"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Iplex Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Iplex (mecasermin rinfabate [rDNA origin] injection) is a man-made form of insulin-like growth factor-1 (IGF-1) used to treat growth failure in children whose bodies do not make enough IGF-1. The brand name of this medication is discontinued, but generic versions may be available. Common side effects include ear infection, swollen lymph nodes, high blood sugar, bruising, injection site reactions, low blood sugar, anemia, bone pain, and abnormal fat distribution.
Iplex dosage is individualized for each patient. Iplex is administered via subcutaneous injection at an initial dose of 0.5 mg/kg, to be increased into the therapeutic dose range of 1 to 2 mg/kg, given once daily. Iplex may interact with insulin or oral diabetes medicines. Tell your doctor all medications and supplements you use. Iplex may be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is unknown if this drug passes into breast milk or if it could harm a nursing baby. Consult your doctor before breastfeeding.
Our Iplex (mecasermin rinfabate [rDNA origin] injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Iplex FDA Prescribing Information: Side Effects
Treatment-emergent adverse events were assessed in the clinical study of IPLEX (mecasermin rinfabate [rDNA origin] injection) in children with Primary IGFD. In this study, 36 patients had an average exposure of 10.4 months (range: 27 days - 22.5 months), for a total of 374 patient-months. Safety information beyond one year of treatment is limited and safety beyond 21 months of treatment has not been established.
The most common treatment-related adverse events occurring in 2 or more ( ≥ 5%) subjects were iron deficiency anemia, lymphadenopathy, thyromegaly, injection site conditions, increased transaminases, hyperglycemia, hypoglycemia, arthralgia, bone pain, muscular atrophy, pain in an extremity, headache, papilledema, hematuria, ovarian cysts, and tonsillar hypertrophy.
Common injection site conditions included erythema, lipohypertrophy, and hair growth at the injection sites.
Hypoglycemia was reported in 11/36 (31%) patients in the study generally rated as mild and asymptomatic. Four hypoglycemic episodes were characterized as symptomatic including two cases that required acute intervention.
Headaches were reported in 8/36 (22%) patients in the study. One adverse event of asymptomatic papilledema was reported. An adverse event of increased intracranial pressure and papilledema (possible intracranial hypertension) was also reported, which resolved with revision of a blocked existing ventriculo-peritoneal shunt.
Increases in liver, spleen, and kidney size were noted in several patients on abdominal ultrasound assessments; occasional measurements near the upper-limit-of-normal were noted. Renal function (as defined by serum creatinine and calculated creatinine clearance) was normal. Two patients had ovarian cysts on pelvic ultrasound and one patient had sonographic evidence of hepatomegaly.
Mild elevations in the serum AST and LDH were found in a significant proportion of patients before and during treatment without treatment discontinuations. Two patients had AST elevations that required temporary interruption of treatment. Echocardiographic evidence of valvulopathy was observed in a few individuals without associated clinical symptoms. Because of the underlying disease and the lack of a control group, the relationship of the valvular changes to drug treatment cannot be assessed.
Since IGF-1 is the main mediator of GH effects and GH may produce acromegalic changes, such changes should be monitored during IPLEX (mecasermin rinfabate [rdna origin] injection) treatment.
By 9 months of treatment, a proportion of patients developed antibodies to the protein complex (90%), rhIGFBP-3 (50%), and/or rhIGF-1 (20%), using assays with varying degrees of sensitivity. No evidence of neutralization of biological activity, such as reduced height velocity, was noted in antibody-positive patients during the first year of IPLEX (mecasermin rinfabate [rdna origin] injection) treatment.
Read the entire FDA prescribing information for Iplex (Mecasermin Rinfabate [rDNA origin] Injection)
Additional Iplex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.