What is Increlex?

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.

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 you are using this medicine at home, your doctor will teach you 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 medicine, each time your 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 (e.g., 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.

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 (0.018 to 0.036 mg per lb) of body weight injected under the skin two times a day. Your doctor may then increase the dose, if needed.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

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.

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.

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:

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.

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.

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.

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.

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.

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.

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.