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Increlex

Generic Name: mecasermin (me-KA-ser-min)
Brand Name: Increlex

Increlex is used for:

Treating growth failure in children with severe primary IGF-1 deficiency 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 known or suspected cancer
  • the patient is a child who has epiphyseal closure (bone growth is complete)

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
  • if you have growth hormone deficiency, poor nutrition, low thyroid function, curvature of the spine (scoliosis), or a certain eye problem called papilledema (swelling of the area around your optic nerve)
  • if you have a history of cancer
  • if you have been taking corticosteroids (eg, prednisone)

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 is usually given as an injection at your doctor's office, hospital, or clinic. If you will be using Increlex at home, a health care provider will teach you how to use it. Be sure you understand how to use Increlex. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
  • Increlex should be given about 20 minutes before or after a meal or snack because it could lower your blood sugar level. If you are unable to eat shortly before or after a dose for any reason, skip your dose and go back to your regular dosing schedule.
  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into muscle or a vein.
  • Injection sites should be rotated to a different site (eg, upper arm, thigh, buttock, stomach) with each injection.
  • Do not use Increlex if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
  • 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 1 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 dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Increlex with caution. Do not drive or perform other possibly unsafe tasks within 2 to 3 hours after receiving Increlex, especially at the beginning of treatment, until you know how you react to it.
  • Increlex may lower your blood sugar levels. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. If severe low blood sugar levels occur despite adequate food intake, the dose of Increlex may need to be lowered by your doctor. Tell your doctor right away if you experience any symptoms of low blood sugar levels.
  • Do not use more than the recommended dose or more often than prescribed without checking with your doctor.
  • Rarely, children using Increlex have experienced a slipped growth plate in the hip. Contact your doctor right away if the patient develops hip or knee pain or a limp.
  • Rarely, increased pressure in the head has been reported in patients using Increlex. The symptoms have gone away after treatment was stopped. Discuss any questions or concerns with your doctor. Contact your doctor right away if you develop symptoms such as vision changes or severe headache, nausea, or vomiting.
  • Lab tests, including blood sugar levels and eye exams, may be performed while you use Increlex. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Increlex has benzyl alcohol in it. Do not use it in NEWBORNS or INFANTS. It may cause serious and sometimes fatal side effects. If you have questions, check with your doctor or pharmacist.
  • Increlex should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
  • Caution is advised when using Increlex in SMALL CHILDREN; they may be more sensitive to low blood sugar levels because of irregular eating habits.
  • PREGNANCY and BREAST-FEEDING: It is not known if Increlex can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Increlex while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Increlex, check with your doctor. Discuss any possible 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 or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); ear pain or discharge; hearing problems; hip or knee pain; irregular heartbeat; joint pain; limp while walking; lumps or bruising at the injection site; pain in arms or legs; seizures; severe or persistent dizziness; severe or persistent headache, nausea, or vomiting; snoring or irregular breathing during sleep (sleep apnea); tonsil enlargement; vision changes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include symptoms of low blood sugar (eg, fast heartbeat, headache, chills, sweating, tremor, increased hunger, changes in vision, anxiety, weakness, dizziness, drowsiness, fainting).

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. Do not use Increlex past the expiration date on the product label. After using a vial for the first time, Increlex is good for 30 days when stored in the refrigerator. Discard any unused medicine 30 days after using a vial for the first time. 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Increlex or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Increlex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Increlex. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using Increlex.

Review Date: August 8, 2016

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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