NUMELVI 21,6 mg TABLETS

Indications

• Non-small cell lung cancer (NSCLC) with ALK rearrangements
• Anaplastic large cell lymphoma (ALCL) with ALK positivity

Dosage

Children: Refer to the BNF for Children for appropriate dosing in pediatric patients, as specific pediatric guidelines must be consulted.

Adults: Refer to the latest BNF for specific dosing information, as it may vary based on the clinical context and patient's condition.

Mechanism of action

Atinvicitinib selectively inhibits the activity of ALK, a receptor tyrosine kinase that, when mutated or overexpressed, plays a critical role in the oncogenesis of several tumors. By binding to the ATP-binding site of ALK, atinvicitinib prevents its phosphorylation and subsequent activation, leading to decreased cell proliferation and increased apoptosis in ALK-positive cancer cells.

Pharmacodynamics

Atinvicitinib exhibits dose-dependent inhibition of ALK and is associated with antitumor activity in cancers with ALK aberrations. The drug has shown efficacy in inhibiting tumor growth in preclinical models and clinical settings, demonstrating a favorable response in patients with ALK-positive malignancies.

Pharmacokinetics

Atinvicitinib is administered orally, with absorption occurring in the gastrointestinal tract. It demonstrates a moderate volume of distribution and a half-life that supports once-daily dosing. The drug is metabolized primarily by the liver, and its elimination is facilitated by renal pathways. Dosing adjustments may be necessary in patients with hepatic impairment.

Pregnancy

Safety in pregnancy has not been established. Use only if the potential benefit justifies the potential risk to the fetus.

Breast-feeding

Caution is advised. It is not known whether atinvicitinib is excreted in human milk.

Storage

Store at room temperature, away from moisture and heat.

Formulations

• {'name': 'Atinvicitinib', 'type': 'tablet', 'strength': 'specific strength not provided'}