IPlex Side Effects

Generic name: mecasermin rinfabate

Note: This document contains side effect information about mecasermin rinfabate. Some of the dosage forms listed on this page may not apply to the brand name iPlex.

Some side effects of iPlex may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to mecasermin rinfabate: subcutaneous solution

Stop using mecasermin rinfabate (the active ingredient contained in iPlex) and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Mecasermin rinfabate may cause a temporary increase in pressure within the brain. Symptoms include pain behind the eyes, and nausea with vomiting. Call your doctor at once if your child has a headache with vomiting.

Mecasermin rinfabate may cause a bone problem called "slipped capital femoral epiphysis.” This happens when the top of the upper leg (femur) slips apart. Get medical attention for your child right away if your child develops a limp or has hip or knee pain.

Mecasermin rinfabate may cause hypoglycemia, or low blood sugar. Symptoms of low blood sugar may include dizziness, headache, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea, or fast or uneven heart rate. Watch for signs of low blood sugar. Carry a piece of non-dietetic hard candy or glucose tablets with you in case you have low blood sugar.

Other sugar sources include orange juice, glucose gel, candy, or milk. Severe hypoglycemia may cause fainting, seizure (convulsions), or death. If your child has severe hypoglycemia and cannot eat or drink, give an injection of glucagon. Your doctor can give you a prescription for a glucagon emergency injection kit and tell you how to give the injection.

Mecasermin rinfabate may cause the tonsils to become enlarged. This can result in snoring, sleep apnea (breathing stops during sleep), trouble swallowing, or a build-up of fluid in the middle ear. Call your doctor if your child has any of these symptoms.

Mecasermin rinfabate may cause worsened scoliosis (caused by fast growth). If your child has scoliosis, your child will need to be checked often for an increase in the curve of the spine.

Mecasermin rinfabate may also cause pain, redness, bruising, or skin changes where the shot was given.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

For Healthcare Professionals

Applies to mecasermin rinfabate: subcutaneous solution

Endocrine

Endocrine side effects have included hypoglycemia, hyperglycemia, tonsilar hypertrophy, adenoid hypertrophy, lymphadenopathy, and thyromegaly.

Local

Local side effects have included erythema, lipohypertrophy and hair growth at the injection sites.

Ocular

Ocular side effects have included papilledema, possibly due to increased intracranial pressure.

Nervous system

Nervous system side effects have included headaches.

Hepatic

Hepatic side effects have included increases in liver size, and increased transaminase (AST) and LDH levels,

Hematologic

Hematologic side effects have included iron deficiency anemia and increased size of the spleen.

Musculoskeletal

Musculoskeletal side effects have included arthralgia, bone pain, muscular atrophy, and pain in an extremity.

Renal

Renal side effects have included increases in kidney size.

Genitourinary

Genitourinary side effects have included ovarian cysts.

Cardiovascular

Cardiovascular side effects have included echographic evidence of valvulopathy.

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