Nilotinib is a small-molecule inhibitor that targets the Bcr-Abl tyrosine kinase. Developed by Novartis, it is mainly used to treat specific types of chronic myeloid leukemia (CML).

Indications of Nilotinib

Main Indications

Nilotinib’s indications are strictly limited to the following two groups of adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+CML).

Chronic Phase (CP) patients: Resistant or intolerant to previous treatment regimens (including imatinib).

Accelerated Phase (AP) patients: Also required to meet the condition of resistance or intolerance to imatinib.

Key Instructions

Definition of Resistance: Including failure to achieve hematologic or cytogenetic remission, or disease progression.

Contraindicated Populations: Not applicable to patients with primary blastic phase CML or Ph-negative leukemia.

Specifications and Properties of Nilotinib

Specifications

Dosage Strength: Each capsule contains 200mg of nilotinib (in the form of nilotinib hydrochloride monohydrate).

Appearance Characteristics: The capsule is light yellow and opaque, with the red marking "NVR/TKI" printed axially.

Excipient Components: Including lactose monohydrate, crospovidone, silicon dioxide, etc. Attention should be paid to the impact of lactose components on relevant contraindicated populations.

Dosage Form Characteristics

Delayed-Release Technology: Ensures the drug is absorbed in the intestines and reduces gastric irritation.

Administration Restrictions: Must be swallowed whole; do not open or chew. It must be taken strictly on an empty stomach (see Storage and Administration Precautions for details).

Storage Methods of Nilotinib

Temperature Control

Store in an environment of 15°C to 30°C (59°F to 86°F). Avoid freezing or exposure to high temperatures (e.g., in cars, bathrooms).

Packaging Protection

The original aluminum foil blister packaging provides effective moisture and light protection. The product must be taken immediately after opening.

For bottled preparations, the built-in desiccant must be retained; do not remove or ingest it by mistake.

Safe Storage

Keep out of the reach of children, and use child-resistant caps.

Handling of Special Cases: If the capsule changes color, is damaged, or the desiccant container swells, it should be discarded immediately.