Nedosiran

Nedosiran is a prescription medication indicated to lower urinary oxalate levels in children 9 years of age and older and adults with primary hyperoxaluria type 1 and relatively preserved kidney function (eg, eGFR 30 mL/min/1.73 m2 and more)

• Nedosiran is available under the following different brand names: Rivfloza

Common side effects of Nedosiran include:

• injection site reactions, such as reddening, pain, bruising, rash, or dimple at the site of injection

Serious side effects of Nedosiran include:

• not available

Rare side effects of Nedosiran include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Injectable SC solution

• 80 mg/0.5 mL (single-dose vial)
• 128 mg/0.8 mL (single-dose prefilled syringe)
• 160 mg/mL (single-dose prefilled syringe)

Hyperoxaluria

Adult dosage

• Dosing based on actual body weight
  • Weighing less than 50 kg: 128 mg (prefilled syringe, 0.8 mL) SC once monthly
  • Weighing 50 kg and more: 160 mg (prefilled syringe, 1 mL) SC once monthly

Pediatric dosage

• Dosing based on actual body weight
  • Children younger than 9 years: Safety and efficacy not established
  • Children aged between 9 and 11 years
  • Weighing less than 50 kg: 3.3 mg/kg (vial dose) SC once monthly, not to exceed 128 mg
  • Weighing 50 kg and more: 160 mg (prefilled syringe, 1 mL) SC once monthly
• Children aged 12 years and older
  • Weighing less than 50 kg: 128 mg (prefilled syringe, 0.8 mL) SC once monthly
  • Weighing 50 kg and more: 160 mg (prefilled syringe, 1 mL) SC once monthly

Dosage Considerations – Should be Given as Follows:

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Nedosiran has no noted severe interactions with any other drugs
• Nedosiran has no noted serious interactions with any other drugs
• Nedosiran has no noted moderate interactions with any other drugs
• Nedosiran has no noted minor interactions with any other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Nedosiran?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Nedosiran?”

Cautions

• None

Pregnancy and Lactation

• Available data from reports of pregnancy are insufficient to evaluate for a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes
• Lactation
  • There are no data on the presence of nedosiran in human or animal milk, its effects on breastfed children, or its effects on milk production