Mecasermin Application Scope

Mecasermin is indicated for the long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Mecasermin Characteristics

Ingredients: Recombinant human insulin-like growth factor-1 (rhIGF-1)
Properties: Biological half-life of approximately 5.8 hours in children with severe primary IGF-1 deficiency .
Specification: Injectable solution at a concentration of 10 mg/mL .
Packaging Specification: Available in vials suitable for subcutaneous injection .
Storage: Refrigerate unopened vials; after opening, vial contents are stable for 30 days when refrigerated .
Expiry Date: Refer to the specific product labeling for expiration information.
Executive Standard: Not specified in the provided sources.
Approval Number: Not specified in the provided sources.
Date of Revision: Information last revised May 2024 .
Manufacturer: Not specified in the provided sources.

Guidelines For The Use Of Mecasermin

Dosage and Administration:

For children aged ≥2 years: 40–80 mcg/kg subcutaneously twice daily. The dose may be increased after 1 week by 40 mcg/kg per dose, not to exceed 120 mcg/kg subcutaneously twice daily .

Administer shortly before or after a meal or snack (within ±20 minutes) to reduce the risk of hypoglycemia .

Adverse Reactions:

Common (>10%): Hypoglycemia (42%), tonsillar hypertrophy (15%).

Less common (1–10%): Cardiac murmur, dizziness, convulsion, headache, lipohypertrophy, thymus hypertrophy, arthralgia, ear problems, otitis media.

Rare (<1%): Anaphylaxis, generalized urticaria, angioedema, dyspnea, local allergic reactions at the injection site, alopecia, abnormal hair texture .

Contraindications

Hypersensitivity to mecasermin or any of its components.

Closed epiphyses (growth plates).

Active or suspected neoplasia; discontinue if neoplasia develops.

Intravenous administration.

Pediatric patients with malignant neoplasia or a history of malignancy .

Precautions

Not a substitute for growth hormone treatment.

Contains benzyl alcohol as a preservative, which is associated with fatal “Gasping Syndrome” in premature infants.

Potential for thickening of facial soft tissues.

Allergic reactions, including localized and severe systemic reactions, have been reported.

Symptoms associated with intracranial hypertension, such as nausea, headache, papilledema, vomiting, and visual changes, have been reported; funduscopic examinations are recommended.

Lymphoid hypertrophy may lead to complications such as chronic middle ear effusions, snoring, and sleep apnea.

Children experiencing rapid growth may have progression of scoliosis.

Caution in patients at risk for diabetes or those being treated for diabetes.

Treat thyroid deficiency prior to initiating therapy.

Evaluate any child with onset of a limp or hip/knee pain for possible slipped capital femoral epiphysis.

Patients should avoid engaging in high-risk activities (e.g., driving, exercise) within 2 to 3 hours after dosing, particularly during initiation of treatment until tolerability and a stable dose are established.

Postmarketing reports have indicated the development of malignant neoplasms in pediatric patients receiving treatment; monitor all patients carefully for the development of neoplasms .

Mecasermin Interactions

Drug Interactions:
- Serious: Macimorelin – avoid or use an alternative drug, as mecasermin may blunt the growth hormone response to macimorelin, impacting the accuracy of diagnostic tests.
- Monitor Closely: Mecasermin may increase the effects of various antidiabetic agents (e.g., insulin, sulfonylureas, metformin) by pharmacodynamic synergism, leading to additive hypoglycemic effects .

Note:

If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
It is only for internal discussion among medical staff and does not serve as a basis for medication. For specific medication guidelines, please consult the attending physician.