Mecasermin (rDNA origin), Injection meh-KAH-sir-men

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. It 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?

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.

Your healthcare provider will determine the exact dosage. Check the label on the medicine for directions about your specific dose. Talk with your provider for specific instructions on the best times to give the injections.

Be sure you know how and when to have shots and how much medicine to use. Use sterile, disposable syringes and needles. Use each syringe and needle only once and dispose of them safely, following your healthcare provider's instructions.

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

Carefully read and follow the directions that come in the package of medicine. Wash your hands before using this medicine. Follow these steps to give the shots:

1. Your healthcare provider will tell you where you can give the shots (abdomen, thigh, upper arm, or other sites). If you are giving the shot in the abdomen, choose a site around the belly button but not in the belly button. Each day, choose a different spot for the shot to lessen irritation. Make sure it is at least 1 inch from the previous injection. Avoid areas that are tender, bruised, red, or hardened.
2. Use an alcohol swab to clean the skin where you will give the shot.
3. Gently pinch up the skin and insert the needle into the skin at a 45° angle. After you insert the needle completely, release your grasp of the skin.
4. Inject all of the solution by gently and steadily pushing down the plunger.
5. After you have given the shot, withdraw the needle and syringe and press an alcohol swab on the spot where the shot was given.
6. Discard the syringe, needle, and drug vial. Use the syringes and needles ONLY ONCE. Throw them away after use. 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.

If you are not sure of how to give the shots, ask your healthcare provider or pharmacist for help.

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?

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

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

Low blood sugar (hypoglycemia) can occur if you miss or delay meals while taking this medicine. Symptoms of low blood sugar include confusion, shaking, weakness, strong hunger, cold sweats, headache, nausea, vision problems, and feeling faint. 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.

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 (confusion, shaking, weakness, strong hunger, cold sweats, severe headache, nausea, fast heartbeat, vision problems, and feeling faint), hip or knee pain, limping, seizures, blood in urine, increased thirst, increased urination, irregular heartbeat, ear pain, decreased hearing, fever.

Other: Headache, dizziness, muscle pain, pain or swelling at the injection site, snoring, swollen tonsils, vomiting.

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:

• corticosteroids such as betamethasone (Celestone), cortisone, dexamethasone, fludrocortisone (Florinef), hydrocortisone (Cortef, Hydrocortone, A-HydroCort), methylprednisolone (Medrol), prednisone, prednisolone, and triamcinolone (Aristospan, Kenalog)
• diabetes medicines such as insulin, glipizide (Glucotrol), glyburide (DiaBeta), metformin (Glucophage), 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. Use this medicine within 30 days after opening the vial. Protect it from direct light.

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.