Mecasermin (Injection)

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your child's exact dose and tell you how often it should be given. This medicine is given as a shot under your child's skin. This medicine must not be injected into a vein or muscle.
• You may be taught how to give this medicine at home. Make sure you understand all instructions before giving your child an injection. Do not give more medicine or give it to the child more often than your doctor tells you to.
• Use a new needle and syringe each time you inject the medicine to your child.
• You will be shown the body areas where this shot can be given. Use a different body area each time you give the child a shot. Keep track of where you give each shot to make sure you rotate body areas.
• Do not use the medicine if it looks cloudy or has particles in it.
• It is best to give this medicine within 20 minutes before or after eating a meal or snack. Never let your child skip a meal once your child received this medicine.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to give the medicine, give it as soon as you can. If it is almost time for the next dose, wait until then to give the medicine and skip the missed dose. Do not give the child extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• If you store this medicine at home, keep it in the refrigerator. Do not freeze.You may keep the opened vial in the refrigerator. Use it within 30 days after opening. Throw away any unused medicine after 30 days. Do not freeze the solution and protect it from direct heat and light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine, containers, and other supplies. You will also need to throw away old medicine after the expiration date has passed.
• Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows about all other medicines your child is using. Tell your doctor if your child is also using insulin or other diabetes medicines.

Warnings While Using This Medicine

• Make sure your doctor knows if your child is pregnant or breastfeeding, or if your child has kidney disease, liver disease, diabetes, enlarged tonsils, head injury, or a curved spine (scoliosis).
• Talk with your doctor if you notice or the child feels that this medicine is causing too much growth.
• This medicine may lower blood sugar levels like insulin. If your child's blood sugar gets too low, the child may feel weak, drowsy, confused, anxious, or very hungry. The child may also sweat, shake, or have blurred vision, a fast heartbeat, or a headache that will not go away.
• If your child has symptoms of low blood sugar (hypoglycemia), check the blood sugar. If your child's blood sugar is 70 mg/dL (milligrams per deciliter) or below, do one of the following: Let the child drink 4 ounces (one-half cup) of fruit juice, or eat 5 to 6 pieces of hard candy, or take 2 to 3 glucose tablets. Re-check the blood sugar 15 minutes later. If your child's blood sugar is above 70 mg/dL, let the child eat a snack or a meal. If the blood sugar is still below 70 mg/dL, let the child drink one-half cup juice, or eat 5 to 6 pieces of candy, or take 2 to 3 glucose tablets.
• Make sure that your child carries candy or some type of sugar at all times, especially if the child is away from home. Your child can take this if the child feels that the blood sugar is too low, even if the child does not have a blood glucose meter. Always carefully follow the doctor's instructions about how to treat low blood sugar.
• Learn what to do if your child's blood sugar gets too low. Teach family members and friends what they can do to help if the child has low blood sugar.
• You should avoid participating in high risk activities, such as driving, within 2 to 3 hours after receiving the medicine, especially at the beginning of mecasermin treatment.
• This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if your child has a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after your child receive the medicine.
• This medicine may enlarge your child's tonsils. Call your doctor right away if your child has swollen tonsils, snoring, trouble with breathing or swallowing, or fluid in the ear. Your doctor may want to check your child's tonsils regularly while using this medicine.
• This medicine may cause a dislocation in the hip bone. Check with your doctor right away if your child has a limp or pain in the hip or knee.
• This medicine contains benzyl alcohol which may cause serious reactions (such as gasping syndrome) for a newborn or premature baby. Discuss this with your doctor if you are concerned.
• Your doctor will need to check your child's progress at regular visits while your child is using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dizziness, drowsiness, or trouble concentrating.
• Ear pain, swelling, discharge, or other signs of ear infection.
• Fast, pounding, or uneven heartbeat.
• Limping, joint pain, or pain in the hip or knee.
• Seizures.
• Severe headache or pain behind the eyes, vision problems, nausea, or vomiting.
• Shakiness, cold sweats, or increased hunger.
• Shortness of breath or wheezing.
• Swollen tonsils, snoring, trouble breathing or swallowing.
• Tiredness, weakness, restlessness, or irritability.

If you notice these less serious side effects, talk with your doctor:

• Pain, redness, or bruising where the shot was given.
• Skin changes such as increased or decreased body fat where the shot was given.
• Thickening of the skin on your child's face.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Introduction

Mecasermin (me-ka-SER-min)

Treats growth delay in children who lack insulin-like growth factor-1 (IGF-1) in their bodies.

Brand Name(s)

Increlex