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Litfulo Side Effects

Generic name: ritlecitinib

Medically reviewed by Drugs.com. Last updated on Oct 12, 2023.

Note: This document contains side effect information about ritlecitinib. Some dosage forms listed on this page may not apply to the brand name Litfulo.

Applies to ritlecitinib: oral capsule.

Warning

Oral route (Capsule)

Warning: Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events (MACE) and ThrombosisIncreased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death, including tuberculosis (TB). Interrupt treatment if serious infection occurs until the infection is controlled. Ritlecitinib should not be given to patients with active tuberculosis. Test for latent TB before and during therapy; treat latent TB prior to use. Monitor all patients for active TB during treatment, even patients with initial negative, latent TB test.Higher rate of all-cause mortality, including sudden cardiovascular death with another Janus kinase inhibitor (JAK) vs. TNF blockers in rheumatoid arthritis (RA) patients. Ritlecitinib is not approved for use in RA patients.Malignancies have occurred in patients treated with ritlecitinib. 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 ritlecitinib. Increased incidence of pulmonary embolism, venous and arterial thrombosis with another JAK inhibitor vs. TNF blockers.

Serious side effects of Litfulo

Along with its needed effects, ritlecitinib (the active ingredient contained in Litfulo) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking ritlecitinib:

Less common

Incidence not known

Other side effects of Litfulo

Some side effects of ritlecitinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

For Healthcare Professionals

Applies to ritlecitinib: oral capsule.

General

The most frequently reported adverse reactions (with an incidence of 1% or greater) include headache, diarrhea, acne, rash, urticaria, folliculitis, pyrexia, atopic dermatitis, dizziness, increased blood creatine phosphokinase, herpes zoster, decreased red blood cell count, and stomatitis.[Ref]

Dermatologic

Common (1% to 10%): Acne (acne and acne pustular), dermatitis atopic, folliculitis, rash (rash and dermatitis allergic), urticaria[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (diarrhea and frequent bowel movements) (10%)

Common (1% to 10%): Stomatitis[Ref]

Hematologic

Common (1% to 10%): Decreased red blood cell count

Rare (0.01% to 0.1%): Decreased platelet count, decreased lymphocyte counts, thromboembolic events[Ref]

Hepatic

Frequency not reported: Liver enzyme elevations[Ref]

Oncologic

Common (1% to 10%): Malignancy[Ref]

Other

Common (1% to 10%): Increased blood creatine phosphokinase, herpes zoster, pyrexia[Ref]

Nervous system

Very common (10% or more): Headache (headache and migraine) (10.8%)

Common (1% to 10%): Dizziness[Ref]

Frequently asked questions

References

1. Product Information. Litfulo (ritlecitinib). Pfizer U.S. Pharmaceuticals Group. 2023.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.