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Ngenla is a brand name for Somatrogon. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 1 INDICATIONS AND 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…
Verbatim from this product's FDA label. Tap a section to expand.
1 ). 1 ). 3 ). 3 ). 3 ). 3 ). 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. 5 mg increments. 2 Perform Fundoscopic Examination Prior to Initiation of NGENLA • Perform fundoscopic examination before initiating treatment with NGENLA to exclude preexisting papilledema.
5) ] . 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.
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.
1 ). To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. gov/medwatch . 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.
1) ]. 034 mg/kg/day). 1% were female. 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).
2) Nasopharyngitis Nasopharyngitis included: rhinitis, pharyngitis, rhinitis allergic, pharyngitis streptococcal, viral pharyngitis, nasopharyngitis. 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%).
5 WARNINGS AND PRECAUTIONS • Severe Hypersensitivity : Severe hypersensitivity reactions may occur. 2 ). • Increased Risk of Neoplasms : Monitor patients with preexisting tumors for progression or recurrence. 3 ). • Glucose Intolerance and Diabetes Mellitus : NGENLA may decrease insulin sensitivity, particularly at higher doses.
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.
5 ). • Fluid Retention: May occur and may be dose dependent. 6 ). 7 ). 8 ). • Slipped Capital Femoral Epiphysis : May develop. 9 ). 10 ). 11 ). • Lipoatrophy: May occur if NGENLA is administered in the same location over a long period of time.
12 ). 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. 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) ] .
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.
1) ] . 2) ]. • Closed epiphyses. 3) ] . 4) ] . 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 ).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of somatropin products or NGENLA. 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.
Skin and subcutaneous tissue disorders – lipoatrophy Musculoskeletal and connective tissue disorders – osteonecrosis in pediatric patients, slipped capital femoral epiphysis
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.
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 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. 6 Fluid Retention Fluid retention during NGENLA therapy may occur.
g. edema and nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent. 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) ] .
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. 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 products or NGENLA .
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. 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. 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. 12 Lipoatrophy When NGENLA is administered subcutaneously at the same site over a long period of time, lipoatrophy may result.
1) ]. 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. 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.