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).
Treatment must not be initiated in patients with an active, serious systemic infection (see Contraindications).
The risks and benefits of treatment with CIBINQO should be carefully considered prior to initiating in 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 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. Discontinuation of CIBINQO should also be considered until the infection has resolved.
Tuberculosis: Patients should be screened for tuberculosis (TB) before starting CIBINQO therapy and consider yearly screening for patients in highly endemic areas for TB. CIBINQO must not be given to patients with active TB (see Contraindications). 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 65 years of age and older and patients with severe atopic dermatitis at baseline (see Adverse Reactions). If a patient develops herpes zoster, temporary interruption of treatment should be considered until the episode resolves.
Eczema herpeticum (disseminated viral infection mostly due to herpes simplex virus) was also reported in clinical studies with CIBINQO. The condition is characterised by rapid spread of vesicular and erosive lesions, fever and malaise inpatients with atopic dermatitis and requires prompt treatment with antiviral agents. Discontinuation or interruption of CIBINQO therapy until the resolution of an eczema herpeticum infection should be considered, depending on the seriousness of the event.
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: Use of live, attenuated vaccines during or immediately prior to CIBINQO therapy is not recommended. Prior to initiating CIBINQO, it is recommended that patients be brought up to date with all immunisations, including prophylactic herpes zoster vaccinations, in agreement with current immunisation guidelines.
Venous 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 CIBINQO (see Adverse Reactions). 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 immobilisation. If clinical features of DVT/PE occur, CIBINQO treatment should be discontinued and patients should be evaluated promptly, followed by appropriate treatment.
Malignancy (including non-melanoma skin cancers): Immunomodulatory drugs may increase the risk of malignancies including lymphoma. More cases of malignancies were observed with a JAK inhibitor other than CIBINQO compared with TNF inhibitors in the treatment of rheumatoid arthritis. Malignancies, including non-melanoma skin cancer (NMSC), were observed in clinical studies with CIBINQO. Clinical data are insufficient to assess the potential relationship of exposure to CIBINQO and the development of malignancies. Long-term safety evaluations are ongoing.
The risks and benefits of 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 CIBINQO therapy in patients who develop a malignancy. Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Haematologic 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. Treatment with 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 haemoglobin value <8 g/dL (see Dosage & Administration). Platelet count and ALC should be monitored 4 weeks after initiation of therapy with CIBINQO and thereafter according to routine patient management (see Table 3).
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. The effect of these lipid parameter elevations on cardiovascular morbidity and mortality has not been determined. More serious cardiac adverse events have been observed with a JAK inhibitor other than CIBINQO compared with TNF inhibitors in the treatment of rheumatoid arthritis. Patients should be monitored and managed according to clinical guidelines, due to the known cardiovascular risks associated with hyperlipidaemia.
Laboratory monitoring: (See Table 3.)
Click on icon to see table/diagram/image
Excipients: Lactose: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet. Patients on low sodium diets can be informed that this medicinal product is essentially 'sodium-free'.
Effects on ability to drive and use machines: No studies have been conducted on the effect of CIBINQO on driving ability or ability to operate machinery. Patients should be informed that dizziness has been reported during treatment with CIBINQO (see Adverse Reactions).
Use in the Elderly: A total of 145 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 no conclusive data in patients above 75 years of age and older.