iPlex

Generic Name: mecasermin rinfabate (meh KAZ er men RIN fa bayt)

What is iPlex?

iPlex 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.

iPlex is used to treat growth failure in children whose bodies do not make enough IGF-1.

iPlex may also be used for other purposes not listed in this medication guide.

Important information about iPlex

Your child should not use iPlex 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 iPlex injection. iPlex may lower blood sugar levels if it is used without eating.

Always eat a meal or snack 20 minutes before or after injecting iPlex.

iPlex 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.

iPlex 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.

iPlex 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.

Before using iPlex

Your child should not use iPlex if the child:

has finished growing (the bone growth plates are closed);

has cancer; or

has other causes of growth failure.

Before receiving iPlex, tell your child’s doctor if the child has:

diabetes;

kidney problems;

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 iPlex.

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 iPlex passes into breast milk or if it could harm a nursing baby. iPlex should not be used while breast-feeding a baby.

How should I use iPlex?

Use iPlex 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.

iPlex 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 iPlex injection.

Do not draw the iPlex 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 iPlex. 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 iPlex 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.

iPlex 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 iPlex.

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 iPlex?

Avoid giving this medication if your child is sick or cannot eat.

Do not give a iPlex injection if the child does not eat a meal or snack within 20 minutes before or after the injection. iPlex may lower blood sugar levels if it is used without eating.

iPlex side effects

Stop using 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.

iPlex 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.

iPlex 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.

iPlex 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.

iPlex 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.

iPlex 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.

iPlex 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 other drugs will affect iPlex?

Before using iPlex, 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 iPlex.

There may be other drugs not listed that can affect iPlex. 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.