Pronunciation:

me-ka-SER-min

Brand Names:

• Increlex
• Iplex

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Uses of This Medicine:

Mecasermin injection is a 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 or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of mecasermin injection in children younger than 2 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of mecasermin injection in the geriatric population. Safety and efficacy have not been established.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

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 healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

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

• Closed epiphyses (eg, growth centers in the bones show no more growth potential) or
• Neoplasia (eg, cancerous or noncancerous tumor), malignant or history of—Should not be used in patients with these conditions.

• Diabetes or
• Enlarged tonsils or
• Head injury or
• Scoliosis (abnormally curved spine), or history of—Use with caution. May make these conditions worse.

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

Proper Use of This Medicine:

Your doctor will prescribe your child's exact dose and tell you how often it should be given. This medicine is given as a shot under your child's skin. This medicine must not be injected into a vein or muscle.

Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If your child is using this medicine at home, your doctor will teach you or your child's caregiver on how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure 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 child's medicine, each time your child's prescription is filled.

This medicine must be taken 20 minutes before or 20 minutes after a snack or meal. Never let your child skip a meal once your child received this medicine.

Use a new needle and syringe each time you inject the medicine to your child.

It is important to follow any instructions from your doctor about the careful selection and rotation of injection sites (eg, upper arms, thighs, buttocks, or abdomen) on your body. This will help to prevent skin problems.

Do not use the medicine if it looks cloudy or has particles in it.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  • For treatment of growth failure caused by IGF-1 deficiency:
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.04 to 0.08 milligram (mg) per kg of body weight injected under the skin 2 times a day. Your doctor may increase the dose, if needed, up to maximum dose of 0.12 mg per kg of body weight 2 times a day.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may keep the opened vial in the refrigerator. Use it within 30 days after opening. Throw away any unused medicine after 30 days. Do not freeze the solution and protect it from direct heat and light.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using This Medicine:

Your doctor will need to check your child's progress at regular visits while your child is using this medicine. Be sure to keep all appointments.

Talk with your doctor if you notice or the child feels that this medicine is causing too much growth.

This medicine may cause hypoglycemia (low blood sugar). Symptoms include: 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, or 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.

Learn what to do if your child's blood sugar gets too low. Teach family members and friends what they can do to help if the child has low blood sugar.

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

This medicine may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if your child has a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after your child receive the medicine.

This medicine may enlarge your child's tonsils. Call your doctor right away if your child has swollen tonsils, snoring, trouble with breathing or swallowing, or fluid in the ear. Your doctor may want to check your child's tonsils regularly while using this medicine.

This medicine may cause a dislocation in the hip bone. Check with your doctor right away if your child has a limp or pain in the hip or knee.

Using this medicine may increase your child's risk of getting cancer. Talk to your child's doctor if you have concerns about this risk.

This medicine contains benzyl alcohol which may cause serious reactions (eg, gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.

Do not take other medicines unless thy have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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.

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

More common

Anxiety

bluish skin color of the fingertips

blurred vision

breathlessness

chest pain

chills

cold sweats

coma

confusion

cool, pale skin

depression

dizziness

fast heartbeat

headache

increased hunger

loss of hearing

nausea

nervousness

nightmares

rapid growth of normal cells of the thymus (no symptoms)

seizures

shakiness

slurred speech

thickening of the skin

unusual tiredness or weakness

Incidence not known

Change in the ability to see colors, especially blue or yellow

cough

difficult or labored breathing

difficulty with swallowing

hives or welts, itching, or skin rash

itching or hives at the injection site

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

limp

pain in the hip or knee

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness of the skin

tightness in the chest

vomiting

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Anxiety

arm or leg pain

backache

changes in vision

excessive sweating

extreme weakness

frequent urination

increase in hands and feet size

increased thirst

increased volume of pale, diluted urine

joint pain

stop in menstruation

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Abnormal response of the tympanic membrane to air pressure

difficulty with moving

difficulty with swallowing

ear pain

earache

large, flat, blue or purplish patches in the skin

muffled hearing

muscle pain or stiffness

redness or swelling in the ear

sense of fullness in the ear

snoring

sore throat

voice changing

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.