ruct patients to promptly report signs and symptoms of hypercalcemia.
Orthostatic Hypotension
Advise patients to sit or lie down if they feel lightheaded or have palpitations after the injection until their symptoms resolve. If these symptoms persist or worsen, advise patients to consult their healthcare provider before continuing treatment [see Dosage and Administration (2.2)].
Use of TYMLOS Pen
Instruct patients and caregivers who administer TYMLOS on how to properly use the TYMLOS pen and to follow sharps disposal recommendations [see Dosage and Administration (2.2)]. Advise patients not to share their TYMLOS pen or needles with other patients and not to transfer the contents of the pen to a syringe.
Advise patients that each TYMLOS pen can be used for up to 30 days, and after the 30-day use period, to discard the TYMLOS pen, even if it still contains unused solution [see How Supplied/Storage and Handling (16.2)].
Manufactured in Germany for:
Radius Health, Inc.
950 Winter Street
Waltham, MA 02451
TYMLOS is a trademark of Radius Health, Inc.
Copyright © 2017, Radius Health, Inc. All rights reserved.
10006082-04
MEDICATION GUIDE
MEDICATION GUIDE
TYMLOS™ (tim lows’)
(abaloparatide)
injection, for subcutaneous use
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.
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.
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 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).
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. TYMLOS is not for pregnant women.
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.
Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist each time you get a new medic |
