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IPLEX™ (mecasermin rinfabate rdna origin injection) (mecasermin rinfabate [rDNA origin] injection) is an aqueous solution for injection containing a binary protein complex of human insulin-like growth factor-1 (rhIGF-1) and human insulin-like growth factor-binding protein-3 (rhIGFBP-3), both produced by recombinant DNA technology.
rhIGF-1 and rhIGFBP-3 are produced by two separate E. coli strains: one containing the human gene for insulin-like growth factor-1 (IGF-1), the other containing the human gene for insulin-like growth factor-binding protein-3 (IGFBP-3). IGF-1 consists of 70 amino acids in a single chain with three intramolecular disulfide bridges and a molecular weight of 7649 daltons. The amino acid sequence of the rhIGF-1 protein is identical to that of endogenous human IGF-1. IGFBP-3 consists of 264 amino acid residues with a molecular weight of 28,732 daltons. The amino acid sequence of the rhIGFBP-3 protein is identical to that of endogenous human IGFBP-3. Endogenous IGFBP-3 contains 18 cysteine residues that are all paired in disulfide bonds to form the biologically active molecule, but the pairings have not been fully elucidated. The rhIGF-1 and rhIGFBP-3 proteins are complexed in a 1:1 molar ratio for formation of mecasermin rinfabate with a molecular weight of 36,381 daltons. IGFBP-3 from human plasma is glycosylated, whereas rhIGFBP-3 produced in E. coli is non-glycosylated. Glycosylated and non-glycosylated IGFBP-3 bind IGF-1 with similar affinities.
Primary structures for rhIGF-1/rhIGFBP-3:
Recombinant human insulin growth factor-1 ( rhIGF-1)
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Recombinant human insulin growth factor binding protein-3 (rhIGFBP-3)
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IPLEX (mecasermin rinfabate rdna origin injection) is prepared to a final concentration of 36 mg/0.6 mL in 50 mM sodium acetate and 105 mM sodium chloride with a final pH of 5.5. IPLEX (mecasermin rinfabate rdna origin injection) is for subcutaneous injection only and is a preservative-free, sterile, clear, colorless-to-slightly-yellow liquid.
What are the possible side effects of mecasermin rinfabate (iPlex)?
Stop using mecasermin rinfabate 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...
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Iplex Patient Information Including Side Effects
Brand Names: iPlex
Generic Name: mecasermin rinfabate (Pronunciation: meh KAZ er men RIN fa bayt)
- What is mecasermin rinfabate (Iplex)?
- What are the possible side effects of mecasermin rinfabate (Iplex)?
- What is the most important information I should know about mecasermin rinfabate (Iplex)?
- What should I discuss with my healthcare provider before using mecasermin rinfabate (Iplex)?
- How should I use mecasermin rinfabate (Iplex)?
- What happens if I miss a dose (Iplex)?
- What happens if I overdose (Iplex)?
- What should I avoid while using mecasermin rinfabate (Iplex)?
- What other drugs will affect mecasermin rinfabate (Iplex)?
- Where can I get more information?
What is mecasermin rinfabate (Iplex)?
Mecasermin rinfabate is a man-made form of insulin-like growth factor-1 (IGF-1), which is normally produced by the body. IGF-1 is important for the growth of bones and muscles.
Mecasermin rinfabate is used to treat growth failure in children whose bodies do not make enough IGF-1.
Mecasermin rinfabate may also be used for other purposes not listed in this medication guide.
What are the possible side effects of mecasermin rinfabate (Iplex)?
Stop using mecasermin rinfabate 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.
What is the most important information I should know about mecasermin rinfabate (Iplex)?
Your child should not use mecasermin rinfabate if your child has cancer, has finished growing (the bone growth plates are closed), or has other causes of growth failure.
This medicine must be given 20 minutes before or after the child eats a meal or snack. Do not use the medicine if the meal or snack is not eaten for any reason. Wait until the child has eaten and 20 minutes have passed before giving the mecasermin rinfabate injection. Mecasermin rinfabate may lower blood sugar levels if it is used without eating.
Always eat a meal or snack 20 minutes before or after injecting mecasermin rinfabate.
Mecasermin rinfabate may cause a bone problem in the top of the upper leg. Get medical attention right away if your child develops a limp or has hip or knee pain.
Know the signs of low blood sugar (hypoglycemia) and how to recognize them in your child. Always keep a source of sugar available in case your child has symptoms of low blood sugar. 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 a temporary increase in pressure within the brain. Call your doctor at once if your child has pain behind the eyes, and nausea with vomiting.
Mecasermin rinfabate may worsen scoliosis. If your child has scoliosis, he or she will need to be checked often for an increase in the curve of the spine.
- Iplex