Nurses Compass
Drug Guide
Ritlecitinib Tosylate
Classification
Therapeutic: Immunosuppressant, Janus kinase (JAK) inhibitor
Pharmacological: Selective JAK3 and TEC family kinase inhibitor
FDA Approved Indications
- Treatment of alopecia areata in adults
Mechanism of Action
Ritlecitinib selectively inhibits Janus kinase 3 (JAK3) and TEC family kinases, thereby modulating the immune response involved in alopecia areata by interfering with cytokine signaling pathways.
Dosage and Administration
Adult: Loading dose of 30 mg orally once daily for 24 weeks. Adjustments based on response and tolerability.
Pediatric: Not approved for pediatric use.
Geriatric: No specific dose adjustments necessary, but monitor for adverse effects in elderly patients.
Renal Impairment: No specific dose adjustment needed.
Hepatic Impairment: Use with caution; no specific recommendations established.
Pharmacokinetics
Absorption: Rapid absorption with peak plasma concentrations achieved in approximately 1-2 hours.
Distribution: Extensively bound to plasma proteins.
Metabolism: Primarily metabolized in the liver via CYP3A4 and other pathways.
Excretion: Excreted mainly in feces with minimal renal excretion.
Half Life: Approximately 8 hours.
Contraindications
- Known hypersensitivity to ritlecitinib or excipients.
Precautions
- Use cautiously in patients with active infections, history of malignancies, or liver impairment. Monitor for infections, cytopenias, and lipid abnormalities during treatment. Not recommended during pregnancy or breastfeeding.
Adverse Reactions - Common
- Upper respiratory tract infections (Frequent)
- Headache (Frequent)
- Nasopharyngitis (Frequent)
Adverse Reactions - Serious
- Serious infections (e.g., pneumonia, herpes zoster) (Rare)
- Liver enzyme elevations (Rare)
- Blood dyscrasias (neutropenia, anemia, lymphopenia) (Rare)
- Thrombosis (Rare)
Drug-Drug Interactions
- CYP3A4 inhibitors or inducers may affect ritlecitinib levels.
- Other immunosuppressants may increase infection risk.
Drug-Food Interactions
- No specific food interactions identified.
Drug-Herb Interactions
- Avoid concomitant use with herbal products that impact immune function.
Nursing Implications
Assessment: Monitor for signs of infection, liver function tests, complete blood counts, lipid profile, and signs of thrombosis.
Diagnoses:
- Risk for infection, Risk for bleeding, Risk for hepatotoxicity.
Implementation: Administer as prescribed, educate patient on infection prevention, monitor lab parameters regularly.
Evaluation: Assess efficacy of alopecia areata treatment, monitor for adverse effects, and adjust treatment accordingly.
Patient/Family Teaching
- Report signs of infection promptly.
- Maintain good hygiene and avoid sick contacts.
- Inform about potential side effects and instruct on when to seek medical help.
- Adherence to medication schedule is crucial.
Special Considerations
Black Box Warnings:
- Serious infections leading to hospitalization or death, including opportunistic infections, herpes zoster, and tuberculosis.
- Malignancies and serious bacterial, fungal, and viral infections.
Genetic Factors: No specific genetic markers required before initiation.
Lab Test Interference: May cause increase in liver enzymes and lipid levels, which should be monitored.
Overdose Management
Signs/Symptoms: Unusual bleeding, infection, or adverse drug reactions.
Treatment: Supportive care, discontinue medication, monitor symptoms, and provide appropriate medical management.
Storage and Handling
Storage: Store at room temperature, 20-25°C (68-77°F).
Stability: Stable until the expiration date on the packaging.