Note: This document contains side effect information about golodirsen. Some dosage forms listed on this page may not apply to the brand name Vyondys 53.
Applies to golodirsen: intravenous solution.
Serious side effects of Vyondys 53
Along with its needed effects, golodirsen (the active ingredient contained in Vyondys 53) 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 golodirsen:
More common
- Fever
Incidence not known
- Blistering, crusting, irritation, itching, or reddening of the skin
- cracked, dry, scaly skin
- difficulty in breathing swallowing
- hives, itching skin, or rash
- nausea
- reddening of the skin, especially around the ears
- swelling of the eyes, face, or inside of the nose
- swelling
- unusual tiredness or weakness
Other side effects of Vyondys 53
Some side effects of golodirsen 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
- Abdominal or stomach pain
- back pain
- constipation
- cough
- diarrhea
- dizziness
- headache
- muscle aches
- sore throat
- stuffy or runny nose
- vomiting
Incidence not known
- 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 golodirsen: intravenous solution.
General
The most commonly reported adverse reactions have included headache, pyrexia, falls, abdominal pain, nasopharyngitis, cough, vomiting, and nausea.[Ref]
Hypersensitivity
Frequency not reported: Hypersensitivity reactions
Nervous system
Very common (10% or more): Headache (41%)
Common (1% to 10%): Dizziness
Gastrointestinal
Very common (10% or more): Abdominal pain (27%), vomiting (27%), nausea (20%)
Common (1% to 10%): Diarrhea, oropharyngeal pain, constipation
Local
Common (1% to 10%): Administration site pain, catheter site related reaction
Immunologic
Common (1% to 10%): Influenza, seasonal allergy
Musculoskeletal
Common (1% to 10%): Back pain, ligament strain, fracture
Respiratory
Very common (10% or more): Nasopharyngitis (27%)
Common (1% to 10%): Rhinitis
Other
Very common (10% or more): Pyrexia (41%), fall (29%)
Common (1% to 10%): Pain, ear infection
Cardiovascular
Common (1% to 10%): Tachycardia
Dermatologic
Common (1% to 10%): Contusion, skin abrasion
