Cibinqo Special Precautions

Infections/serious infections: Serious infections have been reported in patients receiving CIBINQO. The most frequent serious infections in clinical studies were herpes simplex, herpes zoster, and pneumonia (see Adverse Reactions).
The risks and benefits of treatment with 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 traveled 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 CIBINQO. A patient who develops a new infection during treatment with CIBINQO should undergo prompt and complete diagnostic testing and appropriate antimicrobial therapy should be initiated. The patient should be closely monitored and CIBINQO therapy should be interrupted if the patient is not responding to standard therapy.
Tuberculosis: Tuberculosis was observed in clinical studies with abrocitinib. Patients should be screened for tuberculosis (TB) before starting CIBINQO therapy and consider yearly screening for patients in highly endemic areas for TB. 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 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 x 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 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 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 CIBINQO. Use of live, attenuated vaccines should be avoided during or immediately prior to treatment. Prior to initiating 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.
Venous thromboembolism (VTE): Events of deep venous thrombosis (DVT) and pulmonary embolism (PE) have been reported in patients receiving Janus kinase (JAK) inhibitors including abrocitinib (see Adverse Reactions).
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.
CIBINQO should be used with caution in patients at risk for DVT/PE. Risk factors that should be considered in determining the patient's risk for DVT/PE include age ≥65 years, long-term smoking, current malignancy (excluding non-melanoma skin cancer [NMSC]), a medical history of DVT/PE, prothrombotic disorder, use of combined hormonal contraceptives or hormone replacement therapy, patients undergoing major surgery, or prolonged immobilization. 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 TNF inhibitors.
Therefore, in patients 65 years of age and older, patients who are long-term current or long-term past smokers, and patients with a history of atherosclerotic cardiovascular disease or other cardiovascular risk factors, abrocitinib should be used with caution.
Malignancy (excluding non-melanoma skin cancer [NMSC]): Lymphoma and other malignancies have been reported in patients receiving JAK inhibitors, including 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 malignancies, particularly lung cancer, lymphoma and non-melanoma skin cancer (NMSC) was observed with tofacitinib compared to TNF inhibitors.
In patients 65 years of age and older, patients who are long-term current or long-term past smokers, or with other malignancy risk factors (e.g., current malignancy or history of malignancy), abrocitinib should be used with caution.
Non-melanoma skin cancer: NMSCs have been reported in patients receiving abrocitinib. Periodic skin examination is recommended for all patients, particularly those who are at increased risk for skin cancer.
Hematologic abnormalities: Confirmed ALC <0.5 x 10³/mm³ and platelet count <50 x 10³/mm³ were observed in less than 0.5% of patients in clinical studies (see Adverse Reactions). Treatment with CIBINQO should not be initiated in patients with a platelet count <150 x 10³/mm³, an ALC <0.5 x 10³/mm³, an ANC <1 x 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 CIBINQO and thereafter according to routine patient management (see Table 7).
Lipids: Dose-dependent increase in blood lipid parameters were reported in patients treated with CIBINQO (see Adverse Reactions). Lipid parameters should be assessed approximately 4 weeks following initiation of 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 is chosen, interventions to manage lipid concentrations should be implemented according to clinical guidelines.
Laboratory monitoring: (See Table 7.)

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Immunosuppressive conditions or medicinal products: Patients with immunodeficiency disorders or a first-degree relative with a hereditary immunodeficiency were excluded from clinical studies and no information on these patients is available.
Combination with biologic immunomodulators, potent immunosuppressants such as ciclosporin or other Janus kinase (JAK) inhibitors, has not been studied. Their concomitant use with abrocitinib is not recommended as a risk of additive immunosuppression cannot be excluded.
Effects on Ability to Drive and Use Machines: 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 176 patients 65 years of age and older were enrolled in 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.
Use in patients 65 years of age and older: Considering the increased risk of MACE, malignancies, serious infections, and all-cause mortality in patients 65 years of age and older, as observed in a large randomized study of tofacitinib (another JAK inhibitor), abrocitinib should be used with caution in these patients.