Mecasermin Injection
Mecasermin is a man-made form of insulin-like growth factor-1 (IGF-1) used to treat growth failure in children who lack enough of this key growth hormone signal.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 2 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
Mecasermin (Increlex) is a lab-made copy of IGF-1, the hormone that carries growth hormone's signal to bones, for growth failure in children with severe primary IGF-1 deficiency; it is a specialist medicine, on the U.S. market since about 2006, and no substitute for growth hormone. Low blood sugar is what families notice most, plus snoring from enlarged tonsils, headaches and lumpy skin at injection sites. Give each dose within about 20 minutes of a meal or snack and skip it if the child cannot eat, since a severe drop can cause seizures. Report a limp or a bad headache with vision changes or vomiting (possible raised brain pressure) quickly.
Clinical pearls
- Avoid vigorous exercise for 2 to 3 hours after each dose until the right dose is established.
- Rotate among upper arm, thigh, buttock and abdomen with every shot to prevent lumpy fatty buildup under the skin.
- New loud snoring, breathing pauses during sleep or repeated ear infections can signal enlarged tonsils and adenoids, so report them.
- Never double a dose to make up for a missed one, and keep juice or glucose tablets handy for lows.
Patient information guide — a plain-language walkthrough of Mecasermin Injection, written from its FDA label.
What Mecasermin Injection is used for
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Mecasermin injection (brand: Increlex) treats growth failure caused by a specific hormonal deficiency. It is approved for:
- Increlex: Severe primary IGF-1 deficiency in children aged 2 and older — defined by very low IGF-1 levels, very short stature, and normal or elevated growth hormone levels
- Increlex: Growth failure in children aged 2 and older with a growth hormone gene deletion who have developed neutralizing antibodies to growth hormone, making GH therapy ineffective
Increlex is not a substitute for growth hormone for conditions where GH is approved, and it is not indicated for secondary causes of low IGF-1 such as GH deficiency, malnutrition, hypothyroidism, or prolonged high-dose corticosteroid use.
How Mecasermin Injection works
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Normally, growth hormone (GH) signals the liver and other tissues to produce IGF-1, which in turn activates receptors in bones and cells to drive growth. In children with severe primary IGF-1 deficiency, this process is broken — GH is present but IGF-1 is not made in adequate amounts. Mecasermin is a lab-made (recombinant) version of human IGF-1 that bypasses the broken GH step and directly activates the IGF-1 receptor, triggering the cellular signals needed for skeletal growth, cell multiplication, and organ development. It also stimulates the uptake of glucose, fatty acids, and amino acids to fuel growing tissues — which is also why it can lower blood sugar.
Mecasermin Injection dosage
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Increlex is given as a subcutaneous injection (a shot under the skin) twice daily. It must be administered within about 20 minutes of a meal or snack to reduce the risk of low blood sugar — and should be withheld entirely if the child cannot eat at that time.
- Injection sites should be rotated each time (upper arm, thigh, buttock, or abdomen) to prevent skin changes
- Blood sugar monitoring is recommended when starting treatment and until a well-tolerated dose is established
- Never double up on doses to make up for a missed one
- Children should avoid high-risk physical activity for 2–3 hours after each injection, especially early in treatment
Your prescriber will individualize the dose and adjust it based on tolerance and response. Always follow their specific instructions.
Dosing details from the FDA-approved label
From the Mecasermin Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Pediatric patients with short stature associated with severe primary IGF-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone
- Starting dose 0.04 mg/kg to 0.08 mg/kg of body weight twice daily by subcutaneous injection
- If well-tolerated for at least one week, the dose may be increased by 0.04 mg/kg of body weight per dose
- Maximum: 0.12 mg/kg of body weight given twice daily
- Give shortly before or after (± 20 minutes) a meal or snack; withhold the dose if the patient cannot eat; reduce the dose if hypoglycemia occurs despite adequate food intake
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION INCRELEX should be administered subcutaneously. ( 2.2 ) Injection sites should be rotated to avoid lipohypertrophy. ( 2.2 ) Recommended starting dosage: 0.04 mg/kg to 0.08 mg/kg twice daily. If well-tolerated for at least one week, the dose may be increased by 0.04 mg/kg per dose, to the maximum dose of 0.12 mg/kg given twice daily. ( 2.1 ) 2.1 Recommended Dosage Treatment with INCRELEX should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with short stature associated with severe primary IGF-1 deficiency or with growth hormone gene deletion and who have developed neutralizing antibodies to growth hormone. The dosage of INCRELEX should be individualized for each patient. The recommended starting dose of INCRELEX is 0.04 mg/kg to 0.08 mg/kg of body weight twice daily by subcutaneous injection. If well-tolerated for at least one week, the dose may be increased by 0.04 mg/kg of body weight per dose, to the maximum dose of 0.12 mg/kg of body weight given twice daily [see Warnings and Precautions (5.1 and 5.7) ]. Preprandial glucose monitoring is recommended at treatment initiation and until a well-tolerated dose is established. If frequent symptoms of hypoglycemia or severe hypoglycemia occur, preprandial glucose monitoring should continue, and glucose monitoring should also occur at the time of event if possible. If hypoglycemia occurs with recommended doses despite adequate food intake, the dose should be reduced. INCRELEX should be administered shortly before or after (± 20 minutes) a meal or snack. If the patient is unable to eat shortly before or after a dose for any reason, that dose of INCRELEX should be withheld. If one or more doses of INCRELEX is missed, do not increase the subsequent doses to make up for omitted doses. 2.2 Administration Instructions INCRELEX is administered by subcutaneous injection only. Do not administer intravenously. INCRELEX injection sites should be rotated to a different site (upper arm, thigh, buttock or abdomen) with each injection to help prevent lipohypertrophy. INCRELEX should be administered using sterile disposable syringes and needles. The syringes should be of small enough volume so that the prescribed dose can be withdrawn from the vial with accuracy.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Mecasermin Injection side effects
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Common side effects
- Low blood sugar (hypoglycemia), especially in younger children
- Tonsil enlargement (tonsillar hypertrophy)
- Snoring or sleep apnea
- Ear infections or fluid in the middle ear
- Headache or dizziness
- Joint or limb pain
- Lipohypertrophy (fatty tissue buildup at injection sites)
- Vomiting
When to get medical help
- Seek emergency help if severe low blood sugar causes seizures or loss of consciousness
- Call your doctor right away if you notice signs of an allergic reaction: hives, swelling, trouble breathing, or anaphylaxis
- Tell your doctor immediately if the child develops severe headache, vision changes, or vomiting — these may signal increased pressure in the brain (intracranial hypertension)
- Call your doctor if the child develops a limp or hip/knee pain — this may indicate a slipped growth plate (slipped capital femoral epiphysis)
- Report any new lumps, unusual growths, or signs of cancer to the doctor right away
- Tell your doctor if the child's tonsils become very enlarged or if sleep apnea develops
- Monitor for worsening spine curve if the child has scoliosis
The most common side effects seen in clinical trials include:
- Low blood sugar (hypoglycemia) — reported in about 42% of study patients, most often mild to moderate; most frequent in the first month and in younger children
- Tonsil enlargement (tonsillar hypertrophy) — seen in about 15% of patients in the first 1–2 years
- Ear infections and fluid in the middle ear
- Snoring and sleep apnea
- Headache and dizziness
- Joint or limb pain
- Skin thickening or fatty tissue buildup at injection sites (lipohypertrophy)
- Vomiting
Serious reactions — including severe hypoglycemia with seizures, anaphylaxis, increased brain pressure, hip joint slippage, and cancer — have been reported and require immediate medical attention.
Mecasermin Injection warnings and precautions
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- Low blood sugar (hypoglycemia): The biggest day-to-day risk. Always give Increlex with food. Severe cases can cause seizures or loss of consciousness. Monitor blood sugar when starting treatment.
- Allergic reactions / anaphylaxis: Reactions ranging from injection-site redness to full anaphylaxis have occurred. Stop the injection and seek emergency care if systemic symptoms develop.
- Increased brain pressure (intracranial hypertension): Headache, vision changes, nausea, and vomiting can be signs. Eye exams are recommended at the start of and during treatment.
- Tonsil and adenoid enlargement: Can lead to snoring, sleep apnea, and ear problems. Regular check-ups are needed.
- Slipped capital femoral epiphysis (SCFE): A hip growth plate injury that can occur with rapid growth. Report any new limp or hip/knee pain immediately.
- Scoliosis progression: Rapid growth can worsen a pre-existing spinal curve. Children with scoliosis should be monitored regularly.
- Cancer risk: Cases of malignancy have been reported, particularly in children with genetic conditions that already raise cancer risk or in those receiving higher-than-recommended doses. Increlex is contraindicated in children with active or prior cancer.
- Benzyl alcohol toxicity in infants: Increlex contains benzyl alcohol as a preservative, which can cause fatal reactions in neonates and infants. Increlex is not recommended for infants.
Mecasermin Injection interactions
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The FDA label for Increlex does not list specific drug-drug interactions, but because mecasermin has insulin-like effects on blood sugar, be aware of the following:
- Any agent that also lowers blood sugar (such as insulin or other diabetes medications) — combining these could increase the risk of hypoglycemia; discuss with the prescriber
- Skipping meals while on Increlex — not eating around a dose can sharply increase hypoglycemia risk, so food intake must be consistent
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Mecasermin Injection
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- Do not use Increlex if the child has a known allergy to mecasermin or any ingredient in the product
- Do not use if the child has active cancer or a prior history of malignancy
- Do not use for growth promotion after the growth plates (epiphyses) have closed
- Not recommended for infants due to the benzyl alcohol preservative — risk of serious and fatal reactions
- Safety and effectiveness have not been established in children under age 2
- Children with scoliosis need monitoring for spinal curve progression during treatment
- Tell the doctor if the child has any history of increased brain pressure, hip problems, or tonsil issues
- There are no human data on use during pregnancy; exposure is unlikely given the approved pediatric indication, but discuss with a doctor if relevant
- There are no data on whether mecasermin passes into breast milk
- Safety and effectiveness in adults aged 65 and over have not been established
Mecasermin Injection overdose
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Taking too much Increlex primarily causes low blood sugar (hypoglycemia). If the child is still conscious, give oral glucose or food right away. If the child loses consciousness, intravenous glucose or injectable glucagon may be needed — seek emergency care immediately. Long-term overdosing can lead to signs of acromegaly (excessive growth of bones and tissues).
What Mecasermin Injection does in the body
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Mecasermin directly activates IGF-1 receptors found on most cell types in the body, stimulating skeletal growth at the cartilage growth plates of bones, increasing the number of cells throughout the body, and supporting organ growth. It also mimics insulin's effects on metabolism — suppressing the liver's glucose output and increasing glucose use by peripheral tissues — which gives it a meaningful blood-sugar-lowering (hypoglycemic) potential. It also has some inhibitory effect on insulin secretion from the pancreas.
How your body processes Mecasermin Injection
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When injected subcutaneously, mecasermin is nearly completely absorbed. In the bloodstream, more than 80% of IGF-1 is bound to carrier proteins — primarily IGFBP-3 — but children with severe primary IGF-1 deficiency have much lower IGFBP-3 levels, meaning the drug is cleared faster in them than in healthy individuals. The drug is metabolized by the liver and kidneys, with a half-life of roughly 5–6 hours after a single subcutaneous dose in children with severe primary IGF-1 deficiency. No studies have been done in children with kidney or liver impairment.
How to store Mecasermin Injection
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refrigerated at 2º to 8ºC (36º to 46ºF). Avoid freezing the vials of INCRELEX. Protect from direct light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Mecasermin Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Mecasermin Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What exactly is Increlex and why does my child need it?
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How do I give the injection, and does it have to be at a certain time?
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What's the biggest side effect I should watch out for?
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Can my child play sports or exercise normally while taking this?
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Are there any long-term risks I should know about?
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Is it safe for very young children or babies?
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Is Mecasermin Injection available over the counter?
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When was Mecasermin Injection first available?
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Who makes Mecasermin Injection?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Mecasermin Injection on HelloPharmacist
Mecasermin Injection forms and strengths (how it comes)
Mecasermin Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Increlex is used to treat growth failure in children aged 2 and older with severe primary IGF-1 deficiency
- Increlex is used in children with a growth hormone gene deletion who have developed neutralizing antibodies to growth hormone
- Increlex is injected subcutaneously (under the skin) — never given intravenously
- Increlex must be given within about 20 minutes before or after a meal or snack; skip the dose if the child cannot eat
- Increlex injection sites should be rotated with each dose among the upper arm, thigh, buttock, and abdomen to avoid skin changes
- Increlex should be inspected before use — do not use if the solution is cloudy or contains particles
Mecasermin Injection on the U.S. market: products, makers and brands
How Mecasermin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
2 companies list 2 Mecasermin Injection product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 2006. Brand names on the directory include Increlex; the rest are generics.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Mecasermin Injection is used (Medicaid data)
A general measure of how commonly Mecasermin Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q3 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Mecasermin Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Mecasermin Injection prescribed? Of the 1,601 medications we measure, Mecasermin Injection ranks #1,559 by Medicaid prescriptions — more than 3% of them.
Utilization by Mecasermin Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
mecasermin 10 MG/ML Injectable Solution
Summed across the 1 of 4 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 604806
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Mecasermin Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 1 of 4 listed Mecasermin Injection NDCs with Medicaid activity.
Compare Mecasermin Injection products
A representative set of FDA-listed product records for Mecasermin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 40 mg/4 mL | Subcutaneous | Eton Pharmaceuticals, Inc. | BLA | View NDC → |
| 40 mg/4 mL | Subcutaneous | Ipsen Biopharmaceuticals, Inc. | BLA | View NDC → |
Showing 2 of 2 products — FDA National Drug Code Directory. See every product, package size and price: browse all 2 Mecasermin Injection NDCs →
Mecasermin Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Mecasermin Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Mecasermin Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Mecasermin Injection FDA approval history
How Mecasermin Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Mecasermin Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Mecasermin recalls since July 2021.
✅No Mecasermin recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 274403 1 dose form · 1 strength
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Dose form (SCDF) Injectable Solution RxCUI 604805In current FDA listingsClinical drug / strength (SCD) 10 MG/MLRxCUI 604806
Look up RxCUI 274403 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Mecasermin Injection supply and shortage status
Whether Mecasermin Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Mecasermin Injection brand names
Mecasermin Injection is sold under one brand name in the FDA directory — Increlex. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Mecasermin Injection: manufacturers and labelers
2 companies list Mecasermin Injection products with the FDA. By number of product records, the largest are Eton Pharmaceuticals, Inc., Ipsen Biopharmaceuticals, Inc.. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Mecasermin Injection drug class (RxNorm)
Mecasermin Injection belongs to the Somatropin and somatropin agonists class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Mecasermin Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Eton Pharmaceuticals, Inc. is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →