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

silkworm

Lily, it's no problem - ask away!

I had adjuvant chemo (ACT) and H/P for 12 months.

Valntine75

Hello! How is it going? I am scheduled to start next month...hope the side effects aren’t too terrible for you.

laughinggull

Hi ladies,

I saw my MO last week and he said that Neratinib is not indicated for early stage patients and not standard of care and no reason for me to get it. How did you all get the Neratinib and what was the rationale?

I was Stage IIB with very aggressive cancer and lymph node macro mets (plus other ominous signs) after neoadjuvant chemo and targeted therapy (AC, then Taxotere + Herceptin + Perjeta) and I am concerned about stopping systemic treatment after I reach the one year mark on Herceptin + Perjeta.

Thanks

LaughingGull

whywhy

I was going to try to get the drug as well. Trying to figure out the drug cost. Called my insurance company. Although I have met my yearly max out-ot-pocket, this drug is considered specialties and is not included in the max out-of-pocket calculation. I was given rough estimate of a whopping monthly $3000 co-copay. I was told that if the pre-authorization goes through, the cost may be lower. I don't know if I can afford the drug even if the cost came down.

misslil

LaughingGull, not sure what to say on that. I do think this drug is still uncommon in clinical practice, going by seeing my numerous providers almost none of whom have heard of it including my MO initially, RO, the cancer clinic nurses...

Maybe politely print out articles from the studies and bring them to your next appointment? Or ask someone else for a second opinion. There are patient profiles for which the statistics look better than others, but simply being early stage doesn't rule it out as far as I've seen. My MO wasn't enthusiastic about this drug, at all, when I brought it up last year as the drug was new and he'd not even heard of it. After researching it, he was guardedly willing for me to try it as I have some high-risk factors. He's mellowed some now as I haven't had any severe effects getting close to the finish line. In my case, I had DCIS 10 years ago, was diagnosed with early stage HER2+ ER+/PR- in 2016, did TCHP with radiation and surgeries, etc. After finishing a year on Herceptin, I started Nerlynx a few months later.

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whywhy, I'm not sure where you are, but the manufacturer has a copay program you might want to look into, or ask the staff at your clinic if there's something else that could help you. The monthly cost was quoted at $60-80/month before I submitted for the copay program, and only $10/month after.

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One thing that came up as I'm nearing the end of my year on this drug, my MO said the prescription is in twelve 28-day cycles, not actually a full year. Though for me it will probably be about a year as there were some intervals where I didn't take it briefly, or scaled it back while traveling when the SEs tended to surge.

laughinggull

Thank you Misslil.

Zoziana

Hi ladies-I'm back to this board to share how I'm doing with others either on neratinib or thinking of trying it. I'm starting my 8th month on the drug. It's going really well. I was not able to start until 11 mos out from Herceptin end, due to complications from Taxol having to settle down.

Bad side effect in previous treatment: ? If you read previous posts of mine from my taxol time, you will see I had a very rare and unpleasant side effect of taxol, hand-foot syndrome and ended up in a wheelchair for a few months. Made the full treatment but had dose reduction. Very painful, not fun, and significant lingering neuropathy and vascular issues in my feet from that. But, I am doing really well with neratinib! Just because you had a tough side effect or reaction to previous treatment does not mean you will have a bad reaction to neratinib.

Fear starting: I was afraid to start because I'd heard of the side effects, and I did have such a strong and rare reaction to taxol. But all I had read, and knowing my own personal and family history, etc., I wanted to try this drug. Finally, I did (through a study.) The first two weeks were a bit tough, alternating with diarrhea (D) and too much immodium and colestipol and constipation.

Report from 1 month in: By one month in, I needed nothing for D and since that time, there has been only about one day a month when I get diarrhea that requires immodium. First month I was overwhelmingly tired. That got better and by 8 weeks I was back to normal. (The AI drugs, I find, make me tired and so "normal" is back to my AI drug normal, which is a bit more tired than usual for sure.) I eat normally, tons of vegetables etc, but I am a healthful eater and don't drink alcohol but a few times a year now. I also avoid coffee--unless for some reason I am constipated, which does happen on occasion, even on this drug and without neratinib. I exercise quite a lot, I work part-time, and am able to live my life. I think everyone is a bit different on every drug, but from the study doctors I ahve learned that virtually everyone in their arm of the study (over 60 folks) was able to stay on the drug and have their side effects controlled, except for one person. And, most people have some degree of trouble in the first month, so the protocol now is to prevent that D from starting up badly, and then dial down the anti-D drugs after the first month. That worked really well for me.

What I have done that I believe makes this drug easier to handle: Things I have done that I know make my side effects more manageable after that (because when I didn't do these things, I had problems in different ways..): 1) Take drug only with a real meal--a lot of food. (I take mine with my first big meal of the day, lunch (but it is a huge bowl of good oatmeal, pecans, and berries and almond milk, so...brunch?); 2) Stay exceptionally well hydrated. (This drug is very drying, and so are the AI drugs. When I do not drink liquid virtually continuously throughout the day and early evening, my fingers will peel and get tons of hangnails, dry skin patches develop, lips get flaky, etc. I use copious amounts of quality moisturizer everywhere, and coconut oil for the most private dry areas (my dogs are enthusiastic over this last development...ha ha ha.); 3) When I have a day where I may not be able to access a bathroom an hour or so after eating (this is when I almost always will get a BM on this drug, and sometimes it is more urgent and a bit looser than normal, and sometimes there are 2 in a short sequence, but I can't call any of these diarrhea...), I make up (and it's easily portable) a whey or rice based protein shake made with almond milk ( in a mixer shaker travel cup--this is a drink, not a smoothie as I don't want the mixer mess and also I'm not really a fan of smoothies.) I have a coffee and vanilla flavor (and this season, add pumpkin pie spices to the vanilla , and they are quick, tasty, and provide enough protein and carbs for me to take the neratinib on, effectively, a "full stomach", and I have no problems. Also, I get lots of sleep, I exercise regularly, and I think positively as much as possible.

Grateful for the chance to try this drug: I am so very grateful I have been able to get this drug; I was 1.9 cms and Perjeta was not approved for me at the time but regardless, I'm excited about the different mechanism by which neratinib seems to work, and the fact that it seems to penetrate the blood-brain barrier and attaches irreversibly to the cell signalling mechanism (I am no science person or Dr so this is my very basic understanding of how it works.)

Closing thoughts for those thinking of taking this drug:If you are thinking of trying this drug, my advice would be to do so. You can always stop. Remember Puma, the drug company has payment plans to help. And, I think the studies (some of them) are still recruiting, but check the study-clinical trial sites for that. All the studies give you the drug now; they are studies on how best to control side effects.

The FB group for this drug: It's useful, and has helped me at times, but be mindful of negative posts. One caution about that group is that, in my view, you do often get folks complaining about lots of side effects and often I think we don't hear from the large majority of us who do really well on this drug. (Before any D control, only 40% of folks had bad D on the drug (so 60% to start were fine), and with D control, the huge majority of folks will do fine, with minor inconveniences, per the study docs who I see.) That said, the FB group is active and you can get a quick response. The group has its purpose and I am glad it was started but I don't think it replaces the knowledgeable and sane discussions on Breastcancer.org. (Thanks, Moderators, for your role here and also the articles, etc. on the site. )

Closing and Good Luck: I wrote today just to say that even if you had a hard time with chemo, or Perjeta, or Herceptin statistically, you will probably do well on neratinib, after that first adjustment period. I timed my start for a 2 week period where I had some vacation and home time, just so I didn't worry. Typically, anecdotally,from the FB group, days 3-8 seem the hardest for folks. I was fine by day 9, and it stayed that way, as described above. Good luck!

whywhy

Thank you Misslil and Zoziana for all the information. I had my Herceptin and Perjeta infusion today. My onc will send in pre-approval request for Nerlynx. I hope it'll get approved and cost is reasonable.

laughinggull

Thanks Zoziana! Much appreciated

bareclaws

I’ve been taking the drug for 6.5 months now. And I’ve just figured out that spinach and beets are a powerful trigger for side effects. Maybe mushrooms.Has that been the case for anyone else?

Mary7777

It was asked several times but no one who could have answered. I repeat the question to those who take neretinib even if they are hormone negative.

What your oncologist told you to justify the therapy despite the Extenet trial shows an advantage only for hormone positive subgroup?

Please

whywhy

Want to share my experience with Nerlynx. Started the drug on Dec 30th with fear and hope. It soon turned out to be a total disaster. After a couple of days, I lost appetite and was hit hard by fatigue. I don't think fatigue was that bad in worst chemo days. Can't eat or drink much at all. On day 8, Big D hits. It's no joke. Day 9, I started to throw up. Took Zofran left from chemo days and it was no use. By the 10th day, I gave up. Went to my oncologist office two straight days for fluid and electrolytes. I was very disappointed. I thought I was young and otherwise healthy. Went back to running for about six months now and my body was in a good condition. Thought I would survive a few months on it. Guess the drug is not for me. I hope every one else has a easier journey than mine.

Happy New Year!

misslil

I'm sorry to hear you had such a tough experience. It seems there is a lot of variation.

I'm about to finish my year this month, and the main overall concern has been a feeling of fatigue. I hope when I get off the drug that will ease and I won't find it's just me getting older, ugh... Have definitely had some days with D issues off and on, but nothing persistent or severe.

One odd thing is that for a year's Rx on this drug, somehow I seem to have received enough pills to go into 14 months. I can account for 2-3 weeks of that when the supplier was out of inventory for a week, and I had some weeks when I reduced what I was taking during overseas trips. Maybe also during a week when I had bad flu last year. But I can't figure out in the slightest how I wound up with 6 weeks extra pills. Maybe they overfilled one of the bottles, idk.

Barb38

Thanks for the information on Nerlynx. My MO has discussed with me about taking Nerlynx and trying to understand about how everyone deals with the side effects. Is it worse in the begining and does it get better ?

THanks

hahlyn

Misslil

That's funny I have the same with the overage of pills. Also like you on trips weeks where I knew i was on call i decreased. As you know the Big D is fierce at times even with Imodium.

I will be done next month. At first I was going to throw in the towel due to the side effects but I continued to push through.

I saw on the other forum Sept 2016 chemo group your're going to be done this month Congrats!

Hahlyn

misslil

Yes, I'll be done pretty soon. Whatever I decide done means, I guess.

I counted up the remaining pills last weekend, and I still had 21 days worth so it could run well into February if I use them all. It seems hard to throw them out knowing how expensive the drug is.

Glad to hear I'm not the only one with the confusing number of pills to finish out. I even went back to check my credit card records to be sure I hadn't received or missed a shipment. But it was 12 shipments, starting before New Year's 2018.