ONPATTRO® (Patisiran)

ONPATTRO®

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Important Safety Information

ONPATTRO® (patisiran) is an infusion medication designed to treat adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). It decreases symptoms of constipation, diarrhea, dizziness, vomiting, and difficulty urinating, as well as improving the patient’s gait and reducing anxiety and depression.

It is possible to experience an infusion-related reaction — that may require your infusion to be reduced or interrupted. Tell your doctor immediately if you experience any of the following infusion-reaction symptoms:

  • Headache
  • Skin rash
  • Dizziness
  • Rapid heart rate
  • Facial swelling
  • Nausea
  • Body aches
  • Shortness of breath
  • Fatigue
  • Flushing of skin

What is the most important information I should know about ONPATTRO®?

ONPATTRO® may lower the levels of Vitamin A in your blood, which could affect your vision. Your doctor may recommend taking a vitamin A supplement. Only take the amount instructed by your doctor — as overdosing on vitamin A may also affect your vision. Also, talk to your doctor if you experience signs of an allergic reaction, such as hives, breathing difficulties, or swelling of your face, lips, tongue, and/or throat.

Tell your healthcare provider about all medications you’re currently taking — regardless of whether they’re prescription, over-the-counter, herbal, or vitamins. You should also discuss with your doctors about all known allergies.

It is unknown whether ONPATTRO® would harm an unborn child. Talk to your doctor if you’re pregnant or are planning to become pregnant. It may also not be safe to breastfeed while undergoing treatment with ONPATTRO®.

ONPATTRO® Side Effects

As with any prescription medication, ONPATTRO® carries a risk of side effects. The most common ones include:

  • Sinus infections
  • Nasal congestion
  • Common cold
  • Sore throat
  • Bronchitis
  • Other types of respiratory tract infections
  • Nausea
  • Headache
  • Back pain

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

ONPATTRO® is used to treat adults with hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis). Infusions are administered once every three weeks, with each infusion lasting approximately 80 minutes. Doses vary according to the patient’s weight. At least an hour before starting treatment, a medical provider should provide medications to reduce the risk of common infusion-related reactions. Patients should be monitored after each infusion treatment to watch for any adverse reactions.

Please refer to the full prescribing information.