Usual Adult Dose for Primary Hyperoxaluria

At least 20 kg:

• Loading dose: 3 mg/kg subcutaneously once a month for 3 doses
• Maintenance dose: 3 mg/kg subcutaneously every 3 months (quarterly)

Usual Pediatric Dose for Primary Hyperoxaluria

Less than 10 kg:

• Loading dose: 6 mg/kg subcutaneously once a month for 3 doses
• Maintenance dose: 3 mg/kg subcutaneously once a month

• Loading dose: 6 mg/kg subcutaneously once a month for 3 doses
• Maintenance dose: 6 mg/kg subcutaneously every 3 months (quarterly)

• Loading dose: 3 mg/kg subcutaneously once a month for 3 doses
• Maintenance dose: 3 mg/kg subcutaneously every 3 months (quarterly)

Renal Dose Adjustments

Estimated GFR at least 30 mL/min/1.73 m2: No adjustment recommended.
Estimated GFR less than 30 mL/min/1.73 m2: Data not available

Liver Dose Adjustments

Mild or moderate liver dysfunction: No adjustment recommended.
Severe liver dysfunction: Data not available

Comments:

• Mild liver dysfunction: Total bilirubin greater than the upper limit of normal (ULN) to 1.5 times the ULN (1.5 x ULN) or AST greater than ULN
• Moderate liver dysfunction: Total bilirubin greater than 1.5 to 3 x ULN with any AST
• Severe liver dysfunction: Total bilirubin greater than 3 x ULN with any AST

Precautions

CONTRAINDICATIONS: None

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• For subcutaneous use
• Divide injection volumes greater than 1.5 mL equally into multiple syringes.
• Use a sterile 0.3-mL syringe for volumes less than 0.3 mL.
• Administer subcutaneous injection into the abdomen, thigh, or the side/back of the upper arms; rotate injection sites; do not inject into scar tissue or reddened/inflamed/swollen areas.
• If injecting into the abdomen, avoid the area around the navel.
• If more than 1 injection is needed for a single dose, ensure injection sites are at least 2 centimeters apart.
• If dose is delayed/missed, administer as soon as possible; resume prescribed monthly or quarterly dosing from most recently administered dose.

• Store at 2C to 25C (36F to 77F).
• Store in original container until ready for use.

• Dosing is based on actual body weight.
• This drug should be administered by a healthcare professional.