Mecasermin rinfabate injection

What is Mecasermin rinfabate injection?

MECASERMIN RINFABATE (IPLEX™) is a man-made hormone used to increase growth in children who are short for their age because their bodies do not make enough IGF-1.

What should my health care professional know before I receive Mecasermin rinfabate?

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

• any type of cancer

• diabetes or changes in your blood sugar

• sleep apnea or loud snoring

• scoliosis

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

• pregnant or trying to get pregnant

• breast-feeding

How should this medicine be used?

This medicine is given as an injection under the skin. Use as directed on the prescription label. Never inject this medicine into a vein or muscle. You will be taught how to inject it. Only use this medicine if you understand all instructions.

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.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. This medicine has been used in children as young as 3 years old.

What if I miss a dose?

If you forget or do not give a dose, then skip that dose. Give the regular dose the next day at the regular time. Do not give double or extra doses.

What drug(s) may interact with Mecasermin rinfabate?

• corticosteroids like prednisone, dexamethasone, methylprednisolone

• growth hormone

• medicines for attention deficit disorder (ADHD), (examples: dextroamphetamine or methylphenidate)

• medicines for diabetes

• medicines for narcolepsy

• medicines for thyroid disease

• octreotide

Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What should I watch for while taking Mecasermin rinfabate?

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.

Throw away all syringes and needles in a closed container to prevent accidental needle sticks.

What side effects may I notice from receiving Mecasermin rinfabate?

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

• difficulty breathing

• difficulty walking or knee or hip pain

• skin rash or itching

• trouble seeing

•Signs of low blood sugar (hypoglycemia): anxiety or nervousness, confusion, difficulty concentrating, hunger, pale skin, nausea, fatigue, sweating, headache, palpitations, numbness of the mouth, tingling in the fingers, tremors, muscle weakness, blurred vision, cold sensations, uncontrolled yawning, irritability, rapid heartbeat, shallow breathing, and loss of consciousness. You should learn to recognize your own symptoms of hypoglycemia. Your symptoms may be different than others. If you are uncertain about your symptoms of hypoglycemia, check your blood sugar often to help you learn to recognize the symptoms. Hypoglycemia may cause you to not be aware of your actions or surroundings if it is severe, so you should let others know what to do if you cannot help yourself in a severe reaction. Your health care professional or prescriber will teach you how to treat hypoglycemia.

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

• bone or muscle pain

• change in hair growth or look of the face

• lumps under the skin near where you inject the medicine

• pain or swelling where you inject the medicine

• snoring or trouble sleeping

Where can 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 —4 degrees F or colder. Once the medicine thaws, use it within 1 hour. Throw away the vial if it has been out of the freezer for more than 2 hours. Do not use this medicine if it has been in your freezer for more than 2 months.