Lumasiran

Lumasiran is a prescription medication indicated for primary hyperoxaluria type 1 to lower urinary oxalate levels.

• Lumasiran is available under the following different brand names: Oxlumo

Common side effects of Lumasiran include:

• injection site reactions (redness, pain, itching, and swelling)
• abdominal pain

Serious side effects of Lumasiran include:

• hives
• difficulty breathing
• swelling of the face, lips, tongue, or throat

Rare side effects of Lumasiran 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 solution

• 94.5 mg/0.5 mL; single-dose vial for SC injection

Hyperoxaluria

Adult dosage

• Loading dose: 3 mg/kg SC once monthly x 3 doses
• Maintenance dose
  • Begin 1 month after the last loading dose
  • 3 mg/kg SC every 3 months

Pediatric dosage

• Loading dose
  • Children weighing less than 20 kg: 6 mg/kg SC once monthly × 3 doses  
  • Children weighing 20 kg and more: 3 mg/kg SC once monthly × 3 doses
• Maintenance dose
  • Begin 1 month after the last loading dose
  • Children weighing less than 10 kg: 3 mg/kg SC once monthly
  • Children weighing between 10 to 19 kg: 6 mg/kg SC once every 3 months
  • Children weighing 20 kg and more: 3 mg/kg SC once every 3 months

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.

• Lumasiran has no noted severe interactions with any other drugs.
• Lumasiran has no noted serious interactions with any other drugs.
• Lumasiran has no noted moderate interactions with any other drugs.
• Lumasiran 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 Lumasiran?”

Long-Term Effects

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

Cautions

• None

Pregnancy and Lactation

• No data available on the drug’s use in pregnant women to evaluate a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • There is no data on the drug’s presence in human milk or its effects on breastfed children and milk production