• VELSIPITY is contraindicated in women of childbearing potential not using effective contraception; before initiation of treatment in women of childbearing potential, a negative pregnancy test result must be available and counselling should be provided regarding the serious risk to the foetus
  
• Due to the time it takes to eliminate VELSIPITY from the body after stopping treatment, the potential risk to the foetus may persist and women of childbearing potential must use effective contraception during VELSIPITY treatment and for at least 14 days after treatment discontinuation
  
• VELSIPITY should be stopped at least 14 days before a pregnancy is planned. If a woman becomes pregnant during treatment. VELSIPITY must be immediately discontinued. Medical advice should be given regarding the risk of harmful effects to the foetus associated with treatment and follow-up examinations should be performed
  
• VELSIPITY should not be used during breast-feeding
  
• The effect of VELSIPITY on human fertility has not been evaluated
  - In animal studies, no adverse effects on fertility were observed

• Hypersensitivity to the active substance or to any of the excipients
  
• Immunodeficient state
  
• History in the last 6 months of MI, unstable angina pectoris, stroke, TIA, decompensated heart failure requiring hospitalisation, or NYHA Class III/IV heart failure
  
• History or presence of Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or sino atrial block, unless patient has a functioning pacemaker
  
• Severe active infections, active chronic infections such as hepatitis or tuberculosis
  
• Active malignancies
  
• Severe hepatic impairment
  
• During pregnancy and in women of childbearing potential not using effective contraception
  

Interaction studies have only been performed in adults. 

• Effects of inhibitors of CYP2C8, CYP2C9 and CYP3A4 on VELSIPITY:
  Co-administration of VELSIPITY with a therapeutic agent or a combination of agents that are moderate to strong inhibitors of two or more of the CYP2C8, CYP2C9 and CYP3A4 enzymes (e.g. fluconazole) increases the exposure of VELSIPITY and is not recommended
  
• Effect of inducers of CYP2C8, CYP2C9, and CYP3A4 on VELSIPITY:
  Co-administration of VELSIPITY with a therapeutic agent or a combination of agents that are moderate to strong inducers of two or more of the following CYP enzymes (CYP2C8, CYP2C9, and CYP3A4) (e.g. rifampicin, enzalutamide) decreases the exposure of VELSIPITY and is not recommended
  
• Effect of CYP2C9 polymorphism:
  Due to the potential for increased exposure of VELSIPITY, co-administration of VELSIPITY in patients who are known or suspected to be CYP2C9 poor metabolisers (<5% of the population) and who take medicinal products that are moderate or strong inhibitors of CYP2C8 and/or CYP3A4 is not recommended
  
• Beta blockers and calcium channel blockers:
  Caution is recommended for patients receiving medicinal products that slow heart rate or AV conduction because of the potential additive effects on lowering heart rate
  • Patients on other bradycardic medicinal products and on anti-arrhythmic medicinal products (which have been associated with cases of Torsades de Pointes in patients with bradycardia) have not been studied with VELSIPITY

• Anti arrhythmic medicinal products, PT prolonging medicinal products, medicinal products that may decrease heart rate:  
  If treatment with VELSIPITY is considered in patients on Class Ia or Class III anti-arrhythmic medicinal products, advice from a cardiologist should be sought
  • Due to the potential additive effects on heart rate, if treatment initiation with VELSIPITY is        considered in patients on QT prolonging medicinal products, advice from a cardiologist should be sought

• Anti neoplastic, immune-modulating, or non corticosteroid immunosuppressive therapies:
  VELSIPITY has not been studied in combination with anti-neoplastic, immune-modulating, or non-corticosteroid immunosuppressive therapies. Caution should be used during concomitant administration because of the risk of additive immune system effects during such therapy and in the weeks following administration
  
• Oral contraceptives:
  No clinically significant differences in the PK and PD of an oral contraceptive containing 30 mcg ethinyl oestradiol and 150 mcg levonorgestrel were observed when co-administered with VELSIPITY
  

• Vaccinations may be less effective if administered during and for up to 2 weeks after discontinuation of treatment with VELSIPITY
  
• The use of live attenuated vaccine may carry the risk of infection and should therefore be avoided during VELSIPITY treatment and for at least 2 weeks after discontinuation of treatment with VELSIPITY

ELDERLY

RENAL IMPAIRMENT

HEPATIC IMPAIRMENT

PAEDIATRIC POPULATION

BODY WEIGHT