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All about: Increlex

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Generic Name: Mecasermin (mec-A-sir-men)
Brand Name: Increlex

Increlex is used for:

Long-term treatment of growth failure in children with severe primary IGF-1 deficiency (primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Increlex is a hormone. It works by producing effects that are identical to the body's naturally occurring insulin-like growth factor. It stimulates the growth of bones, cells, and internal organs.

Do NOT use Increlex if:

  • you are allergic to any ingredient in Increlex
  • you have an active or suspected tumor or your growth plates have closed, preventing further growth

Contact your doctor or health care provider right away if any of these apply to you.

Before using Increlex :

Some medical conditions may interact with Increlex . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Increlex . However, no specific interactions with Increlex are known at this time.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Increlex may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Increlex :

Use Increlex as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Increlex should be given 20 minutes before or after a meal or snack because it could lower your blood sugar level.
  • This meal should not be given without a meal or snack.
  • Increlex is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Increlex at home, carefully follow the injection procedures taught to you by your health care provider.
  • Injection sites should be rotated to a different site with each injection.
  • If Increlex contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.
  • If severe hypoglycemia (low blood sugar level) occurs despite adequate food intake, the dose of Increlex may need to be lowered. Be sure to know how to recognize the signs and symptoms of low blood sugar (eg, increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting). Report these symptoms to your doctor.
  • Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
  • The dose of Increlex should never be increased to make up for one or more missed doses.
  • If you miss a dose of Increlex , contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Increlex .

Important safety information:

  • Increlex may cause drowsiness, dizziness, blurred vision, or lightheadedness. Do not drive, operate machinery, or do anything else that could be dangerous within 2 to 3 hours after receiving Increlex , especially at the beginning of treatment, until you know how you react to Increlex . Using Increlex alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
  • Increlex contains benzyl alcohol as a preservative, which has been associated with toxicity in newborn infants.
  • Increlex is not recommended for use in CHILDREN younger than 2 years of age. Safety and effectiveness in this age group have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: It is unknown if Increlex can cause harm to the fetus. If you become pregnant while taking Increlex , discuss with your doctor the benefits and risks of using Increlex during pregnancy. It is unknown if Increlex is excreted in breast milk. If you are or will be breast- feeding while you are using Increlex , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Increlex :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in heart rhythm; convulsions; dizziness; ear pain or infections; enlarged glands in neck or chest; headache; hearing problems; increased pressure in the brain; joint pain; low blood sugar (changes in vision, chills, dizziness, drowsiness, fainting, headache, increased heartbeat, increased hunger, nervousness, sweating, tremor, weakness); lumps or bruising at the injection site; nausea; pain in arms or legs; sleep apnea; snoring; swelling in the eye; tonsil enlargement; vision changes; vomiting.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include low blood sugar (increased heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, nervousness, weakness, dizziness, drowsiness, fainting); excessive growth.

Proper storage of Increlex :

Store Increlex in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Protect from direct light. Opened vials are stable for 30 days when stored in the refrigerator. Discard unused medicine. Do not used after its expiration date. Store away from heat, moisture, and light. Keep Increlex out of the reach of children and away from pets.

General information:

  • If you have any questions about Increlex , please talk with your doctor, pharmacist, or other health care provider.
  • Increlex is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Increlex . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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