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USP DI Vol. II - MECASERMIN (Systemic)

MECASERMIN (Systemic)?


Some commonly used brand names are:

In the U.S.?

  • Increlex

? Not commercially available in Canada.


Category

  • Insulin-like growthfactor-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 childhoodgrowth. Mecasermin is used to replace IGF-1 in children who are severely lackingit in their bodies.

This medicine is available only with your doctor's prescription, in thefollowing 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 followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusualor allergic reaction to mecasermin or benzyl alcohol. Also tell your doctorand 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 defectsor other problems. Before taking this medicine, make sure your doctor knowsif you are pregnant or if you may become pregnant.

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

Children?Studies on this medicine have not been done inchildren 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 usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are taking any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of mecasermin. Make sure you tell your doctorif you have any other medical problems, especially:

  • Closed epiphyses (e.g., growth centers in the bones show no moregrowth potential)?Mecasermin should NOT be used in these patients.
  • Hypothyroidism (e.g., underactive thyroid) or
  • Nutrition deficiencies?These problems should be corrected beforestarting treatment with mecasermin.
  • Neoplasia, active or suspected (e.g., cancerous or noncancerous tumor)?Mecaserminshould 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 athome to patients who do not need to be in the hospital. If you are using thismedicine at home, your health care professional will teach you how to prepareand inject the medicine. You will have a chance to practice preparing andinjecting it. Be certain that you understand exactlyhow 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 snackor meal.

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

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

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

Put used needles and syringes in a puncture-resistantdisposable container or dispose of them as directed by your healthcare 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 unlessyour 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 (0.018to 0.036 mg per lb) under the skin two times a day. Your doctor may then increasethe dose, if necessary.

Missed dose?Call your doctor for instructions. Do not doubledoses.

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 yourhealth care professional how you should dispose of any medicine you do notuse. 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 thatyou 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; slurredspeech; unusual tiredness or weakness. It is important to have a source ofsugar such as orange juice, candy, soda, glucose gel, or milk, if these symptomsoccur.

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


Side Effects of This Medicine

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

    Check with your doctorimmediately if any of the following side effects occur:

      More common

        Anxiety; bluish skin color of fingertips; blurred vision; breathlessness; chest pain; chills; cold sweats; coma; confusion; cool pale skin; depression; dizziness; fast heartbeat; fatigue; headache; increased hunger; loss of hearing; nausea; nervousness; nightmares; rapid growth of normal cells of thymus (no symptoms); seizures; shakiness; slurredspeech; thickening of the skin; unusual tiredness or weakness

      Incidence not known

        Change in ability to see colors, especially blue or yellow; limp; pain in hip or knee; vomiting

      Symptoms of overdose

      Get emergency help immediately if any of the followingsymptoms of overdose occur

        Anxiety; backache; blurred vision; changes in vision; chills; cold sweats; coma; confusion; cool pale skin; depression; dizziness; excessive sweating; extremeweakness; fast heartbeat; frequent urination; headache; increase in hands and feet size; increased hunger; increased thirst; increasedvolume of pale diluted urine; joint pain; nausea; nervousness; nightmares; pain in extremities; seizures; shakiness; slurredspeech; stop in menstruation; unusual tiredness or weakness

    Other side effects may occur that usuallydo not need medical attention. These side effects may go away during treatmentas your body adjusts to the medicine. However, check with your doctor if anyof the following side effects continue or are bothersome.

      More common

        Abnormal response of tympanic membrane to air pressure; difficulty in moving; difficulty swallowing; dizziness; ear pain; earache; large, flat, blue or purplishpatches in the skin; muffled hearing; muscle pain or stiffness; pain in armsor legs; pain in joints; redness or swelling in ear; sense of fullness inthe ear; snoring; sore throat; voice changing

Other side effects not listed abovemay also occur in some patients. If you notice any other effects, check withyour doctor.


Developed: 03/24/2006