Litfulo (Ritlecitinib)

LITFULO is a kinase inhibitor indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

• •For recommended testing, evaluations and immunizations prior to LITFULO initiation, see Full Prescribing Information. (
  2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation

  Perform the following evaluations prior to LITFULO initiation:

  • •Tuberculosis (TB) infection evaluation: LITFULO initiation is not recommended in patients with active TB. For patients with latent TB or those with a negative latent TB test who are at high risk for TB, start preventive therapy for latent TB prior to initiation of LITFULO
    [see Warnings and Precautions (5.1)]
    .
  • •Viral hepatitis screening in accordance with clinical guidelines: LITFULO initiation is not recommended in patients with hepatitis B or hepatitis C
    [see Warnings and Precautions (5.1)]
    .
  • •Treatment with LITFULO should not be initiated in patients with an absolute lymphocyte count (ALC) <500/mm³or a platelet count <100,000/mm³
    [see
    Warnings and Precautions (5.7)
    ]
    .
  • •Update immunizations according to current immunization guidelines
    [see
    Warnings and Precautions (5.8)
    ]
    .
  )
• •Recommended dosage is 50 mg orally once daily. (
  2.2 Recommended Dosage

  The recommended dosage of LITFULO is 50 mg orally once daily with or without food

  [see Clinical Pharmacology (12.3)]

  .

  Swallow capsules whole. Do not crush, split, or chew LITFULO capsules.

  If a dose is missed, administer the dose as soon as possible unless it is less than 8 hours before the next dose, in which case, skip the missed dose. Thereafter, resume dosing at the regular scheduled time.
  )
• •For dosage interruption for certain adverse reactions, see Full Prescribing Information. (
  2.4 Treatment Interruption or Discontinuation

  If treatment interruption is indicated, a temporary treatment interruption for less than 6 weeks is not expected to result in significant loss of regrown scalp hair.

  Hematologic Abnormalities

  Recommendations for LITFULO treatment interruption or discontinuation for hematologic abnormalities are summarized in Table 1.

  Table 1. Laboratory Monitoring Guidance

  Laboratory Measure	Recommendation
  ALC = absolute lymphocyte count.
  Platelet Count	Treatment should be discontinued if platelet count is <50,000/mm3
  Lymphocytes	Treatment should be interrupted if ALC is <500/mm3and may be restarted once ALC return above this value.

  ALC and platelet counts are recommended before treatment initiation and at 4 weeks after treatment initiation, and thereafter according to routine patient management

  [see

  Warnings and Precautions (5.7)

  ]

  .
  )

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.

• •
  Lactation
  : Breastfeeding not recommended. (
  8.2 Lactation

  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.
  )
• •
  Severe Hepatic Impairment:
  Not recommended. (
  8.6 Hepatic Impairment

  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)]

  .
  )

• •
  Hypersensitivity:
  Discontinue LITFULO if a clinically significant hypersensitivity reaction occurs. (
  5.6 Hypersensitivity

  Serious reactions including anaphylactic reactions, urticaria and rash have been observed in patients receiving LITFULO in clinical trials. If a clinically significant hypersensitivity reaction occurs, discontinue LITFULO and institute appropriate therapy

  [see Adverse Reactions (6.1)]

  .
  )
• •
  Laboratory Abnormalities:
  Perform ALC and platelet counts prior to LITFULO initiation. Treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities. (
  5.7 Laboratory Abnormalities

  Treatment with LITFULO was associated with decreases in lymphocytes and platelets

  [see Adverse Reactions (6.1)]

  .

  Prior to LITFULO initiation, perform ALC and platelet counts

  [see Dosage and Administration (2.1)]

  . After initiating treatment with LITFULO, treatment interruption or discontinuation are recommended based on ALC and platelet count abnormalities

  [see Dosage and Administration (2.4)]

  .

  Liver Enzyme Elevations – Treatment with LITFULO was associated with increased incidence of liver enzyme elevation compared to placebo. Increases of ALT ≥5 times the upper limit of normal (ULN) and increases of AST ≥5 times the ULN were observed in patients in LITFULO clinical trials. Evaluate at baseline and thereafter according to routine patient management. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. If increases in ALT or AST are observed and drug-induced liver injury is suspected, interrupt LITFULO until this diagnosis is excluded.

  Creatine Phosphokinase (CPK) Elevations – Treatment with LITFULO was associated with increased incidence of CPK elevation compared to placebo.
  )
• •
  Vaccinations:
  Avoid use of live vaccines during or shortly prior to LITFULO treatment. (
  5.8 Vaccinations

  No data are available on the response to vaccination in patients receiving LITFULO. Use of live attenuated vaccines should be avoided during or shortly prior to initiating treatment. Prior to initiating LITFULO, it is recommended that patients be brought up to date with all immunizations, including prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.
  )