Mecasermin
Pronunciation: meh-KASS-er-min.
- Generic name
- mecasermin
- Brand names
- Mecasin, IGF-1 Mecasin, Increlex
- Drug class
- Recombinant human insulin-like growth factor-1 (rhIGF-1)
Availability and supply rules vary by country
Trade names by country: United States
Australia: · Full directory
What mecasermin is and how it works
Uses, formulations, monitoring, and supply rules can differ by patient, product, and country. Follow the exact local product information and professional advice.
Mechanism of action: how mecasermin works
Mecasermin is a recombinant human insulin-like growth factor-1 (rhIGF-1) that directly stimulates cellular growth and development by binding to the IGF-1 receptor. This activation promotes mitogenesis, cell differentiation, and anabolic effects in bone, cartilage, and other tissues, compensating for the lack of endogenous IGF-1 in patients with severe primary IGF-1 deficiency. (1)
What mecasermin is used for
Growth failure in pediatric patients with severe primary IGF-1 deficiency
FDA-approved for pediatric patients 2 years of age and older with severe primary insulin-like growth factor-1 (IGF-1) deficiency, or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH. Not indicated for secondary forms of IGF-1 deficiency (e.g., from GH deficiency, malnutrition, hypothyroidism, or chronic glucocorticoid treatment), and not a substitute for GH therapy in patients who have an approved GH indication. Not indicated for adults. (2)
Before taking mecasermin
Do not take / not appropriate for
- active or suspected malignancy, closed epiphyses, hypersensitivity to Mecasermin or its excipients, and hypoglycemia at the time of injection. (Contraindication) (2)
Tell your clinician about
(2)How to take mecasermin
- General Instructions: Mecasermin is given by subcutaneous injection, usually twice daily, within about 20 minutes before or after a meal or snack to reduce the risk of hypoglycemia (low blood sugar) — do not give a dose if a meal or snack will not be eaten.. Adult Dosing: Mecasermin is not indicated for use in adults; there is no adult dosing regimen. Safety and efficacy have not been established in this population.. Pediatric Dosing (2 years and older): The recommended starting dose is 0.04 to 0.08 mg/kg twice daily. The dose may be increased by 0.04 mg/kg per dose per week up to a maximum of 0.12 mg/kg twice daily, based on tolerance and clinical response.. Administration: Inject subcutaneously in the upper arm, thigh, buttocks, or abdomen, rotating sites with each injection. Never administer intravenously or intramuscularly.. When To Stop: Evidence of malignancy, closed epiphyses, or severe adverse reactions are reasons a clinician may discontinue treatment — always consult your healthcare provider before stopping or changing the dose.. Storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Discard any unused portion after 30 days of first use.
- This page does not provide a dose calculator. Dosing must follow the prescriber, pharmacist, or product label.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (2)
Missed dose
If you miss a dose, take it as soon as you remember, provided it is close to a meal or snack. If it is almost time for the next dose, skip the missed dose and resume your regular schedule. Do not take an extra dose to make up for the missed one.
Overdose
Symptoms of overdose may include severe hypoglycemia, seizures, or increased intracranial pressure. Seek emergency medical attention immediately. Supportive care and monitoring of blood glucose and neurological status are essential. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Hypoglycemia (low blood sugar)
Incidence: Reported in about 42% (30 of 71) of subjects in clinical trials
Tonsillar hypertrophy (enlarged tonsils)
Incidence: Reported in about 15% (11 of 71) of subjects in clinical trials
Injection-site reactions, lipohypertrophy (fat lumps at injection sites), and bruising
Incidence: Reported in clinical trials; exact frequency not separately established
Otitis media (ear infection), snoring, headache, vomiting
Incidence: Reported in clinical trials; exact frequency not separately established
Signs of severe hypoglycemia (confusion, seizures) or anaphylaxis (postmarketing frequency estimated at about 0.3%)
(2)Serious warnings
Risk of severe hypoglycemia, especially if not taken with food — serious
Symptoms: Risk of severe hypoglycemia, especially if not taken with food. Potential for increased intracranial pressure and papilledema. May cause hypertrophy of tonsils and adenoids. Monitor for signs of malignancy or abnormal growths. Not for use in patients with closed epiphyses or active neoplasia.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications recorded in the clinician database — serious
Symptoms: Contraindications recorded in the clinician database: Contraindications include active or suspected malignancy, closed epiphyses, hypersensitivity to Mecasermin or its excipients, and hypoglycemia at the time of injection. Use with caution in patients with a history of neoplasia, diabetes, or intracranial hypertension. Monitor for tonsillar/adenoidal hypertrophy and signs of increased intracranial pressure.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Mecasermin may interact with insulin or other antidiabetic medications, increasing the risk of hypoglycemia. Caution is advised when used with corticosteroids, as they may reduce the effectiveness of Mecasermin. Always inform your healthcare provider about all medicines and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
No adequate human data are available on mecasermin use in pregnancy. Animal reproduction studies did not show embryo-fetal abnormalities. As this medicine is indicated only for pediatric growth failure, pregnancy is not an expected treatment scenario; discuss any pregnancy or possibility of pregnancy with the treating specialist. (2)
Breastfeeding
Data on use during breastfeeding are insufficient to provide specific guidance. Discuss with the treating healthcare provider. (2)
Children
Approved for pediatric patients 2 years of age and older with severe primary IGF-1 deficiency or GH gene deletion with neutralizing antibodies to GH. Frequency: Twice daily. Weight-based dosing: starting dose 0.04 to 0.08 mg/kg twice daily, titrated up to a maximum of 0.12 mg/kg twice daily. Max Daily Dose/Max Single Dose: not separately established beyond the weight-based maximum. Age Restrictions: safety not established in children under 2 years of age. (2)
Renal_impairment
The FDA prescribing information for Increlex (mecasermin) has no dedicated dosing-adjustment subsection for renal or hepatic impairment. It states that no studies have been conducted in children with severe primary IGF-1 deficiency who also have renal impairment, and no studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of mecasermin in this population. Children with significant kidney or liver disease should be monitored closely by the prescribing specialist. (2)
Hepatic_impairment
The FDA prescribing information for Increlex (mecasermin) has no dedicated dosing-adjustment subsection for renal or hepatic impairment. It states that no studies have been conducted in children with severe primary IGF-1 deficiency who also have renal impairment, and no studies have been conducted to determine the effect of hepatic impairment on the pharmacokinetics of mecasermin in this population. Children with significant kidney or liver disease should be monitored closely by the prescribing specialist. (2)
Monitoring
(2)Storage
Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. Protect from light. Discard any unused portion 30 days after first use.
Professional information
Clinician-facing context only. This section does not replace current product labeling.
General (US FDA label)
Indication: Growth failure, pediatric severe primary IGF-1 deficiency (not indicated for adults)
Dose summary: Pediatric patients 2 years and older: starting dose 0.04-0.08 mg/kg subcutaneously twice daily, titrated by 0.04 mg/kg per dose per week as tolerated to a maximum of 0.12 mg/kg twice daily, given within about 20 minutes of a meal or snack. No adult dosing regimen exists — mecasermin is not indicated in adults.
Renal context: The FDA label states no studies have been conducted in children with severe primary IGF-1 deficiency who also have renal impairment; there is no dedicated renal dose-adjustment subsection. (1) (2)
Hepatic guidance
The FDA label states no studies have been conducted to determine the effect of hepatic impairment on mecasermin pharmacokinetics; there is no dedicated hepatic dose-adjustment subsection.
Frequently asked questions
What is Mecasermin injection used for?
Mecasermin is used to treat growth failure in children with severe primary IGF-1 deficiency or those who are unresponsive to growth hormone therapy.
How should Mecasermin be administered?
It should be injected subcutaneously, usually twice daily, shortly before or after a meal or snack to reduce the risk of hypoglycemia.
What are the most common side effects?
The most common side effects are low blood sugar, headache, increased tonsil size, ear infections, and mild injection site reactions.
What should I do if my child misses a dose?
Give the missed dose as soon as possible with a meal or snack. If it is almost time for the next dose, skip the missed dose. Do not take an extra dose to make up for the missed one.
Can Mecasermin be used in adults?
No, Mecasermin is not approved for use in adults. Its safety and effectiveness have not been established in this population.
What precautions should be taken during treatment?
Monitor for signs of hypoglycemia, increased intracranial pressure, and abnormal growths. Regular follow-up with your healthcare provider is essential.
Are there any foods or activities to avoid?
Avoid skipping meals or snacks around dosing times, and avoid activities that require alertness if you experience symptoms of low blood sugar.
What happens if I take too much Mecasermin injection?
Taking too much Mecasermin injection can lead to severe hypoglycemia (low blood sugar), which may manifest as dizziness, confusion, sweating, or seizures. In such cases, immediate medical attention is crucial. If you suspect an overdose, seek emergency medical help without delay. Prompt treatment of hypoglycemia is essential to prevent serious complications.
Can I drink alcohol while taking Mecasermin injection?
Alcohol consumption while taking Mecasermin injection is generally not recommended. Alcohol can interfere with blood sugar regulation, potentially increasing the risk of hypoglycemia, a common side effect of Mecasermin. It is best to discuss alcohol use with your healthcare provider to understand the specific risks and receive personalized advice based on your medical history and treatment plan.
Is Mecasermin injection safe during pregnancy?
Mecasermin is approved only for growth failure in children, so pregnancy is not an expected treatment scenario. No adequate human pregnancy data exist, though animal studies did not show embryo-fetal abnormalities. Any pregnancy or possibility of pregnancy in a patient taking this medicine should be discussed with the treating specialist right away.
What is the mechanism of action of mecasermin?
Mecasermin is a recombinant human insulin-like growth factor-1 (rhIGF-1) that directly stimulates cellular growth and development by binding to the IGF-1 receptor. This activation promotes mitogenesis, cell differentiation, and anabolic effects in bone, cartilage, and other tissues, compensating for the lack of endogenous IGF-1 in patients with severe primary IGF-1 deficiency. (1)
What is the generic name of Mecasermin?
The generic name is mecasermin. It is sold under brand names including Mecasin, IGF-1 Mecasin, Increlex.
What class of drug is mecasermin?
Mecasermin is classed as: Recombinant human insulin-like growth factor-1 (rhIGF-1).
References
- Mecasermin injection clinician-authored medicine recordMedGuideGlobal · null · accessed 2026-08-06 · source 1
- INCRELEX (mecasermin) injection, solution — full prescribing information (Ipsen Biopharmaceuticals)U.S. National Library of Medicine DailyMed · United States · dated initial US approval 2005 · accessed 2026-08-06 · source 2
- INCRELEX (MECASERMIN) INJECTION [ETON PHARMACEUTICALS, INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Mecasermin Injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
- Increlex — FDA approval record (Drugs@FDA BLA021839)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 5
- mecasermin — RxNorm normalized drug concept (RXCUI 274403)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6
Brand names by country
Single-ingredient mecasermin names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- Increlex40 mg/4mL · ipsen biopharmaceuticals, inc.
- GUNA-IGF4 [hp_C]/30mL · guna spa