Contraindications, special warnings & precautions | Litfulo® (ritlecitinib)

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Click here for ▼LITFULO (ritlecitinib) Prescribing Information

Contraindications, Special Warnings and Precautions

Adverse Reactions

Contraindications¹

Hypersensitivity to the active substance(s) or to any of the excipients
Active serious infections, including tuberculosis
Severe hepatic impairment
Pregnancy and breast-feeding

Lactose¹

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product

Elderly¹

There are limited data in patients ≥ age 65 years of age
Age appeared to be a risk factor for lower levels of ALC (absolute lymphocyte count) in patients ≥ age 65 years of age
As there is a higher incidence of infections in the elderly and in the diabetic population in general, caution should be exercised when treating the elderly and patients with diabetes, and particular attention paid with respect to occurrence of infections

Women of childbearing potential¹

Litfulo is not recommended in women of childbearing potential not using contraception
Women of childbearing potential have to use effective contraception during treatment and for 1 month following the final dose of Litfulo

Pregnancy¹

There are no or limited data from the use of ritlecitinib in pregnant women. Studies in animals have shown reproductive toxicity. Ritlecitinib was teratogenic in rats and rabbits at high doses. Litfulo is contraindicted during pregnancy.

Breast-feeding¹

Available pharmacodynamic/toxicological data in animals have shown excretion of ritlecitinib in milk. A risk to newborns/infants cannot be excluded. Litfulo is contraindicated during breast-feeding.

Fertility¹

The effect of ritlecitinib on human fertility has not been evaluated. There were no effects on fertility in rats at clinically relevant exposures.

Serious infections

Serious infections have been reported in patients receiving ritlecitinib.
The most frequent serious infections were appendicitis, COVID-19 infection (including pneumonia) and sepsis. Treatment with Litfulo must not be initiated in patients with an active, serious infection.

The risks and benefits of treatment should be considered in patients:

with chronic or recurrent infection
with a history of serious or an opportunistic infection
who have been exposed to tuberculosis (TB)
who have resided or travelled in areas of endemic TB or mycoses, or
with underlying conditions that may predispose them to infection

Patients should be closely monitored for signs and symptoms of infection during and after treatment with Litfulo.

If a patient develops a serious or opportunistic infection	✓ Litfulo should be interrupted
If a patient develops a new infection during treatment with Litfulo	✓ Undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient ✓ Appropriate antimicobial therapy should be initiated ✓ Patient should be closely monitored

If Litfulo is interrupted, it may be resumed once the infection is controlled

As there is a higher incidence of infections in the elderly and in the diabetic population in general, caution should be exercised when treating the elderly and patients with diabetes, and particular attention paid with respect to occurrence of infections.¹

Tuberculosis (TB)

Patients should be screened for TB before starting therapy with Litfulo
Litfulo must not be given to patients with an active TB
Anti-TB therapy should be started prior to initiating therapy with Litfulo in patients with a new diagnosis of latent TB or previously untreated latent TB. In patients with a negative latent TB test, anti-TB therapy should still be considered before initiating treatment with Litfulo in those at high risk and screening for patients at high risk for TB during treatment with Litfulo shoud be considered.

Viral Reactivation

Viral reactivations, including cases of herpes virus reactivation (e.g., herpes zoster), have been reported. If a patient develops herpes zoster, temporary interruption of treatment may be considered until the episode resolves.
Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy with Litfulo. Patients with evidence of hepatitis B or C infection were excluded from studies with ritlecitinib. Monitoring for reactivation of viral hepatitis according to clinical guidelines is recommended during Litfulo treatment. If there is evidence of reactivation, a liver specialist should be consulted.

Malignancy (including non-melanoma skin cancer [NMSC])

Malignancies, including NMSC have been reported in patients receiving ritlecitinib.
It is not known whether selective JAK3 inhibition may be associated with adverse reactions of Januse Kinase (JAK) inhibition predominantly involving JAK1 and JAK2.
Limited clinical data are available to assess the potential relationship of exposure to ritlecitinib and the development of malignancies.
Long-term safety evaluations of ritlecitinib are ongoing.

The risks and benefits of Litfulo treatment should be considered prior to initiating or continuing therapy in patients with a known malignancy other than a successfully treated NMSC or cervical cancer.

Periodic skin examination is recommended for patients who are at increased risk of skin cancer.

Major adverse cardiovascular events (MACE), deep venous thrombosis (DVT) and pulmonary embolism (PE)

Events of venous and arterial thromboembolism, including MACE, have been reported in patients receiving ritlecitinib.
It is not known whether selective JAK3 inhibition may be associated with adverse reactions of JAK inhibition predominantly involving JAK1 and JAK2.
Long-term safety evaluations of ritlecitinib are ongoing.

The risks and benefits of Litfulo treatment should be considered prior to initiating therapy in patients.

Litfulo should be used with caution in patients with known risks factors for thromboembolism such as:

previous VTE
patients undergoing major surgery
use of combined hormonal contraceptives or hormone replacement therapy
inherited coagulation disorder
immobilisation

In patients with a suspected thromboembolic event, discontinuation of Litfulo and prompt re-evaluation is recommended.

Neurological Events¹

Ritlecitinib-related axonal dystrophy has been observed in chronic Beagle dog toxicity studies.

Treatment with Litfulo should be discontinued in case unexplained neurological symptoms occur.

Please refer to the Litfulo Summary of Product Characteristics for further information on special warnings and precautions for use.

Adverse Reactions

References:

LITFULO® (ritlecitinib). Pfizer. Summary of Product Characteristics.

PP-LGF-GBR-0268. June 2025

Adverse events should be reported. Reporting forms and information can be found at https://yellowcard.mhra.gov.uk or search

for MHRA Yellow Card in Google Play or Apple App Store

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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