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Drug overview for INCRELEX (mecasermin):
Generic name: MECASERMIN
Drug class: Insulin-like Growth Factor-1 (IGF-1) agents
Therapeutic class: Endocrine
Mecasermin, a somatotropin agonist (a somatomedin), is a biosynthetic (recombinant DNA origin) form of human insulin-like growth factor I (IGF-1; IGF-I).
No enhanced Uses information available for this drug.
Generic name: MECASERMIN
Drug class: Insulin-like Growth Factor-1 (IGF-1) agents
Therapeutic class: Endocrine
Mecasermin, a somatotropin agonist (a somatomedin), is a biosynthetic (recombinant DNA origin) form of human insulin-like growth factor I (IGF-1; IGF-I).
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for INCRELEX (mecasermin) have been approved by the FDA:
Indications:
Primary insulin-like growth factor-1 deficiency
Professional Synonyms:
Pituitary dwarfism with normal somatotropin and low somatomedin
Primary IGF-1 deficiency
Primary insulin-like growth factor deficiency
Indications:
Primary insulin-like growth factor-1 deficiency
Professional Synonyms:
Pituitary dwarfism with normal somatotropin and low somatomedin
Primary IGF-1 deficiency
Primary insulin-like growth factor deficiency
The following dosing information is available for INCRELEX (mecasermin):
No enhanced Dosing information available for this drug.
No enhanced Administration information available for this drug.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for INCRELEX (mecasermin):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for INCRELEX (mecasermin):
Drug contraindication overview.
*Patients with known hypersensitivity to mecasermin or any ingredient (e.g., benzyl alcohol) in the formulation. (See Pediatric Use under Cautions.) *Children with closed epiphyses. *Patients with active or suspected malignant neoplasia or a history of malignancy; therapy should be discontinued if evidence of neoplasm develops.
*Patients with known hypersensitivity to mecasermin or any ingredient (e.g., benzyl alcohol) in the formulation. (See Pediatric Use under Cautions.) *Children with closed epiphyses. *Patients with active or suspected malignant neoplasia or a history of malignancy; therapy should be discontinued if evidence of neoplasm develops.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Malignancy |
There are 0 severe contraindications.
There are 7 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hypertrophy of tonsils |
| Hypoglycemic disorder |
| Intracranial hypertension |
| Papilledema |
| Scoliosis |
| Sleep apnea |
| Slipped capital epiphyses |
The following adverse reaction information is available for INCRELEX (mecasermin):
Adverse reaction overview.
Common adverse effects associated with mecasermin include hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy.
Common adverse effects associated with mecasermin include hypoglycemia, local and systemic hypersensitivity, and tonsillar hypertrophy.
There are 21 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute bacterial otitis media Anemia Bruising Hyperglycemia Hypoglycemic disorder Injection site sequelae Lymphadenopathy |
Abnormal hepatic function tests Erythema Hearing loss Hematuria Intracranial hypertension Ovarian cyst |
| Rare/Very Rare |
|---|
|
Anaphylaxis Angioedema Avascular necrosis of bone Dyspnea Neoplasm Seizure disorder Slipped capital epiphyses Urticaria |
There are 14 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Bone pain Hypertrophy of tonsils Lipodystrophy |
Arthralgia Dizziness Earache Foot pain Headache disorder Pain in extremities Pruritus of skin Vomiting |
| Rare/Very Rare |
|---|
|
Abnormal hair texture Alopecia Papilledema |
The following precautions are available for INCRELEX (mecasermin):
Safety and efficacy of mecasermin have not been established in children younger than 2 years of age. Large amounts of benzyl alcohol (i.e., 100-400 mg/kg daily) have been associated with toxicity in neonates; each mL of mecasermin contains 9 mg of benzyl alcohol. The drug is not indicated for use in neonates.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are no available data on mecasermin use in pregnant women. Exposure to mecasermin during pregnancy is unlikely because mecasermin is not indicated for use after epiphyseal closure.
It is not known whether mecasermin is distributed into milk. Use caution. Mecasermin is not indicated for use in adults, including nursing women.
Safety and efficacy of mecasermin have not been established in patients 65 years of age or older. Mecasermin is not indicated for use in adults, including geriatric patients.
The following prioritized warning is available for INCRELEX (mecasermin):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for INCRELEX (mecasermin)'s list of indications:
| Primary insulin-like growth factor-1 deficiency | |
| E34.321 | Primary insulin-like growth factor-1 (IGf-1) deficiency |
Formulary Reference Tool