IMPORTANT SAFETY INFORMATION 

Do not use GIVLAARI if you have ever had a severe allergic reaction to GIVLAARI.

GIVLAARI can cause:

• Severe allergic reaction

  Tell your doctor or nurse right away if you experience any of the following signs or symptoms of a severe allergic reaction during treatment:

  • Swelling – mainly of the lips, tongue or throat which makes it difficult to swallow or breathe
  • Breathing problems or wheezing
  • Feeling dizzy or fainting
  • Rash or hives
  • Itching

  If you have a severe allergic reaction, your doctor or nurse will stop GIVLAARI treatment right away and you may need to take other medicines to control the symptoms.

• Liver problems

  Your doctor will check your liver function by doing blood tests:

  • Before you start using GIVLAARI
  • Once a month for the first 6 months of treatment
  • And when they think it is needed

  If these tests show abnormal results, your doctor or nurse will decide whether to temporarily interrupt or stop treatment with GIVLAARI.

• Kidney problems

  Your doctor will check how your kidneys are working while you are using GIVLAARI.

• Injection site reactions

  GIVLAARI is given as an injection under the skin (called a “subcutaneous injection”). Reactions to this injection may happen during treatment with GIVLAARI.

  Tell your doctor or nurse right away if you experience any of the following symptoms of an injection site reaction during treatment: redness, pain, itchiness, rash, discoloration, or swelling around the injection site.

• Increased blood homocysteine levels

  GIVLAARI may cause increased levels of homocysteine (a type of amino acid) in your blood. Your doctor will check your homocysteine levels before and during treatment by doing blood tests. If your levels are increased, your doctor may check your folate, vitamins B12 and B6, and tell you to take a vitamin B6 supplement.

• Inflammation of the pancreas (pancreatitis)

  Cases of acute pancreatitis including some that were severe, have been reported in patients receiving GIVLAARI. If you have a severe case of acute pancreatitis your doctor or nurse will decide whether to temporarily interrupt or stop treatment with GIVLAARI.

What are the common side effects of GIVLAARI?

The most common side effects of GIVLAARI are nausea and injection site reactions. These are not all the possible side effects of GIVLAARI. Talk to your doctor about side effects that you experience. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-8 00-FDA -1088.

WHAT IS GIVLAARI® (givosiran)?

GIVLAARI is a prescription medicine used to treat acute hepatic porphyria (AHP) in adults.

For additional information about GIVLAARI, please see full Prescribing Information.