"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"...
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 Iplex (mecasermin rinfabate [rdna origin] injection) Side Effects Center for a complete guide to possible side effects
No information provided.
Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.
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.