Iplex

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.

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

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.

Pediatric

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.

Geriatric

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.

Pregnancy

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.

Interactions with 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.

Interactions with Food/Tobacco/Alcohol

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 (e.g., growth centers in the bones show no more growth potential) or
• Neoplasia, active or suspected (e.g., cancerous or noncancerous tumor)—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.

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) 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; 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.

This medicine contains benzyl alcohol which may cause serious reactions (e.g., 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.

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:

• 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

• Change in the ability to see colors, especially blue or yellow
• cough
• difficult or labored breathing
• difficulty with swallowing
• hives or welts
• itching
• 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
• shortness of breath
• skin rash
• tightness in the chest
• vomiting
• wheezing

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

• 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:

• 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.

Applies to mecasermin: subcutaneous solution

Along with its needed effects, mecasermin 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 while taking mecasermin:

• 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

• Change in the ability to see colors, especially blue or yellow
• cough
• difficult or labored breathing
• difficulty with swallowing
• hives or welts
• itching
• 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
• shortness of breath
• skin rash
• tightness in the chest
• vomiting
• wheezing

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

• 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 of mecasermin 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:

• 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

Initial dose: 0.4 to 0.8 mg/kg subcutaneously 2 times a day for at least 7 days

Maximum dose: 0.12 mg/kg subcutaneously 2 times a day

Comments:
-Not a substitute to growth hormone (GH) for approved GH indications.

Uses: Treatment of growth failure in children with severe primary IGF-1 deficiency or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to GH.

Data not available

Safety and efficacy have not been established in patients younger than 2 years or older than 64 years.

Consult WARNINGS section for additional precautions.

Data not available