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Frequently asked questions about GIVLAARI

There are probably a lot of things you want to know about GIVLAARI. Below you can find some answers to frequently asked questions. This information is not intended to replace discussions with your healthcare provider.

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  • GIVLAARI is a prescription medicine used to treat AHP in adults. There are 4 types of AHP:
    • Acute intermittent porphyria (AIP)
    • Hereditary coproporphyria (HCP)
    • Variegate porphyria (VP)
    • ALA-dehydratase deficient porphyria (ADP)
  • Most patients in GIVLAARI clinical studies had AIP, the most common type of AHP

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

If you miss a dose, talk to your doctor about scheduling your next dose as soon as possible.

GIVLAARI can cause liver and kidney problems.

  • 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 has not been studied in women who are pregnant. If you are pregnant or plan to become pregnant, it is important to discuss your treatment plan with your doctor.

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Important Safety Information 

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

GIVLAARI can cause:

  • Severe allergic reaction

    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.

  • Liver problems

    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.

  • Kidney problems

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

  • Injection site reactions

    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.

What are the common side effects of GIVLAARI?

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?

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


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