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Cibinqo

Cibinqo Adverse Reactions

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Full Prescribing Info
Adverse Reactions
Summary of safety profile: The most commonly reported adverse reactions occurring in ≥2% of patients treated with CIBINQO 200 mg in placebo-controlled studies are nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), dizziness (3.4%), and abdominal pain upper (2.2%). The most frequent serious adverse reactions are infections (0.3%) (see Precautions).
Tabulated list of adverse reactions: A total of 3,128 patients were treated with CIBINQO in clinical studies in atopic dermatitis representing 2,089 patient-years of exposure. There were 994 patients with at least 48 weeks of exposure. Five placebo-controlled studies were integrated (703 patients on 100 mg once daily, 684 patients on 200 mg once daily and 438 patients on placebo) to evaluate the safety of CIBINQO in comparison to placebo for up to 16 weeks.
Listed in Table 4 are adverse reactions observed in atopic dermatitis clinical studies presented by system organ class and frequency, using the following categories: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. (See Table 4.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Infections: In placebo-controlled studies, for up to 16 weeks, infections have been reported in 27.4% of patients treated with placebo and in 34.9% and 34.8% of patients treated with CIBINQO 100 mg and 200 mg, respectively. Most infections were mild or moderate. The percentage of patients reporting infection-related adverse drug reactions in the 200 mg and 100 mg groups compared to placebo were: herpes simplex (4.2% and 2.8% vs 1.4%), herpes zoster (1.2% and 0.6% vs 0%), pneumonia (0.1% and 0.1% vs 0%). Herpes simplex was more frequent in patients with a history of herpes simplex or eczema herpeticum. Most of the herpes zoster events involved a single dermatome and were non-serious. All the opportunistic infections were cases of multidermatomal cutaneous herpes zoster (0.6%), most of which were non-serious. The incidence rate of herpes zoster in patients 65 years of age and older (7.40 per 100 patient-years) was higher than that of patients 18 to less than 65 years of age (3.44 per 100 patient-years) and less than 18 years of age (2.12 per 100 patient-years). The incidence rate of herpes zoster in patients with severe atopic dermatitis at baseline (4.93 per 100 patient-years) was higher than that of patients with moderate atopic dermatitis at baseline (2.49 per 100 patient-years) (see Precautions).
In placebo-controlled studies, for up to 16 weeks, the rate of serious infections was 1.81 per 100 patient-years in patients treated with placebo, 3.32 per 100 patient-years in patients treated with CIBINQO 100 mg, and 1.12 per 100 patient-years in patients treated with CIBINQO 200 mg. Among all patients treated with CIBINQO, including the long-term extension study, the rate of serious infections was 2.65 per 100 patient-years in patients treated with CIBINQO 100 mg and 2.33 per 100 patient-years in patients treated with CIBINQO 200 mg. The most commonly reported serious infections were herpes simplex, herpes zoster, and pneumonia (see Precautions).
Venous thrombotic events including pulmonary embolism: Among all patients treated with CIBINQO, including the long-term extension study, the rate of PE was 0.23 per 100 patient-years for 200 mg and 0 for per 100 patient-years for 100 mg. The rate of DVT was 0.23 per 100 patient-years in the 200 mg group and 0 per 100 patient-years in the 100 mg group (see Precautions).
Thrombocytopenia: In placebo-controlled studies, for up to 16 weeks, treatment was associated with a dose-related decrease in platelet count. Maximum effects on platelets were observed within 4 weeks, after which the platelet count returned towards baseline despite continued therapy. Confirmed platelet counts of <50 × 103/mm3 were reported in 0.1% of patients exposed to 200 mg, and in 0 patients treated with 100 mg or placebo. Among all patients exposed to CIBINQO, including the long-term extension study, confirmed platelet counts of <50 × 103/mm3 were reported in 0.1% of patients treated with 200 mg, occurring at Week 4. A higher proportion of patients 65 years of age and older developed a platelet count nadir <75 × 103/mm3 (see Precautions).
Lymphopenia: In placebo-controlled studies, for up to 16 weeks, confirmed ALC <0.5 × 103/mm3 occurred in 0.3% of patients treated with 200 mg and 0% of patients treated with 100 mg or placebo. Both cases occurred in the first 4 weeks of exposure. Among all patients exposed to CIBINQO, including the long-term extension, confirmed ALC <0.5 × 103/mm3 were reported in 0.3% of patients treated with 200 mg and 0.1% of patients treated with 100 mg, most of whom were 65 years of age and older (see Precautions).
Lipid elevations: In placebo-controlled studies, for up to 16 weeks, there was a dose-related increase in low-density lipoprotein cholesterol (LDL-c), total cholesterol, and high-density lipoprotein cholesterol (HDL-c) relative to placebo at Week 4 which remained elevated through the final visit in the treatment period. There was no meaningful change in the LDL/HDL ratio in patients treated with abrocitinib relative to patients treated with placebo. Events related to hyperlipidaemia occurred in 0.4% of patients exposed to 100 mg, 0.6% of patients exposed to 200 mg and 0% patients exposed to placebo (see Precautions).
Creatine phosphokinase elevations (CPK): In placebo-controlled studies, for up to 16 weeks, significant increases in CPK values (>5 × ULN) occurred in 1.8% of patients treated with placebo, 1.8% of patients treated with 100 mg and 3.8% of patients treated with 200 mg of CIBINQO, respectively. Most elevations were transient, and none led to discontinuation. In the clinical studies, there were no reported events of rhabdomyolysis.
Nausea: In placebo-controlled studies, for up to 16 weeks, nausea was reported in 1.8% of patients treated with placebo and in 6.3% and 15.1% of patients treated with 100 mg and 200 mg, respectively. Discontinuation due to nausea occurred in 0.4% of patients treated with CIBINQO. Among patients with nausea, 63.5% of patients had onset of nausea in the first week of therapy. The median duration of nausea was 15 days. Most of the cases were mild to moderate in severity.
Psychiatric disorders: Patients who showed suicidal ideation(s)/behaviour(s) in relevant preliminary investigations were excluded from the clinical trials.
Adolescent population: A total of 635 adolescents (12 to less than 18 years of age) were enrolled in CIBINQO atopic dermatitis studies. The safety profile observed in adolescents in atopic dermatitis clinical studies was similar to that of the adult population (see Dosage & Administration).
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions.
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