LITFULO- ritlecitinib capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

RITLECITINIB TOSYLATE (UNII: EAG4T1459K) (RITLECITINIB - UNII:2OYE00PC25)

Available from:

Pfizer Laboratories Div Pfizer Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older. Limitations of Use : Not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. LITFULO is contraindicated in patients with known hypersensitivity to ritlecitinib or any of its excipients [see Warnings and Precautions (5.6)] .       If a patient becomes pregnant while receiving LITFULO, healthcare providers should report LITFULO exposure by calling 1-877-390-2940. Risk Summary Available data from clinical trials with LITFULO use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of ritlecitinib to pregnant rats and rabbits during organogenesis caused fetotoxicity and fetal malformations at exposures 49 and 55 times the maximum recommended human dose (MRHD) based on area under the curve (AUC) comparison, respectively (see Animal Data) . The background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies carry some risk of birth defects, loss, or other adverse outcomes. The estimated background risks in the U.S. general population of major birth defects and miscarriages are 2-4% and 15-20% of clinically recognized pregnancies, respectively. Data Animal Data In an embryo-fetal development study in pregnant rats, oral administration of ritlecitinib from gestation days 6 to 17 decreased fetal body weights and caused fetal skeletal malformations (malformed vertebrae and ribs) and variations (delayed ossification) at doses ≥175 mg/kg/day (49 times the MRHD based on AUC comparison). Maternal toxicity (lower body weights) was noted at 325 mg/kg/day (102 times the MRHD based on AUC comparison). There was no developmental toxicity at 75 mg/kg/day (16 times the MRHD based on AUC comparison). In an embryo-fetal development study in pregnant rabbits, oral administration of ritlecitinib from gestation days 7 to 19 decreased mean fetal body weights and increased visceral malformations (malpositioned kidneys), skeletal malformations (supernumerary sternebrae, absent thoracic arch, and/or fused thoracic centra), and skeletal variations (delayed ossification) at 75 mg/kg/day (55 times the MRHD based on AUC comparison). There was no developmental toxicity at doses up to 25 mg/kg/day (12 times the MRHD based on AUC comparison). In a pre- and postnatal development study in rats, oral administration of ritlecitinib from gestation day 6 through lactation day 20 had no effects on pre- and postnatal development at doses up to 75 mg/kg/day (14 times the MRHD based on AUC comparison). At 175 mg/kg/day (41 times the MRHD based on AUC comparison), ritlecitinib caused adverse lower postnatal survival and lower offspring body weights, which correlated with delayed sexual maturation in both sexes. Bred females in the F1 generation also exhibited lower mean numbers of corpora lutea at 175 mg/kg/day. Risk Summary There are no data on the presence of ritlecitinib in human milk, the effects on the breastfed infant, or the effects on milk production. Ritlecitinib is present in the milk of lactating rats (see Data) . When a drug is present in animal milk, it is likely that it will be present in human milk. Because of the serious adverse effects in adults, including risks of serious infection and malignancy, advise women not to breastfeed during treatment with LITFULO and for approximately 14 hours after the last dose (approximately 6 elimination half-lives). Data After a single oral 30 mg/kg dose of ritlecitinib to lactating rats, ritlecitinib concentrations in milk over time were higher than those in plasma. The mean milk to plasma AUC ratio was 2.2. The safety and effectiveness of LITFULO for the treatment of alopecia areata have been established in pediatric patients ages 12 years and older. A total of 181 pediatric patients ages 12 to <18 years were enrolled in alopecia areata clinical trials, with 105 pediatric patients ages 12 to <18 years with alopecia areata randomized in a pivotal, double-blind, placebo-controlled trial (Trial AA-I). Efficacy was consistent between the pediatric patients and adults [see Clinical Studies (14)] . The adverse reaction profile in the pediatric patients was similar to adults. The safety and efficacy of LITFULO have not been established in pediatric patients under 12 years of age. No dose adjustment is required for patients ≥65 years of age. A total of 28 patients enrolled in alopecia areata trials were 65 years of age and older, and none were 75 years of age and older. Clinical trials of LITFULO did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly. No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment. LITFULO is not recommended in patients with severe (Child Pugh C) hepatic impairment [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)] .

Product summary:

LITFULO capsules are packaged in child-resistant, white, high-density polyethylene (HDPE) bottles with polypropylene (PP) cap with a foil heat induction seal liner. The bottles contain 1g of desiccant in a high-density polyethylene (HDPE) canister. Do not eat the desiccant. Dosage Form Strength Description Bottle Size (number of capsules) NDC Number Capsules 50 mg of ritlecitinib Size 3, opaque capsules with yellow body and blue cap. The body is printed with “RCB 50” and the cap is printed with “Pfizer” in black. 28 count bottle 0069-0334-28 Store LITFULO at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Keep in original package.

Authorization status:

New Drug Application

Patient Information leaflet

Pfizer Laboratories Div Pfizer Inc
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This Medication Guide has been approved by the U.S. Food and Drug
Administration.
Issued: 6/2023
Medication Guide
LITFULO™ (lit-FUL-oh)
(ritlecitinib)
capsules, for oral use
What is the most important information I should know about LITFULO?
LITFULO may cause serious side effects, including:
1. Serious infections
LITFULO is a medicine that affects your immune system. LITFULO can
lower the ability of your
immune system to fight infections. Some people have had serious
infections while taking LITFULO or
other similar medicines, including tuberculosis (TB), and infections
caused by bacteria, fungi, or viruses
that can spread throughout the body and have been hospitalized. Some
people taking similar medicines to
LITFULO have died from these infections.
•
Your healthcare provider should test you for TB before starting
treatment with LITFULO.
•
Your healthcare provider should watch you closely for signs and
symptoms of TB during treatment
with LITFULO.
You should not start taking LITFULO if you have any kind of infection
unless your healthcare provider
tells you it is okay.
You may be at a higher risk of developing shingles (herpes zoster).
Before starting LITFULO, tell your healthcare provider if you:
•
are being treated for an infection.
•
have an infection that has not gone away or that keeps coming back.
•
have diabetes, chronic lung disease, HIV, or a weak immune system.
•
have TB or have been in close contact with someone with TB.
•
have had shingles (herpes zoster).
•
have had hepatitis B or hepatitis C.
•
live or have lived or have traveled to certain parts of the country
(such as the Ohio and Mississippi
River valleys and the Southwest) where there is an increased chance
for getting certain kinds of
fungal infections. These infections may happen or become more severe
if you use LITFULO. Ask
your healthcare provider if you do not know if you have lived in an
area where these infections are
common.
•
think you have an infection or have symptoms

Summary of Product characteristics

LITFULO- RITLECITINIB CAPSULE
PFIZER LABORATORIES DIV PFIZER INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LITFULO SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LITFULO.
LITFULO™ (RITLECITINIB) CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 2023
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE
CARDIOVASCULAR EVENTS (MACE), AND THROMBOSIS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
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•
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INDICATIONS AND USAGE
LITFULO is a kinase inhibitor indicated for the treatment of severe
alopecia areata in adults and
adolescents 12 years and older. (1)
Limitations of Use: Not recommended for use in combination with other
JAK inhibitors, biologic
immunomodulators, cyclosporine or other potent immunosuppressants (1).
DOSAGE AND ADMINISTRATION
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•
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DOSAGE FORMS AND STRENGTHS
Capsules: 50 mg of ritlecitinib (3)
CONTRAINDICATIONS
LITFULO is contraindicated in patients with known hypersensitivity to
ritlecitinib or any of its excipients. (4)
WARNINGS AND PRECAUTIONS
•
•
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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.
(5.1). MONITOR ALL PATIENTS FOR SIGNS AND SYMPTOMS OF INFECTION DURING
AND AFTER
TREATMENT WITH LITFULO. (5.1)
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. (5.2)
MALIGNANCIES WERE REPORTED IN PATIENTS TREATED WITH LITFULO (5.3).
HIGHER RATE OF
LYMPHOMAS AND LU