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Nutropin Pen 10



The Nutropin AQ Pen 10—The easy Nutropin AQ delivery device

What Is the Nutropin AQ Pen 10?

Nutropin AQ Pen
To make sure your body has the right amount of growth hormone, your healthcare provider may recommend GH replacement therapy with Nutropin AQ, which can be administered with the Nutropin AQ Pen 10. This device offers simplicity, convenience, and enhanced safety features for Nutropin delivery.

The pen delivers Nutropin AQ. Because Nutropin AQ does not need to be mixed, you will spend less time preparing and administering your daily Nutropin therapy, and may reduce your chances of making a dosing mistake.

The Nutropin AQ Pen delivers Nutropin AQ in a prefilled, 10 mg/2 mL (5 mg/mL) cartridge. This cartridge is stable for 28 days after initial use when refrigerated at 2-8°C/36-46°F.

Simple
The Nutropin AQ Pen offers a simple approach to GH therapy

  • Simple device design
  • Few administration steps
  • One-step, dial-back dose knob

    • Convenient
    The Nutropin AQ Pen has a convenient device design which allows for easy transport and dosage adjustment.

  • Small and light
  • Few additional supplies
  • Previous dose memory

    • Safety Features
    The safety features of the Nutropin AQ Pen are important because they can reduce the risk of reconstitution errors, support accurate dosing, and protect against needle contamination and damage.

  • Prefilled cartridge
  • Needle shield-lock
  • Digital dose display
  • Clicks that can be heard and felt

    • The Nutropin AQ Pen is available in the US by prescription only. Healthcare providers should provide patient training prior to use.

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

    Caution:
    Before using your Nutropin AQ Pen 10, please read the following instructions carefully. We also suggest you consult your healthcare provider for a demonstration. The Nutropin AQ Pen 10 is designed for use only with Genentech's Nutropin AQ Pen 10 mg Cartridge (for subcutaneous use only).

    Only use the pen needles recommended by your healthcare provider. 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.

    Always store the pen and cartridges in the refrigerator at a temperature between 2-8°C/36-46°F and out of children's reach. Protect from intense light. Use a cooler to store your Nutropin AQ Pen 10 when traveling and ensure the pen is kept dry. The Nutropin AQ Pen 10 mg Cartridge is designed to withstand a nominal (one hour maximum) period of time outside of the refrigerator on a daily basis. Avoid areas of extreme temperature. Check the expiration date of the cartridge prior to use.

    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.

    Your Nutropin AQ Pen 10 comes with the following:
    1. Alcohol wipes
    2. Pen needles
    3. Active shield
    4. Passive shield
    Your Nutropin AQ Pen 10 mg Cartridges are supplied separately.

    Instructions for Use

    Preparing and injecting
    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, the cartridge should not be used.

    1. Remove the green 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.


    1. 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.




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


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


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


    1. 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.


    1. 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.


    2. 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.


    3. Press the white reset button.


    1. Set the required dose by turning the black dose knob. If you cannot dial the full dose, either start a new cartridge (as described in Part I), or administer the partial dose. Then, start a new cartridge (as described in Part I) to administer the remaining portion of your medication. Your healthcare provider will advise you on the procedure for administering 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.

    1. 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.

    1. 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 provider 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.

    1. Pull the needle shield off the pen (if applicable) 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.


    2. 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 cartridge between injections.
      DO NOT FREEZE.

    For subsequent injections with the Nutropin AQ Pen 10, attach a new needle, push the white reset button, and dial your dose. If you would like to use the dose recall function for subsequent injections, wait at least 2 minutes after your previous injection before pressing the white reset button.

    Storage and Maintenance

    Follow these tips to ensure proper care of your Nutropin AQ Pen 10:
    • Do not immerse the Nutropin AQ Pen 10 in water or expose to moisture.
    • If your pen requires cleaning, do not place underwater. Use a damp cloth to wipe away dirt. Do not use alcohol.
    • Always keep your Nutropin AQ Pen 10 and 10 mg 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 10 and/or 10 mg Cartridge freeze. Contact your healthcare provider/distributor 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 2-8°C/36-46°F.
    • 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 10 mg Cartridge that is being used. Do not remove cartridge between injections.
    • Do not store the Nutropin AQ Pen 10 with needle attached.

    Needles for the Nutropin AQ Pen 10
    Your healthcare provider will recommend a needle that is appropriate for you. The following needle is provided by Genentech, Inc. in your Nutropin AQ Pen 10 kit:

    Name    Gauge/Length
    BD Ultra-Fine™ (Original) 29 g/12.7 mm

    Needles from other regions or countries may not fit on your Nutropin AQ Pen 10. If you travel outside the United States, make sure you take enough needles for the duration of your stay.

    Frequently Asked Questions

    Q: Do I need to change the needle every time I use my Nutropin AQ Pen 10?
    A: Yes. We recommend that a new needle be used for every injection. The needle is only sterile on its first use.

    Q: Where should I store my Nutropin AQ Pen 10?
    A: Your Nutropin AQ Pen 10 should be stored in the case, inside a refrigerator when a cartridge is inserted. When traveling, place your pen case in a water-proof container in a cooler with an ice pack. DO NOT FREEZE OR IMMERSE IN WATER.

    Q: Why do I keep my medication in the refrigerator?
    A: To maintain the potency of Nutropin AQ.

    Q: Can I store my Nutropin AQ Pen 10 in the freezer?
    A: No. Freezing will damage the pen and drug.

    Q: How long can I keep my Nutropin AQ Pen 10 and 10 mg Cartridge outside the refrigerator?
    A: We recommend no longer than one hour per day. Your healthcare provider will advise you regarding pen storage.

    Q: What is the maximum dose the Nutropin AQ Pen 10 can deliver in one injection?
    A: The maximum dose that may be delivered in one injection is 4 mg (40 clicks). If you attempt to dose more than 4 mg at a time, the drug will either be forced out of the needle and wasted or excess pressure will be placed upon the cartridge.

    Q: Is it possible to turn the black dose knob back if I click too many times?
    A: Yes. You can turn the black dose knob backwards until the correct number appears in the LCD.

    Q: What should I do if there is not enough medication left in the cartridge to meet my dosing requirements?
    A: Your healthcare provider will advise you on the procedure for the last dose in the cartridge.

    Q: Why do I have to rewind the black dose knob on my Nutropin AQ Pen 10 every time I replace the cartridge?
    A: This ensures that the plunger push rod completely resets itself back to the starting position. If this is not done, liquid will come out of the needle when a new cartridge is placed into the pen.

    Q: Can I use my Nutropin AQ Pen 10 without the shields?
    A: Yes. Your Nutropin AQ Pen 10 is fully functional without the shields. The shields are optional to help you administer your injection.

    Q: Where is the best place on my body to inject my medication?
    A: Consult your healthcare provider for proper injection sites.

    Q: What should I do if I drop my Nutropin AQ Pen 10?
    A: If you drop the Nutropin AQ Pen 10, check to see if the cartridge is damaged. You should also check the pen to see that the black dose knob is moving up and down properly and that the LCD counter is working. If you discover damage to your cartridge or pen, notify your healthcare provider/pharmacy for a replacement.

    Q: How long can I use my Nutropin AQ Pen 10?
    A: The Nutropin AQ Pen 10 is designed to last 24 months from the time you first use your pen.

    Q: What does "bt" (blinking or steady) mean in the LCD?
    A: The battery in your Nutropin AQ Pen 10 is losing its charge. Please contact your healthcare provider/pharmacy for a replacement pen. Batteries typically last 24 months and have a 4-week life from the time the "bt" first appears.

    Q: How do I replace my Nutropin AQ Pen 10?
    A: Contact your healthcare provider/pharmacy if you need a replacement part or if you need to replace your entire pen.

    Q: How do I use the dose recall function?
    A: If you would like to use the dose recall function for subsequent injections, wait at least 2 minutes after your previous injection before pressing the white reset button.

    Q: Is the Nutropin AQ Pen 10 waterproof?
    A: No. Exposure to moisture may cause the Nutropin AQ Pen 10 LCD window to malfunction. Do not immerse the Nutropin AQ Pen 10 in water. If the Nutropin AQ Pen 10 is accidentally immersed, remove it from the water and dry it immediately.

    Q: What does it mean when either "---" or "------" flashes or appears steady on the digital dose display?
    A: When this occurs, it means this pen has been used for 2 years and should be replaced. Your pen has 4 weeks of life remaining from the time that the flashing bars first appear. Ask your healthcare provider for a replacement Nutropin AQ Pen 10.

    Q: What other risk and side effect information should I be aware of?
    A: Your child's healthcare professional is your primary source of information. Discuss the potential benefits and risks of growth hormone (GH) treatment with your child's pediatric endocrinologist so you are familiar with possible side effects.

    If your child is treated at the hospital for any reason, notify your child's healthcare professional, including your child's pediatric endocrinologist, immediately.

    It is important to notify your child's doctor if allergic reactions occur, such as itching, rash, redness, or swelling at the injection site.

    Should your child develop a limp or worsened curvature of the spine, or complain of hip or knee pain, notify your child's doctor. If your child complains of headache, visual changes, nausea, and/or vomiting, notify your child's healthcare professional immediately.

    If your child has diabetes, consult your child's doctor, as GH may affect the body's response to insulin.

    Discuss with your child's doctor all medications your child is taking, particularly corticosteroids (such as prednisone or hydrocortisone), sex steroids (such as estrogens or testosterone), seizure medication or cyclosporine.

     

    WHO IS NUTROPIN FOR?

    Nutropin® [somatropin (rDNA origin) for injection] and Nutropin AQ® [somatropin (rDNA origin) injection] are human growth hormone, available by prescription only.

    Doctors prescribe Nutropin for children and teenagers with growth failure who:

    • do not make enough growth hormone on their own
    • have chronic renal insufficiency—a slow loss of kidney function—and have not had a transplant
    • have Turner syndrome
    • are not likely to grow to their potential adult height, as determined by a doctor, and whose bones are still able to grow

    Doctors prescribe Nutropin for adults who:

    • have growth hormone deficiency that started either in childhood or as an adult due to brain surgery, radiation therapy, trauma, or diseases of the pituitary gland or the hypothalamus.

    Your doctor will test to see if growth hormone is right for you.

    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

    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 cortisone, hydrocortisone, prednisone, prednisolone, dexamethasone, triamcinolone, or betamethasone
    • 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 (carpel 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, also available from your pharmacy.

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