Eligibility Requirements

To be eligible to seek access to lumasiran through the early access program (EAP), participants must meet certain requirements, including, but not limited to:

• A documented diagnosis of PH1
• All ages
• Relatively preserved renal function (estimated glomerular filtration rate [eGFR] greater than 45 mL/min/1.73 m²) at screening
• Meet the requirements for urine oxalate excretion
• No clinically significant health concerns (with the exception of PH1)
• No clinically significant abnormal laboratory results at screening
• Have not received an investigational agent within 30 days before the first dose of lumasiran or are not in follow-up of another clinical study
• Have not previously or are not currently participating in a lumasiran clinical study
• No history of renal or liver transplant
• Not currently pregnant, planning a pregnancy, or breast-feeding or are of child-bearing potential and willing to use contraception

If you are a patient interested in participating, please speak with your physician about the potential benefits and risks of taking part in the program.

Only a licensed physician can request lumasiran. If you are a patient living in a country where lumasiran is not commercially available and are interested in seeking access to lumasiran through the early access program, please speak to your physician. Alnylam can only respond to a physician requesting access to lumasiran on behalf of a patient in his/her care.

If you are a physician who is seeking to obtain access to lumasiran for a patient in your care, please contact as follows:

• Requests from Canada should go to usmapcoordinators@clinigengroup.com
• Requests from outside Canada should go to managedaccess@clinigengroup.com

If you are a physician or patient and have a medical question, please contact medinfo@alnylam.com.