Norditropin® and Sogroya® – Important Safety Information and Product Overview

Norditropin® (somatropin)

Important Safety Information

Do not use Norditropin® if you:

• Have a critical illness related to heart surgery, stomach surgery, trauma, or severe respiratory problems.
• Are a child with Prader-Willi syndrome who is severely obese or has breathing difficulties, including sleep apnea.
• Have cancer or any active tumor.
• Are allergic to somatropin or any component of Norditropin®.
• Have diabetes-related eye complications (diabetic retinopathy).
• Are a child with closed growth plates (epiphyses).

Before Using Norditropin®

Inform your healthcare provider if you:

• Have a history of heart surgery, stomach surgery, trauma, or respiratory problems.
• Have experienced sleep apnea or other sleep-related breathing disorders.
• Have a history of cancer or tumors.
• Have diabetes.
• Are pregnant, planning pregnancy, breastfeeding, or planning to breastfeed.

Additionally, disclose all prescription medications, over-the-counter products, vitamins, and herbal supplements, as Norditropin® may interact with other medications.

Administration Instructions

• Use Norditropin® exactly as prescribed by your healthcare provider.
• Do not share injection pens or needles, even if the needle has been changed, as this may result in infection transmission.

Potential Serious Side Effects

Norditropin® may cause serious side effects, including:

• Increased risk of death in critically ill patients.
• Increased risk of sudden death in children with severe obesity and Prader-Willi syndrome.
• Increased risk of tumor growth or cancer recurrence.
• Elevated blood sugar levels or worsening diabetes.
• Increased pressure in the skull (intracranial hypertension).
• Serious allergic reactions.
• Fluid retention causing swelling, joint pain, muscle pain, or nerve symptoms.
• Reduced cortisol and thyroid hormone levels.
• Hip or knee problems in children, including slipped capital femoral epiphysis and osteonecrosis.
• Worsening scoliosis.
• Pancreatitis.
• Loss of fat tissue at injection sites.
• Elevated blood levels of phosphorus, alkaline phosphatase, and parathyroid hormone.

Common side effects include:

• Injection site reactions
• Skin rash
• Headache

Indications for Use

Norditropin® is a prescription human growth hormone therapy administered subcutaneously for:

Children with:

• Growth hormone deficiency
• Noonan syndrome
• Turner syndrome
• Small for gestational age (SGA) without catch-up growth
• Idiopathic Short Stature (ISS)
• Prader-Willi syndrome

Adults with:

• Growth hormone deficiency

Sogroya® (somapacitan-beco)

Important Safety Information

Do not use Sogroya® if you:

• Have a critical illness related to heart surgery, stomach surgery, trauma, or severe breathing problems.
• Have cancer or tumors.
• Are allergic to somapacitan-beco or any ingredient in Sogroya®.
• Have diabetic eye disease.
• Are a child with closed growth plates.
• Are a child with severe obesity and Prader-Willi syndrome with breathing difficulties.

Before Using Sogroya®

Inform your healthcare provider if you:

• Have a history of serious medical conditions, surgeries, or respiratory issues.
• Have diabetes, thyroid disease, adrenal problems, or liver disease.
• Have a history of cancer or tumors.
• Are receiving glucocorticoid replacement therapy.
• Have scoliosis.
• Are pregnant, planning pregnancy, breastfeeding, or planning to breastfeed.

Discuss all medications and supplements with your healthcare provider to avoid potential interactions.

Administration Instructions

• Use Sogroya® exactly as prescribed.
• Administer once weekly.
• Missed doses may be taken within 72 hours of the scheduled dose; otherwise, skip and resume the regular schedule.
• Do not share pens or needles.

Potential Serious Side Effects

Sogroya® may cause serious side effects, including:

• Increased risk of death in critically ill patients.
• Increased risk of tumor growth or recurrence.
• Elevated blood sugar levels or diabetes.
• Increased pressure in the skull.
• Severe allergic reactions.
• Fluid retention and swelling.
• Reduced cortisol and thyroid hormone levels.
• Pancreatitis.
• Injection site tissue changes.
• Worsening scoliosis in children.
• Hip and knee disorders in children.
• Increased risk of sudden death in children with severe obesity and Prader-Willi syndrome.
• Increased phosphorus and hormone levels in blood tests.

Most common side effects in children include:

• Cough
• Headache
• Fever
• Ear infections
• Respiratory infections
• Vomiting
• Injection site reactions

Most common side effects in adults include:

• Back pain
• Joint pain
• Indigestion
• Sleep disturbances
• Dizziness
• Swelling of hands and feet
• High blood pressure
• Weight gain
• Anemia

Indications for Use

Sogroya® is a once-weekly human growth hormone therapy administered subcutaneously.

Approved for children with:

• Growth hormone deficiency
• Small for gestational age (SGA)
• Noonan syndrome
• Idiopathic Short Stature (ISS)

Approved for adults with:

• Growth hormone deficiency

Reporting Side Effects

Patients are encouraged to report adverse reactions to the FDA through MedWatch at www.fda.gov/medwatch or by calling 1-800-FDA-1088.