Somapacitan-beco
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alara Ece Dagsali, M.D.
Disclaimer
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
Overview
Somapacitan-beco is a binds to the growth hormone receptor and induces intracellular signalling to up-regulate insulin-like growth factor I (IGF-1) that is FDA approved for the treatment of SOGROYA is indicated for the:
- Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH).
- Replacement of endogenous GH in adults with growth hormone deficiency (GHD).
The following clinically significant adverse drug reactions are described elsewhere in the labeling:. Common adverse reactions include The following clinically significant adverse drug reactions are described elsewhere in the labeling:
- Increased mortality in patients with acute critical illness
Severe hypersensitivity
- Increased risk of neoplasms
- Glucose intolerance and diabetes mellitus
- Intracranial hypertension
- Fluid retention
- Hypoadrenalism
- Hypothyroidism
- Slipped capital femoral epiphysis in pediatric patients
- Progression of preexisting scoliosis in pediatric patients
- Pancreatitis
- Lipohypertrophy/Lipoatrophy
- Sudden death in pediatric patients with Prader-Willi syndrome.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
SOGROYA is indicated for the:
- Treatment of pediatric patients aged 2.5 years and older who have growth failure due to inadequate secretion of endogenous growth hormone (GH).
- Replacement of endogenous GH in adults with growth hormone deficiency (GHD).
‘’’Dosage and Monitoring for Pediatric Patients with GHD’’’
- Recommended dosage of SOGROYA is 0.16 mg/kg based on actual body weight once weekly for treatment-naïve patients and patients switching from daily growth hormone (somatropin).
- Individualize dosage for each patient based on the growth response.
- When switching from daily human growth hormone to once-weekly SOGROYA, choose the preferred day for the weekly dose. Take the final dose of daily treatment on the day before (or at least 8 hours before) the first dose of SOGROYA.
- When switching from a weekly human growth hormone to once-weekly SOGROYA, continue once weekly dosing schedule.
- Assess compliance and evaluate other causes of poor growth such as hypothyroidism, undernutrition, advanced bone age, and antibodies to recombinant human growth hormone if patients experience failure to increase height velocity, particularly during the first year of treatment.
- Patients who were treated with SOGROYA for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuing SOGROYA.
‘’’ Dosage, Titration, and Monitoring for Adult Patients with GHD
*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.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Somapacitan-beco in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Somapacitan-beco in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
‘’’Dosage and Monitoring for Pediatric Patients with GHD’’’
- Recommended dosage of SOGROYA is 0.16 mg/kg based on actual body weight once weekly for treatment-naïve patients and patients switching from daily growth hormone (somatropin).
- Individualize dosage for each patient based on the growth response.
- When switching from daily human growth hormone to once-weekly SOGROYA, choose the preferred day for the weekly dose. Take the final dose of daily treatment on the day before (or at least 8 hours before) the first dose of SOGROYA.
- When switching from a weekly human growth hormone to once-weekly SOGROYA, continue once weekly dosing schedule.
- Assess compliance and evaluate other causes of poor growth such as hypothyroidism, undernutrition, advanced bone age, and antibodies to recombinant human growth hormone if patients experience failure to increase height velocity, particularly during the first year of treatment.
- Patients who were treated with SOGROYA for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuing SOGROYA.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Somapacitan-beco in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Somapacitan-beco in pediatric patients.
Contraindications
SOGROYA is contraindicated in patients with:
- Acute critical illness after open-heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure because of the risk of increased mortality with use of pharmacologic doses of SOGROYA.
- Hypersensitivity to SOGROYA or any of its excipients. Systemic hypersensitivity reactions have been reported postmarketing with somatropin.
- Pediatric patients with closed epiphyses.
- Active malignancy.
- Active proliferative or severe non-proliferative diabetic retinopathy.
- Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to risk of sudden death.
Warnings
‘’’Increased Mortality in Patients with Acute Critical Illness’’’ Increased mortality has been reported after treatment with somatropin in patients with acute critical illness due to complications following open-heart surgery, abdominal surgery and multiple accidental trauma, as well as patients with acute respiratory failure. The safety of continuing SOGROYA treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. SOGROYA is not indicated for the treatment of non-GH deficient adults. ‘’’Severe Hypersensitivity’’’ Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropin. Inform patients and/or caregivers that such reactions are possible, and that prompt medical attention should be sought if an allergic reaction occurs. SOGROYA is contraindicated in patients with known hypersensitivity to somatropin or any excipients in SOGROYA.. ‘’’Increased Risk of Neoplasms’’’ Active Malignancy There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy. Any preexisting malignancy should be inactive, and its treatment complete prior to instituting therapy with SOGROYA. Discontinue SOGROYA if there is evidence of recurrent activity. Risk of Second Neoplasm in Pediatric Patients In childhood cancer survivors who were treated with radiation to the brain/head for their first neoplasm and who developed subsequent growth hormone deficiency (GHD) and were treated with somatropin, an increased risk of second neoplasm has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. Monitor all patients with a history of GHD secondary to an intracranial neoplasm while on somatropin therapy for progression or recurrence of the tumor. New Malignancy During Treatment Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting SOGROYA in these patients. If treatment with SOGROYA is initiated, carefully monitor these patients for development of neoplasms. There is risk of malignant changes of preexisting nevi with somatropin treatment in patients. Monitor patients on SOGROYA therapy carefully for increased growth or potential malignant changes of preexisting nevi. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances, and/or changes in the appearance of preexisting nevi. ‘’’Glucose Intolerance and Diabetes Mellitus’’’ Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients taking somatropin. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving SOGROYA, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or pre-diabetes should be monitored closely. The doses of antidiabetic agents may require adjustment when SOGROYA is initiated. ‘’’Intracranial Hypertension’’’ Intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in patients treated with somatropin. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, intracranial hypertension-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Perform fundoscopic examination before initiating treatment with SOGROYA to exclude preexisting papilledema and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating SOGROYA. If papilledema is observed by fundoscopy during SOGROYA treatment, treatment should be stopped. If intracranial hypertension is confirmed, treatment with SOGROYA can be restarted at a lower dose after intracranial hypertension-associated signs and symptoms have resolved. ‘’’Fluid Retention’’’ Fluid retention during SOGROYA replacement therapy may occur. Clinical manifestations of fluid retention (e.g. edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent. ‘’’Hypoadrenalism’’’ Patients receiving somatropin 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. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of SOGROYA treatment. Monitor patients with known hypoadrenalism for reduced serum cortisol levels and/or need for glucocorticoid dose increases. ‘’’Hypothyroidism’’’ Undiagnosed/untreated hypothyroidism may prevent an optimal response to SOGROYA. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with somatropin therapy. Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated. ‘’’Slipped Capital Femoral Epiphysis in Pediatric Patients’’’ Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Evaluate pediatric patients with the onset of a limp or complaints of persistent hip or knee pain. ‘’’Progression of Preexisting Scoliosis in Pediatric Patients’’’ Somatropin increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression. ‘’’Pancreatitis’’’ Cases of pancreatitis have been reported in patients receiving somatropin. The risk may be greater in pediatric patients compared with adults. Consider pancreatitis in patients who develop persistent severe abdominal pain. ‘’’Lipohypertrophy/Lipoatrophy’’’ When SOGROYA is administered subcutaneously at the same site over a long period of time, tissue lipohypertrophy or lipoatrophy may result. Rotate injection sites when administering SOGROYA to reduce this risk. ‘’’Sudden Death in Pediatric Patients with Prader-Willi Syndrome’’’ There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. SOGROYA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. ‘’’Laboratory Tests’’’ Serum levels of inorganic phosphorus and alkaline phosphatase may increase after SOGROYA therapy. Serum levels of parathyroid hormone may increase with somatropin treatment.
Adverse Reactions
Clinical Trials Experience
‘’’Pediatric Patients with GHD’’’ SOGROYA was studied in a 52-week randomized, open-label, active-controlled, parallel-group clinical study in 200 treatment naïve, prepubertal pediatric patients with growth hormone deficiency. Table 2 shows common adverse reactions that occurred in ≥5% of patients treated with either SOGROYA or somatropin in this trial.
‘’’Adult Patients with GHD’’’ More SOGROYA treated patients shifted from normal baseline levels to elevated phosphate and creatine phosphokinase levels at the end of the trial compared to the placebo group (17.5% vs 4.9% and 9.2% vs. 6.6%, respectively); these laboratory changes occurred intermittently, and were non-progressive.
Postmarketing Experience
There is limited information regarding Somapacitan-beco Postmarketing Experience in the drug label.
Drug Interactions
Glucocorticoid 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.
Cytochrome P450-Metabolized Drugs 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.
Oral Estrogen Oral estrogens may reduce the serum IGF-1 response to SOGROYA.
Insulin and/or Other Hypoglycemic Agents Treatment with SOGROYA may decrease insulin sensitivity, particularly at higher doses.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Somapacitan-beco in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Somapacitan-beco in women who are pregnant.
Labor and Delivery
There are no available data on the use of SOGROYA during pregnancy; however, published studies describing the use of short-acting recombinant growth hormone (rhGH) during pregnancy over several decades have not identified any drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, subcutaneously administered somapacitan-beco was not teratogenic in rats or rabbits during organogenesis at doses approximately 12 times the clinical exposure at the maximum recommended human dose (MRHD) of 8 mg/week. No adverse developmental outcomes were observed in a pre- and post-natal development study with administration of somapacitan-beco to pregnant rats from organogenesis through lactation at approximately 275 times the clinical exposure at the MRHD (see Data). The background risk of birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Nursing Mothers
There is no information on the presence of somapacitan-beco in human milk, the effects on the breastfed infant, or the effects on milk production. Somapacitan-beco-related material was secreted into milk of lactating rats. When a substance is present in animal milk, it is likely that the substance will be present in human milk. Available published data describing administration of short-acting recombinant growth hormone (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. 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.
Pediatric Use
The safety and effectiveness of SOGROYA have been established for the treatment of growth failure due to inadequate secretion of endogenous growth hormone (GH) in pediatric patients 2.5 years of age and older. The use of SOGROYA for this indication is supported by evidence from a 52 week randomized, multi-center, open-label, active-controlled, parallel-group phase 3 trial in 200 treatment-naïve, pediatric patients with GHD. The safety profile from the pediatric trial was similar to that reported in adults Risks in pediatric patients associated with growth hormone use include:
- Sudden death in pediatric patients with Prader-Willi Syndrome. SOGROYA is not indicated for the treatment of pediatric patients with growth failure secondary to genetically confirmed Prader-Willi syndrome
- Increased risk of second neoplasm in pediatric cancer survivors treated with radiation to the brain and/or head
- Slipped capital femoral epiphysis in pediatric patients
- Progression of preexisting scoliosis in pediatric patients
- Pancreatitis
The safety and effectiveness of SOGROYA for the treatment of growth failure due to inadequate secretion of endogenous growth hormone have not been established in pediatric patients less than 2.5 years of age.
Geriatic Use
In clinical studies a total of 52 (15.6%) of the 333 SOGROYA-treated patients were 65 years or older and 3 (0.9%) were 75 years or older. Subjects older than 65 years appeared to have higher exposure than younger subjects at the same dose level. Elderly patients may be more sensitive to the action of somapacitan-beco, and therefore may be at increased risk for adverse reactions. Initiate SOGROYA with a dose of 1 mg once weekly and use smaller increments when increasing the dose.
Gender
There is no FDA guidance on the use of Somapacitan-beco with respect to specific gender populations.
Race
There is no FDA guidance on the use of Somapacitan-beco with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Somapacitan-beco in patients with renal impairment.
Hepatic Impairment
Adult patients: No dose adjustment of SOGROYA is required for patients with mild hepatic impairment. Higher somapacitan-beco exposure was observed in patients with moderate hepatic impairment. In patients with moderate hepatic impairment, initiate SOGROYA with a dose of 1 mg once weekly and use smaller increments when increasing the dose. The maximum dose should not exceed 4 mg once weekly. Somapacitan-beco was not studied in patients with severe hepatic impairment. Therefore, use of SOGROYA is not recommended in patients with severe hepatic impairment. Pediatric patients: Based on the hepatic impairment study in adults, no dose adjustment of SOGROYA is recommended for patients with mild hepatic impairment. Higher systemic exposure of SOGROYA is expected in pediatric patients with moderate and severe hepatic impairment; therefore, SOGROYA is not recommended in these pediatric patients
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Somapacitan-beco in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Somapacitan-beco in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Somapacitan-beco Administration in the drug label.
Monitoring
There is limited information regarding Somapacitan-beco Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Somapacitan-beco and IV administrations.
Overdosage
Acute overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with SOGROYA is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess endogenous growth hormone.
Pharmacology
There is limited information regarding Somapacitan-beco Pharmacology in the drug label.
Mechanism of Action
Somapacitan-beco binds to a dimeric 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.
Structure
There is limited information regarding Somapacitan-beco Structure in the drug label.
Pharmacodynamics
IGF-1 was measured to assess the pharmacodynamic (PD) properties of somapacitan-beco. Somapacitan-beco normalizes the mean IGF-1 standard deviation score (SDS) level from a baseline value below -2 to a value within the reference range (-2 to +2) in treatment-naïve adult patients with GHD. In adult patients with GHD (n=26), somapacitan-beco induces a less than dose proportional IGF-1 response at steady state. Maximum IGF-1 concentrations were observed within 2 to 4 days after dosing. Similar to the somapacitan-beco exposure time course, a steady state IGF-1 response was reached after 1 to 2 weekly doses with limited cumulative IGF-1 response. In pediatric patients with GHD aged 2.5 to 11 years, somapacitan-beco produces a dose linear IGF-1 response, with a change of 0.02 mg/kg on average resulting in a change in IGF-1 standard deviation score (SDS) of 0.32. Approximately 97% of pediatric patients achieved an average IGF-1 SDS level within normal range after 52 weeks of treatment with once weekly Sogroya in Study NCT03811535. IGF-1 SDS levels were -2.03 at baseline and the IGF-1 SDS level change from baseline was 2.36.
Pharmacokinetics
Somapacitan-beco has pharmacokinetic properties compatible with once weekly administration. The reversible binding to endogenous albumin delays elimination of somapacitan and thereby prolongs the in vivo half-life and duration of action. The pharmacokinetics (PK) of somapacitan-beco following subcutaneous administration have been investigated at clinically relevant doses (e.g., 0.01 to 0.32 mg/kg in healthy adults, 0.02 to 0.12 mg/kg in adults with GHD, and 0.02 to 0.16 mg/kg in pediatric patient with GHD). Overall, somapacitan-beco displays non-linear pharmacokinetics, however in the clinically relevant dose range of somapacitan-beco in adults with GHD, somapacitan-beco pharmacokinetics are approximately linear. After subcutaneous administration of 0.02 – 0.16 mg/kg/week somapacitan-beco in pediatric patients with GHD, a non-linear dose-exposure relationship with a greater than dose proportional increase in exposure was observed. ‘’’Absorption’’’ In adults with GHD, a maximum concentration of somapacitan-beco is reached 4 to 24 hours post dose. Steady state exposure is achieved following 1 to 2 weeks of once weekly administration of subcutaneous somapacitan-beco. In pediatric patients with GHD, maximum somapacitan-beco concentrations occurred 8 to 25 hours after dosing at doses from 0.02 mg/kg/week to 0.16 mg/kg/week and increased with increasing dose level. Steady state was achieved following 1 to 2 weekly administration. ‘’’Distribution’’’ Somapacitan-beco is extensively bound (>99%) to plasma proteins. Based on population PK analyses, the estimated volume of distribution (V/F) of somapacitan-beco in adult GHD patients is approximately 14.6 L and 1.7 L in pediatric patients with GHD. ‘’’Elimination’’’ The plasma elimination half-life of somapacitan-beco is approximately 2 to 3 days in adult patients with GHD. Following a dose of 0.16 mg/kg/week, the terminal half-life of somapacitan-beco was about 34 hours in pediatric patients with GHD. Somapacitan-beco was cleared within one week after treatment discontinuation. ‘’’Metabolism’’’: Somapacitan-beco is metabolized via proteolytic cleavage of the linker sequence between the peptide backbone and albumin binder sidechain. Excretion: The primary excretion routes of somapacitan-beco-related material are via the urine and feces. Approximately 81% of the dose is excreted in the urine and approximately 13% is excreted in the feces. No intact somapacitan-beco is excreted indicating full breakdown of somapacitan-beco prior to excretion. Specific Populations ‘’’Body weight’’’: Adults with GHD -The exposure of somapacitan-beco decreases with increasing body weight. However, the somapacitan-beco dose range of 0.1 to 8 mg/week provides adequate systemic exposure to reach target IGF-1 levels over the weight range of 34.5-150.5 kg evaluated in the clinical trials. ‘’’Pediatric patients with GHD’’’: Based on pharmacokinetic analysis, gender and race do not have a clinically meaningful effect on the pharmacokinetics. The exposure of somapacitan-beco decreases with increasing body weight. However, the somapacitan-beco dose of 0.16 mg/kg/week provides adequate systemic exposure for pediatrics to reach target IGF-1 levels over the weight range of 9.9 to 61.8 kg evaluated in the clinical trials. ‘’’Geriatric patients’’’: Adult patients greater than 65 years of age and geriatric patients have a higher exposure than younger subjects at the same somapacitan-beco dose. Female patients receiving estrogen: Female patients and in particular female patients on oral estrogen, have lower exposure than males at the same somapacitan-beco dose . Hepatic impairment: A somapacitan-beco dose of 0.08 mg/kg at steady state resulted in comparable somapacitan-beco exposure between patients with normal hepatic function and mild hepatic impairment (Child-Pugh A). However, higher exposure was observed in patients with moderate hepatic impairment (Child-Pugh B) (ratios to normal hepatic function were 4.69 and 3.52-fold increase for AUC0-168h and Cmax, respectively). Lower somapacitan-beco stimulated
Nonclinical Toxicology
Long term studies in animals with somapacitan-beco to evaluate carcinogenic potential have not been conducted.
Somapacitan-beco was not mutagenic or clastogenic in a standard battery of genotoxicity tests (bacterial mutagenicity (Ames), human lymphocyte chromosome aberration, rat bone marrow micronucleus).
In rat studies evaluating male and female fertility, somapacitan-beco was administered by subcutaneous injection at doses of 1, 2, and 4 mg/kg twice weekly. Males were dosed from four weeks before pairing until termination and females were dosed beginning two weeks prior to mating through gestation day 7. No adverse effects were observed on male or female fertility in rats at doses up to 4 mg/kg (29 times the MRHD, based on AUC).
Clinical Studies
‘’’Pediatric Patients with Growth Hormone Deficiency (GHD)’’’
A randomized, open-label, active-controlled, parallel-group phase 3 study was conducted in 200 treatment-naïve, pediatric patients with growth hormone deficiency (GHD) (NCT03811535). The primary efficacy endpoint was annualized height velocity at Week 52. One hundred thirty two patients (132) received 0.16 mg/kg/week SOGROYA, and 68 received 0.034 mg/kg/day daily somatropin. The patients ranged in age from 2.5 to 11 years with a mean of 6.4 years. Of these patients, 74.5% were male and 25.5% were female. Fifty-seven percent (57%) of patients were Caucasian, 37% of patients were Asian, 0.5% of patients were Black or African American, 5.0% were not reported, and 0.5% were categorized as “other.” The mean baseline height standard deviation score (SDS) of -2.99 (1.02) in SOGROYA group and -3.47 (1.52) in daily somatropin group. Treatment with once-weekly SOGROYA for 52 weeks resulted in an annualized height velocity of 11.2 cm/year. Patients treated with daily somatropin achieved an annualized height velocity of 11.7 cm/year after 52 weeks of treatment.
‘’’Adults with Growth Hormone Deficiency (GHD)’’’ In a 35-week, double-blind, placebo-controlled study, treatment-naïve adult patients with GHD were randomized (2:1:2) and exposed to once-weekly SOGROYA 10 mg/1.5mL (n=120) or placebo (n=60) or a daily somatropin product 10 mg/1.5mL (n=119) for a 34-week treatment period (NCT02229851). In this study, patients were 51.7% female and had a mean age of 45.1 years. Most patients were 23 to 64 years old and most (69.7%) had adult onset GHD. The mean BMI was 27.4 kg/m2. Overall, 66.7% were White, 28.7% were Asian and 2.3% were Black or African American; 4.5% identified as Hispanic or Latino ethnicity. Treatment with SOGROYA demonstrated superiority compared to placebo in reduction in truncal fat percentage (%) as assessed by dual X-ray absorptiometry, with a change of -1.06% for SOGROYA and +0.47% for placebo after 34 weeks (see Table 6). Patients treated with daily somatropin achieved a change in truncal fat % of -2.23% after 34 weeks
How Supplied
SOGROYA (somapacitan-beco) injection is a clear to slightly opalescent and colorless to slightly yellow solution available as one 1.5 mL single-patient-use prefilled pen per carton:
- SOGROYA 5 mg/1.5 mL (3.3 mg/mL) pen (teal) NDC 0169-2035-11
- SOGROYA 10 mg/1.5 mL (6.7 mg/mL) pen (yellow) NDC 0169-2030-11
- SOGROYA 15 mg/1.5 mL (10 mg/mL) pen (red) NDC 0169-2037-11
SOGROYA 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL pens are compatible with FlexPro® PenMate®. The FlexPro PenMate is an accessory device that is dispensed separately with its enclosed Instructions for Use.
Storage
Before and during use: Store in a refrigerator at 36°F to 46°F (2°C to 8°C) with the cap on and in the original carton to protect from light. Do not freeze. Do not use SOGROYA if it has been frozen. Discard prefilled pen if kept above 86°F (30°C). Avoid direct or excessive heat. Avoid sunlight. Refer to storage conditions for SOGROYA . Write the date of first use in the space provided on the carton. Always remove and safely discard the needle after each injection and store the SOGROYA prefilled pen without an injection needle attached. Always use a new needle for each injection to prevent contamination.
Images
Drug Images
{{#ask: Page Name::Somapacitan-beco |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}
Package and Label Display Panel
{{#ask: Label Page::Somapacitan-beco |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
Advise patients and/or caregivers to read the FDA-approved patient labeling (Patient Information and Instructions for Use). Advise patients and/or caregivers to administer SOGROYA once weekly. ‘Hypersensitivity’ - Advise patients and/or caregivers that severe and/or serious systemic hypersensitivity reactions (anaphylaxis and angioedema) have been reported, and to seek prompt medical attention should an allergic reaction ocur ‘Neoplasms’ – Advise patients to report marked changes in skin pigmentation or changes in the appearance of preexisting nevi. ‘Glucose Intolerance/ Diabetes Mellitus’ – Advise patients that new onset pre- /diabetes mellitus or exacerbation of preexisting diabetes mellitus can occur and monitoring of blood glucose during treatment with SOGROYA may be needed. ‘Intracranial Hypertension’ - Advise patients to report to their healthcare provider any visual changes, headache, and nausea and/or vomiting. ‘Fluid Retention’ - Advise patients that fluid retention during SOGROYA replacement therapy may frequently occur. Inform patients of the clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) and to report to their healthcare provider any of these signs or symptoms occur during treatment with SOGROYA. ‘Hypoadrenalism ‘- Advise patients who have or who are at risk for corticotropin deficiency that hypoadrenalism may develop and to report to their healthcare provider if they experience hyperpigmentation, extreme fatigue, dizziness, weakness, or weight loss. ‘Hypothyroidism’ - Advise patients/caregivers that undiagnosed/untreated hypothyroidism may prevent an optimal response to SOGROYA. Advise patients/caregivers they may require periodic thyroid function tests. ‘Pancreatitis’ - Advise patients that pancreatitis may develop and to report to their healthcare provider any new onset abdominal pain. ‘Lipohypertrophy/ Lipoatrophy ‘ – Advise patients that lipohypertrophy or lipoatrophy can occur if SOGROYA is administered subcutaneously at the same site over a long period of time. Advise patients to rotate injection sites when administering SOGROYA to reduce this risk
Precautions with Alcohol
Alcohol-Somapacitan-beco interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
SOGROYA
Look-Alike Drug Names
There is limited information regarding Somapacitan-beco Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.