GENOTROPIN® somatropin for Injection Official Site Safety Info

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).

• In general, somatropin is contraindicated in the presence of active malignancy.
• Physicians should be alert to these abnormalities, which may manifest during somatropin therapy.
• 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.
• Serum concentrations of inorganic phosphate are increased in patients with GHD after therapy with GENOTROPIN.
• Patients received GENOTROPIN at a dose between 0.13 to 0.33 mg/kg/week.
• 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.
• Growth hormone should not be used in children with Prader-Willi syndrome who are very overweight or have severe breathing problems.
• The GENOTROPIN 5 mg and 12 mg cartridges are color-coded to help ensure proper use with the GENOTROPIN PEN delivery device.

DOSAGE FORMS AND STRENGTHS

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 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.

Clinical Studies

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.

2 Prader-Willi Syndrome in Children

Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism. In patients with growth hormone deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Therefore, patients treated with somatropin should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated. Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment [see Drug Interactions (7.1)].

1 Pediatric Patients

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. A puncture-resistant container for the disposal of used syringes and needles should be strongly recommended. Patients and/or parents genopharm hgh should be thoroughly instructed in the importance of proper disposal, and cautioned against any reuse of needles and syringes. This information is intended to aid in the safe and effective administration of the medication. The mean clearance of subcutaneously administered GENOTROPIN in 16 GHD adult patients was 0.3 (± 0.11) L/hrs/kg.

GENOTROPIN® Quick Finder

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.

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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 5

Progression of scoliosis can occur in patients who experience rapid growth. Because somatropin increases growth rate, patients with a history of scoliosis who are treated with somatropin should be monitored for progression of scoliosis. However, somatropin has not been shown to increase the occurrence of scoliosis. Skeletal abnormalities including scoliosis are commonly seen in untreated Turner syndrome patients.

Report Adverse Event

Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended. Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.2). You are no longer growing, so you no longer need to generate as many new cells on a regular basis. GH directly influences the growth and development of cells, bones, cartilage, muscles, skin, blood vessels, nerves, liver and kidneys.

5 Idiopathic Short Stature

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.

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.

2 Dosing of Adult Patients

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.

Instructions For Use

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 ).

• Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins [see Warnings and Precautions (5.6)].
• Treatment with GENOTROPIN for short stature should be discontinued when the epiphyses are fused.
• GENOTROPIN PEN 5 is a reusable multi-dose device holding a 2-chamber cartridge of GENOTROPIN, used to mix and inject GENOTROPIN during a 2 year use period.
• Lower copulation and pregnancy rates were also observed at 3.3 mg/kg/day.
• In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of somatropin treatment [see Drug Interactions (7.1)].
• In children experiencing rapid growth, curvature of the spine may develop or worsen.

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.

• 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.
• This can help to prevent skin problems such as lumpiness or soreness.
• The indicative scale along the side of the cartridge window is a guide.
• If you have any questions about your dose or your treatment with GENOTROPIN, call your healthcare provider right away.
• 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.
• 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)].
• Put the used GENOTROPIN MINIQUICK and needles in a FDA-cleared sharps disposal container right away after use.
• Battery charge is low and will be empty in 1 month.Afterwards the dose can be set and your pen can be used correctly.

Instructions for Use GENOTROPIN 12

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.

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.

Adverse Reactions

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.

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.

GENOTROPIN was administered as a daily SC injection, and the dose was calculated for each patient every 3 months. In Study 1, the treatment group received GENOTROPIN at a dose of 0.24 mg/kg/week during the entire study. During the second year, the control group received GENOTROPIN at a dose of 0.48 mg/kg/week. In Study 2, the treatment group received GENOTROPIN at a dose of 0.36 mg/kg/week during the entire study. During the second year, the control group received GENOTROPIN at a dose of 0.36 mg/kg/week. Undiagnosed/untreated hypothyroidism may prevent an optimal response to somatropin, in particular, the growth response in children.

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.