Generic Name: mecasermin rinfabate (meh KAZ er men RIN fa bayt)
Brand Name: iPlex
What is mecasermin rinfabate?
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 is the most important information I should know about mecasermin rinfabate?
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.
What should I discuss with my healthcare provider before using mecasermin rinfabate?
Your child should not use mecasermin rinfabate if the child:
has finished growing (the bone growth plates are closed);
has cancer; or
has other causes of growth failure.
Before receiving this medication, tell your child's doctor if the child has:
liver problems; or
scoliosis (a curved spine).
If your child has any of these conditions, he or she may need a dose adjustment or special tests to safely use mecasermin rinfabate.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
It is not known whether mecasermin rinfabate passes into breast milk or if it could harm a nursing baby. This medication should not be used while breast-feeding a baby.
How should I use mecasermin rinfabate?
Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your child's prescription label.
Your child's doctor may occasionally change the dose to make sure your child gets the best results from this medication.
Mecasermin rinfabate is given as an injection (shot) under the skin in your child's upper arm, upper thigh, stomach area, or buttocks. Never inject the medicine into a muscle or a vein. Your doctor, nurse, or pharmacist will give you specific instructions on how and where to inject this medicine. Do not inject your child at home if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
Use a different place in the injection skin area each time you give an injection. Your care provider will show you the places on your child's body where you can safely inject the medication. Do not inject into the same place two times in a row.
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.
Do not draw the mecasermin rinfabate dose into a syringe until you are ready to give your child an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.
Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.
Your child may need to eat or restrict certain foods while using this medication. Follow the doctor's instructions about diet and medication.
To be sure this medication is helping your child's condition, the child's blood will need to be tested on a regular basis. An eye exam may also be needed. Do not miss any scheduled appointments.
Store this medication in the freezer until you are ready to use it. It is best to keep the medicine in a deep freezer at a temperature of 4 degrees below 0 Fahrenheit (or -20 degrees Celsius) so it does not thaw between uses.
When you are ready to use the medication, take it out of the freezer and allow it to thaw at room temperature for 45 minutes. Do not warm the medication with hot water or a microwave. Once the medicine thaws, it must be used within 1 hour.
Mecasermin rinfabate can be stored frozen for up to 2 months. Do not use the medication if it has been frozen for longer than 2 months.
What happens if I miss a dose?
Give the injection as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until the next regularly scheduled dose. Do not use extra medicine to make up the missed dose.
Always have the child eat a meal or snack 20 minutes before or after injecting mecasermin rinfabate.
What happens if I overdose?
Seek emergency medical attention if you think your child has received too much of this medicine.
Overdose symptoms may include symptoms of low blood sugar such as headache, nausea, hunger, confusion, drowsiness, weakness, dizziness, blurred vision, fast heartbeat, sweating, tremor, or trouble concentrating.
What should I avoid while using mecasermin rinfabate?
Avoid giving this medication if your child is sick or cannot eat.
Do not give a mecasermin rinfabate injection if the child does not eat a meal or snack within 20 minutes before or after the injection. Mecasermin rinfabate may lower blood sugar levels if it is used without eating.
Mecasermin rinfabate side effects
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.
See also: Side effects (in more detail)
Mecasermin rinfabate dosing information
Usual Pediatric Dose for Primary IGF-1 Deficiency:
Growth failure in children with severe primary Insulin-like Growth Factor-1 deficiency or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone.
3 years old to adult (closed epiphyses):
initial dose: 0.5 mg/kg once daily by subcutaneous injection. To establish tolerability, glucose monitoring should be considered at treatment initiation or when a dose has been increased. The dosage can be titrated up to the maximum of 2 mg/kg per day. Doses should be administered at approximately the same time each day. If the patient is unable to eat shortly before or after a dose for any reason, that dose should be withheld. Subsequent doses should never be increased to make up for one or more missed doses.
What other drugs will affect mecasermin rinfabate?
Before using mecasermin rinfabate, tell the doctor if your child uses any diabetes medications such as insulin or medicines taken by mouth (Glucotrol, Diabeta, Micronase, Orinase, and others). If your child is using any of these drugs, he or she may need a dose adjustment or special tests to safely use mecasermin rinfabate.
There may be other drugs not listed that can affect mecasermin rinfabate. Tell your doctor about all the prescription and over-the-counter medications your child uses. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your child's doctor.
Where can I get more information?
- Your pharmacist can provide more information about mecasermin rinfabate.
- Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
- Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2012 Cerner Multum, Inc. Version: 1.03. Revision Date: 2007-10-08, 2:22:41 PM.