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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: 1 INDICATIONS AND USAGE CIBINQO is indicated for the treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies is…
Verbatim from this product's FDA label. Tap a section to expand.
2 DOSAGE AND ADMINISTRATION • For recommended testing, evaluations, and procedures prior to CIBINQO initiation, see Full Prescribing Information. 1 ) • Recommended dosage is 100 mg orally once daily. 2 ) • 200 mg orally once daily is recommended for those patients who are not responding to 100 mg once daily.
2 ) • Moderate renal impairment: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily. 3 ) • CYP2C19 poor metabolizer: 50 mg once daily or 100 mg once daily for those patients who are not responding to 50 mg once daily.
4 ) • For dosage modifications for certain adverse reactions, see Full Prescribing Information. 1 Recommended Testing, Evaluations, and Procedures Prior to Treatment Initiation Perform the following tests and evaluations prior to CIBINQO initiation: • Tuberculosis (TB) infection evaluation – CIBINQO initiation is not recommended in patients with active TB.
1) ] . 1) ] . 6) ] . 7) ] . 2 Recommended Dosage The recommended dose is 100 mg once daily. If an adequate response is not achieved with CIBINQO 100 mg once daily, consider increasing the dosage to 200 mg once daily. Discontinue CIBINQO if an adequate response is not achieved with 200 mg once daily.
Use the lowest efficacious dose to maintain response. CIBINQO can be used with or without topical corticosteroids. If a dose is missed, administer the dose as soon as possible unless it is less than 12 hours before the next dose, in which case skip the missed dose.
Thereafter, resume dosing at the regular scheduled time. 3) ] . 2) ] . Table 1. Dosage Recommendations in Patients with Renal Impairment Renal Impairment Stage Estimated Glomerular Filtration (eGFR) Glomerular filtration rate was estimated by the Modification of Diet in Renal Disease (MDRD) formula.
Dosage Mild 60 – 89 mL/minute CIBINQO 100 mg once daily Moderate 30 – 59 mL/minute CIBINQO 50 mg once daily Severe Severe Renal Impairment and End-Stage Renal Disease include patients on renal replacement therapy. 3) ]. 5) ]. If an adequate response is not achieved with CIBINQO 50 mg once daily, consider increasing the dosage to 100 mg once daily.
Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily . 3) ] . If an adequate response is not achieved with CIBINQO 50 mg daily, consider increasing the dosage to 100 mg once daily. Discontinue therapy if inadequate response is seen after dosage increase to 100 mg once daily.
6) ] Most common adverse events (≥1% with CIBINQO 100 mg) are nasopharyngitis, nausea, headache, herpes simplex, increased blood creatine phosphokinase, dizziness, urinary tract infection, fatigue, acne, vomiting, impetigo, oropharyngeal pain, hypertension, influenza, gastroenteritis, and dermatitis contact.
1 ) Most common adverse reactions (≥1% with CIBINQO 200 mg and greater than CIBINQO 100 mg) are nausea, headache, herpes simplex, increased blood creatine kinase, dizziness, urinary tract infection, acne, vomiting, gastroenteritis, upper abdominal pain, abdominal discomfort, herpes zoster, and thrombocytopenia.
1 ) To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. gov/medwatch . 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The safety of CIBINQO was evaluated in four randomized, placebo-controlled clinical trials (2 monotherapy, 1 combination therapy with topical corticosteroid, and 1 dose-ranging) and one long-term extension trial in subjects with moderate to severe atopic dermatitis (AD).
A total of 1623 subjects with moderate to severe atopic dermatitis were treated with CIBINQO in these clinical trials representing 1428 patient-years of exposure. There were 634 subjects with at least 1 year of exposure to CIBINQO. In the placebo-controlled clinical trials, a total of 1198 subjects were exposed to CIBINQO with 608 subjects receiving CIBINQO 100 mg once daily and 590 subjects receiving CIBINQO 200 mg once daily for up to 16 weeks.
1%) were 65 years of age or older. 9%). Adverse reactions occurring at ≥1% in any of the treated groups and at a higher rate than in the placebo group are presented in Table 3. 1%) subjects treated with CIBINQO were discontinued from the trials due to adverse reactions.
5 WARNINGS AND PRECAUTIONS • Laboratory Abnormalities : Laboratory monitoring is recommended due to potential changes in platelets, lymphocytes, and lipids. 6 ) • Immunizations : Avoid use of live vaccines immediately prior to, during and immediately after CIBINQO treatment.
1) ] . Serious infections leading to hospitalization or death, including tuberculosis and bacterial, invasive fungal, viral, and other opportunistic infections, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions.
Avoid use of CIBINQO in patients with active, serious infection including localized infections. Consider the risks and benefits of treatment prior to initiating CIBINQO in patients: • with chronic or recurrent infection • who have been exposed to tuberculosis • with a history of a serious or an opportunistic infection • who have resided or traveled in areas of endemic tuberculosis or endemic mycoses • with underlying conditions that may predispose them to infection Closely monitor patients for the development of signs and symptoms of infection during and after treatment with CIBINQO.
If a patient develops a serious or opportunistic infection, discontinue CIBINQO. Initiate complete diagnostic testing and appropriate antimicrobial therapy. The risks and benefits of treatment with CIBINQO should be carefully considered prior to reinitiating therapy with CIBINQO.
Tuberculosis Evaluate and test patients for TB before starting CIBINQO therapy and consider yearly screening for patients in highly endemic areas for TB. CIBINQO is not recommended for use in patients with active TB. For patients with a new diagnosis of latent TB or prior untreated latent TB, or for patients with a negative test for latent TB but who are at high risk for TB infection, start preventive therapy for latent TB prior to initiation of CIBINQO.
Monitor patients for the development of signs and symptoms of TB, including patients who were tested negative for latent TB infection prior to initiating therapy. 1) ] . If a patient develops herpes zoster, consider interrupting CIBINQO until the episode resolves.
2) ]. Antiplatelet therapies except for low-dose aspirin (≤81 mg daily), during the first 3 months of treatment. ( 4 )
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6 Treatment Discontinuation due to Serious Infections or Hematologic Adverse Reactions Serious or Opportunistic Infections If a patient develops a serious or opportunistic infection, discontinue CIBINQO and control the infection. 1) ] .
Hematologic Abnormalities Recommendations for CIBINQO discontinuation for laboratory abnormalities are summarized in Table 2. Table 2. Recommendations for CIBINQO Discontinuation for Hematologic Abnormalities Abbreviations: ALC=absolute lymphocyte count; ANC=absolute neutrophil count; CBC=complete blood count; Hb=hemoglobin Laboratory Measure Recommendation Platelet Count <50,000/mm 3 Discontinue CIBINQO and follow with CBC until >100,000/mm 3 ALC <500/mm 3 Treatment should be temporarily discontinued if ALC is less than 500 cells/mm 3 and may be restarted once ALC return above this value ANC <1,000/mm 3 Treatment should be temporarily discontinued if ANC is less than 1,000 cells/mm 3 and may be restarted once ANC return above this value Hb value <8 g/dL Treatment should be temporarily discontinued if Hb is less than 8 g/dL and may be restarted once Hb return above this value CBC evaluations are recommended at baseline, 4 weeks after treatment initiation and 4 weeks after dosage increase of CIBINQO.
6) ] . 7 Administration Instructions Administer CIBINQO with or without food at approximately the same time each day. Swallow CIBINQO tablets whole with water. Do not crush, split, or chew CIBINQO tablets.
The safety profile of CIBINQO in the monotherapy and the combination trial(s) were similar. Table 3. 5) Herpes simplex Herpes simplex also includes oral herpes, ophthalmic herpes, herpes dermatitis, genital herpes. 0) Specific Adverse Reactions Exposure adjusted incidence rates were adjusted by trial size for all the adverse reactions reported in this section.
5 per 100 patient-years) treated with CIBINQO 200 mg. 2 per 100 patient-years) treated with CIBINQO 200 mg. 3 per 100 patient-years) treated with CIBINQO 200 mg. 3 per 100 patient-years) treated with CIBINQO 200 mg. The most commonly reported serious infections were herpes simplex, herpes zoster, and pneumonia.
Herpes Zoster In the placebo-controlled trials, for up to 16 weeks, opportunistic infections were generally cases of multidermatomal cutaneous herpes zoster. 1 per 100 patient-years) treated with CIBINQO 200 mg. 2 per 100 patient-years) treated with CIBINQO 200 mg.
65 per 100 patient-years) treated with CIBINQO 200 mg. 3 per 100 patient-years) treated with CIBINQO 200 mg. 4 per 100 patient-years), who were treated with CIBINQO 200 mg. 3 per 100 patient-years) who were treated with CIBINQO 200 mg.
No thrombosis occurred in subjects treated with CIBINQO 100 mg. 6 per 100 patient-years) treated with CIBINQO 100 mg. 3 per 100 patient-years) treated with CIBINQO 200 mg. Thrombocytopenia In the placebo-controlled trials, for up to 16 weeks, treatment with CIBINQO 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. 9 per 100 patient-years) treated with CIBINQO 200 mg had adverse reactions of thrombocytopenia; no subjects treated with CIBINQO 100 mg had an adverse reaction of thrombocytopenia.
2 per 100 patient-years) treated with CIBINQO 200 mg and 0 subjects treated with CIBINQO 100 mg or placebo. Both cases occurred in the first 4 weeks of exposure. Lipid Elevations In the placebo-controlled trials, for up to 16 weeks, there was a dose-related percent 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.
0 per 100 patient-years) exposed to CIBINQO 200 mg. 6 per 100 patient-years) treated with CIBINQO 100 mg. 3 per 100 patient-years) treated with CIBINQO 100 mg. 3 per 100 patient-years) treated with 200 mg of CIBINQO. Most elevations were transient, there were no reported adverse reactions of rhabdomyolysis.
Pediatric Subjects (12 to less than 18 years of age) The safety of CIBINQO was assessed in a trial of 284 subjects 12 to less than 18 years of age with moderate-to-severe atopic dermatitis (Trial-AD-4). The safety profile of CIBINQO in these subjects, assessed through the initial treatment period of 12 weeks and the long-term period (213 with at least 52 weeks of abrocitinib exposure), was comparable to the safety profile from trials in adults with atopic dermatitis.
Hepatitis B virus (HBV) reactivation has been reported in patients receiving JAK inhibitors. Perform viral hepatitis screening in accordance with clinical guidelines before starting therapy and monitor for reactivation during therapy with CIBINQO.
3) ] . Monitor patients with inactive HBV for expression of HBV DNA during therapy with CIBINQO. If HBV DNA is detected during therapy with CIBINQO, consult a liver specialist. 2 Mortality In a large, randomized, postmarketing safety trial of another JAK inhibitor in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor, a higher rate of all-cause mortality, including sudden cardiovascular death, was observed in subjects treated with the JAK inhibitor compared with TNF blockers.
CIBINQO is not approved for use in RA. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO. 1) ] . Perform periodic skin examination for patients who are at increased risk for skin cancer.
Exposure to sunlight and UV light should be limited by wearing protective clothing and using broad-spectrum sunscreen. Malignancies, including lymphomas, have occurred in patients receiving JAK inhibitors used to treat inflammatory conditions.
In a large, randomized, postmarketing safety trial of another JAK inhibitor in RA subjects, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed in subjects treated with the JAK inhibitor compared to those treated with TNF blockers.
CIBINQO is not approved for use in RA. A higher rate of lymphomas was observed in subjects treated with the JAK inhibitor compared to those treated with TNF blockers. A higher rate of lung cancers was observed in current or past smokers treated with the JAK inhibitor compared to those treated with TNF blockers.
In this trial, current or past smokers had an additional increased risk of overall malignancies. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients with a known malignancy (other than a successfully treated NMSC), patients who develop a malignancy when on treatment, and patients who are current or past smokers.
1) ]. In a large, randomized, postmarketing safety trial of another JAK inhibitor in RA subjects 50 years of age and older with at least one 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 the JAK inhibitor compared to those treated with TNF blockers.
CIBINQO is not approved for use in RA. Patients who are current or past smokers are at additional increased risk. Consider the benefits and risks for the individual patient prior to initiating or continuing therapy with CIBINQO, particularly in patients who are current or past smokers and patients with other cardiovascular risk factors.
Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. Discontinue CIBINQO in patients that have experienced a myocardial infarction or stroke. 1) ] . Thrombosis, including DVT, PE, and arterial thrombosis have been reported in patients receiving JAK inhibitors used to treat inflammatory conditions.
Many of these adverse reactions were serious and some resulted in death. In a large, randomized, postmarketing safety trial of another JAK inhibitor in RA subjects 50 years of age and older with at least one cardiovascular risk factor, higher rates of overall thrombosis, DVT, and PE were observed compared to those treated with TNF blockers.
CIBINQO is not approved for use in RA. Avoid CIBINQO in patients that may be at increased risk of thrombosis. If symptoms of thrombosis occur, discontinue CIBINQO and evaluate and treat patients appropriately. 1) ] . 1) ] . CBC evaluations are recommended at 4 weeks after initiation and 4 weeks after dose increase of CIBINQO.
6) ]. 1) ] . Lipid parameters should be assessed approximately 4 weeks following initiation of CIBINQO therapy and thereafter patients should be managed according to clinical guidelines for hyperlipidemia. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined.
7 Immunizations Prior to initiating CIBINQO, complete all age-appropriate vaccinations as recommended by current immunization guidelines, including prophylactic herpes zoster vaccinations. Avoid vaccination with live vaccines immediately prior to, during and immediately after CIBINQO therapy.