Mecasermin rinfabate (E. coli) Solution for injection

What is this medicine?

MECASERMIN RINFABATE is a man-made hormone. It is used to treat children who are short for their age because their bodies do not make enough IGF-1.

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 or changes in blood sugar
• sleep apnea or loud snoring
• scoliosis
• an unusual or allergic reaction to mecasermin, 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. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Try to use this medicine at about the same time every day. Use it shortly before a meal. If your child cannot or will not eat, then do not give that day's dose. It is important that your child eat well and not skip meals.

Look at the medicine before using it. It should be clear and colorless or a little yellow. Do not use the medicine if it is cloudy or has solid pieces in it.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

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 drug 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, skip that dose. Take the regular dose the next day at the regular time. Do not take double or extra doses.

What may interact with this medicine?

• growth hormone
• medicines for diabetes
• medicines for thyroid disease
• octreotide
• steroid medicines like prednisone or cortisone
• stimulant medicines for attention disorders, weight loss, or to stay awake

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 the doctor for regular check on the child's progress. The doctor may order blood work. Tell the doctor if your child has any unusual effects from 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
• hip or knee pain
• low blood sugar (ask your doctor or healthcare professional for a list of these symptoms)
• problems walking

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

• aches, pains
• change in hair growth or look of the face
• lumps under the skin at site where injected
• pain or swelling at site where injected
• snoring or trouble sleeping

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.

This medicine will be shipped frozen to you or to your doctor's office. It should be kept frozen at all times until you are ready to use it. Store it in your freezer at -20 degrees C or lower (-4 degrees F or colder). Once the medicine thaws, use it within 1 hour. Throw away the vial if it has been thawed for more than 2 hours. Do not use this medicine if it has been in your freezer for more than 2 months.

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.