APOKYN ® Pen Instructions for Use

Designed to be used only with
3 mL APOKYN ® (apomorphine hydrochloride injection) Cartridges

For more information, call your specialty pharmacy provider or 1-877-7APOKYN (727-6596).

APOKYN ®
(apomorphine hydrochloride injection)

APOKYN Pen

APOKYN ® (apomorphine hydrochloride injection) is for under the skin (subcutaneous) injection only.
Do not inject APOKYN into a vein.
Do not use the APOKYN ® Pen unless you and your care partner have been taught the right way to use it and both of you understand all of the instructions.
The APOKYN Pen is for use only with 3 mL APOKYN ® (apomorphine hydrochloride injection) Cartridges.
The APOKYN Pen is only for use by 1 patient and should not be shared.

Gray Pen Cap	Gray Pen Body	Pen Needle Unit	Cartridge

a. Clip Teal Cartridge Holder	b. Black Rod c. White Dose Window d. White Dose Knob e. Teal Injection Button	f. Outer Needle Shield g. Pink Inner Needle Shield h. Pen Needle i. Pink Paper Tab	j. Rubber Septum k. Metal Cap l. Cartridge Plunger

Read First: Important Safety Information

The APOKYN Pen is a medicine delivery device. It is very important that you or your care partner read this Instructions for Use and follow the instructions for using the APOKYN Pen correctly to receive the correct APOKYN dose.
Always perform a flow check (prime) before every injection and after loading a new cartridge.
The liquid in the APOKYN Cartridge can cause irritation if it gets on your skin or in your eyes. Flush your eyes with cold water and wash the liquid off your skin right away if this happens.
The BD pen needle unit is sterile. Avoid contaminating the needle after opening. Do not place it on a surface or touch other items with the needle.
Do not dial the dose or try to correct a dialing error with the pen needle in the skin. You could receive the wrong dose.
Be careful when removing the needle. Accidental needle sticks can transmit serious infections.

Never store or carry the APOKYN Pen with a pen needle attached.

Never recap pen with needle attached.

Storing or carrying the APOKYN Pen with a pen needle attached may let:

Air enter the cartridge
Medicine leak out

This can affect your APOKYN dose.

The APOKYN Pen should only be used with pen needles (29G × 1/2"). These needles are available through your specialty pharmacy provider or your local pharmacy.

		You must use a new, sterile BD pen needle with each injection.
	Magnification: 50×

How to Use the APOKYN Pen

Step 1

Step 2

Preparing the APOKYN Pen for Cartridge Loading

Step 1. Remove the gray pen cap by pulling it straight off.

Step 2. Unscrew the teal cartridge holder from the gray pen body by turning it clockwise.

	Loading a Cartridge Step 3. Only use APOKYN that is clear and colorless. Do not use an APOKYN Cartridge that contains medicine that is cloudy, green, or contains particles. Call your specialty pharmacy provider for replacement cartridges. Insert the APOKYN Cartridge, metal cap first, into the teal cartridge holder.
	Step 4. Lower the gray pen body onto the teal cartridge holder so that the black rod presses against the cartridge plunger. Screw the teal cartridge holder onto the gray pen body. Tighten the pieces by turning the teal cartridge holder clockwise until no gap remains and 1 of the white arrows line up with the white marker on the gray pen body.
	Step 5. If you already have a cartridge in the pen and have used the pen, you should check the cartridge through the window in the teal cartridge holder to make sure there is enough APOKYN solution in the cartridge to provide your next dose. If the gray cartridge plunger has reached the red line on the cartridge, remove the cartridge and insert a new cartridge into the pen before attaching the pen needle and preparing the dose.
	Attaching the Pen Needle Step 6. Remove the pink paper tab from the back of a new pen needle. Use a new needle for each injection. Never reuse needles.
	Step 7. Holding the APOKYN Pen by the teal cartridge holder, push the pen needle unit onto the pen. Screw the threaded hub of the pen needle onto the teal cartridge holder counter-clockwise. When the needle unit is attached, remove the outer shield that protects the needle with a gentle pull. Save the outer shield. You will use it to remove the needle from the pen after the injection is finished. Do not remove the inner needle shield at this time. The needle is sterile and must stay clean. After opening, do not place the needle on a surface or let it touch anything.

Preparing (Priming) the APOKYN Pen for Use

IMPORTANT – Prior to each injection, it is important that the APOKYN Pen be properly primed.

For a new APOKYN Cartridge (1 that has not been used before), repeat the priming procedure described on the next page (Steps 8-9) 3 or 4 times to make sure all the air has been removed from the needle and cartridge.

For an APOKYN Cartridge you have used before (1 that has been previously primed), repeat the priming procedure described on the next page (Steps 8-9) 1 time to make sure all the air has been removed from the needle and cartridge.

	Step 8. You must prepare (prime) the APOKYN Pen for use before injecting the medicine. To prime the APOKYN Pen, set the dose by turning the dose knob to 0.1 mL. This is important so you can get rid of any air bubbles in the cartridge.
	Step 9. Remove the inner needle shield. Remember, do not let the needle touch anything. With the needle pointing up, firmly push the injection button in as far as it will go and hold for at least 5 seconds. A small stream of medicine must come out of the end of the needle. If it does not, reset the dose by repeating Step 8. Repeat these steps (Steps 8-9) until a small stream of medicine comes out the end of the needle. When medicine comes out of the end of the needle, the APOKYN Pen is primed for injection and ready to use. APOKYN medicine can cause staining to fabric and other surfaces it touches. Be careful where you prime the APOKYN Pen.
	Setting the Dose Step 10. To set the dose, turn the white dose knob until the correct dose (number of mLs) is shown in the window. The dose will appear as a red number between two black lines that will line up next to the letters "mL" on the pen body. Make sure the correct number (dose) appears in the window.
	Step 11. Dose Correction. If you turn the dose knob past your dose, do not dial backwards. If you dial backwards, APOKYN will be pushed through the needle and you will lose medicine. Continue to turn the dial until it is fully turned. Press the injection button fully. This will reset the dial to zero without pushing medicine out of the needle. Repeat Step 10 to redial your dose.
	Giving the Injection Step 12. APOKYN is only for injection under the skin (subcutaneous injection). Choose an injection site on your stomach area, upper arm or upper leg. Change the site with each injection. Do not inject APOKYN into skin that is red or sore. Clean the site with an alcohol swab and allow to air dry. Pinch about an inch of skin and fat tissue of your injection site between your thumb and forefinger. With the other hand, insert the needle all the way into the pinched skin. Step 13. Fully push the teal injection button on the APOKYN Pen. A clicking sound will be heard while the dose is injected. Push the injection button firmly for 5 seconds. Remove the needle from your skin. If medicine keeps dripping from the needle, keep the needle in the skin longer the next time you inject APOKYN.

IMPORTANT – If you set your dose and cannot depress the teal injection button, the cartridge is empty. Remove the pen needle and cartridge and prepare the pen as described in Steps 2-9 with a new cartridge. Set the dose and give the injection.

If you set your dose and the injection button stops before you receive a complete dose, note the number in the window, remove the pen needle and cartridge, and prepare the pen as described in Steps 2-9 with a new cartridge. Set the dose to the number that last appeared in the window and administer the injection. This completes the dose.

Before attempting to replace a cartridge, be sure that a needle unit is not attached to the APOKYN Pen.

	Removing the Pen Needle Step 14. Carefully replace the outer needle shield. Be careful to avoid a needle-stick. Place the outer needle shield in the notch located on the far left side of your carrying case. The opening of the needle shield should be pointing up. Carefully insert the needle (attached to the pen) into the opening of the shield. Without holding onto the shield, push down firmly.
	Step 15. Hold the pen by the teal cartridge holder and unscrew the pen needle from the cartridge holder. Recap the pen. Never recap the pen with a needle attached. Safely dispose of used pen needles in a "sharps" container. Your specialty pharmacy provider will provide you with a "sharps" container. Do not throw used needles in a trash can.

Storage Information

–Store APOKYN cartridges at room temperature, 68°F to 77°F (20°C to 25°C)

Excursions permitted between 59 to 86°F (15 to 30°C) [See USP Controlled Room Temperature]

Proper Disposal

Put your used needles and syringes in an FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) loose needles and syringes in your household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic
- able to be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- upright and stable during use
- leak-resistant
- 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 and 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: http://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.

Care and Storage

The APOKYN Pen can now be stored in its carrying case. Never store or carry the APOKYN Pen with a pen needle attached.

You must store and care for your pen the right way:

Avoid exposure to dust, moisture, and cold or hot temperatures.
Never wash the pen in water or use strong disinfectants. Only a clean, damp cloth should be used for cleaning.
Do not try to repair the pen if it is damaged or if you cannot solve a problem shown in the following "Troubleshooting" section.
Do not use pen for more than 1 year after the first use or after the expiration date on the carton.

For more information, call your specialty pharmacy provider or 1-877-7APOKYN (727-6596).

Troubleshooting

PROBLEM	POSSIBLE CAUSE	HOW TO FIX THE PROBLEM
For more information, call your specialty pharmacy provider or 1-877-7APOKYN (727-6596).
No medicine comes out of the pen (the dosage dial moves freely, but no click is heard).	The pen is in dose correction mode.	Push the injection button all the way in so the dial returns to zero.
The dosage dial does not return to zero during an injection.	The cartridge is empty.	Replace the cartridge as described in Steps 3-5.
	The pen needle is clogged.	Replace the pen needle as described in Steps 14 & 6-7.
The dosage dial does not turn easily.	Dust or dirt is on the pen.	Turn the dial past the highest setting on the pen. Wipe all exposed pen surfaces with a clean, damp cloth.
Pen does not close.	Cartridge is inserted incorrectly.	Remove cartridge and reload it. See Steps 3-4.
Injection button will not depress.	Cartridge is empty.	Replace cartridge. See Steps 3-5.
Injection button stops before a complete dose is delivered.	Not enough medication in cartridge to complete the dose.	Replace cartridge. See Steps 3-5.
Pen does not work.	Mechanical failure.	Replace pen. Call your specialty pharmacy provider or 1-877-7APOKYN (727-6596).
Dose numbers and/or white markers wear off.	Repeated use over extended period of time.	Replace pen. Call your specialty pharmacy provider or 1-877-7APOKYN (727-6596).
Too much force needed to depress injection button.	Defective cartridge.	Replace cartridge. See Steps 3-5.
Unable to read the dose numbers through the dose window.	Incorrect cleaning or improper handling.	Replace pen. Call your specialty pharmacy provider or 1-877-7APOKYN (727-6596).