
|Heart Attack: pain in the chest or spread over the shoulder or arm; a fast heartbeat; shortness of breath; nausea or vomiting||√|
This is not a complete list of side effects. For any unexpected effects while taking OFEV, contact your doctor or pharmacist.
How to store it
Keep out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on carton.
Store at 15-25°C. Store in the original blister in order to protect from moisture.
Do not use this medicine if you notice that the blister containing the capsules is opened or a capsule is broken.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
Reporting suspected side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789, or
- Mail to: Canada Vigilance Program
Postal Locator 0701E
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Forms and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be found at: http://www.boehringer-ingelheim.ca or by contacting the sponsor, Boehringer Ingelheim (Canada) Ltd., at: 1-800-263-5103 ext. 84633.
Please check our website to see if more up-to-date information has been posted (www.boehringer-ingelheim.ca).