Nerlynx Approved by FDA to Treat Early-Stage, HER2-Positive BC

xxyzed

KCMC - it is approved for HER2 positive cancer who completed herceptin within the previous two years since around July last year.
The study on which it was approved released 5 year data around December last year. The data to date indicates it provides most benefit to the sub-groups that are triple positive, those who commenced within 6 months of completing herceptin and those with a lot of positive nodes. Nobody knows if that trend will continue as more data is obtained. The next lot of new data is expected to be released in July.
In practice some oncologists will prescribe it to anyone that meets the her 2 positive, finished herceptin within 2 years guidelines, others will only prescribe to those with lots of positive nodes or who didn’t have a complete response to chemo and are deemed high risk of recurrence, others still have never heard of it.
It’s main side effect is gastrointestinal effects like diarrhoea, heartburn, abdominal discomfort and most people get this for the first month and it improves after that. A lot of oncologists don’t recommend it as they say the side effects outweigh the benefit and there is not enough evidence to demonstrate what the long term benefit, if any, will be.
It is the easiest of all the treatments I have had but there seems to be some people who just can’t manage the drug. I am at high risk of recurrence being stage 3c and am getting the drug via a trial as it is not approved in my country.

KCMC

xxyzed, thank you so much for explaining it. Not sure if the Oncologist will recommend it for my use. I am Triple Positive, Stage IIA, no node involvement. I just feel now is the time to throw everything at this beast. I only get this one chance. I was lucky to add Perjeta to my Herceptin after TCHP was done. Also it is good to hear your side effects are manageable. A lot of times we only hear the negative side effects.

Now I can go in and talk to the Oncologist well informed thanks to you! Much appreciated.

misslil

Has anyone taken a break with this, and how did that go as far as SEs when you started again?

I was a too lax in re-ordering the monthly Rx while I was traveling, and it turns out they are out of stock so it will be nearly a week until I get the next package. I only have one days worth of pills left, thinking I will skip today and then spread the rest out until they are gone.

Suburbs

KCMC, nerlynx is a newer drug for early BC HER2+. So far I have only heard of it being available through specialty pharmacies. Mine is express shipped with signature required. Your MO should be aware of it. There is definitely a mix of opinions on the therapy. Some think it's not worth it. It's not likely to be in stock at most pharmacies.

KCMC

Hi Suburb, I would have to get permission from my insurance company it's listed on my formulary but there is a warning saying that my insurance company would need a "coverage review", My husband is retired military, if I am prescribed it, I would be picking it up at my Military Treatment Facility. You are right, it looks like it is very limited at pharmacies and mail order outlets, it states this on my insurance website. I checked with my nurse navigator and she said I should not have a problem getting it prescribed, my MO would need to write a letter with stats backing it up. I am lucky that there are no copays, deductibles and limits on medications for us, everything is free, thank god, my husband is on a ton of medicine too. I imagine nerlynx probably costs a lot.

Thank you, Suburb!

Hahlyn

Misslil

I took a break early on due to the side effects. Not being on it for a week my body went back to normal. When I restarted I was placed on a reduced dosage from 6 pills to 5 pills. Since I have been doing okay.

Hahlyn

fidget

KCMC,

My husband is retired military also. If you have Tricare Prime, Nerlynx comes mail order through Accredo who is Express Scripts' specialty pharmacy. My copay is $28.00. After all this treatment, I'm sure Tricare just loves me. I just told my husband I'm probably one of the reasons Tricare copays have increased this year.

I'm in my third week and doing better. It's like a rollercoaster. Some days good, others not so much. Is anyone dealing with acne? And how about itchy scalp? Sometimes I wonder what exactly this drug is doing to cause these side effects. The worse side effect I had with TCHP was diarrhea and not much else, well other than losing all of my hair. LOL.

Good luck to everyone on this new treatment!

misslil

I had my monthly check-in with the MO yesterday, and fatigue came up as a topic. I was surprised when he said even after 18 mos from TCHP, there could be residual fatigue -- I guess counting the additional time I was on Herceptin.

But he felt Nerlynx is adding to it, which is good as I was afraid it was just me getting old

I couldn't tell much difference during the 5 days or so until I was able to pick up my Rx refill. But during the interim, I got out of sync taking Arimidex so that's now in the mornings, and the Nerlynx will be at night unless I can rotate them back. I don't like taking pills so I have them split up in the day. Don't know if there will be anything different taking Nerlynx at night vs. mornings.

Suburbs

Misslil, fatigue is my constant nemesis, with and after Herceptin and before nerlynx and with nerlynx. I have been told the same thing - it takes time. Hope everyone is doing ok

Gigilala

the fatigue is awful

Fidget: I have acne and itchy scalp I saw my doctor last week he didn't want to give anything he said wait and see

DazzlingEagle

I thought I was going to be on Nerlynx. My MO is the one who told me about it! Now he says no. I have mixed feelings about it.

NotVeryBrave

Did your MO explain why it was considered before and not now? I would think that with hormone negative status - you would be one that would have it recommended.

BellasMomToo

I'm hormone negative. My MO isn't recommending Nerlynx for me because it really doesn't benefit hormone negative BC. I'm OK with that. If I insist, she'll probably go along. But I'm really glad to be done with treatment. I finished herceptin in 10/2017, so I still have time to start Nerlynx if new data shows it would help HR- afterall.

KCMC

fidget - thank you so much for the info! Really appreciate it, I do have Tricare Prime.

PJP64

I am 3 months out from last Herceptin treatment. My MO is recommending Nerlynx. How were the side effects and how did you manage them?

MinusTwo

PJP - the best thing to do is go back to page 1 of this thread and read through all 9 pages. There are lots of answers to your questions.

bareclaws

Two weeks in now and it's all been manageable. I never took more than 8 mg of Imodium in 24 hours and have gradually tapered it to none. The other side effect has been sleepiness a few hours after I take the pills.

Moderators

Hi PJP64 - Welcome to Breastcancer.org! You can learn more on Nerlynx and what to expect taking this drug in the following article from our main site: http://www.breastcancer.org/treatment/targeted_the...

Hope this helps!

The Mods

Suburbs

PJP64, this drug typically is distributed by a specialty pharmacy. A nurse calls to discuss side effects before shipping usually. My MO and his nurse monitor me closely and also provide guidance. For me, the fatigue has been worse than the diarrhea.

At the beginning, loperamide or Imodium are taken regularly with it. If the loperamide does not work, there is another drug that can be prescribed; however, if memory serves it is an opium derivative, so this is not the standard of care. Here are some tips:

1. Take a high quality probiotic.

2. Some folks take the pills at nighttime as a strategy.

3. It takes a few weeks to sort things out.

4. See a nutritionist and discuss nutritional strategies to minimize intestinal difficulties

5. Make sure you are aware of drug interactions. Proton pump inhibitors like Prilosec do not play well with neratinib.

I am in month 3 and find it doable. I'm not happy about it but so paranoid about recurrence that I am willing to power through the side effects.

Good luck. Keep us posted.

PJP64

Thank you. This is good to hear! Hearing from people who have been on the drug is very helpful. I had a chance to speak with the pharmacist who was very informative and also provided some tips about managing side effects. My MO didn't provide much information about it so I was trying to do my own research about it. Everyone's responses are very much appreciated! I start my regimen tomorrow.

Hahlyn

Hello

Just wondering has anyone been having muscle spasms? I've been getting spasms in my leg and on my side (brutal) My husband and I were out to dinner and one came on strong on my side I had to get up a few times to try to get the pain to subside. I believe from what I read this is a side effect. Wanted to see if anyone is having this.

Thanks. Hahlyn.

Suburbs

hahlyn, yes, I have had recently spasmsin my calves. I've been drinking more electrolyte water to combat this. I am thinking that I need to get back to keeping a journal of side effects. It's something new everyday. It's like TCHP without the loss of the sense of taste some days or like the early days of starting an AI. Nothing is crippling but it is strange wondering what next! Hang in there.

xxyzed

Yes to the muscle spasms. I take a magnesium supplement but was still woken up most of the other night with spasms, first one calf, then half an hour later the other calf, then a few hours later one side of my chest. I was exhausted the next day from all the sleep disruption.

misslil

Yes, I've occasionally had cramps in my feet or calves, usually at night. I'm not sure if it's more though than that often I find I'm so tired at night I fall hard asleep on the sofa which is slightly too short to stretch out comfortably lol.

Hahlyn

Ladies

Glad to hear im not the only one. I'm going to call my MO and see if there is something I can take. The spasms are daily. In the meantime I will try drinking electrolytes and more water and see if that works.

Hahlyn

PJP64

I am on Prilosec for chronic heartburn. I understand that you can’t take this with the Nerlynx, but can take an antacid three hours before taking the Nerlynx. Can you take the antacid a few times a day as long as you aren’t within the three hours of the Nerlynx dosing? I am struggling with not being able to take Prilosec to manage my chronic heartburn while on the Nerlynx so looking for alternatives

Suburbs

PJP64, I had chronic heartburn during chemo but eventually weaned myself off of omaprazole. On nerlynx, I have had occasional heartburn, generally at night, and take tums to combat it. I have to be careful with acidic beverages - no lemon water, for example. I would check with your MO on this. Good luck

NCLive

I am so nervous about starting the Nerlynx on June 25. I've got my Lomotil/8 daily, if needed, and fluids with electrolytes ready. I am to start the anti-diarrhea meds the day before I take the 6 Nerlynx tablets. I lost 30 lbs with severe diarrhea/fluid loss from the TCHP X 6 treatments in the fall of 2016. I would receive my chemo treatments on Monday and go to my local hospital's infusion center for one to two bags of fluids the following Wed, Fri and Mon. I had to decide to take the Nerlynx now because I completed the Herceptin in July 2017. My MO says that if I can manage the SE great; if not, the positive percentage benefit is small, especially since I had complete response to my treatments. Thank you for this thread and the input about the drug side effects.

I am friends with of two long term HER2+ survivors. The first friend was one of the first patients in my area to receive the "new drug." She is in her eighties and 17+ years without recurrence. The second friend received the Herceptin because her doctor happened to attend a medical symposium, where the drug was discussed. She is 15+ years without recurrence.

misslil

NCLive, best wishes with your treatment and minimal side effects. I' m approaching 6 months on Nerlynx, it's been manageable so far for me.

Suburbs

NC live, I'm on month 5 and handling the treatment without the loperamide, but I strongly recommend complying initially as it can get bad. Nothing could be as bad as TCHP, that's for sure. I'm nearly halfway through. The time has flown, thankfully. Wishing you the best in making your decision.