How to Use the TYMLOS Pen
TYMLOS® (abaloparatide) Injection, for Subcutaneous Use
After your healthcare provider has shown you how to prepare and inject your TYMLOS pen, you can watch this video to review the steps for injection. This video will help you understand how to inject TYMLOS.
Read and follow the Instructions for Use so that you inject the TYMLOS pen the right way. Call your healthcare provider if you have any questions about the right way to inject the TYMLOS pen.
Click the Instructions for Use link on this page.
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 we get started with the injection steps, let’s review the following important safety information.
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. See the end of the Medication Guide for a complete list of ingredients in TYMLOS.
- 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 micrograms 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 1-855-672-34871-855-672-3487.
- 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 person trained in the right way to use the pen.
We will now review some considerations about storing your TYMLOS pen. Before using, your TYMLOS pen should be stored in the refrigerator between 36°F to 46°F.
Do not store pens with the needle attached.
Do not freeze or expose your TYMLOS pen to heat.
Good news, after you first open a new pen and use it, you do not need to refrigerate TYMLOS. You should store the pen between 68°F to 77°F for up to 30 days.
Do not freeze it or expose it to heat.
Do not use the TYMLOS pen 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.
Keep the TYMLOS pen, pen needles and all medicines out of reach of children.
When you are ready to give your injection, gather the following supplies:
- 1 TYMLOS pen,
- 1 pen needle,
- 1 alcohol swab,
- 1 cotton ball or gauze pad,
- and 1 sharps disposal container.
The correct needles to use with your TYMLOS pen are 5 to 8 mm, 31 gauge needles.
Compatible needles include:
- BD Ultra-Fine™,
- Easy Comfort,
- Clever Choice™ Comfort EZ™,
- and SureComfort™.
If you are not sure what type of needle to use, ask your healthcare provider or pharmacist.
Here are the parts of your TYMLOS pen you should know:
- Pen cap,
- Cartridge holder,
- Dose display window,
- Dose knob,
- and the Green injection button.
On the back of the device, you can check the lot number and expiration date.
Here are the parts of the pen needle:
- Outer pen needle cap,
- Inner pen needle cap,
- Pen needle,
- and the Protective paper.
Please note that the pen needle is not included with the TYMLOS pen.
Before you begin, wash and dry your hands. Then, check the expiration date on the TYMLOS pen. Do not use the pen if the expiration date has passed. Be sure to call your healthcare provider or pharmacist if the expiration date has passed.
Before using the pen always check the label to be sure it is your TYMLOS pen. Do not use the TYMLOS pen if it looks damaged. If you drop your TYMLOS pen or it becomes damaged, call your healthcare provider or pharmacist or call 1-855-672-34871-855-672-3487.
Pull off the pen cap from your TYMLOS pen.
Check the TYMLOS cartridge. The liquid should be clear, colorless, and free of particles. If not, do not use.
Use a new pen needle for each injection. Pull off the protective paper from the outer needle cap of your pen needle.
Then, keep the needle straight and screw it onto the pen until fixed. A secure fit is ensured even if there is no noticeable stop. Do not over-tighten.
Pull off the outer pen needle cap from the pen needle and keep it to use after your injection.
Carefully pull off the inner pen needle cap and then dispose of it. Once the needle cap is removed, the needle will be exposed, so be careful handling the pen.
If you are using this pen for the first time, go to “Setup of a New TYMLOS Pen.” If you have already used this pen, go to “Set the Dose on your TYMLOS Pen.”
If you are using a new TYMLOS pen, you need to set it up before you use it to remove any air bubbles. This primes your TYMLOS pen. You only need to do this ONCE on Day 1 for each new pen. Otherwise you’ll waste medicine. If you’re not using a new TYMLOS pen, you can skip ahead to the next chapter, “Set the Dose on your TYMLOS Pen.”
To set it up, turn the dose knob on your TYMLOS pen away from you (clockwise), until it stops. You will see “dot 80” line up in the dose display window.
Then, hold the TYMLOS pen with the pen needle pointing up. Lightly tap with your finger on the cartridge holder to move any air bubbles to the top of the cartridge. You should do this even if you do not see any air bubbles.
Press the green injection button until it will not go any further. You should see liquid come out of the needle tip. You will also now see “dot 0” lined up in the dose display window.
If you do not see a drop of TYMLOS come out of the needle tip, you will need to repeat the steps in this chapter, “Setup of a New TYMLOS Pen.” A drop of liquid should come out of the needle tip. If you repeat these steps and liquid still does not come out of the needle tip, call your healthcare provider or pharmacist and use a new TYMLOS pen.
Once you’ve primed your monthly pen, you will need to set your dose each day. While setting your dose, do not push the green injection button. Turn the dose knob on your pen away from you (clockwise) until the dose knob stops and the “dot 80” is lined up in the dose display window.
If you set the dose before you are ready to give your injection, turn the dose knob towards you (counter-clockwise) until the “dot 0” is in the dose display window.
If the pen cannot be set to “dot 80”, there is not enough medicine in the TYMLOS pen for your full dose. Dispose of the pen following the steps in the Disposal chapter of this video and use a new TYMLOS pen for your injection, repeating all the steps needed to set up a new TYMLOS pen.
Injections should be given in the lower stomach area or abdomen. Avoid the 2-inch area around your belly button, or navel.
For each injection, change or rotate, your injection site around your abdomen. Talk to your healthcare provider about how to change, or 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, and avoid areas with scars or stretch marks.
Once you have chosen a site, 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.
When you are ready to inject with your TYMLOS pen, review all the steps in this chapter first. Inject your TYMLOS pen the way your healthcare provider has shown you. Hold the pen so you can see the dose display window during the injection.
Insert the pen needle straight into your skin.
Press the green injection button until it cannot go any further and “dot 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.
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.
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.
To prevent needle stick, carefully follow the next steps. 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 then gently pull until the capped needle comes off. 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.
Firmly replace the pen cap onto the TYMLOS pen. Keep the pen cap on your TYMLOS pen between injections.
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 the next chapter, Disposal, for how to throw away the pen needles and TYMLOS pens.
Throw away (dispose of) your TYMLOS pen, in a FDA-cleared disposal container or puncture resistant container, 30 days after first opening it even if it still contains unused medicine. Put your used pen needles in a FDA-cleared sharps disposal container right away after each use. Do not throw away your used sharps disposal container in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use, leak-resistant, and
- properly labeled to warn of hazardous waste inside the container
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles, syringes, and prefilled syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal. Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
Important Safety Information
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.
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:
- fast heartbeat
- feeling tired (fatigue)
- upper stomach pain
- spinning feeling (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-10881-800-FDA-1088.
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.
Congrats! You’ve now reviewed the steps to use the TYMLOS pen. For more information, see the TYMLOS Instructions for Use, go to www.TYMLOS.com or call 1-855-6-RADIUS1-855-6-RADIUS.
Thank you for watching this video.