Omnitrope (SurePal): Uses, Dosage & Side Effects

What Is Omnitrope and What Is It Used For?

Omnitrope (somatropin) is a recombinant human growth hormone that is structurally identical to the growth hormone naturally produced by the pituitary gland. It is used to treat growth failure in children and growth hormone deficiency (GHD) in adults, promoting skeletal growth, muscle development, and proper fat metabolism.

Growth hormone is essential for normal development throughout childhood and adolescence, and continues to play important metabolic roles in adulthood. When the pituitary gland does not produce enough growth hormone, the body cannot grow and develop properly. Omnitrope replaces the missing hormone, restoring normal growth patterns and metabolic function.

Omnitrope is manufactured using recombinant DNA technology, meaning it is produced by genetically engineered bacteria (Escherichia coli) rather than extracted from human or animal tissue. This manufacturing process ensures a highly pure product with a 191-amino acid sequence identical to that of endogenous human growth hormone. As a biosimilar medicine, Omnitrope was first approved by the European Medicines Agency (EMA) in 2006 and has since been approved globally, including by the U.S. Food and Drug Administration (FDA).

The mechanism of action involves somatropin binding to growth hormone receptors on target cells throughout the body. This binding triggers a cascade of intracellular signaling that stimulates the production of insulin-like growth factor 1 (IGF-1), primarily in the liver. IGF-1 is the main mediator of growth hormone's effects on bone and tissue growth, protein synthesis, and metabolic regulation.

Indications in Children

In pediatric patients, Omnitrope is approved for several growth-related conditions:

• Growth hormone deficiency (GHD): When the pituitary gland does not produce sufficient growth hormone, resulting in short stature and slow growth velocity
• Turner syndrome: A chromosomal condition affecting girls that leads to short stature and other developmental issues. Growth hormone therapy can significantly increase adult height in these patients
• Chronic kidney disease (CKD): When impaired kidney function affects growth. Treatment should continue until kidney transplantation
• Prader-Willi syndrome (PWS): A genetic chromosomal disorder associated with poor growth, low muscle mass, and excessive body fat. Growth hormone improves body composition, increases muscle mass, and reduces excess fat
• Small for gestational age (SGA): Children who were born shorter or lighter than expected and have not achieved catch-up growth by age 4 years or later

Indications in Adults

In adult patients, Omnitrope is prescribed for the treatment of significant growth hormone deficiency, whether it originated in childhood (persistent GHD) or developed during adulthood due to pituitary disease, surgery, radiation therapy, or traumatic brain injury. Adults with confirmed GHD typically experience reduced energy levels, increased body fat (particularly visceral fat), decreased muscle mass, reduced bone density, and impaired quality of life.

For patients who received growth hormone treatment during childhood, retesting is performed after the completion of linear growth. If severe GHD is confirmed, treatment with Omnitrope may be continued into adulthood to maintain metabolic benefits and quality of life.

What Should You Know Before Taking Omnitrope?

Before starting Omnitrope, your physician must confirm the diagnosis of growth hormone deficiency. There are several contraindications, including active malignancy, critical illness, and closed epiphyses (in children treated for growth). Careful monitoring is required for patients with diabetes, thyroid disorders, or a history of cancer.

Contraindications

You must not use Omnitrope in the following situations:

• Hypersensitivity: Known allergy to somatropin or any of the excipients in the formulation
• Active malignancy (cancer): Any active tumor must be inactive and cancer treatment must be completed before starting somatropin therapy
• Closed epiphyses: In children prescribed for growth stimulation who have already completed skeletal maturation
• Acute critical illness: Patients with complications following major cardiac surgery, abdominal surgery, accidental trauma, acute respiratory failure, or similar critical conditions. Somatropin should be discontinued and not initiated in critically ill patients, as increased mortality has been reported in this population

Warnings and Precautions

Discuss the following with your physician before and during treatment with Omnitrope:

• Glucocorticoid replacement: If you are receiving glucocorticoid therapy, your dose may need adjustment as somatropin can reduce the effectiveness of glucocorticoids
• Diabetes risk: Somatropin can impair insulin sensitivity. Blood glucose should be monitored regularly, and patients with diabetes may need dose adjustments of their antidiabetic medications
• Thyroid function: Somatropin therapy may unmask central hypothyroidism or reduce the effectiveness of existing thyroid hormone replacement. Thyroid function should be tested regularly
• Intracranial hypertension: Rare cases of benign intracranial hypertension have been reported. Symptoms include severe headache, visual disturbances, and vomiting. If these occur, treatment should be interrupted temporarily
• Hip and knee pain: Children receiving growth hormone therapy who develop limping or hip/knee pain should be evaluated promptly for slipped capital femoral epiphysis (SCFE) or Legg-Calvé-Perthes disease
• Scoliosis: Rapid growth may worsen pre-existing scoliosis. Regular monitoring for spinal curvature is recommended during treatment
• Pancreatitis: Somatropin can cause inflammation of the pancreas. Seek immediate medical attention for severe abdominal or back pain
• Cancer recurrence: Patients with a history of malignancy should be monitored regularly for tumor recurrence
• Elderly patients: Experience in patients over 80 years is limited. Older adults may be more sensitive to the effects of somatropin and at increased risk of side effects. The lowest effective dose should be used

Special Populations

Children with chronic kidney disease: Kidney function and growth velocity should be assessed before starting treatment. Ongoing medical management of kidney disease should continue alongside somatropin therapy. Treatment must be discontinued at the time of kidney transplantation.

Children with Prader-Willi syndrome: Dietary restrictions must be followed to control weight. Before starting therapy, patients should be evaluated for upper airway obstruction, sleep apnea, and respiratory infections. If signs of upper airway obstruction develop (such as new or increased snoring), the patient should be examined and treatment may need to be interrupted. Rare cases of sudden death have been reported in PWS patients receiving growth hormone, though a causal relationship has not been established.

Children born small for gestational age (SGA): For children aged 9–12 years, specific guidance regarding puberty and growth hormone treatment should be obtained from the prescribing physician. Blood glucose and insulin levels should be checked before treatment begins and annually thereafter.

Pregnancy and Breastfeeding

Omnitrope should not be used during pregnancy or in women who are trying to conceive. There is insufficient data on the use of somatropin in pregnant women. The 5 mg/1.5 ml formulation contains benzyl alcohol, which can accumulate in the body and cause metabolic acidosis – this poses particular risk during pregnancy. If you are pregnant or breastfeeding, consult your physician before using this medicine.

Important Information About Excipients

The different Omnitrope formulations contain varying excipients that are clinically relevant:

• Sodium content: Less than 1 mmol (23 mg) per ml – essentially sodium-free
• Benzyl alcohol (5 mg/1.5 ml formulation): Contains 9 mg benzyl alcohol per ml. Benzyl alcohol can cause allergic reactions and has been associated with serious adverse events including respiratory distress in young children. This formulation must not be given to neonates (up to 4 weeks of age) and should not be used in children under 3 years unless specifically prescribed
• Phenol (10 mg and 15 mg formulations): These contain phenol as a preservative instead of benzyl alcohol

How Does Omnitrope Interact with Other Drugs?

Omnitrope can interact with several classes of medications including corticosteroids, insulin and oral antidiabetics, thyroid hormones, anticonvulsants, ciclosporin, and sex hormones. Dose adjustments of either Omnitrope or the concomitant medication may be necessary during treatment.

Growth hormone influences several metabolic pathways and can alter the pharmacokinetics or pharmacodynamics of other medications. It is essential that you inform your prescribing physician about all medications you are currently taking, have recently taken, or plan to take. This includes prescription drugs, over-the-counter medicines, and herbal supplements.

The cytochrome P450 enzyme system, which metabolizes many drugs in the liver, is influenced by somatropin therapy. Specifically, somatropin has been shown to increase the activity of CYP3A4, which can accelerate the metabolism of drugs processed by this enzyme pathway. This may lead to reduced plasma levels and decreased effectiveness of co-administered medications.

What Is the Correct Dosage of Omnitrope?

Omnitrope dosing is individualized based on body weight or body surface area, the specific condition being treated, and patient response. The injection should be given subcutaneously once daily, preferably at bedtime. Doses are adjusted over time based on clinical response, IGF-1 levels, and any side effects experienced.

The dosage of Omnitrope varies significantly depending on the indication, the patient's age, weight, and clinical response. Your physician will determine the appropriate starting dose and make adjustments during follow-up visits. Do not alter your dose or treatment schedule without consulting your physician.

Children

Adults

Elderly Patients (Over 60 Years)

Elderly patients should start at a lower dose of 0.1–0.2 mg per day, which is increased slowly according to individual needs. The lowest effective dose should be used, and the maintenance dose rarely exceeds 0.5 mg per day. Elderly patients may be more susceptible to side effects and should be monitored closely.

Administration Instructions

Omnitrope is administered as a subcutaneous injection using the SurePal injection pen device. Each cartridge strength has its own dedicated pen:

• Omnitrope 5 mg/1.5 ml → Use with SurePal 5
• Omnitrope 10 mg/1.5 ml → Use with SurePal 10
• Omnitrope 15 mg/1.5 ml → Use with SurePal 15

Inject at approximately the same time each day. Bedtime is recommended, as the body naturally releases more growth hormone during sleep. Rotate injection sites between the thigh and abdomen (avoiding the navel and waistline) to prevent lipoatrophy (local thinning of fat tissue). Ensure at least 1 cm distance from the previous injection site.

Before injection, inspect the solution visually – it should be clear and colorless. Do not use if the solution is cloudy or contains particles. Clean the injection site with an alcohol swab and allow it to dry before injecting. After injection, apply gentle pressure with a sterile gauze pad but do not massage the site.

Missed Dose

Do not take a double dose to make up for a missed injection. If you forget a dose, take the next injection at your usual time the following day. Keep a record of any missed doses and inform your physician at your next appointment. Consistent daily administration is important for optimal treatment results.

Overdose

If too much Omnitrope is injected, contact your healthcare provider or local poison control center immediately. An acute overdose may initially cause hypoglycemia (low blood sugar), followed by hyperglycemia (high blood sugar). Symptoms may include trembling, sweating, drowsiness, feeling "strange," or fainting. Long-term overdose can lead to signs and symptoms consistent with excess growth hormone, including acromegaly (enlarged hands, feet, and facial features).

What Are the Side Effects of Omnitrope?

Like all medicines, Omnitrope can cause side effects, although not everyone experiences them. The most common side effects in adults are joint pain and fluid retention (swollen fingers or ankles). In children, injection site reactions and joint pain are the most frequently reported. Many side effects occur early in treatment and may resolve as the body adjusts.

Side effects of somatropin therapy are generally dose-dependent and often occur during the initial months of treatment. In many cases, they resolve spontaneously as the body adapts or when the dose is reduced. Your physician will monitor you for side effects and adjust the dose accordingly.

Adults

Children

Additional Safety Information

Antibodies to somatropin may form during treatment, but these typically do not interfere with the hormone's therapeutic effect. The skin around the injection site may become uneven or lumpy (lipoatrophy or lipohypertrophy) if injections are given repeatedly in the same location – this can be prevented by rotating injection sites regularly.

Prader-Willi syndrome patients: Rare cases of sudden death have been reported in patients with PWS treated with growth hormone, though these events have not been directly linked to somatropin therapy. Patients with PWS should be monitored closely for signs of upper airway obstruction and sleep apnea.

Somatropin therapy may also cause elevated blood sugar levels or reduced thyroid hormone levels, which your physician can detect through regular blood tests and treat appropriately. Rare cases of pancreatitis (inflammation of the pancreas) have been reported.

In growing children, the treating physician should also evaluate for slipped capital femoral epiphysis (SCFE) and Legg-Calvé-Perthes disease if hip or knee discomfort develops during treatment. These orthopedic conditions can occur more frequently in children who are growing rapidly.

How Should You Store Omnitrope?

Omnitrope must be stored in a refrigerator at 2–8°C (36–46°F) and must never be frozen. Keep in the original packaging to protect from light. After first use, the cartridge should remain in the SurePal pen and be stored refrigerated for a maximum of 28 days.

Proper storage of Omnitrope is essential to maintain the potency and safety of the medication. Somatropin is a protein that can be degraded by heat, freezing, or exposure to light. Follow these storage guidelines carefully:

• Before first use: Store and transport refrigerated at 2–8°C (36–46°F). Do not freeze. Keep in the original packaging to protect from light
• After first use: Leave the cartridge in the SurePal pen and store in the refrigerator at 2–8°C. Use within 28 days of first injection
• Before injection: The solution should be clear and colorless. Do not use if the solution is cloudy or contains particles
• Expiration date: Do not use after the expiry date stated on the label and carton (EXP). The expiry date refers to the last day of the stated month
• Travel: Transport in an insulated cooling bag. Avoid exposure to temperatures outside 2–8°C

Keep this medicine out of the sight and reach of children. Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use – these measures help protect the environment.

What Does Omnitrope Contain?

Omnitrope contains somatropin (recombinant human growth hormone) as its active ingredient. Each formulation also contains buffer salts, stabilizers, and a preservative. The preservative differs between formulations: benzyl alcohol in the 5 mg formulation, and phenol in the 10 mg and 15 mg formulations.

Omnitrope 5 mg/1.5 ml

Each ml contains 3.3 mg somatropin (equivalent to 10 IU). Each cartridge contains 5.0 mg (equivalent to 15 IU) in 1.5 ml.

Excipients: Disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, mannitol, poloxamer 188, benzyl alcohol, and water for injections.

Omnitrope 10 mg/1.5 ml

Each ml contains 6.7 mg somatropin (equivalent to 20 IU). Each cartridge contains 10.0 mg (equivalent to 30 IU) in 1.5 ml.

Excipients: Disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, glycine, poloxamer 188, phenol, and water for injections.

Omnitrope 15 mg/1.5 ml

Each ml contains 10 mg somatropin (equivalent to 30 IU). Each cartridge contains 15.0 mg (equivalent to 45 IU) in 1.5 ml.

Excipients: Disodium hydrogen phosphate heptahydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, poloxamer 188, phenol, and water for injections.

Appearance and Pack Sizes

Omnitrope is a clear, colorless solution for injection supplied in cartridges designed for use with the SurePal pen device. Each strength must be used with its corresponding pen (SurePal 5, SurePal 10, or SurePal 15). Available pack sizes are 1, 5, and 10 cartridges. Not all pack sizes may be marketed in every country.

Frequently Asked Questions About Omnitrope