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LuciRit Ritlecitinib

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Ritlecitinib is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents aged 12 and older.

Ritlecitinib is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents aged 12 and older.

LuciRit Ritlecitinib Information

Product Name: LuciRit

Manufacturer: Lucius Pharmaceuticals

Chinese Name: 利特昔替尼

English Name: Ritlecitinib

Drug Approval Number: 10 L 1035/23

Summary

Ritlecitinib is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents aged 12 and older.

Indications

Approved for the treatment of severe alopecia areata in adults and adolescents aged 12 and older.

Usage Restrictions: Concomitant use with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressive agents is not recommended.

Specifications

Each capsule contains 50mg, and there are 28 capsules per box.

Storage

Store at 20°C to 25°C (68°F to 77°F); permitted temperature range for short-term transportation is 15°C to 30°C (59°F to 86°F).

LuciRit Ritlecitinib Dosage and Administration

Before initiating treatment with Ritlecitinib, please take note of the following:

1.Tuberculosis (TB) Infection: Initiation of Ritlecitinib treatment is not recommended for patients with active TB. For latent TB patients or those with negative TB tests but at high risk, consider initiating preventive treatment for latent TB before starting Ritlecitinib [see Warnings and Precautions].

2.Screen for Viral Hepatitis According to Clinical Guidelines: Initiation of Ritlecitinib treatment is not recommended for patients with hepatitis B or C. Screening for viral hepatitis is advised [see Warnings and Precautions].

3.Patients with Absolute Lymphocyte Count (ALC): Patients with ALC < 500/mm³ or platelet count < 100,000/mm³ should not initiate Ritlecitinib treatment [see Warnings and Precautions].

4.Update Immunizations According to Current Immunization Guidelines [see Warnings and Precautions].

Recommended Dosage

1.The recommended dosage for Ritlecitinib is 50 mg, administered orally once daily, with or without food.
Administration Instructions

2.Swallow the whole capsule. Do not crush, break, or chew the capsule.
Missed Dose Instructions

3.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 the regular dosing schedule resumed.

Severe Hepatic Impairment Patients

The use of Ritlecitinib (LuciRit) is not recommended for patients with severe (Child Pugh C) hepatic impairment [see Special Populations].

Treatment Interruption or Discontinuation

If treatment interruption is necessary, temporarily stopping treatment for less than 6 weeks is not expected to result in significant shedding of regrown scalp hair.
Hematologic Abnormalities

Recommendations for interrupting or discontinuing Ritlecitinib (LuciRit) treatment due to hematologic abnormalities are summarized in the table below.

Laboratory Monitoring Guidelines

Laboratory IndicatorsRecommendations
Platelet CountIf the platelet count is < 50,000/mm³, treatment should be discontinued.
Lymphocyte Count (ALC)If ALC is < 500/mm³, treatment should be interrupted. Once ALC recovers to a value above this threshold, treatment can be resumed.

ALC = Absolute Lymphocyte Count.

It is recommended to perform ALC (Absolute Lymphocyte Count) and platelet count before the start of treatment and at 4 weeks after the initiation of treatment. Subsequent monitoring should be conducted based on routine patient management [see Warnings and Precautions].

LuciRit Ritlecitinib Adverse Reactions

1.Headache, diarrhea, acne, rash, oral mucositis.

2.Urticaria, folliculitis, fever, atopic dermatitis.

3.Dizziness, elevated creatine kinase, herpes zoster, decreased red blood cell count.

LuciRit Ritlecitinib Contraindications

Ritlecitinib (LuciRit) is contraindicated in patients with known hypersensitivity to Ritlecitinib or any of its excipients.

LuciRit Ritlecitinib Precautions

Severe Infections

Severe infections, including appendicitis, COVID-19 infection (including infectious pneumonia), and sepsis, have been reported in patients receiving Ritlecitinib (LuciRit) treatment [see Adverse Reactions]. In opportunistic infections, multiple dermatomal herpes zoster cases were reported in the Ritlecitinib (LuciRit) group.

Patients with active severe infections should avoid the use of Ritlecitinib (LuciRit). Before initiating Ritlecitinib (LuciRit) in the following patients, the risks and benefits of treatment should be considered:
1.Those with chronic or recurrent infections.
2.Those with a history of exposure to tuberculosis (TB).
3.Those with a history of severe or opportunistic infections.
4.Those residing in TB or fungal endemic areas or patients traveling to such areas.
5.Those with underlying conditions that may predispose them to infections.

Monitor patients closely for signs and symptoms of infection during and after Ritlecitinib (LuciRit) treatment. In the case of severe or opportunistic infections, interrupt Ritlecitinib (LuciRit) treatment. For patients with new infections during Ritlecitinib (LuciRit) treatment, conduct a comprehensive diagnostic examination for immunocompromised patients promptly, initiate appropriate antimicrobial therapy, and closely monitor the patient. Once the infection is controlled, Ritlecitinib (LuciRit) may be resumed.

Tuberculosis (TB)

Screen patients for active tuberculosis (TB) before initiating treatment. Patients with active TB should not use Ritlecitinib (LuciRit). In newly diagnosed latent TB or previously untreated latent TB patients, initiate anti-tuberculosis treatment before starting Ritlecitinib (LuciRit) therapy. For patients with negative latent TB tests, consider anti-tuberculosis treatment before initiating Ritlecitinib (LuciRit) in high-risk individuals. Consider screening high-risk TB patients during Ritlecitinib (LuciRit) treatment.

Viral Reactivation

Viral reactivation, including cases of herpes virus reactivation such as herpes zoster, has been reported in clinical trials [see Adverse Reactions]. If a patient develops herpes zoster, consider interrupting treatment until the event resolves.

Before initiating Ritlecitinib (LuciRit) treatment, conduct screening for viral hepatitis according to clinical guidelines. Patients with evidence of HIV infection or hepatitis B or C infection are excluded from clinical trials.

Mortality Rate

In a large, randomized, post-marketing safety study involving RA patients aged 50 and above with at least one cardiovascular risk factor, it was found that patients treated with another JAK inhibitor had a higher all-cause mortality rate compared to those treated with TNF inhibitors, including cardiovascular sudden death.

Before initiating or continuing Ritlecitinib (LuciRit) treatment, consider the individual patient’s benefit-risk profile.

Malignancies and Lymphoproliferative Disorders

Malignancies, including non-melanoma skin cancers (NMSC), have been observed in clinical trials of Ritlecitinib (LuciRit) [see Adverse Reactions].

For patients at an increased risk of skin cancer, regular skin examinations are recommended.

Major Adverse Cardiovascular Events (MACE)

In a large, randomized, post-marketing safety study involving RA patients aged 50 and above with at least one cardiovascular risk factor, a higher incidence of Major Adverse Cardiovascular Events (MACE), defined as cardiovascular death, non-fatal myocardial infarction (MI), and non-fatal stroke, was observed in patients treated with another JAK inhibitor compared to those treated with TNF inhibitors. The risk was increased in current or past smokers.

Before initiating or continuing Ritlecitinib (LuciRit) treatment, consider the individual patient’s benefit-risk profile, especially in current or past smokers and patients with other cardiovascular risk factors. Inform patients of the symptoms of severe cardiovascular events and the actions to take if they occur. Discontinue Ritlecitinib (LuciRit) in patients who experience myocardial infarction or stroke.

Thromboembolism

In a large, randomized, post-marketing safety study involving RA patients aged 50 and above with at least one cardiovascular risk factor, the overall incidence of thrombosis, deep vein thrombosis (DVT), and pulmonary embolism (PE) was higher in patients treated with another JAK inhibitor compared to those treated with TNF inhibitors.

Patients at an increased risk of thrombosis should avoid the use of Ritlecitinib (LuciRit). In the event of thrombosis or symptoms of embolism, patients should interrupt Ritlecitinib (LuciRit) treatment and promptly undergo evaluation and appropriate treatment.

Allergic Reactions

Severe reactions, including allergic reactions, urticaria, and rash, were observed in patients receiving Ritlecitinib (LuciRit) in clinical trials. In the event of clinically significant hypersensitivity reactions, discontinue Ritlecitinib (LuciRit) and administer appropriate treatment.

Laboratory Test Abnormalities

Treatment with Ritlecitinib (LuciRit) is associated with reductions in lymphocyte and platelet counts. Conduct Absolute Lymphocyte Count (ALC) and platelet count before starting Ritlecitinib (LuciRit) treatment [see Dosage and Administration]. After initiating Ritlecitinib (LuciRit) treatment, consider interruption or discontinuation based on abnormalities in ALC and platelet count [see Dosage and Administration].

Vaccination

Data on vaccine responsiveness in patients receiving Ritlecitinib (LuciRit) are not available. Avoid the use of live attenuated vaccines during treatment or shortly before initiating treatment. Before starting Ritlecitinib (LuciRit) treatment, it is recommended to inform patients about the latest status of all vaccinations, including preventive herpes zoster vaccination, in accordance with current immunization guidelines.

Special Population: Use During Pregnancy

Pregnancy

If a patient becomes pregnant during the use of Ritlecitinib (LuciRit), consultation with a healthcare professional should be sought promptly.

Available data from clinical trials involving pregnant women using LuciRit are insufficient to determine the drug-related risks of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. In animal reproductive studies, oral administration of Ritlecitinib to pregnant rats and rabbits during organogenesis resulted in fetal toxicity and fetal malformations at exposures up to 49 times and 55 times, respectively, the maximum recommended human dose (MRHD), based on area under the curve (AUC) comparisons.

Lactation

Due to the risk of severe adverse reactions, including severe infections and malignancies in adults, it is recommended that women refrain from breastfeeding during the period of Ritlecitinib (LuciRit) treatment and for approximately 14 hours after the last dose (approximately 6 elimination half-lives).

Pediatric Use

The safety and efficacy of Ritlecitinib (LuciRit) for the treatment of alopecia have been established in pediatric patients aged 12 and above. The safety and efficacy of Ritlecitinib (LuciRit) in pediatric patients under the age of 12 have not been determined.

Geriatric Use

No dose adjustment is necessary for patients aged 65 and older. Clinical trials of Ritlecitinib (LuciRit) did not include a sufficient number of patients aged 65 and older, so it is unclear whether their response differs from that of younger adult patients. Due to the generally higher incidence of infections in the elderly population, caution should be exercised when treating elderly individuals.

Hepatic Impairment

No dose adjustment is required for patients with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment.

The use of Ritlecitinib (LuciRit) is not recommended for patients with severe (Child-Pugh C) hepatic impairment [see Dosage and Administration].

LuciRit Ritlecitinib Drug Interactions

Effects of Ritlecitinib on Other Drugs

CYP3A Substrates with Narrow Therapeutic Index:

Ritlecitinib is a CYP3A inhibitor. Co-administration of Ritlecitinib may increase the AUC and Cmax of CYP3A substrates, potentially increasing the risk of adverse reactions associated with these substrates.

Management: Consider additional monitoring and dose adjustments based on the approved product labeling of CYP3A substrates where minor changes in concentration may lead to severe adverse reactions.

CYP1A2 Substrates with Narrow Therapeutic Index:

Ritlecitinib is a CYP1A2 inhibitor. Co-administration of Ritlecitinib may increase the AUC and Cmax of CYP1A2 substrates, potentially increasing the risk of adverse reactions associated with these substrates.

Management: Consider additional monitoring and dose adjustments based on the approved product labeling of CYP1A2 substrates when co-administered with Ritlecitinib, where changes in concentration may lead to severe adverse reactions, if the risk is deemed acceptable.

Effects of Other Drugs on Ritlecitinib

CYP3A Inducers

Co-administration of potent CYP3A inducers (such as rifampin) may reduce the AUC and Cmax of Ritlecitinib, potentially resulting in loss or reduction of clinical response.

Management: Co-administration with potent CYP3A inducers is not recommended.

Overdosage

In clinical trials, single oral doses of Ritlecitinib up to 800 mg were administered. Adverse reactions observed at higher doses were comparable to those observed at lower doses, and no specific toxicity was identified.

In healthy adult volunteers, single oral doses up to 800 mg indicated that more than 90% of the administered dose is expected to be eliminated within 48 hours.

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