Ofev Application Scope

Ofev (nintedanib) is indicated for the treatment of adults with:

Idiopathic pulmonary fibrosis (IPF).
Chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (PF-ILD).
Systemic sclerosis-associated interstitial lung disease (SSc-ILD)—to slow the rate of decline in pulmonary function.

ofev nintedanib

Ofev Characteristics

Ingredients: Nintedanib
Properties: Soft/gastro-resistant capsules
Packaging Specification: 100 mg and 150 mg capsules
Storage: Store in original package to protect from moisture. Store at controlled room temperature per local label
Expiry Date: See carton and blister for the expiration date assigned by the manufacturer—follow the printed expiry on the package.
Executive Standard: Product conforms to the approved Summary of Product Characteristics / Prescribing Information in each regulatory jurisdiction (e.g., EMA SmPC, FDA label)
Approval Number: Initial U.S. approval: 2014
Date of Revision: Refer to the “last revised” date on the locally supplied package leaflet or the regulatory agency document
Manufacturer: Boehringer Ingelheim

Guidelines for the Use of Ofev

Dosage and Administration:
- Recommended Dose: The standard recommended dosage is 150 mg taken twice daily, approximately 12 hours apart
- Administration: Ofev should be taken with food. The capsule should be swallowed whole with a full glass of water. It should not be chewed or crushed due to its bitter taste
- Missed Dose: If a dose is missed, the patient should skip that dose and take the next dose at the scheduled time. They should not double the dose to make up for the missed one
Adverse Reactions:
- Common Adverse Reactions:
  
  The most frequently reported side effects include:
  - Diarrhea (very common, may require management)
  - Nausea and vomiting
  - Abdominal pain
  - Decreased appetite
  - Weight loss
  - Elevated liver enzymes (requires monitoring)
- Serious Adverse Reactions:
  
  Although less common, serious side effects can occur, such as:
  - Liver problems (hepatotoxicity)
  - Diarrhea that may lead to dehydration and electrolyte imbalance
  - Bleeding events
  - Gastrointestinal perforation (rare)
  - Heart attack (myocardial infarction) has been reported in clinical trials.
    Patients should be advised to report any severe or persistent side effects to their doctor immediately.
Contraindications: Ofev is contraindicated in patients with known hypersensitivity to nintedanib or any of the excipients.
Precautions:
- Liver function: Test ALT, AST, and bilirubin prior to initiation and periodically during treatment; dose adjustment/interruption is recommended for hepatic impairment or elevated liver enzymes.
- Bleeding risk: use caution in patients at increased risk of bleeding or on full anticoagulation.
- Wound healing: consider interrupting treatment prior to scheduled surgery.
- Pregnancy & lactation: contraindicated in pregnancy; advise contraception during and after treatment as per label.
- Gastrointestinal monitoring: manage diarrhea promptly to avoid dehydration; antidiarrheal therapy and dose modification may be needed.

Ofev Interactions

P-glycoprotein (P-gp) inhibitors (e.g., ketoconazole, clarithromycin, and erythromycin) may increase nintedanib exposure—monitor for adverse reactions; dose adjustments may be necessary per label.
P-gp inducers (e.g., rifampicin) may reduce nintedanib exposure and effectiveness.
Concomitant use with strong CYP inducers/inhibitors is not expected to majorly affect nintedanib (primary elimination is biliary/fecal), but consult label and adjust therapy as recommended.
Use caution when co-administering anticoagulants or antiplatelet agents due to increased bleeding risk.

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.