Israeli Defence Minister Quits Over Gaza Truce in Blow to Netanyahu

Israeli Defence Minister Quits Over Gaza Truce in Blow to Netanyahu

Israeli Defence Minister Quits Over Gaza Truce in Blow to Netanyahu

Israeli Defence Minister Avigdor Lieberman announced his resignation on Wednesday in protest at a Gaza ceasefire that he called a “capitulation to terror”, weakening Prime Minister Benjamin Netanyahu’s conservative coalition government.

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Walmart(!) Neutralizes a Day from Hell…

Walmart(!) Neutralizes a Day from Hell…

A cold day in Hell…
Yes. Walmart, bless its corporate heart, managed to bring a quick, neat end to what started out as a Day from Hell, morphed briefly into a sad but real Day from Heaven, and then began to slide downhill again.
Cassie the (Ailing) Corgi had a pretty good day yesterday — at some moments possibly even rising to a 10 on a scale of 1 (about to expire) to 10 (back to normal). Foolishly, I thought, oh gosh! she’s gonna be OK!
You’d think I’d know better by now, wouldn’t you?
Beginning about 1 in the morning, she started coughing again. And coughed the rest of the night away. By morning she was so exhausted she was immobile.
I call the New Vet at 8 a.m., the instant they open.
In the interim between the time the dogs and I roll out of the sack and the time I can reach the vet, I pick up the laptop and, in the course of glancing at the news and waypoints, visit a complicated draft “page” at Plain & Simple Press where I store material waiting to publish it. Yesterday I spent HOURS updating and fully formatting it, and endless, tedious, mind-numbing job.
This morning? It was A.L.L. G.O.N.E.
Yes. Hours of brain-banging work, disappeared. And no, I couldn’t retrieve it for love nor money. But there wasn’t much time to fret about it…
The vet’s staff asks me to bring in the dog at 8:45.
This was pretty tight because I had to sing at a funeral at 10. And this was not one I was about to miss, since it celebrated the life (and presumed afterlife) of a lovely friend.
Okay. Brush teeth. Wipe off yesterday’s make-up. Throw on some fresh make-up. Lift the dog into the car, where she collapses in a limp pile. Fly through the rush-hour traffic, to the extent that one can fly through such a thing, and make it with eight minutes to spare. Time ticks by as the vet and I and her underlings discuss. It’s pushing 9:15. I still haven’t fed Ruby and still am not dressed in the requisite black duds and still have a half-hour or more to get back to the house and another 15 minutes to get down to the church. Nor, we might add, have I had breakfast or even so much as a swallow of coffee.
Seeing that I’m getting anxious, they suggest I leave the dog at their clinic, where they will test her again for the alleged, never-proven Valley fever and test for heartworm, which can cause the same kind of coughing, lassitude, exercise intolerance, and bloating. At this point, the new vets persist in the theory that the problem is not the diagnosed adrenal tumor but in fact is yet-to-be-provable Valley fever. This is entirely possible: dogs frequently test negative on the first try at Valley fever testing. It has, however, been more than 4 weeks ( by far ) since the first effort, so if she does have the disease, by now she should test positive. They want to put her back on fluconazole. I tell them I’d rather put her down, it made her so sick. They propose another concoction that has even worse side effects.
I fly out the door and arrive at the funeral rehearsal right at 10 a.m., to the director’s surprise (since I’d emailed her that I’d be late). On the way there, I reflect that she was also taking prednisone during the last go-round with fluconazole. Prednisone had some mighty baleful effects on the dog. It occurs to me that there could be some drug interaction.
The funeral comes off very lovely. Dear friend and leader on the choir who just had hip surgery showed up and, amazingly, managed to get up the stairs and participate in the whole ceremony. Old friends who have been off the choir, beautiful voices, also attended: a joy to sit with them and listen to them sing again.
Later, when I get back to the house, I look the drug interaction question up and discover — from Pfizer, the horse’s mouth — that discontinuing fluconazole causes increased metabolism of prednisone, which leads to adrenal insufficiency. Which would explain quite a lot…possibly we could try the fluconazole in the absence of prednisone to see if it will go down any more easily.
Along about 3 p.m., I get back to the veterinary. Cassie is barking and looking pretty perky. WTF? She was at Death’s Door in the morning…I had to carry her through the house to the car and then carry her from the car in the vet’s door.
They did another chest X-ray, since they never were able to extract the image I paid for from MarvelVet. They also did a heartworm test and sent off for another Valley fever titer.
However, it’s beginning to look like the dog probably does not have Valley fever. The white area around the lung and heart that MarvelVet cited as proof of his hypothesis was gone; the sound of her chest has been clear for several weeks, and still is. New Doc believes the problem is and has been a bronchio-pneumonia, probably of bacterial origin because the doxycycline we gave her for the UTI she developed seemed also to help clear up the cough…and doxy is the drug of choice for doggy pneumonia.
Unfortunately the doxy made the dog so sick I had to take her off it after 19 days (of 21 prescribed). She thinks, though, that the dog may be on the mend, and she’ll be OK if we can soothe the cough.
So she suggests Robitussin DM, in a dosage she specified.
As for the adrenal tumor, this new intelligence just in:
New Vet doubts that any of the dog’s symptoms have been caused by the adrenal mass, which the sonogram doc believes to be nonmalignant. New Vet says most adrenal tumors in dogs have no symptoms (this is not altogether accurate, but let’s put our money on it for the moment.) She thinks the bloat probably originated with the prednisone, which should not have been given in conjunction with fluconazole. Other more classic fluconazole side effects, including anorexia and stupor and obvious misery and diarrhea and labored breathing, were caused by…yeah: fluconazole. Taking her off the prednisone without titering her off even more slowly than I did would have caused adrenal symptoms, and giving fluconazole at the same time as prednisone can cause adrenal insufficiency that may or may not go away in the absence of the drugs. Read: we’re talking about an iatrogenic problem aggravating a misdiagnosed ailment… She doesn’t seem to have an explanation for the extreme swings in the dog’s well-being: yesterday Cassie was at a 9 or even a 10 on the 1-10 scale; this morning she was back down at a 1 or 2. The dog does not have and probably never has had a collapsed trachea. So…if our furry friend picked this up while nosing around in the grass during a doggy walk (which is how such infections spread among dawgs), I guess I should feel lucky Ruby didn’t get it, too. Actually, Ruby did cough some, very mildly and for just a few days; she may have had it and thrown it off because she’s so much younger.
This poses the possibility, though, that Cassie could recover. Maybe.
Now, as for that Robitussin DM: for veterinary purposes, the stuff has to have 20 mg of dextromethorphan and 200 mg of guaifenesin per 10 milliliters of sauce. Ohhkayyy…
So I figure I’ll trudge down to the Walgreen’s, stand in line till the cows come home, ask a pharmacist to direct me to the correct concoction, and… ugh, how awful does that sound?
Why do that when I can order it up from Amazon?
Right.
Right?
R-i-i-g-h-t.
Amazon offers approximately 87 gerjillion variants of Robitussin DM . The only one that has this particular proportion of active ingredient-to-active-ingredient-to-inactive-ingredients comes in “prepackaged spoonsful.”
Say what?
I do not want spoonsful, prepackaged in plastic waste or not. This stuff has to be hoovered up into an oral syringe so it can be squirted down the hound’s gullet.
Now in the middle of evening rush hour , whereinat you can not turn east out of my neighborhood because of the effing stupid “reverse lanes” the city has inflicted on us, I set out for the nearest Walgreen’s which rests near the corner of GangBanger’s Way and Commuter Nightmare Place East. This, I dread, because I’ve been harassed in that store’s parking lot before and do not look forward to more harassment. The other nearby Walgreen’s is here in the ‘hood — couldn’t pay me to unlock my car doors in front of that place, especially not at dusk. The third Walgreen’s is way on down East Commuter Nightmare Place; though I can turn into its parking lot (where I also have been harassed), turning out of it in a direction that will bring me home is, shall we say, highly problematic.
O shit o hell o damn i do NOT want to do battle with any one of those dreary Walgreen’s.
But…right about then it dawns on me that I don’t hafta. There’s a Walmart on the way to Nearest Walgreen’s. It’s on my side of the road (no illegal or risky left turns across torrents of traffic) and its exit guides me straight to a left-turn lane that sets me on my way home, via Gangbanger’s way. Hot dayum!
Get into Walmart. It’s crowded — I have to park a long way from the front door. This — crowdedness — is a good thing, because drug-addicted panhandlers tend not to pester anyone when there are a lot of people in the parking lot. Into the store without incident. Quickly snab a fine young pharmacist; tell him the challenge. The kid is ready to rise to it. We sally forth int the Walmart aisle, and darned if he doesn’t find a version of Robitussin DM that comes close to the required proportions.
I say this is 20 mg of dextromethorphan and 200 mg of guaifenesin to 20 milliliters of sauce, not to 10 . He points out that the solution to this is simply to give the dog twice the suggested dose.
Yeah. Well: we do have the possibility that a rushed vet could have the proportion wrong.
I say the solution is even simpler: give her the suggested dose and see if it works. Often OTC stuff like this will work with less than the recommended dose. If it does: bully. If it doesn’t, so then I just give the second half of it. He allows as to how this is an acceptable plan.
I grab the dope, head for the door, and in spite of a hectic scene find a cashier standing there all by his little self. Pay and shoot out the door without having to wait a minute.
Traipse to the far end of the crowded parking lot: not a single panhandler in sight. Yes!
Thank you, Walmart! Who’d’ve thunk it?
Related posts: Days of Our Lives, Dogs of Our Lives Doggy Update: Death Refuses to Have Her Dispatches from Hell…

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Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials

<h1>Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials</h1>

Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features: results from the 5-year long-term extension of the phase III pivotal trials

Download powerpoint Figure 1 Flow chart with patient disposition. *One death occurred during part I; patient died due to MAS. †A patient in the placebo group died due to MAS 2 days after discontinuing the part II phase due to MAS. ‡One patient died from disease progression 3 months after discontinuation from the long-term extension phase due to unsatisfactory therapeutic effect. The grey box represents the patients who discontinued the part I or part II of trial 2 and entered the long-term extension study. Patients who entered the LTE are divided into two subgroups: (1) early responders, defined as patients who had successfully completed the glucocorticoid tapering in part I of trial 2 as per protocol and who were randomised to the withdrawal part; (2) late responders, defined as patients who moved directly from the open-label part of trial 2 and who failed to taper glucocorticoids in part I. LTE, long-term extension; MAS, macrophage activation syndrome. Patients Patients were followed up in the LTE study between 6 July 2009 and 5 December 2014 at 63 centres of PRINTO/PRCSG in 21 countries. Eligibility criteria for the phase III trials have been described previously. 5 In brief, eligible children (2–19 years old) with confirmed sJIA as per the International League Against Rheumatism classification criteria, active systemic features of sJIA, at least two active joints, CRP level >30 mg/L (normal range: 0–10 mg/L) and being treated with a prednisone equivalent of ≤1.0 mg/kg/day were included. Major exclusion criteria included macrophage activation syndrome (MAS) within the last 6 months, active infections, malignancies and concurrent use of other biologics. Assessments Efficacy assessments were performed at least every 3 months to assess the levels of improvement using various composite validated measures: aJIA-ACR 50/70/90, based on the JIA core set variables, 21–24 plus the absence of fever (defined as temperature ≤38°C in the preceding 7 days); clinically inactive disease (CID)/clinical remission on medication (CR), defined as at least 6 months of CID, which were evaluated by either the ACR criteria (CID ACR /CR ACR ) 25 26 or by the Juvenile Arthritis Disease Activity Score 71-CRP (JADAS; CID JADAS /CR JADAS ). 27 Disease activity was measured by JADAS score with the following cut-offs: CID JADAS score ≤1; low disease activity (LDA) score ≤3.8; moderate disease activity score 3.9–10.5; and high disease activity (HDA) score >10.5 27–29 ; systemic features were reflected in the physician global evaluation of disease activity measured on a visual analogue scale. Safety and tolerability of canakinumab were assessed in terms of adverse events (AE), serious AEs (SAE) and clinical and laboratory assessments from first injection until the last available observation. Serious infections, malignancies and cases of MAS were adjudicated by independent committees. 30–33 A three-tiered approach was used to measure anti-canakinumab antibodies (anti-drug antibody (ADAs)), consisting of a screening, a confirmatory and a titration assay, respectively. Serum canakinumab concentrations (pharmacokinetics, PK) were determined to assess the relationships between canakinumab exposure and the immunogenicity data. 34 35 Statistical analysis The European League Against Rheumatism (EULAR) recommendation for reporting LTE studies 36 and the Consolidated Standards of Reporting Trials statement 37 38 were followed. Categorical variables were summarised by absolute frequencies and percentages, while continuous variables were summarised by median and lower and upper quartiles. The aJIA-ACR criteria used the starting day of canakinumab as baseline. Efficacy analyses were performed in two ways: (1) for primary analysis: in the intent-to-treat (ITT) population based on observed data with all discontinuations at different time points counted as missing (n=177; patients enrolled in trial 2) and (2) with missing data imputed using last observation carried forward (LOCF) ( online supplementary appendix ). 39 In exploratory analysis, the hypothesis was tested that early responders achieve more substantial sJIA control as compared with late responders of canakinumab. For the purpose of this analysis, early responders were defined as patients who had successfully completed the glucocorticoid tapering in part I of trial 2 as per protocol and who were randomised to the withdrawal part; late responders were defined as patients who moved directly from the open-label part of trial 2 because they failed to taper glucocorticoids in part I. Mixed model analyses were used to quantify the difference in efficacy responses for early and late responders. Subgroup exploratory analyses were also considered by methotrexate (MTX) coadministration and prior use of biologics using the generalised mixed model framework. All mixed models were adjusted for repeated measures, and include a centre-related random effect and the following covariates: time in study, prior use of biologics, prior use of MTX, prior use of corticosteroid, number of joints with limitation of motion (LOM) and number of active joints. AEs were summarised by presenting the number of events and percentage of patients and time-adjusted frequencies of exposure as per the primary system organ class based on the Medical Dictionary for Regulatory Activities (MedDRA, Version 17.1) preferred term. Results Baseline characteristics and patient disposition over time Demographics and baseline disease characteristics of the 177 patients at baseline as well as the 144 patients rolling over to the LTE study are presented in table 1 . At baseline, as previously reported, 99.4% of patients had HDA (median JADAS=32.5). View this table: View popup Table 1 Demographics and clinical characteristics of patients at baseline (date of first canakinumab administration and at the time of entry into the LTE study) Of the 177 patients (per ITT, denominator is 177 unless otherwise stated) enrolled in trial 2, a total of 144 (81%) continued in the LTE study ( figure 1 ); 122 (69%) stayed for a maximum of 271 weeks. Overall, 75 (42%) patients completed the LTE study. As shown in table 1 , among the 144 patients who entered LTE, there were 96 (54.2%) early responders with a median JADAS of 1.85 denoting an LDA status (62% JADAS LDA and 47.9% CID JADAS ) at baseline of the LTE study, and 48 (27.1%) late responders with a median JADAS of 18.8 denoting HDA status (69% with JADAS HDA at baseline of the LTE). Compared with early responders, the late group had a higher frequency of prior use of biologics (79.2% vs 57.3%) and required higher glucocorticoid doses (0.36 mg/kg/day vs 0.17 mg/kg/day). Similar differences were noted at baseline (day of the first canakinumab administration) in the two groups. A total of 102 (58%) patients discontinued canakinumab: 33 during trial 2 as previously reported 5 and the remaining 69 during the LTE study. Non-response (n=26/102, 25%) and loss of response over time (n=36/102, 35%) were the main reasons for discontinuation with majority coming from the late responders group (n=25/36, 69%), followed by intolerance (n=19/102, 19%). Seven patients (n=7/102, 7%) discontinued canakinumab as per the physicians’/family decision no longer requiring canakinumab. Canakinumab tapering/discontinuation Forty-four (25%) patients received at least three consecutive reduced doses of canakinumab of 2 mg/kg. Of these, 26 (59%) remained on a sustained reduced dose until study end with a median time of follow-up of 25 months. Of these 26 patients, five discontinued canakinumab (no longer requiring study drug) and two discontinued the study (consent withdrawal, n=1; lymphadenitis, n=1). Conversely, of the remaining 18 patients who flared after tapering of canakinumab, 15 regained sJIA control on uptitration of canakinumab to 4 mg/kg/month while three patients did not. In two of those patients disease flare was associated with MAS. sJIA disease control and response to canakinumab F igure 2 shows the change in JADAS score over time in the ITT population for the two major subgroups (early and late responders) who entered the LTE from part I and part II of trial 2.

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Astelin is not allowed to people with: allergy to any antihistamines; narrow angle glaucoma; bladder neck obstruction; symptomatic prostatic hypertrophy; asthmatic attack; stenosing peptic ulcer; pyloroduodenal obstruction. Atelin should not be used in neonates (possible association with SIDS)
Possible side effect
They may include an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Also the most possible side effects include:
bronchospasm (shortness of breath, tightness in chest, wheezing);
fast or uneven heartbeats.
Less serious include:
a bitter taste in your mouth;
headache;
drowsiness or dizziness;
dry mouth, sore throat;
burning in your nose;
weight gain;
nausea;
nosebleed;
cough, sneezing, runny nose, cold symptoms; or
eye redness.
If you experience one of them stop using Astelin and tell your doctor as soon as possible. Also consult your doctor about any side effect that seems unusual.
Drug interaction
Astelin interact with such medication as: cimetidine, sleep medicines, sedatives, tranquilizers, drugs for anxiety, narcotic pain relievers, antidepressants or other psychiatric drugs, other antihistamines. Also note that interaction between two medications does not always mean that you must stop taking one of them. As usual it affects the effect of drugs, so consult your doctor about how these interactions are being managed or should be managed.
Missed dose
If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not take double or extra doses. Take your usual dose next day at the same regularly time.
Overdose
Symptoms of an Astelin overdose are unknown, but possibly may include extreme sleepiness. If you experience one of them or if you experience any unusual symptom call your doctor immediately.
Storage
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store away from heat, moisture, and light. Do not store in the bathroom. Keep the bottle upright with the pump tightly closed. Protect from freezing.
Keep out of the reach of children.
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.
Product Description
Common use
Astelin is an antihistamine nasal spray which is used to treat allergy symptoms such as sneezing and itchy, runny nose. This medication works by blocking the action of histamine, which reduces allergy symptoms. Also Astelin is used for treating such symptoms as runny nose or stuffy nose, and postnasal drip.
Dosage and direction
Astelin should be used for nose only, so please avoid contacting with eyes. Blow your nose before using this medication. The recommended starting dose is 4 sprays a day. After three days the recommended dose is 2 sprays a day.
Note: this instruction is presented here just for a review. It’s very necessary to consult your doctor before using. It will help you to get best results.
Precautions
Use with cautions if your medical history include: allergies, heart disease, kidney problems,high blood pressure, liver problems. Using Astelin with alcohol or CNS depressants can increase side effects. Astelin should not be used during pregnancy, lactation or when becoming pregnant. Do not use Astelin before breast-feeding without a doctor’s permission.
Contraindications
Astelin is not allowed to people with: allergy to any antihistamines; narrow angle glaucoma; bladder neck obstruction; symptomatic prostatic hypertrophy; asthmatic attack; stenosing peptic ulcer; pyloroduodenal obstruction. Atelin should not be used in neonates (possible association with SIDS)
Possible side effect
They may include an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Also the most possible side effects include:
bronchospasm (shortness of breath, tightness in chest, wheezing);
fast or uneven heartbeats.
Less serious include:
a bitter taste in your mouth;
headache;
drowsiness or dizziness;
dry mouth, sore throat;
burning in your nose;
weight gain;
nausea;
nosebleed;
cough, sneezing, runny nose, cold symptoms; or
eye redness.
If you experience one of them stop using Astelin and tell your doctor as soon as possible. Also consult your doctor about any side effect that seems unusual.
Drug interaction
Astelin interact with such medication as: cimetidine, sleep medicines, sedatives, tranquilizers, drugs for anxiety, narcotic pain relievers, antidepressants or other psychiatric drugs, other antihistamines. Also note that interaction between two medications does not always mean that you must stop taking one of them. As usual it affects the effect of drugs, so consult your doctor about how these interactions are being managed or should be managed.
Missed dose
If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not take double or extra doses. Take your usual dose next day at the same regularly time.
Overdose
Symptoms of an Astelin overdose are unknown, but possibly may include extreme sleepiness. If you experience one of them or if you experience any unusual symptom call your doctor immediately.
Storage
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store away from heat, moisture, and light. Do not store in the bathroom. Keep the bottle upright with the pump tightly closed. Protect from freezing.
Keep out of the reach of children.
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.
Side Effects
A bitter taste in the mouth, drowsiness, a burning feeling inside the nose, sneezing fits, cough, nose bleeds, runny nose, nausea, dry mouth, headache, weight gain, muscle aches, or red eyes may occur. If any of these effects last or get worse, 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.
A very serious allergic reaction to this drug 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.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
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FDA Approves Brentuximab Vedotin for Frontline CD30+ PTCL

<h1>FDA Approves Brentuximab Vedotin for Frontline CD30+ PTCL</h1>

FDA Approves Brentuximab Vedotin for Frontline CD30+ PTCL

FDA Approves Brentuximab Vedotin for Frontline CD30+ PTCL Jason M. Broderick @jasoncology Published: Friday, Nov 16, 2018 The FDA has approved brentuximab vedotin (Adcetris) for use in combination with chemotherapy for the frontline treatment of patients with CD30-expressing peripheral T-cell lymphoma (PTCL).The approval, which follows a breakthrough therapy designation, is based on the phase III ECHELON-2 trial, in which combining frontline brentuximab vedotin with CHP (cyclophosphamide, doxorubicin, prednisone) reduced the risk of death by 34% (HR, 0.66; 95% CI, 0.46-0.95; P = .024) and the risk of disease progression or death by 29% (0.71; 95% CI, 0.54-0.93; P = .011) compared with CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone). 1 Key secondary endpoints also demonstrated superiority with the brentuximab vedotin combination, including objective response rate (83% vs 72%; P = .003), complete remission rate (CR; 68% vs 56%; P = .007), and progression-free survival (PFS) in patients with systemic anaplastic large cell lymphoma (sALCL; HR = 0.59; 95% CI, 0.42-0.84; P = .003).No new safety signals emerged with brentuximab vedotin. The label for the antibody-drug conjugate does include a Boxed Warning regarding the risk of progressive multifocal leukoencephalopathy. Seattle Genetics and Takeda Pharmaceutical, the co-developers of brentuximab vedotin, will be presenting additional ECHELON-2 findings at the 2018 ASH Annual Meeting. “The current standard of care for initial treatment of peripheral T-cell lymphoma is multi-agent chemotherapy. That treatment has not significantly changed in decades and is too often unsuccessful in leading to long-term remissions, underscoring the need for new treatments,” Steven Horwitz, MD, Department of Medicine, Lymphoma Service, Memorial Sloan Kettering Cancer Center, said in a statement.“The ECHELON-2 clinical trial demonstrated Adcetris plus CHP was superior to the current standard of care, CHOP, for both progression-free survival and all other key secondary endpoints, including, most importantly, overall survival. With this approval, clinicians have the opportunity to transform the way newly diagnosed CD30-expressing PTCL patients are treated,” added Horwitz. In a statement, the FDA noted that a new review program had acclerated the pace of the approval, which occurred less than 2 weeks from the date that the complete application was submitted. “The Real-Time Oncology Review (RTOR) program allows the FDA to access key data prior to the official submission of the application allowing the review team to begin their review earlier and communicate with the sponsor prior to the application’s actual submission,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products, said in a statement.“When the sponsor submits the completed application, the review team will already be familiar with the data and be able to conduct a more efficient, timely and thorough review. RTOR allowed the FDA to approve this indication within two weeks of the completed application’s submission,” added Pazdur. The double-blind, multicenter, placebo-controlled phase III ECHELON-2 trial randomized approximately 450 newly diagnosed patients with CD30-expressing PTCL, also known as mature T-cell lymphoma, to brentuximab vedotin plus CHP or standard CHOP. PFS per independent review was the primary endpoint, with secondary endpoints including overall survival, PFS in patients with sALCL; approximately 75% of the overall population), objective response rate, CR rate, and safety. According to Seattle Genetics, adverse events (AEs) across all grades reported in ≥20% of patients receiving the brentuximab vedotin combination were peripheral neuropathy, nausea, diarrhea, neutropenia, lymphopenia, fatigue, mucositis, constipation, alopecia, pyrexia, vomiting, and anemia. Serious AEs occurring in ≥2% of patients in the brentuximab vedotin arm were febrile neutropenia, pneumonia, pyrexia, and sepsis. Based on the study results, the investigators recommend that patients with PTCL being treated with frontline brentuximab vedotin plus CHP should receive G-CSF beginning at cycle 1. In March brentuximab vedotin for use in combination with chemotherapy as a frontline treatment for adult patients with stage III or IV classical Hodgkin lymphoma based on findings from the phase III ECHELON-1 trial, which demonstrated superior PFS with brentuximab vedotin plus Adriamycin, vinblastine, and dacarbazine (AVD) compared with standard ABVD (AVD plus bleomycin). In the study, the brentuximab vedotin regimen reduced the risk of progression, death, or initiation of new therapy by 23% compared with ABVD. The 2-year modified PFS rate was 82.1% with brentuximab vedotin compared with 77.25% for standard chemotherapy (HR, 0.77; 95% CI, 0.60-0.98; P = .035). 2 The phase III ECHELON-1 trial enrolled 1334 patients with stage III/IV classical Hodgkin lymphoma. All patients had not received prior treatment with systemic chemotherapy or radiotherapy and had an ECOG performance status of ≤2. Patients ranged in age from 18 to 83, the median age was 36 years, and 58% were men. In both arms, treatment was given on days 1 and 15 of a 28-day cycle. Doxorubicin was given at 25 mg/m 2 , vinblastine was administered at 6 mg/m 2 , and patients received dacarbazine at 375 mg/m 2 . In the investigational arm, brentuximab vedotin was administered at 1.2 mg/kg and in the control group bleomycin was administered at 10 units/m 2 . The primary endpoint of the study was modified PFS by independent review committee. Under the modified criteria, PFS was defined as time to progression, death, or receipt of additional therapy for those not in CR. The modified endpoint was meant to eliminate the potential impact of consolidation treatment with chemotherapy or radiotherapy. Secondary endpoints included overall survival and safety. PFS was met with 117 events in the brentuximab vedotin arm and 146 events in the AVBD arm. At a median follow-up of 24.9 months, the 2-year modified PFS was 82.1% (95% CI, 78.7-85.0) with the brentuximab vedotin regimen compared with 77.2% (95% CI, 73.7-80.4) with ABVD. The CR rate was 73% for the brentuximab vedotin arm and 70% for the ABVD arm. In addition, researchers found that 33% fewer patients treated with the brentuximab vedotin regimen received subsequent chemotherapy or high-dose chemotherapy and transplant compared with the patients treated with ABVD. Brentuximab vedotin also has approved indications for patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation; classical Hodgkin lymphoma after failure of auto-HSCT or after failure of at least 2 prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates; sALCL after failure of at least one prior multiagent chemotherapy regimen; and primary cutaneous anaplastic large cell lymphoma or CD30-expressing mycosis fungoides in patients who have received prior systemic therapy. References FDA Grants Breakthrough Therapy Designation to ADCETRIS® (Brentuximab Vedotin) for Frontline Peripheral T-Cell Lymphomas. Published online November 15, 2018. Accessed November 15, 2018. https://bit.ly/2zeyd7p. Connors J, Jurczak W, Straus D J., et al. Brentuximab vedotin plus doxorubicin, vinblastine, dacarbazine (A+AVD) as frontline therapy demonstrates superior modified progression-free survival versus ABVD in patients with previously untreated stage III or IV Hodgkin lymphoma (HL): the phase 3 echelon-1 study. Presented at: ASH Annual Meeting and Exposition; Dec. 9-12, 2017; Atlanta. Abstract 6.

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Discussion includes the use of bisphosphonates in dialysis and tr

Discussion includes the use of bisphosphonates in dialysis and tr

Discussion includes the use of bisphosphonates in dialysis and tr
Discussion includes the use of bisphosphonates in dialysis and transplantation and the management of post-transplant hyperparathyroidism. The patient had been managed at two hospitals Y-27632 solubility dmso and was reviewed in 1997 when she was 47 years of age with deteriorating renal function secondary to autosomal dominant polycystic kidney disease. The duration of chronic kidney disease was uncertain, but her serum creatinine was 670 µmol/L. Past medical history included hypertension, a bowel perforation secondary to constipation requiring a Hartmann’s procedure and no smoking history. Haemodialysis
commenced in 1998. While undertaking dialysis, CKD-MBD biochemistry included secondary hyperparathyroidism (parathyroid hormone (PTH) 20 pmol/L (normal 1–7 pmol/L)), hypercalcaemia (corrected calcium 2.74 mmol/L, ionized calcium 1.58 mmol/L) and hyperphosphatemia (phosphate 2.81 mmol/L). Figure 1a,b shows biochemical parameters over
time. Management prior to transplantation included calcitriol injections 2 mcg twice weekly, aluminium hydroxide 400 mg/magnesium hydroxide 400 mg/simethicone 30 mg (two tablets twice daily) and calcium carbonate 420 mg (five tablets MI-503 per day). A pretransplantation dual energy X-ray absorptiometry (DEXA) bone scan in August 2000 revealed osteopaenia with a lumbar spine T score of −2.15 and Z score of −1.65, left femoral neck T score of −1.78 and Z score −1.22. Figure 1c shows T score over time. A deceased donor, three antigen mismatch, transplant occurred in August 2000. Initial immunosuppression included cyclosporine, mycophenolate mofetil and prednisone. Nadir creatinine was 90 µmol/L and diabetes developed soon after transplantation. Hypercalcaemia (corrected calcium 3.07 mmol/L) on day 3 post-transplant required a pamidronate infusion. The patient was not taking calcium carbonate,
cholecalciferol or calcitriol. Pamidronate (30–60 mg) Baricitinib was infused for management of hypercalcaemia resulting from hyperparathyroidism. In total, intravenous pamidronate (30–60 mg), given six weekly, was continued for 8 months post-transplant until the time of parathyroidectomy. DEXA in October 2000 reported a lumbar spine T of −2.2 and femoral neck T −2.0. Non-traumatic stress fractures in the pelvis first occurred in March 2001, affecting the left inferior and superior pubic rami. Computed tomography scanning reported sclerosis and an unusual trabecular pattern to the femoral heads with magnetic resonance imaging providing no evidence of avascular necrosis. Prednisone withdrawal over a period of 3 months was planned because of these fractures, bone mineral density (BMD) findings and diabetes. Prednisone was weaned from 7 mg to 1.5 mg daily over 5 months and was complicated by a presumed episode of acute rejection (patient declined biopsy) with a rise in creatinine from 110 to 190 µmol/L requiring treatment with methyl prednisolone and a change from cyclosporine to tacrolimus.

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Product Description
Common use
Astelin is an antihistamine nasal spray which is used to treat allergy symptoms such as sneezing and itchy, runny nose. This medication works by blocking the action of histamine, which reduces allergy symptoms. Also Astelin is used for treating such symptoms as runny nose or stuffy nose, and postnasal drip.
Dosage and direction
Astelin should be used for nose only, so please avoid contacting with eyes. Blow your nose before using this medication. The recommended starting dose is 4 sprays a day. After three days the recommended dose is 2 sprays a day.
Note: this instruction is presented here just for a review. It’s very necessary to consult your doctor before using. It will help you to get best results.
Precautions
Use with cautions if your medical history include: allergies, heart disease, kidney problems,high blood pressure, liver problems. Using Astelin with alcohol or CNS depressants can increase side effects. Astelin should not be used during pregnancy, lactation or when becoming pregnant. Do not use Astelin before breast-feeding without a doctor’s permission.
Contraindications
Astelin is not allowed to people with: allergy to any antihistamines; narrow angle glaucoma; bladder neck obstruction; symptomatic prostatic hypertrophy; asthmatic attack; stenosing peptic ulcer; pyloroduodenal obstruction. Atelin should not be used in neonates (possible association with SIDS)
Possible side effect
They may include an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Also the most possible side effects include:
bronchospasm (shortness of breath, tightness in chest, wheezing);
fast or uneven heartbeats.
Less serious include:
a bitter taste in your mouth;
headache;
drowsiness or dizziness;
dry mouth, sore throat;
burning in your nose;
weight gain;
nausea;
nosebleed;
cough, sneezing, runny nose, cold symptoms; or
eye redness.
If you experience one of them stop using Astelin and tell your doctor as soon as possible. Also consult your doctor about any side effect that seems unusual.
Drug interaction
Astelin interact with such medication as: cimetidine, sleep medicines, sedatives, tranquilizers, drugs for anxiety, narcotic pain relievers, antidepressants or other psychiatric drugs, other antihistamines. Also note that interaction between two medications does not always mean that you must stop taking one of them. As usual it affects the effect of drugs, so consult your doctor about how these interactions are being managed or should be managed.
Missed dose
If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not take double or extra doses. Take your usual dose next day at the same regularly time.
Overdose
Symptoms of an Astelin overdose are unknown, but possibly may include extreme sleepiness. If you experience one of them or if you experience any unusual symptom call your doctor immediately.
Storage
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store away from heat, moisture, and light. Do not store in the bathroom. Keep the bottle upright with the pump tightly closed. Protect from freezing.
Keep out of the reach of children.
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.
Product Description
Common use
Astelin is an antihistamine nasal spray which is used to treat allergy symptoms such as sneezing and itchy, runny nose. This medication works by blocking the action of histamine, which reduces allergy symptoms. Also Astelin is used for treating such symptoms as runny nose or stuffy nose, and postnasal drip.
Dosage and direction
Astelin should be used for nose only, so please avoid contacting with eyes. Blow your nose before using this medication. The recommended starting dose is 4 sprays a day. After three days the recommended dose is 2 sprays a day.
Note: this instruction is presented here just for a review. It’s very necessary to consult your doctor before using. It will help you to get best results.
Precautions
Use with cautions if your medical history include: allergies, heart disease, kidney problems,high blood pressure, liver problems. Using Astelin with alcohol or CNS depressants can increase side effects. Astelin should not be used during pregnancy, lactation or when becoming pregnant. Do not use Astelin before breast-feeding without a doctor’s permission.
Contraindications
Astelin is not allowed to people with: allergy to any antihistamines; narrow angle glaucoma; bladder neck obstruction; symptomatic prostatic hypertrophy; asthmatic attack; stenosing peptic ulcer; pyloroduodenal obstruction. Atelin should not be used in neonates (possible association with SIDS)
Possible side effect
They may include an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Also the most possible side effects include:
bronchospasm (shortness of breath, tightness in chest, wheezing);
fast or uneven heartbeats.
Less serious include:
a bitter taste in your mouth;
headache;
drowsiness or dizziness;
dry mouth, sore throat;
burning in your nose;
weight gain;
nausea;
nosebleed;
cough, sneezing, runny nose, cold symptoms; or
eye redness.
If you experience one of them stop using Astelin and tell your doctor as soon as possible. Also consult your doctor about any side effect that seems unusual.
Drug interaction
Astelin interact with such medication as: cimetidine, sleep medicines, sedatives, tranquilizers, drugs for anxiety, narcotic pain relievers, antidepressants or other psychiatric drugs, other antihistamines. Also note that interaction between two medications does not always mean that you must stop taking one of them. As usual it affects the effect of drugs, so consult your doctor about how these interactions are being managed or should be managed.
Missed dose
If you forgot to take your dose in time, please do it as soon as you remember. But do not take if it is too late or almost time for your next dose. Do not take double or extra doses. Take your usual dose next day at the same regularly time.
Overdose
Symptoms of an Astelin overdose are unknown, but possibly may include extreme sleepiness. If you experience one of them or if you experience any unusual symptom call your doctor immediately.
Storage
Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Store away from heat, moisture, and light. Do not store in the bathroom. Keep the bottle upright with the pump tightly closed. Protect from freezing.
Keep out of the reach of children.
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.
Side Effects
A bitter taste in the mouth, drowsiness, a burning feeling inside the nose, sneezing fits, cough, nose bleeds, runny nose, nausea, dry mouth, headache, weight gain, muscle aches, or red eyes may occur. If any of these effects last or get worse, 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.
A very serious allergic reaction to this drug 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.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
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