An appropriate CIBINQO patient should meet all of the following:
• Platelets ≥150 × 10³/mm³
• Absolute lymphocyte count (ALC) ≥0.5 × 10³/mm³
• Absolute neutrophil count (ANC) ≥1.2 × 10³/mm³
• Haemoglobin (Hb) ≥10 g/dL

Serious infections:

• Treatment must not be initiated in patients with an active, serious systemic infection
   
• If a patient develops a serious infection, sepsis, or opportunistic infection, dose interruption should be considered until the infection is controlled

Vaccines:​​​​​

• 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

Tuberculosis:

• Patients should be screened for tuberculosis (TB) before starting treatment and yearly screening for patients in highly endemic areas for TB should be considered. CIBINQO must 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:

• 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 infection were excluded from clinical studies. 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; such patients had HBV DNA monitored. If HBV DNA is detected, a liver specialist should be consulted.
   
• Viral reactivation, including herpes virus reactivation (e.g. herpes zoster, herpes simplex), was reported in clinical studies (see section 4.8 of the SmPC). 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 section 4.8 of the SmPC). If a patient develops herpes zoster, temporary interruption of treatment should be considered until the episode resolves. 

Prescribing information

Please see the CIBINQO Summary of Product Characteristics for more information.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.