Sogroya (somapacitan-beco) Human Growth Hormone: Side Effects & Dosage

What is Sogroya, and how does it work?

Sogroya is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (GHD).

• Sogroya is a prescription medicine that contains human growth hormone, the same growth hormone made by the human body.
• Sogroya is given by injection under the skin (subcutaneous) and is used to treat adults who do not make enough growth hormone.

It is not known if
Sogroya is safe and effective in children.

What are the side effects of Sogroya?

Sogroya may cause serious side effects, including:

• 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. Your healthcare provider will need to monitor you for a return of cancer or a tumor. Contact the healthcare provider if you start to have changes in moles, birthmarks, or the color of your skin.
• 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, contact the healthcare provider.
• serious allergic reactions. Get medical help right away if you have the following symptoms:
  • 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
• your body holding too much fluid (fluid retention) such as swelling in the hands and feet, pain in your joints or muscles or nerve problems that cause pain, burning or tingling in the hands, arms, legs and feet. Tell your healthcare provider if you have any of these signs or symptoms of fluid retention.
• decrease in a hormone called cortisol. The healthcare provider will do blood tests to check your cortisol levels. Tell your healthcare provider if you have darkening of the skin, severe fatigue, dizziness, weakness, or weight loss.
• decrease in thyroid hormone levels. Decreased thyroid hormone levels may affect how well
  Sogroya works. The healthcare provider will do blood tests to check your thyroid hormone levels.
• severe and constant abdominal pain. This could be a sign of pancreatitis. Tell your healthcare provider if you have any new abdominal pain.
• loss of fat and tissue weakness in the area of skin you inject. Talk to your healthcare provider about rotating the areas where you inject
  Sogroya.
• increase in phosphorus, alkaline phosphatase and parathyroid hormone levels in your blood. Your healthcare provider will do blood tests to check this.

The most common side effects of
Sogroya include:

• back pain
• joint pain
• indigestion
• sleep problems
• dizziness
• swelling of the tonsils (tonsillitis)
• vomiting
• high blood pressure
• increase in the level of an enzyme in your blood called creatine phosphokinase
• weight gain
• low red blood cells (anemia)

These are not all the possible side effects of
Sogroya.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Novo Nordisk at 1-888-668-6444.

Does Sogroya cause addiction or withdrawal symptoms?

Drug Abuse And Dependence

Controlled Substance

• Sogroya contains somapacitan-beco, which is not a controlled substance.

Abuse

• Inappropriate use of Sogroya may result in significant negative health consequences.

Dependence

• Sogroya is not associated with drug related withdrawal adverse reactions.

What is the dosage for Sogroya?

Administration And Use Instructions

• Therapy with
  Sogroya should be supervised by a physician who is experienced in the
  diagnosis and management of patients with the conditions for which Sogroya
  is indicated.
• Perform fundoscopic examination before initiating
  treatment with Sogroya to exclude preexisting papilledema, and periodically
  thereafter. If papilledema is identified, evaluate the etiology and treat
  the underlying cause before initiating therapy with Sogroya.
• Administer
  Sogroya by subcutaneous injection to the abdomen or thigh with regular rotation of injection sites to avoid lipohypertrophy.
• Inspect visually for particulate matter and discoloration.
  Sogroya should be a clear to slightly opalescent and colorless to slightly yellow solution. If the solution is cloudy or contains particulate matter do not use.
• The
  Sogroya prefilled pen dials in 0.05 mg increments and delivers doses from 0.05 mg to 4 mg.
• Instructions for delivering the dosage are provided in the
  prescribing information.

Recommended Dosage, Titration, And Monitoring

• Administer the prescribed dose subcutaneously one time each week (weekly).
• Initiate
  Sogroya with a dosage of 1.5 mg once weekly for treatment naïve patients and patients switching from daily growth hormone (somatropin).
• Increase the weekly dosage every 2 to 4 weeks by approximately 0.5 mg to 1.5 mg until the desired response is achieved.
• Titrate the dosage based on clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations. Draw IGF-1 samples 3 to 4 days after the prior dose.
• Decrease the dosage as necessary on the basis of adverse reactions and/or serum IGF-1 concentrations above the age- and sex-specific normal range.
• The maximum recommended dosage is 8 mg once weekly.

Recommended Dosage And Titration For Specific Populations

Patients Aged 65 Years And Older

Initiate Sogroya with a dosage of 1 mg once weekly and use smaller dose
increment increases when titrating the dosage. See above for monitoring
recommendations and the maximum recommended dosage of Sogroya.

Patients With Hepatic Impairment

• Sogroya is not recommended in patients with severe hepatic impairment.
• For patients with moderate hepatic impairment, initiate Sogroya with a
  dosage of 1 mg once weekly and use smaller dose increment increases when
  titrating the dosage. See above for monitoring recommendations. The maximum recommended dosage is 4 mg once weekly.
• No dosage adjustment is recommended for patients with mild hepatic impairment.

Women Receiving Oral Estrogen

Initiate Sogroya with a dosage of 2 mg once weekly. See above for titration and
monitoring recommendations and the maximum recommended dosage of Sogroya.

Missed Doses

• Administer a missed dose as soon as possible and not more than 3 days after the missed dose (72 hours).
• If more than 3 days have passed since the missed dose, skip the dose and administer the next dose on the regular dosing day.

What drugs interact with Sogroya?

Table 2 includes a list of drugs with clinically important drug interactions when administered concomitantly with
Sogroya and instructions for preventing or managing them.

Table 2: Clinically Important Drug Interactions with Sogroya

Replacement Glucocorticoid TreatmentClinical Impact:Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of
Sogroya may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations.Intervention:Patients treated with glucocorticoid replacement for hypoadrenalism may
require an increase in their maintenance or stress doses following
initiation of Sogroya.Examples:Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1.Cytochrome P450-Metabolized DrugsClinical Impact:Limited published data indicate that GH treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance.
Sogroya may alter the clearance of compounds known to be metabolized by CP450 liver enzymes.Intervention:Careful monitoring is advisable when
Sogroya is administered in combination with drugs metabolized by CP450 liver enzymes.Oral EstrogenClinical Impact:Oral estrogens may reduce the serum IGF-1 response to
Sogroya.Intervention:
Patients receiving oral estrogen replacement may require higher Sogroya
dosages.Insulin and/or Other Hypoglycemic AgentsClinical Impact:Treatment with
Sogroya may decrease insulin sensitivity, particularly at higher doses.Intervention:
Patients with diabetes mellitus may require adjustment of their doses of
insulin and/or other hypoglycemic agents.

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Is Sogroya safe to use while pregnant or breastfeeding?

• There are no available data on Sogroya use in pregnant women; however,
  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.
• There is no information on with the presence of somapacitan-beco in
  human milk, the effects on the breastfed infant, or the effects on milk
  production.
• The developmental and health benefits of breastfeeding should be
  considered along with the mother’s clinical need for Sogroya and any
  potential adverse effects on the breastfed infant from Sogroya or from the
  underlying maternal condition.