Of 1242 overactive bladder patients in placebo-controlled clinical studies of BOTOX, 41.4% (n=514) were 65 years of age or older, and 14.7% (n=182) were 75 years of age or older. Adverse reactions of UTI and urinary retention were more common in patients 65 years of age or older in both placebo and BOTOX groups compared to younger patients (see Table 18). Otherwise, there were no overall differences in the safety profile following BOTOX treatment between patients aged 65 years and older compared to youn ger patients in these studies.
Most practices have a flat cost for each injection of BOTOX® Cosmetic, though some will break it down by “units” used per treatment. Flat rates are usually somewhere between $300 and $1000, while per-unit rates are usually around $10-15 per unit. Though the BOTOX® Cosmetic price paid by physicians is normally about $400 for each vial (each vial contains 100 units, or enough for about 4 or 5 treatments), the vial must be used within a few hours of opening, so if the entire vial is not used, the physician will often have to throw the rest out.
The one side effect that we most commonly see with Botox for migraine, ironically, is increased headache pain in the days immediately following the injections. Interestingly, some patients have the opposite effect, noticing immediate pain relief. That may be due to an acupuncture-like response, where poking needles into unhappy muscles actually makes them feel better.
Before I could try Botox, my health insurance — Cigna — required me to try and fail at least two other meds. I tried tricyclic antidepressants, which made me groggy and turned my brain into molasses, and beta blockers, a class of drugs used for high blood pressure and heart problems. (All treatments to prevent migraines are borrowed from other conditions, except a new class of drugs that was just approved by the Food and Drug Administration.) The beta blockers worked for a few months: they slightly reduced the number of migraines and made the headaches more bearable. But late last year, the migraines became chronic again — I had more than 15 in a month. That’s when my neurologist said: “I think it’s time to try Botox.”
BOTOX blocks neuromuscular transmission by binding to acceptor sites on motor or sympathetic nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP -25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings. When injected intramuscularly at therapeutic doses, BOTOX produces partial chemical denervation of the muscle resulting in a localized reduction in muscle act ivity. In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by BOTOX.
The average price for Botox in the Houston area is $14-15/unit. Most providers nowadays will offer specials. In addition, Botox has a "rewards" program that gives you $25 off each treatment done within 3-6 mos of the last treatment, as long as it's done at the same office. Treatment of the glabella, crow's feet and forehead require 25-50 units, depending on the severity of the lines.
Autonomic dysreflexia associated with intradetrusor injections of BOTOX could occur in patients treated for detrusor overactivity associated with a neurologic condition and may require prompt medical therapy. In clinical trials, the incidence of autonomic dysreflexia was greater in patients treated with BOTOX 200 Units compared with placebo (1.5% versus 0.4%, respectively).
Dr. Schwedt believes ARMR offers hope for patients living with migraine. “ARMR data could lead to breakthroughs in the field,” he says. One hope for ARMR is that it will contribute to the ability for health care providers to use precision medicine to treat their patients. Clinical trials show which migraine therapies are overall effective for groups of people with migraine; however, health care providers are still working to understand which specific therapy is ideal for a particular patient. “One of the challenges we have in this field right now is being able to determine which exact therapy is going to be best for which patient,” Dr. Schwedt says. “For example, we might know that about 50% of patients will benefit from a specific migraine preventive therapy, but we don’t know in advance which 50% that is. I believe the data we’re collecting in ARMR is going to help us get to the stage where we can practice precision medicine, knowing which therapy is most likely to help an individual patient prior to the patient starting that therapy.”
Results can vary depending on who is performing the injection on the patient. It is very important to go to a physician who is experienced at this procedure, does it him- or herself (rather than having a nurse, physician's assistant [PA], or other nonphysician do it), and has a good reputation for performing this type of procedure. The manufacturers of Botox recommend physicians inject the medication themselves. As with most procedures, the skill of the practitioner is related to how often he or she performs the procedure.
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Injection description is very important. It is best to describe the injections as a pinch rather than a bee sting, and to explain that the injections are shallow, with only a half-inch needle. As a result of the superficial technique used with the injections, deep anticoagulation can be continued. The procedure is short, and talking to the patient during the procedure about something other than the injections can help alleviate the patient’s anxiety. It is important to describe onabotulinumtoxinA as a purified protein rather than a toxin or a poison. In addition, stating that it relaxes muscles rather than causing paralysis will be reassuring to the patient. In a very anxious patient, the areas to be injected can be iced first or a local anesthetic cream can be applied. Starting with the trapezius muscle can also help, as these injections are the least painful, and the patient cannot see the needle. Finally, it is important to make sure the injections are performed with a sharp needle, and blunt needles are discarded. Thirty-gauge needles only remain sharp for six to eight needle sticks each.
How Was the Botox Mixed? A factor that many patients are unaware of is that Botox and Dysport come in a powder form that must be mixed with sterile saline to reconstitute the vial. The amount of water that is mixed with the Botox or Dysport can vary and will determine the concentration of the medicine. Some doctors and nurses dilute the powder too much so that the final concentration of Botox or Dysport is weak. So if you go to a provider who advertises a cheap price (for instance below the wholesale price) the injections you may be getting may be very dilute and may not be as effective as a more concentrated (more expensive) injection.
As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody (including neutralizing antibo dy) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to onabotulinumtoxinA in the studies described below with the incidence of antibodies in other studies or to other products may be misleading.
The migraines started later in life, before my lupus diagnosis. While sometimes they’d come out of the blue or I’d wake up with them, other times I’d see them coming. From a neurologist’s suggestion, I learned some of my “triggers” such as weather changes (specifically, drops in barometric pressure and incoming storms), hormonal changes and dairy. This past year I significantly reduced my dairy intake and although that didn’t eliminate the migraines, if I did eat dairy, I was sure to get one. Many of my migraines would also start as tension headaches. My neck is always extremely tight and eventually the constant tightness causes a migraine. Due to this, my old rheumatologist suggested taking a muscle relaxer at the beginning of a headache or before bed to keep my muscles from tensing up overnight and preventing a migraine. It worked sometimes… but definitely not enough.
There were 214 subjects evaluated for the open label period, of which 170 progressed into the randomized, blinded treatment p eriod (88 in the BOTOX group, 82 in the placebo group). Patient evaluations continued for at least 10 weeks post-injection. The primary outcome for the study was a dual endpoint, requiring evidence of both a change in the Cervical Dystonia Severity Scale (CDSS) and an increase in the percentage of patients showing any improvement on the Physician Global Assessment Scale at 6 weeks after the injection session. The CDSS quantifies the severity of abnormal head positioning and was newly devised for this study. CDSS a llots 1 point for each 5 degrees (or part thereof) of head deviation in each of the three planes of head movement (range of scores up to theoretical maximum of 54). The Physician Global Assessment Scale is a 9 category scale scoring the physician's evaluation of the patients' status compared to baseline, ranging from 4 to +4 (very marked worsening to complete improvement), with 0 indicating no change from baseline and +1 slight improvement. Pain is also an important symptom of cervical dystonia and was evaluated by separate assessments of pain frequency and severity on scales of 0 (no pain) to 4 (constant in frequency or extremely severe in intensity). Study results on the primary endpoints and the pain-related secondary endpoints are shown in Table 35.
Serious and/or immediate hypersensitivity reactions have been reported. These reactions include anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea. If such a reaction occurs, further injection of BOTOX should be discontinued and appropriate medical therapy immediately instituted. One fatal case of anaphylaxis has been reported in which lidocaine was us ed as the diluent, and consequently the causal agent cannot be reliably determined.
Galli’s winning film presents herself, and people with migraine, as superheroes, living with a secret identity: migraine. “Other than me laying down on my couch, and knowing what's going on inside my body, nobody sees what's happening,” she says. “It's all happening inside. It's like that same struggle that superheroes have.” The migraine symptoms are superpowers, albeit ones that you don’t want. When her migraine attacks first began, Galli recalls an increased sensitivity to sound, odors, light and “all these things that feel not normal.” Many people with migraine are fighting the disease on their own, because their peers can’t relate to what their feeling on a daily basis. “It's time that we create better awareness and we tell the world that no, we don't need to be alone,” she says. “We don't need to fight alone and hide in the dark.” The film, she hopes, will add to the conversation and bring this disease out of the shadows. For the more than 37 million Americans living with migraine, Galli says: “You’re all superheroes. I hear you, I feel you.”
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Botox lasts only around three months (or more when you first start getting injections), so get ready to go in for maintenance every three to six months. Because it’s only meant to temporarily relax your muscles, it wears off over time, and you’ll notice your wrinkle start to appear again. “As skin ages, the skin loses elasticity and collagen breaks down, so constant muscle and skin contraction can create more permanent creases (wrinkles). Within a few months of injecting the botox, the body makes new acetylcholine receptors, and the nerves are able to conduct their impulses again,” Dr. Shainhouse explains. “You must use neurotoxins continuously in order to reduce muscle movement and prevent long-term skin creasing.” Find out more secrets from dermatologists about how to prevent and treat wrinkles.
I had a consult and the doctor quickly realized that I was a candidate for Botox. He ordered an MRI and doppler of my brain to make sure everything else was A-OK, and then the rest was just waiting on my insurance company. With Botox (I’m not sure if it’s all Botox or just prescription), the insurance company orders it from a pharmacy and sends it to the doctor.
The median duration of response in study NDO-1 and NDO-2, based on patient qualification for re-treatment was 295-337 days (4248 weeks) for the 200 Units dose group compared to 96-127 days (13-18 weeks) for placebo. Re-treatment was based on loss of effect on incontinence episode frequency (50% of effect in Study NDO-1; 70% of effect in Study NDO-2).
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Do not inject into blood vessels. Introduction of these products into the vasculature may lead to embolization, occlusion of the vessels, ischemia, or infarction. Take extra care when injecting soft-tissue fillers; for example, inject the product slowly and apply the least amount of pressure necessary. Rare, but serious, adverse events associated with the intravascular injection of soft-tissue fillers in the face have been reported and include temporary or permanent vision impairment, blindness, cerebral ischemia or cerebral hemorrhage leading to stroke, skin necrosis, and damage to underlying facial structures. Immediately stop the injection if a patient exhibits any of the following symptoms: changes in vision, signs of a stroke, blanching of the skin, unusual pain during or shortly after the procedure. Patients should receive prompt medical attention and, possibly, evaluation by an appropriate healthcare professional specialist should an intravascular injection occur
Normally you would see improvement within a few days. Botox requires two to four days for it to attach to the nerve ending that would normally stimulate the muscle to contract. The maximum effect usually occurs at about 10-14 days. Therefore, whatever effect is obtained two weeks after the injections should be considered the maximum effect that is going to occur.
Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junction disorders (eg, myasthenia gravis or Lambert-Eaton syndrome) should be monitored when given botulinum toxin. Patients with neuromuscular disorders may be at increased risk of clinically significant effects including generalized muscle weakness, diplopia, ptosis, dysphonia, dysarthria, severe dysphagia, and respiratory compromise from onabotulinumtoxinA (see Warnings and Precautions).
OnabotulinumtoxinA is the only treatment approved by the United States Food and Drug Administration for the prevention of headaches in adult patients with chronic migraine (CM). CM assessment involves a detailed history to rule out secondary sources of headache, establish migraine features, and assess the total number of headache days. In order to diagnose migraine, the patient should have had at least five attacks that involve migraine features, as outlined below. In adults, untreated attacks usually last 4 or more hours.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.
Botox was introduced to the world in the late 1980s by ophthalmologists, who began using it to treat optic muscle disorders. It was approved by the Food and Drug Administration (FDA) for the treatment of moderate to severe frown lines between the eyebrows (glabellar lines) in 2002, and its popularity has soared ever since. Botox is consistently one of the top five nonsurgical cosmetic procedures performed each year.
In general, you’ll find that Botox costs about $10-$20 per unit. While some offices and clinics charge a flat rate, depending on the area that they’re working on, you’ll more often find that you are charged based on how many units of Botox are used to achieve the results you’re looking for. You need around 20 units to treat your forehead and 5-6 units to treat crows feet, making Botox an affordable alternative to going under the knife.
BOTOX is administered about every three months, and must be injected at the site of each nerve trigger, relaxing the surrounding muscles so that they won’t compress the nerve and trigger a migraine. It is a potent drug, and we only recommend using it if other preventative treatment options haven’t helped you. It is generally only administered to patients who have at least 14 headaches a month, or don’t respond to other treatments.
A randomized, multi-center, double-blind, placebo-controlled study of the treatment of cervical dystonia was conducted. This study enrolled adult patients with cervical dystonia and a history of having received BOTOX in an open label manner with perceived good response and tolerable side effects. Patients were excluded if they had previously received surgical or other denervation tre atment for their symptoms or had a known history of neuromuscular disorder. Subjects participated in an open label enrichment period where they received their previously employed dose of BOTOX. Only patients who were again perceived as showing a response were advanced to the randomized evaluation period. The muscles in which the blinded study agent injections we re to be administered were determined on an individual patient basis.
Sunburn alert: The AHA/BHA Exfoliating Cleanser and AHA/BHA Cream in the Lytera® 2.0 Advanced Pigment Correcting System contain an alpha-hydroxy acid (AHA) that may increase the skin’s sensitivity to the sun and particularly the possibility of sunburn. Patients should use a sunscreen, wear protective clothing, and limit sun exposure while using these products (or this system) and for a week following.
Botox injections work by weakening or paralyzing certain muscles or by blocking certain nerves. The effects last about three to twelve months, depending on what you are treating. The most common side effects are pain, swelling, or bruising at the injection site. You could also have flu-like symptoms, headache, and upset stomach. Injections in the face may also cause temporary drooping eyelids. You should not use Botox if you are pregnant or breastfeeding.