er 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
nausea
headache
fast heartbeat
feeling very tired (fatigue)
upper stomach pain
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 FDA at 1-800-FDA-1088.
How should I store TYMLOS?
Before first use, store TYMLOS pens in the refrigerator between 36°F to 46°F (2°C to 8°C).
After first use, store your TYMLOS pen for up to 30 days at room temperature between 68°F to 77°F (20°C to 25°C).
Do not freeze the TYMLOS pen or expose it to heat.
Do not use TYMLOS after the expiration date printed on the pen and packaging.
Throw away the TYMLOS pen after 30 days even if some medicine is left in the pen (see “INSTRUCTIONS FOR USE”).
Keep TYMLOS and all medicines out of the reach of children.
General information about the safe and effective use of TYMLOS.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TYMLOS for a condition for which it was not prescribed. Do not give TYMLOS to other people, even if they have the same condition you have. It may harm them.
You can ask your pharmacist or healthcare provider for information about TYMLOS that is written for health professionals.
What are the ingredients in TYMLOS?
Active ingredient: abaloparatide
Inactive ingredients: phenol, sodium acetate trihydrate, acetic acid, and water for injection.
Radius
Radius Health, Inc., 950 Winter St., Waltham, MA 02451
Copyright © 2017, Radius Health, Inc. All rights reserved.
For more information about TYMLOS, visit our website at www.TYMLOS.com or call Radius Health, Inc., at 1-855-672-3487.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 04/2017
10006643-03
INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE
TYMLOS™ (tim lows’)
(abaloparatide)
injection, for subcutaneous use
Instructions for Use
Read and follow this Instructions for Use so that you inject TYMLOS pen the right way. Call your healthcare provider if you have any questions about the right way to inject the TYMLOS pen.
Important information about your TYMLOS pen
Do not try to inject TYMLOS yourself until you or your caregiver receive training from a healthcare provider on the right way to use TYMLOS pen.
Do not share your TYMLOS pen or pen needles with other people, even if the needle has been changed. You may give other people a serious infection, or get a serious infection from them.
Each TYMLOS pen is a prefilled pen containing 30 doses of TYMLOS. Each dose will contain 80 mcg of TYMLOS. You do not have to measure your dose. The pen measures each dose of TYMLOS for you.
Use a new pen needle for each injection. Keep the cap on the TYMLOS pen when not using the pen.
Before using the pen always check the label to be sure it is your TYMLOS pen.
Do not use your TYMLOS pen if it looks damaged. If you drop your TYMLOS pen or it becomes damaged, call your healthcare provider or pharmacist or call 1-855-672-3487.
To clean your TYMLOS pen, wipe the outside of the pen with a clean, damp cloth, if needed.
The TYMLOS pen is not recommended for use by the blind or visually impaired without the help of a pe |
