Amvuttra

About Vutrisiran

• Amvuttra received Food and Drug Administration (FDA) approval on June 13, 2022. 
• Amvuttra is a transthyretin-directed small interfering RNA that belongs to the class of drugs known as RNAi agents. 
• Amvuttra is a small interfering RNA directed towards transthyretin, intended for treating polyneuropathy associated with hereditary transthyretin-mediated amyloidosis in adults.
• Amvuttra is designed to bind to TTR mRNA, initiating RNA interference, a process that facilitates the degradation of mRNA. This action prevents the production of the dysfunctional transthyretin protein associated with familial amyloid polyneuropathy (FAP).
• Hereditary transthyretin amyloidosis (hATTR) with polyneuropathy, previously referred to as Familial Amyloid Polyneuropathy, is a rare genetic condition resulting from mutations in the gene responsible for encoding transthyretin (TTR). 
• This disorder is identified by the widespread extracellular deposition of amyloid across multiple systems, causing dysfunction in various organs and tissues.
• Before starting the treatment it is mandatory to inform about all the pre-existing medical conditions to your health care profession. 

Strength: 

Amvuttra is available as 25 mg/0.5 mL in a single-dose prefilled syringe.

Recommended Dosage:

Amvuttra is exclusively intended for subcutaneous administration and should be administered by a healthcare professional. To prepare the syringe, allow it to reach room temperature if stored in a cold condition and visually inspect the drug solution for clarity and integrity before injection. Verify the syringe’s condition, including checking for damage and ensuring the needle cap is attached, avoiding use if any issues are found.

Choose an appropriate injection site from the abdomen, thighs, or upper arms, avoiding specific areas, and thoroughly clean the selected site. Prepare the syringe by holding the body, removing the needle cap, and immediately disposing of it without touching the needle or any surfaces. Administer the injection by inserting the needle into the pinched skin at a 45°-90° angle, pushing the plunger rod to deliver the medication, and releasing it to activate the needle shield. Dispose of the used syringe promptly into a sharps container, ensuring safe and proper disposal.

• The prescribed dosage for Amvuttra is 25 mg, administered through subcutaneous injection once every 3 months. 
• In case of a missed dose, promptly administer Amvuttra and resume the regular dosing schedule, with injections every 3 months from the most recently administered dose.

Important:

No clinical studies on drug interactions have been conducted with vutrisiran injection. In terms of fertility, subcutaneous administration of Amvuttra to rats at various doses did not adversely affect fertility or reproductive performance. Before starting Amvuttra injections, consult your healthcare provider about your medical history and current medications, including smoking and alcohol consumption. Provide a comprehensive list of medications to ensure a safe introduction of new drugs.

Warnings & Precautions

• In the presence of reduced serum vitamin A levels, exercise caution and supplement with the recommended daily allowance of vitamin A. 
• Prioritize informing your healthcare provider about any existing liver or kidney issues, as Amvuttra’s extensive studies in these populations are limited. 
• Exercise caution as allergic reactions, including severe ones, may occur. Seek immediate medical attention for symptoms such as hives, swelling, difficulty breathing, or dizziness. 
• Be aware of potential chills, fever, flushing, and headache during or after infusion; notify your doctor if you experience these symptoms. 
• Possible side effects include pain, redness, and swelling at the injection site. Keep your healthcare provider informed of any such reactions.
• Before starting the treatment, discuss pre-existing medical conditions with healthcare providers before initiating Amvuttra and promptly report any adverse reactions.

Common Amvuttra Side Effects:

• Arthralgia
• Dyspnea
• Decreased vitamin A
• Pain in the arms or legs
• Joint pain
• Shortness of breath
• Fatigue
• Headache
• Dizziness
• Nausea
• Vomiting
• Diarrhea
• Constipation
• Cough
• Fever

Use in Specific Population

• There is a lack of available data on the use of Amvuttra in pregnant women, and its potential risks for adverse developmental outcomes are unknown. 
• Amvuttra treatment results in decreased serum vitamin A levels, necessitating vitamin A supplementation for patients on Amvuttra. 
• The presence of vutrisiran in human milk, its effects on the breastfed infant, and its impact on milk production are unknown. 
• The decision to breastfeed should consider the developmental and health benefits, the mother’s clinical need for Amvuttra, and potential adverse effects on the infant. 
• Safety and effectiveness in pediatric patients are not established. No dose adjustment is required for patients ≥65 years, with no observed overall differences in safety or effectiveness in this age group. 
• Similarly, no dose adjustment is recommended for mild or moderate renal impairment or mild hepatic impairment. However, Amvuttra has not been studied in patients with severe renal or hepatic impairment.

Storage and Handling

• Store between 2°C to 30°C (36°F to 86°F) in the original carton until ready for use. 
• It is recommended to keep the medicine away from direct light. 
• Do not freeze the medicine. 
• Keep the medicine away from pets and children.