Zuellig Pharma
Concise Prescribing Info
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.
Dosage/Direction for Use
Recommended dose: 100 mg once daily. May be used w/ or w/o medicated topical therapies for atopic dermatitis. Patient needing rapid symptom relief Initial dose: 200 mg once daily for 12 wk. Maintenance dose: 100 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) 50 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.
Special Precautions
Discontinue if adequate therapeutic benefit is not achieved after 24 wk. Serious infections (eg, herpes simplex, herpes zoster & pneumonia). Not to be initiated in patients w/ active, serious systemic infection. Consider risks & benefits of treatment prior to initiating in patients w/ chronic or recurrent infection, history of a serious or an opportunistic infection, underlying conditions predisposing them to infection, exposed to TB, or have resided or 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/ a new diagnosis of or prior untreated latent TB. Viral reactivation. Consider temporary treatment interruption in patients who develops herpes zoster; discontinuation or interruption of therapy until resolution of eczema herpeticum. Perform viral hepatitis screening before starting & during therapy. Use of live, attenuated vaccines during or immediately prior to therapy is not recommended. Risk of DVT/pulmonary embolism (PE) in patients w/ older age, obesity, a medical history of DVT/PE, prothrombotic disorder, concomitantly using combined hormonal contraceptives or HRT & in those undergoing major surgery or prolonged immobilisation. Discontinue treatment & promptly evaluate patients if DVT/PE occurs. May increase risk of malignancies including lymphoma. Consider the risk & benefits of treatment prior to initiating in patients w/ a known malignancy other than a successfully treated non-melanoma skin cancer or cervical cancer in situ or when continuing therapy in patients who develop a malignancy. Periodic skin exam is recommended for patients who are at increased risk for skin cancer. Do not initiate 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 a Hb value <8 g/dL. Monitor platelet count & ALC 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 according to clinical guidelines due to the known CV risks associated w/ hyperlipidaemia. 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 <1 mmol Na (23 mg/tab). Possible dizziness during treatment; may affect ability to drive & use machines. Patients w/ ESRD on renal replacement therapy. Women of reproductive potential should use effective contraception during treatment & for 1 mth following the final dose. Not recommended for childn <12 yr. Elderly ≥65 yr.
Adverse Reactions
Nausea. Herpes simplex, herpes zoster; headache, dizziness; vomiting, upper abdominal pain; acne; increased creatine phosphokinase (>5 × ULN).
Drug Interactions
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 AUCinf & Cmax of dabigatran. Possible increased digoxin levels.
MIMS Class
Other Dermatologicals
ATC Classification
D11AH08 - abrocitinib ; Belongs to the class of agents for atopic dermatitis, excluding corticosteroids. Used in the treatment of atopic dermatitis.
Cibinqo FC tab 100 mg
4 × 7's
Cibinqo FC tab 200 mg
4 × 7's
Cibinqo FC tab 50 mg
4 × 7's
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