roflumilast 500mcg
- Thread starter Everett
- Start date
Everett - I hope you do well with Daliresp. I am really pleased with what it has done for me. In all honestly, I would recommend patients give it a try before committing to any stem cell treatment or as an adjunct to therapy. It took me a good month to get used to it, but once I got over the hump, I have had no further side effects and believe it to be the best medication I have ever used since being diagnosed. The side effects for me were bad, but I was told that they would diminish and they did. Some report no side effects at all, so hopefully you will be one of them.
I also use Advair and Spireva (every other day for the Spireva). I never found that Spireva did much for me, but read that it made the Daliresp work better, so I added it to my regimen. It is very cheap at All Day Chemist so I figured why not and my doctor agreed that it was okay to do that.
I am somewhat disturbed lately to see so many COPD patients getting stem cell treatment with results all over the board. Some see no improvement, some say they have improvements that diminish, some say they got improvements that have lasted for awhile, but there is no real consensus as to whether or not stem cell treatment is working for COPD. I am not a scientist, but I believe it might be because COPD encompasses so many different conditions. What treatment might work for one, may have no effect on another. It's all over the board and since no one is doing any studies or clinicals for the treatment of COPD with stem cells, there is no way to know if stem cell treatment is increasing lung function or regenerating any lung tissue.
Why are clinics reluctant to do serious studies or track patients? In my opinion, it's all about the money. This holds true for other conditions and diseases as well, not just COPD. I truly hope we see a tide change because of Texas and that therapy will become a serious, science motivated business rather than just a lucrative enterprise for those that aren't willing to put patients first.
I also use Advair and Spireva (every other day for the Spireva). I never found that Spireva did much for me, but read that it made the Daliresp work better, so I added it to my regimen. It is very cheap at All Day Chemist so I figured why not and my doctor agreed that it was okay to do that.
I am somewhat disturbed lately to see so many COPD patients getting stem cell treatment with results all over the board. Some see no improvement, some say they have improvements that diminish, some say they got improvements that have lasted for awhile, but there is no real consensus as to whether or not stem cell treatment is working for COPD. I am not a scientist, but I believe it might be because COPD encompasses so many different conditions. What treatment might work for one, may have no effect on another. It's all over the board and since no one is doing any studies or clinicals for the treatment of COPD with stem cells, there is no way to know if stem cell treatment is increasing lung function or regenerating any lung tissue.
Why are clinics reluctant to do serious studies or track patients? In my opinion, it's all about the money. This holds true for other conditions and diseases as well, not just COPD. I truly hope we see a tide change because of Texas and that therapy will become a serious, science motivated business rather than just a lucrative enterprise for those that aren't willing to put patients first.
Reflumilasst side effects
Barb,
What side effects did you experience? Dr.S has me on an antibiotic plus beefed up dosage of prednisone and I am about to go up he wall and can't sleep for over a couple of hours at a time. I don't want to get down physically beyond the COPD. I am getting exhausted and gasping for breath on the slightest exertion.
Everett
Barb,
What side effects did you experience? Dr.S has me on an antibiotic plus beefed up dosage of prednisone and I am about to go up he wall and can't sleep for over a couple of hours at a time. I don't want to get down physically beyond the COPD. I am getting exhausted and gasping for breath on the slightest exertion.
Everett
Prednisone always affected me that way as far as not being able to sleep. I would try taking it early in the morning if you aren't already. That helped me. As for Daliresp (Daxas) the side effects I had were nausea, lack of appetite, diarrhea. I felt like I had the stomach flu. It did not affect my breathing however. Below is what can be found on the internet concerning this medication. It was very difficult for me adjusting to this medicine, but as I mentioned, I now have no recurring side effects of any kind and am very pleased with it. Have you been ill or why did your doctor beef up the prednisone?
Please let your doctor know before you start to take Daxas, if you already take:
a medicine containing theophylline (a medicine to treat respiratory diseases), or
a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term.
a medicine containing fluvoxamine, enoxacin or cimetidine.
The effect of Daxas may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy). Ask your doctor for advice.
Possible Side Effects of Daxas (Daliresp)
Like all medicines, Daxas can cause side effects, although not everybody gets them.
Side effects may occur with certain frequencies, which are defined as follows:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.
Common side effects
Weight decrease, decreased appetite; sleeplessness; headache; diarrhoea, nausea, stomach ache.
Uncommon side effects
Hypersensitivity (a generalised allergic reaction that may affect the skin, mouth and tongue, possibly leading to difficulties in breathing and/or a drop in blood pressure and accelerated heartbeat); feeling anxious; trembling, sensation of spinning head (vertigo), dizziness; sensation of rapid or irregular heartbeat (palpitations); gastritis, vomiting, reflux of stomach acid to the gullet (acid regurgitations), indigestion; rash; muscle pain or cramps; back pain; feeling of weakness or tiredness; feeling unwell.
Rare side effects
Male breast enlargement; feeling nervous or depressed; decreased sense of taste; respiratory tract infections (excluding pneumonia); bloody stools, constipation; elevation of liver or muscle enzymes (seen in blood tests); wheals (urticaria).
In the rare case of a severe allergic reaction, stop taking Daxas and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital. Take your medicine and this leaflet with you to provide full information of your proper treatment. Typical symptoms of a severe allergic reaction are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating.
Please let your doctor know before you start to take Daxas, if you already take:
a medicine containing theophylline (a medicine to treat respiratory diseases), or
a medicine used for treatment of immunological diseases, such as methotrexate, azathioprine, infliximab, etanercept, or oral corticosteroids to be taken long-term.
a medicine containing fluvoxamine, enoxacin or cimetidine.
The effect of Daxas may be reduced if taken together with rifampicin (an antibiotic medicine) or with phenobarbital, carbamazepine or phenytoin (medicines usually prescribed for the treatment of epilepsy). Ask your doctor for advice.
Possible Side Effects of Daxas (Daliresp)
Like all medicines, Daxas can cause side effects, although not everybody gets them.
Side effects may occur with certain frequencies, which are defined as follows:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: frequency cannot be estimated from the available data.
Common side effects
Weight decrease, decreased appetite; sleeplessness; headache; diarrhoea, nausea, stomach ache.
Uncommon side effects
Hypersensitivity (a generalised allergic reaction that may affect the skin, mouth and tongue, possibly leading to difficulties in breathing and/or a drop in blood pressure and accelerated heartbeat); feeling anxious; trembling, sensation of spinning head (vertigo), dizziness; sensation of rapid or irregular heartbeat (palpitations); gastritis, vomiting, reflux of stomach acid to the gullet (acid regurgitations), indigestion; rash; muscle pain or cramps; back pain; feeling of weakness or tiredness; feeling unwell.
Rare side effects
Male breast enlargement; feeling nervous or depressed; decreased sense of taste; respiratory tract infections (excluding pneumonia); bloody stools, constipation; elevation of liver or muscle enzymes (seen in blood tests); wheals (urticaria).
In the rare case of a severe allergic reaction, stop taking Daxas and contact your doctor immediately, or go immediately to the emergency department in the nearest hospital. Take your medicine and this leaflet with you to provide full information of your proper treatment. Typical symptoms of a severe allergic reaction are: swelling of the face, lips, mouth, tongue and/or throat, which may cause difficulty in swallowing or breathing, hives (nettle rash), severe dizziness with very fast heartbeat and heavy sweating.
Everett
I had similar side effects. Rapid heart rate and shortnes of breath in addition to the diarrhea and headaches. I had to give up because I couldn't do anything.
Some people have found taking a pill every other day causes less side effects. Worth trying before giving up. I plan to try again soon.
One thing I have done to help with the feeling "up the wall" is to drink a cup of chamomile tea about 30 minutes before bedtime. A sleepytime blend works pretty well too.
PS: Prednisone is a tool of the devil if you ask me. LOL
I had similar side effects. Rapid heart rate and shortnes of breath in addition to the diarrhea and headaches. I had to give up because I couldn't do anything.
Some people have found taking a pill every other day causes less side effects. Worth trying before giving up. I plan to try again soon.
One thing I have done to help with the feeling "up the wall" is to drink a cup of chamomile tea about 30 minutes before bedtime. A sleepytime blend works pretty well too.
PS: Prednisone is a tool of the devil if you ask me. LOL
It is very strange that the side effects for some people are so severe and then suddenly, they just disappear. I was really miserable for a month. I did lose weight which I needed to do anyway because I didn't want to eat on some days.
Taking Daliresp is like peddling a bike up a steep hill. If you can just get to the top, then you can coast the rest of the way.
Taking Daliresp is like peddling a bike up a steep hill. If you can just get to the top, then you can coast the rest of the way.
Side effects
I had to give up taking roflumalast for now. I had too many sides hitting me. I may try taking it every other day like Jeannine says but will wait until next week. Too much going on to risk the emotional side effect. Barbara and Jeannine--I hope that you both have survived the quakes in your country. . We are still in drought and triple digit temps now and that is tearing my COPD up needless to say.
I had to give up taking roflumalast for now. I had too many sides hitting me. I may try taking it every other day like Jeannine says but will wait until next week. Too much going on to risk the emotional side effect. Barbara and Jeannine--I hope that you both have survived the quakes in your country. . We are still in drought and triple digit temps now and that is tearing my COPD up needless to say.
Someone on COPDliving reported that they got used to the medication by taking it every 3 days to begin with. Like I said, it's tough getting used to it, but for me the benefits are making the month I spent fighting it very much worthwhile. SamE is something that I also took which enhances one's mood. 400mg a day is what I used (200mg in the am and 200 in the pm).
The quake in Colorado was in the southern part of the state. Nothing felt in Denver. I hope you get some rain soon.
The quake in Colorado was in the southern part of the state. Nothing felt in Denver. I hope you get some rain soon.
I am considering taking Daliresp but am scared after listening to all the side effects. While I would welcome the loss of a few pounds I am most afraid of the increased heart rate. Has anyone who is taking this had PFT's prior to beginning this medication and after they were on it a while?
Connie - I didn't experience any increase in heart rate. The clinical trials conducted for the FDA included lung function testing. If you experience side effects and not everyone does, there is light at the end of the tunnel. They go away. I am very impressed with this medication. The weight loss for me was a real plus. No dieting and the pounds just melted off.
http://www.drugs.com/pro/daliresp.html
Effect on Lung Function
While Daliresp is not a bronchodilator, all 1-year trials (Trials 3, 4, 5, and 6) evaluated the effect of Daliresp on lung function as determined by the difference in FEV1 between Daliresp and placebo-treated patients (pre-bronchodilator FEV1 measured prior to study drug administration in three of the trials and post-bronchodilator FEV1 measured 30 minutes after administration of 4 puffs of albuterol/salbutamol in one trial) as a co-primary endpoint. In each of these trials Daliresp 500 mcg once daily demonstrated a statistically significant improvement in FEV1 which averaged approximately 50 mL across the four trials. Table 3 shows FEV1 results from Trials 5 and 6 which had demonstrated a significant reduction in COPD exacerbations.
Table 3. Effect of Daliresp on FEV1 (Click on link above to see table)
Lung function was also evaluated in two 6-month trials (Trials 7 and 8) to assess the effect of Daliresp when administered as add-on therapy to treatment with a long-acting beta agonist or a long-acting anti-muscarinic. These trials were conducted in a different population of COPD patients [moderate to severe COPD (FEV1 40 to 70% of predicted) without a requirement for chronic bronchitis or frequent history of exacerbations] from that for which efficacy in reduction of exacerbations has been demonstrated and provide safety support to the Daliresp COPD program.
No trials have been conducted to assess the effects of Daliresp on COPD exacerbations when added to a fixed-dose combination product containing a long-acting beta agonist and inhaled corticosteroid.
http://www.drugs.com/pro/daliresp.html
Effect on Lung Function
While Daliresp is not a bronchodilator, all 1-year trials (Trials 3, 4, 5, and 6) evaluated the effect of Daliresp on lung function as determined by the difference in FEV1 between Daliresp and placebo-treated patients (pre-bronchodilator FEV1 measured prior to study drug administration in three of the trials and post-bronchodilator FEV1 measured 30 minutes after administration of 4 puffs of albuterol/salbutamol in one trial) as a co-primary endpoint. In each of these trials Daliresp 500 mcg once daily demonstrated a statistically significant improvement in FEV1 which averaged approximately 50 mL across the four trials. Table 3 shows FEV1 results from Trials 5 and 6 which had demonstrated a significant reduction in COPD exacerbations.
Table 3. Effect of Daliresp on FEV1 (Click on link above to see table)
Lung function was also evaluated in two 6-month trials (Trials 7 and 8) to assess the effect of Daliresp when administered as add-on therapy to treatment with a long-acting beta agonist or a long-acting anti-muscarinic. These trials were conducted in a different population of COPD patients [moderate to severe COPD (FEV1 40 to 70% of predicted) without a requirement for chronic bronchitis or frequent history of exacerbations] from that for which efficacy in reduction of exacerbations has been demonstrated and provide safety support to the Daliresp COPD program.
No trials have been conducted to assess the effects of Daliresp on COPD exacerbations when added to a fixed-dose combination product containing a long-acting beta agonist and inhaled corticosteroid.
Saw this on a comment board
I am into my fourth month with Daliresp. Doing very well now. Just about all the side effects are gone - was glad to get rid of the anxiety and insomnia. I haven't lost weight, but I have to eat alot to maintain my current weight. I have gone from 3 1/2 liters of oxygen to 2 1/2 liters without having to decrease my activity. I am happy with that. Very happy. Am anxious to see if anyone else is having any luck with this drug. The only issue I have is that it is very expensive.
More comments here:
http://www.prescriptiondrug-info.com/Discuss/Daliresp-Experience-219303.htm
I am into my fourth month with Daliresp. Doing very well now. Just about all the side effects are gone - was glad to get rid of the anxiety and insomnia. I haven't lost weight, but I have to eat alot to maintain my current weight. I have gone from 3 1/2 liters of oxygen to 2 1/2 liters without having to decrease my activity. I am happy with that. Very happy. Am anxious to see if anyone else is having any luck with this drug. The only issue I have is that it is very expensive.
More comments here:
http://www.prescriptiondrug-info.com/Discuss/Daliresp-Experience-219303.htm
Daliresp and emphysema
The FDA and the manufacturer (Forest Labs) says that this drug is targeted for people with chronic bronchitis and not emphysema. It in intended to reduce exacerbations, but not in patients with pure emphysema and no bronchitis component. COPD is an umbrella term, and two people may have COPD, yet different forms of the disease. There are drugs that help one or the other, but not all COPD sufferers. Another example is albuterol, which helps COPD patients with an asthma component, but not those with pure emphysema.
Here's a quote from WebMD:
"The pill is recommended for people with severe COPD associated with chronic bronchitis who have had flares. Roflumilast has been shown to reduce the risk of COPD flares in this group. It is not intended to treat another form of COPD, which involves primary emphysema."
Here's a quote from the Alpha-1 foundation:
"The FDA said Daliresp is meant for people with severe COPD linked to bronchitis and isn’t intended to treat another form of COPD caused by emphysema. Daliresp is also meant to be used long term to reduce the frequency of flare-ups caused by COPD and isn’t meant to treat acute attacks, which are usually marked by difficulty breathing."
Look at the prescribing information as well as the press from Forest labs for more:
http://www.webmd.com/lung/copd/news/20110301/fda-approves-new-drug-to-treat-copd
http://www.alpha-1foundation.org/news/fda-approves-daliresp-drug-for-bronchitis-patients-will-get-medication-guide-warning-of-risks
https://www.daliresp.com/
Good breathing, Jay
The FDA and the manufacturer (Forest Labs) says that this drug is targeted for people with chronic bronchitis and not emphysema. It in intended to reduce exacerbations, but not in patients with pure emphysema and no bronchitis component. COPD is an umbrella term, and two people may have COPD, yet different forms of the disease. There are drugs that help one or the other, but not all COPD sufferers. Another example is albuterol, which helps COPD patients with an asthma component, but not those with pure emphysema.
Here's a quote from WebMD:
"The pill is recommended for people with severe COPD associated with chronic bronchitis who have had flares. Roflumilast has been shown to reduce the risk of COPD flares in this group. It is not intended to treat another form of COPD, which involves primary emphysema."
Here's a quote from the Alpha-1 foundation:
"The FDA said Daliresp is meant for people with severe COPD linked to bronchitis and isn’t intended to treat another form of COPD caused by emphysema. Daliresp is also meant to be used long term to reduce the frequency of flare-ups caused by COPD and isn’t meant to treat acute attacks, which are usually marked by difficulty breathing."
Look at the prescribing information as well as the press from Forest labs for more:
http://www.webmd.com/lung/copd/news/20110301/fda-approves-new-drug-to-treat-copd
http://www.alpha-1foundation.org/news/fda-approves-daliresp-drug-for-bronchitis-patients-will-get-medication-guide-warning-of-risks
https://www.daliresp.com/
Good breathing, Jay
As always, the very best advice will come from one's own doctor. This drug acts as an anti-inflammatory agent. It's a prescription medication so patients have to consult with a doctor who can then make the determination based on each individual as to whether or not they should be prescribed Daxas/Daliresp.
Jeanne,
I never said that it was unsafe. I have told many people who asked that very thing - try it for a month or two and see if it helps. If not, or the side effects are killer, then you can just stop taking it.
What I AM saying is that both the FDA and the manufacturer (and I provided references above - I'm not making this stuff up!) say that the drug is for people with chronic bronchitis and not for those with just emphysema. This isn't my opinion. This is what the manufacturer and the FDA claims. Of course, the placebo effect is often (usually) more important than the drug itself (did you read the recent study about coffee?).
Before my transplant, my disease consisted of emphysema and asthma, and any bronchitis component I may have had was tiny, if there was any at all. In the same way, I know people who say that they have no asthma component, just pure emphysema, yet they say that albuterol helps them.
If that's so, then either they're wrong about not having asthma, or the placebo effect is what is working for them. Either way, it's all good.
I never said that it was unsafe. I have told many people who asked that very thing - try it for a month or two and see if it helps. If not, or the side effects are killer, then you can just stop taking it.
What I AM saying is that both the FDA and the manufacturer (and I provided references above - I'm not making this stuff up!) say that the drug is for people with chronic bronchitis and not for those with just emphysema. This isn't my opinion. This is what the manufacturer and the FDA claims. Of course, the placebo effect is often (usually) more important than the drug itself (did you read the recent study about coffee?).
Before my transplant, my disease consisted of emphysema and asthma, and any bronchitis component I may have had was tiny, if there was any at all. In the same way, I know people who say that they have no asthma component, just pure emphysema, yet they say that albuterol helps them.
If that's so, then either they're wrong about not having asthma, or the placebo effect is what is working for them. Either way, it's all good.