Zomacton® is the prescription human growth hormone made by Ferring Pharmaceuticals. It is human growth hormone (somatropin) derived from recombinant DNA (rDNA). Zomacton® is injected to replace growth hormone that is not being adequately produced by your body. Since it is made from recombinant DNA, it is in fact, identical in structure to the natural growth hormone made by the body’s pituitary gland.
Dosage Forms and Strengths Available
Zomacton® for injection is supplied as 5 mg and 10 mg of lyophilized, sterile somatropin per vial. The 5mg package contains one vial of ZOMACTON (5 mg per vial) and one vial of diluent [5 mL of bacteriostatic 0.9% sodium chloride for injection, USP (benzyl alcohol preserved)].
The 10 mg carton contains one vial of Zomacton® (10 mg per vial), one syringe of diluent [1 mL of bacteriostatic water for injection with 0.33% metacresol as preservative] and a 25G reconstitution needle, and is supplied in single cartons.
Because some patients may prefer a needle free device, Zomacton® is also available as a proprietary injectable pen – Zoma-Jet 5™. The Zoma-Jet™ device can administer HGH by using a spring to push the active ingredient in solution or suspension through a micro-fine opening in the needle-free syringe.
The primary and most intensively studied benefit of Zomacton® in adults and children with GHD is the stimulation of linear growth.
In clinical studies, Zomacton® has been shown to stimulate linear growth in patients who lack adequate levels of internally produced human growth hormone. In addition to tissue growth, other documented benefits of Zomacton® include:
Increased protein metabolism
Improved carbohydrate metabolism
Improved Lipid Metabolism/Reduction of Body Fat
Improved Mineral Metabolism – particularly resulting in an increase in bodily potassium and phosphorus levels
Improved tissue metabolism – particularly an increase in collagen production
According to the manufacturer the most common possible side effects of Zomacton® include:
Upper respiratory infection
Sore throat (pharyngitis)
Headache, earache (otitis media)
Swollen hands/feet or ankles (edema)
Joint or muscle pain/discomfort (arthralgia, paresthesia, myalgia)
Runny or stuffy nose (rhinitis), back pain, flu symptoms, and changes in liver function (AST)
Some of the potentially severe, though less common side effects of Zomacton® include:
Pancreatitis (children and adults)
Leukemia has been reported in a small number of patients treated with Zomacton®
New-onset type 2 diabetes mellitus has been reported
See your medication’s insert for a complete list of potential side-effects.
Your prescription for Zomacton® will be tailored to best meet your particular goals and lifestyle. You will be carefully monitored over the course of your treatment with Zomacton®, 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 Zomacton®.
Never exceed the recommended dosage of Zomacton® prescribed by your doctor. Acute overdose could cause initial hypoglycemia and subsequent hyperglycemia. Repeated use of doses in excess of those recommended could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess human growth hormone.
As with all medications, in case of accidental overdose, seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Keep Zomacton® and all prescription medications out of the reach of children.
According to its manufacturer, Zomacton® should not be used by:
Patients who have acute critical illness after heart or abdominal surgery, multiple trauma or acute severe breathing problems
Pediatric patients with Prader-Willi syndrome who are severely overweight, have sleep apnea or a history of or existing severe breathing problems
Patients who have active cancer
Patients who are allergic to any of the ingredients provided with ZOMACTON®
Patients with severe visual problems caused by diabetes
Pediatric patients whose growth plates have closed
Before accepting a prescription for Zomacton®, tell your doctor:
If you have or had cancer as a child. Tell your doctor if you experience changes in behavior, headaches, problems with vision, changes in skin coloration or changes in pre-existing moles/birthmarks.
If you have diabetes, pre-diabetes, or risk factors for diabetes.
If you have any visual changes, headache, nausea, and/or vomiting while taking Zomacton®. This may be a sign of increased pressure in the brain. Routine eye exams should be performed by your doctor.
If you are allergic to somatropin or any of its ingredients. Seek prompt medical attention if you experience an allergic reaction.
If you are retaining water during treatment. Depending on your dose, this may frequently occur, however, it is usually brief.
If you have hypoadrenalism and are receiving glucocorticoid replacement therapy. Your doctor may need to adjust the dose of your medication.
Thyroid function should be checked periodically. Thyroid hormone replacement may need to be started or adjusted during Zomacton® therapy.
If you develop a limp or have hip or knee pain during Zomacton® treatment. A fracture in the ball of the hip joint can occur in pediatric patients who have rapid growth.
If you have scoliosis. Progression of existing scoliosis can occur and should be monitored during treatment in pediatric patients who have rapid growth.
If you have abdominal pain. Cases of pancreatitis have been reported in patients and may be greater in pediatric patients receiving somatropin.
If you are taking any other medications because they may affect each how each other works. Your doctor may adjust the dose of ZOMACTON® or of the other medications you are taking.
If you are pregnant or nursing. If ZOMACTON® 5 mg is needed while pregnant or nursing, it should be mixed with normal saline or use ZOMACTON® 10 mg, which contains a benzyl alcohol-free formulation.
How to Use
Zomacton® is injected into a muscle or under the skin, to the back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites. You will be shown exactly how to administer your Zomacton® 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
To further assist with the Zomacton® injection process, you may download this convenient complete step-by-step instruction guide for Zomacton®5 and Zomacton®10 provided by the manufacturer.
The daily dosage of Zomacton® varies by your age, weight and the condition it is being prescribed for. The recommended dose is up to 0.1 mg/kg administered subcutaneously three (3) times per week (up to 0.3 mg/kg/week).
According to the Prescribing Information provided by the National Institutes for Health, Zomacton® should be administered subcutaneously as follows:
Pediatric dosage: Divide the calculated weekly dosage into equal doses given either 3, 6, or 7 days per week
GH deficiency: 0.18 mg/kg/week to 0.3 mg/kg/week
Turner syndrome: Up to 0.375 mg/kg/week
ISS: Up to 0.37 mg/kg/week
SHOX deficiency: 0.35 mg/kg/week
SGA: Up to 0.47 mg/kg/week
Adult dosage: Either of the following two dosing regimens may be used:
Non-weight based dosing: Initiate with a dose of approximately 0.2 mg/day (range, 0.15 mg/day to 0.3 mg/day) and increase the dose every 1 to 2 months by increments of approximately 0.1 mg/day to 0.2 mg/day, according to individual patient requirements
Weight-based dosing (Not recommended for obese patients): Initiate at 0.006 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.0125 mg/kg daily
*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 Zomacton®