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For more information about our FDA-approved therapies, please see the Full Prescribing Information:

Vutrisiran: Hypersensitivity Reactions

Standard response letter on vutrisiran and hypersensitivity reactions.

Vutrisiran: Pain in Extremity

Standard response letter on vutrisiran and the adverse event of pain in extremity.

Efficacy and Safety of Vutrisiran and Patisiran

Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.

ALN-HTT02: Phase 1b Study

Standard response letter on the phase 1 study of ALN-HTT02.

Mivelsiran: cAPPricorn-1 Study

Standard response letter on mivelsiran and the phase 2 cAPPricorn-1 study in patients with sporadic or hereditary CAA

Givosiran: Use in Patients with Pre-Existing Renal Impairment

Standard response letter on the use of givosiran in patients with pre-existing renal impairment.

Givosiran: Post-Dose Monitoring

Standard response letter on givosiran and monitoring post-injection.

Givosiran: Mechanism of Action and Chemical Properties

Standard response letter on the mechanism of action and chemical properties of givosiran.

Vutrisiran: HELIOS-B Study

Standard response letter on vutrisiran and the HELIOS-B study, a phase 3 study evaluating the efficacy and safety of vutrisiran in patients with the cardiomyopathy of ATTR, including both hATTR and wtATTR.

Diagnosing AHP Infographic

This infographic discusses the clinical and demographic presentation of an AHP patient and how to assess for AHP diagnosis.

Lumasiran: ILLUMINATE-B Study Overview

Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-B, a study evaluating the efficacy and safety of lumasiran in infants and children less than 6 years old with PH1.

Lumasiran: Clinical Pharmacology

Standard Response Letter on lumasiran and its pharmacokinetic and pharmacodynamic properties.

Patisiran: Observation Period After Infusion

Standard Response Letter on the observational period after patisiran infusion in the APOLLO, APOLLO-B, Global OLE, and HELIOS‑A studies.

Patisiran: Management of Extravasation

Standard response letter on patisiran and management of extravasation. This medical information response contains information on extravasation prevention guidelines that were provided to patisiran clinical trial sites.

Givosiran: Pancreatitis

Standard response letter on givosiran and the adverse event of pancreatitis.

Vutrisiran: Use in Patients Undergoing Dialysis

Standard response letter on the use of vutrisiran in patients undergoing dialysis.

Vutrisiran: Pharmacokinetic and Pharmacodynamic Properties

Standard Response Letter on vutrisiran and its pharmacokinetic and pharmacodynamic properties.

Givosiran: Hemin Use

Standard response letter on givosiran and hemin use. This medical information response contains clinical data from the ENVISION study.

Patisiran: Management of Infusion-Related Reactions

Standard response letter on the management of infusion-related reactions in patisiran clinical studies.

Givosiran: Renal Effects

Standard response letter on renal effects observed with the use of givosiran.

Patisiran: Compatibility with Commonly Used Infusion Components

Standard response letter on patisiran and compatibility with commonly used infusion components based on a compatibility and stability study.

Givosiran: Anaphylactic Reactions and Hypersensitivity

Standard response letter on givosiran and hypersensitivity, including anaphylactic reactions, observed.

Vutrisiran: Orthostatic Hypotension

Standard response letter on the quantitative effect of vutrisiran on orthostatic hypotension in the HELIOS-A study, assessed using the postural blood pressure component of mNIS+7.

Vutrisiran: Cross-Reactivity with Patisiran

Standard response letter on the cross-reactivity between vutrisiran and patisiran.

Givosiran: CYP Enzyme Interactions

Standard response letter on CYP enzyme drug-drug interactions with givosiran.

For further information regarding your request, please connect with us by reaching out to your local Medical Science Liaison or contacting our Medical Information team.

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Vutrisiran: Hypersensitivity Reactions Standard response letter on vutrisiran and hypersensitivity reactions.

Vutrisiran: Pain in Extremity Standard response letter on vutrisiran and the adverse event of pain in extremity.

Efficacy and Safety of Vutrisiran and Patisiran Standard response letter on the efficacy and safety of vutrisiran and patisiran, summarizing data from the HELIOS-A study and the APOLLO study.

ALN-HTT02: Phase 1b Study Standard response letter on the phase 1 study of ALN-HTT02.

Mivelsiran: cAPPricorn-1 Study Standard response letter on mivelsiran and the phase 2 cAPPricorn-1 study in patients with sporadic or hereditary CAA

Givosiran: Use in Patients with Pre-Existing Renal Impairment Standard response letter on the use of givosiran in patients with pre-existing renal impairment.

Givosiran: Post-Dose Monitoring Standard response letter on givosiran and monitoring post-injection.

Givosiran: Mechanism of Action and Chemical Properties Standard response letter on the mechanism of action and chemical properties of givosiran.

Vutrisiran: HELIOS-B Study Standard response letter on vutrisiran and the HELIOS-B study, a phase 3 study evaluating the efficacy and safety of vutrisiran in patients with the cardiomyopathy of ATTR, including both hATTR and wtATTR.

Diagnosing AHP Infographic This infographic discusses the clinical and demographic presentation of an AHP patient and how to assess for AHP diagnosis.

Lumasiran: ILLUMINATE-B Study Overview Standard response letter on the lumasiran phase 3 clinical study ILLUMINATE-B, a study evaluating the efficacy and safety of lumasiran in infants and children less than 6 years old with PH1.

Lumasiran: Clinical Pharmacology Standard Response Letter on lumasiran and its pharmacokinetic and pharmacodynamic properties.

Patisiran: Observation Period After Infusion Standard Response Letter on the observational period after patisiran infusion in the APOLLO, APOLLO-B, Global OLE, and HELIOS‑A studies.

Patisiran: Management of Extravasation Standard response letter on patisiran and management of extravasation. This medical information response contains information on extravasation prevention guidelines that were provided to patisiran clinical trial sites.

Givosiran: Pancreatitis Standard response letter on givosiran and the adverse event of pancreatitis.

Vutrisiran: Use in Patients Undergoing Dialysis Standard response letter on the use of vutrisiran in patients undergoing dialysis.

Vutrisiran: Pharmacokinetic and Pharmacodynamic Properties Standard Response Letter on vutrisiran and its pharmacokinetic and pharmacodynamic properties.

Givosiran: Hemin Use Standard response letter on givosiran and hemin use. This medical information response contains clinical data from the ENVISION study.

Patisiran: Management of Infusion-Related Reactions Standard response letter on the management of infusion-related reactions in patisiran clinical studies.

Givosiran: Renal Effects Standard response letter on renal effects observed with the use of givosiran.

Patisiran: Compatibility with Commonly Used Infusion Components Standard response letter on patisiran and compatibility with commonly used infusion components based on a compatibility and stability study.

Givosiran: Anaphylactic Reactions and Hypersensitivity Standard response letter on givosiran and hypersensitivity, including anaphylactic reactions, observed.

Vutrisiran: Orthostatic Hypotension Standard response letter on the quantitative effect of vutrisiran on orthostatic hypotension in the HELIOS-A study, assessed using the postural blood pressure component of mNIS+7.

Vutrisiran: Cross-Reactivity with Patisiran Standard response letter on the cross-reactivity between vutrisiran and patisiran.

Givosiran: CYP Enzyme Interactions Standard response letter on CYP enzyme drug-drug interactions with givosiran.