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Givlaari Side Effects

Generic name: givosiran

Medically reviewed by Drugs.com. Last updated on June 3, 2020.

Note: This document contains side effect information about givosiran. Some of the dosage forms listed on this page may not apply to the brand name Givlaari.

For the Consumer

Applies to givosiran: subcutaneous solution

Side effects requiring immediate medical attention

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

Rare

  • 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
  • tightness in the chest
  • trouble breathing

Side effects not requiring immediate medical attention

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

  • 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

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

Hypersensitivity

Uncommon (0.1% to 1%): Anaphylactic reaction, hypersensitivity

In clinical trials, 1 patient experienced an anaphylactic reaction and 1 patient experienced a hypersensitivity reaction.

Hepatic

Very common (10% or more): Transaminase elevations (13%)

Renal

Very common (10% or more): Increase serum creatinine (15%; includes blood creatinine increased, glomerular filtration rate decreased, chronic kidney disease [decreased eGFR])

Local

Very common (10% or more): Injection site reactions (25%)

Gastrointestinal

Very common (10% or more): Nausea (27%)

Dermatologic

Very common (10% or more): Rash (17%; includes pruritus, eczema, erythema, rash, pruritic rash, urticaria)

Immunologic

As with all oligonucleotides, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay and therefore comparison of antibody incidence is misleading. In placebo-controlled and open-label clinical studies, 1 of 111 patients with acute hepatic porphyria (AHP;0.9%) developed treatment-emergent anti-drug antibodies (ADA) during treatment. No clinically significant differences in the clinical efficacy, safety, pharmacokinetic, or pharmacodynamic were observed in the patients who tested positive for ADA.

Uncommon (0.1% to 1%): Treatment emergent anti-drug antibodies

Other

Very common (10% or more): Fatigue (10%)

References

1. "Product Information. Givlaari (givosiran)." Alnylam Pharmaceuticals, Cambridge, MA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.