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Ofev

4.59
A specialist medicine used to slow the progression of scarring in the lungs associated with pulmonary fibrosis.


Ingredient
Availability
In Stock
Delivery
Airmail (14-21 days) | EMS trackable (5-9 days)
Product is shipped in a fully discreet envelope with no content disclosure, including all required documentation inside

Product Sheet

Alternative/Local Brand
Ofev
Active Ingredient(s)
Nintedanib
Primary Category
Lung Disease Treatment
Therapeutic Class
Antifibrotics, Tyrosine Kinase Inhibitors
Pharmacological Class
TK Inhibitor
Indications
Idiopathic pulmonary fibrosis, Chronic fibrosing interstitial lung diseases
Contraindications
Severe liver impairment, Hypersensitivity to peanuts or soya
Minor Side Effects
Nausea, Weight loss, Abdominal pain
Moderate Side Effects
Diarrhoea, Vomiting, Decreased appetite
Serious Side Effects
Liver damage, Blood clots, Gastrointestinal perforation
Dosage Forms
Capsule
Administration Route
Oral
Mechanism of Action
Nintedanib blocks several pathways (tyrosine kinases) involved in the scarring of lung tissue. By inhibiting these signals, it slows down the progression of lung fibrosis and helps preserve lung function.
Prescription Status
Rx
Manufacturer
Boehringer Ingelheim
Patient Summary
A specialist medicine used to slow the progression of scarring in the lungs associated with pulmonary fibrosis.
Onset Time
Several weeks
Duration
12 hours (usually taken twice daily)
Storage Instructions
Store below 25°C in a dry place.
Drug Interactions
Ketoconazole, Rifampicin, Anticoagulants
Age Restrictions
Adults only
Pregnancy Use
Must not be used during pregnancy; use effective contraception.
Alternative Drugs
Esbriet, Pirfenidone

Ofev: Nintedanib Overview

Ofev is the brand name for the medication nintedanib, a targeted therapy classified under respiratory health. It is supplied as a 100 mg capsule and requires a prescription in Hong Kong. Nintedanib is approved for the treatment of idiopathic pulmonary fibrosis (IPF) and systemic sclerosis-associated interstitial lung disease (SSc-ILD). The Hong Kong Department of Health aligns its approvals with major regulators such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

How Nintedanib Works in the Body

Nintedanib belongs to a class of drugs known as tyrosine kinase inhibitors (TKIs). It blocks several intracellular enzymes-particularly the platelet-derived growth factor (PDGF), fibroblast growth factor (FGF), and vascular endothelial growth factor (VEGF) receptors. By inhibiting these pathways, nintedanib reduces the proliferation of fibroblasts and the formation of excess scar tissue (fibrosis) within the lungs.

  • Onset of action: Clinical effects on lung function become measurable after several weeks of continuous dosing.
  • Peak plasma concentration: Occurs approximately 2-4 hours after oral intake.
  • Duration: The drug’s half-life is around 9-12 hours, supporting a twice-daily dosing schedule.

By slowing fibrotic progression, nintedanib helps preserve forced vital capacity (FVC), a key measure of lung function.

Conditions Treated with Ofev

  • Idiopathic Pulmonary Fibrosis (IPF): A chronic, progressive scarring of lung tissue with no identifiable cause.
  • Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD): Lung involvement that occurs in patients with systemic sclerosis, leading to fibrosis.

Both indications are approved by the FDA, EMA, and are recognized by Hong Kong’s health authority for use in adults with a confirmed diagnosis. Ofev is not indicated for asthma, chronic obstructive pulmonary disease (COPD), or acute respiratory infections.

Off-Label and Investigational Applications

Current peer-reviewed literature has explored nintedanib in other fibrotic disorders, such as:

  • Non-small cell lung cancer (NSCLC) maintenance therapy: Studied in combination with chemotherapy, but not approved for this use.
  • Liver fibrosis: Early-phase trials show potential antifibrotic activity; still investigational.

These uses are not approved by regulatory agencies. Off-label use should only occur under close medical supervision with a thorough risk-benefit assessment.

Who Should (Not) Use Ofev?

Ideal Patient Profile

  • Adults diagnosed with IPF or SSc-ILD confirmed by high-resolution CT and multidisciplinary evaluation.
  • Patients with adequate liver and kidney function (baseline laboratory values within normal limits).

Absolute Contraindications

  • Known hypersensitivity to nintedanib or any capsule excipients.
  • Severe hepatic impairment (Child-Pugh Class C).

Relative Contraindications

  • Moderate hepatic impairment (Child-Pugh Class B) - dose adjustment may be needed.
  • Moderate to severe renal impairment (creatinine clearance <30 mL/min) - monitor closely.
  • Pregnancy or breastfeeding - nintedanib may harm the fetus; contraception is required.

Special Populations

  • Pregnancy & lactation: Contraindicated; discuss reliable contraception with a healthcare provider.
  • Elderly: No specific age limit, but monitor for increased sensitivity to side effects.
  • Pediatric: Not approved for use in children; safety and efficacy have not been established.

Safety Profile: Side Effects and Interactions

Common Side Effects

  • Diarrhea: Reported in > 50 % of patients; usually mild to moderate and improves with supportive care.
  • Nausea or vomiting: Often transient when therapy is initiated.
  • Abdominal pain: May be alleviated by taking the capsule with food.
  • Reduced appetite: Monitor nutritional status, especially in frail patients.

Serious Adverse Events

  • Liver enzyme elevations: ALT/AST may rise; regular monitoring is essential.
  • Severe gastrointestinal bleeding: Rare but requires immediate medical attention.
  • Cardiovascular events: Hypertension and rare cases of myocardial infarction have been observed.

Drug Interactions

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): May lower nintedanib exposure, reducing efficacy.
  • Anticoagulants (warfarin, direct oral anticoagulants): Increased risk of bleeding; monitor coagulation parameters.
  • P-glycoprotein inhibitors (e.g., verapamil): May raise plasma concentrations; dose adjustment may be necessary.

If you take any other medication, supplement, or herbal product, inform your healthcare provider before starting Ofev.

Food and Lifestyle Interactions

  • Take with food: Improves tolerability of gastrointestinal side effects.
  • Alcohol: Use caution; excessive consumption can worsen liver enzyme elevations.
  • Driving: No direct impairment, but severe diarrhea or dizziness may affect safety; assess individually.

How to Take Ofev

  • Standard dosing: The usual regimen is 150 mg taken twice daily (morning and evening). If the 100 mg capsule is the only strength available, the typical approach is 100 mg taken twice daily, with the possibility of titrating to 150 mg twice daily based on tolerance and clinical response.
  • Administration: Swallow the capsule whole with a glass of water; do not crush or chew.
  • With or without food: Recommended to take with meals to minimize gastrointestinal upset.
  • Missed dose: Take the missed dose as soon as you remember, unless the next scheduled dose is within 6 hours; in that case, skip the missed dose and resume the regular schedule. Do not double-dose.
  • Dose adjustments: May be required for hepatic impairment or severe diarrhea; your physician will guide any changes.
  • Overdose: Symptoms can include severe diarrhea, nausea, vomiting, and elevated liver enzymes. Seek emergency medical care; supportive measures are the mainstay of treatment.
  • Discontinuation: Abrupt stopping is acceptable, but patients should be monitored for disease progression. No tapering is required for nintedanib itself.

Monitoring and Follow-Up

  • Liver function tests (ALT, AST, bilirubin): Baseline, then every 4-8 weeks for the first three months, and periodically thereafter.
  • Renal function (serum creatinine, eGFR): Baseline and as clinically indicated, especially in patients with pre-existing kidney disease.
  • Pulmonary function (FVC, DLCO): Every 3-6 months to assess disease progression.
  • Weight and nutritional status: Monitor regularly due to risk of appetite loss and gastrointestinal side effects.

Patients should contact their healthcare provider promptly if they experience persistent diarrhea, signs of liver injury (yellowing of skin/eyes), or unexplained shortness of breath.

Storage and Handling

  • Store Ofev capsules at room temperature (15-30 °C), protected from excess moisture and direct light.
  • Keep the container tightly closed and out of reach of children.
  • Do not use the medication after the expiration date printed on the packaging.
  • Dispose of unused capsules according to local pharmacy waste guidelines or Hong Kong’s Department of Health disposal instructions.

Medication-Specific Glossary

Tyrosine Kinase Inhibitor (TKI)
A drug that blocks enzymes (tyrosine kinases) involved in cell signaling pathways that promote fibrosis and abnormal cell growth.
Forced Vital Capacity (FFC)
The maximum amount of air a person can forcefully exhale after a full inhalation; a primary measure of lung function in fibrotic diseases.
Fibrosis
The formation of excess connective tissue (scar tissue) that stiffens organs-in this case, the lungs-reducing their ability to expand and contract.

Medical Disclaimer

This article provides educational information about Ofev (nintedanib) and is not a substitute for professional medical advice. Treatment decisions, including use for unapproved indications, must be made under the guidance of a qualified healthcare provider. The content is intended for informational purposes and does not constitute medical recommendations. Always consult a physician before starting, stopping, or changing any medication regimen.

Ofev FAQ

Can Ofev be taken with other lung medications?

Ofev can be co-prescribed with many inhaled therapies (e.g., bronchodilators) used for symptom control, but potential interactions with systemic agents such as anticoagulants or CYP3A4 modulators should be reviewed by a pharmacist or physician.

What should I do if I develop severe diarrhea while on Ofev?

Contact your healthcare provider promptly. They may recommend dose reduction, temporary interruption, or supportive treatment such as loperamide, depending on severity.

Is there a need for dose titration when starting Ofev?

Clinical practice often begins with 100 mg twice daily to assess tolerability, then increases to the approved 150 mg twice daily if the patient tolerates the lower dose. Your prescriber will decide the best approach.

Can Ofev affect laboratory test results for drug screening?

Standard drug tests do not detect nintedanib. However, its impact on liver enzymes may be reflected in routine blood panels, which should be interpreted by a clinician.

How long does it take to see a benefit in lung function?

Improvements in the rate of FVC decline are typically observed after several weeks of consistent therapy, but the drug does not reverse existing fibrosis; it slows further progression.

Are there any dietary restrictions while using Ofev?

No specific foods need to be avoided, but taking the capsule with a meal reduces gastrointestinal side effects. Limit excessive alcohol intake to protect liver health.

What are the visual changes, if any, associated with Ofev?

Some patients report mild eye irritation or photosensitivity; wearing sunglasses outdoors can help. If you notice significant visual disturbances, seek ophthalmologic evaluation.

Is Ofev covered by Hong Kong’s public health insurance?

Coverage varies by individual insurance plans and the Hospital Authority’s formulary. Patients should verify reimbursement eligibility with their insurer or hospital pharmacy.

Can I travel internationally with Ofev capsules?

Yes, but keep the medication in its original labeled container, carry a copy of the prescription, and be prepared to show it at customs if requested.

What is the difference between Ofev and other antifibrotic drugs?

Ofev (nintedanib) targets multiple tyrosine kinases (PDGF, FGF, VEGF), whereas pirfenidone, another antifibrotic, primarily modulates transforming growth factor-β pathways. Both aim to slow lung function decline in IPF, but their side-effect profiles differ.

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