NUTROPIN AQ® ((SOMATROPIN) INJECTION FOR SUBCUTANEOUS USE)
What is Nutropin AQ ?
Nutropin AQ [somatropin (rDNA origin)] for Injection is a human growth hormone (hGH) produced by recombinant DNA technology. Nutropin AQ has 191 amino acid residues and a molecular weight of 22,125 daltons. The amino acid sequence of the product is identical to that of pituitary-derived hGH. Nutropin AQ may contain not more than fifteen percent deamidated GH at expiration. The deamidated form of GH has been extensively characterized and has been shown to be safe and fully active.
Nutropin AQ is a sterile liquid intended for subcutaneous administration. The product is nearly isotonic at a concentration of 5 mg of GH per mL and has a pH of approximately 6.0. Each pen cartridge or NuSpin contain either 5 mg, 10 mg or 20 mg of somatropin formulated in 17.4 mg sodium chloride, 5 mg phenol, 4 mg polysorbate 20, and 10 mM sodium citrate [See HOW SUPPLIED/Storage and Handling].
Nutropin is a highly purified preparation. Biological potency is determined using a cell proliferation bioassay.
Nutropin is a sterile, white, lyophilized powder intended for subcutaneous administration after reconstitution with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved). The reconstituted product is nearly isotonic at a concentration of 5 mg/mL growth hormone (GH) and has a pH of approximately 7.4.
Each 5 mg Nutropin vial contains 5 mg (approximately 15 IU) somatropin, lyophilized with 45 mg mannitol, 1.7 mg sodium phosphates (0.4 mg sodium phosphate monobasic and 1.3 mg sodium phosphate dibasic), and 1.7 mg glycine.
Each 10 mg Nutropin vial contains 10 mg (approximately 30 IU) somatropin, lyophilized with 90 mg mannitol, 3.4 mg sodium phosphates (0.8 mg sodium phosphate monobasic and 2.6 mg sodium phosphate dibasic), and 3.4 mg glycine.
Bacteriostatic Water for Injection, USP is sterile water containing 0.9 percent benzyl alcohol per mL as an antimicrobial preservative packaged in a multidose vial. The diluent pH is 4.5–7.0.
NUTROPIN AQ effect and side effect
WHO IS NUTROPIN THERAPY FOR?
Nutropin AQ® 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.
Other Medical ProblemsTOP
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Brain tumor or
Cancer, active or
Closed epiphyses (normal bone growth stopped) in children or
Diabetic retinopathy (eye condition) or
Prader-Willi syndrome (a genetic disorder), if severely overweight or have severe breathing problems or
Severe illness after surgery or major medical emergency (eg, open heart surgery, abdominal surgery, accidental trauma, or respiratory failure)—Should not be used in patients with these conditions.
Cancer, history of or
Fluid retention, history of or
Hypopituitarism (pituitary gland produces low hormone levels) or
Hypothyroidism (underactive thyroid gland) or
Otitis media (ear infection) in children, history of or
Pancreatitis (inflammation or swelling of the pancreas) or
Scoliosis (abnormally curved spine)—Use with caution. May make these conditions worse.
Diabetes, or a family history of—Use with caution. May prevent insulin from working properly. .
Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Turner syndrome—May increase risk of having thyroid and hearing problems.
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.
How to Proper Use Nutropin AQ?
This medicine is given as a shot under your skin or into a muscle. Somatropin may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your doctor will teach you how to prepare and inject the medicine. Be sure that you understand exactly how the medicine is prepared and injected.
If you are using this medicine to treat short bowel syndrome, carefully follow your doctor’s instructions about any special diet. Take all other medicines or supplements your doctor has prescribed as part of your combination treatment.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.
There are many different forms (eg, vial, cartridge, injection device) available for this medicine. Make sure your doctor, nurse, or pharmacist instructs you on how to prepare and administer this medication. Also, read all instructions carefully to be sure you know how to use your device.
Each time you get your medicine, check to be sure you have received the proper device. Talk to your pharmacist if you have questions about the device that you were given.
You will be shown the body areas where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will help prevent skin problems from the injections.
Use a new needle, unopened vial, or syringe each time you inject your medicine.
You might not use all of the medicine in each vial (glass container). Use each vial only one time. Do not save an open vial. If the medicine in the vial has changed color, or if you see particles in it, do not use it.
Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
How should you USE AND store Nutropin AQ?
For subcutaneous injection.
Therapy with Nutropin AQ should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with growth hormone deficiency (GHD), chronic kidney disease, Turner syndrome, idiopathic short stature, or adult patients with either childhood-onset or adult-onset GHD.
Use & Storage
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Store unopened vials, cartridges, and injection devices of Nutropin® and Nutropin AQ® in the refrigerator, away from heat and direct light. Do not freeze.
Store unopened vials of Saizen® and Zorbtive® at room temperature, away from heat and direct light. Do not freeze.
Store the medicine that has been mixed in the refrigerator. The Nutropin® or Saizen® vials and Zorbtive® that has been mixed should be used within 14 days. The Saizen® click.easy® cartridge that has been mixed should be used within 21 days. Nutropin AQ® vial, cartridge, and injection device should be used within 28 days. Make sure you understand how long you can store the medicine after it has been mixed. Throw away any mixed medicine that has not been used within this time.
Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.