Mecasermin Injection

WHY is this medicine prescribed?

Mecasermin injection is used to replace insulin-like growth factor (a natural hormone produced by your body) in children 2 years of age or older whose bodies do not make enough of this hormone and who are short for their age. Mecasermin is a human insulin-like growth factor (hIGF) analog. It works by replacing a hormone that promotes normal growth of bones and tissues.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Mecasermin comes as a solution (liquid) in a vial to inject subcutaneously (under the skin). It is usually injected twice a day at around the same time of day. Mecasermin must be injected within 20 minutes before a meal or 20 minutes after a meal. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use mecasermin injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You may receive your first dose of mecasermin injection in your doctor's office or your doctor may allow you or a caregiver to perform the injections at home. Before you use mecasermin injection for the first time, you or the person who will be giving the injections should read the manufacturer's information for the patient that comes with it. These instructions describe how to inject a dose of mecasermin. Be sure that you understand these directions.Ask your healthcare provider if you have any questions about how to inject the medication or how to dispose of used needles and syringes after you inject the medication.

Your doctor will probably start you on a low dose of mecasermin and may gradually increase your dose after at least 1 week.

You can inject mecasermin anywhere on your upper arms, front of your thighs (upper leg), buttocks, or on your stomach. Choose a different spot each time you inject your medication.

Always look at mecasermin solution before injecting it. Check that the expiration date has not passed and that the liquid is clear and colorless. The liquid should not contain visible particles. Do not use if it is expired or if the liquid is cloudy or contains particles.

Do not reuse or share needles. Dispose of used needles in a puncture-resistant container that is out of the reach of children. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before using mecasermin injection,

• tell your doctor and pharmacist if you are allergic to mecasermin, any other medications, or any of the ingredients in mecasermin injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: insulin and oral medications for diabetes. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have or ever have had cancer. Your doctor will probably tell you not to use mecasermin injection. Mecasermin should not be used in children whose growth plate has closed and whose bones are no longer growing (usually after puberty).

• tell your doctor if you have or have ever had diabetes, sleep apnea (stops breathing for short periods of time during sleep), papilledema (swelling of the optic nerve caused by increased pressure in the brain), or scoliosis (curving of the spine).

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using mecasermin injection, call your doctor.

• mecasermin injection can cause hypoglycemia (low blood sugar), especially when you first start your treatment with mecasermin injection. Never use mecasermin injection if you or your child has symptoms of hypoglycemia, including dizziness, tiredness, restlessness, hunger, sweating, difficulty concentrating, nausea, or irregular heartbeat, or if you have checked your blood sugar and found it to be low. Be sure to ask your doctor or pharmacist if you have any questions about what you should do if you or your child has hypoglycemia.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Mecasermin must be injected shortly before or after a meal. If you remember your dose within 20 minutes after your meal, inject the missed dose right away. If more than 20 minutes has passed since your meal, skip the missed dose and continue your regular dosing schedule. Do not inject a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Mecasermin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• injection site pain, redness, bruising, and itching
• snoring
• excessive daytime sleepiness
• ear pain
• sore throat
• headache
• vomiting
• dizziness
• joint pain, pain in arms or legs

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• vision changes, headache, nausea, and vomiting
• hives; rash; itching; difficulty breathing or swallowing; sweating; swelling of the eyes, face, mouth, lips, tongue or throat; hoarseness; lightheadedness; fainting; or chest pain
• limping or persistent knee or hip pain
• loss of consciousness
• seizures

Mecasermin injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in to protect from light, tightly closed, and out of reach of children. Store it in the refrigerator, but do not freeze.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• dizziness, tiredness, restlessness, hunger, sweating, difficulty concentrating, nausea, or fast or irregular heartbeat
• loss of consciousness

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to mecasermin injection.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.