Usual Adult Dose for Rheumatoid Arthritis

15 mg orally once a day

Comments:

• This drug may be used as monotherapy or in combination with methotrexate or other nonbiologic disease modifying antirheumatic drugs (DMARDs).
• This drug is not recommended in patients with an absolute lymphocyte count (ALC) less than 500 cells/mm3, absolute neutrophil count (ANC) less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL.
• Limitations of use: This drug is not recommended in combination with other Janus kinase (JAK) inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

Use: Treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers.

Usual Adult Dose for Psoriatic Arthritis

15 mg orally once daily

Comments:

• Limitations of use: Not recommended to use in combination with other JAK inhibitors, biologic DMARDs, or with potent immunosuppressants such as azathioprine and cyclosporine.

Use: Adults with active psoriatic arthritis with inadequate response or intolerance to TNF blockers

Usual Adult Dose for Atopic Dermatitis

Initiation dose: 15 mg orally once daily
Maximum dose: 30 mg orally once daily (if no response with initial dose)
Duration of therapy: Discontinue if no response is achieved with 30 mg/day dose

Comments:

• Use the lowest dose to maintain response
• Limitations of use: Not recommended to use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants

Use: Adults with refractory, moderate to severe atopic dermatitis that has not been adequately controlled with other systemic drug products, including biologics, or when other therapies are inadvisable

Usual Geriatric Dose for Atopic Dermatitis

Adults 65 years of age and older: 15 mg orally once daily

Comments:

• Use the lowest dose to maintain response
• Limitations of use: Not recommended to use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants

Use: Adults 65 years and older with refractory, moderate to severe atopic dermatitis that has not been adequately controlled with other systemic drug products, including biologics, or when other therapies are inadvisable

Usual Pediatric Dose for Atopic Dermatitis

Patients 12 years of age and older weighing at least 40 kg:
Initiation dose: 15 mg orally once daily
Maintenance dose: 30 mg orally once daily (if no response with initial dose)
Maximum dose: 30 mg orally once daily
Duration of therapy: Discontinue if no response is achieved with 30 mg dose

Comments:

• Use the lowest dose to maintain response
• Limitations of use: Not recommended to use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants

Use: Pediatric patients older than 12 years old and weighing at least 40 kg with refractory, moderate to severe atopic dermatitis that has not been adequately controlled with other systemic drug products, including biologics, or when other therapies are inadvisable

Renal Dose Adjustments

Rheumatoid Arthritis and Psoriatic Arthritis:
No adjustment recommended.

Atopic Dermatitis:

• Mild and Moderate Renal Dysfunction: No adjustment recommended
• Severe Renal Dysfunction (CrCl less than 30 mL/min): 15 mg once a day

Liver Dose Adjustments

Mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment: No adjustment recommended.
Severe (Child-Pugh C) hepatic impairment: Not recommended.

Dose Adjustments

Patients receiving strong CYP450 3A4 inhibitors:

• Recommended dosage: 15 mg once a day

Infections:

• Interrupt treatment in severe infections, including serious opportunistic infections, until infection is treated and controlled.

Recommended Dose Interruptions for Laboratory Abnormalities:

• Absolute Neutrophil Count (ANC): Interrupt therapy if ANC is less than 1000 cells/mm3; restart when ANC is above 1000 cells/mm3.
• Absolute Lymphocyte Count (ALC): Interrupt therapy if ALC is less than 500 cells/mm3; restart when ANC is above 500 cells/mm3.
• Hemoglobin (Hb): Interrupt therapy if Hb is less than 8 g/dL; restart when Hb is above 8 g/dL.
• Hepatic transaminases: Interrupt therapy if drug-induced liver injury is suspected.

Precautions

US FDA requires a medication guide to assure safe use. For additional information: www.fda.gov/drugs/drug-safety-and-availability/medication-guides

US BOXED WARNINGS:
SERIOUS INFECTIONS:

• Patients treated with this drug are at increased risk of serious infections that may lead to hospitalization or death.
• Most patients that developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
• If a serious infection develops, interrupt therapy until the infection is controlled.
• Infections include:
• Active tuberculosis (TB) which may present with pulmonary or extrapulmonary disease. Test for latent TB before initiating and during therapy. Treatment for latent infection should be considered prior to initiating therapy.
• Invasive fungal infections (e.g., cryptococcosis, pneumocystosis)
• Bacterial, viral (e.g., herpes zoster), and other infections due to opportunistic pathogens.
• The risks and benefits of therapy should be considered prior to initiating therapy in patients with chronic or recurrent infection.
• Patients should be closely monitored for infection during and after completing therapy, including TB in patients who tested negative for latent TB prior to initiating therapy.

MORTALITY

• Higher rate of all-cause mortality, including sudden cardiovascular death was reported with another Janus kinase (JAK) inhibitor vs. tumor necrosis factor (TNF) blockers in RA patients.

MALIGNANCIES:

• Higher rates of lymphoma and other malignancies (lung cancers) have been reported with another JAK inhibitors vs. TNF blockers in RA patients.

THROMBOSIS:

• Thrombosis (e.g., deep venous thrombosis), pulmonary embolism, and arterial thrombosis has occurred in patients treated with JAK inhibitors used to treat inflammatory conditions vs other TNF blockers.
• Many adverse events were serious and fatal.
• Consider risk versus benefit prior to treating patients who may be at increased risk.
• Evaluate and treat patients with symptoms of thrombosis.

CONTRAINDICATIONS:

• Known hypersensibility to the active ingredient or any of the excipients

Safety and efficacy have not been established in patients younger than 18 years for juvenile idiopathic arthritis and psoriatic arthritis.
Safety and efficacy have not been established in patients younger than 12 years for atopic dermatitis.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Prior to treatment initiation:

• Consider evaluating for:
• Active and latent TB: If positive, treat prior to initiating treatment with this drug.
• Viral hepatitis: This drug is not recommended in patients with active hepatitis B or C.
• Complete blood count: Treatment initiation is not recommended in patients with an absolute lymphocyte count less than 500 cells/mm3, absolute neutrophil count less than 1000 cells/mm3, or hemoglobin level less than 8 g/dL.
• Baseline hepatic function: This drug is not recommended in patients with severe hepatic dysfunction.
• Pregnancy status: Verify the pregnancy status of females of reproductive potential prior to starting treatment. This drug is not recommended during pregnancy.
• Update immunizations according to immunization clinical guidelines.

Administration advice:

• This drug may be taken with or without food.
• Tablets should be swallowed whole, not split, crushed, or chewed.
• Therapy should be interrupted if a patient develops a serious infection until the infection is controlled.

Storage requirements:

• Store at 2C to 25C (36F to 77F).
• Store in the original bottle to protect from moisture.

General

• Limit exposure to sunlight and UV light, wearing protective clothing and using a broad-spectrum sunscreen.

Monitoring:

• Hematologic parameters (ANC, ALC, Hb levels)
• Development of signs and symptoms of TB, including in patients that tested negative prior to treatment initiation
• Lipids and cholesterol
• Liver enzymes, and reactivation of viral hepatitis
• Periodically perform skin examination in patients at risk of skin cancer.

Patient advice:

• Read the Patient Information and Instructions for Use.

Frequently asked questions

• What are the most common skin conditions? (with photos)
• What are the new drugs for the treatment of rheumatoid arthritis (RA)?