Nedosiran

Nedosiran is used to reduce oxalate levels in the urine of adults and children who are at least 9 years old and have primary hyperoxaluria type 1 (PH1) with preserved kidney function.

Nedosiran may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Nedosiran is injected under the skin in the stomach or upper thigh once a month. Do not inject within 2 inches of your belly button or in areas where the skin is bruised or has scars. Do not inject into the same place two times in a row.

A healthcare provider may give you this injection or may teach you how to properly use the medication by yourself. Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors, or has particles in it. Ask your doctor or pharmacist if you don't understand how to use an injection.

Doses are based on weight. Your dose may change if you gain or lose weight.

Throw away a prefilled syringe or vial after one use, even if there is still medicine left inside. Do not reuse a needle, vial, or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Store in the refrigerator in the original container. Protect from light and do not freeze.

Take the medicine out of the refrigerator and let it reach room temperature for 30 minutes before injecting your dose. Do not heat a syringe with hot water, sunlight, or a microwave.

You may store this medicine at room temperature away from moisture, heat, and light for up to 28 days (4 weeks). Throw the medicine away if not used within 28 days. Do not put it back into the refrigerator.

Use only as directed. Inform your doctor if you take other medicines or have any other medical conditions or allergies.

Tell your doctor before using nedosiran if you have other health problems, use other medications, or if you have any allergies.

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

Ask a doctor if it is safe to breastfeed while using this medicine.

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

Common side effects of nedosiran may include:

• bruising, swelling, warmth, redness, oozing, bleeding, or dimpling at the injection site.

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

Usual Adult Dose for Primary Hyperoxaluria:

Body Weight greater than or equal to 50 kg: 160 mg subcutaneously once monthlyBody Weight less than 50 kg: 128 mg subcutaneously once monthlyUse: To lower urinary oxalate in patients with primary hyperoxaluria type 1 and relatively preserved kidney function (eGFR over or equal to 30 mL/min/1.73 m2)

Usual Pediatric Dose for Primary Hyperoxaluria:

Children 9 to 11 years old:Body Weight greater than or equal to 50 kg: 160 mg subcutaneously once monthlyBody Weight less than 50 kg: 3.3 mg/kg subcutaneously once monthly, not to exceed 128 mg (vial, dose volume rounded to nearest 0.1 mL)Children 12 years and older:Body Weight greater than or equal to 50 kg: 160 mg subcutaneously once monthlyBody Weight less than 50 kg: 128 mg subcutaneously once monthlyUse: To lower urinary oxalate in children 9 years of age or older with primary hyperoxaluria type 1 and relatively preserved kidney function (eGFR over or equal to 30 mL/min/1.73 m2)

Use the medicine as soon as you remember, but if you are more than 7 days late for the dose, start a new monthly schedule on the day you remember.

Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

Other drugs may affect nedosiran, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.