4 posts tagged “ALS treatments”

Want to know more about Radicava (edaravone)? Here’s a snapshot:

Posted August 17th, 2017 by

With the recent FDA approval of Radicava (edaravone), we wanted to know more about how it works and what it means for patients living with ALS. We asked Maria Lowe, Pharm.D., BCPS, and our Health Data Integrity team, to give us a snapshot of the drug, how it’s used and what you should know. Maria’s rundown is meant to give you more context so you can have better conversations with your care team – as always, talk with your physician before starting any type of new treatment.

Radicava: The quick hits

  • Radicava works as a free radical scavenger.
  • When free radical (toxic by-products of cells that are highly unstable and reactive) levels are too high, cells are damaged resulting in oxidative stress (which may damage motor neurons). The way in which Radicava works to help patients with ALS is not fully understood yet; however, researchers believe that by getting rid of these free radicals it can help prevent some cell damage.
  • In clinical trials, treatment with Radicava was found to slow the decline in functional disability as measured by ALSFRS-r scores for some patients. However, it is important to note that Radicava does not stop the death of motor neurons (it’s not a cure).
  • Radicava may be taken in conjunction with riluzole (consult healthcare provider).
  • Radicava is administered intravenously (60 mg IV over 60 min) daily for 14 days, followed by a 14-day drug-free period. Subsequent cycles are administered daily for 10 days over a 14-day period followed by 14-day drug-free periods. Because this drug is meant for long term use, patients will need to have a peripherally inserted central catheter (PICC line) or some other kind of catheter installed.

Clinical trials and FDA approval

  • FDA approval for Radicava was based on a Phase III clinical trial conducted in Japan only in Japanese patients. Patients enrolled had to have ALS for less than two years, have normal respiratory function as well as the ability to complete most activities of daily living.
    • Radicava may be processed and function differently in different patient populations. Post marketing data will be important for determining the effects and impact of the drug in patients other than those who participated in the clinical trials.

Side effects and reactions:

  • The most common side effects reported in clinical trials include bruising, problems walking (gait disturbance), and headache.
  • Hypersensitivity reactions:  Radicava may cause allergic reactions that could happen after the infusion has finished.
    • Symptoms to watch for: Hives, swelling, dizziness, wheezing, shortness of breath, itching, and fainting.
    • If you’ve experience allergies to other medications before, inform your healthcare provider.
  • Sulfite allergic reactions: Since Radicava includes sodium bisulfite as an ingredient, those with sulfite allergies should be cautious when taking this drug.
    • Those with asthma have a higher risk of developing sulfite sensitivity. Let your healthcare provider know if you have asthma.
    • Symptoms to watch for: Hives, trouble breathing/ swallowing, itching, swelling, dizziness, asthma attacks (in people with asthma), wheezing and fainting.
    • If you have a sulfa allergy, you may or may not have a reaction to this drug. Sulfa allergies are a result of hypersensitivity to a chemical structure called sulfonamides, which are common in many antibiotics. Sulfites are chemically different from sulfonamides and any reaction to sulfites is not related to sensitivity to sulfa drugs. Both can cause reactions, but they are not related.
  • If you are pregnant or plan on becoming pregnant and/or are breastfeeding, let your healthcare provider know. It is not known if Radicava will harm the baby or if it passes into breast milk.

Availability and access

  • Radicava is expected to be available in August of this year as a brand name drug and it’s estimated it will cost around $145,000 per year in out of pocket costs (does not account for insurance coverage).
  • Because the drug isn’t available yet, many insurance companies may not have developed policies regarding coverage. Different insurance programs will develop such policies of coverage of new drugs at different times.
  • MT Pharma America (MTPA), the manufacturing company for Radicava, has developed a program called Searchlight Support to help people with ALS learn more about this treatment and to help them find and secure coverage through their insurance.
    • Searchlight Support offers out of pocket support options only to certain eligible patients with commercial insurance. Patients with Medicaid, Medicare and other government funded insurance may not qualify.

Interested in learning more about whether Radicava is right for you?

Check out the medication guide and contact the Searchlight Support program to learn more about the potential financial support programs and to find an infusion center near you.

Share this post on Twitter and help spread the word.

 

Disclaimer: At PatientsLikeMe, we’re all about transparency, so please keep in mind that this piece is solely to provide a snapshot of Radicava so you can stay informed and make better decisions with your care team. This content isn’t sponsored and we don’t have a financial relationship with the drug manufacturer.


PatientsLikeMe at the 2nd Annual White Coat Affair for ALS TDI

Posted November 28th, 2012 by

On Friday, November 2nd, several PatientsLikeMe team members donned their finest to attend the 2nd Annual White Coat Affair, a charity gala benefiting the ALS Therapy Development Institute (ALS TDI).  Founded by PatientsLikeMe Co-Founder and Chairman Jamie Heywood in 1999, ALS TDI is the world’s most advanced research laboratory dedicated to ALS, also known as Lou Gehrig’s disease.

The PatientsLikeMe Team Along with ALS Patient Steve Saling (Front) at the 2nd Annual White Coat Affair for ALS TDI

This gala fundraiser was held in conjunction with ALS TDI’s 8th Annual Leadership Summit, which included in-depth scientific presentations by top ALS researchers, a discussion panel with industry leaders and an awards ceremony honoring individuals who have made extraordinary contributions to ALS research and advocacy.  (View the summit webcast here.)  PatientsLikeMe was a proud sponsor of this annual gathering of the most influential minds in the ALS community.  In particular, we were honored to witness the posthumous awarding of the Stephen Heywood Patients Today Award – given annually to an individual who exemplifies what it means to be an educator, role model and advocate – to beloved PatientsLikeMe member Persevering (Rob Tison).

Keeping with the Laboratory Theme, The Name Cards Were Inspired by the Periodic Table of Elements

Held at the Fairmont Copley Plaza in Boston the next night, A White Coat Affair was an opportunity for summit attendees to unwind and socialize via cocktails, a dinner program, live music and dancing.  In honor of the theme, servers wore white lab coats, name cards were labeled like the periodic table and vases were filled with brightly colored liquid to resemble lab tubes.  A special highlight of the dinner program this year was the Young Perspectives on ALS segment, which featured the stories of two young people living with ALS (Corey Reich and Pete Frates) as well as four young people who are the children of ALS patients (Katie Shambo, Sam Ketchum, Jenn Sutherland and Alex Heywood).

As you might have guessed, Alex Heywood is the son of Stephen Heywood and nephew of PatientsLikeMe Co-Founders Jamie Heywood and Ben Heywood.  Both ALS TDI and PatientsLikeMe were inspired by Stephen’s seven-year battle with ALS, a rapidly progressive neurodegenerative disease with an average life expectancy of two to five years following diagnosis.

Young ALS Patients and the Sons and Daughters of ALS Patients Were the Focus of This Year's Dinner Program

Approximately 350 guests attended A White Coat Affair, helping to raise $450,000 towards ALS TDI’s efforts to discover and develop effective treatments for ALS. After a decade of progress, the institute is entering a time of great promise, with several therapies in clinical trials and their own work on Gilenya (a drug currently approved for treating multiple sclerosis) and other potential therapeutics moving into the clinical realm.  Learn more about ALS TDI’s current research projects here.

To see more photos from the 2nd Annual White Coat Affair, visit the event’s Facebook page.