New FDA Approval: Tymlos for Osteoporosis

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
Posted on

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?

You can see the press announcement here, or check out the official Tymlos website.


Drugs featured in this story

Filed under