Product image of Increlex (Mecasermin) supplied by GNH India

Increlex

Active Ingredient:
Mecasermin
Origin:
EU

Increlex (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 India 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.

Manufacturer / TM Owner

Esteve Pharmaceuticals, S.A.

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Indications & Clinical Uses

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.

How It Works

  • Recombinant human IGF‑1 (mecasermin) binds to IGF‑1 receptors on target cells, activating the PI3K‑Akt and MAPK signaling cascades. This triggers protein synthesis, cell proliferation, and differentiation, leading to anabolic effects that enhance bone and tissue growth. By restoring IGF‑1 activity, the drug compensates for endogenous deficiency, thereby supporting linear growth in pediatric patients.

Side Effects

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.

Precautions & Warnings

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.

Avoid Interactions

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

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.

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.

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.

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.

To order Increlex, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India 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.

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.

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.

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.

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GNH India Pharmaceuticals Limited

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