Description

Buy NGENLA 24mg by Pfizer: The Advanced Once-Weekly Growth Hormone Therapy

NGENLA (somatrogon-ghla) is a prescription medication manufactured by Pfizer for the treatment of growth failure in children aged 3 years and older who have growth hormone deficiency (GHD), a condition where the body does not produce enough natural growth hormone. Approved by the FDA in 2023, NGENLA represents a significant advancement in growth hormone therapy as the first once-weekly treatment option for pediatric GHD.

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, enabling once-weekly dosing compared to daily growth hormone products.

The 24 mg pre-filled pen delivers doses from 0.2 mg to 12 mg of somatrogon in increments of 0.2 mg (0.01 mL). The solution is clear and colourless to slightly light yellow with a pH of approximately 6.6. Each 1.2 mL of solution contains 24 mg of somatrogon (20 mg/mL). The pen is designed for single-patient use and should be disposed of after 28 days of first use.

Key Feature: Once-Weekly Dosing

The key feature of NGENLA is its dosing schedule; it is administered as a single weekly subcutaneous injection, differing from traditional daily human growth hormone (HGH) treatments. This allows for a 28-day shelf life after first use, providing five weeks’ worth of medication from one pen when stored in the refrigerator.

The once-weekly administration significantly reduces injection burden compared to daily growth hormone products, potentially improving treatment adherence and quality of life for pediatric patients and their caregivers.

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 0.2 mg to 12 mg in 0.2 mg increments

• High Concentration: 24 mg/1.2 mL (20 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

• Accurate Dosing: The pre-filled pen allows for precise dose delivery in 0.2 mg increments, with doses ranging from 0.2 mg to 12 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

• 28-Day Shelf Life: After first use, the pen remains effective for 28 days when stored in the refrigerator

• 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 who is 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.

The pre-filled pen delivers doses from 0.2 mg to 12 mg in a single injection in 0.2 mg increments. For patients requiring doses higher than 12 mg (body weight exceeding 18 kg), two injections should be administered at different injection sites.

For patients switching from daily growth hormone products, the once-weekly NGENLA therapy may be initiated on the day following their last daily injection. Dose titration may be performed based on growth velocity, adverse reactions, body weight, and serum IGF-1 concentrations.

Missed Dose: 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.

Changing the Dosing Day: The day of weekly administration can be changed if necessary as long as the time between two doses is at least 3 days.

Storage Instructions

Before First Use (Unused Pens):

• Store in the original carton in the refrigerator between 36°F to 46°F (2°C to 8°C)

• Unused pens may be used until the expiration date printed on the pen label

• Do not freeze the pen or expose it to heat or direct sunlight

After First Use (Up to 28 Days):

• Write the date of first use on the pen label to remember when to dispose of it

• Store the remaining NGENLA in the refrigerator between 36°F to 46°F (2°C to 8°C)

• Keep the pen cap on the pen when it is not in use

• Do not store the pen with a needle attached

• Do not use the NGENLA pen if it has been more than 28 days after first use, even if it contains unused medicine

• Do not shake the pen; shaking can damage the product

• Before administration, inspect the solution visually. If flakes, particles, or discoloration are observed, do not use the pen

Side Effects

The most common adverse reactions reported in 5% or more of patients treated with NGENLA include:

• Injection site reactions (pain, swelling, rash, itching, bleeding)

• Nasopharyngitis (common cold)

• Headache

• Pyrexia (fever)

• Anemia (low red blood cells)

• Cough

• Vomiting

• Hypothyroidism (decreased thyroid hormone levels)

• Abdominal pain

• Rash

• Oropharyngeal pain (throat pain)

Serious Side Effects

NGENLA may cause serious side effects, including:

• High risk of death in people with critical illnesses (heart or stomach surgery, trauma, or serious breathing problems)

• Serious allergic reactions (anaphylaxis, angioedema)

• Increased risk of growth or recurrence of cancer or tumors

• New or worsening high blood sugar (hyperglycemia) or diabetes

• Increased pressure inside the skull (intracranial hypertension)

• Fluid retention (swelling in hands and feet, joint or muscle pain)

• Decreased cortisol levels (hypoadrenalism)

• Decreased thyroid hormone levels

• Slipped capital femoral epiphysis (hip pain or limp)

• Worsening of scoliosis

• Pancreatitis (severe abdominal pain)

• Lipoatrophy (loss of fat at injection sites)

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 (cancer or tumors)

• Active proliferative or severe non-proliferative diabetic retinopathy

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

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 24 mg pen delivers doses from 0.2 mg to 12 mg in 0.2 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. After first use, it may be stored for up to 28 days in the refrigerator. 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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