Brand Name(s):Revatio

Indication:Pulmonary Hypertension, WHO functional class II & III



Review Date:Jul-23

Important Safety Information:
Increased risk of mortality in paediatric patients with pulmonary arterial hypertension with the use of higher than recommended doses of Revatio (sildenafil citrate)…………………………

-In a clinical study of Revatio for the treatment of PAH in paediatric patients with doses in the range of 10-80 mg three times a day, a higher risk of mortality among patients in the higher compared with lower study-specific dose groups was observed.

-Therefore, prescribers are reminded that doses of Revatio higher than those recommended in the SmPC should not be used. For patients who weigh 20 kg or less, the dose is 10 mg three times a day and for patients > 20 kg the dose is 20 mg three times a day.

-If your patients are currently being prescribed doses that are higher than recommended in the SmPC, these doses should be titrated down to the recommended dose in a timely manner in accordance with your medical judgment of the patient’s condition.

30 September 2011
Pfizer & MHRA…………………………Update 2020 – Revised SPC: Revatio (sildenafil) preparations – SPC now states that, outside its authorised indications, sildenafil should not be used in neonates with persistent pulmonary hypertension of the newborn as risks outweigh the benefits. Sildenafil is not licensed for use in patients <1 year.