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NGENLA is a brand name for Somatrogon, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NGENLA (somatrogon) is indicated for: • the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency). 1.1 Pediatrics Pediatrics (3 years old to epiphyseal fusion): The efficacy and safety of Ngenla in pediatric patients 3…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Ngenla treatment should be initiated and supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure due to growth hormone deficiency. • Ngenla has not been studied in patients with renal impairment.
• Ngenla has not been studied in patients with hepatic impairment. • Do not shake; shaking can damage the medicine. 66 mg/kg body weight administered once weekly by subcutaneous (SC) injection. 66 mg/kg/week on the day following their last daily injection.
Regular monitoring of Insulin-like Growth Factor-1 (IGF-1) concentrations is recommended during treatment with Ngenla. Ngenla dosage may be adjusted as necessary based on growth velocity, body weight, and serum insulin-like growth factor 1 (IGF-1) concentrations.
Dose titration When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose. The target IGF-1 standard deviation score (SDS) should be the upper normal range not exceeding 2 SDS (see 7 WARNINGS AND PRECAUTIONS).
In patients whose blood IGF-1 concentrations exceed the mean reference value for their age and sex by more than 2 SDS, the dose of Ngenla should be reduced by 15%. More than one dose reduction may be required in some patients. Monitor growth rate closely during the first year of Ngenla treatment.
g. hypothyroidism, undernutrition, advanced bone age ) and consider discontinuation of Ngenla treatment. Treatment should be discontinued when there is evidence of closure of the epiphyseal growth plates. 4 Administration Ngenla can be given in the abdomen, thighs, buttocks, or upper arms.
Use a different site of injection each week. If more than one injection is required to deliver a complete dose, administer each injection at a different injection site. Administer Ngenla once weekly, on the same day each week, at any time of the day.
The designated injection site should be prepared as instructed in the instructions for use. Always use a new sterile needle for each injection. The pre-filled pen may be used straight from the refrigerator. For a more comfortable injection, allow up to 30 minutes for the pre-filled pen to reach room temperature (20° to 25°C).
The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days (>72 hours). After selecting a new dosing day, the once weekly dosing should be continued. If deemed appropriate, caregivers/parents can administer Ngenla to a person in their care/their child, or patients can self-inject (with caregiver/parental supervision), once they have been adequately trained by a health care professional on the use of proper subcutaneous injection technique and on the determination of the correct dose.
). Continuous rotation of the injection site may help reduce or prevent these reactions. On rare occasions, injection site reactions may require discontinuation of therapy. g. anaphylaxis, angioedema) have been reported with daily growth hormone products.
If a serious hypersensitivity reaction occurs, immediately discontinue use of Ngenla and treat promptly per standard of care and monitor until signs and symptoms resolve. Do not use in patients with previous hypersensitivity to Ngenla (see 2 CONTRAINDICATIONS).
Monitoring and Laboratory Tests Ngenla dosage may be adjusted as necessary, based on growth velocity, body weight, and serum insulin-like growth factor 1 (IGF-1) concentrations. When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose.
2 Recommend Dose and Dosage Adjustment). 7 Drug- Laboratory Test Interactions). Musculoskeletal Epiphyseal disorders No epiphyseal disorders were reported with the administration of Ngenla in clinical trials. Based on the experience with daily growth hormone products, epiphyseal disorders, including slipped capital femoral epiphysis, may occur more frequently in patients with endocrine disorders or in Product Monograph Page 11 of 60 NGENLA (somatrogon) Unclassified / Non classifié patients undergoing rapid growth.
Any pediatric patient with the onset of a limp or complaints of hip or knee pain during treatment should be carefully evaluated. Scoliosis Progression of scoliosis can occur in pediatric patients who experience rapid growth. Because somatrogon increases growth rate, signs of development or progression of scoliosis should be monitored during treatment with Ngenla.
Reproductive Health:
Female and Male Potential • Fertility The risk of infertility in males and females of reproductive potential has not been studied in humans. Animal data from a fertility and early embryonic development study conducted in rats demonstrated that somatrogon administration resulted in an increase in estrous cycle length coupled with a decrease in the number of estrous cycles and an increase in the copulatory interval.
). • Ngenla is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure (see 7 WARNINGS AND PRECAUTIONS). • Ngenla is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations • Ngenla treatment should be initiated and supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure due to growth hormone deficiency.
• Ngenla has not been studied in patients with renal impairment. • Ngenla has not been studied in patients with hepatic impairment. • Do not shake; shaking can damage the medicine. 66 mg/kg body weight administered once weekly by subcutaneous (SC) injection.
66 mg/kg/week on the day following their last daily injection. Regular monitoring of Insulin-like Growth Factor-1 (IGF-1) concentrations is recommended during treatment with Ngenla. Ngenla dosage may be adjusted as necessary based on growth velocity, body weight, and serum insulin-like growth factor 1 (IGF-1) concentrations.
Dose titration When monitoring for IGF-1, samples should always be drawn 4 days after the prior dose. The target IGF-1 standard deviation score (SDS) should be the upper normal range not exceeding 2 SDS (see 7 WARNINGS AND PRECAUTIONS).
In patients whose blood IGF-1 concentrations exceed the mean reference value for their age and sex by more than 2 SDS, the dose of Ngenla should be reduced by 15%. More than one dose reduction may be required in some patients. Monitor growth rate closely during the first year of Ngenla treatment.
g. hypothyroidism, undernutrition, advanced bone age ) and consider discontinuation of Ngenla treatment. Treatment should be discontinued when there is evidence of closure of the epiphyseal growth plates. 4 Administration Ngenla can be given in the abdomen, thighs, buttocks, or upper arms.
• Ngenla is contraindicated in patients with closed/fused epiphyses. • Ngenla is contraindicated in patients with active tumours and/or malignancy (see 7 WARNINGS AND PRECAUTIONS). • Ngenla is contraindicated in patients with acute critical illness due to complications following open heart or abdominal surgery, multiple accidental trauma, or acute respiratory failure (see 7 WARNINGS AND PRECAUTIONS).
• Ngenla is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Product Monograph Page 5 of 60 NGENLA (somatrogon) Unclassified / Non classifié
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5 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. In each case, patients can then resume their regular once weekly dosing schedule.
, an increase in the number of corpora lutea) and increases in the number of implantations and the percentage of pre -implantation loss were also observed. The effects were observed at doses of 3, 10, and/or 30 mg/kg body weight administered by SC injection once every two days.
However, there were no effects on mating, fertility, and pregnancy indices or on early embryonic development in rats (see 16 NON-CLINICAL TOXICOLOGY). 1 Pregnant Women There are no studies of Ngenla use by pregnant women. Animal data from a pre- and post-natal development study conducted in rats demonstrated an increase in post-natal body weight in offspring of maternal animals administered somatrogon at doses of 10 and 30 mg/kg body weight once every two days.
Reproductive assessment in the offspring also demonstrated an increase in time to mating at a maternal dose of 30 mg/kg body weight once every two days. The effects were related to maternal somatrogon administration but were considered non- adverse (see 16 NON-CLINICAL TOXICOLOGY).
Animal reproduction studies are not always predictive of human response; therefore, it is unknown whether Ngenla can cause fetal harm when administered to a pregnant woman. Ngenla should be used during pregnancy only if clearly needed.
7 Drug- Laboratory Test Interactions). 2 Breast-feeding It is unknown if somatrogon is excreted in human milk. Precaution should be exercised because many drugs can be excreted in human milk. 3 Pediatrics The efficacy and safety of Ngenla have been evaluated in pediatric patients aged 3 to 11 years with growth failure due to growth hormone deficiency (see 1 INDICATIONS).
4 Geriatrics Ngenla is not indicated for use in adults. The efficacy and safety of Ngenla in geriatric patients aged 65 years of age and older have not been established (see 1 INDICATIONS). 1 Adverse Reaction Overview The description of adverse reactions in this section is based on clinical experience with somatrogon in a Phase 3 study (CP-4-006) in pediatric patients with GHD.
9%, respectively) (see 7 WARNINGS AND PRECAUTIONS). Most events of injection site pain were mild or moderate in severity for both treatment groups. 6%]). The anatomical injection site that was most frequently associated with injection site pain for both treatment groups was the arm (left and right), and this was the site most frequently associated with severe pain events.
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials; therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use. 1 Clinical Trial Adverse Reactions – Pediatrics The main safety data are derived from a Phase 3 safety and efficacy study (CP-4-006) in pediatric patients with growth failure due to GHD (see 14 […]
Use a different site of injection each week. If more than one injection is required to deliver a complete dose, administer each injection at a different injection site. Administer Ngenla once weekly, on the same day each week, at any time of the day.
The designated injection site should be prepared as instructed in the instructions for use. Always use a new sterile needle for each injection. The pre-filled pen may be used straight from the refrigerator. For a more comfortable injection, allow up to 30 minutes for the pre-filled pen to reach room temperature (20° to 25°C).
The day of weekly administration can be changed if necessary as long as the time between 2 doses is at least 3 days (>72 hours). After selecting a new dosing day, the once weekly dosing should be continued. If deemed appropriate, caregivers/parents can administer Ngenla to a person in their care/their child, or patients can self-inject (with caregiver/parental supervision), once they have been adequately trained by a health care professional on the use of proper subcutaneous injection technique and on the determination of the correct dose.
5 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. In each case, patients can then resume their regular once weekly dosing schedule.
66 mg/kg body weight/week have not been studied. Based on experience with daily growth hormone products, short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the effects of growth hormone excess.
Treatment of overdose with Ngenla should consist of general supportive measures. For management of a suspected drug overdose, contact your regional poison control centre. Product Monograph Page 7 of 60 NGENLA (somatrogon) Unclassified / Non classifié 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognize the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
6. Each carton contains one single-patient-use, disposable pre-filled pen containing a preserved solution of somatrogon. Each pre-filled pen is capable of setting and delivering a variable dose that is determined based on patient body weight.
The medicinal product, the primary container (cartridge, bilayer disc seal, plunger stopper) and the […]