Fedratinib (Inrebic) is an oral kinase inhibitor used to treat specific types of myelofibrosis (MF).
Indications of Fedratinib (Inrebic)
Intermediate-2 or High-Risk Primary Myelofibrosis
Used for the treatment of intermediate-2 or high-risk primary myelofibrosis (MF) in adult patients.
Secondary Myelofibrosis
Used for the treatment of secondary myelofibrosis in adult patients, including post-polycythemia vera myelofibrosis and post-essential thrombocythemia myelofibrosis.
Specifications and Properties of Fedratinib (Inrebic)
Dosage Form and Content
100mg Capsule: Reddish-brown opaque capsule, with "FEDR 100mg" printed in white on the capsule shell, containing white to off-white powder.
Each capsule contains 117.3mg of fedratinib dihydrochloride monohydrate (equivalent to 100mg of fedratinib).
Excipient Components
The capsule contents include silicified microcrystalline cellulose and sodium stearyl fumarate.
The capsule shell contains gelatin, red iron oxide, titanium dioxide, and white ink.
Administration Method
The capsule can be swallowed whole, or the capsule can be opened and its contents mixed with approximately 180mL of nutritional supplement for oral administration or administration via a nasogastric tube.
The mixture must be taken within 2 hours after preparation. After administration via a nasogastric tube, the tube must be flushed with 60mL of water.
Storage Methods of Fedratinib (Inrebic)
Environmental Requirements
Temperature Control: Store in an environment below 30°C (86°F), avoiding high temperatures or freezing.
Packaging: Store in the original sealed bottle, with each bottle containing 120 capsules.
Precautions
If the prepared mixture is not used within 2 hours, it must be discarded; after administration via a nasogastric tube, the tube must be flushed with 60mL of water.
The capsule contents are cytotoxic drugs; avoid direct contact with skin or mucous membranes. If contact occurs, rinse thoroughly with clean water immediately.
Discard expired or unused medications to prevent accidental access by children.
Avoid exposing the drug to humid environments or direct sunlight.
