SOGROYA Dosage & Rx Info | Uses, Side Effects

Sogroya Generic Name & Formulations

Legal Class

General Description

Somapacitan-beco 5mg/1.5mL, 10mg/1.5mL, 15mg/1.5mL; per prefilled pen; soln for SC inj.

Pharmacological Class

Growth hormone (GH).

How Supplied

Single-use prefilled pen—1

Manufacturer

Novo Nordisk

Generic Availability

Mechanism of Action

Somapacitan-beco binds to a dimeric growth hormone (GH) receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by insulin-like growth factor-1 (IGF-1) produced in the liver, while others are primarily a consequence of the direct effects of somapacitan-beco.

Sogroya Indications

Indications

Growth failure in children due to inadequate secretion of endogenous growth hormone (GH). Replacement of endogenous GH in adults with growth hormone deficiency (GHD).

Sogroya Dosage and Administration

Adult

Administer under supervision by experienced healthcare provider. Individualize. Give by SC inj in upper arms, thigh, abdomen or buttocks; rotate inj site weekly. Treatment-naïve or switching from daily GH (somatropin): 1.5mg once weekly. Increase weekly dose by 0.5–1.5mg every 2–4 weeks until desired response; titrate dose based on clinical response and IGF-1 levels. Max dose: 8mg once weekly. ≥65yrs: initially 1mg once weeky and increase in smaller dose increments. Moderate hepatic impairment: initially 1mg once weekly and increase in smaller dose increments; max 4mg once weekly. Concomitant oral estrogen: initially 2mg once weekly.

Children

Administer under supervision by experienced healthcare provider. Individualize. Give by SC inj in upper arms, thigh, abdomen or buttocks; rotate inj site weekly. <2.5yrs: not established. ≥2.5yo: Treatment-naïve or switching from daily GH (somatropin): 0.16mg/kg once weekly. Switching from weekly human GH: continue once weekly dosing schedule. Assess compliance and other causes if failure to increase height velocity. If epiphyses are closed, re-evaluate before continuing treatment.

Sogroya Contraindications

Contraindications

Acute critical illness after open heart or abdominal surgery, or multiple accidental trauma, or those with acute respiratory failure. Pediatric patients with closed epiphyses. Active malignancy. Active proliferative or severe non-proliferative diabetic retinopathy. History of upper airway obstruction or sleep apnea, severe obesity, or severe respiratory impairment in children with Prader-Willi syndrome (PWS).

Sogroya Boxed Warnings

Not Applicable

Sogroya Warnings/Precautions

Warnings/Precautions

Increased mortality in those with acute critical illness (see Contraindications). Not for treatment of children with growth failure due to PWS. Increased risk of malignancies; if preexisting, complete treatment prior to Sogroya initiation; discontinue if there is evidence of recurrent activity. History of GHD secondary to intracranial neoplasm: monitor routinely for tumor progression or recurrence. Monitor for increased growth or malignant changes of preexisting nevi. Diabetes. Obesity. Intracranial hypertension: perform routine funduscopic exam at baseline to exclude preexisting papilledema and periodically thereafter; discontinue if papilledema develops. Hypoadrenalism: monitor for reduced serum cortisol levels. Hypothyroidism. Scoliosis (monitor). Monitor thyroid function, glucose tolerance. May increase serum phosphorous, alkaline phosphatase, parathyroid hormone after therapy. Hepatic impairment: Moderate (peds): not recommended. Severe hepatic impairment: not recommended. Elderly. Pregnancy. Nursing mothers.

Sogroya Pharmacokinetics

Absorption

Maximum concentration reached: 4 to 24 hours post dose (adults); 8 to 25 hours post dose (pediatric).
Steady state exposure is achieved following 1 to 2 weeks.

Distribution

>99% serum protein bound.
Estimated volume of distribution: ~14.6 L (adults); 1.7 L (pediatric).

Metabolism

Proteolytic cleavage.

Elimination

Renal (~81%), fecal (~13%).
Half-life: ~2–3 days (adults); ~34 hours (pediatric).

Sogroya Interactions

Interactions

May require increase in maintenance or stress doses of glucocorticoids in hypoadrenalism. Concomitant drugs metabolized by CYP450 enzymes; monitor. Antidiabetic medications may need to be adjusted. Women on oral estrogen: may need higher Sogroya dose (see Adults).

Sogroya Adverse Reactions

Adverse Reactions

Back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, peripheral edema, vomiting, adrenal insufficiency, hypertension, blood creatine phosphokinase increase, weight increase, anemia; severe hypersensitivity reactions, fluid retention, hyperglycemia, impaired glucose tolerance, intracranial hypertension, hypoadrenalism, slipped capital femoral epiphysis (monitor), pancreatitis, lipoatrophy. Peds: nasopharyngitis, headache, pyrexia, pain in extremity, inj site reaction.

Sogroya Clinical Trials

See Literature

Sogroya Note