Ofev 150mg Capsules

Nintedanib is a small molecule tyrosine kinase inhibitor that targets multiple receptors, including vascular endothelial growth factor receptor (VEGFR 1, 2, and 3), fibroblast growth factor receptor (FGFR 1, 2, and 3), and platelet-derived growth factor receptor (PDGFR α and β). It also inhibits Src family kinases (Src, Lck, Lyn) and colony-stimulating factor 1 receptor (CSF1R). By inhibiting these pathways, nintedanib is thought to block the proliferation, migration, and differentiation of fibroblasts, which are key processes in the pathogenesis of fibrotic diseases like idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:

Allergic Reaction: Rash, hives, itching, red, swollen, blistered, or peeling skin with or without fever, wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Bleeding: Vomiting or coughing up blood, vomit that resembles coffee grounds, blood in the urine, black, red, or tarry stools, bleeding from the gums, abnormal vaginal bleeding, unexplained bruises or bruises that enlarge, or uncontrollable bleeding.
High Blood Pressure: Severe headache or dizziness, fainting, or changes in vision.
Urinary Tract Infection (UTI): Blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Stomach or Bowel Perforation: Stomach swelling or severe stomach pain, which can be life-threatening.
Liver Problems: Dark urine, fatigue, decreased appetite, nausea, stomach pain, light-colored stools, vomiting, or yellowing of the skin or eyes, which can be life-threatening.
Severe Blood Clots: Heart attack symptoms, such as chest pain or pressure, arm, back, neck, or jaw pain, or shortness of breath. Stroke symptoms, such as confusion, numbness or weakness on one side of the body, severe dizziness or headache, or changes in speech or vision.

Other Possible Side Effects

Most people experience few or no side effects, but some may occur. If you experience any of the following side effects, consult your doctor or seek medical attention if they bother you or persist:

Headache
Stomach pain
Weight loss
Dizziness, fatigue, or weakness
Back pain
Nose or throat irritation
Common cold symptoms
Diarrhea, vomiting, upset stomach, or decreased appetite (common side effects that can be managed with your doctor's guidance)

If you experience any severe or persistent side effects, contact your doctor for advice.

Reporting Side Effects

If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have liver disease, as this may affect how your body processes the medication.
If you are currently taking any of the following medications: carbamazepine, phenytoin, rifampin, or St. John's wort, as these may interact with this drug.
If you are breastfeeding, as you should not breastfeed while taking this medication.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.

Important Warnings and Cautions for Patients Taking This Medication

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Bleeding Risks
You may experience easier bleeding, which can increase the risk of injury. To minimize this risk, be cautious and take steps to avoid injury. Use a soft-bristled toothbrush and an electric razor for shaving. Although rare, some bleeding problems associated with this medication have been fatal.

Monitoring and Lab Tests
Regularly undergo blood work and other laboratory tests as directed by your doctor to monitor your condition.

Blood Pressure
This medication may cause high blood pressure. Ensure that your blood pressure is checked regularly, as advised by your doctor.

Fertility and Pregnancy
This medication may affect fertility, potentially impacting your ability to have children. Discuss this with your doctor. If you are pregnant or plan to become pregnant, it is crucial to take precautions. A pregnancy test will be conducted before initiating this medication to confirm that you are not pregnant. If you can become pregnant, use effective birth control while taking this medication and for 3 months after your last dose. If you become pregnant, notify your doctor immediately.

Birth Control and Vomiting/Diarrhea
If you are taking birth control pills and experience vomiting or diarrhea, the effectiveness of your birth control may be reduced. In such cases, use an additional form of birth control, such as condoms.

Smoking
If you smoke, it is recommended that you quit smoking before starting this medication and avoid smoking during treatment. Smoking may decrease the effectiveness of this medication. Consult your doctor for guidance.

• Strong P-glycoprotein (P-gp) and CYP3A4 inducers (e.g., rifampin) - concomitant use is not recommended due to potential for decreased nintedanib exposure and efficacy.

• Strong P-gp inhibitors (e.g., ketoconazole, erythromycin, cyclosporine, ritonavir) - may increase nintedanib exposure. Use with caution; consider dose reduction if not tolerated.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir) - may increase nintedanib exposure (minor pathway, but still relevant).

• Moderate P-gp inhibitors/inducers
• Moderate CYP3A4 inhibitors/inducers

• Anticoagulants (e.g., warfarin) - Nintedanib is a mild inhibitor of P-gp. Monitor for bleeding, especially in patients with increased risk.

• Diarrhea (frequency, severity)
• Nausea
• Vomiting
• Abdominal pain
• Fatigue
• Loss of appetite
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Unusual bleeding or bruising
• Chest pain, shortness of breath, weakness on one side of body (signs of arterial thromboembolic events)

Nintedanib can cause fetal harm when administered to a pregnant woman. Based on animal studies, it is advised to avoid use during pregnancy. Females of reproductive potential should be advised to use effective contraception during treatment and for at least 3 months after the last dose.

It is not known whether nintedanib or its metabolites are excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, women should not breastfeed during treatment with nintedanib.

Safety and effectiveness in pediatric patients have not been established.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients, but greater sensitivity of some older individuals cannot be ruled out. No specific dose adjustment is required based on age alone.

• Always take Ofev with food to minimize gastrointestinal side effects and optimize absorption.
• Diarrhea is a very common side effect; patients should be advised on appropriate management (e.g., loperamide) and hydration from the start of therapy.
• Regular liver function monitoring is crucial, especially during the initial months of treatment.
• Patients should be educated on signs of liver injury, bleeding, and GI perforation and instructed to seek immediate medical attention if these occur.
• Dose reductions or temporary interruptions are common strategies for managing adverse events, rather than immediate discontinuation.

• Pirfenidone (Esbriet) - another antifibrotic agent approved for IPF.
• Symptomatic management and supportive care for interstitial lung diseases.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.