Mecasermin Rinfabate
Pronunciation: (meh-KASS-er-min RIN-fa-bate).
- Generic name
- Mecasermin rinfabate
- Brand names
- Iplex, Mecasig, Rinfate
- Drug class
- Recombinant human insulin-like growth factor (IGF-1) complex
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What Mecasermin rinfabate 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 rinfabate works
Mecasermin rinfabate is a complex of recombinant human insulin-like growth factor-1 (rhIGF-1) and its binding protein IGFBP-3. IGF-1 stimulates systemic body growth, especially in bones and tissues, by binding to the IGF-1 receptor and activating intracellular signaling pathways that promote cell proliferation and differentiation. The binding protein (IGFBP-3) prolongs the half-life of IGF-1 and modulates its bioavailability, reducing the risk of hypoglycemia compared to IGF-1 alone. (1)
What Mecasermin rinfabate is used for
Severe primary IGF-1 deficiency (SPIGFD) — the FDA-approved indication, when the product was available
Severe primary IGF-1 deficiency (SPIGFD) — the FDA-approved indication, when the product was available (2)
Growth hormone gene deletion with neutralizing antibodies to growth hormone — the other FDA-approved indication, when the product was available
Growth hormone gene deletion with neutralizing antibodies to growth hormone — the other FDA-approved indication, when the product was available (2)
Laron syndrome and growth hormone insensitivity generally — related clinical concepts described in the clinician record; broader than the precise approved label wording above
Laron syndrome and growth hormone insensitivity generally — related clinical concepts described in the clinician record; broader than the precise approved label wording above (2)
Before taking Mecasermin rinfabate
Do not take / not appropriate for
- active or suspected malignancy, closed epiphyses, and hypersensitivity to any component of the formulation. (Contraindication) (2)
- Regular monitoring for adverse effects and growth response is essential. (Contraindication) (2)
Tell your clinician about
(2)How to take Mecasermin rinfabate
- REGULATORY NOTE: Mecasermin rinfabate (IPLEX) was withdrawn from the US market around 2008-2009. The dosing below describes how it was used while available, for informational/historical purposes; it should not be confused with the currently available related product, mecasermin alone (Increlex), which uses different dosing.. General Instructions: Mecasermin rinfabate was administered as a subcutaneous injection ONCE DAILY (the DB previously stated twice daily; the FDA label specifies once daily). It was always given with food or shortly after eating to minimize the risk of hypoglycemia.. Adult Dosing: Mecasermin rinfabate was not indicated for adult use, as safety and efficacy were not established in adults.. Pediatric Dosing (corrected): initial dose 0.5 mg/kg subcutaneously ONCE DAILY, titrated to a therapeutic range of 1-2 mg/kg once daily, up to a maximum of 2 mg/kg per day. This replaces the DB's earlier incorrect frequency (twice daily) and an internally inconsistent weight-based figure (0.04-0.12 mg/kg/dose) that actually belongs to the different, related product mecasermin alone (Increlex), not mecasermin rinfabate.. Administration: Given by subcutaneous injection only — never intravenously. Injection sites were rotated to avoid lipoatrophy; not injected into areas that were tender, bruised, red, or hard.. If Severe Side Effects Occurred: Treatment was stopped if malignancy developed, if there was evidence of closed growth plates (epiphyses), or if severe adverse reactions occurred — always a decision made by the treating endocrinologist, never by the patient or caregiver alone.. Storage (when the product was in distribution): stored FROZEN at -15.5°C to -1.5°C (-4.1°F to 29.3°F) before first use; thawed by warming the vial in the hand for about 2 minutes (never shaken); used within 12 hours of thawing, or within 2 hours if refrigerated after thawing. This corrects the DB's earlier claim of simple refrigeration with a 30-day discard window.
- 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
Mecasermin rinfabate was given once daily with food. If a dose was missed, the family was advised to administer it as soon as possible with food, unless it was almost time for the next dose, in which case the missed dose was skipped and the regular schedule resumed. An extra dose was never given to make up for a missed one.
Overdose
Symptoms of overdose may include severe hypoglycemia, seizures, or loss of consciousness. Seek emergency medical attention immediately. Supportive care and glucose administration may be required. (2)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms to a healthcare professional.
Hypoglycemia
Incidence: Reported in the clinician-authored database; frequency not established
Injection site reactions
Incidence: Reported in the clinician-authored database; frequency not established
Tonsillar hypertrophy
Incidence: Reported in the clinician-authored database; frequency not established
Intracranial hypertension
Incidence: Reported in the clinician-authored database; frequency not established
Scoliosis progression
Incidence: Reported in the clinician-authored database; frequency not established
Lipoatrophy
Incidence: Reported in the clinician-authored database; frequency not established
Allergic reactions
Incidence: Reported in the clinician-authored database; frequency not established
Serious warnings
REGULATORY STATUS — serious
Symptoms: REGULATORY STATUS: Mecasermin rinfabate (IPLEX) was voluntarily withdrawn from the US market around 2008-2009, following a patent-dispute settlement, and is no longer commercially available there. It is presented here for informational/historical purposes only. Do not confuse it with the currently available related product mecasermin alone (Increlex), which has different dosing.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Risk of severe hypoglycemia — can cause unconsciousness, convulsions, or death — serious
Symptoms: Risk of severe hypoglycemia — can cause unconsciousness, convulsions, or death; the medication was not given if a child could not eat or would skip a meal. Monitor for signs of intracranial hypertension (persistent headache, vomiting, vision changes) — periodic eye exams were recommended. Contraindicated in active or suspected malignancy. May cause tonsillar/adenoidal hypertrophy, with risk of sleep apnea or hearing changes. Risk of slipped capital femoral epiphysis and scoliosis progression with rapid growth — regular growth and orthopedic monitoring was important.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Contraindications — serious
Symptoms: Contraindications: active or suspected malignancy (neoplasia); closed epiphyses (growth plates already closed); hypersensitivity to any component of the formulation; and intravenous administration — this product was given by subcutaneous injection only, never IV. Use with caution in patients with a history of hypoglycemia, intracranial hypertension, or those at risk for tonsillar/adenoidal hypertrophy. Regular monitoring for adverse effects and growth response was essential.
Action: Follow the urgency stated and seek prompt or emergency care when indicated. (2)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Recorded interactions | Mecasermin rinfabate may interact with insulin or other antidiabetic medications, increasing the risk of hypoglycemia. Use caution when combining with corticosteroids, as they may reduce the effectiveness of IGF-1 therapy. Always inform your healthcare provider of all medications and supplements you are taking. | (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Historically classified Pregnancy Category C. Effects on an unborn child had not been studied in humans; animal (rabbit) studies showed fetal loss at doses above typical human exposure, though a direct causal link was unclear. This is a historical/informational entry, since the product is no longer available in the US. (2)
Breastfeeding
It was not known whether mecasermin rinfabate was excreted in human milk. (2)
Children
Frequency: Administered once daily (corrected from an earlier 'twice daily' figure).. Weight Based: Initial 0.5 mg/kg, titrated to a therapeutic range of 1-2 mg/kg (corrected from an earlier '0.04-0.12 mg/kg/dose' figure, which belongs to the different, related product mecasermin alone/Increlex).. Max Daily Dose: Not to exceed 2 mg/kg per day.. Max Single Dose: Individualized within the 1-2 mg/kg once-daily range.. Age Restrictions: Not studied in children under 3 years of age. (2)
Renal_impairment
No validated fixed dose-adjustment table for renal or hepatic impairment was found in the independent literature reviewed; this is a historical/informational entry given the product's discontinuation. (2)
Hepatic_impairment
No validated fixed dose-adjustment table for renal or hepatic impairment was found in the independent literature reviewed; this is a historical/informational entry given the product's discontinuation. (2)
Monitoring
(2)Storage
When the product was in distribution: stored FROZEN at -15.5°C to -1.5°C (-4.1°F to 29.3°F) before first use; thawed by warming the vial in the hand for about 2 minutes (never shaken); used within 12 hours of thawing, or within 2 hours if refrigerated (2-8°C) after thawing.
Professional information
Clinician-facing context only. This section does not replace current product labeling. Mecasermin rinfabate (IPLEX) has been withdrawn from the US market since approximately 2008-2009; this section is retained for informational/historical and clinician-education purposes.
General — FDA label (historical; product withdrawn from US market ~2008-2009)
Indication: Severe primary IGF-1 deficiency (SPIGFD)
Dose summary: Initial 0.5 mg/kg SC once daily, titrated to a therapeutic range of 1-2 mg/kg once daily, maximum 2 mg/kg/day. Not established for adult use.
Renal context: No validated fixed renal-dose-adjustment table found in the independent literature reviewed. (2)
Frequently asked questions
Is Mecasermin rinfabate (IPLEX) still available?
No. IPLEX (mecasermin rinfabate) was voluntarily withdrawn from the US market around 2008-2009 following a patent-dispute settlement. Mecasermin alone (Increlex, a different, related product with different dosing) remains available in the US for IGF-1 replacement. Ask your endocrinologist about currently available options.
What was Mecasermin rinfabate used for?
While available, mecasermin rinfabate was used to treat growth failure in children and adolescents with severe primary IGF-1 deficiency or those with growth hormone gene deletion who had developed neutralizing antibodies to growth hormone.
How was Mecasermin rinfabate administered?
It was given as a subcutaneous injection ONCE daily (not twice daily), with meals or snacks to reduce the risk of hypoglycemia.
What should I do if my child misses a dose?
This medication was given once daily with food. If a dose was missed, it was administered as soon as possible with food, unless it was almost time for the next dose, in which case the missed dose was skipped and the regular schedule resumed. An extra dose was never given to make up for a missed one.
What are the most common side effects?
Common side effects include headache, mild hypoglycemia, nausea, vomiting, ear infections, and injection site reactions.
Can adults use Mecasermin rinfabate?
Mecasermin rinfabate is not typically indicated for adults, as its safety and efficacy have not been established in adult populations.
What should I avoid while using this medication?
Avoid taking the medication on an empty stomach, injecting into irritated skin, and engaging in activities that require alertness if you have symptoms of low blood sugar.
How was Mecasermin rinfabate stored?
When it was in distribution, IPLEX was stored FROZEN before first use, thawed by warming the vial in the hand for about 2 minutes (never shaken), and used within 12 hours of thawing (or within 2 hours if refrigerated after thawing). This is different from simple refrigeration.
What happens if I take too much Mecasermin rinfabate?
Taking too much Mecasermin rinfabate can lead to hypoglycemia (low blood sugar), characterized by symptoms like dizziness, sweating, and confusion. Severe overdose may cause seizures or loss of consciousness. If an overdose is suspected, seek immediate emergency medical help. Do not attempt to self-treat or delay seeking professional assistance.
Can I drink alcohol while taking Mecasermin rinfabate?
It is generally advisable to exercise caution or avoid alcohol consumption while taking Mecasermin rinfabate. Alcohol can affect blood sugar levels, potentially increasing the risk of hypoglycemia, especially in individuals already prone to it due to the medication's effects. Consult your healthcare provider for personalized advice regarding alcohol intake during your treatment.
Is Mecasermin rinfabate safe during pregnancy?
Mecasermin rinfabate's safety during pregnancy falls under a specific pregnancy category, indicating that its use should be carefully considered. It is crucial to consult your doctor if you are pregnant, planning to become pregnant, or breastfeeding. Your healthcare provider can assess the potential risks and benefits to both you and the fetus, and recommend the most appropriate course of action.
What is the mechanism of action of Mecasermin rinfabate?
Mecasermin rinfabate is a complex of recombinant human insulin-like growth factor-1 (rhIGF-1) and its binding protein IGFBP-3. IGF-1 stimulates systemic body growth, especially in bones and tissues, by binding to the IGF-1 receptor and activating intracellular signaling pathways that promote cell proliferation and differentiation. The binding protein (IGFBP-3) prolongs the half-life of IGF-1 and modulates its bioavailability, reducing the risk of hypoglycemia compared to IGF-1 alone. (1)
What is the generic name of Mecasermin Rinfabate?
The generic name is Mecasermin rinfabate. It is sold under brand names including Iplex, Mecasig, Rinfate.
What class of drug is Mecasermin rinfabate?
Mecasermin Rinfabate is classed as: Recombinant human insulin-like growth factor (IGF-1) complex.
References
- Mecasermin rinfabate — clinician-authored recordMedGuideGlobal clinician-authored medicine record (internal database) · United States · accessed 2026-08-06 · source 1
- IPLEX (mecasermin rinfabate) Drug Information: Dosing, Side Effects and InteractionsRxList (WebMD LLC); references FDA-approved prescribing information · United States · accessed 2026-08-06 · source 2
- Voluntary U.S. market withdrawal of IPLEX (mecasermin rinfabate)Multiple corroborating sources (Drugs.com FDA approval history, RxList, Insmed litigation settlement reports) · United States · accessed 2026-08-06 · source 3
- MUSKEL (ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT, BOS TAURUS ANKLE JOINT, SUS SCROFA ANKLE JOINT, BOS TAURUS JOINT CAPSULE, SUS SCROFA JOINT CAPSULE, BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN, METENKEFALIN, ERSOFERMIN, BOS TAURUS SOLAR PLEXUS, SUS SCROFA SOLAR PLEXUS, CALCITONIN, BOS TAURUS FRONTAL LOBE, SUS SCROFA FRONTAL LOBE, BOS TAURUS HIP JOINT, SUS SCROFA HIP JOINT, BOS TAURUS HIPPOCAMPUS, SUS SCROFA HIPPOCAMPUS, BOS TAURUS HYPOTHALAMUS, SUS SCROFA HYPOTHALAMUS, MECASERMIN RINFABATE) SPRAY [VIATREXX BIO INCORPORATED] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 4
- Mecasermin rinfabate — RxNorm normalized drug concept (RXCUI 616877)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 5
Brand names by country
Single-ingredient Mecasermin rinfabate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.