3 posts tagged “drug information”

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.

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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.


Ocrevus: You asked, we answered

Posted August 7th, 2017 by

Last month, we asked the MS community to share their questions about Ocrevus. Now, PatientsLikeMe’s Maria Lowe, Pharm.D., BCPS, sheds more light on what it is, how it works and what patients need to 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.

  1. What is Ocrevus (ocrelizumab)?

Ocrelizumab is a medication that was FDA approved for the treatment of adults with relapsing or primary progressive forms of multiple sclerosis in March, 2017. While the exact way ocrelizumab works isn’t fully understood, researchers believe it works by blocking certain types of B cells that appear to play a role in the autoimmune destruction of nerve cells in patients with MS.

Treatment with ocrelizumab begins with an initial intravenous (IV) infusion over a period of at least 2.5 hours followed by a second infusion two weeks later. After these first two doses, ocrelizumab is administered every six months via an IV infusion over at least 3.5 hours.

  1. Do you really need a washout period before starting ocrelizumab?

A number of MS treatments work by interfering with the body’s immune system in the hope of preventing autoimmune destruction of nerve cells. When more than one these treatments is used at the same time, it may result in additive effects which leaves the immune more suppressed than if those treatments were used alone. This may increase risk of infection. As a result, there are some instances where switching between certain treatments for MS would mean that you should have a “washout period” to help reduce the overlap of two immunosuppressive treatments and reduce the risk of infection.

This is especially important when you’re transitioning from one drug with prolonged immunosuppressive effects to another (such as: Zybrinta (daclizumab), Gilenya (fingolimod),Tysabri (natalizumab), Aubagio (teriflunomide), or Novantrone (mitoxantrone)). A washout period means that you would stop one immunosuppressive treatment for a period of time before starting the next one. While this does help reduce the risk of serious infections, it may increase the risk of a relapse because there’s a period without treatment where your body’s immune system is no longer suppressed.

Whether or not a washout period is needed depends on what treatment was tried previously and current disease status. According to the FDA-approved prescribing information for ocrelizumab, use with other immune-modulating or immunosuppressive therapies could increase the risk of further suppressing the immune system, leaving the body more vulnerable to infections. However, recommendations for a specific washout period or waiting time before switching from another disease-modifying MS treatment to ocrelizumab haven’t been decided. If you’re planning to switch from one MS treatment to another, it’s important to discuss this with your healthcare provider to determine if a washout period would be right for you.

  1. Could rebound relapses occur when starting ocrelizumab?

While a washout period may reduce the risk of immunosuppression, it may result in an MS relapse as a result of being without treatment and possibly as a result of a rebound overreaction of the body’s immune system. Research indicates that rebound relapses might be more common after stopping natalizumab and fingolimod when compared to other available disease modifying treatments for MS. Some data suggests that shorter (8-12 week) washout periods after stopping natalizumab treatment might be better than longer (16 weeks) ones when it comes to preventing rebound relapses.

So far, clinical trials have found that ocrelizumab is effective in reducing relapses and slowing the worsening of MS. However, there isn’t any data available about the risk of rebound relapses after stopping ocrelizumab. The approved prescribing information for ocrelizumab doesn’t describe a specific washout period requirement prior to starting treatment. If you’re considering switching to this treatment it’s crucial to consult with your healthcare provider to determine if such a transition would be beneficial to you and if so, how such a transition might work for you. 

  1. What are the most common side effects for ocrelizumab?

The most common adverse reactions observed in the three clinical trials used to support FDA approval of ocrelizumab include upper respiratory tract infections and infusion reactions. Patients with primary progressive MS (PPMS) also experienced skin reactions and lower respiratory tract infections. Other side effects that patients experienced with lesser frequency include:

  • Depression
  • Back pain
  • Pain in extremities
  • Skin reactions
  • Cough
  • Diarrhea
  • Swelling in the limbs

It’s important to note that ocrelizumab is associated with a handful of warnings regarding its use. These warnings are in the FDA-approved prescribing information and summarize specific adverse effects that might be important to consider when making choices about starting treatment.

Ocrelizumab was approved with 3 different warnings:

  • Infusion reactions: Reactions to infusions might include symptoms like: itching, low blood pressure, difficulty breathing, or fever. Reactions may happen up to 24 hours following the administration of ocrelizumab. In order to help minimize the risk of reactions, patients should receive certain medications prior to their ocrelizumab infusions. These may include a steroid, an antihistamine, and an antipyretic (like acetaminophen) to help prevent infusion reactions. In addition, all patients receiving ocrelizumab infusions need to be monitored for at least an hour after they have completed their infusion to detect if such a reaction may be happening. If you’re receiving treatment with ocrelizumab and you experience any of these symptoms, be sure to let your healthcare provider know right away.
  • Infections: Because ocrelizumab affects your immune system, it may increase the risk of developing infections. The most common infections observed in the clinical trials of ocrelizumab include respiratory tract infections and herpes infections (such as cold sores, herpes zoster [also known as shingles] and genital herpes). Ocrelizumab shouldn’t be administered if you have an active infection. It’s important to tell your healthcare provider if you have any signs or symptoms of infection at any point during your treatment.
  • Increased risk of malignancy: Treatment with ocrelizumab may be associated with an increased risk of certain types of cancer, including breast cancer. It’s important to discuss your individual risk factors with your healthcare provider before deciding if starting ocrelizumab is a good choice for you.

As with all new drugs, we’ll continue to learn more about its side effects as it becomes more widely used.

  1. Is it safe to take acyclovir or Zostavax while using ocrelizumab?

There are no known drug interactions between acyclovir and ocrelizumab. If you’re prone to herpes outbreaks or if you’re concerned about the potential increased risk of herpes infections, be sure to discuss this with your healthcare provider before deciding if ocrelizumab is right for you and what steps you can take to minimize the risk of these outbreaks.

Zostavax is a vaccine that is used to prevent shingles, also known as zoster or herpes zoster. Shingles occurs as a result of the varicella zoster virus (the same virus that causes chicken pox) becoming reactivated in the body. Zostavax is a live vaccine which means it contains a weakened version of the varicella zoster virus. Because the virus is only weakened and not completely dead, patients with a compromised immune system may develop an active infection after receiving such a vaccine. Since ocrelizumab lowers the body’s immune response, it’s recommended that any live vaccines are administered at least 6 weeks before starting treatment.

  1. What is the role of low-dose naltrexone (LDN) for MS and can it be used with ocrelizumab?

Naltrexone is an opioid antagonist that is FDA-approved to treat drug and alcohol addiction. At significantly lower doses, naltrexone has also been used off-label (meaning outside of its FDA approved indications) to treat a variety of diseases including MS and Parkinson’s disease. Some studies with this treatment have shown that it might be helpful for certain aspects of MS (including improving patient quality of life) but the overall impact on MS progression and symptom control is not conclusively known.

Currently, there is no known drug interaction between ocrelizumab and naltrexone. Have you tried either treatment for your MS? Share your experience with the community by filling out a treatment evaluation.

For more information about ocrelizumab, check out the patient medication guide.

Sources:

http://www.nationalmssociety.org/Treating-MS/Complementary-Alternative-Medicines/Low-Dose-Naltrexone

http://onlinelibrary.wiley.com/doi/10.1002/ana.22006/abstract

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761053Orig1s000ClinPharmR.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf

http://jamanetwork.com/journals/jamaneurology/fullarticle/2516773

http://www.medscape.com/viewarticle/863241 (You’ll need to make an account)

http://www.medscape.com/viewarticle/846498#vp_1 (You’ll need to make an account)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5087255/  

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761053lbl.pdf

https://www.fda.gov/downloads/drugs/guidances/ucm075096.pdf

https://www.gene.com/download/pdf/ocrevus_medguide.pdf 

http://www.merck.com/product/usa/pi_circulars/z/zostavax/zostavax_ppi.pdf

http://www.mayoclinic.org/diseases-conditions/shingles/basics/causes/con-20019574

https://www.cdc.gov/shingles/about/overview.html 

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