GENOTROPIN® somatropin for Injection Official Site Safety Info

In renal cells, at least a portion of the breakdown products are returned to the systemic circulation. The mean terminal half-life of intravenous GENOTROPIN in normal adults is 0.4 hours, whereas subcutaneously administered GENOTROPIN has a half-life of 3.0 hours in GHD adults. The observed difference is due to slow absorption from the subcutaneous injection site. In healthy adult males, following an SC injection in the thigh of 0.03 mg/kg, the extent of absorption (AUC) of a concentration of 5.3 mg/mL GENOTROPIN was 35% greater than that for 1.3 mg/mL GENOTROPIN.

Instructions for Use GENOTROPIN 12

Hold the GENOTROPIN MINIQUICK with the needle-end pointing up, and re-attach and screw the needle directly (not at an angle) on top of the device. Blank screenTo save the battery energy, the dose display is activated for 2 minutes and then automatically disappears. Although the display is no longer visible, the dose remains available for delivery. The injection button is rotated too fast or too slow.Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.

• Skeletal abnormalities including scoliosis are commonly seen in untreated Turner syndrome patients.
• The pen has a use period of 2 years starting from the first use by the patient.
• GENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients.
• That is a direct result of shifting hormone levels, plus changes in blood pressure and skin sensitivity; all of which are governed by GH.
• Published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children.
• Limited published data indicate that somatropin treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance in man.

2 Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment

INSTRUCTIONS FOR USEGENOTROPIN 5 (JEEN-o-tro-pin 5)GENOTROPIN PEN 5 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection. The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. In GHD patients, administration of somatropin has resulted in lipid mobilization, reduction in body fat stores, and increased plasma fatty acids. Somatropin is a human growth hormone produced by recombinant DNA technology in Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of 22,124 daltons.

3 Preparation and Administration

It should be used with caution in nursing mothers because it is not known whether growth hormone is passed into human milk. Growth hormone should not be used in patients who are critically ill because of surgery, trauma, or respiratory failure. Growth hormone should not be used to increase height in children after the growth plates have closed. The display will continue to show until the battery is completely empty. Your pen can still be used correctly, but the dose size will not be displayed. The selected dose size.The number indicates the dose size (in mg) that your pen will deliver if the injection button is fully pressed in.

Instructions for Use GENOTROPIN MINIQUICK

Patients with scoliosis should be checked regularly to make sure their scoliosis does not get worse during their growth hormone therapy. If necessary, your child’s doctor may prescribe GENOTROPIN, which is a growth hormone therapy for children and adults with certain growth disorders. Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 12Put the used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the needles and cartridges in the household trash. Throwing away (disposing of) used needles, cartridges and your GENOTROPIN PEN 5Put the used needles and cartridges in a FDA-cleared sharps disposal container right away after use. Following a 0.03 mg/kg subcutaneous (SC) injection in the thigh of 1.3 mg/mL GENOTROPIN to adult GHD patients, approximately 80% of the dose was systemically available as compared with that available following intravenous dosing.

2 Prader-Willi Syndrome (PWS)

Cases of pancreatitis have been reported rarely in children and adults receiving somatropin treatment, with some evidence supporting a greater risk in children compared with adults. Published literature indicates that girls who have Turner syndrome may be at greater risk than other somatropin-treated children. Pancreatitis should be considered in any somatropin–treated patient, especially a child, who develops persistent severe abdominal pain. The safety and effectiveness of GENOTROPIN in patients aged 65 and over have not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of GENOTROPIN, and therefore may be more prone to develop adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.2)].

• Similar bioavailability has been observed in healthy adult male subjects.
• That is a direct result of shifting hormone levels, plus changes in blood pressure and skin sensitivity; all of which are governed by GH.
• Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi.
• Attach the Needle Guard (Optional)The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury.
• Elderly patients may be more sensitive to the action of GENOTROPIN, and therefore may be more prone to develop adverse reactions.
• Skeletal abnormalities including scoliosis are commonly seen in untreated Turner syndrome patients.
• Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins.

Clinical Pharmacology

The amino acid series in Genopharm is identical to the body’s naturally produced human growth hormone (HGH). In studies of GENOTROPIN in children with Turner syndrome, side effects included flu, throat, ear, or sinus infection, runny nose, joint pain, and urinary tract infection. Use a different place on the body each day for growth hormone injections. This can help to prevent skin problems such as lumpiness or soreness. Growth hormone should not be used in patients who have been recently diagnosed with cancer, with cancer, or who are being treated for cancer. So, the presence of these brain tumors should be ruled out before treatment is started.

Clinical Studies

Limited published data indicate that somatropin treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance in man. These data suggest that somatropin administration may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, cyclosporine). Careful monitoring is advisable when somatropin is administered in combination with other drugs known to be metabolized by CYP450 liver enzymes.

• Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus.
• In studies of GENOTROPIN in children with GHD, side effects included injection site reactions, such as pain, redness/swelling, inflammation, bleeding, scarring, lumps, or rash.
• The linear growth response was greater in Study 055 wherein patients were treated with a larger dose of GENOTROPIN.
• If necessary, your child’s doctor may prescribe GENOTROPIN, which is a growth hormone therapy for children and adults with certain growth disorders.
• Patients received either GENOTROPIN or no treatment for the first year of the studies, while all patients received GENOTROPIN during the second year.
• A total of 38 patients were treated with GENOTROPIN alone in the two studies.
• Safety and effectiveness of GENOTROPIN have been established in pediatric patients with ISS based on data from one randomized, open-label, clinical trial with GENOTROPIN in 102 pediatric patients [see Clinical Studies (14.5)].
• The injection button is rotated too fast or too slow.Point the pen away from your face, press the injection button, press the red release button and continue preparing your dose.

10 Slipped Capital Femoral Epiphyses in Pediatric Patients

• Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone [see Dosage and Administration (2)].
• Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended.
• In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent GHD and were treated with somatropin, an increased risk of a second neoplasm has been reported.
• In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence [see Contraindications (4)].
• If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplasms.
• In patients with GHD or PWS, treatment with GENOTROPIN also normalizes concentrations of IGF-I (Insulin-like Growth Factor-I/Somatomedin C).
• Elderly patients may be more likely to have side effects with growth hormone therapy.
• Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated.
• Changes in body composition were also observed in the patients receiving GENOTROPIN (see Table 4).

Safety and effectiveness of GENOTROPIN have been established in pediatric patients with ISS based on data from one randomized, open-label, clinical trial with GENOTROPIN in 102 pediatric patients [see Clinical Studies (14.5)]. Fluid retention during somatropin replacement therapy in adults may occur. Clinical manifestations of fluid retention (e.g., edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent. Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, practitioners should thoroughly consider the risks and benefits of starting somatropin in these patients.

Instructions for Use GENOTROPIN 5

In the event of an allergic reaction, seek prompt medical attention. Growth hormone should not be used in children with Prader-Willi syndrome who are very overweight or have severe breathing problems. The problem could be because the needle has been inserted at an angle onto the rubber stopper.Carefully replace the outer needle cover on the needle and unscrew counterclockwise (turn to the left) to remove the needle.

Novartis-Bio Somatropin HGH 100iu Kit

Children receiving 0.48 mg/kg/week demonstrated a significant improvement in height standard deviation score (SDS) compared with children treated with 0.24 mg/kg/week. Both of these doses resulted in a slower but constant increase in growth between months 24 to 72 (data not shown). Changes in body composition were also observed in the patients receiving GENOTROPIN (see Table 4). These changes included a decrease in the amount of fat mass, and increases in the amount of lean body mass and the ratio of lean-to-fat tissue, while changes in body weight were similar to those seen in patients who received no treatment.

• The doses of antihyperglycemic drugs (i.e., insulin or oral/injectable agents) may require adjustment when somatropin therapy is instituted in these patients.
• Some cases of pancreatitis (inflamed pancreas) have been reported rarely in children and adults receiving growth hormone.
• Thyroid function should be checked regularly during growth hormone therapy.
• In studies of GENOTROPIN in children with GHD, side effects included injection site reactions, such as pain, redness/swelling, inflammation, bleeding, scarring, lumps, or rash.
• In the event of an allergic reaction, seek prompt medical attention.
• The linear growth response was greater in Study 055 wherein patients were treated with a larger dose of GENOTROPIN.
• Safety and effectiveness of GENOTROPIN have been established in pediatric patients with ISS based on data from one randomized, open-label, clinical trial with GENOTROPIN in 102 pediatric patients [see Clinical Studies (14.5)].

Growth hormone should not be used if it is shown that a previous brain tumor has come back or is getting larger. GENOTROPIN MINIQUICK is a device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject a single dose of GENOTROPIN. The GENOTROPIN 5 mg and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN PEN delivery device. The 5 mg cartridge has a green tip to match the green pen window on the Pen 5, while the 12 mg cartridge has a purple tip to match the purple pen window on the Pen 12.

Scoliosis is also commonly seen in untreated patients with Prader-Willi syndrome. Physicians should be alert to these abnormalities, which may manifest during somatropin therapy. A lower starting dose and smaller dose increments should be considered for older patients, who are more prone to the adverse effects of somatropin than younger individuals. In addition, obese individuals are more likely to manifest adverse effects when treated with a weight-based regimen.

DOSAGE FORMS AND STRENGTHS

Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses. GENOTROPIN cartridges contain m-Cresol and should not be used by patients allergic to it. Growth hormone should only be used during pregnancy if clearly needed.

Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders since these patients have an increased risk of ear and hearing disorders. Somatropin treatment may increase the occurrence of otitis media in patients with Turner syndrome. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) genopharm hgh as these patients are also at risk for these conditions. Monitor patients on somatropin therapy carefully for increased growth, or potential malignant changes, of preexisting nevi. In studies of GENOTROPIN in adults with GHD, side effects included fluid retention, joint or muscle pain, stiffness, and changes in sensation. Usually these side effects did not last long and depended on the dose of GENOTROPIN being taken.

Adverse Reactions

The amino acid sequence is identical to that of human growth hormone of pituitary origin. In patients on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal [see Dosage and Administration (2.2)]. GENOTROPIN is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients.

The reconstituted concentration is 5 mg/mL with a deliverable volume of 1 mL. In patients with diabetes mellitus requiring drug therapy, the dose of insulin and/or oral/injectable agent may require adjustment when somatropin therapy is initiated [see Warnings and Precautions (5.4)]. Pharmacologic glucocorticoid therapy and supraphysiologic glucocorticoid treatment may attenuate the growth‑promoting effects of somatropin in children. Therefore, glucocorticoid replacement dosing should be carefully adjusted in children receiving concomitant somatropin and glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS).

These effects on body composition were maintained when treatment was continued beyond 6 months. Bone mineral density declined after 6 months of treatment but returned to baseline values after 12 months of treatment. In perinatal and postnatal studies in rats, somatropin doses of 0.3, 1, and 3.3 mg/kg/day produced growth‑promoting effects in the dams but not in the fetuses.

Of the 3,031 patients receiving GENOTROPIN, 61 (2%) developed symptoms of carpal tunnel syndrome, which lessened after dosage reduction or treatment interruption (52) or surgery (9). Other adverse events that have been reported include generalized edema and hypoesthesia. These events were reported early during therapy and tended to be transient and/or responsive to dosage reduction. Response to somatropin therapy in pediatric patients tends to decrease with time.

The 5 mg and 12 mg presentations of GENOTROPIN lyophilized powder contain m-cresol as a preservative. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6)]. The GENOTROPIN dosage and administration schedule should be individualized based on the growth response of each patient. As a bodybuilding drug, HGH supplements increase lean body mass, shorten recovery time between workouts, and enhance overall performance with less risk of detection than other performance-enhancing drugs. Genopharm is produced by gene recombination DNA technology (rHGH ) . It contains high purity human growth hormone (HGH) consisting of 191 amino acids.

In childhood cancer survivors, treatment with growth hormone may increase the risk of a new tumor, particularly certain benign brain tumors. This risk may be higher in patients who were treated with cranial radiation. Also, patients and their doctors should check regularly for skin changes. As seen in Table 6, height velocity SDS and height SDS values were smaller at baseline and after treatment with GENOTROPIN when the normative standards were utilized as opposed to the Turner syndrome standard. Patients who received GENOTROPIN showed significant increases in linear growth during the first year of study, compared with patients who received no treatment (see Table 3). Linear growth continued to increase in the second year, when both groups received treatment with GENOTROPIN.

Patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin therapy. The doses of antihyperglycemic drugs (i.e., insulin or oral/injectable agents) may require adjustment when somatropin therapy is instituted in these patients. Non-weight based — based on published consensus guidelines, a starting dose of approximately 0.2 mg/day (range, 0.15–0.30 mg/day) may be used without consideration of body weight. The dose should be decreased as necessary on the basis of adverse events and/or serum IGF-I concentrations above the age- and gender-specific normal range. Maintenance dosages vary considerably from person to person, and between male and female patients. Two randomized, open-label, clinical trials were conducted that evaluated the efficacy and safety of GENOTROPIN in Turner syndrome patients with short stature.

The injection button is rotated too fast or too slow.Point your pen away from your face, press the injection button, press the red release button and continue preparing your dose. The pen has a use period of 2 years starting from the first use by the patient. Your pen should not be used near electrical or electronic equipment, including mobile phones. If your pen has been damaged, it should not be used and should be disposed of as instructed by your healthcare provider. Please see accompanying directions for use of the reconstitution and/or delivery device.

The linear growth response was greater in Study 055 wherein patients were treated with a larger dose of GENOTROPIN. Adult GHD patients treated with GENOTROPIN at the recommended adult dose [see Dosage and Administration (2)] demonstrate a decrease in fat mass and an increase in lean body mass. When these alterations are coupled with the increase in total body water, the overall effect of GENOTROPIN is to modify body composition, an effect that is maintained with continued treatment.

Turner syndrome patients were treated with GENOTROPIN alone or GENOTROPIN plus adjunctive hormonal therapy (ethinylestradiol or oxandrolone). A total of 38 patients were treated with GENOTROPIN alone in the two studies. In Study 055, 22 patients were treated for 12 months, and in Study 092, 16 patients were treated for 12 months. Patients received GENOTROPIN at a dose between 0.13 to 0.33 mg/kg/week. Patients who received any dose of GENOTROPIN showed significant increases in growth during the first 24 months of study, compared with patients who received no treatment (see Table 5).

Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses in susceptible patients. As a result, previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. Therefore, glucose levels should be monitored periodically in all patients treated with somatropin, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus.