GIVLAARI

Before taking this medicine

Do not use GIVLAARI if you have a known severe allergy to givosiran. Severe allergic reactions, including anaphylaxis, have occurred. Medical support must be available during administration, and you should be monitored for signs of an allergic reaction. If anaphylaxis occurs, treatment must be stopped and appropriate medical care given. GIVLAARI requires monitoring for liver and kidney problems. Liver function should be checked before and periodically during treatment; severe or clinically significant liver enzyme increases may require treatment to be interrupted or stopped. Kidney function should be monitored as clinically needed. Injection-site reactions can occur, including reactions at previous injection sites. Blood homocysteine should be checked before and during treatment; if levels rise, your clinician may consider vitamin B6 supplementation. Acute upper abdominal pain, significant increases in pancreatic enzymes or scan findings may indicate acute pancreatitis and require assessment and appropriate management.