round your abdomen. Talk to your healthcare provider about how to change (rotate) your injection site for each injection. Do not use the same injection area for each injection. Do not inject into areas where the skin is tender, bruised, red, scaly, or hard. Avoid areas with scars or stretch marks.
Figure M
Step 15. Wipe the injection site with an alcohol swab and allow it to dry. Do not touch, fan, or blow on the injection site after you have cleaned it.
Giving your TYMLOS pen injection
Read Step 16 and Step 17 before you give your injection.
Inject your TYMLOS pen the way your healthcare provider has shown you.
Step 16. (See FIGURE N.)
Hold the pen so you can see the dose display window during the injection.
Insert the pen needle straight into your skin.
Figure N
Step 17. (See FIGURE O.)
Press the green injection button until it cannot go any further and “•0” is in the dose display window. Do not move the TYMLOS pen after inserting the needle.
Continue to press the green injection button while counting to 10. Counting to 10 will allow the full dose of TYMLOS to be given.
Figure O
Step 18. After counting to 10, release your finger from the green injection button and slowly remove the TYMLOS pen from the injection site by pulling the pen needle straight out.
Remove the pen needle
Step 19. Carefully place the outer needle cap back on the pen needle. Press on the outer needle cap until it snaps into place and is secure. (See FIGURE P.)
Figure P
Caution: To prevent needle stick injury, carefully follow Step 20.
Step 20. Unscrew the capped needle (like unscrewing a cap from a bottle). To unscrew the capped needle you may need to turn it 8 or more turns and then gently pull until the capped needle comes off. (See FIGURE Q.)
Figure Q
Note: Do not push on the outer needle cap while unscrewing the needle. You should see a gap widening between the outer needle cap and the pen as you unscrew the needle. (See FIGURE R.)
Figure R
Replace pen cap
Step 21. Firmly replace the pen cap onto the TYMLOS pen. (See FIGURE S.)
Keep the pen cap on your TYMLOS pen between injections.
Figure S
After your injection
Step 22. Press a cotton ball or gauze pad over the injection site and hold for 10 seconds. Do not rub the injection site. You may have slight bleeding. This is normal.
You may cover the injection site with a small adhesive bandage, if needed.
Dispose of the pen needle. See “HOW SHOULD I THROW AWAY (DISPOSE) OF THE PEN NEEDLES AND TYMLOS PENS?”.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Issued: 04/2017
PRINCIPAL DISPLAY PANEL - NDC: 70539-001-01 - 80 MCG PREFILLED PEN LABEL
80 mcg Prefilled Pen Label
PRINCIPAL DISPLAY PANEL - NDC: 70539-001-02 - 80 MCG CARTON LABEL
80 mcg Carton Label
PRINCIPAL DISPLAY PANEL - NDC: 70539-001-99 - SAMPLE 80 MCG PREFILLED PEN LABEL
Sample 80 mcg Prefilled Pen Label
PRINCIPAL DISPLAY PANEL - NDC: 70539-001-98 - SAMPLE 80 MCG CARTON LABEL
Sample 80 mcg Carton Label
INGREDIENTS AND APPEARANCE
TYMLOS
abaloparatide injection, solution
PRODUCT INFORMATION
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70539-001
Route of Administration SUBCUTANEOUS
ACTIVE INGREDIENT/ACTIVE MOIETY
Ingredient Name Basis of Strength Strength
ABALOPARATIDE (UNII: AVK0I6HY2U) (ABALOPARATIDE - UNII:AVK0I6HY2U) ABALOPARATIDE 2000 ug in 1 mL
INACTIVE INGREDIENTS
Ingredient |
