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Nutropin AQ® (somatropin) FAQs

It’s normal to have questions about any kind of new diagnosis or treatment you may be given. This section will give you answers to some of the most frequently asked questions about growth hormone therapy and the devices used to give it.

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Growth Hormone Therapy and Safety Information

GH and GH Therapy FAQs

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Growth hormone (often referred to as hGH, or simply GH) is a protein that is produced by the pituitary gland. This gland is an organ about the size of a pea, located at the base of the brain. It releases GH into the bloodstream.

Your doctor may perform blood tests periodically to adjust your growth hormone dose. These blood tests measure things like insulin-like Growth Factor 1 (IGF-1), which is produced when GH tells the liver to make it. IGF-1 then goes to bones, muscles, and organs to signal growth and/or metabolism. Because IGF-1 lasts longer in the bloodstream then GH, doctors can indirectly measure the amount of GH by looking at the levels of IGF-1. Ask your doctor for details.

Common side effects reported in adults and children taking Nutropin therapy include injection site reactions. Additional common side effects in adults include swelling, joint pain, and carpal tunnel syndrome.

Nutropin therapy must be given by injection because it is a protein. If the medication were taken by mouth, it would be broken down by digestion in the stomach and intestines and would never get to the rest of the body to do its job.

Injection sites, which may be located on the thigh, upper arm, abdomen, or buttock, should always be rotated to avoid damage to the fat tissue (lipoatrophy). Even if you prefer to inject one place on your body, it is important to rotate where you inject your medication. Rotating injection sites with each injection helps to reduce the chances of problems developing at the injection site. You should call your doctor if any of the following symptoms are noticed at an injection site:

  • 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

Tell your doctor about ALL the medications your child is taking, including supplements. Make sure you discuss any new medication, especially glucocorticoid steroids like hydrocortisone or prednisone, and ANY other condition or illness your child has or develops. Your child may need the other medications, and they should not be stopped while on GH therapy unless your doctor tells you otherwise.

Depending on the cause of your GH deficiency, other pituitary hormones may be needed to keep your body healthy. GH is produced by the pituitary gland—a small gland located at the base of the brain. This small gland is responsible for releasing and controlling many hormones in our bodies. Each of these hormones is released in varying amounts into the bloodstream. Once in the blood, each hormone travels to a different part of the body to perform a specific task. GH released from the pituitary is important for growth, body composition, and lipid metabolism. Each of the other hormones released from the pituitary are important for other reasons—from salt and water regulation, to helping our bodies deal with stress. Nutropin AQ is prescribed to replace the function of GH, and other hormone medications may have been prescribed to replace other deficient hormones. Talk to your doctor if you have any questions about your medications.

Children with growth failure in CKD should continue to receive Nutropin AQ treatments up to the time they receive a kidney transplant, and subject to their healthcare team’s medical judgment.

Some children who have CKD and who are treated with GH may have a risk of increased pressure in the head (combined with visual changes, headache, nausea, and/or vomiting). Patients with growth failure in CKD should have regular check-ups to:

  • Check for any signs of a kidney-related bone disease called renal osteodystrophy
  • Make sure your child’s bones are growing as they should
  • Talk about any safety concerns
  • Monitor your child’s weight so his or her medication doses are correct
  • Monitor for complications of CKD
  • Assess your child’s nutrition
  • Check for a limp, or hip or knee pain

This is not a comprehensive list of side effects associated with Nutropin use and CKD. Please talk to your doctor for more information.

To optimize therapy for patients who require dialysis, the following guidelines for injection schedule are recommended:

  • Hemodialysis patients should receive their injection at night, just prior to going to sleep or at least 3 to 4 hours after hemodialysis. This helps to prevent the GH injection from causing a hematoma due to heparin exposure during dialysis
  • Continuous cycling peritoneal dialysis (CCPD) patients should receive their injection in the morning after they have completed dialysis
  • Continuous ambulatory peritoneal dialysis (CAPD) patients should receive their injection in the evening at the time of the overnight exchange

Healthcare professionals should assess your overall treatment plan to determine the best time of day to administer Nutropin therapy.

  • Patients having serious complications after undergoing open heart surgery, abdominal surgery, serious injuries involving many body systems, or life-threatening breathing problems. Deaths have been reported in such cases
  • Children who have Prader-Willi syndrome (PWS) and are very overweight or have a history of severe breathing problems. Deaths have been reported in children with PWS who are very overweight, have a history of blocked upper airways, sleep apnea (pauses in breathing during sleeping), or other severe breathing problems
  • Patients who have active cancer. Because growth hormone deficiency can be an early sign of some tumors in the brain or pituitary gland, the presence of these types of tumors should be ruled out by your doctor before you start Nutropin therapy
  • Patients who are allergic to somatropin, the active ingredient in Nutropin therapy, or the inactive ingredients in Nutropin therapy
  • Adults or children with certain types of eye disease caused by diabetes
  • Children and teenagers whose bones have finished growing

Yes. You should continue to take Nutropin while you are away from home, unless your doctor tells you otherwise. Supplies should be protected from light and kept inside a travel cooler, where they can be kept cold (36° to 46°F [2° to 8°C]) but never frozen. Nutropin AQ should be used within 28 days after its initial use.

Ask your travel agent or airline if there are any rules that might affect how you bring your medication and injection supplies on a plane or into another country.

Other travel tips:

  • Keep Nutropin in a cooler at 36°F to 46°F (2°C to 8°C), but do not allow it to freeze
  • Carry a copy of your prescription with you
  • GH is not known to be affected by X-ray screening
  • Take enough supplies to last for your whole trip
  • Dispose of needles and syringes safely, according to the instructions your doctor gave you. If in doubt, take them home with you for disposal

You may experience discomfort, soreness or redness where Nutropin is injected. Contact your healthcare professional immediately if you experience ongoing injection site discomfort.

Nutropin AQ® NuSpin®

Nutropin AQ® NuSpin® FAQs

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Yes. A new needle must be used for every injection. The needle is sterile only for one single injection. When you’re done, slide the outer cover over the entire needle, unscrew the needle, and dispose of it in your sharps container.

Store your NuSpin, without the needle, inside a refrigerator at 36°F to 46°F (2°C to 8°C). The device should not be left outside of the refrigerator for more than one hour per day. When you travel, place the device in a water-resistant container and put it in a cooler. DO NOT FREEZE. KEEP DRY. NuSpin devices must be used within 28 days of first use. Throw away any unused Nutropin after 28 days of first use. Before giving an injection, check the manufacturer's expiration date on the cartridge or pen. Do not use if it has expired. Do not inject medication if the solution is cloudy.

Nutropin AQ should be stored in the refrigerator in order for the active ingredients of the drug to work as expected until the manufacturer's expiration date.

No. Freezing the device will damage the pen and drug.

Ask your doctor or nurse for more advice on where to inject. You should be sure to inject Nutropin at a different recommended place on your body each time to avoid tissue breakdown. A doctor or nurse should provide injection training and supervise the first injection.

No. Water may cause the device to malfunction. Do not immerse the device in water. If your device is accidentally immersed, remove it from the water and dry it immediately. If you are concerned that the device is not functioning properly, call 1-866-NUTROPIN (1-866-688-7674).

If you drop your device, always check for damage. If you have a NuSpin, be sure that the black dose knob and the activator are moving properly. If your device is damaged, call your specialty pharmacy for a replacement, or call 1-866-NUTROPIN (1-866-688-7674).

  • The Nutropin AQ NuSpin 5 delivers a minimum dose of 0.05 mg to a maximum dose of 1.75 mg, in increments of 0.05 mg.
  • The Nutropin AQ NuSpin 10 delivers a minimum dose of 0.1 mg to a maximum dose of 3.5 mg, in increments of 0.1 mg.
  • The Nutropin AQ NuSpin 20 delivers a minimum dose of 0.2 mg to a maximum dose of 7 mg, in increments of 0.2 mg.

The very first time you use any NuSpin, you must prime it. The "P" in the window means "Prime." Note that the "P" position also indicates a dose amount.

  • On a NuSpin 5, it is a 0.35 mg dose
  • On a NuSpin 10, it is a 0.7 mg dose
  • On a NuSpin 20, it is a 1.4 mg dose

No. The cartridges are overfilled to account for this initial priming step.

If the dose knob stops before returning to 0.0, your NuSpin is empty, and you have not received your full dose. The number shown in the dose window is the amount you still need for a full dose. To get your full dose, use a full NuSpin and set it to the number shown in the window of the old NuSpin. Remember to prime the new one first before you inject. If you are not sure about giving a second injection, ask your doctor about other options.

It is normal to notice a bubble(s) after priming or before your next injection. The bubble(s) will not interfere with injections. All injection devices have bubbles after priming. However, the size and ability to see the bubbles may vary. You can’t get rid of bubbles completely because of the way the needle works with the device. NuSpin has an exposed cartridge housing that makes the bubbles and drug easy to see. If you have any further questions, talk with your doctor.

It is important that you use the proper needles on the NuSpin device. Both BD Ultra-Fine and NovaFine® AutoCover® needles work well with the NuSpin. You may also be twisting the needle too tightly on the pen device. It is important that you put the needle on the device right before the injection, and remove it right after the injection. Leaving the needle on can cause leakage. Also, after the injection is given, remember to count off 3 to 5 seconds before you withdraw the needle. If you have any further questions, talk with your doctor.

BD Ultra-Fine is a trademark of Becton, Dickinson and Company. NovaFine and Autocover are registered trademarks of Nova Nordisk A/S.

No. The NuSpin only needs to be primed once, at first use. If you have further questions, ask your doctor.

The NuSpin device is prefilled and the cartridge cannot be replaced. When the NuSpin device is empty, simply dispose of the entire device. If the empty NuSpin is disposed of with the needle attached, discard the entire device the same way you discard your used needles.

To clean the NuSpin use a damp cloth. Do not place it underwater. Do not use alcohol.

You may experience discomfort, soreness or redness where Nutropin is injected. Contact your healthcare professional immediately if you experience ongoing injection site discomfort.

Important Safety Information

INDICATIONS:

WHO IS NUTROPIN THERAPY FOR?

Nutropin AQ® (somatropin) injection for subcutaneous use is a human growth hormone that is available by prescription only.
Doctors prescribe Nutropin therapy for children and teenagers who are short or growing slowly because they:

  • Do not make enough growth hormone on their own
  • Have idiopathic short stature, which means they are shorter than 98.8% of other children of the same age and sex; are growing at a rate not likely to allow them to reach normal adult height; and no other cause of short stature can be found
  • Have Turner syndrome
  • Have chronic kidney disease (CKD) up to the time of kidney transplant

Doctors prescribe Nutropin therapy for adults who have growth hormone deficiency that began either in:

  • Adulthood as a result of pituitary disease, diseases of the hypothalamus, surgery, radiation therapy, or trauma; or
  • Childhood. Patients treated for growth hormone deficiency in childhood, whose bones have stopped growing, should be reevaluated to see if they need to continue with growth hormone therapy

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

IMPORTANT SAFETY INFORMATION

Nutropin therapy and your safety:

Please read this Important Safety Information carefully. Then, if you have any questions, talk with your doctor.

NUTROPIN THERAPY IS NOT FOR:

  • Patients having serious complications after undergoing open heart surgery, abdominal surgery, serious injuries involving many body systems, or life-threatening breathing problems. Deaths have been reported in such cases
  • Children who have Prader-Willi syndrome (PWS) and are very overweight or have a history of severe breathing problems. Deaths have been reported in children with PWS who are very overweight, have a history of blocked upper airways, sleep apnea (pauses in breathing during sleeping), or other severe breathing problems
  • Patients who have active cancer. Because growth hormone deficiency can be an early sign of some tumors in the brain or pituitary gland, the presence of these types of tumors should be ruled out by your doctor before you start Nutropin therapy
  • Patients who are allergic to somatropin, the active ingredient in Nutropin therapy, or the inactive ingredients in Nutropin therapy
  • Adults or children with certain types of eye disease caused by diabetes
  • Children and teenagers whose bones have finished growing

What should you tell your doctor before starting Nutropin therapy?

  • If you take cyclosporine, hormone replacement therapy, insulin or other diabetes medications, drugs containing steroids, or drugs for seizures. These medications may need to be adjusted during Nutropin therapy
  • If you had cancer as a child. An increased risk of a new tumor, particularly certain brain tumors, has been reported in patients taking Nutropin therapy. If you have pre-existing tumors or growth hormone deficiency caused by abnormal tissue in the brain, you should be watched closely for the worsening or return of this condition
  • If you have diabetes, risk factors for diabetes, or impaired glucose tolerance. If so, your doctor should monitor your blood sugar closely during Nutropin therapy. New cases of type 2 diabetes have been reported in patients taking Nutropin therapy
  • If you have pituitary hormone deficiency(s) (an inability of the pituitary gland to produce sufficient hormones) or adrenal hormone deficiency (an inability of the adrenal glands to produce sufficient hormones, primarily cortisol). Your doctor may further monitor your hormone levels or your hormone replacement therapy closely while you are taking Nutropin therapy
  • If you are pregnant, nursing, or plan to become pregnant. It is not known whether Nutropin is excreted in human milk. Nutropin therapy should be used during pregnancy only when clearly needed

While taking Nutropin, contact your doctor immediately if you experience:

  • Changes in upper airway obstruction (including onset of or increased snoring) and/or new onset sleep apnea, in patients with PWS. These patients should also have effective weight control and be monitored by a doctor for signs of respiratory infection
  • Changes in vision, a bad headache, or nausea with or without vomiting. This may be a sign of increased pressure in the brain
  • Any allergic reaction you experience to the injection of Nutropin therapy
  • A limp or have hip or knee pain
    • A fracture in the ball of the hip joint can occur in children who have endocrine problems and in children who have rapid growth
    • Children with growth failure due to CKD should be examined periodically for evidence of loss of bone minerals. Hip x-rays should be taken before starting Nutropin therapy in these children
  • Progression of scoliosis (curvature of the spine) that can occur in children who have rapid growth. Nutropin therapy has not been shown to increase the occurrence of this condition
  • Increases in laboratory test serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone (PTH), or IGF-1
  • Abdominal pain. Cases of pancreatitis (inflammation of the pancreas) have been reported rarely in children and adults receiving Nutropin therapy

Other important information about Nutropin

  • Adults may retain water during Nutropin therapy. This may be brief but may increase with higher doses of Nutropin therapy
  • Patients should have their thyroid function tested periodically during Nutropin therapy. Thyroid hormone treatment may need to be started or adjusted
  • Patients should be sure to inject Nutropin at a different recommended place on their body each time to avoid tissue breakdown. A doctor or nurse should provide injection training and supervise the first injection
  • The use of Nutropin therapy has not been studied in patients over 65 years of age. Elderly patients may be more sensitive to Nutropin therapy and may experience more side effects
  • Patients with Turner syndrome should be monitored closely by a doctor for ear infections and cardiovascular problems during Nutropin therapy

What are common possible side effects of Nutropin therapy?

Common side effects reported in adults and children taking Nutropin therapy include injection site reactions. Additional common side effects in adults include swelling, joint pain, and carpal tunnel syndrome.

You may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

How should you store Nutropin?

Nutropin must be kept refrigerated (36° to 46°F [2° to 8°C]). Do not freeze. Cartridges and NuSpin pens must be used within 28 days of initial use. Throw away any unused Nutropin after 28 days of initial use. Before giving an injection, check the manufacturer’s expiration date on the cartridge or pen. Do not use if it has expired. Do not inject medication if the solution is cloudy.

Please see accompanying Nutropin full Prescribing Information for additional Important Safety Information.