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NGENLA® (somatrogon-ghla)
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
NGENLA® Quick Finder
Highlights
Indications and Usage
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.
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Dosage and Administration
2 DOSAGE AND ADMINISTRATION
2.1 Important Dosing and Administration Information
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- NGENLA treatment should be supervised by a healthcare provider who is experienced in...
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Dosage Forms and Strengths
3 DOSAGE FORMS AND STRENGTHS
NGENLA (somatrogon-ghla) is a clear and colorless to slightly light yellow solution available as:
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- Injection: 24 mg/1.2 mL (20 mg/mL) in a single-patient-use, disposable...
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Contraindications
4 CONTRAINDICATIONS
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- 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...
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Warnings and Precautions
5 WARNINGS AND PRECAUTIONS
5.1 Increased Mortality in Patients with Acute Critical Illness
Increased mortality in patients with acute critical illness due to...
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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
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- Increased mortality in patients with acute critical illness [see...
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Drug Interactions
7 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.
...
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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no available...
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Overdosage
10 OVERDOSAGE
Acute overdosage may lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with growth hormone may cause fluid retention. Long-term overdosage could result in signs and symptoms of...
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Description
11 DESCRIPTION
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...
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Clinical Pharmacology
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Somatrogon-ghla binds to the GH receptor and initiates a signal transduction cascade culminating in changes in...
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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
14 CLINICAL STUDIES
14.1 Treatment-Naïve Pediatric Patients with Growth Hormone Deficiency
A multi-center, randomized, open-label, active-controlled, parallel-group...
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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
NGENLA (somatrogon-ghla) injection is a clear and colorless to slightly light yellow...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
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- Hypersensitivity...
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Instructions For Use
Instructions for Use
NGENLA® (en’ JEN-lah)
(somatrogon-ghla)
24 mg
injection, for subcutaneous use
Read this Instructions for Use before you...
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Report Adverse Event
To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.