Cibinqo

Moderate-to-severe atopic dermatitis in adults & adolescents ≥12 yr who are candidates for systemic therapy.

Patient at higher risk of VTE, major adverse CV event (MACE) & malignancy Initially 100 mg once daily. May be increased to 200 mg once daily if patient does not respond adequately to 100 mg once daily. Patient who is not at higher risk of VTE, MACE & malignancy w/ high disease burden or inadequate response to 100 mg once daily 200 mg once daily, decreased to 100 mg once daily upon disease control. Re-treatment 200 mg once daily if disease control is not maintained after dose reduction. Adolescent 12-17 yr weighing ≥59 kg Initially 100 mg or 200 mg once daily, 25 to <59 kg Initially 100 mg once daily. May be increased to 200 mg once daily if patient does not respond adequately to 100 mg once daily. Patient receiving acid reducing agents (eg, antacids, PPIs, H₂ receptor antagonists) 200 mg once daily. Concomitant use w/ dual strong CYP2C19 & moderate CYP2C9 inhibitors, or strong CYP2C19 inhibitors alone (eg, fluvoxamine, fluconazole, fluoxetine & ticlopidine); moderate renal impairment [estimated GFR (eGFR) 30 to <60 mL/min] Reduce dose by ½ to 100 mg or 50 mg once daily. Severe renal impairment (eGFR <30 mL/min) Initially 50 mg once daily. Max daily dose: 100 mg. Elderly ≥65 yr 100 mg once daily.

May be taken with or without food: Swallow whole, do not split/crush/chew. Take at approx the same time each day. Take tab w/ food in patients who experience nausea.

Hypersensitivity. Active serious systemic infections including TB. Severe (Child Pugh C) hepatic impairment. Pregnancy & lactation.

Discontinue treatment in patients w/ suspected VTE, regardless of dose; if platelet counts are <50 x 10³/mm³. Interrupt treatment if absolute lymphocyte count (ALC) is <0.5 x 10³/mm³, ANC is <1 x 10^3/mm³, or Hb is <8 g/dL; temporarily if patient is not responding to standard therapy; develops herpes zoster. Consider dose interruption if patient develops serious infection, sepsis or opportunistic infection. Not to be initiated in patients w/ active, serious systemic infection; platelet count <150 x 10³/mm³, ALC <0.5 x 10³/mm³, ANC <1.2 x 10³/mm³ or Hb <10 g/dL. Not to be given in patients w/ active TB. Serious infections eg, herpes simplex, herpes zoster & pneumonia; viral reactivation, including herpes virus reactivation; DVT & pulmonary embolism; lymphoma & other malignancies; non-melanoma skin cancer; MACE; dose-dependent increase in blood lipid parameters. Monitor patients w/ abnormal lipid parameters. Patients w/ history of atherosclerotic CV disease or other CV risk factors (eg, current or past long-time smokers); malignancy risk factors (eg, current or history of malignancy); diabetes (higher incidence of infections); medical history of herpes zoster, confirmed ALC <1 x 10³/mm³ prior to treatment, severe atopic dermatitis at baseline; known VTE risk factors other than malignancy & CV risk factors eg, previous VTE, major surgery, immobilisation, use of combined hormonal contraceptives or HRT, inherited coagulation disorder. Consider risks & benefits of treatment prior to initiation in patients w/ chronic or recurrent infection, history of serious or opportunistic infection, underlying conditions that may predispose to infection; who have been exposed to TB, resided or travelled in areas of endemic TB or endemic mycoses. Closely monitor patients for development of signs & symptoms of infection during & after treatment. Screen patients for TB before starting treatment & yrly if in highly endemic areas for TB. Prompt & complete diagnostic testing & initiate appropriate antimicrobial therapy in patient who develops new infection during treatment. Start preventive therapy for latent TB prior to treatment initiation in patients w/ new diagnosis of latent TB or prior untreated latent TB. Perform screening for viral hepatitis before & during therapy; periodic skin exam for all patients particularly those at increased risk for skin cancer. Evaluate patients w/ signs & symptoms of VTE & re-evaluate periodically to assess for changes in VTE risk. Monitor CBC 4 wk after therapy initiation & thereafter according to routine patient management. Assess lipid parameters approx 4 wk following therapy initiation & thereafter according to CV disease risk. Update all immunizations including prophylactic herpes zoster vaccinations prior to treatment initiation. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose galactose malabsorption. Avoid use of live, attenuated vaccines during or immediately prior to treatment. Not recommended to use concomitantly w/ biologic immunomodulators, potent immunosuppressants eg, ciclosporin or other Janus kinase inhibitors; moderate or strong CYP2C19/CYP2C9 enzyme inducers eg, rifampicin, apalutamide, efavirenz, enzalutamide, phenytoin. ESRD patients on renal replacement therapy. Women of childbearing potential should use effective contraception during treatment & 1 mth after final dose. Childn <12 yr. Elderly ≥65 yr.

Nausea. Herpes simplex, herpes zoster; headache, dizziness; vomiting, upper abdominal pain; acne; increased creatine phosphokinase >5× ULN.

Increased active moiety exposure w/ fluvoxamine or fluconazole. Decreased active moiety exposure w/ rifampicin; famotidine. Reduced efficacy w/ products increasing gastric pH. Increased AUC_inf & C_max of dabigatran; omeprazole. May increase digoxin levels. Increased AUC_inf of caffeine. Concomitant use w/ narrow therapeutic index medicines that are primarily metabolised by CYP2C19 enzyme (eg, S-mephenytoin & clopidogrel); other medicines primarily metabolized by CYP2C19 enzyme (eg, citalopram, clobazam, escitalopram & selumetinib).

Other Dermatologicals

D11AH08 - abrocitinib ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.

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