Increlex

Increlex is a prescription medication used to treat primary IGF-1 deficiency, a rare condition which causes children to be very short for their age because their bodies do not make enough IGF-1.

Increlex belongs to a group of drugs called growth hormone preparations. It works by replacing IGF-1, a protein in the body that plays an important role in childhood growth.

This medication comes in injectable form to be given directly under the skin (subcutaneously) twice daily.

Common side effects include injection site reactions (such as pain, redness, or bruising), low blood sugar, enlarged tonsils, and increased pressure in the brain.

Increlex is a prescription medication used to treat primary IGF-1 deficiency, a rare condition which causes children to be very short for their age because their bodies do not make enough IGF-1.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Ipsen Biopharmaceuticals, Inc.

Serious side effects have been reported with Increlex. See the "Increlex Precautions" section.

Common side effects of Increlex include the following:

• injection site reactions such as redness, pain, bruising, or increase or loss of fat in that area
• enlarged tonsils
• low blood sugar
• increased pressure in the brain

This is not a complete list of Increlex side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

No drug interactions have been studied by the manufacturer. However, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Serious side effects have been reported with Increlex including the following:

Hypoglycemia. Increlex can cause low blood sugar. Because of this, Increlex should only been given within 20 minutes of eating a snack or a meal. Do not give your child Increlex if he/she is sick or cannot eat. You will need to monitor your child's blood sugar while starting out on Increlex. High-risk activities such as driving should not be performed within 2 to 3 hours of taking Increlex, especially while Increlex treatment is just beginning. Talk to your doctor about treatments for low blood sugar and seek immediate medical attention if your child experiences any of the following signs or symptoms of low blood sugar:

• dizziness
• tiredness
• restlessness
• hunger
• irritability
• trouble concentrating
• sweating
• nausea
• fast or irregular heartbeat

Hypersensitivity and Allergic Reactions, including Anaphylaxis. Severe allergic reactions can occur with Increlex. Call your doctor immediately if your child develops any of the following signs or symptoms of an allergic reaction:

• hives (red itchy welts)
• trouble breathing or swallowing
• dizziness
• pale, clammy skin
• passing out
• swelling of the face, eyes, lips, tongue, arms, or legs

Intracranial Hypertension. Increlex can cause a temporary increase in the pressure in the brain. Tell your doctor if your child experiences a headache that won't go away, blurred vision, or nausea and vomiting.

Lymphoid Tissue Hypertrophy. Increlex can cause enlarged tonsils that can cause problems such as snoring, difficulty breathing or swallowing, sleep apnea (a condition where you briefly stop breathing while sleeping), or fluid in the middle ear.

Slipped Capital Femoral Epiphysis. Patients taking Increlex may develop a bone problem in which the femur (top of the upper leg) slips apart from the rest of the bone. Get immediate medical help if your child experiences hip or knee pain or develops a limp.

Progression of Preexisting Scoliosis. Increlex can worsen scoliosis in patients who experience rapid growth. If your child has a history of scoliosis, he/she should be monitored for progression of this condition.

Benzyl Alcohol. Increlex contains benzyl alcohol, which has been associated with severe side effects, especially in children. Your doctor should monitor the amount of benzyl alcohol your child receives from all sources.

Your child should not take Increlex if he/she:

• is allergic to Increlex or to any of its ingredients.
• has finished growing and the growth plates at the ends of the bones are closed
• has cancer

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Increlex, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Increlex, tell your child's doctor about all of your child's medical conditions. Especially tell your doctor if your child:

• has diabetes
• has kidney problems
• has liver problems
• has scoliosis (a condition where the spine is curved)
• is pregnant or breast-feeding

Tell your child's doctor about all the medicines your child takes including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Increlex falls into category C. There are no well-controlled studies that have been done in pregnant women. Increlex should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Increlex crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Increlex.

Take Increlex exactly as prescribed.

Increlex comes in an injectable form to be given directly under the skin (subcutaneously) twice daily.

This medication should be given within 20 minutes before or after a meal or snack.

Skip your child's dose if your child cannot eat for any reason. Give the next dose at the regularly scheduled time. Do not make up for the missed dose and give 2 doses at the same time.

Follow the directions given to you by your child's doctor for preparing and injecting Increlex.

To inject Increlex:

1. Wash your hands.
2. Use a new disposable needle and syringe for each dose.
3. Check the Increlex liquid to make sure it is clear and colorless. Do not use if the liquid is cloudy or has particles in it.
4. If using a new vial, remove the protective cap. Wipe the rubber stopper of the vial with an alcohol swab.
5. Pull back on the plunger of the syringe equal to the dose of Increlex you are injecting.
6. Put the needle through the rubber stopper of the vial and push the plunger to inject air into the vial.
7. Leaving the syringe in the vial, turn both upside down and pull the plunger back to withdraw the correct dose into the syringe.
8. Check the syringe for air bubbles. If air bubbles are present, tap the side of the syringe until the bubbles float to the top and then push them out with the plunger. Draw the liquid back into the syringe to make the correct dose. (Note: If using syringes that measure doses in units, the dose in mg will need to be converted to units by your physician.)
9. Remove the needle from the vial and select an appropriate injection site (upper arm, thigh, buttocks, or stomach). The injection site should be changed with each injection.
10. Use an alcohol swab or soap and water to clean the skin where you are going to inject. Let the skin dry.
11. Lightly pinch the skin and stick the needle in the way your child's doctor showed you.
12. Release the skin and slowly push in the plunger all the way.
13. Pull the needle straight out and gently press on the injection site with a cotton ball or gauze for a few seconds. Do not rub the area.
14. Follow your doctor's instructions on discarding the needle and syringe.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your child's doctor recommends may be based on the following:

• your child's weight
• your child's age
• how your child responds to this medication

The correct dose of Increlex to be given is different for each child and will be determined by your child's doctor. The recommended starting dose of Increlex is 40 to 80 mcg per kg of body weight given twice daily by subcutaneous injection. This dose may be increased each week, up to the maximum dose of 0.12 mg/kg twice daily.

If you take too much Increlex, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Increlex is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store new unopened vials of Increlex in the refrigerator.
• Once a vial of Increlex is opened, you may store it in the refrigerator for 30 days after you start using the vial.
• Do not freeze Increlex.
• Keep Increlex out of direct heat and bright light.
• Keep this and all medications out of the reach of children.