Usual Adult Dose for Atopic Dermatitis

100 mg orally once a day

• Maximum dose: 200 mg/day

Duration of therapy: If no adequate response is achieved with 100 mg/day after 12 weeks, the dose can be increased to 200 mg/day. Discontinue if inadequate response is seen after this dosage increase.

Comments:

• This drug should not be used in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, or immunosuppressants.
• This drug can be used with or without topical corticosteroids.

Use: Refractory moderate to severe atopic dermatitis in patients, whose condition has not been adequately controlled with other systemic drug products.

Usual Pediatric Dose for Atopic Dermatitis

100 mg orally once a day

• Maximum dose: 200 mg/day

Duration of therapy: If no adequate response is achieved with 100 mg/day after 12 weeks, the dose can be increased to 200 mg/day. Discontinue if inadequate response is seen after this dosage increase.

Comments:

• This drug should not be used in combination with other Janus kinase (JAK) inhibitors, biologic immunomodulators, or immunosuppressants.
• This drug can be used with or without topical corticosteroids.

Use: Refractory moderate to severe atopic dermatitis in pediatric patients 12 years of age and older, whose condition has not been adequately controlled with other systemic drug products.

Renal Dose Adjustments

• Mild renal dysfunction (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min): 100 mg once per day
• Moderate renal dysfunction (eGFR 30 to 59 mL/min): 50 mg once per day
• Severe renal dysfunction (eGFR 15 to 29 mL/min): Not recommended
• End-stage renal disease (including patients in renal replacement therapy): Not recommended

Comments:

• Patients with mild and moderate renal dysfunction: If no adequate response is achieved after 12 weeks, the dose can be doubled.

Liver Dose Adjustments

Mild and Moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction: Not recommended

Dose Adjustments

CYP450 2C19 Poor Metabolizers: 50 mg orally once a day

• If an adequate response is not achieved after 12 weeks, the dosage can be increased to 100 mg/day.
• Discontinue treatment if an adequate response is not obtained after dosage increase.

Patients taking strong CYP450 2C19 inhibitors: 50 mg once per day

• If an adequate response is not achieved after 12 weeks, the dosage can be increased to 100 mg/day.
• Discontinue treatment if an adequate response is not obtained after dosage increase.

Development of Serious or Opportunistic Infections:

• Treatment should be discontinued until the infection is controlled.
• Risks and benefits should be carefully considered before restarting treatment with this drug.

Hematologic Abnormalities:

• Discontinue treatment with this drug if:
• Platelet count falls lower than 50,000/mm3: Discontinue and monitor until platelet count is greater than 100,000/mm3.
• Absolute lymphocyte count (ALC) less than 500/mm3: Temporarily discontinue until ALC return above this value.
• Absolute neutrophil count (ANC) less than 1000/mm3: Temporarily discontinue until ANC return above this value.
• Hemoglobin (Hb) less than 8 g/dL: Temporarily discontinue until Hb levels return above this value.
• Complete blood counts (CBC) are recommended at baseline, 4 weeks after treatment initiation, and 4 weeks after any dosing increase.
• CBC evaluations may be extended for any patients receiving chronic therapy with this drug who develop hematologic abnormalities.

Precautions

US BOXED WARNINGS:
SERIOUS INFECTION:

• Patients treated with this drug may be at increased risk of serious bacterial, fungal, viral and opportunistic infections leading to hospitalization or death.
• The most commonly reported serious infections included herpes simplex, herpes zoster, and pneumonia.

Recommendations:

• Treatment should be discontinued if serious or opportunistic infection occur.
• Patients should be tested for latent tuberculosis (TB) before and during treatment; patients with latent TB should be treated prior to use.
• All patients should be monitored for active TB during treatment, even those with initial negative latent TB test.
• Use of this drug should be avoided in patients with active, serious infections including localized infections; the risks and benefits of treatment should be carefully considered prior to initiating treatment in patients with chronic/recurrent infections.

MORTALITY:

• Higher rate of all-cause mortality, including sudden cardiovascular death has been reported in patients receiving other JAK inhibitors vs TNF blockers in Rheumatoid Arthritis (RA). This drug is not approved for use in RA patients.

MALIGNANCIES:

• Malignancies have been reported with this drug. Higher rates of lymphomas and lung cancers have occurred with other JAK inhibitors in patients with RA.

MAJOR ADVERSE CARDIOVASCULAR EVENTS (MACE)

• MACE has been reported with this drug. Higher rates of MACE (defined as cardiovascular death, myocardial infarction, and stroke) have occurred with other JAK inhibitors in patients with RA.

Recommendation:

• Treatment should be discontinued in patients who have experienced a myocardial infarction or stroke.

THROMBOSIS:

• Deep venous thrombosis (DVT) and pulmonary embolism (PE) have occurred with this drug.
• Increased incidence of DVT, PE, and arterial thrombosis have occurred with other JAK inhibitors in patients with RA, many of which were serious, and some resulted in death.
• A higher rate of thrombosis occurred in RA patients 50 years of age and older with at least one cardiovascular disease risk factor treated with another JAK inhibitor compared with patients treated with TNF blockers.

Recommendations:

• Use should be avoided in patients at risk of thrombosis.
• If symptoms of thrombosis occur, treatment should be discontinued and patients should be treated appropriately.

CONTRAINDICATIONS:

• In patients taking antiplatelet therapies, except for low-dose aspirin (up to 81 mg per day), during the first 3 months of treatment.

Safety and efficacy have not been established in patients younger than 12 years.

Consult WARNINGS section for additional precautions.

Dialysis

Not recommended

Other Comments

Administration advice:

• Prior to treatment perform the following tests:
• TB infection evaluation: Treatment is not recommended in patients with active TB. Start preventive TB therapy before starting treatment with this drug, on those patients with latent TB or those with negative latent TB test who are at high risk for TB.
• Viral hepatitis screening: Treatment initiation is not recommended in patients with active HBV or HCV.
• CBC: Treatment initiation is not recommended in patients with platelet count less than 150,000/mm3, ALC less than 500/mm3, ANC less than 1000/mm3, or Hb value less than 8 g/dL.
• Complete any necessary immunizations, including herpes zoster vaccinations, in agreement with immunization guidelines, before starting treatment with this drug.
• Administer orally with or without food at approximately the same time each day.
• Swallow tablets whole with water. Do not crush, split, or chew tablets.
• If a dose is missed, administer as soon as possible unless it is less than 12 hours before the next dose, in which case skip the missed dose. Resume treatment dosing at the regular scheduled time.

Limitations of use: This drug is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.

Storage requirements:

• Store in original package and child resistant container at room temperature between 68F to 77F (20C to 25C), with excursions permitted between 59F and 86F (15C to 30C).

Monitoring:

• Laboratory monitoring is recommended due to potential hematological (changes in platelet levels, lymphocytes), and lipid abnormalities.
• CBC evaluations are recommended at baseline, 4 weeks after treatment initiation, and 4 weeks after dose increase.
• Closely monitor patients that develop hematological abnormalities.

Patient advice:

• It is advised to read the US FDA-approved patient labeling (Medication Guide).
• It is advised to report any pregnancy to 1-877-311-3770.
• Contact your health care provider if you have any symptoms or signs of infection (fever, chills, cough, muscle aches, diarrhea). This drug may increase your risk to develop herpes zoster (shingles).
• This drug may increase the risk for certain cancers, including skin cancers. It is advised to have regular skin examinations, limit exposure to sunlight and UV light, wear protective clothing and using broad-spectrum sunscreen.
• This drug may increase your risk of cardiovascular events. Contact your health care provider immediately if any cardiovascular signs or symptoms develop (discomfort, pain or pressure in your chest, lightheadedness, shortness of breath, nausea/vomiting, slurred speech) especially if you are a current or past smoker or have other risk factors.
• This drug may increase your risk of thrombotic events. Contact your health care provider immediately if any signs or symptoms of pulmonary embolism (sudden shortness of breath, unexplained pain in your upper back or chest) or deep venous thrombosis (swelling, pain, and tenderness in one or both legs).
• Live vaccinations are not recommended while on treatment. Avoid vaccinations prior, during, and immediately after treatment with this drug.
• Retinal detachment has been reported in patients using this drug. Contact your health care provider if you develop any sudden changes in your vision.
• This drug may temporarily impair fertility in women.
• Breast-feeding is not recommended during treatment with this drug.

Frequently asked questions

• What are the most common skin conditions? (with photos)