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ALIMENTARY TRACT AND METABOLISM › OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS › OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS › Various alimentary tract and metabolism products
nedosiran
A16AX25
Forms & Strengths
- Subcutaneous injection: 160 mg/0.5 mL in a single-dose pre-filled syringe
Adult Dosing
- Primary hyperoxaluria type 1 (PH1): 160 mg subcutaneously once monthly
Pediatric Dosing
- Pediatric patients aged 9 years and older with PH1: 160 mg subcutaneously once monthly
- Safety and efficacy in patients younger than 9 years have not been established
Indications
- Treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels in pediatric patients aged 9 years and older and adults
Mechanism of Action
- Small interfering RNA (siRNA) directed against hepatic lactate dehydrogenase A (LDHA)
- Silences the LDHA gene via RNA interference, reducing hepatic production of oxalate involved in PH1 pathophysiology
Contraindications
- History of severe hypersensitivity to nedosiran or any of its inactive ingredients
Adverse Reactions
- Injection site reactions (pain, erythema, pruritus)
- Upper respiratory tract infection
- Back pain
- Abdominal pain
Drug Interactions
- No formal clinical drug-interaction studies have been conducted
- Not a substrate, inhibitor, or inducer of cytochrome P450 enzymes, minimizing potential for metabolic drug interactions
Curated Content: Needs Vetting Before Put to Clinical Use