GENOTROPIN® Instructions for Use GENOTROPIN MINIQUICK

Instructions for Use GENOTROPIN MINIQUICK

Instructions for Use GENOTROPIN MINIQUICK

INSTRUCTIONS FOR USE
GENOTROPIN MINIQUICK (JEEN-o-tro-pin MIN-ee-kwik)
Growth Hormone Delivery Device containing GENOTROPIN (somatropin) for injection

GENOTROPIN MINIQUICK is a device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject a single dose of GENOTROPIN.

For each injection you will need:

• 2 alcohol pads (not included)
• 1 GENOTROPIN MINIQUICK device with the 2-chamber cartridge of GENOTROPIN inside. The 2-chamber cartridge of GENOTROPIN contains the growth hormone powder in one chamber and the liquid in the other.
• 1 injection needle. A needle for injection is provided with each device. If you need additional needles, ask your healthcare provider for a 29 gauge (29 G), 30 gauge (30 G), or 31 gauge (31 G) Becton Dickinson pen needle.
• 1 sharps disposal container (not included). See "Throwing away (disposing of) your GENOTROPIN MINIQUICK and needles" in Step 12.

Parts of the GENOTROPIN MINIQUICK (See Figure A)

Storage instructions for your GENOTROPIN MINIQUICK

• Keep your GENOTROPIN MINIQUICK in the original carton to protect it from light.
• Before you mix the growth hormone powder with the liquid in the syringe, you can store the GENOTROPIN MINIQUICK in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC). You can also store the GENOTROPIN MINIQUICK at room temperature between 68ºF to 77ºF (20ºC to 25ºC) for up to 3 months. Do not freeze.
• Inject the GENOTROPIN right after you mix it. If that is not possible, you can keep the GENOTROPIN MINIQUICK in the refrigerator between 36ºF to 46ºF (2ºC to 8ºC) for up to 24 hours after mixing it. Do not freeze.

Using your GENOTROPIN MINIQUICK

Step 1.
Wash your hands well with soap and water before using the GENOTROPIN MINIQUICK.

Step 2.
Open the plastic bag that contains your GENOTROPIN MINIQUICK by tearing the bag along the dotted lines on the plastic.

Step 3. Wipe the rubber stopper on the GENOTROPIN MINIQUICK with an alcohol pad. (See Figure B)	Figure B
Step 4. Peel the seal from the back of the injection needle. Leave both the inner needle cover and the outer needle cover on the needle. (See Figure C)	Figure C
Step 5. Attach the needle onto the GENOTROPIN MINIQUICK by pushing it down and turning it clockwise (to the right) until it will no longer turn. Make sure the needle is placed directly over the rubber stopper (not at an angle), before screwing the needle onto the rubber stopper of the GENOTROPIN MINIQUICK. (See Figure D)	Figure D
Step 6. Hold the GENOTROPIN MINIQUICK with the needle pointing up. Turn the plunger rod clockwise (to the right) until it will not go any further. (See Figure E) This will automatically mix the growth hormone powder and the liquid. Do not shake the GENOTROPIN MINIQUICK. Shaking may cause the growth hormone to not work as well. Make sure the solution (combined growth hormone powder and liquid) is clear, and that the growth hormone powder is completely dissolved. If you see particles in the solution, or if the solution is discolored, do not inject it. Call the Pfizer Bridge Program at 1-800-645-1280.	Figure E
Step 7. Choose an injection site (thigh, buttocks, or abdomen) as recommended by your healthcare provider. Choose a different site each time you give yourself an injection. Each new injection should be at least 1 inch from the site you used before (See Figure F). Avoid areas that are bony, bruised, red, sore or hard. You should also avoid areas that have scars or skin problems. Clean the injection site with the alcohol swab. Allow the injection site to dry.	Figure F
Step 8. Remove the outer needle cover and the inner needle cover from the needle. Save the outer needle cover. (See Figure G)	Figure G
Step 9. Pinch a fold of skin at the injection site firmly, and push the needle straight into the skin at a 90°angle. (See Figure H)	Figure H
Step 10. Push the plunger rod in as far as it will go, to inject all of the medicine in the GENOTROPIN MINIQUICK into the fold of skin. (See Figure I) Wait a few seconds to be sure that all of the growth hormone solution has been injected. Pull out the needle.	Figure I
Step 11 Replace the outer needle cover on the needle. (See Figure J)	Figure J

Step 12. Throwing away (disposing of) your GENOTROPIN MINIQUICK and needles

Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and syringes in the 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 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 reuse the GENOTROPIN MINIQUICK or needles.
• Do not throw away (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: Always keep the sharps disposal container out of the reach of children.

If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.

Use this device only for the person for whom it was prescribed.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

LAB-0227-8.0
Revised: January 2020