Ritlecitinib

Ritlecitinib, sold under the brand name Litfulo^®, is a prescription oral medication used to treat severe alopecia areata, a condition that causes hair loss when the immune system attacks hair follicles. The United States Food and Drug Administration (FDA) approved Litfulo for this use for adults and children ages 12 and older.

Ritlecitinib is a janus kinase (JAK) inhibitor, which means it blocks certain signals in the immune system that cause inflammation and hair loss. By calming down the immune response, ritlecitinib helps people with alopecia areata regrow hair they’ve lost and prevent further hair shedding.

Common side effects include headache, acne, upper respiratory tract infections, nausea, and increased creatine phosphokinase levels. More serious risks include infections, elevated liver enzymes, and a potential increase in blood lipid levels, such as cholesterol.

Ritlecitinib should not be used by people with active infections or those who are pregnant or breastfeeding.

Litfulo (ritlecitinib) is indicated for:

• The treatment of severe alopecia areata in adults and adolescents 12 years and older

Kinase inhibitor

Most common adverse reactions (incidence ≥1%) are:

• Headache

• Diarrhea

• Acne

• Rash

• Hives

• Folliculitis

• Fever

• Atopic dermatitis

• Dizziness

• Blood creatine phosphokinase increased

• Herpes zoster

• Red blood cell count decreased

• Inflammation of the lining of the mouth

The cost of Litfulo (ritlecitinib) may vary depending on factors such as your insurance plan, the quantity and dosage, and where you buy it. Liftulo is a limited distribution drug, which means it’s only available at specialty pharmacies. In other words, you won’t be able to fill a prescription for ritlecitinib at your local CVS.

Without insurance, the average retail price of Litfulo is about $4,300 for a 28-day supply. Pfizer, the drug’s maker, offers financial assistance resources to eligible folks through its Pfizer Dermatology Patient Access program.

There is currently no generic version of Litfulo available in the United States.

You can get a prescription for ritlecitinib after being evaluated by your primary care provider or a specialist who can determine if the medicine is right for you based on factors like your symptoms and medical history.

• Litfulo is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients

• Drug interactions: Certain CYP3A substrates, certain CYP1A2 substrates, certain CYP3A inducers

• Hypersensitivity

• Laboratory abnormalities

• Vaccinations: Avoid use of live vaccines during or shortly prior to Litfulo treatment

• Breastfeeding: Breastfeeding not recommended

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

Increased risk of serious bacterial, fungal, viral, and opportunistic infections that may lead to hospitalization or death, including tuberculosis (TB). Interrupt treatment if serious infection occurs until the infection is controlled. Litfulo should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; start treating latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.. Monitor all patients for signs and symptoms of infection during and after treatment with Litfulo.

Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Litfulo is not approved for use in RA patients.

Malignancies were reported in patients treated with Litfulo. Higher rate of lymphomas and lung cancers with another JAK inhibitor vs. TNF blockers in RA patients.

Higher rate of MACE (defined as cardiovascular death, myocardial infarction, and stroke) with another JAK inhibitor vs. TNF blockers in RA patients..

Thrombosis has occurred in patients treated with Litfulo. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers.

There are other medications available to treat the symptoms of alopecia areata, many of which are prescribed off-label at the discretion of a healthcare provider. Some of these drugs may be better suited to you than others. If you’re interested in finding an alternative to ritlecitinib, talk with your provider to learn more about other medications that may work well for you.

Alternative medication options to ritlecitinib:

• Corticosteroids, including steroid shots

• Dupixent^® (dupilumab), for folks who also have or are at risk for eczema

• Immunotherapy drugs, including dibutyl squarate and diphencyprone

• Oral and topical minoxidil 

• Other JAK inhibitors, including Leqselvi^® (deuruxolitinib), Olumiant^® (baricitinib), and Xeljanz^® (tofacitinib)

*This information is from the label for brand name Litfulo^®. See the Full Prescribing Information for more complete information. Ritlecitinib, the active ingredient in Litfulo, may also be the active ingredient in other medications, and this information may not be accurate for all medications that include the active ingredient ritlecitinib.