TM Owner Novo Nordisk
Rivfloza 80mg/0.5mL Injection
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Indications & Clinical Uses
- Rivfloza 80mg/0.5mL is an injection of nedosiran, a small interfering RNA (siRNA) therapy distributed by Novo Nordisk and approved by the US FDA in 2023; it lowers urinary oxalate levels in children aged 9 years and older and adults with primary hyperoxaluria type 1 (PH1) who have relatively preserved kidney function (eGFR 30 mL/min/1.73m2 or above).
- Rivfloza is given as a subcutaneous injection once a month; the 80mg strength is supplied in a single-dose vial, while the 128mg and 160mg strengths come as pre-filled syringes that may be self-administered by patients aged 12 and over or trained caregivers after appropriate instruction.
- No EU/EMA marketing authorisation has been identified for Rivfloza to date, so this content is based on the US Prescribing Information.
Side Effects
- The most common side effect of Rivfloza, reported in 1 in 5 patients (20% or more) in clinical trials, is injection site reactions, including redness, pain, bruising, rash and, rarely, skin thinning (atrophy) at the injection site; these reactions were generally mild and rarely led to stopping treatment.
- Rivfloza has no boxed warning on its current US label.
- Rotating the injection site with each monthly dose can help reduce local reactions.
- Contact your healthcare provider if an injection site reaction is severe, does not improve, or if you notice any other new or worsening symptoms after a dose.
Precautions & Warnings
- Rivfloza has not been studied in children younger than 9 years, in severe hepatic impairment (bilirubin greater than 1.5 times the upper limit of normal), or in severe renal impairment (eGFR below 30 mL/min/1.73m2), so it is not recommended in these groups.
- Data in pregnancy are limited; animal studies showed pregnancy loss at higher-than-clinical doses in rabbits, so Rivfloza should be used in pregnancy only if clearly needed, and it is not known whether nedosiran passes into breast milk.
- The 80mg vial is intended for administration by a healthcare professional or trained caregiver, while the 128mg and 160mg pre-filled syringes may be self-injected by patients aged 12 and older after training; injections are given only by the subcutaneous route, never intravenously or intramuscularly.
Avoid Interactions
- Rivfloza (nedosiran) is not a cytochrome P450 enzyme inhibitor or inducer and is not a substrate or inhibitor of major drug transporters, so it is not expected to interact with most other medicines through these pathways; pyridoxine (vitamin B6), which is sometimes used in PH1, did not meaningfully change nedosiran levels in studies.
- Even so, always tell your healthcare provider and pharmacist about every prescription medicine, over-the-counter product, vitamin and herbal supplement you take, since Rivfloza is a newer therapy and interaction data remain limited.
- Do not mix Rivfloza with other injectable medicines in the same syringe, and use each vial or pre-filled syringe for a single dose only.
References
Frequently Asked Questions
Rivfloza (nedosiran) lowers urinary oxalate levels in children aged 9 and over and adults with primary hyperoxaluria type 1 (PH1), a rare genetic condition, when kidney function is relatively preserved. It is an FDA-approved siRNA therapy distributed by Novo Nordisk.
Rivfloza is given as one subcutaneous injection each month. The 80mg dose comes in a single-dose vial usually given by a healthcare professional or trained caregiver; the 128mg and 160mg doses come in pre-filled syringes that patients aged 12 and over may self-inject after training.
The main side effect of Rivfloza is injection site reactions - redness, pain, bruising or rash - reported in 1 in 5 patients. These are usually mild. Tell your healthcare provider if a reaction is severe, does not improve, or if you notice any new symptoms.
Rivfloza does not interact with most other medicines through the liver enzymes many drugs use, but always tell your healthcare provider and pharmacist about everything you take. Never mix Rivfloza with other injections in the same syringe, and use each vial or syringe only once.
Your healthcare provider will regularly check your urine and blood oxalate levels and monitor kidney function (eGFR) while you take Rivfloza, since it is not recommended if eGFR falls below 30 mL/min/1.73m2. Injection sites should be rotated and checked each month for reactions.
Rivfloza is approved for children aged 9 and older, but is not established in younger children. Pregnancy data are limited, and animal studies showed pregnancy loss at high doses, so it should be used in pregnancy only if clearly necessary.
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