Nintedanib (Ofev) is a kinase inhibitor primarily indicated for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
How to Use Nintedanib (Ofev)
Recommended Dosage
The standard recommended dose is 150mg per dose, twice daily, with an interval of approximately 12 hours between the two doses.
Capsules should be taken with food and swallowed whole with an appropriate amount of liquid.
Chewing or crushing the capsules is not allowed. The drug has a bitter taste, and chewing or crushing may affect its pharmacokinetic properties.
Management of Missed Doses
If a dose is missed, there is no need to make up for it; simply take the regular dose at the next scheduled time.
The maximum daily dose should not exceed 300mg (i.e., two 150mg doses). Overdosing may increase the risk of adverse reactions.
Necessary Tests Before Medication
Before initiating Ofev treatment, the doctor will arrange for the patient to undergo liver function tests, including measurements of alanine transaminase (ALT), aspartate transaminase (AST), and bilirubin levels.
This is because nintedanib is mainly excreted through the hepatobiliary system, and abnormal liver function may affect drug metabolism.
After the start of treatment, regular liver function monitoring is still required: once a month for the first 3 months, then once every 3 months thereafter, or more frequently if clinically necessary.
Dose Adjustment of Nintedanib (Ofev)
Dose Adjustment for Liver-Related Adverse Reactions
When ALT or AST increases to 3-5 times the upper limit of normal (ULN), treatment should be interrupted or the dose reduced to 100mg twice daily.
After liver function indicators return to baseline levels, re-administration can be initiated at 100mg twice daily, and then consideration can be given to resuming the standard dose based on tolerability.
If ALT or AST > 5 times ULN, or > 3 times ULN accompanied by symptoms of severe liver injury, Ofev should be permanently discontinued.
Dose Adjustment for Gastrointestinal Adverse Reactions
Diarrhea is the most common adverse reaction, with an incidence rate of up to 62%.
When diarrhea symptoms first appear, patients should promptly replenish fluids and use antidiarrheal drugs (such as loperamide).
If diarrhea persists, temporary interruption of Ofev treatment may be necessary.
The same principle applies to gastrointestinal reactions such as nausea and vomiting; antiemetic drugs can be considered for symptomatic treatment.
For Smokers
Smoking can reduce the exposure to nintedanib, which may affect its efficacy.
Patients are advised to quit smoking before starting Ofev treatment and avoid smoking during the treatment period.
Storage Requirements for Nintedanib (Ofev)
Routine Storage Conditions
Ofev capsules should be stored at room temperature, with an ideal temperature range of 15-30°C (59-86°F).
The original packaging consists of high-density polyethylene (HDPE) bottles with child-resistant caps, which can effectively protect the drug.
If repackaging is required, USP-compliant airtight containers should be used.
Special Precautions
Moisture protection: The drug should be kept dry and away from high-humidity environments.
Heat protection: Avoid exposing the drug to excessive heat; do not store it in direct sunlight or high-temperature areas (such as kitchens or bathrooms).
Ofev should be kept out of the reach of children. Expired or no longer needed drugs should be disposed of safely.
