Drug Information

Givlaari

What is GIVLAARI?

(GIVLAARI) Givosiran is used to treat a certain inherited disorder (acute hepatic porphyria). This disorder causes a buildup of certain chemicals (porphyrins) in the body which can lead to liver and nerve problems. Givosiran works by reducing the amount of porphyrins in the body.

How should I use GIVLAARI?

This medication is given by injection under the skin by a health care professional. It is given as directed by your doctor, usually once a month. The dosage is based on your medical condition, weight, and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, mark the days on a calendar you need to receive this medication. Tell your doctor if your condition gets worse.

What should I tell my health care provider before I take GIVLAARI?

Before using givosiran, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding.

What may interact with GIVLAARI?

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

What if I miss a dose of GIVLAARI?

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

What side effects may I notice from receiving GIVLAARI?

Pain, redness, itching, or swelling of the skin at the injection site may occur. Nausea or tiredness may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), signs of kidney problems (such as change in the amount of urine). A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Where should I keep GIVLAARI?

Not applicable. This medication is given in a clinic or doctor's office and will not be stored at home.

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