Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied NGENLA (somatrogon-ghla) injection is a clear and colorless to slightly light yellow solution containing a preservative and supplied as one single-patient-use disposable prefilled pen per carton available in the following packages: 24 mg/1.2 mL Prefilled Pen NDC: 0069-0505-02 60 mg/1.2 mL Prefilled Pen NDC: 0069-0520-02 Somatrogon-ghla solution concentration 20 mg/mL 50 mg/mL Color scheme Lilac pen cap, injection button and label Blue pen cap, injection button and label Dose increments 0.2 mg/0.01 mL 0.5 mg/0.01 mL Maximum dose 12 mg (0.6 mL) 30 mg (0.6 mL) Not made with natural rubber latex. Sterile needles are required for administration but not included. Consult the Instructions for Use for needles that can be used. Storage and Handling Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. After first use: Store the pen refrigerated at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days. Do not freeze or shake. Do not expose to heat. Do not use if it has been frozen. Store away from direct sunlight. Always remove and safely discard the needle after each injection and store the NGENLA prefilled pen without an injection needle attached. Always use a new needle for each injection. Replace the cap on your prefilled pen when it is not in use. Write the date of first use in the space provided on the pen label. The prefilled pen should not be used more than 28 days after first use.; PRINCIPAL DISPLAY PANEL - 24 mg Cartridge Label NDC 0069-0505-01 Store refrigerated 24mg Ngenla ® (somatrogon-ghla) Injection 24 mg/1.2 mL (20 mg/mL) For Subcutaneous Injection Only mg Single-patient-use Rx only PRINCIPAL DISPLAY PANEL - 24 mg Cartridge Label; PRINCIPAL DISPLAY PANEL - 24 mg Cartridge Carton One single-patient-use disposable prefilled pen Rx only NDC 0069-0505-02 24mg Ngenla ® (somatrogon-ghla) Injection 24 mg/1.2 mL (20 mg/mL) For Subcutaneous Injection Only READ ENCLOSED INSTRUCTIONS BEFORE USE Write the date of first use in the space provided on the pen label. Discard the pen 28 days after first use, even if it contains unused medicine. Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. After first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) between each use for up to 28 days. Do not freeze or shake. Do not expose to heat. Store away from direct sunlight. Do not use if it has been frozen. PRINCIPAL DISPLAY PANEL - 24 mg Cartridge Carton; PRINCIPAL DISPLAY PANEL - 60 mg Cartridge Label NDC 0069-0520-01 Store refrigerated 60mg Ngenla ® (somatrogon-ghla) Injection 60 mg/1.2 mL (50 mg/mL) For Subcutaneous Injection Only mg Single-patient-use Rx only PRINCIPAL DISPLAY PANEL - 60 mg Cartridge Label; PRINCIPAL DISPLAY PANEL - 60 mg Cartridge Carton One single-patient-use disposable prefilled pen Rx only NDC 0069-0520-02 60mg Ngenla ® (somatrogon-ghla) Injection 60 mg/1.2 mL (50 mg/mL) For Subcutaneous Injection Only READ ENCLOSED INSTRUCTIONS BEFORE USE Write the date of first use in the space provided on the pen label. Discard the pen 28 days after first use, even if it contains unused medicine. Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. After first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) between each use for up to 28 days. Do not freeze or shake. Do not expose to heat. Store away from direct sunlight. Do not use if it has been frozen. PRINCIPAL DISPLAY PANEL - 60 mg Cartridge Carton
- 16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied NGENLA (somatrogon-ghla) injection is a clear and colorless to slightly light yellow solution containing a preservative and supplied as one single-patient-use disposable prefilled pen per carton available in the following packages: 24 mg/1.2 mL Prefilled Pen NDC: 0069-0505-02 60 mg/1.2 mL Prefilled Pen NDC: 0069-0520-02 Somatrogon-ghla solution concentration 20 mg/mL 50 mg/mL Color scheme Lilac pen cap, injection button and label Blue pen cap, injection button and label Dose increments 0.2 mg/0.01 mL 0.5 mg/0.01 mL Maximum dose 12 mg (0.6 mL) 30 mg (0.6 mL) Not made with natural rubber latex. Sterile needles are required for administration but not included. Consult the Instructions for Use for needles that can be used. Storage and Handling Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. After first use: Store the pen refrigerated at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days. Do not freeze or shake. Do not expose to heat. Do not use if it has been frozen. Store away from direct sunlight. Always remove and safely discard the needle after each injection and store the NGENLA prefilled pen without an injection needle attached. Always use a new needle for each injection. Replace the cap on your prefilled pen when it is not in use. Write the date of first use in the space provided on the pen label. The prefilled pen should not be used more than 28 days after first use.
- PRINCIPAL DISPLAY PANEL - 24 mg Cartridge Label NDC 0069-0505-01 Store refrigerated 24mg Ngenla ® (somatrogon-ghla) Injection 24 mg/1.2 mL (20 mg/mL) For Subcutaneous Injection Only mg Single-patient-use Rx only PRINCIPAL DISPLAY PANEL - 24 mg Cartridge Label
- PRINCIPAL DISPLAY PANEL - 24 mg Cartridge Carton One single-patient-use disposable prefilled pen Rx only NDC 0069-0505-02 24mg Ngenla ® (somatrogon-ghla) Injection 24 mg/1.2 mL (20 mg/mL) For Subcutaneous Injection Only READ ENCLOSED INSTRUCTIONS BEFORE USE Write the date of first use in the space provided on the pen label. Discard the pen 28 days after first use, even if it contains unused medicine. Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. After first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) between each use for up to 28 days. Do not freeze or shake. Do not expose to heat. Store away from direct sunlight. Do not use if it has been frozen. PRINCIPAL DISPLAY PANEL - 24 mg Cartridge Carton
- PRINCIPAL DISPLAY PANEL - 60 mg Cartridge Label NDC 0069-0520-01 Store refrigerated 60mg Ngenla ® (somatrogon-ghla) Injection 60 mg/1.2 mL (50 mg/mL) For Subcutaneous Injection Only mg Single-patient-use Rx only PRINCIPAL DISPLAY PANEL - 60 mg Cartridge Label
- PRINCIPAL DISPLAY PANEL - 60 mg Cartridge Carton One single-patient-use disposable prefilled pen Rx only NDC 0069-0520-02 60mg Ngenla ® (somatrogon-ghla) Injection 60 mg/1.2 mL (50 mg/mL) For Subcutaneous Injection Only READ ENCLOSED INSTRUCTIONS BEFORE USE Write the date of first use in the space provided on the pen label. Discard the pen 28 days after first use, even if it contains unused medicine. Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. After first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) between each use for up to 28 days. Do not freeze or shake. Do not expose to heat. Store away from direct sunlight. Do not use if it has been frozen. PRINCIPAL DISPLAY PANEL - 60 mg Cartridge Carton
Overview
Somatrogon-ghla, a human growth hormone analog, is a fusion protein produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. It is comprised of the amino acid sequence of human growth hormone (hGH) with one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and 2 copies of CTP (in tandem) at the C-terminus. Somatrogon-ghla has an approximate molecular weight of 40 KDa. NGENLA (somatrogon-ghla) injection is a sterile, clear and colorless to slightly light yellow solution for subcutaneous use supplied in a 24 mg/1.2 mL (20 mg/mL) or 60 mg/1.2 mL (50 mg/mL) single-patient-use prefilled pen. Each 1.2 mL of solution contains either 24 mg or 60 mg of somatrogon-ghla, and the inactive ingredients citric acid monohydrate (0.3 mg), histidine (1.9 mg), metacresol (4 mg, as a preservative), poloxamer 188 (2 mg), sodium chloride (10 mg) and sodium citrate (2.8 mg) in water for injection. NGENLA has a pH of approximately 6.6.
Indications & Usage
NGENLA is indicated for the treatment of pediatric patients aged 3 years and older who have growth failure due to an inadequate secretion of endogenous growth hormone. NGENLA is a human growth hormone analog indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone ( 1 ).
Dosage & Administration
• NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients with growth hormone deficiency ( 2.1 ). • Administer NGENLA by subcutaneous injection once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms with weekly rotation of injection site ( 2.1 ). • The recommended dosage is 0.66 mg/kg based on actual body weight administered once weekly ( 2.3 ). • Individualize dosage for each patient based on the growth response ( 2.3 ). • Patients switching from daily growth hormone may initiate treatment with once-weekly NGENLA on the day following their last daily injection ( 2.3 ). • If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site ( 2.3 ). 2.1 Important Dosing and Administration Information • NGENLA treatment should be supervised by a healthcare provider who is experienced in the diagnosis and management of pediatric patients aged 3 years and older with growth failure due to growth hormone deficiency (GHD) [see Indications and Usage (1) ] . • Refer patient to the Instructions for Use for complete administration instructions. • Administer NGENLA by subcutaneous injection, once weekly, on the same day each week, at any time of the day in the abdomen, thighs, buttocks, or upper arms. Rotate the injection site weekly. • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If flakes, particles or discoloration are observed, do not use the pen. Do not shake; shaking can damage the product. • Prefilled pens deliver somatrogon-ghla in 0.2 mg or 0.5 mg increments. 2.2 Perform Fundoscopic Examination Prior to Initiation of NGENLA • Perform fundoscopic examination before initiating treatment with NGENLA to exclude preexisting papilledema. If papilledema is identified, evaluate the etiology and treat the underlying cause before initiating treatment with NGENLA [see Warnings and Precautions (5.4) ] . 2.3 Recommended Dosage and Monitoring for Pediatric Patients with GHD • Recommended dosage of NGENLA is 0.66 mg/kg based on actual body weight administered once weekly by subcutaneous (SC) injection. • Individualize dosage for each patient based on the growth response. • The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days. After selecting a new dosing day, the once weekly dosing should be continued. • When switching from daily growth hormone, the once-weekly NGENLA may be initiated on the day following their last daily injection. • If more than one injection is required to deliver a complete dose, each injection should be administered at a different injection site. 2.4 Missed Dose • If a dose is missed, administer NGENLA as soon as possible within 3 days after the missed dose. • If more than 3 days have passed, skip the missed dose and administer the next dose on the regularly scheduled day.
Warnings & Precautions
• Severe Hypersensitivity : Severe hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention ( 5.2 ). • Increased Risk of Neoplasms : Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin – in particular meningiomas in patients treated with radiation to the head for their first neoplasm ( 5.3 ). • Glucose Intolerance and Diabetes Mellitus : NGENLA may decrease insulin sensitivity, particularly at higher doses. Monitor glucose levels periodically in all patients receiving NGENLA, especially in patients with existing diabetes mellitus or at risk for its development ( 5.4 ). • Intracranial Hypertension : Perform fundoscopic examinations prior to initiation of treatment with NGENLA and periodically thereafter. If preexisting papilledema is identified, evaluate the etiology and treat the underlying cause before initiating. If papilledema occurs with NGENLA, stop treatment ( 5.5 ). • Fluid Retention: May occur and may be dose dependent. Reduce dose as necessary ( 5.6 ). • Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism ( 5.7 ). • Hypothyroidism : Monitor thyroid function periodically as hypothyroidism may become evident or worsen after initiation with NGENLA ( 5.8 ). • Slipped Capital Femoral Epiphysis : May develop. Evaluate patients with the onset of a limp or persistent hip or knee pain ( 5.9 ). • Progression of Preexisting Scoliosis : Monitor for development or progression of scoliosis ( 5.10 ). • Pancreatitis : Consider pancreatitis in patients with persistent severe abdominal pain ( 5.11 ). • Lipoatrophy: May occur if NGENLA is administered in the same location over a long period of time. Rotate injection sites ( 5.12 ). 5.1 Increased Mortality in Patients with Acute Critical Illness Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported with somatropin [see Contraindications (4) ] . The safety of continuing NGENLA treatment for the approved indication in patients who concurrently develop these illnesses has not been established. 5.2 Severe Hypersensitivity Severe systemic hypersensitivity reactions including anaphylaxis and angioedema have been reported with somatropin. Inform patients and/or caregivers that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs. NGENLA is contraindicated in patients with known hypersensitivity to somatrogon-ghla or any excipients in NGENLA [see Contraindications (4) ] . 5.3 Increased Risk of Neoplasms Active Malignancy There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy [see Contraindications (4) ] . Any preexisting malignancy should be inactive, and its treatment should be completed prior to instituting therapy with NGENLA. Discontinue NGENLA if there is evidence of recurrent malignancy. 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 GHD and were treated with somatropin, an increased risk of a 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 NGENLA 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 NGENLA in these patients. If treatment with NGENLA is initiated, carefully monitor these patients for development of neoplasms. Monitor patients on NGENLA therapy carefully for increased growth or potential malignant changes of preexisting nevi. Advise patients and/or caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of preexisting nevi. 5.4 Glucose Intolerance and Diabetes Mellitus Treatment with growth hormone may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients receiving growth hormone. Patients with undiagnosed pre-diabetes and diabetes mellitus may experience worsened glycemic control and become symptomatic. Monitor glucose levels periodically in all patients receiving NGENLA, 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 NGENLA is initiated. 5.5 Intracranial Hypertension Intracranial hypertension (IH) 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, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of somatropin dose. Perform fundoscopic examination before initiating treatment with NGENLA to exclude preexisting papilledema and periodically thereafter. If papilledema is identified prior to initiation, evaluate the etiology and treat the underlying cause before initiating NGENLA. NGENLA should be temporarily discontinued in patients with clinical or fundoscopic evidence of IH. If IH is confirmed, restart treatment with NGENLA at a lower dose after IH-associated signs and symptoms have resolved. 5.6 Fluid Retention Fluid retention during NGENLA 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. 5.7 Hypoadrenalism Patients receiving growth hormone therapy who have or are at risk for pituitary hormone deficiency(s) 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 NGENLA treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism [see Drug Interactions (7) ] . 5.8 Hypothyroidism Undiagnosed/untreated hypothyroidism may prevent an optimal response to NGENLA therapy. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during treatment with growth hormone therapy. Therefore, patients should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated. 5.9 Slipped Capital Femoral Epiphysis Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients receiving NGENLA with the onset of a limp or complaints of persistent hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly. 5.10 Progression of Preexisting Scoliosis NGENLA increases growth rate, and progression of preexisting scoliosis can occur in patients who experience rapid growth. Growth hormone treatment has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for disease progression. 5.11 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. 5.12 Lipoatrophy When NGENLA is administered subcutaneously at the same site over a long period of time, lipoatrophy may result. Rotate injection sites when administering NGENLA to reduce this risk [see Dosage and Administration (2.1) ] . 5.13 Sudden Death in Pediatric Patients with Prader-Willi Syndrome There have been reports of sudden death 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. NGENLA is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome. 5.14 Laboratory Tests Serum levels of phosphorus, alkaline phosphatase, and parathyroid hormone may increase with NGENLA therapy. If a patient is found to have abnormal laboratory tests, monitor as appropriate.
Contraindications
• Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with somatropin [see Warnings and Precautions (5.1) ] . • Hypersensitivity to somatrogon-ghla or any of the excipients in NGENLA [see Warnings and Precautions (5.2) ] . • Closed epiphyses. • Active malignancy due to the risk of malignancy progression [see Warnings and Precautions (5.3) ] . • Active proliferative or severe non-proliferative diabetic retinopathy [see Warnings and Precautions (5.4) ] . • Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions (5.13) ] . • Acute critical illness ( 4 ). • Hypersensitivity to somatrogon-ghla or excipients ( 4 ). • Closed epiphyses ( 4 ). • Active malignancy ( 4 ). • Active proliferative or severe non-proliferative diabetic retinopathy ( 4 ). • Prader-Willi syndrome who are severely obese or have severe respiratory impairment ( 4 ).
Adverse Reactions
The following clinically significant adverse reactions are described elsewhere in the labeling: • Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1) ] • Severe hypersensitivity [see Warnings and Precautions (5.2) ] • Increased risk of neoplasm [see Warnings and Precautions (5.3) ] • Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4) ] • Intracranial hypertension [see Warnings and Precautions (5.5) ] • Fluid retention [see Warnings and Precautions (5.6) ] • Hypoadrenalism [see Warnings and Precautions (5.7) ] • Hypothyroidism [see Warnings and Precautions (5.8) ] • Slipped capital femoral epiphysis [see Warnings and Precautions (5.9) ] • Progression of preexisting scoliosis [see Warnings and Precautions (5.10) ] • Pancreatitis [see Warnings and Precautions (5.11) ] • Lipoatrophy [see Warnings and Precautions (5.12) ] • Sudden death in pediatric patients with Prader-Willi syndrome [ see Warnings and Precautions (5.13) ] Adverse reactions reported in ≥5% of patients treated with NGENLA are: injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Safety data are derived from a safety and efficacy study in pediatric patients with GHD [see Clinical Studies (14.1) ]. The data from the 12-month main study period reflect exposure of 109 patients to NGENLA administered once weekly (0.66 mg/kg/wk) and 115 patients to somatropin administered once daily (0.034 mg/kg/day). The mean age across the treatment groups, was 7.7 years (min 3.01, max 11.96); 40.2% of patients were >3 years to ≤7 years, 59.8% were >7 years, 71.9% of patients were male, and 28.1% were female. In this study, 74.6% of patients were White, 20.1% were Asian, 0.9% were Black or African American, 0.5% were American Indian or Alaska Native, 0.5% were Native Hawaiian or Other Pacific Islander, and for 3.6% race information was missing; 10.7% of patients identified as Hispanic or Latino. Baseline disease characteristics were balanced across treatment groups. Table 1 shows the adverse reactions that occurred in ≥5% of patients treated with NGENLA or daily somatropin during the 12-month main study period. Reporting of injection site reactions was solicited through the use of a patient diary after each weekly injection for patients administered NGENLA and once weekly for patients administered daily injections of somatropin. Table 1 Adverse Reactions Occurring in ≥5% of NGENLA- or Somatropin-Treated Pediatric Patients (52 Weeks of Treatment) Adverse reactions that are medically related were grouped to a single preferred term. Adverse Drug Reactions Daily Somatropin (N=115) n (%) NGENLA (N=109) n (%) Injection site reactions Injection site reactions included: injection site pain (39% somatrogon-ghla vs 25% daily somatropin), injection site swelling/induration/hypertrophy/inflammation (10% somatrogon-ghla vs 1% daily somatropin), injection site erythema (8% somatrogon-ghla vs none daily somatropin), injection site pruritus (5% somatrogon-ghla vs none daily somatropin), injection site hemorrhage (5% somatrogon-ghla vs none daily somatropin). 29 (25.2) 46 (42.2) Nasopharyngitis Nasopharyngitis included: rhinitis, pharyngitis, rhinitis allergic, pharyngitis streptococcal, viral pharyngitis, nasopharyngitis. 33 (28.7) 36 (33) Headache 25 (21.7) 18 (16.5) Pyrexia 17 (14.8) 18 (16.5) Anemia 10 (8.7) 10 (9.2) Cough 9 (7.8) 9 (8.3) Vomiting 9 (7.8) 8 (7.3) Hypothyroidism 3 (2.6) 7 (6.4) Abdominal pain 8 (7.0) 7 (6.4) Rash 7 (6.1) 6 (5.5) Oropharyngeal pain 4 (3.5) 6 (5.5) Arthralgia 8 (7.0) 5 (4.6) Otitis media 10 (8.7) 5 (4.6) Tonsillitis 6 (5.2) 5 (4.6) Bronchitis 9 (7.8) 3 (2.8) Laboratory Tests More NGENLA-treated patients shifted from normal eosinophil levels at baseline to elevated eosinophil levels at the end of the 12-month study compared to the daily somatropin group (29% vs 12%). 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of somatropin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Musculoskeletal and connective tissue disorders – osteonecrosis in pediatric patients
Drug Interactions
Table 2 includes a list of drugs with clinically significant drug interactions when administered concomitantly with NGENLA and instructions for preventing or managing them. Table 2 Clinically Significant Drug Interactions with NGENLA Replacement Glucocorticoid Treatment Clinical 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. Growth hormone inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of NGENLA 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 NGENLA [see Warnings and Precautions (5.7) ] . 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. Supraphysiologic Glucocorticoid Treatment Clinical Impact: Supraphysiologic glucocorticoid treatment may attenuate the growth-promoting effects of NGENLA in pediatric patients. Intervention: Carefully adjust glucocorticoid replacement dosing in pediatric patients receiving glucocorticoid treatments to avoid hypoadrenalism and an inhibitory effect on growth. Cytochrome P450-Metabolized Drugs Clinical Impact: Limited published data indicate that growth hormone treatment increases cytochrome P450 (CYP450)-mediated antipyrine clearance. NGENLA may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes. Intervention: Careful monitoring is advisable when NGENLA is administered in combination with drugs metabolized by CYP450 liver enzymes. Oral Estrogen Clinical Impact: Oral estrogens may reduce the serum IGF-1 response to NGENLA. Intervention: Patients receiving oral estrogen replacement may require higher NGENLA dosages. Insulin and/or Other Antihyperglycemic Agents Clinical Impact: Treatment with NGENLA may decrease insulin sensitivity, particularly at higher doses. Intervention: Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other antihyperglycemic agents [see Warnings and Precautions (5.4) ] . • Replacement Glucocorticoid Treatment: Patients treated with glucocorticoid for hypoadrenalism may require an increase in their maintenance or stress dose following initiation of NGENLA ( 7 ). • Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment: Adjust glucocorticoid dosing in pediatric patients to avoid both hypoadrenalism and an inhibitory effect on growth ( 7 ). • Cytochrome P450-Metabolized Drugs: NGENLA may alter the clearance. Monitor carefully if used with NGENLA ( 7 ). • Oral Estrogen: Larger doses of NGENLA may be required ( 7 ). • Insulin and/or Other Antihyperglycemic Agents: Dose adjustment of insulin or antihyperglycemic agent may be required ( 5.4 , 7 ).
Storage & Handling
Storage and Handling Before first use: Store refrigerated at 36°F to 46°F (2°C to 8°C) in the original carton to protect from light. After first use: Store the pen refrigerated at 36°F to 46°F (2°C to 8°C) between each use, for up to 28 days. Do not freeze or shake. Do not expose to heat. Do not use if it has been frozen. Store away from direct sunlight. Always remove and safely discard the needle after each injection and store the NGENLA prefilled pen without an injection needle attached. Always use a new needle for each injection. Replace the cap on your prefilled pen when it is not in use. Write the date of first use in the space provided on the pen label. The prefilled pen should not be used more than 28 days after first use.
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