Mecasermin Rinfabate Injection

What is this medicine?

MECASERMIN RINFABATE (ME ka SER min) 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. It is not used if the child has finished growing and his or her bone growth plates have closed.

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 your child cannot or will not eat. It is important that your child eat well and not skip meals. 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 or a little yellow. Do not use this medicine if it is cloudy, thickened, or has solid particles in it.

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.

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

• ear pain or discharge

• joint pain

• leg, hip or knee pain

• seizures

• signs and symptoms of low blood sugar such as feeling anxious; confusion; dizziness; increased hunger; unusually weak or tired; sweating; shakiness; cold; irritable; headache; blurred vision; fast heartbeat; loss of consciousness

• swelling of the tonsils, irregular breathing during sleep, or snoring

• symptoms of increased pressure in the head such as continued or severe headache; nausea; vomiting; changes in vision or eye pain

• walking with a limp

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

What may interact with this medicine?

• other growth hormones

• medicines for diabetes

• steroid medicines like prednisone or cortisone

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.

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.

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

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

• cancer

• diabetes

• kidney disease

• liver disease

• sleep apnea or loud snoring

• scoliosis

• thyroid disease

• an unusual or allergic reaction to mecasermin, other medicines, foods, dyes, or other preservatives

• pregnant or trying to get pregnant

• breast-feeding

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 sugar is very important when you start this medicine and whenever the dose is changed. 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.

Learn how to check your blood sugar. Learn the symptoms of low blood sugar and how to manage them. Always carry a quick-source of sugar with you in case you have symptoms of low blood sugar. Examples include orange juice, glucose gel, candy, or milk. Make sure others know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, such as seizures or unconsciousness. They must get medical help at once. If a child becomes unresponsive, you may need to administer an injection of glucagon. Make sure you understand how to do this before starting therapy with this medicine.