Sogroya: Uses, Dosage & Side Effects

What Is Sogroya and What Is It Used For?

Sogroya contains the active substance somapacitan, a modified form of human growth hormone (hGH, also called somatropin) produced by recombinant DNA technology in Escherichia coli. Its amino-acid sequence is identical to the 191-residue natural 22 kDa human growth hormone except that a single amino-acid substitution at position 101 (leucine to cysteine) allows covalent attachment of a non-proteinogenic side-chain. This side-chain consists of a C16 fatty acid linked to the protein backbone through a hydrophilic spacer and binds reversibly to circulating serum albumin. Because albumin has a very long half-life and is ubiquitous in the bloodstream, this “albumin-binding” technology dramatically extends the circulating half-life of somapacitan to approximately 2-3 days, enabling once-weekly subcutaneous administration while the active hormone continues to interact with its receptor in a physiological manner.

Growth hormone is a peptide hormone produced by the anterior pituitary gland in a pulsatile pattern, mostly during sleep. In the circulation it binds to the growth hormone receptor (GHR) on cells of the liver, bone, muscle, adipose tissue, and other organs, activating the JAK2/STAT5 intracellular signalling cascade. The most important downstream effect is the hepatic production of insulin-like growth factor 1 (IGF-1), which together with direct GHR signalling mediates almost all anabolic actions of growth hormone: linear bone growth in children, maintenance of muscle and bone mass, lipolysis in adipose tissue, and modulation of protein and carbohydrate metabolism throughout the body. When the pituitary fails to produce adequate amounts of growth hormone — whether because of congenital defects, tumours, surgery, radiation, trauma, or other causes — replacement therapy with an exogenous growth hormone such as Sogroya can restore near-physiological IGF-1 levels and reverse many of the clinical consequences of deficiency.

Sogroya is authorised by the European Medicines Agency (EMA) in the European Union, the U.S. Food and Drug Administration (FDA), the UK Medicines and Healthcare products Regulatory Agency (MHRA), the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), and regulatory authorities in numerous other jurisdictions. The approved indications and population have broadened since the drug was first launched for adults in 2020-2021:

• Adult growth hormone deficiency (AGHD): Sogroya is approved as replacement therapy for adults with confirmed growth hormone deficiency, either of childhood onset that persists into adulthood or of adult onset caused by hypothalamic or pituitary disease, radiation, trauma, or surgery. Diagnosis requires biochemical confirmation, typically with a stimulation test such as the insulin tolerance test or the macimorelin test.
• Paediatric growth hormone deficiency (GHD): Sogroya is approved for children aged 3 years and older with short stature due to inadequate endogenous growth hormone secretion. It is intended to support normal linear growth until near-final adult height is reached.
• Selected additional paediatric indications: In some regulatory territories (varying by country and over time), somapacitan may also be approved or under evaluation for short stature associated with Noonan syndrome, Turner syndrome, or short children born small for gestational age (SGA) who have failed to show catch-up growth. Approval status should be checked locally, as indications continue to evolve.

The clinical development programme for Sogroya includes a comprehensive set of phase 3 studies known collectively as the REAL programme. REAL 1 evaluated weekly somapacitan versus daily norditropin in adults with AGHD, demonstrating non-inferior efficacy on body composition and IGF-1 levels. REAL 2 assessed long-term safety in adult patients switching from daily growth hormone. REAL 3 was a dose-finding paediatric study in children with GHD. REAL 4 compared once-weekly somapacitan with daily growth hormone as first-line treatment in prepubertal children with GHD, showing non-inferior height velocity at 52 weeks and similar safety. REAL 5 is the Japanese pivotal study in adults. Across these studies more than 1,000 patients received somapacitan for up to several years, generating substantial evidence for its efficacy, safety, and impact on treatment burden.

Growth hormone deficiency in adults is characterised by increased fat mass (particularly visceral adiposity), decreased lean body mass, reduced bone mineral density, dyslipidaemia, impaired cardiac function, reduced exercise capacity, and diminished quality of life with depressive and cognitive symptoms. Replacement therapy aims to reverse these features and normalise serum IGF-1 into the age- and sex-appropriate reference range. In children, untreated severe GHD results in progressively reduced growth velocity, delayed bone age, and eventually short adult stature; early diagnosis and treatment allow most children to reach a height within the normal population range.

What Should You Know Before Using Sogroya?

Contraindications

Certain medical conditions are absolute contraindications to starting or continuing treatment with Sogroya. Your prescribing endocrinologist will carefully assess these before initiating therapy:

• Hypersensitivity: Sogroya must not be given to patients with known hypersensitivity to somapacitan or to any of the excipients (histidine, mannitol, phenol, poloxamer 188, hydrochloric acid, sodium hydroxide, water for injections).
• Active malignancy: Growth hormone therapy must not be used in patients with evidence of active tumour growth. Any benign or malignant tumour (including pituitary adenoma or craniopharyngioma that caused the GHD) must be inactive and antitumour therapy completed before treatment is started.
• Acute critical illness: Sogroya must not be used in patients with acute critical illness suffering complications following open-heart surgery, abdominal surgery, multiple accidental trauma, acute respiratory failure, or similar life-threatening conditions. Randomised trials with very high doses of growth hormone in intensive-care patients showed increased mortality.
• Active proliferative or severe non-proliferative diabetic retinopathy: Growth hormone can exacerbate retinopathy and must therefore not be used when these conditions are active.
• Closed epiphyses in children: When used to promote linear growth, Sogroya must not be continued after the growth plates (epiphyses) have fused, because no further height gain is possible and continuing therapy only increases exposure without benefit.

Warnings and Precautions

Before and during treatment with Sogroya, tell your doctor if any of the following apply to you or your child:

• Diabetes and impaired glucose tolerance: Growth hormone is counter-regulatory to insulin and can raise blood glucose. Patients with diabetes may require dose adjustments of their insulin or oral antidiabetic medicines. Patients without diabetes should have HbA1c and fasting glucose checked periodically, especially if they are overweight, have a family history of diabetes, or have other risk factors.
• Hypothyroidism: Growth hormone treatment can unmask or worsen central hypothyroidism by increasing the peripheral conversion of T4 to T3 and altering thyroid axis feedback. Thyroid function (TSH, free T4) should be measured before starting and during therapy, and levothyroxine initiated or adjusted as needed.
• Adrenal insufficiency: Growth hormone inhibits the 11-beta-hydroxysteroid dehydrogenase 1 enzyme, potentially reducing endogenous cortisol availability and unmasking previously undiagnosed central hypoadrenalism. Patients on glucocorticoid replacement may need a dose increase. Symptoms of adrenal crisis (weakness, nausea, vomiting, hypotension) require urgent medical attention.
• Hypopituitarism and multi-axis replacement: Most patients with GHD have deficiencies of other pituitary hormones. Optimisation of gonadal, thyroid, and adrenal replacement before starting somapacitan is essential, and dose review is required when sex steroids (particularly oral oestrogens) are added or withdrawn.
• Intracranial hypertension: Benign intracranial hypertension (pseudotumor cerebri) with headache, visual disturbance, nausea, and papilloedema has been reported with all growth hormone products, usually within the first weeks of treatment. Fundoscopy should be performed before starting and if symptoms occur; treatment should be interrupted if intracranial hypertension is confirmed.
• Scoliosis in children: Rapid growth during GH treatment can worsen pre-existing scoliosis. Children should be monitored clinically and referred to orthopaedics if scoliosis progresses.
• Slipped capital femoral epiphysis (SCFE): Children with endocrine disorders including GHD are at increased risk of SCFE. Any child who develops hip or knee pain or a limp during therapy should be evaluated promptly.
• Pancreatitis: Cases of pancreatitis have been reported with growth hormone treatment, particularly in children. Any severe persistent abdominal pain, especially with nausea and vomiting, should be investigated urgently.
• Fluid retention: Peripheral oedema, arthralgia, myalgia, and carpal tunnel syndrome may occur, especially in adults at the start of therapy or after dose increases. Symptoms usually improve with dose reduction.
• Liver and kidney impairment: There are limited data on somapacitan in severe hepatic or renal impairment. More frequent IGF-1 monitoring and individualised dose adjustments may be required.
• Prader-Willi syndrome: Sogroya is not specifically indicated for Prader-Willi syndrome. Growth hormone therapy in this group has been associated with sudden death, especially in severely obese patients or those with severe respiratory impairment; specific expertise is required if any growth hormone is used in this population.
• Injection site care: Rotate injection sites between the thigh, abdomen, buttock, and upper arm to reduce the risk of lipoatrophy (localised fat loss).

Other Medications

Tell your doctor about all medicines, supplements, and herbal products you are taking. Growth hormone can affect the metabolism of several drugs and can interact with endocrine replacement therapies, as detailed in the next section.

Pregnancy and Breastfeeding

There are no or very limited clinical data on the use of somapacitan in pregnant women. Animal studies have not shown direct or indirect harmful reproductive effects, but as a precaution Sogroya should not be used during pregnancy unless clearly necessary. Women of childbearing potential do not usually require contraception specifically because of Sogroya, but the underlying pituitary disease and any concurrent medication should be considered. If you become pregnant during treatment, discuss the risks and benefits of continuing therapy with your specialist.

It is not known whether somapacitan passes into human breast milk. Because the drug is a large protein it is likely to be degraded in the infant’s gastrointestinal tract and unlikely to cause significant systemic exposure, but a risk to the breastfed child cannot be fully excluded. A decision on whether to breastfeed while using Sogroya should take into account the benefits of breastfeeding for the infant and the benefits of therapy for the mother.

In children, fertility is not directly affected by growth hormone replacement. In adults with hypopituitarism, the management of fertility depends on concurrent gonadotropin deficiency and is independent of Sogroya treatment.

Driving and Operating Machinery

Sogroya is not expected to have any significant effect on the ability to drive or use machines. However, side effects such as headache, dizziness, or fatigue might occasionally interfere. If you experience such symptoms, do not drive or operate machinery until they have resolved.

Important Information About Ingredients

Each pre-filled pen contains less than 1 mmol of sodium (23 mg), meaning Sogroya is essentially “sodium-free” and suitable for patients on a low-sodium diet. The pen also contains phenol as a preservative, which allows multi-dose use within the stated in-use period. Patients with rare inherited problems should note that the product does not contain gluten, lactose, or known pharmaceutical allergens other than those listed in the formulation.

How Does Sogroya Interact with Other Drugs?

Somapacitan itself is not metabolised by cytochrome P450 enzymes because it is a large protein that is cleared through proteolysis. However, growth hormone as a class is known to interact with several drugs through pharmacodynamic and indirect pharmacokinetic mechanisms. These interactions are relevant for almost every patient starting somapacitan, because most have co-existing pituitary hormone deficiencies and co-morbidities that require concurrent therapy.

Major Interactions

Minor Interactions

It is particularly important in adult women to be aware of the interaction between oral oestrogen (combined oral contraceptives or oral hormone replacement therapy) and growth hormone signalling. Oral oestrogens undergo first-pass hepatic metabolism and decrease hepatic IGF-1 generation, meaning women on oral oestrogen typically require higher doses of Sogroya to achieve the same IGF-1 level. Switching to a transdermal oestrogen preparation (patches, gels) bypasses this effect and is often preferred during growth hormone therapy. Any change in oestrogen route or dose should prompt a re-check of IGF-1 and a dose review.

What Is the Correct Dosage of Sogroya?

Sogroya is a specialist medicine and must only be prescribed and titrated by or under the supervision of a physician experienced in the management of growth hormone deficiency. The optimal dose is highly individual: it depends on age, sex, body weight (in children), concomitant oestrogen therapy, other pituitary replacement, clinical response, and most importantly serum IGF-1 measured 3-4 days after the last injection. The aim is to bring IGF-1 into the age- and sex-appropriate reference range without exceeding it.

Adults

Children

Elderly Patients

Renal and Hepatic Impairment

Missed Dose

Overdose

Acute overdose of somapacitan is unlikely given the pre-filled pen design, but repeated over-dosing can lead to features of supra-physiological growth hormone exposure: fluid retention with peripheral oedema and arthralgia, increased blood glucose, paraesthesias, and, with prolonged use, acromegaly-like features (coarsening of facial features, soft-tissue thickening, carpal tunnel syndrome). Severe acute hypoglycaemia has been described after accidental administration to non-GHD individuals. Treatment is supportive; dose reduction or temporary cessation until symptoms resolve is usually sufficient. Contact your doctor or poisons information centre if you suspect an overdose.

How Sogroya Is Administered

Sogroya is supplied as a clear, colourless-to-slightly-yellow solution in a disposable, multi-dose pre-filled pen. Three pen strengths (5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL) are colour-coded to help patients and caregivers select the correct device. A new needle (NovoFine or NovoTwist, sold separately in many markets) should be attached for each injection and discarded immediately after use in a sharps container.

The injection is given subcutaneously into the fatty tissue of the thigh, abdomen (at least 5 cm away from the navel), buttock, or upper arm. Sites should be rotated each week to avoid lipoatrophy. The injection time can be chosen to fit the patient’s routine; most people pick a consistent day of the week (e.g., Sunday evening) to improve adherence. The injection can be given independently of meals and at any time of day.

What Are the Side Effects of Sogroya?

Like all medicines, Sogroya can cause side effects, although not everyone gets them. Most adverse reactions are mild to moderate, particularly in children, and often improve after the first weeks of treatment or with dose reduction. The side-effect pattern differs somewhat between adults and children, as summarised below.

Side Effects in Adults

Side Effects in Children

The safety profile in children from the REAL 3 and REAL 4 studies is broadly similar to adults, but with a different frequency distribution. Infections and pyrexia are more common because children generally have more viral illnesses, while fluid retention and arthralgia are less prominent.

If you experience any side effect, including those not listed here, tell your doctor, pharmacist, or nurse. You can also report suspected side effects to your national pharmacovigilance authority (e.g., the EMA in Europe, the FDA MedWatch program in the United States, the MHRA Yellow Card Scheme in the United Kingdom, or the PMDA in Japan), which helps regulators continue to monitor the benefit-risk balance of Sogroya.

How Should Sogroya Be Stored?

Correct storage preserves the stability and potency of somapacitan and is essential for safe, effective treatment. The pre-filled pen is a multi-dose device, so storage conditions after the first injection are particularly important.

• Unopened pens (before first use): Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Keep the pen in the outer carton to protect it from light. Do not freeze. Do not place next to the freezer compartment or cooling elements inside a domestic fridge. If the pen has been frozen, it must be discarded.
• After first use (in-use): The pen may be stored in a refrigerator (2-8°C) for up to 6 weeks or at room temperature below 30°C (86°F) for up to 3 weeks — whichever is shorter. After the in-use period, the pen must be discarded even if solution remains. Check the specific wording in your local patient information leaflet, as storage directions may vary slightly by region.
• Protection from light and heat: Always keep the pen cap on when not in use. Do not leave the pen in direct sunlight, in a hot car, or near a heat source.
• Travel: Use an insulated travel pouch with a cooling element (but not in direct contact) for longer journeys. On flights, always carry the pen in your hand luggage, never in the hold (risk of freezing).
• Inspection: Before each injection, inspect the solution through the pen window. Do not use if the solution is cloudy, discoloured, or contains visible particles.
• Disposal: Used pens and needles must be discarded in a puncture-resistant sharps container according to local regulations. Do not dispose of medicine via household wastewater or domestic waste. Ask your pharmacist how to dispose of unused medicine — these measures help protect the environment.
• Out of reach of children: Keep Sogroya out of the sight and reach of children at all times.
• Expiry date: Do not use Sogroya after the expiry date stated on the carton and pen label after EXP. The expiry date refers to the last day of that month.

What Does Sogroya Contain?

Active Substance

The active substance is somapacitan, a long-acting human growth hormone derivative produced in Escherichia coli by recombinant DNA technology. Each pre-filled pen contains 1.5 mL of solution:

• Sogroya 5 mg/1.5 mL: Contains 5 mg somapacitan (3.3 mg/mL).
• Sogroya 10 mg/1.5 mL: Contains 10 mg somapacitan (6.7 mg/mL).
• Sogroya 15 mg/1.5 mL: Contains 15 mg somapacitan (10 mg/mL).

The three strengths are provided in pens with distinct colour coding on the dose window and label to help patients and caregivers select the correct device. Each pen allows multiple doses to be delivered in increments appropriate to the specific strength; follow your local instructions for use for exact dose-setting details.

Inactive Ingredients (Excipients)

• Histidine
• Mannitol
• Phenol (preservative)
• Poloxamer 188
• Hydrochloric acid (for pH adjustment)
• Sodium hydroxide (for pH adjustment)
• Water for injections

Appearance

Sogroya is a clear to slightly opalescent, colourless to slightly yellow sterile solution. The pre-filled pen is a plastic disposable multi-dose device containing a glass cartridge. Cartridges are fixed in the pen and cannot be replaced. Each pen is designed to deliver multiple weekly injections within the in-use stability window.

Pack Sizes and Manufacturer

Sogroya is available in packs of 1 pre-filled pen; not all pack sizes or strengths may be marketed in every country. Sogroya is developed, manufactured, and marketed by Novo Nordisk A/S (Bagsværd, Denmark) and distributed worldwide by its national affiliates. The marketing authorisation holder in the EU is Novo Nordisk A/S; in the US, Novo Nordisk Inc.