Ofev

The active ingredient in Ofev is nintedanib, which is a tyrosine kinase inhibitor. The mechanism of action involves inhibiting a protein called tyrosine kinase. This protein is involved in scar tissue formation in your lungs. Ofev, by blocking its activity, can treat lung scarring caused by some kinds of interstitial lung disease. This relieves your lung symptoms, such as shortness of breath and cough.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Ofev. However, the following is a synopsis of the general guidelines for the use of Ofev:

• Ofev is normally given twice a day, every 12 hours. Follow the recommendations on your prescription label and read any drug guidelines or instruction sheets. Your doctor may occasionally adjust your dosage.
• Your doctor will run blood tests to ensure that you do not have any conditions that would prevent you from safely using Ofev.
• If you have no hepatic (liver) impairment, take it with food; if you have slight hepatic impairment, take it separately. Take the capsules with a full glass of water.
• Swallow the capsule whole, without crushing, chewing, breaking, or opening it.
• Ofev can cause severe diarrhea that can be fatal if dehydrated. You may need to take medicine to prevent or treat diarrhea.
• Drink plenty of fluids and contact your doctor right away if you experience diarrhea while taking Ofev.
• You will need to have frequent liver function tests to ensure that nintedanib is not harming your liver. The next several doses may be delayed depending on the results.

The most common side effects of Ofev seen in clinical trials as compared to placebo include:

• Nausea and vomiting.
• Diarrhea.
• Increased liver enzymes.
• Fatigue.
• Weight loss.
• Back pain.
• Abdominal pain.
• Dizziness.
• High blood pressure.
• Low thyroid hormone.
• Hair loss.
• Headaches.

Some individuals may experience serious adverse reactions while using Ofev. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Liver damage or failure: yellowing of the skin (jaundice) or whites of the eyes, confusion, weariness, low appetite, nausea, stomach discomfort, and vomiting.
• Heart attack symptoms: chest pain, shortness of breath, pain in the jaw, neck, or back, and a feeling of weakness or lightheadedness.
• Other symptoms of blood clots in the body: chest pain, difficulty breathing, weakness, and numbness or tingling in the arms and legs.
• Serious bleeding problems: difficult-to-stop bleeds, persistent bruising, weakness, weariness, headaches, dizziness, bloody stool, and blood in the urine.
• Severe injury to the stomach or intestines: abrupt and severe pain or tenderness in the stomach area, bloating, nausea, vomiting, rectal hemorrhage, and appetite changes.
• Allergic reaction or hypersensitivity to the medication: skin rash or hives, shortness of breath, and swelling of your face, tongue, or throat.

These are not all of the possible side effects of Ofev. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Ofev, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if any of the following apply to you:

• Liver disease.
• Heart issues or coronary arterial disease.
• A blood clot.
• Bleeding problems (in you or a family member).
• Surgery on the stomach or intestine or gastrointestinal perforation.
• Diverticular disease.
• You are a smoker.
• You take a blood thinner, such as warfarin (Coumadin or Jantoven).
• Are pregnant or plan on becoming pregnant.

You should not use Ofev if you are allergic to nintedanib or any of the inactive ingredients in the product.

Ofev takes 6 to 12 weeks to begin working, with clinical trials of persons with interstitial lung disease showing less of a decrease in lung capacity (as evaluated by an FVC or Forced Vital Capacity) after at least 6 weeks in those taking Ofev.

When Ofev is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Carbamazepine.
• Erythromycin.
• Ketoconazole.
• Phenytoin.
• Pirfenidone.
• Rifampicin.
• NSAIDs.

Ofev (nintedanib) 150 mg is typically administered orally twice a day, 12 hours apart.

If you have liver problems, your dosage will be adjusted accordingly.

If you miss your last dose, skip it and take your next dose at the normal time. Do not use two dosages at the same time.

Store Ofev at room temperature and out of reach of children.

Boehringer Ingelheim Pharmaceuticals is the company that manufactures Ofev.

No, there are no generic versions of Ofev available.

Do not discontinue Ofev (nintedanib) without visiting your doctor first. This prescription must be taken exactly as directed, or your illness will worsen.

Pregnant women should not use Ofev (nintedanib) since it can harm their unborn child. All sexually active females who are capable of becoming pregnant should take a pregnancy test before and throughout treatment with Ofev. They should also use an effective form of birth control during treatment and for at least three months following therapy.

Nintedanib is present in the milk of lactating rats. Because of the possibility for serious side effects to your breastfed infant, you should either discontinue nursing or discontinue the medication.