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The risks and benefits of treatment with Abrocitinib (Cibinqo) should be carefully 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 (Cibinqo). A patient who develops a new infection during treatment with Abrocitinib (Cibinqo) should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated. The patient should be closely monitored and Abrocitinib (Cibinqo) therapy should be interrupted if the patient is not responding to standard therapy.
Tuberculosis: Tuberculosis was observed in clinical studies with Abrocitinib (Cibinqo). Patients should be screened for tuberculosis (TB) before starting Abrocitinib (Cibinqo) therapy and consider yearly screening for patients in highly endemic areas for TB. Abrocitinib (Cibinqo) should not be given to patients with active TB. 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 Abrocitinib (Cibinqo).
Viral reactivation: Viral reactivation, including herpes virus reactivation (e.g., herpes zoster, herpes simplex), was reported in clinical studies (see Adverse Reactions). The rate of herpes zoster infections was higher in patients who were treated with 200 mg, 65 years of age and older, with a medical history of herpes zoster, with a confirmed ALC <1 × 103/mm3 prior to the event and patients with severe atopic dermatitis at baseline (see Adverse Reactions). 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 Abrocitinib (Cibinqo). Patients with evidence of active hepatitis B or hepatitis C (positive hepatitis C PCR) infection were excluded from clinical studies (see Pharmacology: Pharmacokinetics under Actions). 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 treatment with Abrocitinib (Cibinqo); 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 (Cibinqo). Use of live, attenuated vaccines should be avoided during or immediately prior to treatment. Prior to initiating Abrocitinib (Cibinqo), it is recommended that patients be brought up to date with all immunizations, including prophylactic herpes zoster vaccinations, in agreement with current immunization guidelines.
Thrombotic events including pulmonary embolism: Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving Janus kinase (JAK) inhibitors including Abrocitinib (Cibinqo) (see Adverse Reactions). Abrocitinib (Cibinqo) should be used with caution in patients at high risk for DVT/PE. Risk factors that should be considered in determining the patient's risk for DVT/PE include older age, obesity, a medical history of DVT/PE, prothrombotic disorder, use of combined hormonal contraceptives or hormone replacement therapy, patients undergoing major surgery, or prolonged immobilization. If clinical features of DVT/PE occur, Abrocitinib (Cibinqo) treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
Malignancy (including non-melanoma skin cancers): Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical studies with Abrocitinib (Cibinqo). Clinical data are insufficient to assess the potential relationship of exposure to Abrocitinib (Cibinqo) and the development of malignancies. Long-term safety evaluations are ongoing.
The risks and benefits of Abrocitinib (Cibinqo) treatment should be considered prior to initiating in patients with a known malignancy other than a successfully treated NMSC or cervical cancer in situ or when considering continuing Abrocitinib (Cibinqo) therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Hematologic abnormalities: Confirmed ALC <0.5 × 103/mm3 and platelet count <50 × 103/mm3 were observed in less than 0.5% of patients in clinical studies (see Adverse Reactions). Treatment with Abrocitinib (Cibinqo) should not be initiated in patients with a platelet count <150 × 103/mm3, an ALC <0.5 × 103/mm3, an ANC <1 × 103/mm3 or who have a hemoglobin value <8 g/dL (see Dosage & Administration). Complete blood count should be monitored 4 weeks after initiation of therapy with Abrocitinib (Cibinqo) and thereafter according to routine patient management (see Table 7.)
Lipids: In patients with a high burden of cardiovascular risk factors, including hyperlipidemia, the risks and benefits of Abrocitinib compared to that of other available therapies for atopic dermatitis should be considered. Dose dependent increase in blood lipid parameters were reported in patients treated with Abrocitinib (Cibinqo) (see Adverse Reactions). Lipid parameters should be assessed approximately 4 weeks following initiation of Abrocitinib (Cibinqo) therapy and thereafter according to their risk for cardiovascular disease (see Table 7). The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. Patients with abnormal lipid parameters should be further monitored and managed according to clinical guidelines, due to the known cardiovascular risks associated with hyperlipidemia. If Abrocitinib (Cibinqo) is chosen interventions to manage lipid concentrations should be implemented according to clinical guidelines.
Laboratory monitoring: See Table 7.
Click on icon to see table/diagram/imageEffects on Ability to Drive and Use Machines: Abrocitinib (Cibinqo) has no or negligible sedating effect. However, patients who experience dizziness after the intake of Abrocitinib should refrain from driving or using machines until the dizziness resolves.
Use in the Elderly: A total of 173 patients 65 years of age and older were enrolled in Abrocitinib (Cibinqo) studies. The safety profile observed in elderly patients was similar to that of the adult population 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; patients 65 years and older were more likely to develop low platelet and ALC values; the incidence rate of herpes zoster in patients 65 years of age and older was higher than that of younger patients (see Adverse Reactions). There are limited data in patients above 75 years of age.
