Nedosiran Dosage

Medically reviewed by Drugs.com. Last updated on Mar 29, 2024.

Applies to the following strengths: 160 mg/mL; 128 mg/0.8 mL; 80 mg/0.5 mL

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)

Renal Dose Adjustments

Mild and Moderate Renal Dysfunction: No adjustment recommended.
Severe Renal Dysfunction: Data not available

Liver Dose Adjustments

Mild Liver Dysfunction: No adjustment recommended.
Moderate and Severe Liver Dysfunction: Data not available

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 9 years.

Dialysis

Data not available

Other Comments

Administration advice:

Dosing is based on actual body weight.
If a planned dose is missed, administer as soon as possible. If the dose has been missed for more than 7 days, administer as soon as possible, and resume monthly dosing from the most recently administered dose.
Patients 12 years and older may inject their dose using the pre-filled syringes. In patients younger than 12, administration by a healthcare professional or caregiver is recommended.
Administer by subcutaneous injection in the abdomen, at least 2 inches from the navel, or the upper thigh. Do not inject into a vein or into scarred or bruised skin.
Read the US FDA-approved patient labeling for further administration instructions.

Storage requirements:

Store refrigerated at 2C to 8C (36F to 46F)
If needed, it can be stored at 15C to 30C (59F to 86F) for a maximum of 28 days. Do not freeze.
Store in the original carton, away from direct heat and light.

Patient advice: