Important Safety Information

What are the most important things I should know about ONPATTRO™ (patisiran)?

ONPATTRO can cause:

• Infusion-related reactions

  ONPATTRO is given as a drip into a vein (called an "intravenous infusion"). Reactions to this infusion may happen during treatment with ONPATTRO. Before each infusion you will be given medicines that help to lower the chance of infusion-related reactions.

  Tell your doctor or nurse right away if you experience any of the following signs of an infusion-related reaction during treatment:

  • Reddening of the face or body (flushing), skin warm
  • Body aches or pain, including pain in the back, neck, or joints
  • Feeling sick (nausea)
  • Stomach pain
  • Feeling short of breath, cough, or other breathing problems
  • Headache
  • Chest discomfort or chest pain
  • Rash
  • Chills
  • Dizziness
  • Feeling tired (fatigue)
  • Rapid heart rate
  • Facial swelling

  If you have an infusion-related reaction, your doctor or nurse may slow down or stop your infusion, and you may need to take other medicines. When these reactions stop, or get better, your doctor or nurse may decide to start the infusion again.

• Low Vitamin A levels

  Treatment with ONPATTRO lowers the amount of vitamin A in your blood. Your doctor will tell you to take a vitamin A supplement every day. You should not take more than the amount of vitamin A recommended by your doctor.

  Low vitamin A levels can affect vision. If you have problems with your vision (e.g., night blindness) while taking ONPATTRO, talk to your doctor.  Your doctor may refer you to an eye specialist.

The most common side effects of ONPATTRO are respiratory infections, such as colds, sinus infections, and nasal congestion, and infusion-related reactions. These are not all the possible side effects of ONPATTRO. 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 1-800-FDA-1088.

Indication

What is ONPATTRO?

ONPATTRO is a medicine that treats the polyneuropathy caused by an illness called hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). ONPATTRO is used in adults only.

For additional information about ONPATTRO, please see the full Prescribing Information.