Givosiran

Givosiran is used to treat acute hepatic porphyria in adults.

Acute hepatic porphyria is a rare genetic condition that can lead to dangerous attacks affecting the nervous system. Symptoms can include severe stomach pain, nausea, vomiting, numbness, weakness, or changes in mental status. This condition is more often seen in women during their child-bearing years.

Givosiran may also be used for reasons not mentioned in this medication guide.

Follow all directions and read all medication guides or instruction sheets. Your doctor may change your dose from time to time.

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 how well your liver is working 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 your weight. Your dose may need to change if you gain or lose weight.

You will need to have blood tests often, and your next dose might be postponed depending on the results.

You should not use givosiran if you are allergic to it.

Tell your doctor if you are pregnant or planning 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 for both mother and baby. The benefit of treating this disorder may be more important than any risks to the baby.

It may not be safe to breastfeed while using givosiran. Ask your doctor about any risks.

Get emergency medical help if you notice signs of an allergic reaction: hives; trouble breathing; swelling of your face, lips, tongue, or throat.

Your injections may be delayed or stopped permanently if you experience certain side effects.

Common side effects of givosiran may include:

• nausea; or
• pain, itching, rash, discoloration, or swelling at the injection site.

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.

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 health care professional.Use: For the treatment of acute hepatic porphyria (AHP)

Get the missed injection as soon as you can, and then return to your regular injection schedule. Do not use two doses at the same time.

Since givosiran is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes it is not safe to use certain medications together. Some drugs can change the blood levels of other medications 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.