Rivfloza (nedosiran sodium)
Oxalosis Agent - Oxalate Inhibitor Subcutaneous Syringe (Ml); Subcutaneous Vial (Ml)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Nedosiran is a small interfering RNA (siRNA) that targets LDH A.
Nedosiran is a synthetic, double-stranded small interfering RNA (siRNA) that is conjugated to an N-acetyl D-galactosamine (GalNAc) ligand. The GalNAc ligand ensures that the drug is delivered to hepatocytes. Following subcutaneous administration and delivery to the liver, nedosiran degrades LDH A messenger RNA via RNA interference, resulting in reduced levels of hepatic LDH A.
This reduced level of LDH A in the liver causes a decrease in LDH enzyme activity, which in turn decreases conversion of glyoxylate to oxalate in the liver and ultimately reduces oxalate levels in the urine and plasma.
Nedosiran exhibits dose-proportional increases in plasma exposure following single subcutaneous doses ranging from 1.5-6 mg/kg, and has time-independent pharmacokinetics with multiple monthly doses of 160 mg (if actual body weight >=50 kg), 128 mg (if actual body weight <50 kg), or 3.3 mg/kg (if 6-11 years of age). Nedosiran does not accumulate in plasma after repeated monthly administration. The time to maximum concentration of nedosiran ranges from 2-12 hours with a median of 6 hours.
Nedosiran is 85.6% protein bound. The mean elimination half-life is 15 hours. Nedosiran is primarily metabolized by endonucleases or exonucleases to oligonucleotides.
Following administration of a dose of nedosiran, approximately 27% of the administered dose is excreted unchanged into the urine within 24 hours. No clinically significant differences in pharmacokinetics or pharmacodynamics of nedosiran were observed based on age (2-73 years), sex, race, or ethnicity.
Generic name: nedosiran sodium
Drug class: Oxalosis Agent - Oxalate Inhibitor
Therapeutic class: Genitourinary Therapy
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
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Indications
The following indications are listed for Rivfloza:
- Primary Hyperoxaluria Type I
Also known as: 2-Oxoglutarate Glyoxylate Carboligase Deficiency, Alanine-Glyoxylate Aminotransferase Deficiency, Glycolic Aciduria, Hepatic Agt Deficiency, Oxalosis Type I, Primary Hyperoxaluria Type 1.
Dosing
Dosage of nedosiran sodium is expressed in terms of nedosiran.
Nedosiran sodium is administered by subcutaneous injection. The drug is commercially available in a single-dose prefilled syringe and a single-dose vial that does not require reconstitution or dilution before administration.
Nedosiran prefilled syringes can be administered by a healthcare professional, caregiver, or patient >=12 years of age; a healthcare professional or caregiver may administer nedosiran prefilled syringes in patients 2-<12 years of age weighing >=39 kg. Nedosiran vials are intended to be used under the guidance or supervision of a healthcare professional. However, a caregiver may administer doses from the vials to pediatric patients if deemed appropriate by a healthcare professional, and with medical follow-up as needed, after receiving proper training on how to prepare the vials for administration.
Administer nedosiran by subcutaneous injection into the abdomen (>=2 inches from the navel) or upper thigh, and avoid administration into a vein or into scarred or bruised skin. Following administration, discard any unused portion of the drug.
If a planned dose of nedosiran is missed, administer the missed dose as soon as possible. If the planned dose is missed by >7 days, resume monthly dosing from the time of the most recently administered dose.
Store nedosiran prefilled syringes and vials in their original container, away from light and direct heat, and refrigerated at 2-8degreesC until ready for use; do not freeze. If needed, nedosiran prefilled syringes and vials can be stored in their original container, away from light and direct heat, at room temperature (15-30degreesC) for a maximum of 28 days (4 weeks).
| Drug label | Dosing type | Instructions |
|---|---|---|
| Rivfloza 160 Mg/Ml Syringe | Maintenance | Inject 160 mg by subcutaneous route once a month. |
| Rivfloza 128 Mg/0.8 Ml Syringe | Maintenance | Inject 128 mg by subcutaneous route once a month. |
No dosing information is available for this tab.
Drug interactions
Nedosiran is not an inhibitor or inducer of cytochrome P-450 (CYP) enzymes, and is not a substrate or inhibitor of drug efflux and uptake transporters.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
*None.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
- No disease contraindications
Adverse reactions
The most common adverse reaction with nedosiran (reported in >=20% of patients in clinical trials) is injection site reactions.
There are no severe adverse reactions for this drug.
More Frequent
- Injection site erythema
- Injection site pain
- Injection site sequelae
Precautions
No enhanced messaging available.
Safety and efficacy of nedosiran have been established in pediatric patients >=2 years of age based on evidence from an adequate and well-controlled trial conducted in adults and pediatric patients >=9 years of age and a single-arm study in pediatric patients 2 to <12 years of age.
Safety and efficacy of nedosiran have not been established in pediatric patients <2 years of age.
Insufficient data are available to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes with the use of nedosiran in pregnancy. In animal studies, no adverse developmental effects were found when nedosiran was administered subcutaneously to pregnant mice at 58 times the maximum recommended human dose (MRHD). Subcutaneous administration of nedosiran to pregnant rabbits during organogenesis resulted in increased fetal loss and adverse developmental effects (cardiovascular and skeletal malformations). However, nedosiran is not pharmacologically active in mice or rabbits and the cause for such observed toxicities is unclear.
It is not known whether nedosiran is distributed into human milk. The effects of the drug on breast-fed infants or on the production of milk are also unknown. Consider the developmental and health benefits of breastfeeding along with the mother's need for nedosiran and any potential adverse effects on the breast-fed child from nedosiran or the underlying maternal condition.
No dosage adjustment is recommended in geriatric patients.
Clinical studies of nedosiran did not include patients >=65 years of age to determine whether they respond differently from younger patients. The manufacturer does not recommend dosage adjustment of nedosiran in geriatric patients.
ICD codes
| Code | Type | Description |
|---|---|---|
| Primary hyperoxaluria type I | ||
| E72.53 | ICD10CM | Primary hyperoxaluria |
| E72.530 | ICD10CM | Primary hyperoxaluria, type 1 |
| E72.538 | ICD10CM | Other specified primary hyperoxaluria |
| E72.539 | ICD10CM | Primary hyperoxaluria, unspecified |
ICD code information from First Databank (FDB).
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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