Omnitrope® is the prescription human growth hormone made by Sandoz. It is created in the lab using recombinant DNA, so that its amino acid sequences are is identical to that of the human growth hormone (somatropin) that is normally produced by your pituitary gland. It is prescribed for people with growth failure due to GHD, Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, and Idiopathic Short Stature. It is also indicated for adults with growth hormone disorders. Omnitrope® may also be used to prevent severe weight loss in people with AIDS, or to treat short bowel syndrome.
Dosage Forms and Strengths Available
Omnitrope® is available as an injectable cartridge, or as standard injectable vials. Omnitrope® Cartridge is a clear, colorless, sterile solution for subcutaneous injection. Omnitrope® for Injection is a lyophilized powder that is reconstituted for subcutaneous injection.
Omnitrope® Cartridges and vials (for injection) are available as :
5 mg/1.5 mL Cartridge is a prefilled sterile somatropin solution containing benzyl alcohol in a glass cartridge ready to be administered with the Omnitrope® Pen 5
10 mg/1.5 mL Cartridge is a prefilled sterile somatropin solution in a glass cartridge ready to be administered with the Omnitrope® Pen 10.
5.8 mg/vial is supplied with two vials, one containing somatropin as a powder and the other vial containing diluent (Bacteriostatic Water for Injection containing benzyl alcohol as a preservative)
The primary and most intensively studied benefit of Omnitrope® in adults and children with GHD is the stimulation of linear growth. In addition to tissue growth, other documented benefits of Omnitrope® include:
Increased protein metabolism
Improved carbohydrate metabolism
Improved Lipid Metabolism
Improved Mineral Metabolism – particularly resulting in an increase in bodily potassium and phosphorus levels
Improved tissue metabolism – particularly an increase in collagen production
More common – some of the more common side effects of Omnitrope® include:
Injection site reactions (redness, soreness, swelling, rash, itching, pain, or bruising),
Pain in your arms or legs
Joint stiffness or pain
Cold-like symptoms such as stuffy nose, sneezing, sore throat.
Less common – some of the potentially severe, though less common side effects of Omnitrope® include:
Severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate
Increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss
Sudden and severe pain behind your eyes, vision changes
Swelling in your head, face, hands, or feet
Numbness or tingling in your wrist, hand, or fingers
See your medication’s insert for a complete list of potential side-effects.
Your prescription for Omnitrope® will be tailored to best meet your particular goals and lifestyle. You will be carefully monitored over the course of your treatment with Omnitrope®, so any chance of side effects should be kept to a minimum. Tell your doctor if you are experiencing any of these or other side effects while taking Omnitrope®.
Overdose can cause tremors or shaking, cold sweats, increased hunger, headache, drowsiness, weakness, dizziness, fast heartbeat, and nausea. Long-term overdose may cause excessive growth.
As with any medication, in case of accidental overdose, seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Keep Omnitrope® and all prescription medications out of the reach of children.
According to its manufacturer, Omnitrope® should not be used in children and adults with any of the following medical conditions because serious side effects, including death, can occur:
A critical illness caused by certain types of heart or stomach surgery, serious injury or a sudden and severe breathing problem (respiratory failure)
Prader-Willi syndrome sufferers who are severely overweight or have a history of breathing problems including sleep apnea
Cancer or other tumors
Allergies to growth hormone or any of the ingredients in the medicine
Certain types of eye problems caused by diabetes
Omnitrope® should also not be used in children who have completed their growth
Before accepting a prescription for Omnitrope®, tell your doctor if you have ever had an allergic reaction to a growth hormone medicine, or to drug preservatives such as benzyl alcohol, metacresol or glycerin.
In addition to the contraindications listed above, you should not take Omnitrope® if you are allergic to somatropin, or if you have:
Diabetic retinopathy (a serious eye condition caused by diabetes)
Recently undergone open heart surgery or stomach surgery
Recently experienced trauma or other medical emergency
Breathing problems (such as lung failure).
To make sure you can safely take Omnitrope®, tell your doctor if you have any of these other conditions:
Kidney disease (or if you are on dialysis)
A pituitary gland disorder
High blood pressure (hypertension);
A pancreas disorder (especially in children)
Carpal tunnel syndrome
How to Use
Omnitrope® is injected into a muscle or under the skin. You will be shown exactly how to administer your Omnitrope® injections. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Use exactly as prescribed by your doctor
Do not use in larger or smaller amounts or for longer than recommended.
Follow the directions on your prescription label
Use a different place on your body each time you give the injection
Do not inject this medicine into skin or muscle that is red, sore, infected, or injured
If using the vial form:
Do not shake the medication bottle or you may ruin the medicine
When mixing use a gentle swirling motion.
Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.
Use a disposable needle only once
Throw away used needles in a puncture-proof container (ask your doctor or pharmacist where you can get one and how to dispose of it)
Keep this container out of the reach of children and pets
The daily dosage of Omnitrope® varies by your age, weight and the condition it is being prescribed for. The weekly dose is usually divided over 6 or 7 days of subcutaneous injections. For most adult patients with GHD, the recommended dosage at the start of therapy is not more than 0.04 mg/kg/week given as a daily subcutaneous injection. According to the Prescribing Information provided by the National Institutes for Health, Omnitrope® should be administered subcutaneously as follows:
Pediatric GHD: 0.16 to 0.24 mg/kg/week, divided into 6 to 7 daily injections
Prader-Willi Syndrome: 0.24 mg/kg/week, divided into 6 to 7 daily injections
Small for Gestational Age: Up to 0.48 mg/kg/week, divided into 6 to 7 daily injections
Turner Syndrome: 0.33 mg/kg/week, divided into 6 to 7 daily injections
Idiopathic Short Stature: Up to 0.47 mg/kg/week, divided into 6 to 7 daily injections
Adult GHD: not more than 0.04 mg/kg/week (divided into daily injections) to be increased as tolerated to not more than 0.08 mg/kg/week); to be increased gradually every 1 to 2 months
OMNITROPE® Cartridges 5 mg/1.5 mL and 10 mg/1.5 mL must be used with the corresponding OMNITROPE® Pen 5 and Pen 10 delivery system, respectively
Injection sites should always be rotated to avoid lipoatrophy ( 2.3)
*Dosing information is provided for informational purposes only, and should not be construed as any kind of instructions for use. Consult your physician or pharmacist for guidance regarding your particular dose of Omnitrope®