Getting Started

Help your patients access GIVLAARI® (givosiran) with Alnylam Assist®

To make the process convenient for your patient, Alnylam Assist® provides 3 separate options
for initiating and completing the Start Form.

 

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Electronic Start Form

Complete and submit the Electronic Start Form online with your patient

OR

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Downloadable Start Form

Print, complete with your patient, then fax the Start Form to 1-833-256-2747

OR

DocuSign Start Form icon

DocuSign Start Form

Begin the Start Form, then send to your patient via email to complete their portion
See DocuSign Instructions

What happens next:

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Your patient's dedicated Case Manager will reach out to you and your patient within 1-2 business days of receiving a completed Start Form

Alnylam Assist® personalized services for patients on treatment icon

The Alnylam Assist® team will facilitate acquisition of GIVLAARI for your patient via specialty distributor or specialty pharmacy

Alnylam Assist® provides personalized support for your patients throughout the treatment process

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A dedicated Case Manager

Alnylam Assist® will connect patients with a dedicated Alnylam Case Manager who can provide personalized support throughout the GIVLAARI treatment process.

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Disease and product education

Patient Education Liaisons (PELs) are available to help patients gain a better understanding of acute hepatic porphyria.

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Benefit verification

Coverage for GIVLAARI will vary by plan and by patient. Alnylam Assist® can help determine patient-specific coverage requirements.

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Financial assistance

Eligible patients* may qualify for the Alnylam Assist® Quick Start Program, Patient Assistance Program (PAP), or Commercial Copay Program.

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Treatment coverage

Alnylam Assist® can explain the requirements and processes for prior authorizations, claims, and appeals.

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Coding and billing

A Field Reimbursement Director can provide education about billing, coding, and the reimbursement process for GIVLAARI.

Clickable link to learn more information at www.alnylamassist.com.

Monday–Friday, 8AM–6PM ET

phone icon: 1-833-256-2748  | phone icon: 1-833-256-2747

To learn more,

visit www.AlnylamAssist.com.

*Patients must meet specified eligibility criteria to qualify for assistance. Alnylam reserves the right to make eligibility determinations and to modify or discontinue the program at any time.

 

IMPORTANT SAFETY INFORMATION

Contraindications

GIVLAARI® (givosiran) is contraindicated in patients with known severe hypersensitivity to givosiran. Reactions have included anaphylaxis.

Anaphylactic Reaction

Anaphylaxis has occurred with GIVLAARI treatment (<1% of patients in clinical trials). Ensure that medical support is available to appropriately manage anaphylactic reactions when administering GIVLAARI. Monitor for signs and symptoms of anaphylaxis. If anaphylaxis occurs, immediately discontinue administration of GIVLAARI and institute appropriate medical treatment.

Hepatic Toxicity

Transaminase elevations (ALT) of at least 3 times the upper limit of normal (ULN) were observed in 15% of patients receiving GIVLAARI in the placebo-controlled trial. Transaminase elevations primarily occurred between 3 to 5 months following initiation of treatment.

Measure liver function tests prior to initiating treatment with GIVLAARI, repeat every month during the first 6 months of treatment, and as clinically indicated thereafter. Interrupt or discontinue treatment with GIVLAARI for severe or clinically significant transaminase elevations. In patients who have dose interruption and subsequent improvement, reduce the dose to 1.25 mg/kg once monthly. The dose may be increased to the recommended dose of 2.5 mg/kg once monthly if there is no recurrence of severe or clinically significant transaminase elevations at the 1.25 mg/kg dose.

Renal Toxicity

Increases in serum creatinine levels and decreases in estimated glomerular filtration rate (eGFR) have been reported during treatment with GIVLAARI. In the placebo-controlled study, 15% of patients receiving GIVLAARI experienced a renally-related adverse reaction. The median increase in creatinine at Month 3 was 0.07 mg/dL. Monitor renal function during treatment with GIVLAARI as clinically indicated.

Injection Site Reactions

Injection site reactions were reported in 25% of patients receiving GIVLAARI in the placebo-controlled trial. Symptoms included erythema, pain, pruritus, rash, discoloration, or swelling around the injection site. One (2%) patient experienced a single, transient, recall reaction of erythema at a prior injection site with a subsequent dose administration.

Drug Interactions

Concomitant use of GIVLAARI increases the concentration of CYP1A2 or CYP2D6 substrates, which may increase adverse reactions of these substrates. Avoid concomitant use of GIVLAARI with CYP1A2 or CYP2D6 substrates for which minimal concentration changes may lead to serious or life-threatening toxicities. If concomitant use is unavoidable, decrease the CYP1A2 or CYP2D6 substrate dosage in accordance with approved product labeling.

Adverse Reactions

The most common adverse reactions that occurred in patients receiving GIVLAARI were nausea (27%) and injection site reactions (25%).

INDICATION

GIVLAARI is indicated for the treatment of adults with acute hepatic porphyria (AHP).

For additional information about GIVLAARI, please see full Prescribing Information.