Nutropin

Nutropin

• What is Nutropin?
• Instructions for Use
• Storage and Maintenance

What Is Nutropin?

Nutropin
Nutropin is produced by Genentech using recombinant DNA technology, and has the same amino acid sequence as growth hormone produced naturally in the human body.

Additional Genentech products
Nutropin is also available in a liquid version called Nutropin AQ that does not require mixing (reconstitution or suspension). This formulation may be administered simply, conveniently, and safely by vial and syringe using the Nutropin AQ Pen 10.

How Nutropin is supplied
Nutropin is supplied as 5 mg (approximately 15 IU) or 10 mg (approximately 30 IU) of lyophilized, sterile somatropin 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, USP (benzyl alcohol preserved). NDC 50242-072-03.

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, USP (benzyl alcohol preserved). NDC 50242-018-21.

Nutropin 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.

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Instructions for Use

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

• Wash your hands thoroughly with soap and warm water before preparing the medication.
• Clean the rubber stopper on the top of the vial with an alcohol wipe. Be sure not to touch the top of the vials after cleaning.
• If you accidentally touch the rubber seal, clean it with an alcohol wipe.
• Use needles only once.
• Do not share needles.

Preparing Nutropin
Before using, Nutropin is packaged in dry powdered form and should be mixed, or reconstituted, with the diluent (mixing fluid) supplied.

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

Steps for preparing the injection

Write the date on both the diluent vial and the vial of reconstituted Nutropin, so you will know exactly when the diluent was opened and when the medication was reconstituted. The unopened diluent can be used until the expiration date (EXP) printed on the vial label. Reconstituted Nutropin must be used within 14 days after reconstitution.
Remove and dispose of the needle guard from the needle and syringe used for reconstitution. 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 provider has ordered to be mixed with each vial of dry powdered medication.
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.
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.
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.
Using the syringe you have filled with diluent, insert the needle slowly into the center of the rubber stopper in the vial of Nutropin.
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 Disposing of Used Needles and Syringes.)
Hold the vial between your hands and gently roll it to dissolve the white powder. Or swirl the vial with a gentle rotary motion until the powder is completely dissolved. Don't shake the vial after the medication has been reconstituted. 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 vial to your pharmacist or healthcare provider.) Immediately after combining the medication with the diluent, the mixture should be clear; there should not be 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.

Measuring the Dose
The medication should be clear before you start. You may notice small, colorless particles in the Nutropin 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 to your pharmacist or healthcare provider.

Check the date you wrote on the vial to be sure it is not more than 14 days old.

Steps for giving the injection

Wipe the top of the vial vigorously with an alcohol wipe.
Remove and save the plastic needle guard and draw air into the syringe by pulling back on the plunger. The amount of air should be equal to the dose.
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.
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 continuous 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.
With the syringe and vial still held 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.
When taking 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 have to gently tap the vial to withdraw as much of the solution as possible. Do not inject cloudy or hazy medication; return it to your pharmacist or healthcare provider. Unused contents of a reconstituted vial of Nutropin should never be used to reconstitute a new vial of medication.
Remove the needle from the vial of medication. Be careful not to touch the needle. Your Nutropin is now ready to inject. The injection should be given as soon after filling the syringe as possible; do not store the Nutropin in the syringe.
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.

Selecting the injection site
It is very important to rotate the site of your Nutropin injections—that is, you should choose a different injection site each time you use the medication. The injection should not go very deep. It should be given in the subcutaneous space (the fatty layer just beneath the skin's surface).

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

Abdomen. The tissue below the skin of the abdomen absorbs medication readily. Injections in this area sometimes hurt less. Avoid giving the injection too close to the navel. Also, be careful to avoid giving the injection where a waistband might chafe and irritate the injection site.
Thighs. The front or outside of the thigh provides a good injection site. To locate this site, think of dividing the leg between the hip bone and the knee into thirds. The injection is given into the skin on the middle third on the front or outside of the thigh (but not into the muscle).
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. Occasionally, a problem may develop at an injection site. Contact your healthcare provider 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 at an injection site (such as swelling, pus, persistent redness or pain, or skin that is hot to the touch)

Administering 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 provider as a source of information. Call them if you have any questions about giving an injection.

Steps for giving the injection

Expose the injection site completely (never give an injection through clothing). Your healthcare provider will advise you on the recommended skin cleaning technique. Applying firm pressure, clean the injection site thoroughly with an alcohol wipe. Allow the alcohol to dry from the skin before inserting the needle.
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.
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.
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.
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.
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 provider and/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 can 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.

To prevent injury:

• 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.

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

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Storage and Maintenance

How to store Nutropin
Nutropin must be refrigerated at 2–8°C/36–46° before (powder form) and after (liquid form) reconstitution. Reconstituted Nutropin cannot be used after 14 days and should be discarded. Unopened vials of Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), should also be refrigerated at 2–8° C/36–46°F.

It is important to protect all vials from light, including the reconstituted medication, and store them in a clean, safe place in the refrigerator when not in use.

DO NOT FREEZE. If vials appear frozen, do not use.

See Indications and Important Safety Information