Mecasermin (E. Coli) Solution for injection

What is this medicine?

MECASERMIN is a man-made growth factor. It is used to increase growth in children who are short for their age. It is only for children whose bodies do not make enough growth factor.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• any type of cancer
• diabetes
• liver disease
• sleep apnea or loud snoring
• scoliosis
• underactive or overactive thyroid
• an unusual or allergic reaction to mecasermin, benzyl alcohol, other medicines, foods, dyes, or other preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is for injection under the skin. You will be taught how to prepare and give this medicine. The doses should be given about 20 minutes before or after a snack or a meal. Skip the dose if you can not eat for any reason. Do not take your medicine more often than directed. It is important to follow the directions given to you by your health care professional or doctor.

Always check the appearance of your medication before using it. It should be clear and colorless like water. Do not use this medicine if it is cloudy, thickened, colored, or has solid particles in it. Do not use any medicine that has been frozen or has been open for more than 30 days.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. While this medicine may be prescribed for children as young as 3 years of age for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, contact your doctor or health care professional for advice. Do not try to make up missed doses or use double or extra doses.

What may interact with this medicine?

• growth hormone
• medicines for attention deficit disorders like dextroamphetamine or methylphenidate
• medicines for diabetes
• medicines for narcolepsy
• steroid medicines like prednisone or cortisone

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress.

Dangerously low blood sugar can occur when this medicine is injected and no food is eaten within 20 minutes. Checking and recording your blood glucose is very important when you start this medicine and when your dose is changed. You should avoid participating in any high-risk activities like driving within 2 to 3 hours after a dose until a well-tolerated dose of this medicine has been established.

You should be aware of signs and symptoms of low blood sugar including: dizziness, tiredness, restlessness, hunger, irritability, trouble concentrating, sweating, nausea, or fast or irregular heartbeat. Always have a source a sugar such as orange juice, glucose gel, candy, or milk available in case symptoms of low blood sugar occur. In some cases severely low blood sugar may result in unconsciousness. If a child becomes unresponsive, and can not ingest a sugar source, you may need to administer an injection of glucagon. Make sure you understand how to do this before starting therapy with this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• changes in vision
• develop a limp
• difficulty swallowing
• ear infection
• leg, hip or knee pain
• nausea, vomiting
• seizures
• severe headache
• sleep apnea
• snoring

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• increase or decrease in fat under the skin near where injected
• muscle pain
• pain or swelling at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store in the refrigerator between 2 and 8 degrees C (35 and 46 degrees F). Do not freeze. Protect from light. Once opened, vials must be discarded after 30 days. Throw away any unopened medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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.