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

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

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Amvuttra is given as a subcutaneous injection (under the skin) once every 3 months.

A healthcare provider will give you this injection.

Your doctor may have you take extra vitamin A while you are using Amvuttra. 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 vitamin A.

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:

25 mg administered by subcutaneous injection once every 3 months.

Use: treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

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

It is not known whether Amvuttra will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

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

Since Amvuttra 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.

Common side effects of Amvuttra may include:

• joint stiffness (arthralgia)
• shortness of breath (dyspnea)
• decreased vitamin A levels.

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.