Alnylam Assist Dedicated Case Manager

Your Patient’s Dedicated Case Manager, Shontae

Alnylam Assist® Case Managers Support
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Alnylam Assist® is comprised of dedicated, passionate individuals with diverse backgrounds and expertise in healthcare patient support and delivery. You are encouraged to contact them directly.

Alnylam Assist™ Case Managers

Case Managers

Alnylam Assist® is committed to the patient experience of those who start treatment with GIVLAARI™ (givosiran). Each patient is partnered with a dedicated, personal Case Manager who can provide support and assistance throughout treatment:

Insurance benefit verification and connecting with a Field Reimbursement Specialist

Financial assistance and affordable access options for eligible patients*

Facilitation of product orders

Connecting patients with a Patient Education Liaison (PEL)

*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.

Patient Education Liaisons

Patient Education Liaisons (PELs) are professionals with backgrounds in nursing or genetic counseling who are experienced in educating patients and their families about matters related to hereditary acute hepatic porphyria (AHP). PELs support patients and their families in a number of ways:

Engaging patients and families with educational resources

Answering questions about AHP and treatment with GIVLAARI

Providing customized education, including one-on-one education or family meetings

Field Reimbursement Directors

Field Reimbursement Directors (FRDs) are experienced professionals who provide education on the reimbursement process. FRDs can assist with:

GIVLAARI billing and coding requirements

Chart documentation best practices

Payer requirements

Payer issue identification and resolution

Personalized Support Throughout the Treatment Process

What is the enrollment process for the Alnylam Assist® program?

Everything you need to know about the enrollment process and its requirements, including what your patients need to know, can be found on this site. View the enrollment process ›

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IMPORTANT SAFETY INFORMATION

Contraindications

GIVLAARITM (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.