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Cibinqo is a brand name for Abrocitinib. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Cibinqo is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy.
Verbatim from this product's EMA label. Tap a section to expand.
Treatment should be initiated and supervised by a healthcare professional experienced in the diagnosis and treatment of atopic dermatitis. 4). If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily.
• A dose of 200 mg once daily may be appropriate for patients who are not at higher risk of VTE, MACE and malignancy with high disease burden or for patients with an inadequate response to 100 mg once daily. Upon disease control, dose should be decreased to 100 mg once daily.
If disease control is not maintained after dose reduction, re-treatment with 200 mg once daily can be considered. In adolescents (12 years to 17 years of age), weighing 25 kg to < 59 kg, a starting dose of 100 mg once a day is recommended.
If the patient does not respond adequately to 100 mg once daily, the dose can be increased to 200 mg once daily. In adolescents weighing at least 59 kg, a starting dose of 100 mg or 200 mg once daily may be appropriate. The lowest effective dose for maintenance should be considered.
Discontinuation of treatment should be considered in patients who show no evidence of therapeutic benefit after 24 weeks. Cibinqo can be used with or without medicated topical therapies for atopic dermatitis. 4 Laboratory monitoring Table 1.
Laboratory measures and monitoring guidance Laboratory measures Monitoring guidance Action Complete blood count including Platelet Count, Absolute Lymphocyte Count (ALC), Absolute Neutrophil Count (ANC) and Haemoglobin (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 is < 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 the patient’s risk for cardiovascular disease and clinical guidelines for hyperlipidaemia.
2%). 4). Tabulated list of adverse reactions A total of 3 848 patients were treated with abrocitinib in clinical studies in atopic dermatitis. Among them 3 050 patients (representing 5 166 patient-years of exposure) were integrated for safety analysis.
The integrated safety analysis included 1 997 patients receiving a constant dose of abrocitinib 200 mg and 1 053 patients receiving a constant dose of 100 mg. There were 2 013 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 abrocitinib in comparison to placebo for up to 16 weeks.
Listed in Table 2 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. 12 Table 2. Adverse reactions System organ class Very common Common Uncommon Infections and infestations Herpes simplexa Herpes zosterb Pneumonia Blood and lymphatic system disorders Thrombocytopenia Lymphopenia Neutropeniac Metabolism and nutrition disorders Hyperlipidaemiad Nervous system disorders Headache Dizziness Vascular disorders Venous thromboembolisme Gastrointestinal disorders Nausea Vomiting Abdominal pain upper Skin and subcutaneous tissue disorders Acne Investigations Creatine phosphokinase increased ˃ 5 × ULNf a.
Herpes simplex includes oral herpes, ophthalmic herpes simplex, genital herpes, and herpes dermatitis. b. Herpes zoster includes ophthalmic herpes zoster. c. Neutropenia includes neutrophil count decreased and granulocytopenia. d. Hyperlipidaemia includes dyslipidaemia and hypercholesterolaemia.
g. current malignancy or history of malignancy) Infections/serious infections Serious infections have been reported in patients receiving abrocitinib. 8). As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes.
2). 3). Risks and benefits of treatment prior to initiating abrocitinib should be considered for patients: • with chronic or recurrent infection • who have been exposed to TB • with a history of a serious or an opportunistic infection • who have resided or travelled in areas of endemic TB or endemic mycoses; or • with underlying conditions that may predispose them to infection.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with abrocitinib. A patient who develops a new infection during treatment should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated.
The patient should be closely monitored and therapy should be temporarily interrupted if the patient is not responding to standard therapy. Tuberculosis Tuberculosis was observed in clinical studies with abrocitinib. Patients should be screened for TB before starting treatment and yearly screening for patients in highly endemic areas for TB should be considered.
3). For patients with a new diagnosis of latent TB or prior untreated latent TB, preventive therapy for latent TB should be started prior to initiation of treatment. g. 8). 8). If a patient develops herpes zoster, temporary interruption of treatment should be considered until the episode resolves.
Screening for viral hepatitis should be performed in accordance with clinical guidelines before starting therapy and during therapy. 2). 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.
1. 4). 2). 6). 6
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Patients should be monitored according to clinical guidelines for hyperlipidaemia. 4). 4). Interruption of dosing may be needed for management of laboratory abnormalities as described in Table 1. Missed doses If a dose is missed, patients should be advised to take the dose as soon as possible unless it is less than 12 hours before the next dose, in which case the patient should not take the missed dose.
Thereafter, dosing should be resumed at the regular scheduled time. g. 5). g. 5). g. 5). e. estimated glomerular filtration rate (eGFR) of 60 to < 90 mL/min. 2). In patients with severe (eGFR < 30 mL/min) renal impairment, 50 mg once daily is the recommended starting dose.
2). Abrocitinib has not been studied in patients with end-stage renal disease (ESRD) on renal replacement therapy. Hepatic impairment No dose adjustment is required in patients with mild (Child Pugh A) or moderate (Child Pugh B) hepatic impairment.
3). 4). Paediatric population The safety and efficacy of Cibinqo in children under 12 years of age have not yet been established. No data are available. Method of administration This medicinal product is to be taken orally once daily with or without food at approximately the same time each day.
In patients who experience nausea, taking tablets with food may improve nausea. Tablets should be swallowed whole with water and should not be split, crushed or chewed because these methods have not been studied in clinical trials.
e. Venous thromboembolism includes pulmonary embolism and deep vein thrombosis. f. Includes changes detected during laboratory monitoring (see text below). 8% of patients treated with abrocitinib 100 mg and 200 mg, respectively. Most infections were mild or moderate.
1% versus 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. 96 per 100 patient-years in the abrocitinib 200 mg group), most of which were non-serious multidermatomal cutaneous infections.
61 per 100 patient-years). 4). 12 per 100 patient-years in patients treated with 200 mg. 48 per 100 patient-years treated with 200 mg. 4). 05 per 100 patient-years for 100 mg. 4). 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. 1% of patients exposed to 200 mg, and in 0 patients treated with 100 mg or placebo. 15 per 100 patients-years for 200 mg and 0 per 100 patient-years for 100 mg, most occurring at Week 4.
Patients 65 years of age and […]
Patients who had HBV DNA above the lower limit of quantification (LLQ) were excluded. Patients who had HBV DNA negative or below 7 LLQ could initiate treatment; such patients had HBV DNA monitored. If HBV DNA is detected, a liver specialist should be consulted.
Vaccination No data are available on the response to vaccination in patients receiving abrocitinib. Use of live, attenuated vaccines should be avoided during or immediately prior to treatment. Prior to initiating treatment with this medicinal product, it is recommended that patients be brought up to date with all immunisations, including prophylactic herpes zoster vaccinations, in agreement with current immunisation guidelines.
8). In a large randomized active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a dose dependent higher rate of VTE including deep venous thrombosis (DVT) and pulmonary embolism (PE) was observed with tofacitinib compared to TNF inhibitors.
A higher rate of VTE was observed with abrocitinib 200 mg compared to abrocitinib 100 mg. 4 “Major adverse cardiovascular events (MACE)” and “Malignancy”) abrocitinib should only be used if no suitable treatment alternatives are available.
In patients with known VTE risk factors other than cardiovascular or malignancy risk factors, abrocitinib should be used with caution. VTE risk factors other than cardiovascular or malignancy risk factors include previous VTE, patients undergoing major surgery, immobilisation, use of combined hormonal contraceptives or hormone replacement therapy, inherited coagulation disorder.
Patients should be re-evaluated periodically during abrocitinib treatment to assess for changes in VTE risk. Promptly evaluate patients with signs and symptoms of VTE and discontinue abrocitinib in patients with suspected VTE, regardless of dose.
Major adverse cardiovascular events (MACE) Events of MACE have been observed in patients taking abrocitinib. In a large randomized active-controlled study of tofacitinib (another JAK inhibitor) in rheumatoid arthritis patients 50 years and older with at least one additional cardiovascular risk factor, a higher rate of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction (MI) and non-fatal stroke, was observed with tofacitinib compared to […]