Mega PTH Patient Counseling Information

Instruction for Use Pen Injector: Preparing the Pen: 1. Wash hands before preparing the pen for use.
2. Remove the pen injector from the refrigerator.
3. Remove the pen cap by pulling it off.
4. A number of medicines come in pen delivery devices. Check the label on the pen before each use to make sure the patient is using pen injector.
5. Look at the Teriparatide medicine in the cartridge. It should be clear and colorless, and it should not have particles in it. If it is not clear and colorless, or if it has particles, do not use it.
6. Use an alcohol swab to wipe the rubber seal on the end of the pen.
Attaching the Needle: 1. Always use a new needle for each injection. Do not store the pen with the needle attached. Storing the pen with the needle attached may let Teriparatide leak from the pen, and air bubbles can form in the cartridge.
2. Pull off the paper tab from the outer needle shield and throw the paper tab away.
3. Attach the capped needle to the end of the pen by pushing it on and turning it clockwise (to the right). Do not over-tighten the needle since it must be removed after the injection.
4. Hold the pen with the needle pointing up and remove the outer needle shield. Keep the outer needle shield because it will be needed to remove the needle after the injection is finished.
5. Pull off the inner needle shield and throw it away.
Priming the Pen: Always use a new needle for every injection.
The pen must be primed before every injection.
The patient must prime the pen to make sure the medicine is flowing and that the patient is receiving the correct dose. Priming removes air bubbles that might affect the dose. Small air bubbles may collect in the Teriparatide cartridge during normal use.
Note: A small air bubble may stay in the cartridge when the patient has finished the priming step. If patient has properly primed the pen, this small air bubble will not harm the patient or affect Teriparatide dose.
The very small amount of the prime dose does not affect the total supply of 28 days of therapy that the pen will deliver.
1. Turn the dose knob anti-clockwise (to the left) until the number "2" in the dose window.
2. With the arrow and number "2" in the dose window in line, hold the pen with the needle pointing up. Tap the clear cartridge holder gently with the finger so any air bubbles collect near the top.
3. Using the thumb, if possible, push in the blue injection button all the way and keep pressing. Continue to hold the blue injection button firmly and count s-1-o-w-1-y to 5. The patient should see either a few drops or a tiny stream of Teriparatide come out of the tip of the needle. If nothing comes out of the tip of the needle, repeat the "Priming the Pen" instructions.
4. Number "0" and arrow notch are in line in the dose window. This means that the priming is complete.
Setting the Dose: The numbers in the dose window do indicate the size of the dose. Number "2" means 20 μL, number "4" means 40 μL etc.
1. Turn the dose knob anti-clock clockwise (to the left) until the patient sees the arrow notch and number "8" are in line in the dose window.
2. When the number "8" and arrow notch are in line, set the 20-mcg dose and the pen is "ready to inject."
Injecting the Dose: Make injections just below the surface of the skin (the subcutaneous tissue).
1. Prepare the skin for the injection as instructed by the health care professional.
2. Lightly hold a fold of skin as shown below, and push the needle straight into the skin. The skin may need to be pinched up to avoid a deep injection into a muscle (intramuscular), especially in the thigh area. Ask the health care professional for more instructions about injection technique and changing sites (rotation).
3. Still see the number "8" and arrow notch are in line in the dose window. Inject the Teriparatide by using the thumb, if possible, to push in the blue injection button all the way.
4. Continue to hold down the blue injection button firmly and count s-l-o-w-l-y to 5 to ensure that the Teriparatide has been completely injected into the skin. Remove the needle from the skin when finished counting.
5. When the injection is complete, the patient must see number "0" and arrow notch are in line in the dose window. This tells that the injection button has been pushed in all the way and that the full dose has been injected.
After an Injection: 1. Carefully replace the outer needle shield as instructed by the health care professional.
2. Remove the capped needle by turning it counterclockwise (to the left). Place the used needle in a puncture-resistant disposable container and properly throw it away as directed by the health care professional.
3. Replace the cap on the pen.
4. Store the pen injector in the refrigerator at 36°F to 46°F (2°C to 8°C) at all times. The patient should inject Teriparatide right after the patient takes the pen out of the refrigerator. Put the pen back into the refrigerator right after use.
5. The patient can use the pen injector for up to 28 days including the first injection from the pen. After 28 days, throw away the pen injector, even if it is not completely empty. Throw away the pen as directed by the health care professional.
6. Never share a pen injector.
7. Do not freeze the pen injector. Do not use Teriparatide if it has been frozen.
8. Do not use the pen injector after the expiration date printed on the carton and pen label.
9. Do not store or throw away the pen with a needle attached.