Dosing & Uses
Not indicated for adult use
Dosage Forms & Strengths
injectable solution
- 10mg/mL
Growth Failure
Indicated for 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
<2 years: Safety and efficacy not established
≥2 years: 40-80 mcg/kg SC q12hr, may increase after 1 week by 40 mcg/kg/dose, not to exceed 120 mcg/kg SC q12hr
Rett Syndrome (Orphan)
Orphan designation for treatment of Rett syndrome
Sponsor
- Keck Graduate Institute of Applied Life Sciences; 535 Watson Drive; Claremont, California 91711
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (1)
- macimorelin
mecasermin, macimorelin. unspecified interaction mechanism. Avoid or Use Alternate Drug. Drugs that may blunt the growth hormone (GH) response to macrimorelin may impact the accuracy of the diagnostic test. Discontinue GH products at least 1 week before administering macimorelin.
Monitor Closely (26)
- acarbose
mecasermin increases effects of acarbose by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- chlorpropamide
mecasermin increases effects of chlorpropamide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- glimepiride
mecasermin increases effects of glimepiride by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- glipizide
mecasermin increases effects of glipizide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- glyburide
mecasermin increases effects of glyburide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- insulin aspart
mecasermin increases effects of insulin aspart by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- insulin degludec
mecasermin, insulin degludec. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
- insulin degludec/insulin aspart
mecasermin, insulin degludec/insulin aspart. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
- insulin detemir
mecasermin increases effects of insulin detemir by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- insulin glargine
mecasermin increases effects of insulin glargine by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- insulin glulisine
mecasermin increases effects of insulin glulisine by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- insulin inhaled
mecasermin, insulin inhaled. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Both drugs decrease blood glucose.
- insulin lispro
mecasermin increases effects of insulin lispro by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- insulin NPH
mecasermin increases effects of insulin NPH by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- insulin regular human
mecasermin increases effects of insulin regular human by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- metformin
mecasermin increases effects of metformin by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- miglitol
mecasermin increases effects of miglitol by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- nateglinide
mecasermin increases effects of nateglinide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- pioglitazone
mecasermin increases effects of pioglitazone by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- repaglinide
mecasermin increases effects of repaglinide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- rosiglitazone
mecasermin increases effects of rosiglitazone by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- saxagliptin
mecasermin increases effects of saxagliptin by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- sitagliptin
mecasermin increases effects of sitagliptin by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- tolazamide
mecasermin increases effects of tolazamide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- tolbutamide
mecasermin increases effects of tolbutamide by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
- vildagliptin
mecasermin increases effects of vildagliptin by pharmacodynamic synergism. Use Caution/Monitor. Additive hypoglycemic effects.
Minor (0)
Adverse Effects
>10%
Hypoglycemia (42%)
Tonsillar hypertrophy (15%)
1-10%
Cardiac murmur (>5%)
Dizziness (>5%)
Convulsion (>5%)
Headache (>5%)
Lipohypertrophy (>5%)
Thymus hypertrophy (>5%)
Arthralgia (>5%)
Ear problems (>5%)
Otitis media (>5%)
<1%
Anaphylaxis
Generalized urticaria
Angioedema
Dyspnea
Local allergic reactions at the injection site (eg, pruritus, urticaria)
Alopecia, hair texture abnormal
Postmarketing Reports
Systemic hypersensitivity: anaphylaxis, generalized urticaria, angioedema, dyspnea
Local allergic reactions at the injection site: pruritus, urticaria
Skin and Subcutaneous Tissue Disorders: alopecia, hair texture abnormal
General disorders and administrative site conditions: Injection site reactions (eg, erythema, pain, hematoma, hemorrhage, induration, rash, swelling)
Musculoskeletal and connective tissue disorders: Osteonecrosis/avascular necrosis (occasionally associated with slipped capital femoral epiphysis)
Neoplasms Benign, Malignant and Unspecified (including cysts and polyps)
Warnings
Contraindications
Hypersensitivity to product or components
Closed epiphyses
Active or suspected neoplasia; discontinue if neoplasia develops
IV administration
Pediatric patients with malignant neoplasia or a history of malignancy
Cautions
Do not give without meal/snack 20 min before/after (risk of hypoglycemia)
Not a substitute for GH treatment
Contains benzyl alcohol as preservative (associated with fatal "Gasping Syndrome" in preemies)
Possibility of thickening of facial soft tissues
Allergic reactions reported include localized (injection site) reactions to severe systemic reactions, including anaphylaxis requiring hospitalization
Symptoms associated with intracranial hypertension including nausea, headache, papilledema, vomiting, visual changes reported; funduscopic examinations are recommended
Lymphoid hypertrophy that may lead to complications such as chronic middle ear effusions, snoring, and sleep apnea reported
Children experiencing rapid growth may have progression of scoliosis
Caution in patients at risk for diabetes or patients being treated for diabetes
Treat thyroid deficiency prior to 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 (eg, driving, exercise, etc.) within 2 to 3 hours after dosing, particularly during initiation of treatment until tolerability and stable dose established
There have been postmarketing reports of malignant neoplasms in pediatric patients who have received treatment; unknown whether there is relationship between therapy and new occurrence of neoplasia; monitor all patients receiving therapy carefully for development of neoplasms; advise patients/caregivers to report development of new neoplasms; if malignant neoplasia develops, discontinue treatment
Pregnancy & Lactation
Pregnancy
There are no available data on use in pregnant women; exposure during pregnancy is unlikely because the drug is not indicated for use after epiphyseal closure
Animal data
- In animal reproduction studies, there were no observed embryo-fetal development abnormalities with intravenous administration to pregnant rats and rabbits during fetal organogenesis given at exposures up to 11 and 3 times maximum recommended human dose (MRHD) of 0.24 mg/kg/day based on body surface area (BSA), respectively
Lactation
There is no information available on presence of mecasermin in human or animal milk, effects on breastfed infant, or on milk production; the developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breast-fed child from treatment or from underlying maternal condition
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Recombinant human IGF-1 used as replacement therapy in patients primary severe IGF-I deficiency, growth hormone receptors in the liver that are unresponsive to GH
Pharmacokinetics
Metabolism: Liver, kidney
Half-Life: 5.8 hr (mecasermin); >12 hr (mecasermin rinfabate)
Excretion: Likely as native proteins
Vd: 0.184-0.33 L/kg
Protein binding: 80% bound to IFGBP-3 and an acid-labile subunit
Administration
SC Injection
Give shortly before/after meal or snack (~20 minutes) to avoid hypoglycemia
If hypoglycemia occurs with recommended doses despite adequate food intake, the dose should be reduced
Rotate injection site to avoid lipodystrophy
Storage
Refrigerate unopened vials; after opening, vial contents are stable for 30 days when refrigerated
Images
Patient Handout
mecasermin subcutaneous
NO MONOGRAPH AVAILABLE AT THIS TIME
USES: Consult your pharmacist.
HOW TO USE: Consult your pharmacist.
SIDE EFFECTS: Consult your pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Consult your pharmacist.
DRUG INTERACTIONS: Consult your pharmacist.Keep a list of all your medications with you, and share the list with your doctor and pharmacist.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: No monograph available at this time.
MISSED DOSE: Consult your pharmacist.
STORAGE: Consult your pharmacist.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Information last revised July 2016. Copyright(c) 2022 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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