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Nutropin AQ vial and syringe delivers liquid GH for use with a syringe

To make sure your body has enough growth hormone, your doctor may prescribe GH replacement therapy with Nutropin AQ^® [somatropin (rDNA origin) injection]. Learn about Nutropin AQ with vial and syringe below, including:

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

Features

As a liquid growth hormone for GH therapy, Nutropin AQ is ready for immediate injection; no mixing is necessary. Nutropin AQ is 10 mg of sterile liquid GH per vial. Once opened, a vial may be used for up to 28 days, if properly stored.

Nutropin AQ is:

• Easy to use
  • Already mixed
  • Quick to prepare
• Convenient
  • Few supplies needed
  • Easy to learn how to give injections

Nutropin AQ is available in the US by prescription only. Healthcare professionals should provide patient training prior to use.

Please click here for full prescribing information for Nutropin AQ and Nutropin^® [somatropin (rDNA origin) for injection].

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Using your Nutropin AQ vial and syringe

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

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

• Wash your hands thoroughly with soap and warm water before preparing an injection.
• Clean the rubber stopper on the top of the vial with an alcohol wipe. Be sure not to touch the top of the vial after cleaning.
• If you accidentally touch the rubber seal, clean it with an alcohol wipe.
• Use needles only once.
• Never share needles.

How to measure the dose

The medication should be clear before you start. You may notice small, colorless particles in the Nutropin vial after it has been refrigerated. That's okay. These small particles are protein. The medication has not lost its effectiveness. Allow the vial to warm to room temperature, and then swirl it gently.

If the medication is cloudy or hazy, do not inject it. Return the cloudy Nutropin vial to your specialty pharmacist or call 1-866-NUTROPIN.

Nutropin AQ is supplied in a 10 mg vial. Write the date on the vial when you open it so you will remember when it was first opened and used. Before each use, check the expiration date printed on the vial label and make sure that the Nutropin AQ solution is clear. Do not use the vial of Nutropin AQ more than 28 days after your first use of it: instead, throw it away.

Follow these steps to measure a dose:

1. Wipe the top of the vial vigorously with an alcohol wipe.

2. Remove and save the plastic needle guard, and then draw air into the syringe by pulling back on the plunger. The amount of air should be equal to the dose.

3. Slowly insert the needle straight through the center of the rubber stopper of the vial and gently push the plunger to discharge the air into the vial.

4. Turn the vial upside down with the needle still in it and hold the vial in one hand. Be sure the tip of the needle is in the solution. Using your other hand, slowly pull back on the plunger in a single motion until the correct amount of solution is in the syringe. Try not to inject the medication back into the vial, as this could cause the solution to become cloudy or hazy.

5. While continuing to hold the syringe and vial upside down in one hand, gently tap the syringe to dislodge any large air bubbles. The bubbles will rise to the top of the syringe and can be pushed back into the vial by gently pushing in the plunger. Be sure the correct amount of medication remains in the syringe. If there were many bubbles that had to be pushed out of the syringe, you may need to withdraw more Nutropin solution.

6. When you take the last dose from a vial, insert the needle tip just past the rubber stopper. Turn the vial upside down and tilt it so that the needle tip is completely covered with solution. You may need to gently tap the vial to withdraw as much of the solution as possible. If the solution is cloudy or hazy, do not inject it. Return the cloudy Nutropin vial to your specialty pharmacist or call 1-866-NUTROPIN.

7. Remove the needle from the vial. Be careful not to touch the needle. Your Nutropin solution is now ready to inject. The injection should be given as soon after filling the syringe as possible; do not store the growth hormone in the syringe.

8. To avoid sticking yourself when recapping the needle, set the needle guard on the table. Without touching or holding the guard, slide the needle into it and "scoop" it up. Then use your free hand to click the guard onto the syringe.

How to select the injection site

It is important to rotate the site of your Nutropin AQ injections. You should choose a different place to inject yourself each time.

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.

Nutropin is injected into the fatty layer just under the skin (the subcutaneous tissue). The injection should not go very deep into your skin.

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 give the injection

You can learn to give injections skillfully. However, no matter how routine the injections become, it is always important that you pay close attention to what you are doing at all times. Your healthcare team will give you hands-on training on how to give injections. The instructions below will provide you with a review of that training, but do not replace your healthcare professional as a source of information. Call them if you have any questions about giving an injection.

Follow these steps to give the injection:

1. Expose the injection site completely (never give an injection through clothing). Your healthcare professional will advise you on the skin cleaning technique they recommend. Here is one suggested tip: applying firm pressure, clean the injection site thoroughly with an alcohol wipe. Allow the alcohol to dry from the skin before inserting the needle.

2. Double-check that the correct amount of Nutropin is in the syringe, then remove the needle guard from the syringe. Hold the syringe the way you would hold a pencil.

3. Squeeze the skin between your thumb and index finger before and during the injection. Insert the needle into the skin at a 45°-90° angle with a quick, firm motion.

4. Slowly (taking a few seconds) inject the medication by gently pushing the plunger until the syringe is empty. Count to 5 and then remove the needle.

5. Withdraw the needle quickly, pulling it straight out, and apply pressure over the injection site with a dry gauze pad or cotton ball. You may gently massage the area for added comfort. A drop of blood may appear. Put a Band-Aid^® on the injection site if you'd like.

6. Do not recap the needle prior to disposal. Safely dispose of plastic needle guards and all used needles and syringes as instructed by your healthcare professional or by following the steps outlined below.

Remember, your healthcare team is your primary source of information and care. They are available to help answer any questions you may have about treatment with Nutropin

.

Ask your healthcare team about any possible side effects or unusual reactions that might occur because of the injections or the medication itself.

Disposing of used needles and syringes

For safety reasons, it's important to correctly dispose of plastic needle guards and used needles and syringes after you've given an injection. There may be special regulations in your state about what kind of containers may be used for needle disposal. Your healthcare team will instruct you on the proper disposal of items used for the injection. In addition, they may need to review special state and local laws with you.

To prevent injury, safely dispose of plastic needle guards and all used needles and syringes after a single use. Follow these rules:

• Do not recap the injection needle with the plastic needle guard prior to disposal.
• Safely dispose of the plastic needle guard and all used needles and syringes after a single use.
• Always store your disposal container out of the reach of children.

Learn more about how to properly dispose of your needles, and get tips for traveling with your GH medication.

Band-Aid^® is a registered trademark of Johnson & Johnson.

Storing and maintaining your Nutropin AQ vial and syringe

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

• Avoid excessive temperatures. Nutropin AQ vial contents are stable for 28 days after first use when stored at 36°F to 46°F (2°C to 8°C).
• Do not let your Nutropin AQ freeze.
• Always keep your Nutropin vials refrigerated and protected from light when not in use.

Read some Frequently Asked Questions about Nutropin AQ.

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, an ingredient in the liquid used to mix Nutropin Injection. Sterile water should be used when mixing Nutropin for newborns.

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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