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Nutropin AQ Pen^® delivers liquid GH from a prefilled cartridge (available in both 10 mg and 20 mg)

Learn about Nutropin AQ Pen 20 or Nutropin AQ Pen 10 below, including:

• Features
• Using it
• How to select the injection site
• Storing and maintaining it

Features

The Nutropin AQ Pen delivers Nutropin AQ^® [somatropin (rDNA origin) injection] in a prefilled cartridge that keeps for 28 days after your first use if properly stored.

Because Nutropin AQ does not need to be mixed, you may spend less time preparing, and reduce your chances of making a mixing mistake.

The Nutropin AQ NuSpin features a pioneering design that helps you make sure you give the full dose of Nutropin AQ.

Nutropin AQ Pen:

• Easy to use
• Brief routine
• One-step, dial-back dose knob
• Convenient
• Small, light, and easy to carry
• Few additional supplies
• Remembers the last dose
• Safety features
• Prefilled cartridges
• Needle shield-lock
• Digital dose display
• Clicks that can be heard and felt

Your Nutropin AQ Pen comes with:

1. Instructions for use
2. Pen needles
3. Active shield
4. Passive shield

Cartridges

Nutropin AQ Pen 20 mg or 10 mg cartridges are supplied separately.

• Nutropin AQ Pen 20 uses only a 20 mg/2 mL (10 mg/mL) cartridge.
• Nutropin AQ Pen 10 uses only a 10 mg/2 mL (5 mg/mL) cartridge.

Needles

Your healthcare professional will recommend a needle that is appropriate for you. Needles from other regions or countries may not fit on your Nutropin AQ Pen. If you travel outside the United States, make sure you take enough needles for the duration of your stay.

The Nutropin AQ Pen 20 and the Nutropin AQ Pen 10 are available in the US by prescription only. Your healthcare professional should provide training before you use it.

Please click here for full prescribing information for Nutropin AQ and Nutropin.

Using your Nutropin AQ Pen

Before using your Nutropin AQ Pen, please read the following instructions carefully. We also suggest you consult your healthcare professional for a demonstration.

• The Nutropin AQ Pen 20 is designed for use only with Genentech’s Nutropin AQ Pen 20 mg Cartridge (for injection only).
• The Nutropin AQ Pen 10 is designed for use only with Genentech’s Nutropin AQ Pen 10 mg Cartridge (for injection only).

Only use the pen needles recommended by your healthcare professional. The dosage scale located beside the window of the cartridge holder should not be used as a dose measurement. It should only be used to estimate the dosage remaining in the cartridge. Always refer to the LCD, not audible clicks, for setting an injection of Nutropin AQ. The clicks are audible confirmation that the black dose knob has been moved.

To guard against the spread of infection, follow these safety measures:

• Wash your hands with soap and water before using your pen.
• Clean the cartridge rubber seal with an alcohol swab.
• Avoid touching the cartridge rubber seal at all times.
• If you unintentionally touch the rubber seal, clean it with an alcohol swab.
• Use needles only once.
• Do not use the same needle for more than one person.
• Always dispose of used needles in a proper disposal container.
• Always store your disposal container and needles out of the reach of small children.

How to select the injection site

It is very important to rotate the site of your Nutropin AQ Pen injections. Choose a different place to inject yourself each time. The injection should not go very deep into your skin. It should be given in the subcutaneous space (the fatty layer just beneath the skin’s surface).

Be sure to inject Nutropin at a different recommended place on your body each time. Your doctor or nurse should supervise the first injection and provide training and instruction. You may experience discomfort, soreness, or redness where Nutropin is injected. Contact your doctor immediately if you experience ongoing injection site discomfort.

The following areas are good injection sites because you may be able to grasp the right amount of skin needed for your injection:

Abdomen. The tissue below the skin of the abdomen absorbs medication readily. Injections in this area sometimes hurt less. Avoid giving injections too close to the navel. Also, be careful to avoid giving injections where a waistband might chafe and irritate the injection site.

Thighs. The front or outside of the thigh is a good place for an injection. to find this site, think of dividing the leg between the hip bone and the knee into thirds. The injection is given into the skin (not the muscle) on the middle third on the front or outside of the thigh.

Buttocks. As with the abdomen, injections in the upper, outer area of the buttocks sometimes hurt less. The person receiving the injection should lie face down on a flat surface with toes pointed inward.

Upper arms. The largest part on the back portion of the arm may also serve as an injection site.

Problems at an injection site

Occasionally, a problem may develop at an injection site. Contact your healthcare professional if you notice any of the following:

• A lump that doesn't go away
• Bruising that doesn't go away
• Any signs of infection or inflammation such as swelling, pus, persistent redness or pain, or skin that is hot to the touch

You may report side effects to the FDA at 1-800-FDA-1088 or to Genentech Drug Safety/Adverse Events at 1-888-835-2555.

How to prepare and inject

Follow the instructions in this section if you are using the pen for the first time or are replacing an empty cartridge. Inspect all new cartridges prior to use. If the solution is cloudy or contains any solid matter, do not use the cartridge.

1. Remove the pen cap and unscrew the cartridge holder from the pen. If necessary, remove the empty cartridge and discard it properly.

2. Press the white reset button.

3. Turn the black dose knob counter-clockwise back to its starting position until it no longer turns. (See illustration.) Then turn the dose knob clockwise until the first click position is reached (approximately 1/8 turn). This ensures that the plunger push rod is reset to the starting position. If this is not done when the dosage knob is first depressed, Nutropin AQ will be wasted or the cartridge may crack.

4. Insert a cartridge into the cartridge holder, then screw the cartridge holder back onto the pen. (Be careful not to touch the rubber seal.)

5. Remove the paper seal from a new needle assembly and screw it onto the cartridge holder.

6. Carefully remove both protective caps from the needle by pulling gently. Do not throw the larger cap away as it may be used later for proper needle removal and disposal.

7. Holding the pen with the needle pointing upward, gently tap the cartridge holder to move any air bubbles to the top. While still holding the pen in the upright position, push in the black dose knob until it locks into position. You should see a drop of medicine appear. Be patient. If medicine doesn't appear within a few seconds, you may need to push the reset button again.

8. If no drop of medicine appears, push the white reset button again. Now turn the black dose knob clockwise (see illustration) by one click, which equals 0.1 mg. If you accidentally turn it too far, go back one click.

9. While still holding the pen in the upright position, push in the black dose knob again and watch the needle tip for a drop of medicine to appear. Repeat steps 8 and 9 until it appears.

10. Press the white reset button.

11. Set the required dose by turning the black dose knob. If you cannot dial the full dose, either start a new cartridge or administer the partial dose. Then, start a new cartridge to administer the remaining portion of your medication. (Ask your healthcare professional to walk you through the procedure for using the last dose in the cartridge.)

Prepare the injection site by wiping with an alcohol wipe. Injection sites include the upper arms, abdomen, and upper thighs. Rotate the injection sites to avoid discomfort.

12. If you are using the passive shield (or no shield), proceed to step 13. If you are using the active shield, slide the shield onto the pen, and push the 2 black lock knobs on the needle shield toward the tip.

13. Set the tip of the pen on the prepared injection site, and press the needle into the skin by pushing the pen downward until the shield is totally depressed. Your healthcare professional will show you how to do this. Now you are ready to administer the dose. Press down on the black dose knob until it locks in place. Wait 5 seconds then withdraw the needle from the skin.

14. Pull the needle shield off the pen (if you used one) and place the larger needle cap on a flat surface. Slide the needle in to pick it up and push the cap completely down over the needle. Twist off the needle and discard it properly.

15. Attach the pen cap and return it to its case with the black dose knob pressed in. You should always store the pen in a refrigerator. Do not remove the cartridge between injections. DO NOT FREEZE.

For future injections with the Nutropin AQ Pen, attach a new needle, push the white reset button, and dial your dose. If you would like to use the dose recall function for future injections, wait at least 2 minutes after your previous injection before pressing the white reset button.

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Storing and maintaining your Nutropin AQ Pen

Keep the Nutropin AQ Pen and cartridges in a refrigerator at 36°F to 46°F (2°C to 8°C) to keep it fresh. Keep it out of children's reach. Don't keep the pen out of the refrigerator more than one hour per day. It's also important to keep it out of direct sunlight.

When you travel, place your Nutropin AQ Pen in a waterproof container inside a cooler with an ice pack. The Nutropin AQ Pen cartridges are designed to withstand a brief time (one hour maximum) outside of the refrigerator each day. Avoid extreme temperatures. Always check the expiration date of the cartridge prior to use.

Follow these tips to ensure proper care of your Nutropin AQ Pen:

• Do not immerse the Nutropin AQ Pen in water or expose to moisture.
• If your pen requires cleaning, do not place it underwater. Use a damp cloth to wipe away dirt. Do not use alcohol.
• Always keep your Nutropin AQ Pen and Cartridge refrigerated and protected from light when not in use.
• You may remove the pen and cartridge from the refrigerator up to 45 minutes prior to use.
• Do not let your Nutropin AQ Pen or Cartridge freeze. Contact your healthcare professional for a replacement if either the pen or cartridge malfunctions.
• Avoid excessive temperatures. Cartridge contents are stable for 28 days after first use when stored at 36°F to 46°F (2°C to 8°C)
• When priming a new cartridge, you may need to repeat Part I, steps 8 and 9, up to a total of 6 times to remove air bubbles. Small bubbles may remain and will not affect the dose.
• The pen should contain the Nutropin AQ Pen cartridge that is being used. Do not remove cartridge between injections.
• Do not store the Nutropin AQ Pen with the needle attached.
• Nutropin AQ Pen 20 uses only a 20 mg/2 mL (5 mg/mL) cartridge.
• Nutropin AQ Pen 10 uses only a 10 mg/2 mL (5 mg/mL) cartridge.

Read some Frequently Asked Questions about Nutropin AQ Pen.

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Other ways to take Nutropin:

• Nutropin AQ^® NuSpin™ Liquid GH from a prefilled, automatic device
• Nutropin AQ Pen^®Liquid GH from a cartridge, delivered by a device (available in both 10 mg and 20 mg sizes)
• Nutropin AQ^® with vial and syringe Liquid GH for use with a syringe
• Nutropin vial and syringe GH in dry powdered form, to be mixed with a special fluid for use with a syringe

IMPORTANT SAFETY INFORMATION

Nutropin and your safety:
Please read this important safety information carefully. Then, if you have any questions, talk with your doctor.

Nutropin is NOT for:

• Children and teenagers whose bones have finished growing
• Patients who have certain types of eye disease caused by diabetes
• Patients who have active cancer or any brain tumors
• Patients who are critically ill after open heart surgery or abdominal (stomach) surgery, are severely hurt, or have severe breathing problems
• Children and teenagers who have Prader-Willi syndrome and are very overweight or have trouble breathing
• Patients with a known sensitivity to benzyl alcohol when using Nutropin reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). For use in newborns, see WARNINGS in full Prescribing Information

If any of these apply, talk to your doctor before you start taking Nutropin.

If you are about to start taking Nutropin, or are already taking it, be sure to tell the doctor who prescribed it:

• About ALL of the medications you are taking, including supplements
• If you have or develop a brain tumor
• If you are given any new medication, especially glucocorticoid steroids like hydrocortisone or prednisone
• If you are pregnant or if you become pregnant
• About ANY other condition or illness you have or develop

What are the possible side effects of Nutropin?
You may experience discomfort, soreness, or redness where Nutropin is injected.

Contact your doctor immediately if you experience:

• Ongoing injection site discomfort
• Curvature of the spine (scoliosis)
• Joint pain
• Puffy hands and/or feet (caused by fluid retention)
• Changes in vision, a bad headache, or nausea with or without vomiting
• Hip or knee pain
• A need to limp when you walk
• Pain in wrist (carpal tunnel)
• Allergic reaction

Be sure to inject Nutropin at a different recommended place on your body each time. Your doctor or nurse should supervise the first injection and provide training and instruction.

Your doctor is your primary source of information about your treatment.

Please see the full Prescribing Information for Nutropin and Nutropin AQ, available from your pharmacy and at www.nutropin.com, for more about Nutropin and safety.

Questions? Call the Nurse Hotline at 1-866-NUTROPIN (1-866-688-7674).

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