Individual results may vary

Treatment with
GIVLAARI® (givosiran)

Individual results may vary

Treatment with
GIVLAARI® (givosiran)

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.

Safety profile of GIVLAARI

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Severe allergic reaction

GIVLAARI can cause a severe allergic reaction. 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.

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Liver problems

GIVLAARI can cause liver problems. Your doctor will check your liver function before and during treatment with GIVLAARI by doing blood tests. If these tests show abnormal results, your doctor or nurse will decide whether to temporarily interrupt or stop treatment with GIVLAARI.

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Kidney problems

GIVLAARI can cause kidney problems. Your doctor will check how your kidneys are working while you are using GIVLAARI.

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Injection site reactions

Reactions to GIVLAARI injections may happen during treatment. 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.

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Most common side effects

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.

 

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.

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.