What is Viltolarsen?
Viltolarsen can be used to treat Duchenne muscle dystrophy among adults and children with a specific gene mutation. You will be tested by your doctor for this mutation.
The FDA approved viltolarsen on an "accelerated basis". In clinical trials, viltolarsen was effective for some patients, but more studies are required.This medication guide does not list all possible uses of Viltolarsen.
Side effects of Viltolarsen
If you experience any of the following symptoms of an allergic reaction, seek immediate medical attention: hives; itching; rash; blistering or peeling skin; fever.
Viltolarsen may cause serious side effects. If you experience:
- Pink, brown, or red urine
- Foaming urine
- You may experience swelling of the face, hands, or feet.
Some of the common side effects associated with viltolarsen include:
- Redness, swelling, or bruising where an injection has been given
- Fever;
- Cold symptoms may include stuffy nose and sneezing.
There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.
Similar/related drugs
Viltepso, Amondys 45, Exondys 51, Emflaza, Vyondys, Elevidys, and Deflazacort
Warnings
Tell your doctor if you have any medical conditions, allergies, or medicines that you take. Also, tell him if you're pregnant or nursing.
Before you take this drug
Inform your doctor if kidney problems have ever occurred.Inform your doctor if you are pregnant or nursing.
How to take Viltolarsen?
You will be tested by your doctor to ensure that you are not suffering from any conditions that would make it unsafe for you to use viltolarsen.Viltolarsen infusions are usually given once a week. This injection will be given by a healthcare provider.The infusion may take up to 60 minutes.
You may need to have your kidney function checked if you use this medication.The Viltolarsen dosage is based on your weight. Your dose needs may change if you gain or lose weight.
Details on dosage
Adult dose for muscle dystrophy:
80 mg/kg IV once a week
Comments:
This drug was approved through an accelerated approval procedure based on the increased production of dystrophin in skeletal muscles observed in patients treated with it. Continued approval could be conditional upon the verification and description of clinical benefit in a confirmation trial.
Use: To treat Duchenne muscle dystrophy in patients with a confirmed mutation that allows exon 53 to be skipped.
The usual pediatric dose for muscular dystrophy:
80 mg/kg IV once a week
Comments:
This drug was approved through an accelerated approval procedure based on the increased production of dystrophin in skeletal muscles observed in patients treated with it. Continued approval could be conditional upon the verification and description of clinical benefit in a confirmation trial.
Use: To treat Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation that allows exon 53 to be skipped.
What happens if I miss the dose?
If you are unable to attend your appointment for viltolarsen, call your doctor.
What happens if I overdose?
Overdoses are unlikely because viltolarsen will be administered by a health professional in a medical environment.
What should be avoided?
If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.
Interaction with other drug
Other drugs, such as vitamins and herbal remedies, may also affect viltolarsen. Inform your doctor of all the medicines you are taking and those that you stop or start using.
