ritlecitinib tosylate: prescribing and clinical use
Focused clinical detail for use alongside current product information, local policy and patient-specific assessment.
ritlecitinib tosylate: clinical details
Prescribing considerations
- Specialist initiation and supervision are required.
- Assess infection history, tuberculosis exposure, malignancy, cardiovascular and thromboembolic risk before treatment.
- Screen for tuberculosis and viral hepatitis; treat latent tuberculosis when indicated.
- Bring immunisations up to date before treatment and avoid live attenuated vaccines immediately before or during therapy.
- Use caution with recurrent infection, diabetes, older age, previous venous thromboembolism, immobilisation, major surgery, combined hormonal contraception or hormone replacement therapy.
- Consider periodic skin examination in people at increased risk of skin cancer.
- Avoid concurrent systemic immunosuppressants.
Contraindications and cautions
- Hypersensitivity to ritlecitinib or an excipient
- Active serious infection, including active tuberculosis
- Severe hepatic impairment
- Pregnancy
- Breastfeeding
Monitoring
- Check absolute lymphocyte and platelet counts before treatment, early after initiation and subsequently according to clinical management; follow SmPC thresholds for interruption or discontinuation.
- Monitor for infection during and after treatment, including shingles and opportunistic infection.
- Monitor patients at risk for hepatitis reactivation and obtain hepatology advice if reactivation is suspected.
- Reassess unexplained neurological symptoms promptly and discontinue treatment as specified in the SmPC.
- Re-evaluate promptly if venous or arterial thromboembolism is suspected.
- Review clinical benefit and ongoing benefit–risk regularly.
Clinical pharmacology
Ritlecitinib is an irreversible, selective inhibitor of JAK3 and TEC-family kinases. It suppresses common gamma-chain cytokine signalling and reduces cytolytic activity of natural-killer cells and CD8-positive T cells. It moderately inhibits CYP3A and CYP1A2.
Formulation and product differences
- The selected product is an oral hard capsule containing ritlecitinib tosylate equivalent to ritlecitinib.
- The capsule contains lactose monohydrate and is unsuitable for people with specified rare hereditary disorders of galactose or glucose absorption.
- Capsules must be swallowed whole; crushing, splitting or chewing has not been studied.
ritlecitinib tosylate preparations and strengths
Capsule
Route: Oral
Strengths: 50 mg
ritlecitinib tosylate interactions
Tell the specialist and pharmacist about all prescribed, non-prescribed and herbal products. Important examples include:
Systemic immunosuppressants
Combined use is not recommended because additive suppression of the immune system and infection risk cannot be excluded.
CYP3A substrates with a narrow safety margin, including quinidine, ciclosporin, pimozide and ergot alkaloids
Ritlecitinib can increase exposure, potentially increasing serious adverse effects; review and adjustment of the interacting medicine may be needed.
Colchicine, everolimus, tacrolimus or sirolimus
Concentrations may rise; follow the interacting medicine's adjustment and monitoring guidance.
Sources
These sources were used to prepare and review this medicine page.
Prepared and reviewed by the iatroX editorial team.