Sogroya

Pediatric Growth Hormone Deficiency

Sogroya is prescribed for children 2.5 years of age and older who experience growth failure because their bodies do not produce enough natural growth hormone. It serves as a replacement for the missing hormone to help support physical growth and development.

Adult Growth Hormone Deficiency

This medication is also used to treat adults with growth hormone deficiency (GHD). This condition may be categorized in two ways:

• Childhood-onset: Patients who were deficient in growth hormone as children and continue to be deficient as adults.
• Adult-onset: Patients who develop a deficiency later in life, often due to damage to the pituitary gland from surgery, radiation therapy, trauma, or disease.

In adults, Sogroya is used to maintain appropriate hormone levels, which are important for regulating metabolism and body composition.

Mechanism of Action

Sogroya (somapacitan-beco) is a recombinant human growth hormone. It works by mimicking the actions of the natural growth hormone produced by the pituitary gland. When the medication is injected, it travels through the body and attaches to growth hormone receptors on the surface of target cells.

This attachment triggers a series of signals inside the cells that lead to several important biological effects:

• Tissue Growth: It promotes the growth of bones and muscles, which is particularly important for children who are not growing at a typical rate.
• Hormone Production: It stimulates the liver and other tissues to release insulin-like growth factor 1 (IGF-1), a hormone that further supports growth and development.
• Metabolic Support: It helps regulate the way the body processes and uses proteins, fats, and sugars.

Weekly Dosing Technology

The primary difference between Sogroya and traditional growth hormone treatments is how long it stays active in the body. Sogroya is modified to bind to albumin, a protein naturally found in the blood. This binding protects the medication from being quickly cleared out by the kidneys or broken down by the body. Because it circulates in the bloodstream for an extended period, it only needs to be injected once a week to maintain effective levels.

Common Side Effects

Some people using Sogroya may experience mild side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• Back pain or joint pain
• Indigestion or stomach discomfort
• Dizziness
• Difficulty falling asleep or staying asleep
• Swelling in the hands, arms, feet, or legs
• Nausea or vomiting
• Tonsillitis

Serious Side Effects

While less common, some side effects can be serious. Contact your healthcare provider immediately or seek emergency medical care if you experience:

• Vision changes or severe headaches: These may be signs of increased pressure in the brain.
• High blood sugar: Symptoms include increased thirst, frequent urination, or blurred vision.
• Allergic reactions: Signs include rash, hives, itching, or swelling of the face, lips, or tongue.
• Hip or knee pain: This may indicate a bone problem called slipped capital femoral epiphysis, especially in children.
• Severe stomach pain: Pain that spreads to the back may be a sign of pancreatitis.
• New or worsening skin changes: Lumps or thinning of the skin at the injection site.
• Adrenal or thyroid issues: Extreme tiredness, dizziness, or feeling cold.
• Worsening of scoliosis: If you have a curvature of the spine, it may worsen during rapid growth.

Contraindications

Sogroya should not be used in individuals with the following conditions:

• Acute critical illness resulting from major surgery, trauma, or acute respiratory failure.
• Active malignancy (cancer).
• Severe vision problems caused by diabetes (active proliferative or severe non-proliferative diabetic retinopathy).
• Known hypersensitivity to somapacitan-beco or any of the ingredients in the medication.

Major Warnings and Precautions

Increased Mortality in Critical Illness

Increased mortality has been reported in patients with acute critical illness who receive pharmacologic amounts of growth hormone. The safety of continuing Sogroya for those who develop these conditions has not been established.

Risk of Malignancy

There is an increased risk of tumor progression or recurrence in patients with active or previous cancer. Healthcare providers monitor for new or worsening skin lesions or other signs of tumor growth during treatment. In children, those with certain genetic conditions may have an increased risk of developing new tumors.

Glucose Intolerance and Diabetes

Treatment with growth hormone may decrease insulin sensitivity, which can lead to high blood sugar levels, glucose intolerance, or the development of type 2 diabetes. Regular monitoring of blood glucose levels is often necessary, especially for those with pre-existing diabetes.

Intracranial Hypertension

Increased pressure in the brain (intracranial hypertension) can occur, causing symptoms such as headache, nausea, vomiting, and visual changes. These symptoms usually resolve after stopping treatment or reducing the dose.

Other Potential Complications

• Fluid Retention: Some patients may experience swelling (edema), joint pain, or carpal tunnel syndrome. These effects are often temporary and may be related to the dosage.
• Hormonal Changes: Sogroya may affect how the body processes other hormones. It can unmask or worsen hypothyroidism (low thyroid) or affect adrenal gland function, which may require adjustments to other medications.
• Pancreatitis: Inflammation of the pancreas has been reported in patients receiving growth hormone. This should be considered if persistent, severe abdominal pain develops.
• Injection Site Reactions: To prevent skin changes such as lipoatrophy (loss of fat under the skin), it is important to rotate the injection site regularly.
• Bone and Joint Issues: In pediatric patients, growth hormone may be associated with a slipped capital femoral epiphysis or the progression of pre-existing scoliosis.

Pregnancy

There is not enough research on the use of Sogroya in pregnant women to determine if it causes birth defects, miscarriage, or other developmental issues. In animal studies, some fetal abnormalities were observed when the medication was given at doses much higher than the standard human dose. Because of the lack of human data, healthcare providers typically only recommend Sogroya during pregnancy if the potential benefit to the patient outweighs the potential risk to the unborn baby.

Breastfeeding

It is not known whether Sogroya passes into human breast milk, how it might affect a nursing infant, or if it impacts the production of milk. Because many medications can be passed through breast milk, it is important to discuss the potential risks and benefits with a healthcare professional if you are breastfeeding or planning to breastfeed while using this medication.

Available Forms

Sogroya is supplied as a clear and colorless solution for injection. It is administered subcutaneously, which means it is injected into the fatty tissue just beneath the skin.

The medication is provided in the following delivery system:

• Pre-filled Pen: A disposable, single-patient-use injection device.

The pen is designed to be used with compatible disposable needles. It features a dose-setting mechanism that allows the user to select the prescribed amount of medication for each injection.

FDA Approval History

The U.S. Food and Drug Administration (FDA) initially approved Sogroya (somapacitan-beco) in August 2020. It was the first once-weekly human growth hormone (hGH) therapy approved for adults with growth hormone deficiency. In April 2023, the FDA expanded the approval to include the treatment of pediatric patients 2.5 years of age and older who have growth failure due to inadequate secretion of endogenous growth hormone.

Regulatory Oversight

Sogroya is a prescription-only medication. There are currently no Boxed Warnings or Risk Evaluation and Mitigation Strategy (REMS) requirements associated with its use. The FDA-approved labeling includes warnings regarding potential risks common to the growth hormone class, such as:

• Increased mortality in patients with acute critical illness
• Risk of progression or recurrence of tumors
• Glucose intolerance and diabetes mellitus
• Intracranial hypertension
• Fluid retention

Healthcare providers are advised to monitor patients regularly for these conditions and adjust treatment as necessary based on clinical response and laboratory testing of insulin-like growth factor-1 (IGF-1) levels.

Insurance and Coverage

The out-of-pocket cost for Sogroya is largely determined by your health insurance plan. Many insurance providers require prior authorization for this medication. This process involves your healthcare provider submitting documentation to the insurance company to confirm that the treatment is medically necessary before coverage is approved.

Specialty Pharmacies

Sogroya is a specialty medication and is typically dispensed through specialty pharmacies rather than standard retail pharmacies. These pharmacies are equipped to handle injectable growth hormones and can often assist with navigating insurance benefits and coordinating delivery.

Financial Assistance

Programs may be available to help reduce the cost of Sogroya for eligible patients. These options often include:

• Copay Savings Cards: These may be available for patients with commercial or private insurance to help lower their monthly out-of-pocket expenses.
• Patient Assistance Programs: Some programs provide the medication at a lower cost or for free to individuals who meet specific income requirements or who do not have insurance coverage.

Because prices can vary significantly based on the pharmacy and your specific insurance tier, it is recommended to contact your insurance provider or the manufacturer's support services for the most accurate cost information.