Mecasermin (rDNA origin), Injection

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KEY POINTS

• This medicine is given by injection to treat severe primary insulin-like growth factor (IGF-1) deficiency in children. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects your child.
• This medicine may cause low blood sugar, bone problems, enlarged tonsils, or other unwanted side effects. Tell your healthcare provider if your child has any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat your child about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes.

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What are other names for this medicine?

Type of medicine: human insulin-like growth factor

Generic and brand names: mecasermin (rDNA origin), injection; Increlex

What is this medicine used for?

This medicine is given by injection (shots) to treat severe primary insulin-like growth factor (IGF-1) deficiency in children.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before taking this medicine, tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine or to benzyl alcohol
• Cancer or tumors
• Diabetes
• Ear infection or hearing disorder
• Kidney or liver problems
• Problems with the growth plate in the leg
• Scoliosis
• Thyroid problems

Females of childbearing age: Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known whether this medicine will harm an unborn baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Check the label on the medicine for directions about your specific dose. Your healthcare provider will determine the exact dosage. Be sure you know when to use the medicine and how much medicine you should use. Carefully follow the instructions for using this medicine. If you are not sure how to use this medicine, ask your healthcare provider or pharmacist for help.

Your healthcare provider will teach you how to inject this medicine under your child's skin. Ask your provider for specific instructions on the best times to give the injections. Most often, you will inject this medicine under your child's skin shortly (20 minutes) before or after a meal or snack. Skip your child's dose of this medicine if for any reason your child cannot eat. Do not make up for the skipped dose by giving 2 doses the next time. You may need to check your child’s blood sugar prior to injections. Talk to your healthcare provider about this.

Check with your healthcare provider before using this medicine in children under age 2.

Do not use this medicine if it is cloudy or has particles in it.

Ask your healthcare provider or pharmacist how to dispose of any used needles, syringes, or vials. Put used needles in rigid puncture-resistant containers with lids or caps, such as heavy plastic bleach bottles with screw caps. DO NOT throw needles directly into garbage cans or dumpsters. Never share needles or syringes with anyone else.

What if I miss a dose?

Ask your healthcare provider what to do if you miss a dose. If you miss a dose, follow your healthcare provider's instructions. Do not give your child double doses.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: tremors, cold sweats, increased hunger, headache, drowsiness, restlessness, irritability, weakness, trouble concentrating, dizziness, fast heartbeat, nausea.

What should I watch out for?

This medicine may cause bone problems. Contact your healthcare provider right away if your child has hip or knee pain, or starts to limp.

This medicine may cause enlarged tonsils. Contact your healthcare provider if your child has pain or fullness in the ear, trouble breathing or swallowing, sleep apnea (stops breathing briefly during sleep), or starts snoring.

Your healthcare provider may want to see your child regularly to check his or her progress. Keep all appointments.

Low blood sugar (hypoglycemia) can happen if your child misses or delays meals while taking this medicine. Symptoms of low blood sugar include shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, and weakness. It is a good habit to carry glucose tablets or gel to treat low blood sugar. Your child can also eat honey or candy, or drink a glass of orange juice or nondiet soda to quickly raise blood sugar level. Talk about this with your healthcare provider.

Your child should avoid high risk activities such as skateboarding, bicycling, or driving for up to 3 hours after taking this medicine until you know how the medicine affects them. Be sure to talk about this with your healthcare provider.

If your child needs emergency care, surgery, or dental work, tell the healthcare provider or dentist that your child is taking this medicine.

What are the possible side effects?

Along with its needed effects, this medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your child’s body adjusts to the medicine. Tell your healthcare provider if your child has any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in the chest; swelling of the lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Symptoms of hypoglycemia (shaking, anxiety, cold sweats, irritability, fast heartbeat, feeling faint, strong hunger, vision problems, headache, nausea, slurred speech, confusion, unusual mood changes, tingling in the lips or tongue, weakness), hip or knee pain, limping, seizures, increased thirst, increased urination, fast or irregular heartbeat, ear pain or fullness, decreased hearing, fever, snoring, swollen tonsils, trouble breathing or swallowing, sleep apnea, headache that won't go away, severe nausea and vomiting, blurred vision.

Other: Headache, dizziness, muscle pain, pain or swelling at the injection site, redness or bruising at the injection site.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if your child is taking:

• Diabetes medicines such as glimepiride (Amaryl), glipizide (Glucotrol), glyburide (Glynase), insulin, metformin (Fortamet, Glucophage, Riomet), pioglitazone (Actos), repaglinide (Prandin), and rosiglitazone (Avandia)

If you are not sure if your child's medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your child's medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes. Be sure that you tell all healthcare providers who treat your child about all the products your child is taking.

How should I store this medicine?

Store this medicine in the refrigerator. Do not let it freeze. Protect it from direct light. Use this medicine within 30 days after opening the vial. Discard any unused medicine after 30 days.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Keep all medicines out of the reach of children.

Do not share medicines with other people.