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    • #14610
      Dagmar Munn
      Keymaster

      One of our forum members is scheduled to get a catha-port next week, in preparation for receiving Radicava treatments. This member is wondering if any members have feedback – positive, negative, non-committal, about the treatments. In addition, this member still works.

      Do you think the treatment protocol will accommodate a normal work schedule? What other considerations do you suggest? Please share yours (or your pALS’s) experiences and any advice to help our member who is pondering these questions.

    • #14612
      Jay
      Participant

      Yes – I just started Radicava 2 month ago. The port procedure was fairly easy – no pain but it will take 4-8 weeks to become 100% firm. I feel absolutely no difference with it in(without needle)  and remain as active as possible – no restrictions whatsoever.

      With needle in ( 14 days on) it is a little cumbersome. You cannot get it wet and it is protected by a sometimes itchy bandage. Again only a very minor discomfort but really non restrictive other than itchy. For showering – I use a large bandage to put over the needle bandage – double protection – buy at the local Walgreen .

      Application of medicine – Takes about 2 hours per day. I work full time so mostly during dinner time – again just takes time – but watch tv – read – etc.

      Application prep – ( all above assumes a caregiver at home) . You need to be diligent in prep – lots of sterilization considerations – cleaning each step is critical but doable once routine is established. Need to avoid risk of infection.

      There is some flexibility once routine starts – its only 10 days on an 14 days  off. -u pick the 10 days on – i like that aspect.

      Does it work and is it worth – not a fair question – but i believe it works – so that’s all we can go on.

      I say you have to try it and make your own determination. if you work, your insurance will cover most of it and Radicava will pick up the rest ( i believe)

      I hope this helps and wish you all the best on this journey

       

       

       

       

       

    • #14614
      Glen North
      Participant

      I was on Radicava for 6 months, I am very in tune with my body and decided to go off it because I wasn’t benefiting at all!  It was somewhat time consuming, but a small price to pay if it actually worked.  as mentioned previously I don’t think the FDA should have let it go to market with the limited testing that was done.

    • #14615
      JULIE SUAREZ
      Participant

      Thank you both for your input.  It has been a very long road to getting the porta-cath appointment scheduled and I’m left wondering, because that’s how my brain works, was the delay for a reason.  My concern is that as of right now, thank God, I’m able to walk with AFO’s and the use of a cane and the first side effect listed is that it may cause gait problems.  Initially, I was 100% in and anything that might help I would try.  And, I do have seasonal asthma and that is a possible contraindication too!

    • #14616
      Dagmar Munn
      Keymaster

      Are any of you also taking Riluzole along with Radicava?

    • #14617
      Jay
      Participant

      yes  I am also on Riluzole as well ( why not) . With respect to gait problems – doctors indicated that most patients with ALS develop gait problems with or without Radicava – again hard to tell .

      We have to fight this battle with everything we have – faith and attitude being number 1 and 2.

      give it a try and see if it how it impacts your abilities – it is your decision to continue or not.

       

    • #14618
      Paul Mueller
      Participant

      My wife has the bulbar ALS. She is currently  and going into her third year of Riluzole and Radicava treatments. We go to a local  hospital for the radicava infusions it takes about an hour  for us, we are both retired so time is not as important but we use the flexibility  of the ten days in fourteen to our advantage especially when planning vacations. Does it help? We think so as does her neurologist. She has a port and has had no issues. Hope this helps.There are two other ALS patients  we know of in our area also on both riluzole  and radicava.

    • #14620
      Christine Moretti
      Participant

      I couldn’t agree more with Jay. I ha w been on Radicava since October 2017. In fir a penny, in for a pound when it comes to trying whatever I can to fight this disease.

      One caveat, though, I was DX’d with PLS in 2016 and have been fortunate to have my progression remain slow. That being said, I’d like to think that the infusions are beneficial in some way.

      I no longer work and my insurance does not cover at home infusions, so I go to a nearby neurology infusion center for treatment. It’s all good.

      My port has been in since the second infusion. Fingers crossed. The needle is only slightly annoying the first day and you do have to take care to not get it wet. I have had zero side effects on Radicava.

      Wishing you the best with your decision and experience with the drug.

    • #14621
      Jon Carlin
      Participant

      I was the sole caregiver for my 76 year old partner who was on Radicava for more than one year. The regime calls for infusions 5 days a week for two weeks. Two weeks off and then resume. Depending on scheduling determines if it would interfere with work.

      We didn’t find Radicava particularly helpful but then everyone is different and reacts differently. The port was routine with no discomfort.

    • #14624
      Martino Caretto
      Participant

      Diagnosed in June 17: on Radicava since October 17. On mechanical ventilation and with PEG since Feb 19. Wheelchair bound since end 18.Infusions administered at home through port, no issues, rather easy. Not in a position to say if progression has been impacted by Radicava. Also on Riluzole since 10/17.

       

    • #14627
      Liz
      Participant

      Radicava days make him feel better

      My husband has been receiving Radicava IV infusions at home since May of 2018.  It always makes him feel better and he usually experiences a little “bounce back” on the days receives the infusions. We still do the infusions regularly.

      <b>Staying employed with ALS </b>

      He has had ALS for around 6 or 7 years.  He has bulbar onset where his voice was initially affected.   He worked full time with the ALS until 2018.  He continued to work full time for many years with ALS and when his voice didn’t cooperate, he used a text to speech program on his computer called “natural reader.”

      <b>First Radicava infusion at hospital </b>

      The first Radicava infusion occurred at the hospital as part of their protocol to make sure there was no adverse reaction. They infused through a regular IV line. I do not recall whether that protocol was set by the company or the ALS doctor.

      <b>Initial treatment</b>

      The initial treatment required 14 days of infusions in a row.   We were traveling out of town to a family reunion so during the car trip, we had the infusion running. I brought the IV pole and adjusted the height to the ceiling level of the car.   It was very problem free.

      <b>Initial 14 consecutive days of treatment</b>

      For the initial 14 consecutive days of treatment, it was done through a normal IV access. The nurse came by to the house and put in the IV.  Before we left for the trip, they replaced the IV with one on top of the hand. While at the family reunion, the IV blew and we could not get the medicine through. A quick trip to a nearby ER with medicine bag in hand, and problem solved. They simply put a new IV line in the arm and it was problem free for the remainder of the trip.  Now we always use the chest port and that makes it so easy.

      <b>Radicava Dosing Pattern</b>
      <p class=”p1″><span class=”s1″>The initial treatment requires 14 consecutive days treatment phase. <span class=”Apple-converted-space”>  Then, </span>14 days off.</span></p>
      <p class=”p1″><span class=”s1″>Thereafter, IV Radicava infusions for any 10 out of 14 days, followed by 14 days off, then any 10 out of the next 14 days IV infusions and continuing in that pattern indefinitely. </span></p>
      For us, since the Radicava makes him feel better, we wanted him to have it the first available day so we chose to do 5 days on, then de-access the chest port and stay off for 4 days, then re-access the chest port and do 5 consecutive days of treatment.  This way, he feels better as soon as the first available day of treatment in the beginning of the dosing schedule plus, he gets in the last 5 days of the 14 day window so that will carry him through.  Plus, to reduce risk of infection, it is good to have the chest port only accessed for 5 days.  If you leave the needle in too long, you run the risk of infection.

      <b>Summary of our Radicava dosing pattern:</b>

       

      We continue in this fashion:

      5 days on

      4 days off

      5 days on

      14 days off

      repeat indefinitely.

      <b>What to expect when you open the box of medicine</b>

      The box of Radicava is sealed with a silver sticker. When you open the box, there are two clear bags of medication each in a clear sealed plastic bag. Only pull out one bag. You will see a pink pill sealed inside the bag. As long as the pill is pink, it means that the outer plastic bag has remained sealed and  that  the medication has not oxidized.   You throw the pill  away with the outer plastic wrap.

      Once the medication has been taken out of the plastic seal, you have either 24 or 48 hours (I can’t remember which) to use it although I always use it immediately. It only takes 30 minutes to dispense the first bag of medicine and the home nurse will show you how to do that. Ask them to write the instructions down because for the first few times, you will want to have the instructions as a reminder. If I can find the instructions that the nurse originally wrote for me, I will post them.

      I set the timer on my phone for 25 minutes so that I am nearby when the first bag is almost empty. At that point, I pull out the second bag so that I am prepared to quickly switch the bags so that I do not have to prime the IV line again.   It takes 30 minutes to empty each bag for a grand total of 60 minutes.   After you have opened the clear plastic bag that the IV medicine is in, you can see after the bag has been opened and before you discard it, you can see how the pink pill starts to turn purple and or blue from oxidation. Nothing to worry about but I only tell you that so that you know what it looks like in the event it has been exposed to air before you open the bag.  I have never once had a bad bag where the pill was anything other than pink when I first opened it.

      <b>Chest port</b>

      My husband had the chest port surgery  done at Temple Hospital in Philadelphia as an outpatient. He was originally scheduled to go under anesthesia but the surgeon came in and asked  him if he could “soldier through with topical anesthesia, the surgery would be done in 15 minutes, he would put surgical glue on him, tell him put a shirt on and go home following completion of surgery. He said it would hurt a bit and that he would mostly feel more like pressure but that it would be over very quickly. My husband said that on a scale of 1 to 10, the pain level was a 5. There were two small incisions. I asked my husband :  knowing what he knows now,  after having the surgery done, would he choose to do the same thing or would he rather be put under anesthesia. He said he would do it exactly the same way because it was around 20 minutes of pressure on the area, a little pain and then it was completely done and over and he got to go home immediately with no recovery time whatsoever. They literally told him “put your shirt on, you can go home now.” He was able to use the chest port the next day and it has been problem free ever since.

      <b> Itchiness from the plastic covering over the chest port :</b>

      In the beginning, after the nurse would come and put the needle in the chest port (they call that “accessing the chest port”), she would put a plastic clear sticky covering on top of the area to prevent infection. My husband experienced an allergic reaction and ended up with elevated blisters beneath the sticker area.  The pharmacy who mails the medication then changed the sticker covering to some thing called “IV 3000“ for people with sensitive skin.

      On each side of the clear sticker, there is an orange strip. The nurse takes off the orange strip after she puts the covering on so that he does not have any type of irritation. If memory serves me correctly, on the edges where the orange strip is, it contains a certain amount of the cleaning agent chlorhexidine  to which apparently my husband has an allergic reaction .  The home nurse also puts a clear sticker covering on top of the chest port needle called Tegaderm. Ask them to leave you extra coverings in case it starts to come loose before the next port change.

      <b>New covering I saw at the hospital that seals around the tube coming out of the chest port.</b>

      The hospital put a plastic cover over the chest port and then a second separate piece on the lower part of the area to help seal the tube and keep it germ free. It worked very well and my husband had no allergic reaction to it. The hospital nurse sent me home with one so that I can show the home nurse.

      <b>Say no to hospice services</b>

      Not that you are anywhere near close to this but the ALS doctor told me to always say no to any request for hospice services because the first thing they will do is take away the Radicava infusions and the Riluzole pills.

      <b>Radicava results </b>

      Throughout the course of the Radicava treatment, it seems that it takes the patient from wherever they are and reverses the symptoms to some degree during the dosing stage.  If you cannot move your arm, then after each treatment you might be able to move your arm up to your chest level. If you can’t move your leg, after treatment you may be able to  move your leg.    In our particular situation, the results were more noticeable in the beginning. On the days that my husband has the Radicava infusions, his voice would be improved. The results are a little bit  different for everyone from my experience of talking to other people but most people seem to report feeling a little bounce back, slightly more energy and overall feeling better.

      <b>Slows down disease progression</b>

      As the ALS doctor says to us, who’s to really know whether it has slowed  down the progression or not but in our particular situation, he has had ALS for six or seven years now so it seems as if it has clearly slowed down the progression. 💪🏻

      <b>Nightmare of Insurance company approval </b>

      I’m providing this information although it may not help in your particular situation because it sounds as if it’s a non-issue but in our situation, I was very glad to have the information. We could not get the insurance company to approve the Radicava treatment when it was first approved by the FDA. No matter how much I argued with them that it’s the first medication that the FDA has approved for ALS in 22 years, it fell on deaf ears. The ALS doctor told me she has over 200 patients and less than 25 of them are on the Radicava because they can’t get approval from their insurance company. She told me that I needed to sit down at the kitchen table and treat this as a job for two solid weeks from 9 AM to 5 PM. That is exactly what I did. I made phone calls all day to the insurance company and asked to speak to their supervisor, then their supervisor etc. and I just continued to make calls. She told me to make myself become the world’s biggest pest until they finally approved. She said in her experience two weeks of nonstop pestering generally results in approval of the Radicava treatment. After two solid weeks of pestering, it was approved.

       

      <b>Say NO to infusion center unless it’s close, convenient and what YOU want</b>

      Then, they told us we would have to go to an infusion center. We live in the middle of nowhere and that would be a very difficult process. Again, I went back to the phone and pestered for four solid days straight and ended up getting home infusions approved. Initially I was overwhelmed when they told me that I would do the infusions but now it is a big nothing and I could do it with my eyes closed and one hand tied behind my back.

       

      <b>Does it help? Yes, it has for us.</b>👍🏻

      <b><i>I truly believe this medicine has and continues to make a big difference.  It buys time until the next type of treatment for ALS is available. </i></b>

       

      <b>Next treatment? I am watching Nurown</b>

      We continue taking the Radicava to slow down this disease holding out hope for new treatments on the horizon. In particular, I keep my eye on Nurown, made by Brainstorm which is now in its third clinical trial stage and has been granted orphan drug status to make it go through the system quicker than the normal slow process. Even with the fast track, it still takes 7 to 10 years for treatments to be approved. On the bright side,  Nurown has been in the works for years and is now in its third clinical trial stage. It seems as if it reverses the disease by 25% with the initial treatment. My limited understanding of this is that they extract bone marrow from the patient. They put it in petri dishes, clean it up and expand it with their “secret formula.“ They get enough of the patient’s stem cells to make approximately  three treatments. The first treatment is given to the patients and they see approximately a 25% reversal of the disease. The treatment starts to wear off after a few months and another treatment is necessary. The results are even more dramatic for the second and subsequent treatments. Last week the FDA met with the makers of Neuron and agreed to do everything in their power to fast track this new ALS treatment and it may even be available as early as the end of this year. 🤞

      The bottom line is that Radicava slows down the disease and buys time until the new Neuron treatment becomes available or any other treatments for that matter.  <b> <i>You have nothing to lose and everything to gain. </i></b>

       

      <b>Mitsubishi Pharmaceutical, the maker of </b><b> Radicava </b>

      One of the nurses from  Mitsubishi  Pharmaceutical reached out to me when they realized we were interested in the Radicava infusions. Of course I know since they are employed by Mitsubishi Pharmaceutical, the maker of Radicava, it is in their interest to get as many people as possible to purchase the Radicava infusions. With that being said, however, I found the information they provided to me to be absolutely invaluable. They told me what to expect the insurance company to say and they gave me the perfect answers to give back to the insurance company. Everything they told me that would happen, did indeed happen and I was thoroughly prepared with all the answers they gave me in advance. For instance, the insurance company said that the Radicava medication is only to be given to people who have been diagnosed with ALS for less than two years. Mitsubishi told me that nowhere in the instructions for the medication does it have any requirement that someone needs to be diagnosed with ALS for less than two years. In fact, that information from the insurance company only relates to one small clinical trial where the qualifying criteria to get into the clinical trial required trial patients to have ALS for less than two years. It was simply one of the limiting factors in a clinical trial and has nothing to do with the final instructions for the medication. Mitsubishi Pharmaceutical has at least one nurse on staff to help navigate the troubled insurance waters and I found that to be most helpful in our particular situation.

      <b>Organization</b>

      For the 10 days a month that the Radicava infusions are given, the specialty pharmacy company sends a large box with all the necessary supplies.   To make life easier, we bought a good size dresser or I guess technically a chest of drawers to put all the supplies in. The nurse organized it the first time and now each month when the supplies come, we put them in their place. It just makes life easier.

       

    • #14630
      Lazar Kogan
      Participant

      When I inquired about Radicava treatment for my wife who is a patient with a very respectable physician in an ALS clinic the response was that he would not suggest this treatment to any of his relatives should they be diagnosed with ALS. Enough said!

    • #14631
      Liz
      Participant

      Did you inquire further regarding his reasons for not recommending the treatment?  Efficacy? Safety? I have seen firsthand the benefits of the treatment so I would be curious as to why he does not recommend it.

    • #14632
      Lazar Kogan
      Participant

      Efficacy is the main reason.

    • #14637
      HD
      Participant

      I’ve been taking Radicava for two years. I am fairly active (i still work, drive, walk, swim, etc) so getting a chest port was a no-brainer for me. There’s zero discomfort when it’s accessed. Getting stuck in a vein in the crook of your arm, then leaving the line in for several days, I found to be both painful and inconvenient (you essentially can’t bend your arm while the line is in). I decided to get the chest port after my first cycle of infusions was done through my arm. Sure, you have a plastic thing sticking out of your chest for 10 days every month, but it doesn’t impede on the use of your arms if you are still able to use them. Bathing is inconvenient either way, but there are ways to cover the area. Also, there are full body wipes you can buy on Amazon that work well in lieu of showering or taking a bath. If you are still active and are going to take Radicava, I highly recommend the chest port.

      The other question i see being asked is if the drug is effective. The day I was told I didn’t qualify for the Nurown phase 2 clinical trial was the day I asked my neurologist to get me approved for Radicava. The truth is, I don’t know how effective it has been. I was a slow progressor my first year after diagnosis, and continue to progress at the same pace. Has it prevented faster progression? Perhaps. Has it done nothing? Perhaps. Have I gotten worse from it? Definitely not. I believe in my mind it has helped me, yet take no issue with someone who doesn’t think it helped them. But to have expectations that your symptoms would improve because of it is simply misguided. There has been no clinical evidence to support that.

    • #14638
      Elizabeth Benz
      Participant

      I’ve been on Radicava for a few months now.  Our regime is 10 of 14 days on, then 14 days off for a 28 day full cycle.  My spouse was trained to do the infusions at home and he doesn’t mind too much.  He also has to flush the lines daily which is quick and easy. The supplies are delivered to us monthly.  We do have to go in to the clinic weekly for my PICC line dressing change.  On the whole so far, so good.  I really hope the trial for a pill form will work out.  That would  be great!

      As far as does it work?  I don’t know.  My understanding is that it is hoped to slow the progression.  As I get weaker I think that the impact of increasing weakness becomes ever more apparent as it impacts my function more.  But I plan to keep giving it a shot in the hope that it is helping..

    • #14639
      Kathryn F. Kennedy
      Participant

      I have been on Radicava for 14 months, as well as Riluzole.  No side effects whatsoever!

      I am on the same regimen as most of y’all —14 days straight, followed by 14 days off for the 1st month.  Thereafter, 10 Infusions in a 14 day period followed by 14 days off.  2 bags are required each treatment and it requires about 1 hour for both bags and 20 minutes on each end for prep, etc.

      Living in Northeast Texas, there is no Infusion Center  licensed to administer Radicava.  Fortunately, we do have a Parish RN (Sue) assigned to our church and she drives to my house (60 miles round trip), adhering to the above regimen, since January 2019.  Plus Medicare covers the cost!  We are so blessed!

      My only issue was my Mediport which was worn out after that much use.  I now have a PICC line inserted and it is so much easier!  I simply have someone wrap it up in Saran Wrap while showering!

      I am a CR9orf72 (genetic) ALS person, so my response could be different.  But when I reflect on the other 6 relatives who had ALS, I firmly believe it has been beneficial in slowing down the dx process.

      I am approved for Hospice but delaying admission to continue my Radicava and Riluzole for at least another 2-3 months.  Will see how it goes from here!  I am indeed declining and my ALS-FRS has finally declined to 25 out of 50 which means Medicare will not approve me past June of this year.

      Hope this helps!

       

       

       

    • #14649
      Anonymous
      Inactive

      I decided not to use it because of the limited testing that was done, the lack of efficacy, possibility of gait disturbance and the regimen of administration.

    • #14652
      JULIE SUAREZ
      Participant

      Thank you all for your continued responses, experiences and thoughts!  I’m still debating but appreciate all the input.

    • #14659
      Liz
      Participant

      Today my husband finished Day 3 of this round of IV Radicava. He felt better after the treatment. On the 10 days a month he receives Radicava, he always feels better than the days without Radicava. We joke around and call it Liquid Gold….the good stuff!

       

    • #14667
      Marianne Opilla
      Participant

      I am entering Phase 3 oral Radicava trial later this month.  I will continue Riluzole.

    • #14681
      Anonymous
      Inactive

      I always feel better on days when I eat apples.

    • #14682
      Anonymous
      Inactive

      Here is an article you might want to read:
      Mitsubishi Tanabe pulls Radicava app after skeptical EU regulators ask for new trial.
      https://www.fiercepharma.com/pharma/mitsubishi-tanabe-s-radicava-stalls-eu-after-approval-body-asks-for-further-als-study

    • #14683
      Eric Barnett
      Participant

      I don’t understand why this isn’t available in pill form?

    • #14688
      Anonymous
      Inactive
    • #14716
      Romolo Pallini
      Participant

      I am on Radicava since begin 2019  , and continue to take Riluzole. no side effects.

      hard to say if Radicava helps, progression (at the least the visible effects of ALS are not linear).

      I am an engineer, and if I can measure and correlate data, I can’t form a firm opinion.

      as a”feeling (again not data driven ) I believe it doesn’t do much. but given no side effects I may stay on it a bit longer and evaluate further.

      PS: I have no port, they insert a pic line in my arm veins , it can stay 3 days, and no secondary issues. a good , non intrusive way to start the Radicava Jurney.

      PS,PS: I wend to Korea for Stem Cell treatment 4 times, I will write about it later.

       

    • #14718
      Kathryn F. Kennedy
      Participant

      Please provide update on the Stem Cell treatment when you can.  Thanks!

    • #14723
      Lee
      Participant

      I have been on Radicava for over 2 years. I am now in my 30th cycle. I do 10 days of infusions, then 18 days off. That way my wife and I have 18 days to travel or whatever else we want to do. I have a port in my chest, and my wife does the infusions at home. I get the port accessed at the beginning of the 10 days, and then de-accessed at the end. We have a routine and it is no big deal. I also take Riluzole, and Acetyl-L-Carnitine at the recommendation of one of my doctors.

      My progression has been slow, and I am still quite functional. I have no idea whether Radicava and the other medications have had any effect on my progression (it is impossible for an individual to know that, which is why we do clinical trials). I have not noticed any side effects. I sometimes get dizzy, but that also happened before Radicava. I would recommend it to others.

       

    • #14733
      Romolo Pallini
      Participant

      HI,

      I have been to Korea 4 Times in the last 12 months.

      I did not notice any change on the pace of disease progression.

      in Seoul a meet an American doctor with ALS, he went 3 times with good visible results.

      so……hard to say if treatment helps or not.

      cost is about 40K each injection + travel.

      procedure is not to painful , but annoying as you have to stay flat 6h after each procedure.

      1st trip bone marrow extraction . after 6 hours flat.

      2nd trip.: day one spinal fluid extraction. after 6 hours flat.

      day 2 Stem Cells ( mixed with spinal fluid) injections . again 6 hours flat. this procedure may result in Flu like symptoms.

      No sure I will do one more injection as I don’t see good results. but we all react to treatments in different ways.

      good luck, and contact me for more details

    • #14738
      Jonathan L Maddock
      Participant

      I started Radicava September 2019, initially with a PICC line, and a chest port since December. I prefer the chest port. It interferes less with life in general, and is easier for showering.

      I do my own infusions at home. I use a local hospital to access the port, and I de-access it myself.

      Radicava does seem to improve talking/walking slightly. I’m taking it for the long haul and slowing of progression. That’s hard to assess, but my insurance is paying for it, so bring it on. Anything to give the miracle discovery more time to happen!

      Jon

    • #14739
      Kathryn F. Kennedy
      Participant

      We are all different but I like my PICC line better!  Had a Mediport previously.  I too will continue with Radicava.   Fortunately it’s on my Medicare Formulary!

    • #14753
      Cyndi Zach
      Participant

      I will be starting Radicava in oral form this month as part of an efficacy and tolerance study through my ALS clinic.  The drug will be new for me.  Same schedule as the iv form.  I’ll keep you updated.

    • #14758
      Mario
      Participant

      Are there possibilities in Italy for therapy with Radicava? in which country is therapy possible? In Italy doctors only give Riluzole. thank you all

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