What is givosiran?
Givosiran is used to treat acute hepatic porphyria in adults.
Acute hepatic porphyria is a rare genetic disorder that can cause life-threatening attacks on the nervous system. Symptoms include severe stomach pain, nausea and vomiting, numbness, weakness, or mental status changes. This disorder is more common in women during their child-bearing years.
Givosiran may also be used for purposes not listed in this medication guide.
You will need frequent blood tests and your next dose may be delayed based on the results.
Before taking this medicine
You should not use givosiran if you are allergic to it.
Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether givosiran will harm an unborn baby. However, having acute hepatic porphyria during pregnancy may cause serious medical problems in both mother and baby. The benefit of treating this disorder may outweigh any risks to the baby.
It may not be safe to breastfeed while using givosiran. Ask your doctor about any risk.
How should I take givosiran?
Follow all directions and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Givosiran is injected under the skin, usually once per month.
A healthcare provider will give you this injection.
You will need frequent blood tests to check your liver function before and during treatment with givosiran. Your next dose may be delayed based on the results.
Your kidney function may also need to be checked.
Givosiran doses are based on weight. Your dose needs may change if you gain or lose weight.
What happens if I miss a dose?
Get the missed injection as soon as possible, and then go back to your regular injection schedule. Do not use two doses at one time.
What happens if I overdose?
Since givosiran is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.
What should I avoid while taking givosiran?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Givosiran side effects
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Your injections may be delayed or permanently discontinued if you have certain side effects.
Common side effects of givosiran may include:
pain, itching, rash, discoloration, or swelling where an injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Givosiran dosing information
Usual Adult Dose for Porphyria:
2.5 mg/kg subcutaneously once a month
-Dosing is based on actual body weight.
-Administration should be performed by a healthcare professional.
Use: For the treatment of acute hepatic porphyria (AHP).
What other drugs will affect givosiran?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may affect givosiran, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
More about givosiran
- Side effects
- Drug interactions
- Dosage information
- During pregnancy
- En español
- Drug class: miscellaneous metabolic agents
Related treatment guides
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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