Back in July, the FDA approved Adlyxin for diabetes type 2, and it is now available in pharmacies!
When people think about injectable diabetes medications, the first thing that comes to mind tends to be insulin medications like Humalog (insulin lispro) or Lantus (insulin glargine). However, the FDA has been approving many new non-insulin products recently, like Victoza and Byetta, and now Adlyxin!
What is Adlyxin indicated for?
Adlyxin is a GLP-1 agonist, a hormone that helps stimulate the production of insulin and normalize blood sugar levels. It is indicated for the treatment of adult patients with type 2 diabetes, in conjunction with diet and exercise.
Adlyxin is currently available in over 60 countries under the name of Lyxumia and has been approved in Europe since 2013.
How is Adlyxin to be used?
Adlyxin is available in a disposable pre-filled pen in strengths of 50 mcg/ml and 100 mcg/ml. Adlyxin is to be injected subcutaneously, once daily, an hour before the first meal of the day. For the first 14 days of treatment, patients will use the 10 mcg pen. On day 15, the dosage should be increased to 20 mcg once daily.
What are the common side effects associated with Adlyxin?
Possible side effects include nausea, vomiting, headache, diarrhea, dizziness, and low blood sugar. Be sure to speak with your doctor if you experience any of these side effects for a prolonged period of time.
How does Adlyxin compare to other medications in its class?
Adlyxin is similar to medications like Victoza and Byetta, as they all require once-daily injections. However, other medications, like Bydureon, Trulicity, and Tanzeum are once-weekly injections. There are pros and cons to both of these types, so be sure to speak with your doctor to discuss which will be best for you.
Impaired sleep (insomnia) is a major complaint from patients in my practice, with huge personal and economic costs. When it comes to treatments for either difficulty going to sleep or staying asleep, looking for an easily reversible cause is the first step.
One of the first places to look: many drugs may affect the quality and duration of sleep. These 18 meds have been shown in studies to do just that. If you are struggling with insomnia and take one of these medications, asking your doctor to try an alternative may allow you to get some zzz’s.
- Prednisone. A steroid given for asthma or COPD, hives, and other skin conditions, prednisone has been shown to disrupt your sleep.
- Sertraline (Zoloft). Studies show sertraline is a significant disruptor of sleep. Sertraline is a selective serotonin reuptake inhibitor (SSRI) prescribed for depression and obsessive compulsive disorder—if you are struggling with sleep disturbance after starting sertraline, ask your doctor about another option in the same class of meds.
- Paroxetine (Paxil). An SSRI used for anxiety, depression, and OCD, studies reveal that paroxetine significantly affects sleep.
- Fluoxetine (Prozac). Another well known SSRI used for depression, panic disorder, OCD, and premenstrual dysphoric disorder, fluoxetine has also been shown in studies to contribute to insomnia.
- Citalopram (Celexa). Another SSRI that may disrupt sleep.
- Fluvoxamine (Luvox). Yet another old school SSRI, this antidepressant may disrupt your sleep.
- Donepezil (Aricept). Donepezil is indicated for the treatment of dementia, specifically Alzheimer’s, and may cause disrupted sleep in folks taking it.
- Venlafaxine (Effexor). Slightly different from SSRIs, this SNRI (serotonin, norepinephrine reuptake inhibitor) is prescribed for generalized anxiety disorder and depression. Studies show it significantly contributes to insomnia.
- Pramipexole (Mirapex and Mirapex ER). These medications are used for restless leg syndrome (RLS) and Parkinson’s disease. Studies show they may contribute to sleep disturbance.
- Rotigotine (Neupro). Neupro is a brand-name-only patch prescribed for restless leg syndrome and Parkinson’s disease, and it may cause insomnia.
- Ropinirole (Requip). Another medication used for the treatment of restless leg syndrome, ropinirole may contribute to insomnia.
- Varenicline (Chantix). Prescribed for folks who want to quit smoking, studies reveal that Chantix may disrupt your sleep.
- Rivastigmine (Exelon). This patch is used for the treatment of dementia and has been shown in studies to affect sleep.
- Naltrexone (Revia). Naltrexone is an opioid receptor antagonist used for alcohol dependence. It’s also part of the new weight loss medication Contrave (a combination of naltrexone and bupropion). Naltrexone can negatively affect sleep.
- Olanzapine (Zyprexa). Olanzapine is used for bipolar disorder and psychosis associated with dementia and studies show it may contribute to insomnia.
- Levodopa. Part of Sinemet (a combination of levodopa and carbidopa), it’s used for restless leg syndrome as well as Parkinson’s disease and may cause insomnia.
- Amantadine (Symmetrel). Amantadine is an antiviral medication that also happens to be used for Parkinson’s disease and schizophrenia, and it may negatively impact sleep.
- Cabergoline (Dostinex). Cabergoline is a medication that’s effective both for restless leg syndrome and for lowering levels of prolactin in those with prolactin-producing pituitary tumors. Studies show cabergoline may cause insomnia.
Hope this helps.
Ref: Doufas A, Panagioutou O. Insomnia From Drug Treatments: Evidence From Meta-analyses of Randomized Trials and Concordance With Prescribing Information. Mayo Clin. Proc Jan 2017: 92(1): 72-87.
Osteoporosis affects one in four women ages 65 and older, making it more likely that you will break a bone in the hip, forearm, wrist, or spine.
Osteoporosis occurs when you lose bone, don’t make enough bone, or a combination—and it can be caused by many things, including genetic makeup, diet, diseases and even some medications. Some common symptoms include back pain, loss of height over time, stooped posture, and bones that fracture more easily than expected.
There are some treatments out there that can help, but for the first time in 15 years, the FDA has approved a new bone-building medication for osteoporosis: Tymlos (abaloparatide).
What is Tymlos used for?
Tymlos is approved for the treatment of osteoporosis in women who are postmenopausal and at high risk for fracture.
What dosage form(s) and strength(s) will Tymlos be available in?
Tymlos will be available in a 3120 mcg/1.56 mL prefilled pen that can deliver 30 doses of the medication. One benefit of the prefilled pen: it dispensed pre-measured doses, so you don’t have to measure each time.
What’s the usual dose of Tymlos?
Tymlos is used at 1 dose of 80 mcg injected subcutaneously, once daily.
How should you use the prefilled Tymlos pen?
The prefilled Tymlos pen should be injected into the lower stomach area, avoiding the 2 inch area around your belly button.
You will need to rotate your injection site daily around your lower stomach area.
What type of medication is Tymlos?
Tymlos is a human parathyroid hormone related peptide analog.
What are the common side effects associated with Tymlos?
The most common side effects associated with Tymlos include increased calcium levels, dizziness, nausea, headache, fatigue, upper stomach pain, and a sensation of feeling off balance.
Is there anything important to know about using Tymlos?
Yes—first, Tymlos has a boxed warning for the possibility that it may cause bone cancer.
You will also need a prescription for pen needles to go along with your Tymlos pen—even though it is pre-filled, it doesn’t come with the pen needles you’ll need to use to inject the medication. The correct needles to use with your Tymlos pen are 8 mm, 31 gauge Clickfine needles. Some examples include ReliOn, smart sense, and TopCare to name a few.
Before your first use, your Tymlos pen should be stored in the refrigerator. After your first use, you can store your Tymlos pen at room temperature for up to 30 days.
When was Tymlos approved by the FDA?
Tymlos was approved by the FDA on April 28, 2017.
When will Tymlos be available?
According to the manufacturer, Radius Health, Tymlos will be available in the United States in June.
Is there anything unique about Tymlos?
Yes. Tymlos is the first new bone-building medication for postmenopausal women with osteoporosis in the United States in 15 years.
Are any similar medications available?
Yes, Forteo (teriparatide) is a similar injection used to treat osteoporosis.
How can I find out if my insurance company will cover Tymlos?
Tymlos has a patient support program called Together With Tymlos. The Together With Tymlos patient support program can be reached at 1-866-896-5674 Monday through Friday 8 AM to 8 PM ET.
Together With Tymlos offers patient services like coverage support, medication dispensing support (where and how to fill your prescription), a clinical educator network, savings offers, and others.
Where will I be able to get Tymlos?
Tymlos will be a specialty medication that must be obtained from a specialty pharmacy. Together With Tymlos will be able to provide you with more information on which specialty pharmacies you may obtain the medication from.
Where can I get more information on Tymlos?
About a year ago, the FDA released findings that fluoroquinolone antibiotics can cause dangerous side effects involving the tendons, muscles, joints, nerves and central nervous system, and advised that use should be restricted in uncomplicated situations.
However, the FDA has reviewed all reports and updated their safety warning. Although some negative side effects are still possible, the FDA does not believe that fluoroquinolone antibiotics can result in detachment of the retina, or tears in the aorta blood vessel.
At this time, the FDA has determined that fluoroquinolone antibiotics should be avoided, if possible, in the following infections: acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, and uncomplicated urinary tract infections. Your doctor may prescribe a fluoroquinolone antibiotic for one of these infections if there are no other treatment options available for you. Be sure to speak with your doctor about the possible side effects.
What are fluoroquinolone antibiotics?
Fluoroquinolone antibiotics include Cipro (ciprofloxacin), Levaquin (levofloxacin), Avelox (moxifloxacin), Factive (gemifloxacin), and ofloxacin. These drugs are typically used to treat urinary tract infections, sinus infections, respiratory infections, typhoid, and pneumonia.
What side effects are related to fluoroquinolone antibiotics?
If you have been prescribed a fluoroquinolone antibiotic be sure to seek medical attention if you experience any side effects like unusual joint or tendon pain, muscle weakness, tingling or pricking sensation, numbness in arms or legs, confusion or hallucinations.
What has been done to warn people about these serious side effects?
Drug manufacturers of all fluoroquinolone antibiotics are required to update their boxed warning and patient medication guides to reflect the side effects. The FDA will continue to assess the safety issues with fluoroquinolone antibiotics.
Methicillin-resistant Staphylococcus aureus (MRSA) surgical site infections have been catastrophic for patients—they result in longer hospital stays and poorer outcomes. More than 80% of the time, infections result because of Staph aureus that we are carrying, in our nose or on our skin.
For those of us who may be carriers of Staph aureus (it lives in our nose)—does attempting to decolonize our nose with Bactroban (mupirocin) antibiotic ointment help prevent these infections after surgery? Let’s find out.
First, know that in most studies about 10 – 18% of us will have a positive nasal swab for Staph aureus, meaning we are a carrier of that bacteria in our noses.
The medical community has spent the last few years trying to answer whether Bactroban 2% ointment used twice a day for 5 days in your nostrils prior to surgery prevents surgical site infections. How this works: during your pre-operative visit a nasal screening swab is done and if you are positive for S. aureus you are treated with 5 nights of ointment in your nose before your surgery. So should we do it before all surgeries?
Hip and knee replacement surgeries:
Here, the data is the most convincing. For reducing infections after hip and knee replacement, the answer appears to be yes. If your nasal swab is positive for S. aureus, treatment with Bactroban for 5 days before surgery has been shown to decrease surgical site infections by 69%.
Which other surgical patients get the most benefit from pre-screening and treatment?
Cardiovascular or vascular procedures with implantation of prosthetic grafts and orthopedic joint procedures. The benefit of Bactroban in other device-related surgical procedures like hernia mesh is unknown and currently not supported by the medical/surgical literature.
Does it lower risk of death along with lower surgical site infection risk?
In a large study using Bactroban ointment and chlorhexidine wipes, the authors found that treatment prior to surgery (in those whose nasal swabs were positive) reduced infections by 60%. The bonus here was that longer-term follow up also noted decreased mortality in those screened and treated. Detection and decolonization of Staph aureus not only prevents surgical-site infections but also reduces 1-year mortality in some surgical patients (Bode, NEJM Jan 2010).
What do I use?
The best regimen to decolonize your nose and skin of Staph aureus isn’t clear. The current recommendation is nasal Bactroban twice a day for 5 days. To decolonize the skin, some also recommend using 2% or 4% chlorhexidine gluconate (also known as Hibiclens) body cleansing once a day for 2 – 3 days prior to surgical admission.
How do I use it?
Bactroban (mupirocin), one gram in each nostril, twice a day for 5 days. It’s a prescription that comes in prepacked tubes (a pack of 10, each with 1 gram). You should know though, it’s much cheaper to get a tube (22 grams) of Bactroban ointment and estimate a gram in each nostril. One gram is two finger tip units, so squeeze along your fingertip to estimate.
Take home message:
While there is some debate, hospital-acquired infections with S. aureus in surgical patients can be prevented by screening to see if you are a carrier—and treating with Bactroban nasal ointment if S. aureus is found.