Ritlecitinib

Ritlecitinib is a prescription medication used for the treatment of severe alopecia areata in patients aged 12 years and above.

• Ritlecitinib is available under the following different brand names: Litfulo

Common side effects of Ritlecitinib include:

• headache
• diarrhea
• acne
• rash
• hives
• inflamed hair pores (folliculitis)
• fever
• eczema
• dizziness
• shingles
• decreased red blood cell counts
• mouth sores, redness, and swelling of the lining of the mouth

Serious side effects of Ritlecitinib include:

• serious infections

Rare side effects of Ritlecitinib include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Capsule

• 50 mg

Alopecia areata

Adult dosage

• 50 mg orally once a day

Pediatric dosage

• Children aged younger than 12 years: Safety and efficacy not established
• Children aged 12 years and older: 50 mg orally once a day

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Ritlecitinib has severe interactions with no other drugs
• Ritlecitinib has serious interactions with at least 31 other drugs
• Ritlecitinib has moderate interactions with at least 46 other drugs
• Ritlecitinib has minor interactions with no other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Known hypersensitivity to Ritlecitinib or any of its excipients

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Ritlecitinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Ritlecitinib?”

Cautions

• In a large, randomized, postmarketing safety study of another JAK inhibitor in patients with RA aged 50 years and older with at least 1 CV risk factor, a higher rate of all-cause mortality, including sudden CV death, was observed in patients treated with the JAK inhibitor compared TNF blockers
• Similarly, increased risk for MACE and thromboembolic events were observed with another JAK inhibitor in patients with RA aged 50 years and older; avoid in patients who may be at increased risk of thrombosis; if symptoms of thrombosis or embolism occur, patients should interrupt therapy and be evaluated promptly and treated appropriately
• Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical trials; consider risks and benefits of treatment before initiating or continuing therapy in patients with a known malignancy other than a successfully treated NMSC or cervical cancer; perform periodic skin examinations for patients who are at increased risk for skin cancer
• Consider benefits and risks for individual patients before initiating or continuing therapy, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors; patients should be informed about symptoms of serious cardiovascular events and steps to take if they occur; discontinue in patients that have experienced myocardial infarction or stroke
• Serious reactions including anaphylactic reactions, urticaria, and rash observed in clinical trials; discontinue and institute appropriate therapy if clinically significant rash occurs
• Serious infections
  • Serious infections were reported; common serious infections reported were appendicitis, COVID-19 infection (including pneumonia), and sepsis; among opportunistic infections, multi-dermatomal herpes zoster was reported
  • Avoid use with an active, serious infection
  • Consider the risks and benefits of treatment before initiating in patients
  • With chronic or recurrent infection
• Who has been exposed to TB
  • With a history of a 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
  • Screen for TB and viral hepatitis before initiating
  • Monitor for viral reactivation, including herpes zoster
• Caution in patients with HIV or other immunocompromised conditions
  • Patients who develop new infections during treatment should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient; initiate appropriate antimicrobial and closely monitor; therapy may be resumed once the infection is controlled
  • If a patient develops herpes zoster, consider interrupting treatment until the episode resolves
• Laboratory abnormalities
  • Treatment is associated with decreased lymphocytes and platelets
  • Evaluate ALC, platelet counts, and liver enzymes at baseline and thereafter according to routine patient management
  • Elevated CPK was observed compared with placebo
• Drug interaction overview
  • Inhibitor of CYP3A4 and CYP1A2
  • Substrate of CYP3A
  • Vaccinations
    • Avoid live attenuated vaccines during or shortly before initiating treatment
    • No data are available on vaccination response in Ritlecitinib-treated patients
    • Before initiating, review patient immunization status (including herpes zoster) and immunize accordingly in agreement with current immunization guidelines
  • Strong CYP3A4 inducers
    • Avoid
    • Coadministration with strong CYP3A inducers may decrease Ritlecitinib AUC and peak. plasma concentration, which may result in loss of or reduced efficacy
  • Sensitive CYP3A4 or CYP1A2 substrates
    • Monitor/modify the dose of sensitive CYP3A4/CYP1A2 substrates
    • Ritlecitinib inhibits CYP3A4 and CYP1A2 substrates; coadministration increases AUC and peak plasma concentration sensitive substrates, which may increase the risk of adverse reactions
    • Additional monitoring and dosage adjustment may be needed by the product labeling of CYP3A or CYP1A2 substrates

Pregnancy and Lactation

• Data from clinical trials are insufficient regarding use in pregnant women to identify the drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Pregnancy registry: Report exposures during pregnancy by calling 1-877-390-2940
• Lactation
  • Data are unavailable on the presence of human milk, its effects on breastfed infants or milk production
  • Ritlecitinib?is present in the milk of lactating rats; when a drug is present in animal milk, it will likely be present in human milk
  • Owing to the serious adverse effects in adults, including risks of serious infection and malignancy, advise women not to breastfeed during treatment and for approximately 14 hours after the last dose (approximately 6 elimination half-lives)