Ritlecitinib

LITFULO is a kinase inhibitor. Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family by blocking the adenosine triphosphate (ATP) binding site.

• LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.

• LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see Warnings and Precautions (5.6) ] . LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients.contraindicated

• For recommended testing, evaluations and immunizations prior to LITFULO initiation, see Full Prescribing Information. ( 2.1 ) • Recommended dosage is 50 mg orally once daily. ( 2.2 ) • For dosage interruption for certain adverse reactions, see Full Prescribing Information. ( 2.4 ) 2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation Perform the following evaluations prior to LITFULO initiation: • Tuberculosis (TB) infection evaluation: LITFULO initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of LITFULO [see Warnings and Precautions (5.1) ] . • Viral hepatitis screening in accordance with clinical guidelines: LITFULO initiation is not recommended in patients with hepatitis B or hepatitis C [see Warnings and Precautions (5.1) ] . • Treatment with LITFULO should not be initiated in patients with an absolute lymphocyte count (ALC) <500/mm 3 or a platelet count <100,000/mm 3 [see Warnings and Precautions (5.7) ] . • Update immunizations according to current immunization guidelines [see Warnings and Precautions (5.8) ] . 2.2 Recommended Dosage The recommended dosage of LITFULO is 50 mg orally once daily with or without food [see Clinical Pharmacology (12.3) ] . Swallow capsules whole. Do not crush, split, or chew LITFULO capsules. If a dose is missed, administer the dose as soon as possible unless it is less than 8 hours before the next dose, in which case, skip the missed dose.

• Hypersensitivity: Discontinue LITFULO if a clinically significant hypersensitivity reaction occurs. ( 5.6 ) • Laboratory Abnormalities: Perform ALC and platelet counts prior to LITFULO initiation. Treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities. ( 5.7 ) • Vaccinations: Avoid use of live vaccines during or shortly prior to LITFULO treatment. ( 5.8 ) 5.1 Serious Infections Serious infections have been reported in patients receiving LITFULO. The most frequent serious infections have been appendicitis, COVID-19 infection (including pneumonia), and sepsis [see Adverse Reactions (6.1) ] . Among opportunistic infections, multi-dermatomal herpes zoster was reported with LITFULO. Avoid use of LITFULO in patients with an active, serious infection. Consider the risks and benefits of treatment prior to initiating LITFULO in patients: • with chronic or recurrent infection • who have been exposed to TB • with a history of serious infection or an opportunistic infection • who have resided or traveled in areas of endemic TB or mycoses, or • with underlying conditions that may predispose them to infection Closely monitor patients for the development of signs and symptoms of infection during and after treatment with LITFULO. Interrupt LITFULO if a patient develops a serious or opportunistic infection.

The following clinically significant adverse reactions are described elsewhere in the labeling: • Serious Infections [see Warnings and Precautions (5.1) ] • Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions (5.3) ] • Thromboembolic Events [see Warnings and Precautions (5.5) ] • Hypersensitivity [see Warnings and Precautions (5.6) ] • Laboratory Abnormalities [see Warnings and Precautions (5.7) ] Most common adverse reactions (incidence ≥1%) are headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, blood creatine phosphokinase increased, herpes zoster, red blood cell count decreased, and stomatitis. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of LITFULO was evaluated in three randomized, placebo-controlled clinical trials and one long-term trial in subjects with alopecia areata, including alopecia totalis and alopecia universalis, who were 12 years of age and older. A total of 1628 subjects were treated with LITFULO representing 2085 subject-years of exposure. There were 1011 subjects with at least 1 year of exposure to LITFULO.

• Lactation : Breastfeeding not recommended. ( 8.2 ) • Severe Hepatic Impairment: Not recommended. ( 8.6 ) 8.1 Pregnancy Pregnancy Exposure Registry If a patient becomes pregnant while receiving LITFULO, healthcare providers should report LITFULO exposure by calling 1-877-390-2940. Risk Summary Available data from clinical trials with LITFULO use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ritlecitinib to pregnant rats and rabbits during organogenesis caused fetotoxicity and fetal malformations at exposures 49 and 55 times the maximum recommended human dose (MRHD) based on area under the curve (AUC) comparison, respectively (see Animal Data ) . The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. The estimated background risks in the U.S. general population of major birth defects and miscarriages are 2-4% and 15-20% of clinically recognized pregnancies, respectively.

Metabolism

Ritlecitinib AUC 0-tau and C max increase in an approximately dose-proportional manner up to 200 mg. Steady state was reached approximately by Day 4.

LITFULO was administered in clinical trials up to a single oral dose of 800 mg. Adverse reactions were comparable to those seen at lower doses and no specific toxicities were identified. Pharmacokinetics (PK) data up to and including a single oral dose of 800 mg in healthy adult volunteers indicate that more than 90% of the administered dose is expected to be eliminated within 48 hours. There is no specific antidote for overdose with LITFULO. Treatment should be symptomatic and supportive, and monitor patients for signs and symptoms of adverse reactions [see Clinical Trials Experience (6.1) ] . In case of an overdose, call Poison Control Center at 1-800-222-1222 for latest recommendations.

• Jun 23, 2023NDANDA215830Pfizer

1. 1Drug Ineffective30818%
2. 2Therapeutic Product Effect Incomplete1337.6%
3. 3Condition Aggravated1116.4%
4. 4Off Label Use1076.1%
5. 5Headache794.5%
6. 6Diarrhoea593.4%
7. 7Alopecia573.3%
8. 8Product Dose Omission Issue502.9%
9. 9Urticaria492.8%
10. 10Pruritus472.7%
11. 11Acne412.4%
12. 12Fatigue392.2%
13. 13Rash382.2%
14. 14Blood Creatine Phosphokinase Increased331.9%
15. 15Nausea331.9%

The 10 most recently updated of 33 ClinicalTrials.gov registrations naming Ritlecitinib as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Learn About the Medicine Called Ritlecitinib in Adults With Severe Alopecia Areata in Real-world Settings
  Completed · Observational · 123 enrolled · Pfizer
  NCT07200128updated 2026-06-10
• Characterization And Clinical Outcomes of AA Patients Treated With Ritlecitinib
  Recruiting · Observational · 850 enrolled · Pfizer
  NCT06531109updated 2026-06-01
• Janus Kinase (JAK) Inhibitors to Preserve C-Peptide Production in New Onset Type 1 Diabetes (T1D)
  Active not recruiting · Phase 2 · Interventional · 78 enrolled · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  NCT05743244updated 2026-05-29
• Combination Approach With Ritlecitinib and nbUVB Compared to Ritlecitinib Alone for Treating Vitiligo
  Recruiting · Phase 2 · Interventional · 56 enrolled · Centre Hospitalier Universitaire de Nice
  NCT07152626updated 2026-05-20
• A Study to Learn About Litfulo Capsule in People With Severe Alopecia Areata in Routine Clinical Practice.
  Recruiting · Observational · 3,000 enrolled · Pfizer
  NCT07152119updated 2026-05-18
• Utilization and Effectiveness of Ritlecitinib in a Real-World Population With Severe AA in the US
  Active not recruiting · Observational · 300 enrolled · Pfizer
  NCT07226531updated 2026-05-14
• A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
  Active not recruiting · Phase 3 · Interventional · 550 enrolled · Pfizer
  NCT06873945updated 2026-05-13
• A 16-Week Study to Learn About the Study Medicine Called Ritlecitinib in Adults With Long Lasting Painful Red Skin Lumps, Known by the Medical Term, Hidradenitis Suppurativa, or HS.
  Recruiting · Phase 2 · Interventional · 240 enrolled · Pfizer
  NCT07228390updated 2026-04-29
• A 52-Week Study to Learn About the Safety and Effects of Ritlecitinib in Participants With Nonsegmental Vitiligo
  Active not recruiting · Phase 3 · Interventional · 394 enrolled · Pfizer
  NCT06163326updated 2026-04-29
• A Long-Term Study to Learn About The Study Medicine Called Ritlecitinib in Children With Severe Alopecia Areata.
  Recruiting · Phase 3 · Interventional · 140 enrolled · Pfizer
  NCT07029828updated 2026-04-28

Frequently asked questions

How does Ritlecitinib work?

LITFULO is a kinase inhibitor. Ritlecitinib irreversibly inhibits Janus kinase 3 (JAK3) and the tyrosine kinase expressed in hepatocellular carcinoma (TEC) kinase family by blocking the adenosine triphosphate (ATP) binding site.

What is Ritlecitinib used for?

According to FDA labeling, Ritlecitinib carries indications including: LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Ritlecitinib?

Ritlecitinib is classified as Janus-associated kinase (JAK) inhibitors, Janus Kinase Inhibitors, Tyrosine Kinase Inhibitors, Decreased Immunologic Activity.

What are the brand names for Ritlecitinib?

Ritlecitinib is marketed under brand names including Litfulo.

What are the contraindications for Ritlecitinib?

Ritlecitinib labeling lists contraindications including: LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see Warnings and Precautions (5.6) ] . LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients.. Always consult the full prescribing information and a clinician.