Drug Strength and Dosage: Details on potency, form, administration times, and additional information
In a significant development for individuals living with Multiple Sclerosis (MS), the Food and Drug Administration (FDA) has approved Vumerity, an oral disease-modifying therapy, for treating relapsing forms of the condition in adults. This article aims to provide an overview of the long-term risks, side effects, and usage guidelines for Vumerity.
Vumerity, a delayed-release oral capsule, comes in one strength: 231 milligrams (mg). The typically recommended dosage for people with MS is 462 mg (two 231-mg capsules) twice per day after 7 days. However, doctors may prescribe Vumerity to treat certain forms of MS or Clinically Isolated Syndrome (CIS), with a starting dose of 231 mg (one capsule) twice per day.
While Vumerity offers a potential solution for managing MS, its long-term use is associated with certain risks and side effects. Common side effects may include flushing, indigestion, abdominal pain, diarrhea, nausea, vomiting, itchy skin, and rash. These side effects often diminish over time but can persist in some patients.
More serious risks related to long-term use include lymphopenia, a significant decrease in white blood cell levels, potentially increasing susceptibility to infections. There is also a rare but potentially life-threatening brain infection called Progressive Multifocal Leukoencephalopathy (PML), caused by JC virus reactivation, particularly in patients with prolonged lymphopenia or immunosuppression.
Long-term use of Vumerity may also lead to liver damage, with monitoring recommended to catch elevations in liver enzymes or injury. Serious gastrointestinal complications, such as digestive tract blockage, tears, ulcers, or bleeding, are uncommon but have been reported post-market.
It's important to note that Vumerity works by activating the Nrf2 pathway, reducing oxidative stress and inflammation in the central nervous system, which underlies its efficacy in relapsing forms of MS. However, this immune modulation does not fully eliminate the risks associated with the therapy.
Compared to older fumarate medications, Vumerity is designed to cause less gastrointestinal distress, which may improve long-term tolerability. However, its safety profile still requires regular monitoring.
Long-term management usually involves ongoing monitoring for infections, blood counts, and liver function. Benefits in reducing relapse rates have been sustained for up to 5 years in some studies.
To help manage side effects, taking Vumerity with a small snack may help reduce flushing, one of its side effects. It's recommended to take Vumerity at the same time each day, such as morning and evening. Vumerity isn't available in a generic version.
It's crucial to follow your doctor's instructions regarding Vumerity usage. Do not take more Vumerity than prescribed. If you believe you've taken too much, contact your doctor or call America's Poison Centers at 800-222-1222 or use its online tool.
Use a medication reminder, such as an alarm, note, reminder app, or medication management tool, to help remember your doses. If you have trouble opening medication bottles, ask your pharmacist about easy-open containers or tools that can make it easier. For those who have difficulty swallowing capsules, consider tips for swallowing pills or discuss alternatives with your doctor or pharmacist.
In summary, the long-term risks of Vumerity include immune suppression leading to infections (including rare PML), liver toxicity, and gastrointestinal complications, alongside more common manageable side effects such as flushing and GI upset. Continuous medical supervision including blood tests and symptom monitoring is essential to mitigate these risks during prolonged treatment.
- Vumerity, an FDA-approved drug, is a delayed-release oral capsule that comes in a strength of 231 mg, used for treating multiple sclerosis and Clinically Isolated Syndrome.
- Common side effects of Vumerity include flushing, indigestion, abdominal pain, diarrhea, nausea, vomiting, itchy skin, and rash, which may diminish over time.
- Long-term use of Vumerity may lead to serious risks such as lymphopenia, Progressive Multifocal Leukoencephalopathy (PML), liver damage, and gastrointestinal complications.
- To help manage side effects of Vumerity, taking it with a small snack or using a medication reminder may help reduce flushing.
- Long-term management of MS with Vumerity involves ongoing medical supervision, blood tests, and symptom monitoring to mitigate potential risks during prolonged treatment.
