Ritlecitinib Dosage

Medically reviewed by Drugs.com. Last updated on Dec 12, 2023.

Applies to the following strengths: 50 mg

Usual Adult Dose for Alopecia

Initial dose: 50 mg orally once daily

Comments:

This drug is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Following tests should be performed before starting this treatment:
Evaluation for Tuberculosis (TB) infection: Do not start this treatment in patients who have active TB. For patients with latent TB or those who have tested negative for latent TB but are at a high risk of developing TB, it is recommended to begin preventive therapy for latent TB before initiating this drug.
Viral hepatitis screening in accordance with clinical guidelines: Initiation of this drug is not recommended for patients with hepatitis B or hepatitis C.
Treatment with this drug should not be initiated if the patient has an absolute lymphocyte count (ALC) less than 500/mm3 or a platelet count less than 100,000/mm3.
Ensure that immunizations are up to date in accordance with current immunization guidelines.
Check the absolute lymphocyte count (ALC) and platelet counts before starting treatment and again at 4 weeks after initiating treatment. Subsequently, these counts should be monitored regularly as part of routine patient management.
If there is a need for treatment interruption, it is not anticipated that a temporary interruption lasting less than 6 weeks would lead to a substantial loss of regrown scalp hair.

Use: For the treatment of severe alopecia areata

Usual Pediatric Dose for Alopecia

12 years and older:
Initial dose: 50 mg orally once daily

Comments:

This drug is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
Following tests should be performed before starting this treatment:
Evaluation for Tuberculosis (TB) infection: Do not start this treatment in patients who have active TB. For patients with latent TB or those who have tested negative for latent TB but are at a high risk of developing TB, it is recommended to begin preventive therapy for latent TB before initiating this drug.
Viral hepatitis screening in accordance with clinical guidelines: Initiation of this drug is not recommended for patients with hepatitis B or hepatitis C.
Treatment with this drug should not be initiated if the patient has an absolute lymphocyte count (ALC) less than 500/mm3 or a platelet count less than 100,000/mm3.
Ensure that immunizations are up to date in accordance with current immunization guidelines.
Check the absolute lymphocyte count (ALC) and platelet counts before starting treatment and again at 4 weeks after initiating treatment. Subsequently, these counts should be monitored regularly as part of routine patient management.
If there is a need for treatment interruption, it is not anticipated that a temporary interruption lasting less than 6 weeks would lead to a substantial loss of regrown scalp hair.

Use: For the treatment of severe alopecia areata in adolescents 12 years and older

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Mild and moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction: Use is not recommended

Dose Adjustments

Hematologic Abnormalities:

Platelet count: Discontinue the treatment if platelet count is less than 50,000/mm3.
Lymphocytes: Interrupt the dosing if ALC is less than 500/mm3 and resume once the ALC is above this value.

Precautions

US BOXED WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE), and THROMBOSIS:

There is an increased risk of severe bacterial, fungal, viral, and opportunistic infections, including tuberculosis (TB), that may require hospitalization or lead to death. If a serious infection occurs, treatment with this drug should be paused until the infection is under control.
This drug should not be administered to patients with active tuberculosis. It is important to test for latent TB before and during therapy, and latent TB should be treated prior to using this drug.
Monitoring for active TB should be conducted for all patients throughout treatment, even if they initially test negative for latent TB.
Another Janus kinase inhibitor (JAK) has been associated with a higher rate of all-cause mortality, including sudden cardiovascular death, compared to TNF blockers in rheumatoid arthritis (RA) patients. This drug is not approved for use in RA patients.
Cases of malignancies have been reported in patients treated with this drug. There is a higher incidence of lymphomas and lung cancers with another JAK inhibitor compared to TNF blockers in RA patients.
Another JAK inhibitor has been associated with a higher rate of major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, and stroke, compared to TNF blockers in RA patients.
Thrombosis has occurred in patients treated with this drug. There is an increased risk of pulmonary embolism, venous thrombosis, and arterial thrombosis with another JAK inhibitor compared to TNF blockers.

CONTRAINDICATIONS:

Hypersensitivity to this drug or any of its excipients.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

This drug can be administered with or without food.
This capsule should be swallowed whole. Do not crush, split, or chew.
If a dose is missed, it should be taken as soon as possible unless it is within 8 hours of the next scheduled dose. In such cases, the missed dose should be skipped, and regular dosing should be resumed at the usual scheduled time.

Storage requirements:

Store at 20C to 25C (68F to 77F). Excursions permitted between 15C to 30C (59F to 86F).
This drug product should be kept in original package.

Monitoring:

Monitoring for active TB should be conducted for all patients throughout treatment, even if they initially test negative for latent TB.
Laboratory monitoring of ALC and platelet counts are recommended before treatment initiation and at 4 weeks after treatment initiation, and thereafter routinely.

General:
Limitations of Use: Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

Patient advice:

Advice patients to read FDA approved labeling.
Patients should be instructed not to crush, split, or chew the capsules.
Patients should be informed that taking this drug may lead to the development of infections, some of which can be serious. They should be instructed to notify their healthcare provider if they experience any signs or symptoms of an infection.
Patients should be advised that the use of this drug increases the risk of herpes zoster.
Patients should be informed that this drug may raise the risk of certain cancers, including skin cancers. Regular skin examinations are recommended while using this drug.
Patients should be advised that cases of pulmonary embolism and retinal artery occlusion have been reported in clinical trials with this drug. They should be instructed to seek immediate medical attention if they experience any signs or symptoms of a blood clot.
Patients should be advised to discontinue this drug and seek immediate medical attention if they develop any signs and symptoms of a severe allergic reaction.
Patients should be informed that this drug may impact certain laboratory tests and that blood tests are required before and during treatment with this drug.
Patients should be advised that receiving live vaccines is not recommended while undergoing this treatment and shortly before initiating treatment. They should inform their healthcare provider about their medication before considering vaccination.
Pregnant individuals and those of reproductive potential should be advised to inform their healthcare providers if they are pregnant or planning to become pregnant while being treated with this drug. They should also report their pregnancy to Pfizer Inc. by calling 1-877-390-2940.
Women should be advised not to breastfeed while undergoing this treatment and for a period of 14 hours following the last dose.