Comprehensive medication guide to Givlaari including estimated pricing, availability information, side effects, and how to find it in stock at your local pharmacy.
Estimated Insurance Pricing
With commercial insurance and enrollment in the Alnylam Assist® Commercial Copay Program, out-of-pocket costs may be significantly reduced or eliminated. Without copay assistance, specialty-tier cost sharing can be $5,000+ per month. Medicare patients benefit from the $2,000 annual Part D out-of-pocket cap (effective 2025) and may also be eligible for Part B coverage if administered in a physician's office.
Estimated Cash Pricing
Givlaari costs approximately $39,000–$43,000 per single-dose vial at list price, translating to roughly $575,000 per year. No generic is available. Cash pay is effectively inaccessible without manufacturer assistance; Alnylam Assist® Patient Assistance Program provides free medication to eligible uninsured patients who meet financial criteria.
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Givlaari (givosiran) is an FDA-approved prescription medication for the treatment of adults with acute hepatic porphyria (AHP), a group of rare genetic diseases that cause life-threatening neurovisceral attacks. It was developed by Alnylam Pharmaceuticals and approved by the FDA on November 20, 2019 — becoming the first disease-modifying therapy to target the root cause of AHP at the genetic level.
AHP encompasses four types: acute intermittent porphyria (AIP), variegate porphyria (VP), hereditary coproporphyria (HCP), and ALA dehydratase deficient porphyria (ADP). In all of these conditions, genetic mutations disrupt heme production in the liver, leading to toxic buildup of the compounds ALA and PBG, which trigger attacks involving severe abdominal pain, neurological symptoms, muscle weakness, seizures, and potentially fatal respiratory failure.
Givlaari is given once monthly as a subcutaneous injection at a dose of 2.5 mg/kg of body weight. It must be administered by a healthcare professional. In the pivotal ENVISION clinical trial, Givlaari reduced porphyria attacks by approximately 70% compared to placebo, and at 36 months of follow-up, 86–96% of patients experienced zero attacks in the final 3 months. AHP affects an estimated 1 in 50,000 people and is more common in women during their childbearing years.
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Givlaari is a small interfering RNA (siRNA) therapeutic that uses RNA interference (RNAi) — a naturally occurring gene-silencing mechanism — to reduce levels of the ALAS1 enzyme in liver cells. ALAS1 (delta-aminolevulinate synthase 1) is the enzyme that controls the first and rate-limiting step of heme production. When ALAS1 is overactivated in people with AHP (by triggers such as fasting, alcohol, certain medications, or hormonal changes), it causes a toxic buildup of ALA and PBG that triggers attacks.
Givlaari works by delivering a synthetic double-stranded RNA molecule into liver cells, where it activates the RISC complex to find and degrade ALAS1 messenger RNA (mRNA). With less mRNA, the liver produces less ALAS1 enzyme, lowering the flow through the heme pathway and reducing ALA and PBG levels. This reduces attack frequency without modifying the underlying DNA.
Liver-specific delivery is achieved through a GalNAc targeting ligand attached to the siRNA. Hepatocytes (liver cells) express high levels of asialoglycoprotein receptors (ASGPR) that bind GalNAc with high affinity, directing Givlaari specifically to the liver after subcutaneous injection. This targeted delivery system enables the once-monthly dosing schedule and allows subcutaneous (rather than intravenous) administration.
189 mg/mL — subcutaneous injection (single-dose vial)
Standard dose: 2.5 mg/kg once monthly administered by healthcare professional. Dose reduction to 1.25 mg/kg if significant ALT elevation occurs.
Givlaari is not on the FDA's official drug shortage list, but it is genuinely difficult to access for many patients. The medication is distributed through a limited specialty pharmacy network — only CVS Specialty and Accredo are designated in-network specialty pharmacies, with McKesson as the exclusive specialty distributor. This means Givlaari cannot be obtained at any retail or independent pharmacy.
Beyond distribution constraints, Givlaari's list price of approximately $575,000 per year means that every major insurer requires prior authorization before covering a single dose. Most payers also require step therapy (documented prior hemin use) and specialist prescriber involvement. Prior authorization reviews take 15–30 days on average, and denials are common. Annual renewals require ongoing laboratory monitoring. These structural barriers can create significant treatment gaps even without any manufacturing shortage.
If you are having trouble locating where to receive your Givlaari injection or which specialty pharmacy has your prescription, medfinder contacts specialty pharmacies and clinical administration sites on your behalf to find out who can fill and administer your prescription — and texts you the results.
Givlaari is not a controlled substance, so there are no DEA scheduling requirements for prescribers. However, most major insurance plans require Givlaari to be prescribed by or in consultation with a physician who specializes in acute hepatic porphyria or related conditions. This prescriber qualification is an insurance prior authorization requirement, not a legal DEA mandate.
The following specialties are recognized by payers as eligible prescribers of Givlaari:
Telehealth consultations are available through some academic porphyria centers for patients in rural areas or those who cannot travel to a specialist center. Telehealth can facilitate the specialist consultation needed for prior authorization and ongoing management, though the injection itself must be administered in person. The American Porphyria Foundation (porphyriafoundation.org) and Alnylam Assist® (1-833-256-2748) can help patients find a qualified prescriber near them.
No. Givlaari (givosiran) is not a controlled substance. It does not appear on the DEA's schedule of controlled substances (Schedules I–V). There are no federal restrictions on refills or prescription quantities based on controlled substance status.
However, Givlaari is a specialty medication that requires prior authorization from all major insurers, a specialist prescriber, and access to a limited specialty pharmacy distribution network. These are administrative and cost-related barriers — not regulatory scheduling restrictions. Prescriptions may be transmitted electronically or by fax, and there are no special prescription pads or state-level quantity limits based on scheduling.
The following side effects occurred in more than 20% of patients in clinical trials:
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Panhematin (hemin for injection)
FDA-approved IV hemin therapy by Recordati Rare Diseases; treats acute AHP attacks and can be used off-label for prophylaxis. Lower cost than Givlaari but requires IV infusion; associated with vein damage and coagulopathy with repeated use.
Glucose/carbohydrate loading
Oral or IV glucose administration for mild acute attacks; suppresses ALAS1 via insulin-mediated PGC-1α inhibition. Not effective for moderate or severe attacks; supportive measure only.
GnRH analogues
Used off-label in women with cyclical AHP attacks tied to the menstrual cycle; suppresses hormonal fluctuations that trigger attacks. Requires specialist supervision.
Liver transplantation
Reserved for severe, refractory AHP unresponsive to other treatments; corrects the hepatic enzyme deficiency but carries significant surgical risk and requires lifelong immunosuppression.
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CYP1A2 substrates (theophylline, clozapine, olanzapine, alosetron, tizanidine)
majorGivlaari inhibits CYP1A2, increasing plasma concentrations of substrates by up to 3.1-fold. Avoid sensitive CYP1A2 substrates or reduce doses per prescribing information.
CYP2D6 substrates (aripiprazole, brexpiprazole, atomoxetine, amitriptyline, codeine)
majorGivlaari inhibits CYP2D6, increasing plasma concentrations of substrates by up to 2.4-fold. Avoid sensitive CYP2D6 substrates or reduce doses per prescribing information.
Fezolinetant (Veozah)
majorContraindicated. Givlaari significantly increases fezolinetant exposure via CYP1A2 inhibition, risking serious adverse effects.
Porphyria attack-triggering medications (barbiturates, sulfonamides, most anti-epileptics, rifampin)
majorThese medications can trigger AHP attacks independent of Givlaari's CYP interaction profile. Check American Porphyria Foundation drug list before prescribing any new medication to an AHP patient.
Givlaari represents a genuine breakthrough for people living with acute hepatic porphyria. For decades, the only option for preventing attacks was off-label prophylactic hemin — an intravenous infusion that required repeated IV access and caused its own complications over time. Givlaari's once-monthly subcutaneous injection, grounded in precision RNA interference technology, reduced attacks by approximately 70% in clinical trials and enabled most patients to achieve near-complete attack suppression with long-term use.
The challenge with Givlaari is not its effectiveness — it is access. At $575,000 per year, it requires prior authorization from every major payer, a specialist prescriber, and distribution through a limited specialty pharmacy network. Patients and families must be prepared to navigate this system proactively: enrolling in Alnylam Assist®, maintaining monitoring labs, renewing prior authorizations on time, and appealing denials when they occur.
If you or someone you care for has been prescribed Givlaari and needs help locating a specialty pharmacy or administration site, medfinder contacts specialty pharmacies and clinical sites on your behalf and texts you the results — helping ensure that access challenges don't become dangerous treatment gaps.
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