Individual results may vary

Lina, patient with AIP

Individual results may vary

Lina, patient with AIP

What is GIVLAARI® (givosiran)?

GIVLAARI is a medicine used to treat acute hepatic porphyria (AHP) in adults. There are 4 types of AHP: acute intermittent porphyria (AIP), variegate porphyria (VP), hereditary coproporphyria (HCP), and ALA-dehydratase deficient porphyria (ADP).

How GIVLAARI works

In people with AHP, the heme production process in the liver does not work properly because of a genetic mutation. In the liver, this process is controlled by an enzyme called aminolevulinic acid synthase 1 (ALAS1).

When ALAS1 is activated, the heme production process is unable to keep up. This causes toxic substances called aminolevulinic acid (ALA) and porphobilinogen (PBG) to build up. ALA and PBG are associated with attacks and other AHP symptoms.

GIVLAARI reduces the amount of ALAS1 in the liver, which leads to a reduction in levels of the toxins ALA and PBG.

In the liver, GIVLAARI reduces the level of ALAS1.

Reduction of ALAS1 icon
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This leads to a reduction in levels of toxins ALA and PBG.

Icon of toxins ALA and PBG in a liver

ALA

PBG

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ALA and PBG are associated with attacks and other AHP symptoms.

How GIVLAARI is given

GIVLAARI is given once a month as a subcutaneous injection (under the skin) by a healthcare professional. If a dose is missed, they should administer GIVLAARI as soon as possible. Your doctor may adjust your dose if you experience side effects.

Monthly appointment calendar
GIVLAARI is given once a month as a subcutaneous injection (under the skin) by a healthcare professional.
 

IMPORTANT SAFETY INFORMATION

Do not use GIVLAARI if you have ever had a severe allergic reaction to GIVLAARI.

  • Tell your doctor or nurse right away if you experience any of the following signs or symptoms of a severe allergic reaction during treatment:

    • Swelling – mainly of the lips, tongue or throat which makes it difficult to swallow or breathe
    • Breathing problems or wheezing
    • Feeling dizzy or fainting
    • Rash or hives
    • Itching

    If you have a severe allergic reaction, your doctor or nurse will stop GIVLAARI treatment right away and you may need to take other medicines to control the symptoms.

  • Your doctor will check your liver function by doing blood tests:

    • Before you start using GIVLAARI
    • Once a month for the first 6 months of treatment
    • And when they think it is needed

    If these tests show abnormal results, your doctor or nurse will decide whether to temporarily interrupt or stop treatment with GIVLAARI.

  • Your doctor will check how your kidneys are working while you are using GIVLAARI.

  • GIVLAARI is given as an injection under the skin (called a “subcutaneous injection”). Reactions to this injection may happen during treatment with GIVLAARI.

    Tell your doctor or nurse right away if you experience any of the following symptoms of an injection site reaction during treatment: redness, pain, itchiness, rash, discoloration, or swelling around the injection site.

  • GIVLAARI may cause increased levels of homocysteine (a type of amino acid) in your blood. Your doctor will check your homocysteine levels before and during treatment by doing blood tests. If your levels are increased, your doctor may check your folate, vitamins B12 and B6, and tell you to take a vitamin B6 supplement.

The most common side effects of GIVLAARI are nausea and injection site reactions. These are not all the possible side effects of GIVLAARI. Talk to your doctor about side effects that you experience. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-8 00-FDA -1088.


WHAT IS GIVLAARI® (givosiran)?

GIVLAARI is a prescription medicine used to treat acute hepatic porphyria (AHP) in adults.


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