Patisiran is used to treat adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis (damage of multiple nerves throughout the body).

Patisiran may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Patisiran is given as an infusion into a vein. A healthcare provider will give you this injection once every 3 weeks.

This medicine must be given slowly, and the infusion can take about 80 minutes to complete.

Tell your caregivers if you feel any burning, pain, or swelling around the IV needle when patisiran is injected.

You may be given other medications to help prevent serious side effects or an infusion reaction.

Your doctor may have you take vitamin A while you are using patisiran. Take only the amount of vitamin A your doctor has prescribed, especially if you are pregnant. An overdose of vitamin A can cause vision problems or other serious side effects.

Call your doctor at once if you have vision problems (especially at night) while you are taking patisiran.

Patisiran doses are based on weight. Your dose needs may change if you gain or lose weight.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if this medicine is effective. You may also need frequent eye exams.

Usual Adult Dose for Amyloidogenic Transthyretin Amyloidosis:

Recommended dose based on actual body weight:
-Weight less than 100 kg: 0.3 mg/kg intravenously once every 3 weeks
-Weight 100 kg or greater: 30 mg intravenously once every 3 weeks

Infuse at an initial rate of approximately 1 mL/min for the first 15 minutes, then increase to approximately 3 mL/min over 80 minutes.

PREMEDICATION: Administer on the day of infusion at least 60 minutes prior to the start of infusion:
-Oral acetaminophen 500 mg
-Intravenous Corticosteroid (e.g., dexamethasone 10 mg or equivalent)
-Intravenous H1 blocker (e.g., diphenhydramine 50 mg or equivalent)
-Intravenous H2 blocker (e.g., ranitidine 50 mg or equivalent)

Comments:
-The duration of infusion may be extended in the event of an infusion-related reaction (IRR).
-If intravenous premedications are not available or not tolerated, oral equivalents may be used.
-If patients are tolerating the infusion, but experiencing adverse reactions to corticosteroid premedication, reduce corticosteroid in 2.5 mg increments to a minimum dexamethasone 5 mg intravenous dose or equivalent.
-Some patients may require additional or higher doses of one or more premedications to reduce the risk of IRRs.

Use: For the treatment of adults with polyneuropathy of hereditary transthyretin-mediated amyloidosis.

Before using patisiran tell your doctor about all your medical conditions or allergies.

Patisiran may harm an unborn baby. Tell your doctor if you are pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of patisiran on the baby.

It may not be safe to breastfeed while using patisiran. Ask your doctor about any risk.

Call your doctor for instructions if you miss an appointment for your patisiran injection.

Since patisiran is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your medical caregiver if you feel dizzy, nauseated, light-headed, itchy, sweaty, or have a headache, chest tightness, back pain, trouble breathing, or swelling in your face.

Common side effects of patisiran may include:

• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.