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Nutropin^® [somatropin (rDNA origin) for injection] vial and syringe offers GH in dry powdered form, to be mixed with a special fluid that is provided in the package.

To make sure your body has enough growth hormone, your doctor may prescribe GH replacement therapy with Nutropin. Learn about Nutropin with vial and syringe below, including:

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

Features

Nutropin comes in a dry powdered form and should be mixed, or reconstituted, with the mixing fluid that is provided in the package. Nutropin is 5 mg or 10 mg of sterile GH per vial.

Each 5 mg carton contains one vial of Nutropin (5 mg per vial) and one 10 mL multiple-dose vial of Bacteriostatic Water for Injection. Each 10 mg carton contains one vial of Nutropin (10 mg per vial) and one 10 mL multiple-dose vial of Bacteriostatic Water for Injection.

Patients with a known sensitivity to benzyl alcohol, an ingredient in the liquid used to mix Nutropin Vial and Syringe should let their doctor know before taking Nutropin. Use sterile water when mixing Nutropin for newborns.

Nutropin is also available in a liquid version called Nutropin AQ^® [somatropin (rDNA origin) injection] that does not require mixing. Nutropin AQ may be given simply, conveniently, and safely by vial and syringe or by using the Nutropin AQ NuSpin or Nutropin AQ Pen.

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

Please see the full prescribing information for Nutropin.

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Using Nutropin vial and syringe

Before using your Nutropin, 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.

Preparing your Nutropin

Nutropin is packaged in dry powdered form. You will need to mix it with the diluent—the special fluid that comes with Nutropin.

The vial of reconstituted medication may contain more than one dose, depending on how much medication your healthcare professional has prescribed. Make sure to follow dosing instructions given by your healthcare professional.

Steps for preparing the injection:

1. Write the date on the vial of reconstituted Nutropin, so you will know exactly when the medication was reconstituted.

The unopened diluent can be used until the expiration date (EXP) printed on the vial label. Before each use, check the expiration date printed on the vial label and make sure that the Nutropin solution is clear. Reconstituted Nutropin must be used within 14 days after reconstitution.

2. Remove the needle guard from the needle and syringe and dispose of it. Pull on the plunger of the needle and syringe until you have pulled an amount of air into the syringe that equals the amount of diluent (fluid) your healthcare professional has ordered to be mixed with each vial of dry powdered medication.

3. Slowly insert the needle into the vial of diluent so that it goes straight through the center of the rubber stopper. Push the plunger to discharge the air into the vial. The air will make it easier to withdraw liquid from the vial later on.

4. Turn the vial of diluent upside down with the syringe needle still in it and hold it in one hand. Be sure the tip of the needle is in the diluent. Use your other hand to pull back the plunger slowly until the correct amount of diluent is in the syringe.

5. Double-check to be sure you have the correct amount of diluent in the syringe. Remove the needle from the vial. It is important that you do not allow the needle to touch anything except the tops of vials that have been cleaned with alcohol, the insides of needle guards, and properly prepared injection sites. Do not use needles that have come in contact with any other surface.

Now that you have the correct amount of diluent in the syringe, you are ready to reconstitute the medication by adding the diluent to the powder in the vial of Nutropin.

6. Using the syringe you have filled with diluent, insert the needle slowly into the center of the rubber stopper in the vial of Nutropin.

7. Slowly inject the diluent against the side of the vial. to avoid creating air bubbles in the medication, do not squirt the diluent directly onto the powder. When the syringe is empty, remove the needle from the vial and safely dispose of the used needle and syringe. (Please see (Please see Disposing of Used Needles and Syringes.)

8. Hold the vial between your hands and gently roll it to dissolve the white powder. You can also swirl the vial with a gentle rotary motion until the powder is completely dissolved. Do not shake the vial. Because Nutropin is a protein, shaking can result in a cloudy or hazy solution. (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.)

Just after you have combined the medication with the diluent, the mixture should be clear; there should be no solid particles floating on the surface. If you see lumps of powder floating or sticking to the sides of the vial, continue to gently swirl the solution until all of the powder has dissolved.

If you see any air bubbles, wait until they rise to the surface and disappear before continuing. The unused contents of a reconstituted vial of Nutropin should never be used to reconstitute a new vial of medication.

How to measure the dose

The GH 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.

However, 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.

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 Nutropin vial and syringe

Follow these tips to ensure proper care of your Nutropin:

• Avoid excessive temperatures. Nutropin must be refrigerated at 36°F to 46°F (2°C to 8°C) before (powder form) and after (liquid form) reconstitution. Unopened vials of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), should be refrigerated at the same temperatures.
• Reconstituted Nutropin cannot be used after 14 days and should be discarded.
• Do not let your Nutropin freeze. If vials appear frozen, do not use.
• 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^®Reusable device that uses liquid GH cartridges (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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