• Severe alopecia areata.

Contraindicated in:

• Hypersensitivity
• Active, serious infection
• Severe hepatic impairment
• Lactation: Lactation.

Use Cautiously in:

• Chronic, recurrent infection
• Previous exposure to tuberculosis (TB)
• History of serious or opportunistic infection
• Lived or traveled in areas of endemic TB or mycoses
• Predisposed to infection
• >50 yr old with 1 cardiovascular risk factor (may ↑ risk of all-cause mortality, cardiovascular death, MI, stroke, and thrombosis)
• Current or past history of smoking (↑ risk of malignancy, cardiovascular death, MI, or stroke)
• Known malignancy (other than a successfully treated non-melanoma skin cancer or cervical cancer)
• OB: Safety not established in pregnancy
• Pedi: Children <12 yr (safety and effectiveness not established)
• Geri: Infection risk may be ↑ in older adults.

CV: ARTERIAL THROMBOSIS, CARDIOVASCULAR DEATH, DEEP VEIN THROMBOSIS, MI.

Derm: acne, atopic dermatitis, folliculitis, rash, urticaria.

GI: diarrhea, ↑ liver enzymes, stomatitis.

Hemat: anemia, lymphopenia, thrombocytopenia.

MS: ↑creatine kinase.

Neuro: headache, dizziness, STROKE.

Resp: PULMONARY EMBOLISM.
Misc: fever, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS), (INCLUDING TB, BACTERIAL, INVASIVE FUNGAL, VIRAL, AND OTHER INFECTIONS DUE TO OPPORTUNISTIC PATHOGENS)INFECTION , MALIGNANCY.

Drug-Drug:

• May ↑ risk of adverse reactions and ↓ antibody response to live vaccines; avoid concurrent use.
• May ↑ levels and risk of toxicity of CYP3A substrates.
• May ↑ levels and risk of toxicity of CYP1A2 substrates.
• Strong CYP3A inducers, including rifampin, may ↓ levels and effectiveness; concurrent use not recommended.

• Capsules: 50 mg;

• PO (Adults): 50 mg once daily.

Litfulo

• Irreversibly inhibits Janus kinase 3 and the tyrosine kinase expressed in the hepatocellular carcinoma (TEC) kinase family by blocking the adenosine triphosphate binding site, both of which may inhibit T cell activation.

• Reduction in scalp hair loss.

Therapeutic Classification: n/a

Pharmacologic Classification: kinase inhibitors

Absorption: 64% absorbed following oral administration.

Distribution: Unknown.

Metabolism/Excretion: Metabolized by multiple pathways, including glutathione S-transferase and several CYP450 enzymes (CYP3A, CYP2C8, CYP1A2, and CYP2C9). Primarily excreted as metabolites in the urine (66%), with 20% excreted in the feces.

Half-life: 1.3–2.3 hr.

(reduction in scalp hair loss)

ROUTE	ONSET	PEAK	DURATION
PO	6–8 wk	unknown	24 wk

• Instruct patient to take ritlecitinib as directed. If a dose is missed, administer dose as soon as possible, unless it is <8 hr before next dose; then skip missed dose and resume dosing at the regular scheduled time. If therapy is held, a temporary interruption for <6 wk is not expected to result in significant loss of regrown scalp hair. Advise patient to read Medication Information before starting ritlecitinib and with each Rx refill in case of changes.
• Advise patient to notify health care professional if signs and symptoms of infections (fever; sweating; chills; muscle aches; cough or shortness of breath; blood in phlegm; weight loss; warm, red, or painful skin or sores on the body; diarrhea or stomach pain; burning on urination or urinating more often than usual; feeling very tired), heart attack or stroke (chest discomfort lasting more than a few minutes, or that goes away and comes back; severe tightness, pain, pressure, or heaviness in chest, throat, neck, or jaw; pain or discomfort in arms, back, neck, jaw, or stomach; shortness of breath with or without chest discomfort; breaking out in a cold sweat; nausea or vomiting; light-headedness; weakness in one part or on one side of body; slurred speech), blood clots (swelling, pain or tenderness in one or both legs; sudden, unexplained chest or upper back pain; shortness of breath or difficulty breathing; changes in vision, especially in one eye only), or hypersensitivity reactions occur.
• Inform patient that ritlecitinib may increase risk of cancer (lymphoma, lung cancer). Advise patient to have periodic skin examinations and to tell health care professional if they have ever had any type of cancer.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise patient to avoid live attenuated vaccines during or shortly before starting therapy.
• Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy and for 14 hr after last dose. If patient becomes pregnant while receiving ritlecitinib, health care professional should report pregnancy exposure the Pregnancy Exposure Registry by calling 1-877-390-2940.

RIT-le-SYE-ti-nib