Cibinqo

Abrocitinib

Moderate to severe atopic dermatitis in adults ≥18 yr who are candidates for systemic therapy & whose disease is not adequately controlled w/ topical medications or for whom topical treatments are otherwise medically inadvisable.

Recommended starting dose: 100 mg or 200 mg once daily. May be used w/ or w/o medicated topical therapies for atopic dermatitis. Patient at higher risk of VTE, major adverse CV event (MACE) & malignancy Recommended starting dose: 100 mg once daily. Dose can be increased to 200 mg once daily. Patient receiving strong CYP450 2C19 inhibitors (eg, fluvoxamine, fluconazole, fluoxetine & ticlopidine) Reduce dose by ½ to 100 mg or 50 mg once daily. Renal impairment: Moderate (eGFR 30 to <60 mL/min) Reduce dose by ½ to 100 mg or 50 mg once daily, severe (eGFR <30 mL/min) Recommended starting dose: 50 mg once daily. Max daily dose: 100 mg. Elderly ≥65 yr Recommended starting dose: 100 mg once daily.

May be taken with or without food: Swallow whole w/ water, do not crush/split/chew. Take at approx the same time each day.

Hypersensitivity. Active serious systemic infections including TB. Severe hepatic impairment. Pregnancy & lactation.

Consider discontinuation if adequate therapeutic benefit is not achieved after 24 wk. Possible serious infections (eg, herpes simplex, herpes zoster & pneumonia). Not to be initiated in patients w/ active, serious systemic infection. Carefully consider risks & benefits of treatment in patients w/ chronic or recurrent infection, history of serious or opportunistic infection, underlying conditions predisposing them to infection, exposed to TB, or have resided/traveled in areas of endemic TB or mycoses. Closely monitor for signs & symptoms of infection during & after treatment. Perform prompt & complete diagnostic testing & initiate appropriate antimicrobial therapy in patient who develops new infection during treatment. Screen for TB before starting therapy & consider yrly screening for patients in highly endemic areas for TB; not to be given to patients w/ active TB. Start preventive therapy for latent TB prior to treatment initiation in patients w/ new diagnosis of or prior untreated latent TB. Viral reactivation including herpes virus reactivation (eg, herpes zoster, herpes simplex). Consider temporary treatment interruption in patient who develops herpes zoster; discontinue or interrupt therapy until resolution of eczema herpeticum. Perform viral hepatitis screening before starting & during therapy. Avoid use of live, attenuated vaccines during or immediately prior to treatment. Consider benefits & risks prior to initiating or continuing therapy. Potential MACE. Patients who are long-term current or long-term past smokers & w/ history of ASCVD or other CV risk factors. Risk of DVT/pulmonary embolism (PE) in patients w/ age ≥65 yr, long-term smoking, current malignancy [excluding non-melanoma skin cancer (NMSC)], medical history of DVT/PE, prothrombotic disorder, use of combined hormonal contraceptives or HRT & those undergoing major surgery or prolonged immobilisation. Re-evaluate patients periodically during treatment to assess for changes in VTE risk. Discontinue use in patients w/ suspected VTE. Possible lymphoma & other malignancies. NMSC; periodic skin exam is recommended for all patients particularly those who are at increased risk for skin cancer. Do not initiate treatment in patients w/ platelet count <150 × 10³/mm³ (discontinue if platelet count <50 × 10³/mm³), ALC <0.5 × 10³/mm³, ANC <1 × 10³/mm³ or those who have Hb value <8 g/dL. 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 their CV disease risk. Monitor & manage patients w/ abnormal lipid parameters. Not recommended in concomitant use w/ moderate or strong CYP2C19/CYP2C9 enzyme inducers (eg, rifampin, apalutamide, efavirenz, enzalutamide, phenytoin). Do not use in patients w/ rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Contains Na <1 mmol. Possible dizziness during treatment; refrain from driving or using machines until dizziness resolves. Patients w/ ESRD on renal replacement therapy. Advise women of reproductive potential to use effective contraception during treatment & for 1 mth following the final dose. Not recommended for childn <12 yr. Consider increased risk of MACE, malignancies, serious infections & all-cause mortality in patients ≥65 yr. Elderly ≥75 yr.

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

Exposure may be affected by strong CYP2C19/CYP2C9 inhibitors/inducers or OAT3 transporter inhibitors. Increased exposure w/ fluvoxamine or fluconazole. Reduced exposure w/ rifampin. Absorption may be reduced by H₂-receptor antagonists (eg, famotidine) or PPIs (eg, omeprazole). Increased AUC_inf & C_max of dabigatran; omeprazole. May increase levels of P-gp substrates w/ narrow therapeutic index (eg, digoxin). Concomitant use w/ narrow therapeutic index medicines that are primarily metabolized by CYP2C19 enzyme (eg, S-mephenytoin, clopidogrel).

Other Dermatologicals

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

POM