Ofev 100mg Capsules

Nintedanib is a small molecule tyrosine kinase inhibitor that targets multiple receptors, including vascular endothelial growth factor receptor (VEGFR) 1-3, fibroblast growth factor receptor (FGFR) 1-3, and platelet-derived growth factor receptor (PDGFR) α and β. It also inhibits Fms-like tyrosine kinase-3 (FLT3), Lck, and Src kinases. By inhibiting these pathways, nintedanib is thought to block the signaling pathways involved in the pathogenesis of fibrotic processes, such as those seen in idiopathic pulmonary fibrosis (IPF) and other chronic fibrosing interstitial lung diseases.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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, pale 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 medications can cause side effects, but many people experience none or only mild effects. If you encounter 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 any of these side effects concern you, do not improve, or are severe, contact your doctor for advice.

Reporting Side Effects

For more information about side effects or to report any concerns, contact your doctor or the FDA at 1-800-332-1088. You can also report side effects 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 and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication with your other medications 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. Have your blood pressure 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 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.
This medication can harm an unborn baby. A pregnancy test will be conducted before you start taking this medication to confirm that you are not pregnant.
If you may become pregnant, use birth control while taking this medication and for 3 months after your last dose. If you become pregnant, notify your doctor immediately.

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) inducers (e.g., rifampin, carbamazepine, phenytoin, St. John's Wort): May significantly decrease nintedanib exposure, reducing efficacy. Avoid co-administration.
• Strong P-glycoprotein (P-gp) inhibitors (e.g., ketoconazole, erythromycin, cyclosporine, ritonavir): May significantly increase nintedanib exposure, increasing risk of adverse reactions. Consider dose reduction to 100 mg BID if co-administration is necessary and adverse reactions occur.

• Anticoagulants (e.g., warfarin, dabigatran): Increased risk of bleeding. Monitor closely.
• Antiplatelet agents (e.g., aspirin, clopidogrel): Increased risk of bleeding. Monitor closely.

• Diarrhea (frequency, severity)
• Nausea
• Vomiting
• Abdominal pain
• Fatigue
• Loss of appetite
• Yellowing of skin or eyes (jaundice)
• Dark urine
• Unusual bleeding or bruising
• Headache
• Dizziness
• Signs of hypertension (e.g., severe headache, blurred vision)

Nintedanib is classified as Pregnancy Category D. Based on animal studies, it can cause fetal harm. It should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus. 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 unknown whether nintedanib or its metabolites are excreted in human milk. However, animal studies have shown excretion of nintedanib and its metabolites into milk. Due to the potential for serious adverse reactions in breastfed infants, breastfeeding is not recommended during treatment with nintedanib and for at least 3 months after the last dose.

The safety and effectiveness of nintedanib in pediatric patients have not been established. It is not indicated for use in this population.

No overall differences in safety or effectiveness were observed between elderly patients (≥65 years) and younger patients. No specific dose adjustment is required based on age alone. However, elderly patients may be more susceptible to adverse reactions, and monitoring for age-related decline in organ function is prudent.

• Always take nintedanib with food to minimize gastrointestinal side effects, especially diarrhea.
• Proactive management of diarrhea is crucial; advise patients to have anti-diarrheal medication (e.g., loperamide) readily available and to start it at the first sign of diarrhea.
• Regular monitoring of liver function tests is essential, particularly during the first 3 months of treatment, due to the risk of drug-induced liver injury.
• Educate patients on the signs and symptoms of liver injury, bleeding, and GI perforation, and instruct them to seek immediate medical attention if these occur.
• Nintedanib is a P-gp substrate; avoid co-administration with strong P-gp inducers (e.g., rifampin) and be cautious with strong P-gp inhibitors (dose reduction may be needed).
• Patients should be advised to use effective contraception due to the teratogenic potential of the drug.

• Pirfenidone (Esbriet) for Idiopathic Pulmonary Fibrosis (IPF).
• For other chronic fibrosing interstitial lung diseases, treatment depends on the specific diagnosis and may include immunosuppressants (e.g., mycophenolate mofetil, azathioprine, rituximab) or other targeted therapies.

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, 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 this 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.