Givlaari Side Effects

Generic name: givosiran

Medically reviewed by Drugs.com. Last updated on Jul 3, 2024.

Note: This document provides detailed information about Givlaari Side Effects associated with givosiran. Some dosage forms listed on this page may not apply specifically to the brand name Givlaari.

Applies to givosiran: subcutaneous solution.

Serious side effects of Givlaari

Along with its needed effects, givosiran (the active ingredient contained in Givlaari) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking givosiran:

More common side effects

• agitation
• blood in the urine
• coma
• confusion
• dark urine
• decreased urine output
• depression
• dizziness
• headache
• irritability
• lethargy
• loss of appetite
• muscle twitching
• nausea or vomiting
• rapid weight gain
• seizures
• stomach pain
• stupor
• swelling of the face, ankles, or hands
• unusual tiredness or weakness
• yellow eyes or skin

Rare side effects

• chest tightness
• cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives, itching, or skin rash
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• trouble breathing

Other side effects of Givlaari

Some side effects of givosiran may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common side effects

• bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

For healthcare professionals

Applies to givosiran: subcutaneous solution.

General adverse events

The most commonly reported adverse reactions included fatigue, injection site reactions, and nausea.^[Ref]

Dermatologic

• Very common (10% or more): Rash (17%)^[Ref]

Rash included eczema, erythema, pruritus, pruritic rash, and urticaria.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (27%)
• Postmarketing reports: Acute pancreatitis^[Ref]

Hepatic

• Very common (10% or more): Increased ALT (14.6%), transaminase elevations (13%)^[Ref]

Hypersensitivity

• Uncommon (0.1% to 1%): Anaphylactic reaction, hypersensitivity^[Ref]

In clinical trials, one patient experienced an anaphylactic reaction, and one patient experienced a hypersensitivity reaction.^[Ref]

Immunologic

• Uncommon (0.1% to 1%): Treatment emergent antidrug antibodies^[Ref]

In clinical study, one patient developed treatment emergent antidrug antibodies during treatment.^[Ref]

Local

• Very common (10% or more): Injection site reactions (up to 36%)
• Frequency not reported: Injection site erythema, injection site pain, injection site pruritus^[Ref]

Metabolic

• Very common (10% or more): Increased blood homocysteine (16%)^[Ref]

Increased blood homocysteine included abnormal blood homocysteine and hyperhomocysteinemia.^[Ref]

Other

• Very common (10% or more): Fatigue (10%)^[Ref]

Renal

• Very common (10% or more): Increase serum creatinine (15%)^[Ref]

Increased serum creatinine included chronic kidney disease (decreased estimated GFR), decreased glomerular filtration rate, renal impairment, and increased blood creatinine.^[Ref]

Further information

Givlaari side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer