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.
Last week, GoodRx rolled out exclusive new savings on more than 40 brand-name prescriptions, and we also promised to pursue discounts for more drugs.
Today, we’re happy to announce new Inside Rx discounts for 6 more brands:
- Colcrys (treats gout): 45% off retail price
- Uloric (treats gout): 16% off retail price
- Amitiza (treats constipation): 40% off retail price
- Dexilant (treats GERD): 40% off retail price
- Trintellix (treats depression): 24% off retail price
- AirDuo Respiclick (treats COPD): just released so no comparison available yet
Like all GoodRx coupons, these new discounts are easy to use—just search for your drug and print out the discount. There are no fees, forms, paperwork, or sign-ups required. These discounts work at most major pharmacy chains.
A reminder—if you have insurance, you may also want to consider manufacturer co-pay programs. Just click on the Savings Tips link after you search for a drug to see which option will save you the most. On the Savings Tips page, we also list patient assistance programs and other valuable savings tips.
Keep in mind, there are a few restrictions attached to these discounts (learn more here).
We know that many other brand-name drugs are still too expensive, and we are continuing to expand the Inside Rx program. We’ll be adding more drugs and discounts soon. If you take a prescription that is too expensive, email us at email@example.com, and we’ll make finding a lower price for your prescription a priority.
On April 21st, the FDA approved Renflexis (infliximab-abda), the second biosimilar to the popular medication Remicade, (infliximab) indicated for immune disorders.
A biosimilar is like a generic medication in that it is less expensive than the brand name medication. However, the difference is that biosimilars are made out living cells, so they may be slightly different from their counterpart. This usually means that the pharmacist will not substitute these medications without approval from a doctor. For more information on what a biosimilar is, read our previous blog post here.
What is Renflexis indicated for?
Renflexis is indicated for multiple conditions including crohn’s disease, pediatric crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
How is Renflexis to be used?
Renflexis will be available as an intravenous infusion in a strength of 100mg/20ml. Your dose of Renflexis will be determined by your doctor based on your weight and your specific condition. It is to be administered by your doctor at his or her office as an intravenous infusion over a period of no less than 2 hours.
Renflexis is considered a specialty medication, which means that it will most likely be delivered to your home or readily available at a designated specialty pharmacy.
What are the most common side effects associated with Renflexis?
The most common side effects include infections, infusion-related reactions, headache and abdominal pain. More serious side effects include more life-threatening infections or cancer.
What other biosimilars for Remicade exist?
Renflexis should be available in pharmacies in about six months.