Lilly HumatroPen 24 mg User Manual

PV6520AMP_7P1V1.qxp:Layout 1 1/19/09
HumatroPen ® 24 mg
Growth Hormone Delivery System
Injection Device for Use with Humatrope ® [somatropin (rDNA origin) for injection] Cartridges
1
Read this section completely before you begin. Then,
SECTION
move on to Section 2.
WHAT YOU NEED TO KNOW ABOUT THE HUMATROPEN
Read these instructions carefully BEFORE using the HumatroPen
in order to get the most benefit from the Humatrope
completely may result in too much or too little Humatrope being injected.

INTRODUCTION

The HumatroPen 24 mg is an injection device intended for use with Humatrope 24 mg Cartridges. Your
healthcare professional has prescribed the Humatrope dose and Pen that you or your child should receive.
DO NOT CHANGE the dose or Pen unless directed by your healthcare professional.
If your healthcare professional changes the prescribed cartridge size from the 24 mg Humatrope Cartridge to
the 6 mg or 12 mg Humatrope Cartridge, you must get a new HumatroPen to match the new cartridge size.
Before using the HumatroPen 24 mg, make sure that you thoroughly read this user manual. It explains the Pen
operations and has a troubleshooting guide, should questions arise.
These instructions do not take the place of talking with your healthcare
professional about your or your child's medical condition, or its treatment. If you
are having problems using the HumatroPen 24 mg, call 1-800-545-5979.

IMPORTANT INFORMATION ABOUT THE HUMATROPEN 24 MG

• Where you see in this manual, please pay special attention.
• DO NOT USE the Pen if any part of the Pen or Cartridge appears broken or damaged. Contact your
healthcare professional.
• Confirm that you have a 24 mg Humatrope Cartridge to match the HumatroPen 24 mg. If it does not
match DO NOT USE and contact your healthcare professional. This is important to ensure the correct
dose of Humatrope is given.
• DO NOT use the Humatrope Cartridge past the expiration date.
• Follow Section 2 ONLY to set up a new Cartridge before first use.
• Section 3 of this manual should be used for every injection.
• DO NOT transfer the contents of the Humatrope Cartridge to a syringe.
• DO NOT SHARE the HumatroPen 24 mg or Pen Needles.
• The HumatroPen 24 mg is not recommended for use by blind or visually impaired individuals without
the assistance of a sighted individual trained in its use.

ABOUT PEN NEEDLES

What kinds of Needles can be used with the HumatroPen 24 mg?
• Pen Needles are not included. You may need a prescription to get the Needles from your pharmacist.
• Becton, Dickinson and Company Pen Needles are suitable for use with your HumatroPen 24 mg.
• Ask your healthcare professional what Needle gauge and length is best to use.
• Follow your healthcare professional's instructions on safe handling of needles.
Must a new Needle be used for each injection?
• Yes, a new Needle must be used for each injection.
• Remove the Needle immediately after each injection. Use a new Needle for each injection. This will help
minimize the risk of infection, prevent leakage of Humatrope, keep out air bubbles, and reduce Needle
clogs.
How do I throw away used Needles?
• Throw away used Needles in a puncture-proof container. Follow your healthcare professional's
instructions on how to do this safely.

CARE AND STORAGE FOR THE HUMATROPEN 24 MG

Care
• Soiled parts can be cleaned with a damp cloth. DO NOT USE alcohol or other cleaning agents.
• DO NOT SOAK or immerse the Pen in liquid.
• DO NOT APPLY oil or any other lubricant.
Storage
• Store the HumatroPen 24 mg with attached Humatrope Cartridge in the storage case in the refrigerator
until the time of the next injection. DO NOT FREEZE.
• All Humatrope Cartridges and diluent must be refrigerated at temperatures between 36°F to 46°F (+2°C
and +8°C ). DO NOT FREEZE. A prepared Cartridge can be left on a Pen for 28 days in the refrigerator.
DO NOT USE any prepared Cartridge after 28 days.
• Let the HumatroPen 24 mg with attached Humatrope Cartridge stand at room temperature for 10 minutes
before injecting. Discomfort may be noticed at the injection site if Humatrope is injected cold.
• Daily room temperature exposure should not exceed 30 minutes.
• DO NOT STORE the Pen with the Needle attached.

REPLACEMENT

The HumatroPen 24 mg has been designed to be used for up to 3 years after first use. Record the date the Pen
was first used here: __ / __ / __. Contact your healthcare professional if a new HumatroPen 24 mg is needed,
or when the Pen has been used for 3 years.
Please see the accompanying complete Humatrope Patient Information Sheet . For additional
information, call 1-800-545-5979 or visit www.humatrope.com
1:13 PM Page 1
24
mg
PEN USER MANUAL
® 24 mg. You need to use the Pen correctly
® treatment. Failure to follow these instructions
PV 6520 AMP HUMATROPEN 24 MG PARTS
Humatrope
24 mg Cartridge
(sold separately)
Pen Rubber
Cap Seal
SECTION
® 24 MG
Be sure to follow the reconstitution (mixing) directions as described in the Humatrope Cartridge Kit.
Perform the New Cartridge Setup only once at the beginning of each new Cartridge. For daily use, DO NOT
REPEAT this one-time-only New Cartridge Setup. If you do, you may run out of Humatrope early.

STEP A - CHECK THE PEN AND CARTRIDGE

Be sure to check the Cartridge:
• For 24 mg Cartridge label
• For expiration date
• Contents should be clear and free
of particles
NOTE
DO NOT USE the Cartridge past the
expiration date.
DO NOT USE the Pen if any part of the Pen
or Cartridge appears broken or damaged.
Contact your healthcare professional.

STEP B - ATTACH THE CARTRIDGE

Use the White Tip of the Cartridge to
push the Screw back.
NOTE
The Screw may not be out when you
get the Pen.

STEP C - ATTACH THE NEEDLE

Remove the Paper Tab from the end
of the Outer Cap.

STEP D - REMOVE AIR FROM NEW CARTRIDGE

Dial 5.00 mg.
NOTE
• The Pen must be set up before injecting the first dose from each new 24 mg Cartridge.
• Setting up the new Cartridge is important to remove large air bubbles that may be present after reconstitution (mixing).
• If a stream is not seen after several attempts, contact your healthcare professional or Lilly.

STEP E - CONTINUE ON TO DAILY USE

• DO NOT REPEAT Cartridge Setup before each dose.
• Leave the Cartridge attached and DO NOT REMOVE until the Cartridge is empty.
• Go to Section 3, Step 3, for instructions on how to inject the first dose.
PEN NEEDLE PARTS (PEN NEEDLES NOT INCLUDED)
Injection
Button
24 mg
Screw Pen Body
Outer Cap
Dose
Front
Window
Housing
Dose
White
Knob
Tip
2
Read and follow the directions in this section only after
you have read Section 1.
GETTING STARTED

NEW CARTRIDGE SETUP

Pull off the Pen Cap.
Push the White Tip of a reconstituted
Cartridge into the Pen Body. Screw
the 24 mg Pen Body onto the
Cartridge until it is secure.
NOTE
If the Cartridge is not completely
attached, the Screw may not move
and an incorrect dose may be given.
Push the Needle straight onto the
24 mg Cartridge and screw on
clockwise until secure.
• Point the Needle straight up.
• Push the Injection Button and hold for five seconds.
• Dial 0.20 mg and repeat these steps until you see a stream of liquid.
Inner Cap Paper Tab
Needle
Look at the Injection Button and
the Front Housing to confirm it is
a 24 mg Pen.
CHECK
Check that the number on the Front
Housing matches the Cartridge
strength on the Cartridge label.
If the Pen and Cartridge do not
match, contact your healthcare
professional.
CHECK
Look at the Injection Button and
the Front Housing to confirm it is
a 24 mg Pen.
• Pull off the Outer Cap and the
Inner Cap.
• Keep the Outer Cap to remove the
Needle after the injection.