Content
- Genopharm HGH Somatropin 100iu
- Report Adverse Event
- 12 Otitis Media and Cardiovascular Disorders in Turner Syndrome
- Clinical Pharmacology
- 2 Prader-Willi Syndrome in Children
- 2 Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment
- DRUG INTERACTIONS
- 3 Cytochrome P450-Metabolized Drugs
- 5 Insulin and/or Oral/Injectable Hypoglycemic Agents
- Related products
- Dosage and Administration
- 2 Prader-Willi Syndrome (PWS)
- 5 Idiopathic Short Stature
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.
Genopharm HGH Somatropin 100iu
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.
Report Adverse Event
- To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display.
- A puncture-resistant container for the disposal of used syringes and needles should be strongly recommended.
- Pfizer does not foresee any long-term supply disruption and we are working to resolve the situation as quickly as possible.
- INSTRUCTIONS FOR USEGENOTROPIN 12 (JEEN-o-tro-pin 12)GENOTROPIN PEN 12 is a medical device used to mix and inject doses of reconstituted GENOTROPIN (somatropin) for injection.
- Somatropin is contraindicated in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment.
- Patients and caregivers who will administer GENOTROPIN should receive appropriate training and instruction on the proper use of GENOTROPIN from the physician or other suitably qualified health care professional.
- GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber.
- Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis.
If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away. Battery charge is low and will be empty in 1 month.Afterwards the dose can be set and your pen can be used correctly. A dose is not set.The injection button has been turned too far in the opposite direction to the arrow on the injection button while setting the dose. Attach the Needle Guard (Optional)The needle guard is intended to hide the needle before, during and after injection and to reduce needle injury. Treatment with GENOTROPIN for short stature should be discontinued when the epiphyses are fused.
- 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.
- In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension) as these patients are also at risk for these conditions.
- Clinical manifestations of fluid retention (e.g., edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent.
- Do not throw away (dispose of) the needles and syringes in the household trash.
- Introduction of somatropin treatment may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.
12 Otitis Media and Cardiovascular Disorders in Turner Syndrome
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.
Clinical Pharmacology
All of the bodily functions governed by GH are the areas that begin to suffer as you age. As GH levels drop, your skin tone deadens, wrinkles appear, and skin slackens. That is a direct result of shifting hormone levels, plus changes in blood pressure and skin sensitivity; all of which are governed by GH. This is due to decreased cell production and a reduced metabolic rate. This is due to the slower rejuvenation of cells, this time in your brain. Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use.
2 Prader-Willi Syndrome in Children
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.
2 Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment
If treatment with somatropin is initiated, these patients should be carefully monitored for development of neoplasms. GENOTROPIN is indicated for the treatment of growth failure in pediatric patients born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years. GENOTROPIN is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. Patients treated with growth hormone should be checked regularly for low serum cortisol levels and/or the need to increase the dose of the glucocorticoids they are taking.
DRUG INTERACTIONS
Limited published data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone. No adverse effects related to somatropin in the breastfeed infant have been reported. Slipped capital femoral epiphyses may occur more frequently in patients with endocrine disorders (including GHD and Turner syndrome) or in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated. In general, somatropin is contraindicated in the presence of active malignancy. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with somatropin.
3 Cytochrome P450-Metabolized Drugs
- In adults with GHD, treatment with GENOTROPIN results in reduced fat mass, increased lean body mass, metabolic alterations that include beneficial changes in lipid metabolism, and normalization of IGF-I concentrations.
- Physicians should be alert to these abnormalities, which may manifest during somatropin therapy.
- Your doctor should do tests to be sure you have GHD, as appropriate.
- In general, somatropin is contraindicated in the presence of active malignancy.
- Table 1 displays the adverse events reported by 5% or more of adult GHD patients in clinical trials after various durations of treatment with GENOTROPIN.
Table 1 displays the adverse events reported by 5% or more of adult GHD patients in clinical trials after various durations of treatment with GENOTROPIN. Also presented are the corresponding incidence rates of these adverse events in placebo patients during the 6-month double-blind portion of the clinical trials. 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. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence [see Contraindications (4)]. Weight based — based on the dosing regimen used in the original adult GHD registration trials, the recommended dosage at the start of treatment is not more than 0.04 mg/kg/week.
5 Insulin and/or Oral/Injectable Hypoglycemic Agents
- Also, patients and their doctors should check regularly for skin changes.
- Although the display is no longer visible, the dose remains available for delivery.
- Growth hormone should not be used in patients who have been recently diagnosed with cancer, with cancer, or who are being treated for cancer.
- 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.
- If a child getting growth hormone therapy starts to limp or gets hip or knee pain, the child’s doctor should be notified and the child should be examined.
- Growth hormone should not be used in patients who are critically ill because of surgery, trauma, or respiratory failure.
- Dosage of diabetes medicines may need to be adjusted during growth hormone treatment.
In vitro, preclinical, and clinical tests have demonstrated that GENOTROPIN lyophilized powder is therapeutically equivalent to human growth hormone of pituitary origin and achieves similar pharmacokinetic profiles in normal adults. In patients with GHD or PWS, treatment with GENOTROPIN also normalizes concentrations of IGF-I (Insulin-like Growth Factor-I/Somatomedin C). In adults with GHD, treatment with GENOTROPIN results in reduced fat mass, increased lean body mass, metabolic alterations that include beneficial changes in lipid metabolism, and normalization of IGF-I concentrations. The safety and efficacy of GENOTROPIN in the treatment of pediatric patients born small for gestational age (SGA) were evaluated in 4 randomized, open-label, controlled clinical trials. The safety and efficacy of GENOTROPIN in the treatment of pediatric patients with Prader-Willi syndrome (PWS) were evaluated in two randomized, open-label, controlled clinical trials. Patients received either GENOTROPIN or no treatment for the first year of the studies, while all patients received GENOTROPIN during the second year.
The mean (± standard deviation) peak (Cmax) serum levels were 23.0 (± 9.4) ng/mL and 17.4 (± 9.2) ng/mL, respectively. Serum concentrations of inorganic phosphate are increased in patients with GHD after therapy with GENOTROPIN. Linear growth is facilitated in part by increased genopharm hgh cellular protein synthesis. Nitrogen retention, as demonstrated by decreased urinary nitrogen excretion and serum urea nitrogen, follows the initiation of therapy with GENOTROPIN. Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia.
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.
Clinical Studies
GENOTROPIN lyophilized powder was compared with placebo in six randomized clinical trials involving a total of 172 adult GHD patients. GENOTROPIN was administered as a daily SC injection at a dose of 0.04 mg/kg/week for the first month of treatment and 0.08 mg/kg/week for subsequent months. The only treatment-related adverse event that occurred in more than 1 patient was joint pain. Beneficial changes in body composition were observed at the end of the 6-month treatment period for the patients receiving GENOTROPIN as compared with the placebo patients. Lean body mass, total body water, and lean/fat ratio increased while total body fat mass and waist circumference decreased.
Novartis-Bio Somatropin HGH 100iu Kit
GENOTROPIN MUST NOT BE INJECTED if the solution is cloudy or contains particulate matter. The weekly dose should be divided into 6 or 7 subcutaneous injections. Genopharm is also termed recombined Human Growth Hormone, or rHGH ( Somatropin ).
2 Prader-Willi Syndrome (PWS)
If your cartridge is nearly empty you can also dial the injection button until it cannot go any further. The dose display will then show the maximum dose that can be delivered. GENOTROPIN is supplied in a two-chamber cartridge, with the lyophilized powder in the front chamber and a diluent in the rear chamber. The metabolic fate of GENOTROPIN involves classical protein catabolism in both the liver and kidneys.
Patient Counseling Information
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.
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.
This may occur if the pen gets dirty due to contact with food, liquids or GENOTROPIN, or if the needle becomes clogged. Some liquid may appear from the needle tip, and the numbers may disappear from the dose display. To correct this, turn the injection button in the opposite direction of the arrow until numbers reappear on the dose display.
- 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.
- In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.
- If your cartridge is nearly empty you can also dial the injection button until it cannot go any further.
- Your pen should not be used near electrical or electronic equipment, including mobile phones.
- 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.
- In patients with growth hormone deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment.
- Some liquid may appear from the needle tip, and the numbers may disappear from the dose display.
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.
In order to reach the defined treatment goal, estrogen-replete women may need higher doses than men. Oral estrogen administration may increase the dose requirements in women. Both studies demonstrated statistically significant increases from baseline in all of the linear growth variables (i.e., mean height velocity, height velocity SDS, and height SDS) after treatment with GENOTROPIN (see Table 6).
Young rats at the highest dose showed increased weight gain during suckling but the effect was not apparent by 10 weeks of age. No adverse effects were observed on gestation, morphogenesis, parturition, lactation, postnatal development, or reproductive capacity of the offspring due to somatropin. In expanded post-trial extension studies, diabetes mellitus developed in 12 of 3,031 patients (0.4%) during treatment with GENOTROPIN. All 12 patients had predisposing factors, e.g., elevated glycated hemoglobin levels and/or marked obesity, prior to receiving GENOTROPIN.