GNH USA

Europe — EMA

Increlex

GNH USA supplies Increlex (Mecasermin), an insulin‑like growth factor‑1 analog for primary IGF‑1 deficiency and growth‑hormone gene deletion‑related growth

Mecasermin

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What is Mecasermin?

Mecasermin, the active ingredient in Increlex, is an insulin‑like growth factor‑1 (IGF‑1) analog presented as a solution for injection for subcutaneous use. It is indicated for children with growth failure due to primary IGF‑1 deficiency or due to a growth‑hormone gene deletion.

GNH USA supplies Increlex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, with a focus on quality assurance and regulatory compliance across EU and global markets.

What is Mecasermin used for?

Increlex (mecasermin) is used to address growth disorders that stem from deficiencies in the IGF‑1 pathway.

- Primary IGF‑1 deficiency: promotes linear growth and improves height velocity in affected children. - Growth‑hormone gene deletion: stimulates growth in children lacking functional growth‑hormone production. - Severe IGF‑1‑related growth failure: provides an IGF‑1 replacement to achieve catch‑up growth when conventional GH therapy is ineffective.

What are the side effects of Mecasermin?

The safety profile of Increlex includes a range of observed adverse reactions, which are categorized by frequency and severity.

Common Side Effects: - Hypoglycemia: low blood sugar episodes, especially when administered without adequate carbohydrate intake. - Injection site reactions: redness, swelling, or pain at the subcutaneous injection site. - Headache: mild to moderate intensity. - Nausea or vomiting: gastrointestinal discomfort following dosing. - Lipohypertrophy: localized thickening of subcutaneous tissue.

Serious or Rare Side Effects: - Intracranial hypertension: signs of increased intracranial pressure such as headache, visual changes. - Pancreatitis: abdominal pain with elevated pancreatic enzymes. - Severe allergic reactions: rash, urticaria, or anaphylaxis. - Tumor progression: potential acceleration of pre‑existing malignancies.

What precautions apply to Mecasermin?

Before initiating Increlex therapy, healthcare professionals should consider several precautionary measures to ensure safe use. - Blood glucose monitoring: regularly check glucose levels to detect hypoglycemia. - IGF‑1 level assessment: measure serum IGF‑1 to guide dosing and avoid excess. - Intracranial pressure evaluation: monitor for signs of increased intracranial pressure, especially in patients with prior CNS disorders. - Contraindication in active malignancy: avoid use in patients with known active cancer due to potential tumor growth stimulation. - Concomitant insulin or hypoglycemic agents: adjust doses to reduce hypoglycemia risk. - Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

What does Mecasermin interact with?

Increlex may interact with other medicines, requiring attention to avoid adverse outcomes.

Major Interactions (Avoid): - Insulin or oral hypoglycemics: combined use can cause severe hypoglycemia. - Concurrent growth hormone therapy: may lead to excessive IGF‑1 levels and related toxicity. - High‑dose glucocorticoids: can diminish the anabolic response to mec­asermin.

Moderate Interactions (Monitor Closely): - Thyroid hormone replacement: IGF‑1 can affect thyroid hormone metabolism; monitor thyroid function tests. - Diuretics: may alter fluid balance and affect IGF‑1 distribution. - Antiepileptic drugs (e.g., carbamazepine): potential induction of IGF‑1 clearance; observe clinical response.

Frequently asked questions

What is Increlex used for?+
Increlex is prescribed for children who have growth failure caused by a lack of endogenous insulin‑like growth factor‑1 (IGF‑1) or by a genetic deletion of the growth‑hormone gene. By providing recombinant IGF‑1, the medication helps stimulate linear growth and improve height velocity in these specific pediatric conditions.
How does mec­asermin work?+
Mecasermin is a recombinant form of human IGF‑1. It binds to IGF‑1 receptors on the surface of target cells, activating intracellular signaling pathways such as PI3K‑Akt and MAPK. These pathways promote protein synthesis, cell proliferation, and bone growth, thereby compensating for the missing endogenous IGF‑1 and supporting normal growth in children.
What determines the dose of Increlex?+
The dose of Increlex is individualized by the prescribing physician based on factors such as the child’s weight, age, severity of IGF‑1 deficiency, and serum IGF‑1 levels. The prescriber will adjust the dose to achieve target IGF‑1 concentrations while monitoring for safety, especially blood‑glucose changes.
Is Increlex safe during pregnancy or breastfeeding?+
Safety of mec­asermin in pregnancy and lactation has not been established. It is classified as a pregnancy category with unknown risk, and the drug is generally avoided unless the potential benefit to the mother outweighs possible risks to the fetus or infant. Breastfeeding mothers should consult their healthcare provider before use.
How do I order Increlex from GNH USA?+
To order Increlex, submit an enquiry on the product page at gnh-usa.com, specifying the required quantity. GNH USA works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details—including cold‑chain handling if needed—and assistance with import documentation.
How does Increlex compare with other growth‑hormone therapies?+
Increlex provides recombinant IGF‑1 directly, whereas traditional growth‑hormone products deliver GH that stimulates the body’s own IGF‑1 production. In cases of primary IGF‑1 deficiency or GH‑gene deletion, IGF‑1 replacement with mec­asermin is more effective because the upstream GH pathway is non‑functional, making Increlex the preferred option.
How should Increlex be stored and handled?+
Increlex should be stored in a refrigerator at 2‑8 °C. Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking the solution. If temporary storage at room temperature is unavoidable, limit exposure to no more than 24 hours and return it to refrigeration promptly.
How is Increlex administered?+
Increlex is given as a subcutaneous injection, typically into the abdomen, thigh, or upper arm. The injection should be performed using aseptic technique, rotating sites to reduce local irritation. Dosing frequency and volume are determined by the prescriber, and patients or caregivers are instructed on proper reconstitution and injection procedures.
What are the most serious risks to watch for while using Increlex?+
The most serious risks
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Mecasermin
Route
Subcutaneous Use
Manufacturer
Esteve Pharmaceuticals, S.A.
Origin
EU

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