Givosiran

Generic name: Givosiran
Brand names: Givlaari
Dosage form: subcutaneous solution (189 mg/mL)
Drug class: Miscellaneous metabolic agents

Usage of 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.

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:

nausea; or

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.

Before taking Givosiran

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.

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How to use Givosiran

Usual Adult Dose for Porphyria:

2.5 mg/kg suBCutaneously once a monthComments:-Dosing is based on actual body weight. -Administration should be performed by a healthcare professional.Use: For the treatment of acute hepatic porphyria (AHP).

Warnings

You will need frequent blood tests and your next dose may be delayed based on the results.

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.

Disclaimer

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