Somapacitan

Somapacitan is a human growth hormone analog used to replace endogenous growth hormone in adults with growth hormone deficiency.

• Somapacitan is available under the following different brand names: Sogroya, somapacitan-beco

Common side effects of Somapacitan include:

• back pain,
• joint pain,
• indigestion/heartburn,
• sleep disorder,
• dizziness,
• tonsillitis,
• swelling of extremities,
• vomiting,
• adrenal insufficiency,
• high blood pressure (hypertension),
• increased blood creatine phosphokinase,
• weight gain, and
• anemia

Serious side effects of Somapacitan include:

• high risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems.
• increased risk of growth of cancer or a tumor that is already present and increased risk of the return of cancer. 
• new or worsening high blood sugar (hyperglycemia) or diabetes. Your blood sugar may need to be monitored during treatment with SOGROYA.
• increase in pressure in the skull (intracranial hypertension). If you have headaches, eye problems, nausea or vomiting.
• serious allergic reactions like:
  • swelling of your face, lips, mouth, or tongue
  • trouble breathing
  • wheezing
  • severe itching
  • skin rashes, redness, or swelling
  • dizziness or fainting
  • fast heartbeat or pounding in your chest
  • sweating
  • body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in the joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet.
  • decrease in a hormone called cortisol leading to darkening of the skin, severe fatigue, dizziness, weakness, or weight loss.
  • decrease in thyroid hormone levels.
  • severe and constant abdominal pain. 
  • loss of fat and tissue weakness in the area of skin you inject. 
  • increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood.

Rare side effects of Somapacitan include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and geriatric dosage

Injection, solution

• 10 mg/1.5 mL (6.7 mg/mL) prefilled pen

Growth Hormone Deficiency

Adult dosage

• Initial dose: 1.5 mg SC every week for either patients who are treatment naïve or those switching from daily growth hormone (somatropin)
• Increase weekly dose every 2-4 weeks by ~0.5-1.5 mg until the desired response is achieved (based on clinical response and serum [insulin-like growth factor 1] IGF-1 concentrations)
• Not to exceed 8 mg every week

Geriatric dosage

• Initial dose, age above 65 years: 1 mg SC every week for either patient who are treatment naïve or those switching from daily growth hormone (somatropin)
• Increase weekly dose every 2-4 weeks by small increments that are recommended for younger adults until desired response is achieved (based on clinical response and serum IGF-1 concentrations)
• Not to exceed 8 mg every week

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Somapacitan has severe interactions with no other drugs.
• Somapacitan has serious interactions with the following drug:
  • macimorelin
• Somapacitan has moderate interactions with at least 61 other drugs.
• Somapacitan has minor interactions with no other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Acute critical illness after open heart surgery, abdominal surgery, multiple accidental trauma, or those with acute respiratory failure; risk of increased mortality with pharmacologic doses of somapacitan

Active malignancy

• Hypersensitivity to drug or any of its excipients; systemic hypersensitivity reactions reported with other growth hormone products
• Active proliferative or severe nonproliferative diabetic retinopathy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Somapacitan?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Somapacitan?”

Cautions

• Increased mortality was reported after treatment with pharmacologic amounts of growth hormone products in patients with acute critical illness owing to complications following open heart surgery, abdominal surgery, and multiple accidental trauma, as well as those with acute respiratory failure
• May decrease insulin sensitivity, particularly at higher doses; new-onset type 2 diabetes mellitus reported in patients taking growth hormone products; patients with undiagnosed prediabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic; monitor glucose levels periodically in all patients receiving therapy, especially with prediabetes/diabetes or risk factors for diabetes mellitus (eg, obesity, family history)
• Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting reported with growth hormone products; symptoms usually occur within the first 8 weeks of initiating; perform a funduscopic examination before initiating and periodically thereafter; if papilledema observed by funduscopy during treatment, stop therapy; if intracranial hypertension diagnosed, may restart treatment at a lower dose after intracranial hypertension-associated signs and symptoms have resolved
• Serious systemic hypersensitivity reactions, including anaphylactic reactions and angioedema, were reported postmarketing with growth hormone products
• Fluid retention may occur, manifested by edema and nerve compression syndromes, including carpal tunnel syndrome/paresthesia; these symptoms are usually transient and dose-dependent
• Patients receiving growth hormone therapy who have or are at risk for corticotropin deficiency may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism; additionally, those treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan
• Undiagnosed/untreated hypothyroidism may prevent an optimal response; in patients with a growth hormone deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy; periodically monitor thyroid function
• Pancreatitis reported; consider this in patients who develop persistent severe abdominal pain
• SC administration at the same site over a long time may cause tissue lipohypertrophy or lipoatrophy; rotate injection sites
• Increased serum levels of inorganic phosphorous, alkaline phosphatase, and the parathyroid hormone may occur
• Malignancies
  • Active malignancy
  • Increased risk of malignancy progression with growth hormone treatment in patients with active malignancy
  • Any preexisting malignancy should be inactive, and its treatment complete before initiating somapacitan
  • Discontinue the drug if there is evidence of recurrent activity
• New skin malignancy
  • Potential risk of malignant changes of preexisting nevi
  • Monitor carefully for increased growth, or potential malignant changes, of preexisting nevi
  • Advise patients to report changes in skin pigmentation or changes in nevi appearance
• Drug interaction overview
  • Glucocorticoids
    • Patients treated with glucocorticoid replacement for hypoadrenalism may require increased maintenance or stress doses after initiating somapacitan
    • Microsomal enzyme 11 beta-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for the conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue
    • Growth hormone inhibits 11βHSD-1; consequently, individuals with untreated growth hormone deficiency have relative increases in 11βHSD-1 and serum cortisol
    • Initiating somapacitan may inhibit 11βHSD-1 and reduce serum cortisol concentrations
  • CYP450 substrates
    • Limited data suggest growth hormone increases CYP450-mediated clearance
  • Monitor CYP450 substrates
  • Oral estrogen
    • Oral estrogens may reduce serum IGF-1 response to somapacitan
    • Higher estrogen dosage may be required
    • Insulin and/or other hypoglycemic agents
    • Somapacitan may decrease insulin sensitivity, particularly at higher doses
    • Insulin or other hypoglycemia agents may require dose adjustment

Pregnancy and Lactation

• Data are not available regarding use in pregnant women
• Published studies with short-acting recombinant growth hormone (rhGH) use in pregnant women over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Lactation
  • Data are not available regarding the presence in human milk, its effects on the breastfed infant, or its effects on milk production
  • Somapacitan-related material was secreted into the milk of lactating rats; when a substance is present in animal milk, it is likely to be present in human milk.
  • Available published data describing the administration of short-acting rhGH to lactating women for 7 days reported that short-acting rhGH did not increase the normal breastmilk concentration of growth hormone and no adverse effects were reported in breastfed infants