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Ofev

Common Name:

nintedanib

How does this medication work? What will it do for me?

Nintedanib belongs to the class of medications called protein kinase inhibitors. It is used to treat idiopathic pulmonary fibrosis (IFP) – a condition causing scarring of the lungs for no apparent reason. As a result, the lining of the lungs becomes thicker, making it more difficult to breathe. This medication does not cure IFP, however it slows down how quickly the illness progresses.

Nintedanib works by blocking the effects of some of the substances that cause scarring of the lungs.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

100 mg
Each peach-colored, opaque, oblong soft-gelatin capsule, imprinted on one side in black with the Boehringer Ingelheim company symbol and "100", contains 100 mg of nintedanib. Nonmedicinal ingredients: medium chain triglycerides, hard fat, soya lecithin (E322); capsule shell: gelatin, glycerol 85 %, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), black ink (Opacode®); black ink: shellac glaze, iron oxide black (E172), propylene glycol (E1520).

150 mg
Each brown, opaque, oblong soft-gelatin capsule, imprinted on one side in black with the Boehringer Ingelheim company symbol and "150" contains 150 mg of nintedanib. Nonmedicinal ingredients: medium chain triglycerides, hard fat, soya lecithin (E322); capsule shell: gelatin, glycerol 85 %, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), black ink (Opacode®); black ink: shellac glaze, iron oxide black (E172), propylene glycol (E1520).

How should I use this medication?

The recommended dose of nintedanib is 150 mg taken twice a dayThe doses should be taken approximately 12 hours apart. The capsules should be taken with food to reduce possible upset stomach. Swallow the capsules whole, with water. Do not crush or chew the capsule.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, in the original blister packaging to protect it from light and moisture. Keep this medication out of sight and reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not this medication if you:

  • are allergic to nintedanib or any ingredients of the medication
  • are allergic to peanuts or soya
  • are pregnant
What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • constipation
  • decreased appetite
  • gas
  • heartburn
  • nausea
  • stomach pain
  • weight loss

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • diarrhea
  • increased blood pressure
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
  • signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • vomiting

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of bleeding in the stomach (e.g., bloody, black, or tarry stools, spitting up of blood, vomiting blood or material that looks like coffee grounds)
  • signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Birth control: Effective birth control must be used during treatment and for at least 3 months after stopping therapy. If you are using birth control pills or another form of hormonal birth control, it is advised that a barrier method also be used. Tell your doctor immediately if you become pregnant while using this medication.

Bleeding problems: Nintedanib may increase your risk of bleeding. This risk may be greater if you are taking medications such as warfarin or if you have bleeding problems. If you develop unexplained bruising, nosebleeds, dark or tarry stools, or start coughing up blood, contact your doctor immediately or seek immediate medical attention.

Blood pressure: Nintedanib may cause increased blood pressure. If you have a history of blood pressure problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Diarrhea: Many people who take nintedanib experience mild-to-moderate diarrhea. Diarrhea causes fluid loss from the body and can contribute to other side effects of this medication. If you experience diarrhea while taking nintedanib, contact your doctor as soon as possible.

Gastrointestinal perforation: Nintedanib has also been linked to serious digestive system problems, including gastrointestinal perforation (a tear or hole in the wall of the digestive tract). People who are taking corticosteroids or non-steroidal anti-inflammatory medications, have had recent abdominal surgery, or those who have had digestive system problems may be at increased risk of experiencing gastrointestinal perforation.

If you experience symptoms of a gastrointestinal perforation, such as severe stomach pain, fever, chills, nausea or vomiting, seek immediate medical attention.

Heart problems: Nintedanib may affect your heart function and cause heart problems such as heart attack, decreased oxygen supply to the heart, heart failure, and a slow heart rate. Get immediate medical attention if you experience shortness of breath, sudden chest pain, or an extremely slow heart rate. If you have a history of heart problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver problems: Nintedanib has not been studied in people who have moderate to severe liver problems and may itself cause liver problems. If you have decreased liver function discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Wound healing: Nintedanib may affect the way wounds heal. If you are having surgery, a dental procedure, or have recently had surgery, let your doctor know. You may need to temporarily stop taking nintedanib. Your doctor will tell you when you can restart the medication.

Pregnancy: This medication should not be used during pregnancy, as it may cause harm to the developing baby if it is taken by the mother while pregnant. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if nintedanib passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between nintedanib and any of the following:

  • amiodarone
  • apixaban
  • argatroban
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • carvedilol
  • cyclosporine
  • dabigatran
  • dronedarone
  • edoxaban
  • grapefruit juice
  • heparin
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • ledipasvir
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • lumacaftor
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • pirfenidone
  • propafenone
  • other protein kinase inhibitors (e.g., crizotinib, dabrafenib, imatinib, lapatinib, nilotinib, sunitinib)
  • quinidine
  • quinine
  • rifampin
  • rivaroxaban
  • St. John’s wort
  • simeprevir
  • velpatasvir
  • warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Ofev

Last Updated: 08/09/2020