Cibinqo

Cibinqo

abrocitinib

Manufacturer:

Pfizer Manufacturing Deutschland

Distributor:

Pfizer
Concise Prescribing Info
Contents
Abrocitinib
Indications/Uses
Patients ≥12 yr w/ moderate to severe atopic dermatitis, including the relief of pruritus, who have an inadequate response to prescribed topical therapy or for whom these treatments are not advisable.
Dosage/Direction for Use
Recommended dose: 100 or 200 mg once daily. Max 200 mg daily. Patients w/ moderate renal impairment (eGFR 30-<60 mL/min) 100 mg or 50 mg once daily. Patients w/ severe renal impairment (eGFR <30 mL/min) 50 mg once daily, max: 100 mg daily. Elderly ≥65 yr 100 mg once daily.
Administration
May be taken with or without food: Take at approx same time each day. Swallow whole, do not crush/split/chew.
Contraindications
Active serious systemic infections including TB. Severe hepatic impairment. Pregnancy & breast-feeding.
Special Precautions
Patients w/ chronic or recurrent infection; who have been exposed to TB; w/ history of serious or opportunistic infection; resided or travelled in areas of endemic TB or endemic mycoses or w/ underlying conditions that may predispose to infection. Patients should be screened for TB before starting therapy & consider yrly TB screening in highly endemic areas. Viral reactivation including herpes virus (eg, herpes zoster/simplex). Avoid use of live, attenuated vaccines during or immediately prior to treatment. DVT & pulmonary embolism. Malignancies including non-melanoma skin cancer. Hematological abnormalities.CV risk factors including hyperlipidemia. Monitor CBC including platelet count, ALC, ANC & Hb, lipid parameters before initiation of treatment. Patients who experience dizziness after therapy should refrain from driving or using machines until dizziness resolves. Women of childbearing potential. Pregnancy & lactation. Childn ≥12 yr.
Adverse Reactions
Herpes simplex/zoster, pneumonia; thrombocytopenia, lymphopenia; hyperlipidemia; headache, dizziness; thrombotic events including pulmonary embolism; nausea, vomiting, upper abdominal pain; acne; increased blood creatinine phosphokinase.
Drug Interactions
Increased exposure w/ fluvoxamine or fluconazole. Reduced exposure w/ rifampin. Increased AUCinf & Cmax of dabigatran etexilate.
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.
Presentation/Packing
Form
Cibinqo FC tab 100 mg
Packing/Price
14's
Form
Cibinqo FC tab 200 mg
Packing/Price
14's
Form
Cibinqo FC tab 50 mg
Packing/Price
14's
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