Patient Support From TYMLOS
IMPORTANT SAFETY INFORMATION AND INDICATIONS
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.
Do not take TYMLOS:
- if you had an allergic reaction to abaloparatide or any of the other ingredients in TYMLOS. The inactive ingredients in TYMLOS are phenol, sodium acetate trihydrate, acetic acid, and water for injection.
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.
- have or have had any of the following: cancer in your bones; radiation therapy involving your bones; too much calcium in your blood; or an increase in your parathyroid hormone (hyperparathyroidism).
- will have trouble injecting yourself with the TYMLOS pen and do not have someone who can help you.
- are pregnant or plan to become pregnant, because TYMLOS is not for pregnant women, or if you are breastfeeding or plan to breastfeed. It is not known if TYMLOS passes into your breast milk; you should not take TYMLOS and breastfeed.
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:
The most common side effects of TYMLOS in women with postmenopausal osteoporosis include:
- dizziness, nausea, headache, fast heartbeat, feeling tired (fatigue), upper stomach pain, and spinning feeling (vertigo).
The most common side effects of TYMLOS in men with osteoporosis include:
- redness at injection site, dizziness, joint pain, swelling at injection site, pain at injection site, bruising, abdominal bloating, diarrhea, nausea, abdominal pain, and bone pain.
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 the FDA at 1-800-FDA-1088.
How should I use TYMLOS?
- Read the complete Instructions for Use provided with your medicine.
- 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.
- You should not use TYMLOS for more than 2 years over your lifetime.
What is TYMLOS?
TYMLOS is a prescription medicine used to:
It is not known if TYMLOS is safe and effective for children and young adults 18 years and younger. TYMLOS should not be used in children and young adults whose bones are still growing.
Please see full Prescribing Information, including Medication Guide at tymlospi.com