Deuruxolitinib Dosage

Usual Adult Dose for Alopecia

8 mg orally twice a day

Comments:

• This drug is not recommended for use in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, cyclosporine, or any other potent immunosuppressants.

Use: For the treatment of adults with severe alopecia areata

Renal Dose Adjustments

Mild and Moderate Renal Dysfunction (Estimated GFR [eGFR] 30 to less than 90 mL/min/1.73 m2): No adjustment recommended
Severe Renal Dysfunction or End-Stage Renal Disease (eGFR less than 30 mL/min/1.73 m2): Not recommended

Liver Dose Adjustments

Mild and Moderate Liver Dysfunction (Child Pugh A and B): No adjustment recommended
Severe Liver Dysfunction (Child Pugh C): Not recommended

Dose Adjustments

Serious or Opportunistic Infections:

• Interrupt treatment until the infection is controlled.

Hematological Abnormalities:

• Absolute Lymphocyte Count (ALC) less than 500 cells/mm3: Interrupt treatment and resume when ALC is greater or equal to 500 cells/mm3.
• Absolute Neutrophil Count (ANC) less than 1000 cells/mm3: Interrupt treatment and resume when ANC is greater or equal to 1000 cells/mm3.
• Hemoglobin (Hb) less than 8 g/dL: Interrupt treatment and resume when Hb is greater or equal to 8 g/dL.

Precautions

US BOXED WARNING(S):
Serious Infections, Mortality, Malignancy, Major Adverse Cardiovascular Events (MACE) and Thrombosis:

• Increased risk of serious bacterial, fungal, viral, and opportunistic infections including tuberculosis (TB), that may lead to hospitalization or death. Interrupt treatment with this drug if a serious infection occurs until the infection is controlled. 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 JAK vs. tumor necrosis factor (TNF) blockers in RA patients. This drug is not approved for RA.
• Malignancies have occurred in patients treated with this drug. 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 vs. TNF blockers in RA patients.
• Thrombosis has occurred in patients treated with this drug. Increased incidence of pulmonary embolism, venous and arterial thrombosis was observed with another JAK inhibitor vs. TNF blockers.

CONTRAINDICATIONS:

• Patients who are CYP450 2C9 poor metabolizers
• Patients using moderate of strong CYP450 2C9 inhibitors

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Before treatment with this drug:
• Perform CYP450 2C9 genotype determination
• Evaluate for use of concomitant CYP450 2C9 inhibitors
• This drug is not recommended in patients with active TB. Patients with negative test who are at risk of TB should start preventive therapy for TB before starting treatment.
• This drug is not recommended in patients with active hepatitis B or C. If hepatitis B is diagnosed, follow clinical guidelines and refer to a liver specialist.
• Take this drug with or without food.
• If a dose is missed, skip the missed dose and resume dosing at the next scheduled dose.
• Complete any necessary immunizations, including herpes zoster, according to current clinical guidelines prior to treatment.

Storage requirements:

• Store tablets in the original bottle to protect from moisture.
• Store at 20C to 25C (68F to 77F), with excursions permitted between 15C and 30C (59F and 86F).

Monitoring
Prior and during treatment as clinically appropriate:
Gastrointestinal: Patients with gastrointestinal risks for signs or symptoms of gastrointestinal perforation.
Hematologic: Anemia, complete blood counts, neutropenia, and lymphopenia
Hepatic: Hepatitis B
Infections: Active or latent tuberculosis, signs or symptoms of infection
Metabolic: Changes in lipids parameters

General:

• An FDA-approved test for the detection of CYP450 2C9 variants to direct the use of this drug is not currently available.
• To report suspected adverse reactions, contact Sun Pharmaceutical Industries, Inc at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).-Inform your healthcare provider if you have history of any type of cancer, cardiovascular disease of smoking.
• Inform your healthcare provider of all the medications you are taking.
• Inform your healthcare provider if you are pregnant or planning to become pregnant.
• Contact your healthcare provider if you develop any signs or symptoms of infection.
• Contact your healthcare provider if you develop any cardiovascular or thrombosis symptoms.
• Seek medical care immediately if you experience new onset of abdominal pain, fever, chills, nausea, or vomiting.
• Inform your healthcare provider if you are taking this drug before a potential vaccination.

See also:

Further information

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

Medical Disclaimer