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CIBINQO is a brand name for Abrocitinib, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
). If a patient develops herpes zoster, temporary interruption of treatment may be considered until the episode resolves. Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy and during therapy with CIBINQO.
Patients with evidence of active hepatitis B or hepatitis C (positive hepatitis C PCR) infection were excluded from clinical studies. Patients who were hepatitis B surface antigen negative, hepatitis B core antibody positive, and hepatitis B surface antibody positive had testing for hepatitis B virus (HBV) DNA.
Patients who had HBV DNA above the lower limit of quantification (LLQ) were excluded. Patients who had HBV DNA negative or below LLQ could initiate CIBINQO (abrocitinib) Page 13 of 45 Unclassified / Non classifié treatment with CIBINQO; such patients had HBV DNA monitored.
If HBV DNA is detected, a liver specialist should be consulted. Monitoring and Laboratory Tests Table 3. Laboratory monitoring guidance Laboratory measure Monitoring guidance Action Complete blood count including Platelet Count, Absolute Lymphocyte Count (ALC), Absolute Neutrophil Count (ANC), and Hemoglobin (Hb) Before treatment initiation, 4 weeks after initiation and thereafter according to routine patient management.
Platelets:
Treatment should be discontinued if platelet counts are < 50 × 103/mm3. 5 × 103/mm3 and may be restarted once ALC returns above this value. Treatment should be discontinued if confirmed.
ANC:
Treatment should be interrupted if ANC is < 1 × 103/mm3 and may be restarted once ANC returns above this value. Hb: Treatment should be interrupted if Hb < 8 g/dL and may be restarted once Hb returns above this value. Lipid parameters Before treatment initiation, 4 weeks after initiation and thereafter according to clinical guidelines for hyperlipidemia.
Patients should be monitored according to clinical guidelines for hyperlipidemia. Reproductive Health • Fertility Based on findings in rats, oral administration of CIBINQO may impair female fertility. Impaired fertility in female rats was reversible 1 month after cessation of abrocitinib oral administration (see 16 Non-Clinical Toxicology, Reproductive and developmental toxicity).
1. 1.
Pregnancy Women of childbearing potential:
Women of reproductive potential should be advised to use effective contraception during treatment with CIBINQO and for at least 1 month after the last dose. Consider pregnancy planning and prevention for females of reproductive potential.
CIBINQO (abrocitinib) Page 14 of 45 Unclassified / Non classifié Pregnancy:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The limited human data on use of CIBINQO in pregnant women are not sufficient to evaluate a drug- associated risk for major birth defects or miscarriage. In animal embryo-fetal development studies, oral administration of CIBINQO to pregnant rats during organogenesis resulted in fetotoxicity at exposures equal to approximately 17 times the unbound human AUC at the maximum recommended clinical dose of 200 mg once daily.
No fetal malformations were observed. CIBINQO increased the incidence of skeletal variations at equal to or greater than 11 times the unbound human AUC at the maximum recommended clinical dose of 200 mg once daily (see 16 Non-Clinical Toxicology, Reproductive and developmental toxicity).
In a pre- and postnatal development study in pregnant rats, CIBINQO oral administration during gestation and through lactation resulted in lower postnatal survival, lower offspring body weights and/or dystocia with prolonged parturition at exposures equal to or greater than approximately 11 times the unbound human AUC at the maximum recommended clinical dose of 200 mg once daily (see 16 Non-Clinical Toxicology, Reproductive and developmental toxicity).
CIBINQO should not be used during pregnancy unless clearly necessary. 2. Breastfeeding There are no data on the presence of CIBINQO in human milk, the effects on the breast-fed infant, or the effects on milk production. CIBINQO was secreted in milk of lactating rats.
Women should not breast-feed while treated with CIBINQO. A risk to newborns and infants cannot be excluded and CIBINQO should not be used during breast-feeding. 3.
Pediatrics Pediatrics (12-17 years of age):
Based on the data submitted and reviewed by Health Canada, the safety and efficacy of CIBINQO in pediatric patients 12-17 years of age has been established for treatment of moderate to severe atopic dermatitis. Of the 3848 patients with atopic dermatitis exposed to CIBINQO, a total of 635 adolescents (12 to less than 18 years of age) were enrolled in CIBINQO studies.
The safety profile observed in adolescents in atopic dermatitis clinical studies was similar to that of the adult population. 5 × 103/mm3.
Pediatrics under 12 years of age:
The safety and efficacy of CIBINQO in pediatric patients under 12 years of age have not yet been established. Therefore, Health Canada has not authorized an indication for pediatric use in pediatric patients under 12 years of age. 4.
Geriatrics A total of 176 patients 65 years of age and older were treated with abrocitinib in clinical studies in atopic dermatitis. The safety profile observed in elderly patients was generally similar to that of the adult population overall with the following exceptions: a higher proportion of patients 65 years of age and older discontinued from clinical studies and were more likely to have serious adverse events compared to younger patients.
5 × 103/mm3 occurred only in patients 65 years of age and older. A higher proportion of patients 65 years of age and older had platelet counts <75 × 103/mm3. The incidence rate of herpes zoster in […]