Lumasiran is used to treat a type of hyperoxaluria (high levels of oxalate in your urine). Oxalate is a natural chemical contained in the body and in certain foods. Too much oxalate in the urine can cause kidney stones or kidney failure.

Lumasiran is for use in adults and children of all ages.

Lumasiran may also be used for purposes not listed in this medication guide.

You may need to follow a special diet to help control your condition.

Lumasiran is injected under the skin.

A healthcare provider will give you this injection.

Lumasiran is usually given once every 1 to 3 months.

Lumasiran doses are based on weight in children. Your child's dose needs may change if the child gains or loses weight.

You may need to follow a special diet. Follow all instructions of your doctor or dietitian. Learn about the foods to eat or avoid to help control your condition.

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)

Use: For the treatment of primary hyperoxaluria type 1 (PH1) to lower urinary oxalate levels

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

10 to less than 20 kg:
-Loading dose: 6 mg/kg subcutaneously once a month for 3 doses
-Maintenance dose: 6 mg/kg subcutaneously every 3 months (quarterly)

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)

Use: For the treatment of PH1 to lower urinary oxalate levels

Tell your doctor if you are pregnant or breastfeeding.

Call your doctor for instructions if you miss an appointment for your lumasiran injection.

Since lumasiran is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include pain, redness, itching, or swelling where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.