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|Increlex

MECASERMIN (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Increlex

† Not commercially available in Canada.

Category

• Insulin-like growth factor-1 replenisher

Description

Mecasermin (mek-a-SER-min) is a synthetic (man-made) version of insulin-like growth factor-1 (IGF-1) hormone. IGF-1 is produced in the liver and plays an important role in childhood growth. Mecasermin is used to replace IGF-1 in children who are severely lacking it in their bodies.

This medicine is available only with your doctor"s prescription, in the following dosage forms:

• Parenteral
• Injection (U.S.)

Before Using This Medicine

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mecasermin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to mecasermin or benzyl alcohol. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Mecasermin has not been studied in pregnant women. However, in animal studies, mecasermin has not been shown to cause birth defects or other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether mecasermin passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their doctor.

Children—Studies on this medicine have not been done in children under 2 years of age.

Older adults—This medicine is not used in adults or older adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other medical problems—The presence of other medical problems may affect the use of mecasermin. Make sure you tell your doctor if you have any other medical problems, especially:

• Closed epiphyses (e.g., growth centers in the bones show no more growth potential)—Mecasermin should NOT be used in these patients.

• Hypothyroidism (e.g., underactive thyroid) or
• Nutrition deficiencies—These problems should be corrected before starting treatment with mecasermin.

• Neoplasia, active or suspected (e.g., cancerous or noncancerous tumor)—Mecasermin should NOT be used. It should be discontinued if signs of neoplasia occur.

Proper Use of This Medicine

Dosing—Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using this medicine at home, your health care professional will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be certain that you understand exactly how the medicine is to be prepared and injected .

It is important to read the patient information and instructions for use, if provided with your medicine, each time your prescription is filled.

This medicine must be taken 20 minutes before or 20 minutes after a snack or meal.

If a meal or snack is not given, then the dose should not be given.

It is important to follow any instructions from your doctor about the careful selection and rotation of injection sites on your body . This will help to prevent skin problems.

This medicine should NEVER be injected into a vein or muscle. It should always be injected under the skin.

Put used needles and syringes in a puncture-resistant disposable container or dispose of them as directed by your health care professional. Do not reuse needles and syringes .

The dose of these medicines will be different for different patients. Follow your doctor"s orders or the directions on the label . The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

• For injection
  • For treatment of growth failure caused by IGF-1 deficiency:
    • Children—At first, 0.04 to 0.08 milligrams (mg) per kg (0.018 to 0.036 mg per lb) under the skin two times a day. Your doctor may then increase the dose, if necessary.

Missed dose—Call your doctor for instructions. Do not double doses.

Storage—To store this medicine:

• Keep out of the reach of children.
• Store in the refrigerator. However, keep the medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check you at regular visits .

This medicine may cause low blood sugar with the following symptoms that you should be aware of: anxiety; blurred vision; chills; cold sweats; coma; confusion; cool pale skin; depression; dizziness; fast heartbeat; headache; increased hunger; nausea; nervousness; nightmares; seizures; shakiness; slurred speech; unusual tiredness or weakness. It is important to have a source of sugar such as orange juice, candy, soda, glucose gel, or milk, if these symptoms occur.

You should avoid participating in high risk activities such as driving within 2 to 3 hours after your mecasermin injection, especially at the beginning of mecasermin treatment.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 03/24/2006

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