Yes, Givosiran, marketed under the brand name Givlaari, is FDA approved. The U.S. Food and Drug Administration (FDA) approved Givosiran on November 20, 2019, for the treatment of acute hepatic porphyria (AHP) in adults.
Givosiran is a medication used to treat acute hepatic porphyria (AHP), a rare genetic disorder that can cause severe and potentially life-threatening attacks on the nervous system. These attacks can result in symptoms such as severe abdominal pain, nausea, vomiting, numbness, weakness, and mental status changes. AHP is more common in women during their child-bearing years.
Givosiran is indicated for the treatment of adults with acute hepatic porphyria. It helps to reduce the frequency and severity of attacks associated with this condition.
Givosiran is administered as a subcutaneous injection, usually given once per month. The dosage is based on the patient's actual body weight:
Common Side Effects
Serious Side Effects
Some side effects may necessitate delaying or permanently discontinuing treatment. These include:
Patients should inform their healthcare provider about all medications they are currently taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements, as some drugs can affect the blood levels of Givosiran or its efficacy.
Givosiran (Givlaari) is an FDA-approved treatment for acute hepatic porphyria (AHP) in adults. Approved in November 2019, it offers a significant advancement in managing this rare and debilitating condition by reducing the frequency and severity of porphyria attacks. Patients should closely follow their healthcare provider's instructions and undergo regular monitoring to ensure the safe and effective use of this medication.
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