Ofev

The recommended dose of Ofev (Nintedanib) is 150 mg taken twice a day. The 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 Ofev (Nintedanib) 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 Ofev (Nintedanib) at room temperature, in the original blister packaging to protect it from light and moisture. Keep Ofev (Nintedanib) 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.

In addition to its desired action, this medication may cause some adverse effects, notably: it may decrease your appetite; it may cause diarrhea; it may cause stomach ache; it may reduce your blood clotting ability; it may cause nausea or, rarely, vomiting; occasionally, it may cause weight loss. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

100 mg
Each peach-coloured, opaque, oblong soft-gelatin capsule, imprinted on one side in black with the Boehringer Ingelheim company symbol and "100", contains 100 mg of Ofev (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 Ofev (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).

Do not Ofev (Nintedanib) if you:

• are allergic to Ofev (Nintedanib) or any ingredients of the medication
• are allergic to peanuts or soya
• are pregnant

There may be an interaction between Ofev (Nintedanib) and any of the following:

• anticoagulants (e.g., Dalteparin, Enoxaparin, warfarin, Apixaban, dabigatran, Rivaroxaban, warfarin)
• Apalutamide
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Carbamazepine
• Cobicistat
• conivaptan
• Dronedarone
• Enzalutamide
• grapefruit juice
• Heparin
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Letrozole
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Phenobarbital
• Phenytoin
• other protein kinase inhibitors (e.g., Crizotinib, Dabrafenib, imatinib, Lapatinib, Nilotinib, Sunitinib)
• rifampin
• rifabutin
• tobacco (smoked)
• St. John's wort
• Verapamil

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 Ofev (Nintedanib). 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.

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 Ofev (Nintedanib).

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, you should also use a barrier method, such as condoms. Tell your doctor immediately if you become pregnant while using Ofev (Nintedanib).

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

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

Gastrointestinal perforation: Ofev (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 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: Ofev (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 Ofev (Nintedanib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ofev (Nintedanib), and whether any special monitoring is needed.

Liver problems: Decreased liver function or liver disease may cause Ofev (Nintedanib) to build up in the body, causing side effects. Ofev (Nintedanib) has not been studied for 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 Ofev (Nintedanib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Ofev (Nintedanib), 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: Ofev (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 Ofev (Nintedanib). Your doctor will tell you when you can restart the medication.

Pregnancy: Ofev (Nintedanib) 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 Ofev (Nintedanib), contact your doctor immediately.

Breast-feeding: It is not known if Ofev (Nintedanib) passes into breast milk. If you are breast-feeding and are taking Ofev (Nintedanib), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Ofev (Nintedanib) have not been established for children.

This medication is typically used twice a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. The capsule of this medication should not be opened, crushed or chewed. It must be used regularly and continuously to maintain its beneficial effects. Be sure to keep an adequate supply on hand. If you forget a dose, simply skip it and then take the next dose at the regularly scheduled time. This medication may irritate the stomach, and should be taken with food. It is best to avoid coffee, spicy food or alcohol. Avoid grapefruit and grapefruit juice during your treatment. Grapefruit can seriously affect how this medication works.