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Givlaari

Givlaari (givosiran) is a small interfering RNA (siRNA) therapeutic used for the treatment of acute hepatic porphyria (AHP), a rare genetic disorder characterized by the buildup of porphyrins in the body. Givlaari works by reducing the production of toxic porphyrin precursors, helping to prevent acute attacks and manage the symptoms associated with the condition.

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Frequently Asked Questions

How quickly does Givlaari work?

Patients may start to notice a reduction in the frequency of acute attacks within the first few months of treatment.

How quickly does Givlaari work?

Patients may start to notice a reduction in the frequency of acute attacks within the first few months of treatment.

Can I take Givlaari while pregnant?

Consult your healthcare provider for guidance, as the use during pregnancy should be evaluated based on risks and benefits.

What should I do if I miss a dose?

If you miss a dose, contact your healthcare provider for instructions on when to administer the next dose.

Are there any specific storage instructions for Givlaari?

Store in the refrigerator and protect from light. Do not freeze. Keep out of reach of children.

Is Givlaari safe for long-term use?

Long-term use should be monitored by a healthcare provider to assess efficacy and minimize the risk of side effects.

Comprehensive Drug Guide

How Does Givlaari Work?

Givlaari acts by targeting and degrading the mRNA that encodes for the enzyme aminolevulinate synthase 1 (ALAS1), which is involved in heme biosynthesis. By reducing ALAS1 production, Givlaari decreases the accumulation of porphyrin precursors, thereby alleviating the symptoms and preventing the acute attacks of AHP.

Common Dosages

Givlaari is typically available in the following form:

Injectable solution: Common dosage is 189 mg/3 mL.

Typical Dosing

The typical dosing for Givlaari is:

For AHP Treatment: Administered as a subcutaneous injection of 2.5 mg/kg once every month.

Typical Dosing

FDA Approved Indications

Treatment of acute hepatic porphyria in adults and pediatric patients aged 12 years and older.

Who Shouldn't Take Givlaari?

Hypersensitivity: Known hypersensitivity to givosiran or any components of the formulation.

Advice From The Pharmacist

How to Use: Givlaari should be administered by a healthcare provider or trained individual. Rotate injection sites to minimize local reactions.
Monitor for Side Effects: Patients should be monitored for signs of liver dysfunction and potential injection site reactions.
Avoid Live Vaccines: Patients should avoid live vaccines while receiving Givlaari due to potential effects on immune response.

Side Effects of Givlaari

Common Side Effects

Injection site reactions: Such as redness, swelling, or pain.
Nausea
Fatigue
Headache

Uncommon/Severe Side Effects

Hepatotoxicity: Elevated liver enzymes, which may require monitoring and intervention.
Severe allergic reactions: Such as rash, itching, or difficulty breathing.

Risks and Warnings of Givlaari

Liver Function Monitoring: Regular liver function tests are recommended due to the risk of hepatotoxicity.
Caution in Patients with Liver Disease: Use with caution in patients with pre-existing liver conditions.

Interactions with Givlaari

Common Drug Interactions

Drug Interactions: Givlaari may interact with other medications that affect liver enzymes. Always inform your healthcare provider about all medications you are taking.
Food Interactions: Not significant; no specific food interactions are noted.

Alternatives to Givlaari

Other Therapeutic Options: Such as heme arginate or glucose loading to manage acute attacks.
Supportive Care: Symptom management during acute porphyric attacks.