Download mecasermin

mecasermin
Pronunciation: ME ka SER min
Brand: Increlex
What is the most important information I should know about mecasermin?
• Your child should not receive this medication if he or she is allergic to mecasermin, or if the child has cancer or has
finished growing and his or her bone growth plates are closed. Mecasermin is not for use in children who have growth
hormone deficiency, malnutrition, underactive thyroid, or those who are taking long-term steroid medications.
• Before your child receives mecasermin, tell the doctor if your child has diabetes, kidney disease, liver disease, a
curved spine (scoliosis), or if the child has ever had an allergic reaction to a preservative called benzyl alcohol.
• Mecasermin is injected under the skin. You and your child may be shown how to use injections at home. Make sure
you fully understand how to give the injection and properly dispose of used needles and syringes.
• Do not give this medication as an IV injection directly into a vein. Use a different place on your child's upper arm, thigh,
stomach, or buttocks each time you give your child a mecasermin injection.
• Give the mecasermin injection 20 minutes before or after the child eats a meal or snack.
meal or snack will be missed.
before or after the injection.
Skip the dose if the child's
Mecasermin can cause low blood sugar, which may be worse if the child does not eat
• Call your doctor at once if your child has a serious side effect such as blurred vision, headache or pain behind the
eyes (sometimes with vomiting), pain in the hip or knee, walking with a limp, seizures, or swollen tonsils (snoring,
breathing problems during sleep, ear pain, feeling of fullness in the ears, muffled hearing).
• Mecasermin can cause side effects that may impair thinking, reactions, or physical abilities. The child should avoid
driving or doing anything else that requires alertness or coordination for the first 2 or 3 hours after a mecasermin
injection.
• Take care not to let your child's blood sugar get too low while using mecasermin. Know the signs of low blood sugar
(hypoglycemia) and how to recognize them
What is mecasermin?
• Mecasermin is a man-made form of insulin-like growth factor-1 (IGF-1), a substance that is normally produced in the
body. IGF-1 is important for the growth of bones and muscles.
• Mecasermin is used to treat growth failure in children whose bodies do not make enough IGF-1.
• Mecasermin may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before using mecasermin?
• Your child should not use this medication if he or she is allergic to mecasermin, or if the child has cancer or has
finished growing and his or her bone growth plates are closed. Mecasermin is not for use in children who have growth
hormone deficiency, malnutrition, underactive thyroid, or those who are taking long-term steroid medications.
• To make sure your child can safely use mecasermin, tell your doctor if the child has other medical conditions,
especially:
·
diabetes;
·
·
·
·
kidney disease;
liver disease;
a curved spine (scoliosis); or
a history of allergic reaction to a preservative called benzyl alcohol.
• FDA pregnancy category C. It is not known whether mecasermin will harm an unborn baby. This medication should
not be used during pregnancy.
• It is not known whether mecasermin passes into breast milk or if it could harm a nursing baby. You should not breastfeed while you are using mecasermin.
How is mecasermin given?
• Mecasermin is injected under the skin. You may be shown how to use injections at home. Do not use this medicine at
home if you do not fully understand how to give the injection and properly dispose of used needles and syringes.
• Do not give this medication as an IV injection directly into a vein.
• Use a different place on your child's upper arm, thigh, stomach, or buttocks each time you give your child a
mecasermin injection. Your care provider will show you the best places on your child's body where to inject the
medication. Do not inject into the same place two times in a row.
• Your doctor may occasionally change your child's dose to make sure your child gets the best results. The doctor may
also want you to check the child's blood sugar before meals until the correct dose is determined.
• Mecasermin is usually given twice per day. Give the mecasermin injection 20 minutes before or after the child eats a
meal or snack. Skip the dose if the child's meal or snack will be missed.
which may be worse if the child does not eat before or after the injection.
Mecasermin can cause low blood sugar,
• Take care not to let your child's blood sugar get too low while using mecasermin. Know the signs of low blood sugar
(hypoglycemia) and how to recognize them:
·
hunger, weakness, nausea, irritability, tremors;
·
·
·
·
·
drowsiness, dizziness, headache, blurred vision;
confusion, trouble concentrating;
sweating, fast heartbeat;
seizure (convulsions); or
fainting, coma (severe hypoglycemia can be fatal).
• 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. If your child has severe hypoglycemia and cannot eat or drink, use 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.
• Call your doctor if hypoglycemia symptoms do not get better after eating or drinking a sugar source.
• Use a disposable needle only once. 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.
• To be sure this medication is not causing harmful effects, your child will need to be checked on a regular basis. Do
not miss any scheduled visits to your doctor.
• Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.
• Store new unopened vials (bottles) of mecasermin in the refrigerator. Do not freeze. Throw away any mecasermin that
has become frozen.
• Once you have opened a vial and started using it, the medication will keep for up to 30 days if stored in the refrigerator.
What happens if I miss a dose?
• Use the missed dose as soon as you remember.
before or after the injection.
is almost time for your next scheduled dose.
Do not
medicine to make up the missed dose.
Be sure the child receives a meal or snack either 20 minutes
Skip the missed dose if it
use extra
What happens if I overdose?
• Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of mecasermin can
cause hypoglycemia.
• Symptoms of severe hypoglycemia include extreme weakness, blurred vision, sweating, trouble speaking, tremors,
stomach pain, confusion, seizure (convulsions), or coma.
What should I avoid while using mecasermin?
• Mecasermin can cause side effects that may impair thinking, reactions, or physical abilities. The child should avoid
driving or doing anything else that requires alertness or coordination for the first 2 or 3 hours after a mecasermin
injection.
What are the possible side effects of mecasermin?
• Get emergency medical help if your child has any of these
swelling of your child's face, lips, tongue, or throat.
signs of an allergic reaction:
hives; difficulty breathing;
• Call your doctor at once if your child has a serious side effect such as:
·
·
·
·
blurred vision, severe headache or pain behind the eyes, sometimes with vomiting;
pain in the hip or knee, walking with a limp;
seizure (convulsions); or
swollen tonsils -- snoring, breathing problems during sleep, pain or fullness in your ear, hearing problems.
• Less serious side effects may include:
·
dizziness;
·
joint pain;
·
thickening of facial skin;
·
easy bruising; or
·
pain, redness, bruising, or skin changes where the injection was given.
• This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect mecasermin?
• Tell your doctor about all other medications your child uses, especially insulin or diabetes medications your child
takes by mouth.
• This list is not complete and other drugs may interact with mecasermin. Tell your doctor about all medications your
child uses. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication
without telling your doctor.
Where can I get more information?
• Your doctor or pharmacist can provide more information about mecasermin.
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.
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
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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: 5.01. Revision Date: 8/27/2012.