Over the next couple weeks, payers and PBMs will continue to make publicly available their
“I am very happy to have increased our market access for TYMLOS in the
Radius is committed to continuing to enable access to TYMLOS for all appropriate patients.
About TYMLOS (abaloparatide) injection
TYMLOS® (abaloparatide) injection was approved by the
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TYMLOS?
TYMLOS may cause serious side effects including:
- Possible bone cancer (osteosarcoma). During animal drug testing, TYMLOS caused some rats to develop a bone cancer called osteosarcoma. It is not known if people who take TYMLOS will have a higher chance of getting osteosarcoma.
- Tell your healthcare provider right away if you have pain in your bones, pain in any areas of your body that does not go away, or any new or unusual lumps or swelling under your skin that is tender to touch.
Before you take TYMLOS, tell your healthcare provider about all of your medical conditions, including if you:
- have Paget’s disease of the bone or other bone disease, will have trouble injecting yourself with the TYMLOS pen and do not have someone who can help you
- have or have had cancer in your bones, have or have had radiation therapy involving your bones, have or have had too much calcium in your blood, have or have had too much of an enzyme called alkaline phosphatase in your blood, have or have had an increase in your parathyroid hormone (hyperparathyroidism)
- are pregnant or plan to become pregnant because TYMLOS is not for pregnant women, or are breastfeeding or plan to breastfeed. It is not known if TYMLOS passes into your breast milk. You and your healthcare provider should decide if you will take TYMLOS or breastfeed. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of TYMLOS?
TYMLOS can cause serious side effects including:
- Decrease in blood pressure when you change positions. Some people may feel dizzy, have a faster heartbeat, or feel lightheaded soon after the TYMLOS injection is given. These symptoms generally go away within a few hours. Take your injections of TYMLOS in a place where you can sit or lie down right away if you get these symptoms. If your symptoms get worse or do not go away, stop taking TYMLOS and call your healthcare provider.
- Increased blood calcium (hypercalcemia). TYMLOS can cause some people to have a higher blood calcium level than normal. Your healthcare provider may check your blood calcium before you start and during your treatment with TYMLOS. Tell your healthcare provider if you have nausea, vomiting, constipation, low energy, or muscle weakness. These may be signs there is too much calcium in your blood.
- Increased urine calcium (hypercalciuria). TYMLOS can cause some people to have higher levels of calcium in their urine than normal. Increased calcium may also cause you to develop kidney stones (urolithiasis) in your kidneys, bladder or urinary tract. Tell your healthcare provider right away if you get any symptoms of kidney stones which may include pain in your lower back or lower stomach area, pain when you urinate, or blood in your urine.
The most common side effects of TYMLOS include:
- dizziness, fast heartbeat, upper stomach pain, nausea, headache, feeling very tired (fatigue), vertigo
These are not all the possible side effects of TYMLOS. Call your doctor for medical advice about side effects. You may report side effects to
If you take more TYMLOS than prescribed you may experience symptoms such as muscle weakness, low energy, headache, nausea, dizziness (especially when getting up after sitting for a while) and a faster heartbeat. Stop taking TYMLOS and call your healthcare provider right away.
INDICATIONS AND USAGE
What is TYMLOS?
TYMLOS is a prescription medicine used to:
- decrease the chance of having a fracture of the spine and other bones in postmenopausal women with thinning and weakening bones (osteoporosis).
- treat osteoporosis in postmenopausal women who are at high risk for bone fracture.
It is not known if TYMLOS is safe and effective for children 18 years and younger.
It is not recommended that people use TYMLOS for more than 2 years during their lifetime.
TYMLOS should not be used in children and young adults whose bones are still growing.
For the TYMLOS prescribing information, including Boxed Warning, please visit www.tymlospi.com.
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics in the areas of osteoporosis and oncology. Radius' lead product, TYMLOS (abaloparatide) injection, was approved by the
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding coverage, pricing and other expectations for TYMLOS (abaloparatide), the incidence of osteoporotic fractures and the healthcare burden associated with osteoporosis, and the potential clinical uses and therapeutic and other benefits of our product candidates, including abaloparatide patch, elacestrant and RAD140.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we expect to need to raise additional funding, which may not be available; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the U.S. or be successfully commercialized in any market in which it is approved, including as a result of risk related to coverage, pricing and reimbursement; risks related to competitive products and any collaboration agreements failing to be successful; risks related to clinical trials, including our reliance on third parties to conduct key portions of our clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates or during commercialization, if approved; risks related to manufacturing, supply and distribution; and the risk of litigation or other challenges regarding our intellectual property rights. These and other important risks and uncertainties discussed in our filings with the
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Source: Radius Health Inc.