Indications for: CIBINQO
In adults with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable.
Limitations of Use:
Not recommended in combination with other JAK inhibitors, biologic immunomodulators, or with other immunosuppressants.
Swallow whole. 100mg once daily; if inadequate response after 12 weeks, consider increasing to max 200mg once daily. May be used with or without topical corticosteroids. Poor CYP2C19 metabolizers, moderate renal impairment (eGFR 30–59mL/min), or concomitant strong CYP2C19 inhibitors: 50mg once daily; if inadequate response after 12 weeks, consider increasing to max 100mg once daily.
Antiplatelet therapies, except for low-dose aspirin (≤81mg daily), during the first 3 months of treatment.
Serious infections. Mortality. Malignancy. Major adverse cardiovascular events (MACE). Thrombosis.
Increased risk of serious infections (eg, TB, bacterial, viral, invasive fungal, or other opportunistic pathogens). Avoid in active, serious, or localized infections. Consider the risks/benefits in chronic, recurrent, or history of serious or opportunistic infections. Travel to, or residence in, areas with endemic TB or mycoses. Conditions that predispose to infection. Test/treat latent TB infection prior to and per applicable guidelines during therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of herpes virus or hepatitis occurs; interrupt treatment if serious or opportunistic infection. Screen for viral hepatitis before starting therapy. RA patients age ≥50yrs with ≥1 CV risk factor treated with another JAK inhibitor: increased rate of all-cause mortality (including sudden CV death), MACE (CV death, MI, stroke), or thrombosis. Discontinue in those with previous MI or stroke, or with symptoms of thrombosis. Avoid in those with increased risk for thrombosis. Increased rate of malignancies (esp. lymphomas, lung cancers). Consider benefits/risks prior to or continuing therapy (esp. smokers, with other CV risk factors, or with a known malignancy). Perform periodic skin exam in those with skin cancer risk. Update immunizations based on current guidelines prior to initiation. Do not initiate therapy if platelets <150,000/mm3, lymphocytes <500/mm3, ANC <1000/mm3, or hemoglobin <8g/dL. Monitor CBCs at baseline, 4 weeks after initiation, and 4 weeks after dose increase. Monitor lipids 4 weeks following initiation and manage hyperlipidemia. Severe hepatic or renal impairment (eGFR 15–29mL/min), ESRD (eGFR <15mL/min): not recommended. CYP2C19 poor metabolizers. Elderly. Pregnancy. Nursing mothers: not recommended (during and for 1 day after the last dose).
Janus kinase (JAK) inhibitor.
See Contraindications. Increased risk of bleeding with antiplatelet drugs. Avoid concomitant live vaccines. Potentiated by strong CYP2C19 inhibitors: reduce dose (see Adult). Potentiated by moderate to strong inhibitors of both CYP2C19 and CYP3A4 inhibitors: avoid. Antagonized by strong CYP2C19 or CYP2C9 inducers: avoid. Potentiates P-gp substrates (eg, digoxin); monitor or titrate substrate dose appropriately.
Nasopharyngitis, nausea, headache, herpes simplex, increased blood creatinine phosphokinase, dizziness, UTI, fatigue, acne, vomiting, oropharyngeal pain, influenza, gastroenteritis, impetigo, hypertension, contact dermatitis, upper abdominal pain, abdominal discomfort, herpes zoster, thrombocytopenia; other serious or opportunistic infections, TB, malignancies, thrombosis, cytopenias, lipid elevations, non-melanoma skin cancer, retinal detachment.
Generic Drug Availability: