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Givosiran

Generic name: Givosiran [gi-VOE-si-ran]
Brand name: Givlaari
Dosage form: subcutaneous solution (189 mg/mL)
Drug class: Miscellaneous metabolic agents

What is Givosiran?

Givosiran can help adults suffering from acute hepatic porphyria.Acute hepatic porphyria (AHP) is a rare genetic disease that can lead to life-threatening attacks of the nervous system. The symptoms include nausea, vomiting, severe stomach pains, numbness, and mental changes. The disorder is most common among women who are pregnant.This medication guide does not list all possible uses of Givosiran.

Side effects of Givosiran

If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: hives, difficulty breathing, swelling of your lips, face, tongue, or throat.If you experience certain side effects, your injections could be delayed or discontinued permanently.

Some of the common side effects associated with givosiran include:

  • Nausea;
  • Pain, itching, or rash where an injection has been given

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Similar/related drugs

chlorpromazine, thorazine, hemin, givlaari, and panhematin

Warnings

Your next dose could be delayed, depending on the results of your blood tests.

Before you take this drug

If you have an allergy to givosiran, then it is best not to use it.Inform your doctor immediately if you plan to become pregnant.Givosiran is not known to harm an unborn child. Acute hepatic porphyria in pregnancy can cause serious health problems for both mother and child. This disorder can be treated without causing any harm to the child.Ask your doctor if you are concerned about any risks. You should consult your doctor if you are concerned about any risks.

How to take Givosiran?

Please read the instructions and all the guides that come with your medication. Sometimes your doctor will change the dose.Givosiran injections are usually given once a month.This injection will be administered by a healthcare provider.Before and during the treatment with givosiran, you will need to have frequent blood tests performed in order to monitor your liver function. The results may delay your next dose.You may also be required to have your kidney function checked.Givosiran dosage is based on your weight. Your dose may shift if your weight fluctuates significantly;

Details on dosage

Adult dose for porphyria:

Subcutaneously, 2.5 mg/kg once a month
Comments:
Dosing is determined by the actual weight of your body.
A healthcare professional should administer the medication.
Use: To treat acute hepatic porphyria.

What happens if I miss the dose?

Do not use two doses at once. Never use two doses in one go.

What happens if you overdose?

Overdoses are unlikely because givosiran will be administered by a health professional in a medical environment.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Interaction with other drug

It is sometimes not safe to take certain medications together. Some drugs may affect the blood levels of drugs that you are taking, increasing side effects or making them less effective.Other medications, such as prescription and over-the-counter medicines, vitamins, and herbal products, may also affect givosiran. Inform your doctor of all the medicines you are taking and those that you stop or start using.

 

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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