patisiran (lipid complex) 2 mg/mL intravenous solution

Generic name:
Patisiran lipid complex - injection

Pronunciation
(PAT-i-SIR-an)

Brand name(s)
Onpattro

This medication is used to treat nerve problems due to a certain inherited condition (transthyretin-mediated amyloidosis). This condition causes a protein that your body normally makes (transthyretin-TTR), to change shape and build up in different parts of your body, which can affect the nerves, heart, and stomach/intestines. This medication works by decreasing the buildup of TTR in your body.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once every 3 weeks. The injection is given over about 80 minutes. The dosage is based on your medical condition, weight, and response to treatment. To decrease the risk of side effects during the injection, your doctor will prescribe other medications (such as acetaminophen, dexamethasone, diphenhydramine) for you to use before each injection. Carefully follow your doctor's treatment directions.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition does not get better or if it gets worse.

Flushing, chills, dizziness, shortness of breath, chest discomfort/pain, fast/pounding heartbeat, or facial swelling may occur during the injection. Back/neck/muscle/joint pain, nausea, abdominal pain, headache, or tiredness may also occur. Tell your doctor right away if you have side effects during your injection. Your doctor may manage some side effects with other medications or by giving the injection over a longer time.

Cold-like symptoms (such as runny/stuffy nose, sore throat), upset stomach, muscle spasms, a feeling of spinning (vertigo), or pain/redness/swelling at the injection site may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Get medical help right away if you have any very serious side effects, including:

• fast/slow/irregular heartbeat
• fainting

This medication decreases vitamin A levels in your blood. Ask your doctor about taking a vitamin A supplement. Tell your doctor right away if you develop signs of a lack of vitamin A, especially vision changes such as dry eyes, blurred vision, or trouble seeing in dim light (night blindness).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using patisiran lipid complex, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Lab and/or medical tests may be done while you are using this medication. Keep all medical and lab appointments.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.