Rivfloza (nedosiran) is an injectable medication that's used to lower oxalate levels in the urine in people 9 years and older with a rare inherited, genetic condition called primary hyperoxaluria type 1 (PH1). This medication belongs to the drug class called small interfering RNA (siRNA). It works to stop the liver from making oxalate. Rivfloza (nedosiran) is injected under the skin once a month. The most common side effect is having an injection site reaction. Rivfloza (nedosiran) is a brand-name medication; it isn't available as a lower-cost generic.
To lower oxalate levels in the urine in people 9 years and older with primary hyperoxaluria type 1 (PH1)
People with primary hyperoxaluria type 1 (PH1) often have a buildup of oxalate in the urine. This can lead to kidney stones.
Rivfloza (nedosiran) is a type of small interfering RNA (siRNA). It targets lactate dehydrogenase A (LDHA), a protein found in liver cells that helps make oxalate.
This medication lessens the amount of LDHA in the liver, which then lessens the amount of oxalate that's made. This lessens how much oxalate your body gets rid of through the urine, which might help lower your risk of developing kidney stones and kidney problems.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Can give at home after you get trained on how to inject the medication yourself
Only need to take once per month
Available in a prefilled syringe for convenience
Injections can be uncomfortable
Doesn't cure PH1; only helps to control symptoms
Not approved for children younger than 9 years old
Don't inject Rivfloza (nedosiran) at home until a healthcare professional has shown you or your caregiver how to inject it safely and properly. Read the Instructions for Use, and ask your prescriber or pharmacist if you have any questions.
Keep Rivfloza (nedosiran) in the refrigerator until you're ready to take your dose. If needed, you can keep the medication at room temperature in the original packaging for up to 28 days (4 weeks).
Before you inject Rivfloza (nedosiran), remove the medication from the refrigerator and let it sit out so it can reach room temperature. This can take about 30 minutes. Don't warm it up any other way because this could damage the medication.
Check that the medication inside of the vial or prefilled syringe is colorless to yellow and doesn't have any particles before you inject. Don't use the medication if it looks cloudy or contains particles, and contact your prescriber or pharmacist.
Tips for injecting Rivfloza (nedosiran):
Wash your hands and clean the injection site (stomach or upper thigh) with an alcohol wipe. Let it dry, but don't blow on it or fan the area.
Pinch your skin with one hand, and insert the needle at a 45 degree angle with the other. Push the plunger of the syringe all the way down until the syringe is empty. Then, remove the syringe from the injection site.
Place the needle directly into a sharps container right after injecting. Don't put it in the regular trash because this can raise the risk for needle-stick injuries.
You can gently place a cotton ball or gauze over the injection site if there's a little blood.
Your dose of Rivfloza (nedosiran) will depend on your age and body weight.
Adults and children ages 12 years and older
Weigh 50 kg (110 lbs) or more: The typical dose is 160 mg injected under the skin once a month.
Weigh less than 50 kg (110 lbs): The typical dose is 128 mg injected under the skin once a month.
Children ages 9 to 11 years old
Weigh 50 kg (110 lbs) or more: The typical dose is 160 mg injected under the skin once a month.
Weigh less than 50 kg (110 lbs): The typical dose is 3.3 mg/kg of body weight (up to 128 mg) injected under the skin once a month.
To lower oxalate levels in the urine in people 9 years and older with primary hyperoxaluria type 1 (PH1)
Lower the oxalate levels in people with primary hyperoxaluria type 1 (PH1)
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American Kidney Fund. (2024). Primary hyperoxaluria and oxalate: Symptoms, causes and treatment.
Fargue, S., et al. (2022). Primary hyperoxaluria type 1: Pathophysiology and genetics. Clinical Kidney Journal.
Groothoff, J., et al. (2024). Nedosiran safety and efficacy in PH1: Interim analysis of PHYOX3. Kidney International Reports.
Liu, A., et al. (2022). Nedosiran, a candidate siRNA drug for the treatment of primary hyperoxaluria: Design, development, and clinical studies. American Chemical Society Pharmacology & Translational Science.
National Kidney Foundation. (n.d.). Calcium oxalate stones.
National Kidney Foundation. (2024). Primary hyperoxaluria type 1.
Novo Nordisk. (2023). Rivfloza- nedosiran injection, solution [package insert]. DailyMed.
Syed, Y. Y. (2023). Nedosiran: First approval. Drugs.
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