The first long-acting dosage form of Nutropin for pediatric growth hormone deficiency, Nutropin Depot is indicated for the long-term treatment of growth failure due to a lack of adequate endogenous growth hormone (hGH or GH) secretion. Nutropin Depot is the only GH available for patients who prefer the convenience of once- or twice-a-month dosing.

Depending on a patient's weight, each dose may require more than one injection. Growth rates may be lower with Nutropin Depot than with daily GH therapy. Patients previously treated with daily growth hormone who were switched to Nutropin Depot experienced decreased growth rates. In a long-term extension study, 19% of patients (14 out of 75) discontinued therapy due to dissatisfaction with growth response. (See important considerations for comparative growth rates.)

Nutropin Depot offers greater freedom in the following ways:

Less frequent injections may result in fewer disruptions to patients' and families' daily routine.
Fewer injections require fewer syringes and other supplies, which reduces the amount of storage and refrigeration space needed.
The number of doses is reduced from as many as 365 to just 12 to 24 per year. Depending on a patient's weight, more than one injection per dose may be required.
Everything needed for suspension and injection is provided with Nutropin Depot.
How does Nutropin Depot work?
Nutropin Depot consists of thousands of tiny balls (microspheres) made of a substance commonly found in medical products such as the "thread" used for dissolvable stitches. Each of these microspheres contains molecules of GH. Once Nutropin Depot suspension is injected under the skin (subcutaneously), its microspheres degrade, releasing the GH into the body in 2 phases—this is known as biphasic release. About 50% of the drug is released within the first day or two after the injection, and the remainder is released in the secondary (long-acting) phase as the microspheres degrade.

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How Nutropin Depot is supplied
Each kit contains one single-use vial of Nutropin Depot, one vial of diluent, and three needles. Store the kit in a clean, safe place in your refrigerator. Please remember that all needles must be stored out of the reach of children. It is also important that the vials of Nutropin Depot and diluent not be frozen. Freezing will damage them, and they cannot be used.

Do not mix the drug, or inject it, until your healthcare provider has thoroughly trained you in the proper technique.

One single-use vial of Nutropin Depot and two needles are used for a single injection. One extra needle is provided in each kit.

Mixing means adding a liquid (diluent) to a dry powder. Nutropin Depot may only be mixed with the diluent provided, before it can be injected. Uses the sterile technique you were trained on by your healthcare provider. Dispose of the syringes and needles properly after each use, out of the reach of children. See step 7 under Giving the medication for instructions on the proper disposal of plastic needle guards, used needles, and syringes.

Selecting the Injection Site

Begin by removing the kit from the refrigerator.

Your healthcare provider will teach you how to locate appropriate areas to give injections. Within each area there are multiple injection sites. It is very important that you change the site for each injection or rotate the area where you give each injection. Even if you develop a preference for one area, you should still rotate the injection site within that area. Following injections, you may notice a “dimple” at one or more of the injection sites. These should go away over time. Until they go away, you should avoid using these areas. This is another reason why it is important to rotate the injection site.

The following drawings indicate recommended injection areas. Each area has several sites for injection within them.

Preferred Area*




*For detailed information about injection site selection, please see Your Family's Guide to Preparing and Administering Nutropin Depot.

Mixing a Nutropin Depot vial
Mix the Nutropin Depot vial only with the diluent and needles provided in the kit. Do not use other solutions for mixing. Unused contents of a mixed Nutropin Depot vial or diluent vial should not be used to mix a new vial of Nutropin Depot. Discard both of these vials after giving the injection.

Your healthcare provider will tell you what size syringe to use with the needles provided in the kit, and how much diluent to add to the Nutropin Depot vial.

Check the expiration date on each vial. Vials of diluent that have not been opened or Nutropin Depot vials that have not been opened or mixed can be used until the expiration date (EXP) printed on each of the vial labels.


Wash your hands thoroughly with soap and water before preparing the medication. This helps prevent infection.


Leave the diluent vial to warm to room temperature for up to 15 minutes before mixing, or hold the diluent vial between your hands and gently roll it to bring the contents up to room temperature. This should help with the overall administration of the drug.


Before you add the diluent to the Nutropin Depot vial, you should tap and shake the vial to make sure the powder is free flowing. This will make it easier to mix.


Remove the protective plastic cap from the tops of both the diluent and Nutropin Depot vials. Do not remove the rubber stoppers. Do not touch the top of the vials. If you accidentally touch the top, clean it with an alcohol swab.


Remove the small plastic cap from the end of the syringe, and firmly attach the needle by twisting counter-clockwise. Be careful not to let the end of the syringe come into contact with anything but the needle. Note: Use only needles provided in the Nutropin Depot kit.


Pull the plastic needle guard straight off and set it aside. Do not allow the needle to touch anything except the tops of vials. Do not use needles that have come in contact with any other surface. Fill the syringe with air by pulling the plunger to the level indicated by your healthcare provider. This will make it easier to withdraw the diluent.


Slowly insert the needle straight through the center of the rubber stopper of the diluent vial and inject all of the air into the vial.


Turn the diluent vial upside down with the needle still in it and hold the vial in one hand. To avoid getting air in the syringe while filling it with the diluent, make sure the tip of the needle is in the diluent. Withdraw the diluent by pulling the plunger to the exact amount your healthcare provider told you. With the syringe and vial still held upside down in one hand, gently tap the syringe with your other hand to dislodge any large air bubbles. The bubbles will rise to the top of the syringe and can be pushed back into the diluent by gently pushing in the plunger. Check again to make sure you have the correct amount of diluent in the syringe. If not, pull back or push in the plunger slowly until the correct amount of diluent is in the syringe. Withdraw the needle from the diluent vial. Do not allow the needle to touch anything except the tops of vials. Do not use needles that have come in contact with any other surface.


To prepare the Nutropin Depot suspension, slowly insert the needle straight through the center of the rubber stopper of the Nutropin Depot vial. Gently place the needle tip against the glass wall of the vial. Slowly inject all of the measured diluent. Withdraw the needle, and replace the plastic needle guard. Set the syringe and needle aside for later use while mixing the Nutropin Depot vial. (See step 7 under Giving the medication for instructions on the proper disposal of plastic needle guards, used needles, and syringes.)


Taking care not to touch the top of the vial, vigorously swirl the Nutropin Depot vial until the contents are completely mixed. It may take up to 2 minutes to form a uniform suspension. After mixing, the vial contents should be thick and milky. If you notice lumps of powder that float or stick to the sides of the vial, continue to swirl the vial until all of the powder has been mixed with the diluent. Once mixed, Nutropin Depot must be administered immediately to prevent settling of the microspheres. Do not store a mixed vial of Nutropin Depot or a filled syringe. Only one Nutropin Depot vial can be used for each injection.


Measuring the Dose

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

Wash your hands thoroughy with soap and water before preparing the medication
Do not remove the rubber stoppers. Try not to touch the tops of the vials. If you do, use an alcohol swab or a cotton ball soaked with isopropyl rubbing alcohol to clean the top of any vial you touched.
Do not allow the needle to touch anything except the rubber stoppers on the tops of the vials. Do not use a needle that has come in contact with any other surface.
Steps

Using the same needle and syringe, pull the plastic needle guard straight off and set it aside. Slowly insert the needle straight through the center of the rubber stopper of the vial containing the Nutropin Depot suspension.


Turn the vial upside down with the needle still in it and hold the vial in one hand. To avoid getting air into the syringe while measuring the dose, make sure the tip of the needle is in the Nutropin Depot suspension. Using your other hand, slowly pull back on the plunger in a continuous motion until the correct amount of Nutropin Depot suspension is in the syringe. With the syringe and vial still held upside down in one hand, gently tap the syringe with your other hand 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. Check again to make sure you have the correct amount of Nutropin Depot in the syringe. If not, pull back the plunger slowly until the correct amount of Nutropin Depot is in the syringe. Because the Nutropin Depot suspension is thick, it may take some time to fill the syringe. If the flow stops, gently push the plunger in, then continue to fill the syringe with the correct amount of Nutropin Depot.


Withdraw the needle from the Nutropin Depot vial and replace the plastic needle guard. This will make it easier to remove the needle from the syringe when you need to change the needle. Do not allow the needle to touch anything except the tops of vials or prepared injection sites. Do not use needles that have come in contact with any other surface.


Before giving the injection, you must change the needle used for adding the diluent and measuring the dose. Remove the used needle by gently twisting the needle guard clockwise. Note: Use only needles provided in the Nutropin Depot kit. Firmly attach a new needle to the filled syringe by twisting it on counterclockwise. Be careful not to let the end of the syringe come in contact with anything but the new needle.


PROCEED IMMEDIATELY TO GIVE THE INJECTION

Giving the medication
Your healthcare provider will provide you with training on how to give an injection. Needles and syringes should be used only once to ensure sterility of both the needle and the syringe. The following is a review of the steps involved in giving the medication:

Holding the syringe upright, gently push in the plunger until you see a drop of Nutropin Depot on the end of the needle to remove any air. If necessary, tap the barrel of the syringe to dislodge any air bubbles before pushing in the plunger. (See step 7 under Giving the medication for instructions on the proper disposal of plastic needle guards, used needles, and syringes.)


Using a circular motion, while applying firm pressure, cleanse the injection site with an alcohol-saturated cotton ball or alcohol swab. Allow the alcohol to dry before inserting the needle.


Remove the plastic needle guard and hold the syringe the way you would hold a pencil.


Gently squeeze the skin between your thumb and index finger before and during the injection. Insert the needle into the skin with a quick, firm motion. This hurts less than pushing the needle in slowly. Your healthcare provider will tell you the correct angle to use for needle insertion.


Slowly (but not over more than 5 seconds) inject the medication by gently pushing the plunger until the syringe is empty. Slowly release the skin during the injection. A few seconds after the injection has been given, quickly withdraw the needle. If the medication leaks out of the injection site, consult your healthcare provider. Attempting to give the injection faster could result in discomfort at the injection site. (See step 7 under Giving the medication for instructions on the proper disposal of plastic needle guards, used needles, and syringes.)


Sometimes the flow of medicine stops before the syringe is empty. If this happens, it is possible that the needle has become clogged. Simply withdraw the needle, replace the needle guard and remove the clogged needle by gently twisting the needle guard clockwise. Note: Use only needles provided in the Nutropin Depot kit.


Firmly attach a new needle to the syringe by twisting counterclockwise. Be careful not to let the end of the syringe come into contact with anything but the new needle. Holding the syringe upright, gently push in the plunger until you see a drop of Nutropin Depot on the end of the needle. If necessary, gently tap the barrel of the syringe to dislodge any air bubbles. (See step 7 under Giving the medication for instructions on the proper disposal of plastic needle guards, used needles, and syringes.) Select and prepare a new injection site. (See Selecting the Injection Site and steps 1 and 2 under Giving the medication.) Inject the remainder of the Nutropin Depot at this site.


Withdraw the needle quickly, pulling it straight out. Gently massage the injection site with a dry gauze pad or cotton ball. A drop of blood may appear. Put a Band-Aid® on the injection site if desired. It is common for swelling and/or a small lump to appear at the injection site but it should go away over time.


To prevent injury, safely dispose of the plastic needle guards and all used needles and syringes after a single use. Your healthcare professional will instruct you on the proper disposal of items used for the injection. In addition, he or she may need to review special state and local laws with you. To prevent injury:

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


Reactions at the injection site are frequent but usually do not last long. These include redness, bumps, pain during and after the injection, “dimples”, and itchiness. It is possible that in rare cases a more severe reaction to the injections may develop. If you notice any of the following signs or symptoms, contact your healthcare provider:

Swelling or a lump at the injection site that doesn’t go away
Rash at the injection site
Any signs of infection or inflammation at an injection site (pus, persistent redness of surrounding skin that is hot to the touch, persistent pus after the injection)
Difficulty breathing
Body rash
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Band-Aid® is a registered trademark of Johnson & Johnson.

Storing Nutropin Depot
Before suspension: Nutropin Depot and diluent vials must be stored at 2–8°C/36–46°F (under refrigeration). Avoid freezing the vials of Nutropin Depot and Diluent for Nutropin Depot. Do not expose the Nutropin Depot vial to temperatures above 25°C (77°F). Expiration dates are printed on the labels.

After suspension: Because Nutropin Depot contains no preservatives, all injections must be given immediately. Do not allow the suspension to settle prior to withdrawal of the dose. Do not shake to resuspend. Solution that has settled may cause needle clogging. Suspended solution cannot be stored or used to suspend another vial of Nutropin Depot.

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Important Safety Information

Contraindications

GH should not be initiated to treat patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or to patients having acute respiratory failure.
GH should not be used for growth promotion in subjects whose bone growth is completed.
GH should not be used in patients with active cancer. GH should be discontinued if evidence of cancer develops.
Precautions

Increased fluid pressure within the skull (intracranial hypertension) has been reported in a small number of patients treated with GH. Funduscopic examination of patients is recommended at the initiation of and periodically during GH therapy.
As with any protein, local or systemic allergic reactions may occur. Parents/patients should be advised to seek prompt medical attention if allergic reactions occur, such as itching, rash, or hives.
GH may reduce insulin sensitivity, particularly in obese individuals; patients should be observed for evidence of glucose intolerance. For patients with diabetes mellitus, the insulin dose may require adjustment when GH therapy is instituted.
Patients with symptomatic low blood sugar (hypoglycemia) associated with GH deficiency should be closely monitored.
Separation of the ball of the hip joint from the thigh bone (slipped capital femoral epiphysis) may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth.
Because GH increases growth rate, patients with a history of scoliosis who are treated with growth hormone should be monitored for progression of scoliosis. GH has not been shown to increase the incidence of scoliosis.
GH patients experiencing headache, nausea, visual changes, and/or vomiting may have a condition called intracranial hypertension and should contact their healthcare professional.
Adverse reactions
Injection site reactions with Nutropin Depot occurred in nearly all patients and were generally mild to moderate, and most resolved without intervention.

In clinical studies involving 138 pediatric patients, Nutropin Depot demonstrated a safety profile similar to that of daily GH therapy, with the exception of frequency and type of injection site reactions.
The most frequent injection site reaction was the occurrence of a pea-sized nodule formed by Nutropin Depot microspheres under the skin. Nodules gradually disappear as the microspheres degrade and the GH is released.
In Phase III trials, pain reported during injection decreased over time as patients gained experience with the therapy.
Pain post-injection, often reported as tenderness or soreness to the touch, was also reported.
The most frequent adverse reactions associated with Nutropin Depot therapy were injection site–related, occurring in nearly all patients. On average, 2 to 3 injection site reactions were reported per injection, and included: nodules (61% of injections), erythema (53%), pain post-injection (47%), pain during injection (43%), bruising (20%), itching (13%), lipoatrophy (13%), and swelling or puffiness (8%). The intensity of these reactions was generally rated mild to moderate, with pain during injection occasionally rated as severe (7%), and most resolved without further intervention.

Adverse reactions that were observed less frequently in clinical trials but were considered possibly, probably, or definitely related to Nutropin Depot therapy included headache (13% of subjects), nausea (8%), lower extremity pain (7%), fever (7%), and vomiting (5%). Please discuss with your physician first about the risks and benefits associated with GH therapy.

Please see full prescribing information for complete information.

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Important Considerations

The mean growth rate for patients previously treated with daily GH was 8.2 ± 3.0 cm/year (range, 3.2 to 13.1 cm/year) and on Nutropin Depot was 5.1 ± 2.0 cm/year (range, 2.4 to 9.6 cm/year) after 6 months. Patients previously treated with daily GH who were switched to Nutropin Depot experienced decreased growth rates.
19% of patients (14 out of 75) in a long-term extension study discontinued therapy due to dissatisfaction with growth response.
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