Uses
Golodirsen is used to treat a certain inherited muscle disorder (Duchenne muscular dystrophy-DMD). This disorder is caused by a lack of a certain muscle protein (dystrophin). This medication can increase the amount of dystrophin in your body.
How to use Vyondys-53 50 Mg/Ml Intravenous Solution Duchenne Muscular Dystrophy-Exon Skipping Antisense Oligonuc
This medication is given by injection into a vein by a health care professional as directed by your doctor. It is usually given once every week over 35 to 60 minutes. The dosage is based on your weight.
Tell your doctor if your condition does not get better or if it gets worse.
Side Effects
Pain at the injection site, headache, nausea, vomiting, diarrhea, dizziness, abdominal pain, or cold-like symptoms (such as runny/stuffy nose, sore throat, cough) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.
Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: kidney problems (such as change in the amount of urine).
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Precautions
Before using golodirsen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems.
This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.
It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Interactions
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Overdose
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.
Lab and/or medical tests (such as kidney function) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.
It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.
Not applicable. This medication is given in a hospital or clinic or doctor's office and will not be stored at home.
Images
Vyondys-53 50 mg/mL intravenous solution
Color: colorlessShape: Imprint:This medicine is a colorless, clear, vial
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CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.