Product image of Increlex (Mecasermin) supplied by GNH India

Increlex

Active Ingredient:
Mecasermin
Origin:
EU

Increlex (Mecasermin)

Mecasermin, the active ingredient in Increlex, is a recombinant human insulin-like growth factor-1 presented as an injection solution for subcutaneous use. It treats severe primary insulin-like growth factor-1 (IGF-1) deficiency and growth failure due to growth hormone gene deletion in pediatric patients.

GNH India supplies Increlex as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, clinics and specialized care centres worldwide. The company adheres to stringent quality standards and regulatory requirements to ensure product integrity. Clients benefit from reliable cold‑chain logistics and dedicated technical support.

Manufacturer / TM Owner

Esteve Pharmaceuticals, S.A.

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Indications & Clinical Uses

Increlex (mecasermin) is used in the IGF‑1 deficiency pathway to promote linear growth in children with specific endocrine disorders.

  • Severe primary IGF‑1 deficiency: replaces deficient IGF‑1, helping to normalize growth velocity and improve height outcomes in affected children.
  • Growth failure due to growth hormone gene deletion: provides exogenous IGF‑1 to bypass the absent GH signal, facilitating linear growth in patients with GH‑gene mutations.
  • Confirmed IGF‑1 deficiency unresponsive to growth hormone therapy: offers an alternative pathway to stimulate growth when GH treatment is ineffective.

How It Works

  • Mecasermin is a recombinant form of human insulin‑like growth factor‑1 (IGF‑1). After subcutaneous injection it enters the circulation and binds to the IGF‑1 receptor on target cells, activating the intracellular PI3K‑Akt and MAPK pathways. This signaling promotes critical protein synthesis, cell proliferation and longitudinal bone growth, effectively substituting for endogenous IGF‑1 that is lacking in certain genetic or hormonal deficiencies.

Side Effects

Mecasermin may be associated with a range of adverse reactions, which are generally categorized by frequency and severity.

Common Side Effects

  • Injection site reactions: redness, swelling or pain at the injection site.
  • Hypoglycemia: low blood glucose, especially when administered without adequate carbohydrate intake.
  • Headache: mild to moderate intensity.
  • Nausea: occasional gastrointestinal discomfort.
  • Peripheral edema: swelling of limbs.
  • Joint pain: arthralgia reported in some patients.

Serious or Rare Side Effects

  • Intracranial hypertension: signs include headache, visual changes, vomiting; requires immediate medical attention.
  • Allergic reactions: rash, urticaria, or anaphylaxis in rare cases.
  • Elevated intracranial pressure leading to papilledema.

Precautions & Warnings

When prescribing mec asermin, clinicians should consider several precautionary measures to ensure safe use.

  • Dose titration: start with low dose and adjust based on IGF‑1 levels and growth response.
  • Blood glucose monitoring: regularly check glucose to detect hypoglycemia.
  • Intracranial pressure monitoring: observe for signs of increased pressure, especially in patients with pre‑existing conditions.
  • Allergy assessment: screen for prior hypersensitivity to recombinant proteins.
  • Long‑term growth surveillance: track height velocity and skeletal maturation.
  • Store at 2-8°C: keep refrigerated, protect from light, do not freeze or shake.

Avoid Interactions

Mecasermin can interact with other agents that affect glucose metabolism or share similar pathways.

Major Interactions (Avoid)

  • Insulin: concurrent use may cause severe hypoglycemia; dose adjustments required.
  • Oral hypoglycemic agents (e.g., sulfonylureas): increased risk of low blood sugar.

Moderate Interactions (Monitor Closely)

  • Glucocorticoids: may blunt IGF‑1 response, requiring dose modification.
  • Thyroid hormone replacement: altered metabolism may affect growth outcomes.
  • Growth hormone therapy: overlapping effects may necessitate careful monitoring.

Frequently Asked Questions

Increlex (mecasermin) is indicated for children with severe primary insulin‑like growth factor‑1 (IGF‑1) deficiency and for those who have growth failure due to a growth hormone gene deletion. It is also used when IGF‑1 deficiency persists despite adequate growth hormone therapy, providing an alternative pathway to support linear growth.

Mecasermin is a recombinant form of human IGF‑1. After subcutaneous injection it circulates and binds to the IGF‑1 receptor on target cells, triggering intracellular signaling cascades such as the PI3K‑Akt and MAPK pathways. These pathways stimulate protein synthesis, cell proliferation, and bone growth, effectively replacing the missing endogenous IGF‑1.

The dose of Increlex is individualized by the prescribing clinician. Factors include the patient’s body weight, age, baseline IGF‑1 levels, and growth response. The prescriber will adjust the dose based on regular monitoring of IGF‑1 concentrations and growth parameters to achieve optimal therapeutic effect while minimizing adverse events.

Increlex is classified as Pregnancy Category B, indicating that animal studies have not shown risk but there are limited human data. It should be used during pregnancy only if the potential benefit justifies the potential risk. Caution is advised while breastfeeding, and the decision should be made in consultation with a healthcare professional.

To order Increlex, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide. After receiving the request, the sales team will verify trade or institutional credentials, then provide pricing, availability, shipping details (including cold‑chain logistics if required) and any necessary import documentation.

The primary alternative to Increlex is recombinant human growth hormone (somatropin). While growth hormone stimulates endogenous IGF‑1 production, Increlex directly replaces IGF‑1, making it effective in patients who lack functional growth hormone receptors or have genetic deletions. In cases of severe IGF‑1 deficiency, mecasermin provides a more direct therapeutic approach than growth hormone therapy.

Increlex must be stored in a refrigerator at 2‑8 °C (36‑46 °F). Keep the vial in its original packaging, protect it from light, and avoid freezing or shaking the solution. If the product is removed from refrigeration, it should be used within the time frame specified in the labeling to maintain potency.

Increlex is administered by subcutaneous injection, typically into the thigh, abdomen, or upper arm. The injection site should be rotated to reduce local irritation. Patients or caregivers should follow aseptic technique, use the appropriate needle size, and dispose of sharps in a designated container after each dose.

The most serious risks include hypoglycemia, especially if meals are missed or carbohydrate intake is insufficient; intracranial hypertension, which may present with severe headache, visual disturbances, or vomiting; and rare allergic reactions such as rash, urticaria, or anaphylaxis. Prompt medical evaluation is essential if any of these symptoms occur.

Increlex is contraindicated in individuals with known hypersensitivity to mecasermin or any component of the formulation. It should be used with caution in patients with uncontrolled diabetes, active malignancies, or pre‑existing intracranial hypertension. Pediatric patients with severe liver or kidney impairment may also be unsuitable candidates, and a clinician should assess each case individually.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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