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What is AMARYL?
Product Description
Common use
Amaryl is an oral blood sugar-lowering drug which belongs to the class of sulfonylureas. Active substance is Glimepiride. It is used together with diet and exercise to treat type 2 (non-insulin dependent) diabetes. The mechanism of its action is to stimulate the secretion and release of insulin from beta cells of the pancreas (pancreatic effect). Amaryl is used to treat non-insulin depending diabetes (type 2) as monotherapy or in combination with insulin (or metformin).
Dosage and direction
The best dose is determined by a physician on a basis of regular measurements of blood sugar content.
Precautions
Be careful your sugar does not fall too low due to stress, skipping a meal, exercising too long, or drinking alcohol. Know signs of hypoglycemia and keep a source of sugar at hand. If your sugar level is too high you may feel very thirsty or hungry. You may also urinate more than usual. Take this medication exactly as prescribed as it is a part of a complicated program consisting of diet, medication, and exercise routines. Tell your doctor if you are pregnant or plan to become pregnant, have adrenal or pituitary gland problems before taking this medication.
Contraindication
Amaryl is contraindicated in patients with history of diabetic ketoacidosis, diabetic coma and prekoma, insulin-dependent diabetes (type 1), severe renal dysfunction, severe hepatic impairment, individual hypersensitivity to Amaryl, other members of sulfonylurea class and sulfonamides.
Possible side effect
If you have any signs of allergic reaction to this medication such as hives, swelling of face and throat, rash or other major symptoms (severe skin rash, itching, redness, pale skin, easy bruising or bleeding, numbness, dark urine, clay-colored stools, abdominal pain, fever, nausea)seek for immediate medical help.
Drug interaction
Diuretics like hydrochlorothiazide (Hydrodiuril, Ezide, Hydro-Par, Microzide, furosemide (Lasix)), corticosteroids such as prednisone and methylprednisolone (Medrol), phenytoin (Dilantin), niacin, and sympathomimetics such as pseudoephedrine (Sudafed) are able to increase blood sugar and diminish effect of Amaryl. Propranolol (Inderal) and atenolol (Tenormin) belong to beta-blockers and also are able to affect blood levels and decrease activity of Amaryl.
Missed dose
Take the missed dose as soon as you remember about it. If it is almost time of your next dose just skip it and return to your regular schedule.
Overdose
Immediate medical attention is needed in case you took too much medicine. Possible side effects include: extreme weakness, confusion, blurred vision, stomach pain, trouble speaking, tremors, sweating, seizure, and coma.
Storage
Store at room temperature in a tight container and keep away from sunlight, moisture, kids and pets.
Disclaimer
We provide only general information about medications which does not cover all directions, possible drug integrations, or precautions. Information on the site cannot be used for self-treatment and self-diagnosis. Any specific instructions for a particular patient should be agreed with your health care adviser or doctor in charge of the case. We disclaim reliability of this information and mistakes it could contain. We are not responsible for any direct, indirect, special or other indirect damage as a result of any use of the information on this site and also for consequences of self-treatment.
Uses
Glimepiride is used with a proper diet and exercise program to control high blood sugar in people with type 2 diabetes. It may also be used with other diabetes medications. Controlling high blood sugar helps prevent kidney damage, blindness, nerve problems, loss of limbs, and sexual function problems. Proper control of diabetes may also lessen your risk of a heart attack or stroke. Glimepiride belongs to the class of drugs known as sulfonylureas. It lowers blood sugar by causing the release of your body’s natural insulin.
How to use Amaryl
Read the Patient Information Leaflet if available from your pharmacist before you start taking glimepiride and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with breakfast or the first main meal of the day, as directed by your doctor, usually once daily. The dosage is based on your medical condition and response to treatment.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor’s instructions carefully.
If you are already taking another diabetes drug (such as chlorpropamide), follow your doctor’s directions carefully for stopping the old drug and starting glimepiride.
Colesevelam can decrease the absorption of glimepiride. If you are taking colesevelam, take glimepiride at least 4 hours before taking colesevelam.
Tell your doctor if your condition does not improve or if it worsens (your blood sugar is too high or too low).
Side Effects
Nausea and upset stomach may occur. If either of these effects persists or worsens, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: yellowing eyes/skin, stomach/abdominal pain, dark urine, unusual tiredness/weakness, easy bleeding/bruising, signs of infection (such as fever, persistent sore throat), mental/mood changes, unusual/sudden weight gain, seizures.
This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don’t have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.
Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your medication dosage may need to be increased.
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<h1>It’s Like Whatever</h1>

It’s Like Whatever

The roller coaster ride continues. This one kind of loops back to before my transplant. I guess I kind of forgot what caused the diagnosis of PSC. I hadn’t thought about it. I had bigger things going on.
After rejection the first week of June we’ve been playing the “right cocktail” of antirejection meds game. Since rejection was so severe I didn’t go back on tacrolimus. They originally switched me to everolimus. I didn’t realize it until about a month after being home, due to high doses of prednisone more than likely, that I was so swollen. From my head to the tops of my knees. My doctors kept blaming the prednisone. I knew it wasn’t that. It felt different. I was so uncomfortable. Couldn’t raise my legs to get up the two steps on to our porch. Couldn’t move my head side to side. Couldn’t fit into any of my clothes. I could literally see and feel the nodes in my armpits, back & neck. They were huge. Since I wasn’t getting any answers I researched it myself. I found some cases of everolimus induced truncal lymphedema. I was looking in the wrong places. I was looking under transplant situations. This medication is a chemotherapy drug as well so I started looking into that side of it and found so many incidences of truncal lymphedema caused by everolimus. I was told in many groups that sometimes it wears off by itself once the med is stopped. Sometimes it doesn’t and you’re stuck with it for life. I knew I needed to see my family doctor. They always have my back and they know me well. She knew after examining me that it wasn’t the prednisone causing all of this. I mean come on, I’ve been on prednisone on and off for the last 18 years. I knew the difference. She sent me to a lymphedema therapist. After my first visit I felt better. I learned a ton about the lymphatic system as well. I saw her about 10 times, twice a week. I would feel better until the next day. I learned how to do the massage therapy on myself and continued it at home. Along with a raw diet and exercise. After talking to my hematologists at Hopkins again they agreed to switch me to sirolimus as long as I took CellCept along with it. This all while still continuing a very slow taper of prednisone. My body loves the sirolimus/CellCept combination!
So at my 6 month post hospitalization recheck we discussed all these medication changes. My kidney functions were normal (they hated the tacrolimus). My sirolimus level was almost the same on every blood draw. And at this point the lymphedema is almost gone. I feel normal again. I actually feel the best I have felt both physically and mentally in years!
But then my doctor brought up Crohn’s. When she did I remembered I never got the chance to follow through with my GI docs at Geisinger about that. After my ileostomy surgery they had told me that they needed to go over all of my records because they weren’t sure if I had ulcerative colitis or Crohn’s. So I called my doc there. My fingers were crossed so hard that it was ulcerative colitis because that would mean I was cured. All I would have to deal with the rest of my life would be post transplant stuff and the possibility of recurrent PSC. But, it was definitely Crohn’s as part of my ileum was involved. I didn’t think hearing that would crush me all over again but it did. It was like hearing the diagnosis for the first time all over again.
So now as we continue tapering prednisone we need to pay attention to see if I have any Crohn’s symptoms. The symptoms are very similar to PSC. I’m currently down to 5mg of prednisone. I haven’t been lower than that. I’ve been on it since transplant. If we can get it stopped successfully then we will attempt to stop the CellCept as well. Then I will only be on the sirolimus. One medication! One! Of course I’m staying positive. It will happen!
But now…my sirolimus level spiked so they changed my dose of that. 4 months of it being consistent and now it wants to act up. If I didn’t have to take any medications, therefore no side effects, I wouldn’t even know I had a liver transplant. I know this roller coaster ride will never end but lately it’s been the boring ride, like the kiddie coaster, and I can SO handle that shit!

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What is ELDEPRYL?
INDICATIONS
Eldepryl is indicated as an adjunct in the management of Parkinsonian patients being treated with levodopa/carbidopa who exhibit deterioration in the quality of their response to this therapy.
INSTRUCTIONS
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
It is best to take this medicine before breakfast and without liquids.
If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack that contains the tablet until you are ready to take it. Remove the tablet from the blister pack by peeling back the foil, then taking the tablet out. Do not push the tablet through the foil. Do not break or split the tablet. Place the tablet on the top of your tongue, where it will melt quickly. Do not eat food or drink liquids for 5 minutes before or after taking this medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
DOSAGE
The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
For oral dosage form (tablets):
For Parkinson’s disease:
Adults—At first, 1.25 milligrams (mg) once a day for at least 6 weeks. After 6 weeks, your doctor may increase your dose to 2.5 mg once a day.
Children—Use and dose must be determined by your doctor. Use and dose must be determined by your doctor.
STORAGE
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
MORE INFO:
Eldepryl is a levorotatory acetylenic derivative of phenethylamine. It is commonly referred to in the clinical and pharmacological literature as l-deprenyl.
SAFETY INFORMATION
It is very important that your doctor check your progress at regular visits to allow for changes in your dose and to check for any unwanted effects.
Do not take selegiline if you have used meperidine (e.g., Demerol®) or an MAO inhibitor (MAOI) (e.g., isocarboxazid, phenelzine, tranylcypromine, Marplan®, Nardil®, or Parnate®) within the past 14 days. If you do, you may develop agitation, confusion, restlessness, stomach or intestinal symptoms, sudden high body temperature, extremely high blood pressure, or severe convulsions.
Do not take cough medicines (e.g., dextromethorphan, Robitussin®, Pediacare®) or pain medicines (e.g., methadone, propoxyphene, tramadol, Darvon®, Dolophine®, Ultram®) while you are using this medicine. Using these medicines together can cause unwanted effects.
Selegiline may cause serious side effects when used together with some antidepressants. Tell your doctor if you have used amitriptyline, doxepin, fluoxetine, fluvoxamine, nortriptyline, paroxetine, sertraline, Elavil®, Luvox®, Pamelor®, Paxil®, Prozac®, or Zoloft® within the past 14 days.
When selegiline is taken at doses of 10 mg or less per day for the treatment of Parkinson’s disease, there are no restrictions on food or beverages you eat or drink. However, the chance exists that dangerous reactions, such as sudden high blood pressure, may occur if doses higher than those used for Parkinson’s disease are taken with certain foods, beverages, or other medicines. These foods, beverages, and medicines include:
Foods that have a high tyramine content (most common in foods that are aged or fermented to increase their flavor), such as cheeses; fava or broad bean pods; yeast or meat extracts; smoked or pickled meat, poultry, or fish; fermented sausage (bologna, pepperoni, salami, summer sausage) or other fermented meat; sauerkraut; or any overripe fruit. If a list of these foods and beverages is not given to you, ask your doctor to provide one.
Alcoholic beverages or alcohol-free or reduced-alcohol beer and wine.
Large amounts of caffeine-containing food or beverages such as coffee, tea, cola, or chocolate.
Any other medicine unless approved or prescribed by your doctor. This especially includes nonprescription (over-the-counter [OTC]) medicine, such as that for colds (including nose drops or sprays), cough, asthma, hay fever, and appetite control; “keep awake” products; or products that make you sleepy.
Also, for at least 2 weeks after you stop taking this medicine, these foods, beverages, and other medicines may continue to react with selegiline if it was taken in doses higher than those usually used for Parkinson’s disease.
Check with your doctor or hospital emergency room immediately if severe headache, stiff neck, chest pains, fast heartbeat, or nausea and vomiting occur while you are taking this medicine. These may be symptoms of a serious side effect that should have a doctor’s attention.
Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.
Selegiline may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.
It is important that your doctor check your skin for melanoma (tumor) regularly if you have Parkinson’s disease.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely.
Hallucinations may occur in some patients. This is more common with elderly patients. If you have hallucinations, check with your doctor.
Some people who have used this medicine had unusual changes in their behavior. Talk with your doctor if you start having problems with gambling or increased sex drive while using this medicine.
SIDE EFFECTS
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
Chest pain (severe)
enlarged pupils
fast or slow heartbeat
headache (severe)
increase in unusual movements of the body
increased sensitivity of the eyes to light
increased sweating (possibly with fever or cold, clammy skin)
mood or other mental changes
nausea and vomiting (severe)
stiff or sore neck
Less common or rare
Bloody or black, tarry stools
bruising
convulsions (seizures)
decreased urine
difficult or frequent urination
difficulty with breathing
difficulty with speaking
difficulty with swallowing
dizziness or lightheadedness, especially when getting up from a lying or sitting position
dry mouth
hallucinations (seeing, hearing, or feeling things that are not there)
increased thirst
irregular heartbeat
large, flat, blue, or purplish patches in the skin
lip smacking or puckering
loss of appetite
loss of balance control
muscle pain or cramps
nausea or vomiting
numbness or tingling in the hands, feet, or lips
puffing of the cheeks
rapid or worm-like movements of the tongue
restlessness or desire to keep moving
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shakiness in the legs, arms, hands, or feet
shortness of breath
swelling of the feet or lower legs
swelling or inflammation of the mouth
tightness in the chest
trembling or shaking of the hands or feet
twisting movements of the body
uncontrolled chewing movements
uncontrolled movements of the face, neck, back, arms, or legs
unusual tiredness or weakness
vomiting of blood or material that looks like coffee grounds
wheezing
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
Agitation or irritability
chest pain
difficulty opening the mouth or lockjaw
dizziness (severe) or fainting
fast or irregular pulse (continuing)
high fever
high or low blood pressure
severe spasm where the head and heels are bent backward and the body arched forward
troubled breathing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Abdominal or stomach pain
dizziness or feeling faint
runny nose
sneezing
stuffy nose
trouble with sleeping
Less common or rare
Anxiety
back or leg pain
blurred or double vision
body aches or pain
burning of the lips, mouth, or throat
chills
constipation
cough
diarrhea
drowsiness
dryness or soreness of the throat
frequent urge to urinate
headache
heartburn
inability to move
increased sweating
irritability (temporary)
memory problems
nervousness
pounding or fast heartbeat
rash
red, raised, or itchy skin
ringing or buzzing in the ears
slow or difficult urination
slowed movements
taste changes
uncontrolled closing of the eyelids
unusual feeling of well-being
unusual weight loss
voice changes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
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Advancing Clinical Trials Endeavoring to Improve Odds Against Pancreatic Cancer

PALM BEACH, Florida, November 28, 2018 /PRNewswire/ — Positive results from clinical trials are headlining the current market for pancreatic cancer treatments in the active biotech industry. Pancreatic cancer is one of the deadliest cancers in the world, but…

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<h1></h1>

Quote: from: Mr Ken on December 14, 2018, 01:17:16 PM
Being on the transplant list is a privilege. Not everyone gets that privilege. I would not be so quick to blow it. Transplant centers are busy and they do not have time to play around with people. They will simply go on to the next person.
I have no idea what the experience is for a transplant but i have seen several people who had it done and within six weeks they were out and about like they nothing done…
You say you do not want to be on dialysis forever. If you do not have the surgery then you will be on dialysis forever. That answers that question / concern cut and dry.
Sounds like the person who put in the PD tube does not know what he /she is doing. There should be no pain with the tube in. Placement is very important and the person putting it in should know exactly where to go with its placement. Not everyone could do PD but if that option is available it does have advantages… Disadvantage is it is a longer process than hemo though it is done mostly at bed time
Mr Ken, you’re absolutely right. It’s a privilege that so many others deserve more than me, because at this point, I’m still very angry at all of this, and probably (definitely) in a state of denial. I’m angry that all of this happened to me, and even though I know that if my kidneys failing is anyone’s fault, it’s mine (I did not take care of my diabetes very well as a child,) I subconsciously look for anyone and everyone else to blame for this. I want to blame my nephrologist. I want to blame all the doctors and nurses in the hospital. I want to blame the dialysis center. I am so full of anger that all of this is happening to me that I don’t know what to do with it, and the only way I’ve been able to deal with it is to rationalize it. I think I am so blinded by this anger and this frustration and this depression/anxiety that I can’t see what a gift it is to have the opportunity to be able to have what so many people wish they could have so badly. If I could give it away to someone more deserving of it than myself, I would, but unfortunately, I don’t think it works that way. And that makes me feel awful.
Thanks everyone- your input and information is really helpful. (Even if I sound like I’m just complaining!)
Charlie B53- I do love reading, so I appreciate the book! I didn’t know you could pretty much eat anything on PD. I’ve been diabetic T1 since I was 10 or so, and have eaten very healthy since I was a child, but I do like a lot of things that I’m told we as kidney patients are not supposed to eat. (Potatoes are my FAVORITE. I love squash, pumpkin, oranges, avocado…) My levels were never bad, so I eat whatever I want. However, the dietitian at the dialysis center is constantly lecturing me about what I have to limit and what I have to eat lots of. (Granted, I’m 100lb soaking wet, and I don’t eat much to begin with, so I don’t know if I even eat enough to HAVE high levels of anything! Did your dialysis center tell you that you had more freedom to eat what you wanted when you were on PD, or was that something you just discovered on your own? Because I feel as though my clinic is always telling me I need to limit everything! Also, like you, my legs were swellling very badly. Not to the point where they were leaking, but they were bad. If I can take one good thing away from going on dialysis, it’s that my legs are back to a normal(ish) size.
UkranianTracksuit- Wow, I can completely relate. I feel like, since I have been diabetic since I was very young, I’m so used to health care routines, that having to maintain another chronic illness isn’t a big deal. The dialysis team slotted me for two weeks training for the manuals/cycler, and I picked up both in four. They were shocked at how quick I could do it, and I told them I’d been diabetic and messing with medical equipment for more years than I haven’t, this is a piece of cake. I think I’ve taken care of my medical issues for so long that I can’t even fathom what it’s like to NOT have anything to take care of. And I’m ABSOLUTELY gun shy. One of the things that was so horrifying to me when I was in the coma was that people were touching and doing things to me, and I didn’t know it. I’m the kind of person that would rather pop stitches and be sewn back up just to give myself a bath rather than have someone help me with it! As far as the scar goes, I am ABSOLUTELY not worried about the scar. I think they’re pretty cool. What I’m worried about is getting a weird belly. I’m VERY thin. As in, stick thin. I always have been. A scar I could care less about, but if the surgery is going to give me a belly, I’m gonna be wicked pissed. I actually do have a few neuropathy issues. Nothing huge, but I’m told they will clear up with the KPx. Thanks so much for your story, very helpful. I’m really glad to hear you’re doing well, that’s super encouraging!
Cupcake- Thanks! (It’s actually a Dodge Challenger, but I know what you meant. Thank you much! He’s my baby!) Would you say that book is worth a read? What do they recommend? PTSD sounds exactly like what I have, in addition to not being able to sleep due to the discomfort of the fluid being in me. I keep having dreams that I’m in the hospital again and I can hear the machines alarming, and I can’t tell if I’m dreaming or not. It feels exactly like it did when I woke up in the hospital, and I can’t tell if I’m dreaming, of if it’s happened again. It’s TERRIFYING. I hope you are recovering well from your transplant and are feeling like a new person!
MooseMom- You sound like my mom. Don’t take that the wrong way, I mean that as the highest of compliments. My mom is very sensible and wise! You are right. I don’t need to worry about choices I don’t need to make yet. and I DO do that. I take medication for my anxiety, but am looking for something that either works better, or something I can do, as far as behavior modification, to help. I’m even looking into CBD oil. (My PD nurse says she has a couple of patients that this works wonders for, but for different issues than mine.) Thanks for your help, and your support! It means a lot.
Simon Dog- Chicks absolutely dig scars. At least I do. It’s not the scar that I’m worried about, though! It’s getting that weird misshapen stomach! Do you know how hard I work for these abs?! … Ok, not very, but I don’t want them to go away! When I went to my consultation, they told me I would probably have to go home with the foley. Right then I was like NOPE NOPE NOPE. If protocol is 72 hours, I don’t know why they would tell me I would have to go home with it. Is it different with women than men? I’ve also heard that they keep the stent in for a very long time, and that the stent is very uncomfortable. Constant pressure up near your kidneys or something. A coworker had one, and he said he was miserable. Who knows if I’ll need the pain killers, though. For some reason I can handle straight up pain, but discomfort…. I’m an absolute grump. Glad you are doing well with your transplant!
Sahern- I am sorry you are having such a difficult time with receiving another transplant. I can’t imagine how frustrating that has to be. Like I said to Mr Ken, if only I could trade places with someone who truly wanted a tx, because I am certainly not ready! Hopefully something will change that will allow you another chance at a kidney. I am talking to my coordinator about prednisone, because I cannot take it. They gave me a list of medications they use, and prednisone is not on it. I took a small dose of it some time ago and it made me AWFUL sick, so I have to make sure to stress it to them that it isn’t an option for me. 22 years us a long time! Can I ask you, though, did knowing that the tx kidney had an expiration date have any bearing on getting a transplant or not? Do you feel kind of… betrayed that it failed on you? If that’s an intrusive question, I apologize. These are just things I think about. sometimes I think, why bother go through all of this, when I am just going to end up needing another transplant later on in life, and by then, I probably won’t be able to get one? And then I have to remind myself of why I’m doing it.
Thanks EVERYONE for taking the time to give me useful and helpful information and stories. I can’t tell you how much I appreciate each and every one of you!

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What is this medicine?
FLUTICASONE; SALMETEROL inhalation is for treating asthma that is not controlled with other asthma medicines or when more than one treatment is necessary. Fluticasone is a corticosteroid which decreases inflammation in the lungs. Salmeterol helps open the airways in the lungs. This medicine is intended for regular use. It will not cure your condition, but when used regularly it can open up your air passages and make breathing easier. It will not relieve an acute asthma attack. Fluticasone; salmeterol can be used along with other inhaled or oral asthma medications.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
an asthmatic attack or bronchospasm
chicken pox or measles (recent exposure or infection)
diabetes
heart disease including high blood pressure, irregular heart beat, blockage in heart vessels
immune system problems
infection, especially fungal infection or tuberculosis
liver disease
osteoporosis or other bone disease
overactive thyroid
pheochromocytoma
seizures
an unusual or allergic reaction to Fluticasone, Salmeterol, other corticosteroids, other medicines, foods, dyes, or preservatives
pregnant or trying to get pregnant
breast-feeding
How should this medicine be used?
DO NOT use this medicine for an asthma attack. If you have severe onset or worsening of cough, wheezing, chest tightness, and/or shortness of breath seek immediate medical attention. Always keep a short-acting asthma medication such as albuterol on hand for asthma attacks.
This medicine is for inhalation through the mouth. Shake the inhaler well for 5 seconds before each spray. Prime the inhaler before the first use with 4 test sprays pointing away from your face. If you drop the inhaler or of it has not been used for 4 weeks, prime it with 2 test sprays pointing away from your face. Avoid contact with eyes. After using the inhaler, rinse your mouth with water to minimize build-up of medicine; do not swallow the water. Clean your inhaler at least once a week. Never place the inhaler in water to determine how much medicine is in it. Do not use more than the recommended dose.
Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.
NOTE: This medicine is only for you. Don’t share it with others.
What if I miss a dose?
If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, take only that dose and continue with your regular schedule, spacing doses evenly. Do not use double or extra doses.
What may interact with this medicine?
arsenic trioxide
astemizole
bepridil
beta-blockers, often used for high blood pressure or heart problems
caffeine
certain antibiotics (such as clarithromycin, erythromycin, gatifloxacin, gemifloxacin, grepafloxacin, levofloxacin, linezolid, moxifloxacin, sparfloxacin)
chloroquine
cisapride
droperidol
halofantrine
levomethadyl
medicines for colds and breathing difficulties
medicines for heart disease or high blood pressure
medicines known as MAO inhibitors, such as phenelzine (Nardil®), tranylcypromine (Parnate®), isocarboxazid (Marplan®), and selegiline (Carbex®, Eldepryl®)
medicines to control heart rhythm (examples: amiodarone, disopyramide, dofetilide, flecainide, procainamide, quinidine, sotalol)
medicines for treating depression or mental illness (amoxapine, haloperidol, maprotiline, pimozide, phenothiazines, risperidone, sertindole, tricyclic antidepressants, ziprasidone)
methadone
pentamidine
probucol
some medicines for weight loss (including some herbal products, ephedra, ephedrine, dextroamphetamine)
steroid hormones such as dexamethasone, cortisone, hydrocortisone
terfenadine
theophylline
thyroid hormones
water pills or diuretics
Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.
What should I watch for while taking this medicine?
Visit your prescriber or health care professional for regular checks on your progress. Carry an identification card with your name, the type and dose of medicine you are taking, and your prescriber’s name and address. It can take up to 2 weeks before you see the full effect of this medicine.
Check with your prescriber or health care professional if your symptoms do not improve. Seek emergency medical attention if your breathing problems get worse quickly while taking this medicine, or if your rescue inhaler (like albuterol) does not help your breathing. If you find that you are using your rescue inhaler more than normal or it is not as effective in treating your symptoms, you should contact your health care professional as soon as possible. You may need a change of therapy or may be having worsening of your lung condition. Do not stop using this medicine except on your prescriber’s advice.
Using your inhalers regularly as prescribed will help control your symptoms; try not to run out of your medications. It is recommended that you keep an extra refill of your inhalers on hand in case you need them.
Tell your prescriber or health care professional if you are exposed to anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.
People who are taking certain dosages of this medicine may need to avoid getting certain vaccines or may need to have changes in their vaccination schedules to ensure adequate protection from certain diseases. Make sure to tell your prescriber or health care professional that you are taking fluticasone; salmeterol before receiving any vaccine.
If you are going to have surgery tell your prescriber or health care professional that you are using this medicine.
What side effects may I notice from this medicine?
Side effects that you should report to your prescriber or health care professional as soon as possible:
chest pain
dizziness or lightheadedness
fever or chills
skin rash and itching (hives)
sore mouth with white patches in the mouth or throat
troubled breathing or wheezing
unusual swelling
unusual tiredness or weakness
vision problems
vomiting
Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
coughing, hoarseness, throat irritation
diarrhea
headache
nausea
nervousness
sore throat
stomach upset
stuffy nose
Where can I keep my medicine?
Keep out of the reach of children in a container that small children cannot open.
Store at room temperature between 15—30 degrees C (59—86 degrees F) with mouthpiece facing down. Keep away from heat or open flames.
Uses
This product is used to control and prevent symptoms (wheezing and shortness of breath) caused by asthma or ongoing lung disease (chronic obstructive pulmonary disease-COPD, which includes chronic bronchitis and emphysema). It contains 2 medications: fluticasone and salmeterol. Fluticasone belongs to a class of drugs known as corticosteroids. It works by reducing the irritation and swelling of the airways. Salmeterol belongs to the class of drugs known as long-acting beta agonists. It works by opening airways in the lungs to make breathing easier. Controlling symptoms of breathing problems can decrease time lost from work or school.
When used alone, long-acting beta agonists (such as salmeterol) may rarely increase the risk of serious (sometimes fatal) asthma-related breathing problems. However, combination inhaled corticosteroid and long-acting beta agonists, such as this product, do not increase the risk of serious asthma-related breathing problems. For asthma treatment, this product should be used when breathing problems are not well controlled with one asthma-control medication (such as inhaled corticosteroid) or if your symptoms need combination treatment.
Before using this medication, it is important to learn how to use it properly. This medication must be used regularly to be effective. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler (such as albuterol, also called salbutamol in some countries) as prescribed.
How to use Advair Diskus Blister, With Inhalation Device
Read the Patient Information Leaflet and Instructions for Use provided by your pharmacist before you start using this medication and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.
Use this device in a level, flat position. Inhale this medication by mouth as directed by your doctor, usually twice daily (in the morning and evening, 12 hours apart). You may or may not taste/feel the drug when you inhale. Either is normal. Do not exhale into the device.
Do not take the inhaler apart or wash the mouthpiece or any part of the device. Close the device after each use.
If you are using other inhalers at the same time, wait at least 1 minute between the use of each medication, and use this drug last.
Gargle and rinse your mouth with water after each use of this medication to help prevent irritation and yeast infections (thrush) in the mouth and throat. Do not swallow the rinse water.
The dosage is based on your medical condition, age, and response to treatment.
Use this medication regularly in order to get the most benefit from it. This medication works best if used at evenly spaced times. To help you remember, use it at the same times each day. Do not increase your dose, use this medication more often, or stop using it without talking with your doctor. Also, do not use other long-acting beta agonists while using this medication.
If you have been using a quick-relief inhaler (such as albuterol, also called salbutamol in some countries) on a regular daily schedule (such as 4 times daily), you must stop this schedule and only use the quick-relief inhaler as needed for sudden shortness of breath/asthma attacks. Consult your doctor for details.
If you are regularly using a different corticosteroid taken by mouth (such as prednisone), you should not stop using it unless directed by your doctor. You may have withdrawal symptoms if the drug is suddenly stopped. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication after you begin using this product. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. See also Precautions section.
It may take 1 week or longer before you get the full benefit of this drug. Tell your doctor if your condition does not improve or if it worsens.
Learn which of your inhalers you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.
Side Effects
Hoarseness, throat irritation, headache, or stomach upset may occur. If any of these effects persist or worsen, tell your doctor promptly.
This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.
Infrequently, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.
Tell your doctor right away if any of these unlikely but serious side effects occur: white patches on tongue/in mouth, signs of infection (such as fever, persistent sore throat), mental/mood changes (such as nervousness), trouble sleeping, vision problems (such as blurred vision), increased thirst/urination, muscle cramps, shaking (tremors).
Get medical help right away if any of these rare but seriouschest pain, fast/irregular heartbeat, severe dizziness, fainting, seizures.
A very serious allergic reaction to this product is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
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Corbus Pharmaceuticals Initiates “DETERMINE” Phase 3 Study in Dermatomyositis

<h1>Corbus Pharmaceuticals Initiates “DETERMINE” Phase 3 Study in Dermatomyositis</h1>

Corbus Pharmaceuticals Initiates “DETERMINE” Phase 3 Study in Dermatomyositis

News for 2018-12-17 Corbus Pharmaceuticals Initiates “DETERMINE” Phase 3 Study in Dermatomyositis
“We are delighted to have achieved many important regulatory and clinical milestones in the development of lenabasum this year, now including the initiation of this Phase 3 DM study,” said Barbara White, M.D., Chief Medical Officer of Corbus. “The double-blinded placebo-controlled 1-year study is designed to include subjects with active muscle and/or skin disease who represent the clinical spectrum of DM, making results applicable to the broad DM population. If the efficacy data from this single Phase 3 study are positive and the safety profile continues to be favorable, we intend to approach regulatory authorities about a registration package for lenabasum for treatment of DM.”
The ETERINE Phase 3 study will test efficacy and safety of lenabasum in approximately 150 adults with DM. Subjects will be randomized to receive lenabasum 20 mg twice per day, lenabasum 5 mg twice per day, or placebo twice per day in a 2:1:2 ratio. The primary efficacy outcome at Week 52 will be Total Improvement Score (TIS), which is a weighted composite measure of improvement from baseline in six endpoints, including Physician Global Assessment of Disease Activity, Physician Global Assessment of Extramuscular Disease Activity, Patient Global Assessment of Disease Activity, Health Assessment Questionnaire (patient-reported disability), Manual Muscle Testing, and muscle enzymes. Evaluation of key organ involvement – muscle, skin, and lungs, will be included in secondary efficacy outcomes. Change from Baseline in the Cutaneous Dermatomyositis Activity and Severity index (“CDASI”) activity score will be a secondary efficacy outcome.
“The start of ETERINE represents an important milestone for Corbus and a major step forward towards our vision of becoming a leader in treating inflammatory and fibrotic diseases by targeting the endocannabinoid system with what we believe is one of the industry’s most innovative pipelines. This study is our third late-stage study in orphan chronic inflammatory diseases, that combined, address approximately 150,000 patients in the U.S. alone,” commented Yuval Cohen, Ph.D., CEO of Corbus.
Progression to Phase 3 testing is supported by data from a Phase 2 trial of lenabasum in subjects with refractory skin-predominant DM. The safety and tolerability profile of lenabasum in DM patients has been acceptable to date, with no serious or severe AEs related to lenabasum. All subjects who started the Phase 2 study completed the double-blind, placebo-controlled 16-week part of the study, and all subjects who started dosing in the open-label extension of the Phase 2 study completed 1-year of dosing. Lenabasum treatment was associated with an improvement of minus 9.4 points from baseline in the CDASI activity score, a validated outcome measure of skin disease severity, at the end of the 16-week double-blinded placebo-controlled portion of the study. At 12 months in the open-label extension, continued improvement in inflammatory skin involvement was observed in DM subjects using a composite outcome, the CDASI activity score. The CDASI activity score improved from study start by a mean of -17.6 points at 12 months in the OLE. An improvement of -4 to -5 points in CDASI activity score is considered medically important, and 84% of subjects had improvement in CDASI activity score exceeding -10 points at 12 months in the OLE. Lenabasum treatment was associated with consistent improvement in other measures of skin disease activity, physician global assessment, patient global assessment, and patient-reported function and symptoms during the double-blinded placebo-controlled portion of the study. Multiple key efficacy outcomes further improved in the ongoing open-label extension Phase 2 trial.
Lenabasum has been granted Orphan Drug Designation for the treatment of DM and Orphan Designation for the treatment of DM from the EMA.
phenomenon from small blood vessel involvement. Malignancy is more common in DM. Overall mortality rate in DM estimated to be about 30% at 5 years. Immunosuppressive or immunomodulating drugs are typically prescribed to control DM disease activity overall or in major organs. Drugs that are used include high dose prednisone, methotrexate, mycophenolate, cyclophosphamide, azathioprine, rituximab, intravenous immunoglobulin, and anti-malarial drugs. These treatments may be associated with significant side effects, such as serious infections, or may not be well-tolerated. FDA-approved treatments for DM include systemic corticosteroids and adrenocorticotropic hormone analogue.
Lenabasum is a rationally-designed, oral, small molecule that selectively binds as an agonist to the cannabinoid receptor type 2 (CB2). CB2 is preferentially expressed on activated immune cells, fibroblasts, muscle cells, and endothelial cells. In both animal and human studies conducted to-date, lenabasum has induced the production of Specialized Pro-resolving lipid Mediators (“SPMs”) that activate endogenous pathways which resolve inflammation and speed bacterial clearance without immunosuppression. Lenabasum is also believed to have a direct effect on fibroblasts to limit production of fibrogenic growth factors and extracellular connective tissue that lead to tissue fibrosis (scarring). Data from animal models and human clinical studies suggest that lenabasum can reduce expression of genes and proteins involved in inflammation and fibrosis. Lenabasum has demonstrated promising activity in animal models of skin and lung inflammation and fibrosis in systemic sclerosis (SSc). Lenabasum is also active in animal models of lung infection and inflammation in cystic fibrosis and joint inflammation and scarring in rheumatoid arthritis.
Lenabasum has demonstrated favorable safety and tolerability profiles in clinical studies to date. Lenabasum improved multiple physician-assessed and patient-reported efficacy outcomes in Phase 2 studies in patients with diffuse cutaneous SSc and skin-predominant dermatomyositis. Lenabasum also reduced pulmonary exacerbations in a Phase 2 cystic fibrosis study. Additional clinical studies are being conducted and/or planned to confirm these results and support applications for regulatory approval.
Corbus Pharmaceuticals Holdings, Inc. is a Phase 3 clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat inflammatory and fibrotic diseases by leveraging its pipeline of endocannabinoid system-targeting synthetic drug candidates. The Company’s lead product candidate, lenabasum, is a novel, synthetic, oral, selective cannabinoid receptor type 2 (CB2) agonist designed to resolve chronic inflammation and fibrotic processes. Lenabasum is currently being evaluated in systemic sclerosis, cystic fibrosis, dermatomyositis, and systemic lupus erythematosus.
Corbus licensed the exclusive worldwide rights to develop, manufacture and market drug candidates from more than 600 novel compounds targeting the endocannabinoid system from Jenrin Discovery LLC. The pipeline includes CRB-4001, a 2 generation, peripherally-restricted, selective cannabinoid receptor type 1 (CB1) inverse agonist designed to eliminate blood-brain barrier penetration and subsequent brain CB1 receptor occupancy that mediates the neuropsychiatric adverse events associated with first-generation CB1 inverse agonists. Potential indications for CRB-4001 include NASH, primary biliary cholangitis, idiopathic pulmonary fibrosis, radiation-induced pulmonary fibrosis, myocardial fibrosis after myocardial infarction and acute interstitial nephritis, among others. Corbus plans to enter a Phase 1
study of CRB-4001 in 2019, intended to be followed by a National Institutes of Health (NIH)-funded proof-of-concept Phase 2 study.
For more information, please visit and connect with the Company on , , and .
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential, “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
Lindsey SmithPhone: +1 (617) 415-7749Email:
Source: Corbus Pharmaceuticals Holdings, Inc.

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