1 What is Ofev?

Brand: Ofev

Generic: Nintedanib

Ofev is a tyrosine kinase inhibitor used for the treatment of idiopathic pulmonary fibrosis. This drug targets growth factor receptors that are involved in the occurrence of pulmonary fibrosis. This drug requires a prescription.

Have a question aboutPulmonary Fibrosis?Ask a doctor now

2 What to Know Before Using

Before using Ofev, you must know all about the risks and complications associated with it. Inform your healthcare provider for any allergic reactions to these drugs or any other drugs, foods, dyes, preservatives, or animals. Carefully read the label of non-prescription drugs for any possible allergic reaction or contraindications.

Studies in children regarding the correlation of age to the effects of nintedanib have not been performed while safety and efficacy have not been established. Studies in the elderly have not demonstrated any geriatric-specific problems that would limit the utility of nintedanib.

Risks to the fetus have to be reported in studies of pregnant women but these may be outweighed by the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk. Infant risk is still undetermined when using this drug during breastfeeding.

Discuss with your healthcare professional about the potential risks and benefits of taking this drug while breastfeeding. Drugs should not be taken together to prevent any interactions but in necessary cases inquire your healthcare provider regarding the adjustments in dosage or any other necessary precautions to prevent any unwanted side effects.

Inform your healthcare professional if you are taking any other drugs such as:

  • Abiraterone
  • Acenocoumarol
  • Amiodarone
  • Apixaban
  • Ardeparin
  • Argatroban
  • Bivalirudin
  • Carbamazepine
  • Certoparin
  • Clarithromycin
  • Cobicistat
  • Conivaptan
  • Cyclosporine
  • Dabigatran
  • Etexilate
  • Dalteparinm
  • Danaparoid
  • Desirudin
  • Diltiazem
  • Dronedarone
  • Drotrecogin Alfa
  • Enoxaparin
  • Erythromycin
  • Etravirine
  • Fondaparinux
  • Fosphenytoin
  • Heparin
  • Itraconazole
  • Ivacaftor
  • Ketoconazole
  • Lepirudin
  • Lomitapide
  • Lopinavir
  • Nadroparin
  • Nilotinib
  • Parnaparin
  • Phenindione
  • Phenprocoumon
  • Phenytoin
  • Primidone
  • Protein C
  • Ranolazine
  • Reviparin
  • Rifampin
  • Ritonavir
  • Rivaroxaban
  • Simeprevir
  • St John's Wort
  • Telaprevir
  • Ticagrelor
  • Tinzaparin
  • Verapamil
  • or Warfarin

Intake of specific food or using alcohol or tobacco with this drug is associated with an increased risk of certain side effects. Your healthcare professional can give you special instructions about the use of food, alcohol, or tobacco.

Inform your doctor if you have any other medical problems such as bleeding problems, blood clots, heart attack, stroke, coronary artery disease, heart disease, stomach or abdominal surgery, or liver disease.

3 Proper Usage

To use Ofev properly, you must follow all instructions given by your doctor. To prevent any side effects, take this drug exactly as directed on the label or as prescribed by your healthcare professional. The capsule must be swallowed whole with liquids. Crushing, breaking, or chewing the drug is not recommended. Take this drug with food.

The dose of this drug will be variable for different patients. The directions on the label or the prescription by your healthcare professional should be followed. The dosage of this drug you take depends on the medical problem for which you are using this drug.

Adults with idiopathic pulmonary fibrosis are given 150 milligrams two times a day, taken 12 hours apart. Use and dose in children must be determined by your healthcare professional.

A missed dose should be taken as soon as possible. However, skip the missed dose and go back to your regular dosing schedule if it is almost time for your next dose.

Store the drug in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Dispose any outdated or expired drugs and ask your healthcare professional for the proper disposal of the drugs.

4 Precautions to Take

Before using Ofev, there are some precautions you must take. Regular visits should be made to your healthcare provider to track your progress and to monitor the effectiveness of the drug. Unwanted effects can be screened using blood tests.

This drug has teratogenic potential and it is recommended to use effective forms of birth control to prevent pregnancy during treatment and at least 3 months after the last dose.

Inform your healthcare professional immediately if you think you have become pregnant while using this drug.

Check with your healthcare professional immediately if you have symptoms of a liver problem such as:

  • Pain or tenderness in the upper stomach
  • Pale stools
  • Dark urine
  • Loss of appetite
  • Nausea
  • Vomiting
  • or Yellow eyes or skin

This drug may cause diarrhea, and check with your healthcare professional before taking any diarrhea drugs as these may make the diarrhea worse or make it last longer.

The risk of bleeding, heart attack, or stroke may be increased when taking this drug. Check with your healthcare professional immediately if you have chest pain or discomfort, dizziness, headache, shortness of breath, nausea or vomiting, pain or discomfort in the arms, jaw, back, or neck, sweating, or unusual bleeding or bruising.

Consult with your healthcare professional immediately if you have symptoms of stomach perforation such as a severe stomach pain that does not go away. It is recommended to stop or avoid smoking while taking this drug.

Consult with your healthcare professional before you take any other prescription or nonprescription drugs, and herbal or vitamin supplements.

5 Potential Side Effects

As with many medications, there are several potential side effects associated with Ofev. Side effects may vary for each individual and prompt medical attention should be given if they occur.

Seek advice from your healthcare professional immediately if you experience any unusual symptoms such as:

  • diarrhea
  • nausea
  • severe abdominal or stomach pain
  • vomiting
  • abdominal or stomach pain or swelling
  • black, tarry stools
  • blood in the eyes
  • blood in the urine
  • blurred vision
  • bruising or purple areas on the skin
  • chest pain or discomfort
  • coughing up blood
  • decreased alertness
  • dizziness
  • headache
  • irregular heartbeat
  • joint pain or swelling
  • nervousness
  • nosebleeds
  • pain or discomfort in the arms, jaw, back, or neck
  • pains in the chest
  • groin, or legs, especially calves of the legs
  • pounding in the ears
  • severe headaches of sudden onset, shortness of breath
  • slow or fast heartbeat
  • sudden loss of coordination
  • sudden onset of shortness of breath for no apparent reason
  • sudden onset of slurred speech
  • sudden vision changes
  • or sweating

Some side effects may occur that usually do not need medical attention. As your body adjusts to the drug, the side effects will slowly disappear. Ask your healthcare professional about ways to prevent or reduce some of these side effects.

If any of the following side effects persists or are inconvenient, or if you notice any other effects, or if you have any questions about them, consult with your health care professional. Report any side effects to the FDA hotline at 1-800-FDA-1088.

6 Related Clinical Trials