Nedosiran

Generic name: nedosiran [ NED-oh-SIR-an ]
Brand names: Rivfloza, Rivfloza Pre-filled Syringe
Dosage form: subcutaneous solution (128 mg/0.8 mL; 160 mg/mL; 80 mg/0.5 mL)
Drug class: Miscellaneous metabolic agents

Medically reviewed by Drugs.com on Mar 29, 2024. Written by Cerner Multum.

What is nedosiran?

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

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

Nedosiran side effects

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 nedosiran may include:

• bruising, swelling, warmth, redness, oozing, bleeding, or dimpling where an injection was given.

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.

Related/similar drugs

Warnings

Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.

Before taking this medicine

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.

How should I use nedosiran?

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.

Nedosiran dosing information

Usual Adult Dose for Primary Hyperoxaluria:

Body Weight greater than or equal to 50 kg: 160 mg subcutaneously once monthly
Body Weight less than 50 kg: 128 mg subcutaneously once monthly

Use: 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 monthly
Body 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 monthly
Body Weight less than 50 kg: 128 mg subcutaneously once monthly

Use: 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)

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while using nedosiran?

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

What other drugs will affect nedosiran?

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.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

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