Description

Buy NGENLA 60mg by Pfizer: The Advanced Once-Weekly Growth Hormone Therapy

NGENLA is a human growth hormone analog produced in Chinese Hamster Ovary (CHO) cells using recombinant DNA technology . It is a fusion protein comprising 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 two copies of CTP in tandem at the C-terminus . This innovative molecular structure provides an extended half-life, allowing for once-weekly dosing compared to daily growth hormone products .

The 60 mg pre-filled pen delivers the medication in a clear and colorless to slightly light yellow solution with a pH of approximately 6.6 . Each 1.2 mL of solution contains 60 mg of somatrogon-ghla, along with inactive ingredients including citric acid monohydrate, histidine, metacresol (as a preservative), poloxamer 188, sodium chloride, and sodium citrate in water for injection . The pen cap, dose button, and label are coloured blue for easy identification of the 60 mg strength .

Mechanism of Action

NGENLA (somatrogon-ghla) acts as a human growth hormone analog, binding to growth hormone receptors on target cells. This binding activates intracellular signaling pathways, including the JAK-STAT pathway, which stimulates the production of insulin-like growth factor 1 (IGF-1) . IGF-1 mediates many of the growth-promoting effects of growth hormone, including linear bone growth, protein synthesis, and cellular proliferation. The CTP extensions in the molecular structure prolong the half-life of the molecule, enabling effective once-weekly administration .

Product Features

• Once-Weekly Dosing: Reduces injection frequency from daily to once weekly, improving treatment adherence and convenience 

• Single-Patient-Use Prefilled Pen: Each pen is designed for individual patient use and delivers doses from 0.5 mg to 30 mg in 0.5 mg increments 

• High Concentration: 60 mg/1.2 mL (50 mg/mL) formulation requiring smaller injection volumes 

• Multiple Injection Sites: Can be administered in the abdomen, thighs, buttocks, or upper arms with weekly rotation of injection site 

• Preservative-Containing: Formulated with metacresol as a preservative, allowing for multi-dose use from a single pen 

• Pharmaceutical-Grade Quality: Manufactured by Pfizer to rigorous quality standards 

Key Benefits

• Convenient Once-Weekly Administration: Significantly reduces injection burden compared to daily growth hormone products 

• Proven Efficacy: Clinically established for the treatment of pediatric growth hormone deficiency, with individualized dosing based on growth response 

• Accurate Dosing: The pre-filled pen allows for precise dose delivery in 0.5 mg increments, with doses ranging from 0.5 mg to 30 mg per injection 

• Flexible Dosing Schedule: Treatment can be initiated on any day of the week, with the dosing day changeable as long as at least 3 days have passed between doses 

• Well-Established Safety Profile: Comprehensive clinical data supports its use with regular monitoring of IGF-1 levels, glucose, and thyroid function 

Recommended Use

NGENLA treatment should be supervised by a healthcare provider experienced in the diagnosis and management of pediatric patients with growth hormone deficiency . The recommended dosage is 0.66 mg/kg based on actual body weight, administered once weekly by subcutaneous injection .

For patients switching from daily growth hormone products, the once-weekly NGENLA therapy may be initiated on the day following their last daily injection . The pre-filled pen delivers doses from 0.5 mg to 30 mg in a single injection in 0.5 mg increments. For patients requiring doses higher than 30 mg (body weight exceeding 45 kg), two injections should be administered at different injection sites .

Dose titration may be performed based on growth velocity, adverse reactions, body weight, and serum IGF-1 concentrations . IGF-1 samples should be drawn 4 days after the prior dose for accurate monitoring. Dose adjustments should target average IGF-1 standard deviation score (SDS) levels between -2 and +2 (preferably close to 0 SDS). If serum IGF-1 concentrations exceed the mean reference value by more than 2 SDS, the dose should be reduced by 15% .

Side Effects

Adverse reactions reported in 5% or more of patients treated with NGENLA include :

• Injection Site Reactions: Pain, redness, swelling, and bruising at the injection site

• Nasopharyngitis: Common cold symptoms

• Headache: May occur during the treatment period

• Pyrexia: Fever

• Anemia: Decreased red blood cell count

• Cough: Respiratory tract irritation

• Vomiting: Gastrointestinal disturbance

• Hypothyroidism: Reduced thyroid function

• Abdominal Pain: Gastrointestinal discomfort

• Rash: Skin reactions

• Oropharyngeal Pain: Throat pain

Contraindications

NGENLA is contraindicated in patients with :

• Acute critical illness following open heart surgery, abdominal surgery, multiple accidental trauma, or acute respiratory failure

• Hypersensitivity to somatrogon-ghla or any of its excipients

• Closed epiphyses (completed bone growth)

• Active malignancy

• Active proliferative or severe non-proliferative diabetic retinopathy

• Prader-Willi syndrome who are severely obese or have severe respiratory impairment

This product should only be used under the guidance of a qualified healthcare professional.

Top 10 Frequently Asked Questions

1. What is NGENLA and what is it used for?
NGENLA (somatrogon-ghla) is a human growth hormone analog developed by Pfizer for the treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone . It was approved by the FDA in 2023 .

2. How is NGENLA administered?
NGENLA is administered by subcutaneous injection once weekly, on the same day each week, at any time of the day. It can be injected in the abdomen, thighs, buttocks, or upper arms with weekly rotation of the injection site .

3. What is the recommended dosage of NGENLA?
The recommended dosage is 0.66 mg/kg based on actual body weight administered once weekly. The dose should be individualized for each patient based on growth response . The 60 mg pre-filled pen delivers doses from 0.5 mg to 30 mg in 0.5 mg increments .

4. How does NGENLA differ from daily growth hormone products?
NGENLA is a long-acting growth hormone analog that requires only once-weekly administration, compared to daily growth hormone products. This significantly reduces injection frequency and may improve treatment adherence .

5. What are the most common side effects of NGENLA?
The most common adverse reactions (reported in 5% or more of patients) include injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain .

6. What monitoring is required during NGENLA treatment?
Regular monitoring of serum IGF-1 concentrations is recommended throughout treatment. IGF-1 samples should be drawn 4 days after the prior dose. Dose adjustments should target average IGF-1 SDS levels between -2 and +2 . Thyroid function and glucose levels should also be monitored periodically .

7. What happens if a dose is missed?
If a dose is missed, NGENLA should be administered as soon as possible within 3 days after the missed dose. If more than 3 days have passed, the missed dose should be skipped and the next dose administered on the regularly scheduled day .

8. How should the pre-filled pen be stored?
NGENLA should be stored in a refrigerator at 2°C to 8°C. The pre-filled pen should be inspected visually for particulate matter and discoloration prior to administration. Do not shake the pen as shaking can damage the product .

9. Is NGENLA suitable for adults?
NGENLA is indicated specifically for pediatric patients aged 3 years and older with growth hormone deficiency. The safety and efficacy of somatrogon in patients over the age of 65 years have not been established .

10. Can NGENLA be used by patients switching from daily growth hormone?
Yes, patients switching from daily growth hormone products may initiate treatment with once-weekly NGENLA on the day following their last daily injection .

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