LISRAYA Film-coated tablet Ref.[116910] Active ingredients: Brepocitinib

Source: FDA, National Drug Code (US)  Revision Year: 2026 

1. Indications and Usage

LISRAYA is indicated for the treatment of dermatomyositis in adult patients.

Limitations of Use:

LISRAYA is not recommended for use in combination with other JAK inhibitors, other TYK2 inhibitors, or biologic DMARDs.

2. Dosage and Administration

2.1 Recommended Evaluations and Immunizations Prior to Treatment Initiation

Prior to LISRAYA treatment initiation, consider performing the following:

  • Active and latent tuberculosis (TB) infection evaluation: If positive, treat for TB prior to LISRAYA treatment [see Warnings and Precautions (5.1)].
  • Viral hepatitis screening in accordance with clinical guidelines: LISRAYA is not recommended in patients with active hepatitis B or hepatitis C [see Warnings and Precautions (5.1)].
  • A complete blood count: Avoid LISRAYA in patients with an absolute lymphocyte count less than 500 cells/mm³, absolute neutrophil count less than 1,000 cells/mm³, or hemoglobin level less than 8 g/dL [see Warnings and Precautions (5.9)].
  • Baseline hepatic and renal function tests: LISRAYA is not recommended in patients with severe hepatic or severe renal impairment [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)].
  • Pregnancy Status: Verify the pregnancy status of females of reproductive potential prior to treatment with LISRAYA [see Warnings and Precautions (5.11) and Use in Specific Populations (8.1, 8.3)].
  • Update immunizations according to current immunization guidelines [see Warnings and Precautions (5.10)].

2.2 Recommended Dosage and Administration

The recommended dosage of LISRAYA is 30 mg once daily, administered orally with or without food [see Clinical Pharmacology (12.3)].

2.3 Recommended Dosage Interruption

Infections

If a patient develops a serious infection, including serious opportunistic infection, interrupt LISRAYA treatment until the infection resolves or is adequately treated. [see Warnings and Precautions (5.1)].

Laboratory Abnormalities

Interruption of LISRAYA treatment may be needed for management of laboratory abnormalities as described in Table 1 [see Warnings and Precautions (5.9)].

Table 1. Recommended Dosage Interruptions for Laboratory Abnormalities:

Laboratory MeasureAction
Absolute Neutrophil Count (ANC)Interrupt LISRAYA treatment if ANC is less than
1,000 cells/mm³; treatment may be restarted once
ANC returns above this value
Absolute Lymphocyte Count (ALC)Interrupt LISRAYA treatment if ALC is less than 500 cells/mm³;
treatment may be restarted once ALC
returns above this value
Hemoglobin (Hb)Interrupt LISRAYA treatment if Hb is less than 8 g/dL;
treatment may be restarted once Hb returns above
this value
Hepatic transaminases (ALT/AST)Interrupt LISRAYA treatment if drug-induced liver
injury is suspected, until this diagnosis is excluded.

10. Overdosage

There is no specific antidote for overdose with LISRAYA. If an overdose of LISRAYA occurs, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for overdose management recommendations.

16.2. Storage and Handling

Store below 30°C (86°F).

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