Advertisement
Advertisement
Cibinqo

Cibinqo

abrocitinib

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Abrocitinib
Indications/Uses
Moderate to severe atopic dermatitis including pruritus relief in patients ≥12 yr who have had inadequate response to prescribed topical therapy or for whom these treatments are inadvisable, can be used w/ or w/o medicated topical therapies.
Dosage/Direction for Use
100 or 200 mg once daily. Patient w/ risk factors for developing or less likely to tolerate ARs, elderly ≥65 yr Recommended starting dose: 100 mg once daily. Patient taking strong CYP450 2C19 inhibitors (eg, fluvoxamine, fluconazole), moderate renal impairment (eGFR 30 to <60 mL/min) Reduce dose to 50 or 100 mg. Severe renal impairment (eGFR <30 mL/min) Recommended starting dose: 50 mg once daily. Max: 100 mg daily.
Administration
May be taken with or without food: Take at approx same time each day. Swallow whole w/ water, do not crush/split/chew.
Special Precautions
Discontinue use if clinical features of DVT/pulmonary embolism (PE) occur. Not to be initiated in patients w/ platelet count <150 x 103/mm3, absolute lymphocyte count <0.5 x 103/mm3, ANC <1 x 103/mm3 or Hb value <8 g/dL; active TB. Viral reactivation including herpes virus eg, herpes zoster/simplex; malignancies including non-melanoma skin cancer. Patients w/ chronic or recurrent infection, exposed to TB, history of serious or opportunistic infection, resided or travelled in endemic TB &/or mycoses areas, underlying conditions predisposing to infection; high risk for DVT/PE eg, obesity, medical history of DVT/PE, prothrombic disorder, undergoing major surgery, prolonged immobilization; CV risk factors; immunosuppressive conditions. Screen for TB before therapy & yrly; viral hepatitis before & during therapy. Monitor for signs & symptoms of infection during & after treatment; CBC 4 wk after initiation & thereafter. Perform periodic skin exam in patients at risk for skin cancer. Assess lipid parameters approx 4 wk following initiation & thereafter. Avoid use of live attenuated vaccines. Not recommended in concomitant use w/ strong CYP inducers eg, rifampin; biologic immunomodulators, potent immunosuppressants eg, ciclosporin or other Janus kinase inhibitors. Concomitant use w/ combined hormonal contraceptives or HRT. May affect ability to drive & use machines. May reduce female fertility. Women of childbearing potential should use effective contraception during & for 1 mth after last dose. Not to be used during pregnancy & lactation. Ped <12 yr. Elderly ≥65 yr.
Adverse Reactions
Nausea. Herpes simplex/zoster; thrombocytopenia; headache, dizziness; vomiting, upper abdominal pain; acne; increased blood creatine phosphokinase.
Drug Interactions
Affected exposures w/ strong CYP2C19/CYP2C9 inhibitors/inducers or OAT3 transporter inhibitors. Increased exposure w/ fluvoxamine or fluconazole. Reduced exposure w/ rifampin. Increased AUCinf & Cmax of dabigatran. Increased levels of P-gp substrates w/ narrow therapeutic index eg, digoxin.
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;28's
Form
Cibinqo FC tab 200 mg
Packing/Price
14's;28's
Form
Cibinqo FC tab 50 mg
Packing/Price
14's;28's
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement
Advertisement