What is Givlaari?
Givlaari (givosiran) is a medication used for the treatment of acute hepatic porphyria (AHP) in adults. It works by reducing the amount of a specific protein called aminolevulinic acid synthase 1 (ALAS1) in the liver, which is responsible for producing the porphyrin precursors that can cause attacks in AHP patients. Givlaari was approved by the United States Food and Drug Administration (FDA) in November 2019.
Who can prescribe Givlaari?
Givlaari can only be prescribed by healthcare professionals who are registered with a Risk Evaluation and Mitigation Strategy (REMS) program. This program is required by the FDA to ensure the safe use of Givlaari in AHP patients. Before prescribing Givlaari, healthcare professionals must complete the required training and certification process.
How is Givlaari taken?
Givlaari is administered as a subcutaneous injection once a month. The injection should be given by a healthcare professional who is trained in subcutaneous injection techniques. The dosage of Givlaari is based on the patient’s weight and is calculated by the healthcare professional.
What are the common side effects of Givlaari?
Common side effects of Givlaari include nausea, vomiting, injection site reactions, and fatigue. In clinical trials, most side effects were mild to moderate in severity and resolved on their own.
What are the precautions that should be taken while using Givlaari?
Givlaari should not be used in patients with severe liver disease or severe renal impairment. Patients with hypersensitivity to Givlaari or its components should not use it. Women who are pregnant or breastfeeding should not use Givlaari.
Conclusion
Givlaari is a medication used for the treatment of acute hepatic porphyria in adults. It can only be prescribed by healthcare professionals who are registered with a REMS program. The medication is administered as a subcutaneous injection once a month and the dosage is based on the patient’s weight. Common side effects of Givlaari include nausea, vomiting, injection site reactions, and fatigue. Medical professionals must adhere to precautions and contraindications while prescribing Givlaari to patients.
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