IPLEX^Ã? ("eye-plex")

(mecasermin rinfabate [rDNA origin] injection)

Read the Patient Information leaflet that comes with IPLEX^Ã? before starting your childs IPLEX^Ã? and each time you get a refill. There may be new information. This information does not take the place of talking to your child's doctor about your childs condition or treatment.

IPLEX^Ã? is an injectable medicine that contains man-made insulin-like growth factor-1 (IGF-1) and insulin-like growth factor binding protein-3 (IGFBP-3). IPLEX^Ã? is used to treat children with severe primary IGF-1 deficiency. Children with severe primary IGF-1 deficiency are very short for their age because their bodies do not make enough IGF-1.

IPLEX^Ã? should not be used in place of growth hormone. IPLEX^Ã? is not for other causes of growth failure.

IPLEX^Ã? is not for children less than 3 years old or adults with primary IGF-1 deficiency.

Your child should not take IPLEX^Ã? if your child:

· has finished growing (bone growth plates are closed)

· has cancer

· is allergic to mecasermin rinfabate or any of the inactive ingredients in IPLEX^�. Check with your childs doctor if you are not sure. See "What are the Ingredients in IPLEX^�?"

· Never inject IPLEX^� into a vein.

Tell your childs doctor about all of your childs health conditions, including if your child:

· has diabetes

· has kidney problems

· has liver problems

· has a curved spine (scoliosis)

· is pregnant or breastfeeding

Tell your doctor about all the medicines your child takes, including prescription and nonprescription medicines, vitamins, and herbal supplements. It is especially important to tell your childs doctor if your child takes insulin or other medicines for diabetes. A dose change may be needed for these medicines.

· IPLEX^� is given as an injection under the skin. See the "Instructions for Use" at the end of this leaflet for step-by-step directions. Your childs doctor or nurse should teach you how to inject IPLEX^�. Do not give your child IPLEX^� unless you understand all of the instructions.

· Use IPLEX^� exactly as prescribed for your child. Your child's doctor will tell you how much IPLEX^� you should give your child. The doctor may change the dose over time.

· Inject IPLEX^� once a day before a meal at the same time every day, either in the morning or in the evening.

· Inject IPLEX^� just below the skin in your childs upper leg (thigh), stomach area (abdomen), buttocks, or upper arm. Change the injection site for each injection ("rotate the injection site").

· Never inject IPLEX^� into a vein.

· Skip your childs dose of IPLEX^� if your child cannot or will not eat for any reason at the time of the injection. Do not make up the missed dose by giving two doses the next time. It is important that your child eat well and not skip meals while taking IPLEX^�.

· Only use IPLEX^� if the liquid is clear, and either colorless or slightly yellow. Do not inject IPLEX^� if the liquid is cloudy. Contact the national pharmacy who sent you your IPLEX^� for instructions on how to return and obtain replacement of IPLEX^�.

· Low blood sugar (hypoglycemia). IPLEX^� may lower your childs blood sugar levels the way insulin does. Do not give your child IPLEX^� if your child has signs of low blood sugar which include:

· dizziness

· headache

· tiredness

· restlessness

· hunger

· irritability

· trouble concentrating

· sweating

· nausea

· fast or irregular heartbeat

Severe low blood sugar may cause unconsciousness, convulsions, or death. Your child should not do risky activities until the doctor has found the right dose for your child.

Before beginning treatment with IPLEX^Ã?, your doctor or nurse will explain to you how to treat low blood sugar. Make sure your child always has a sugar drink or food with them such as orange juice, hard candy, milk, or glucose gel. These are used to treat symptoms of low blood sugar.

If your child is not alert and cannot drink or eat a sugar-drink or food, you must give an injection of glucagon. Glucagon raises the blood sugar when it is injected. Your childs doctor or nurse will instruct you how to give this injection. It is important that your child have a well-balanced diet including protein and fat such as meat and cheese in addition to sugar-containing foods. Do not give your child IPLEX if your child is sick and cannot eat.

Your child's doctor will tell you if and when you need to check your child's blood-sugar level. Your childs doctor will explain how to do this.

· Enlarged tonsils. IPLEX^� may enlarge your childs tonsils. Some signs of enlarged tonsils are snoring, problems breathing or swallowing, earaches, problems hearing, and breathing problems during sleep (sleep apnea, which can also cause excessive daytime sleepiness). Call your childs doctor if your child gets any of these symptoms. Your doctor should do regular exams to check your childs tonsils.

· Increased pressure in the brain (intracranial hypertension). Signs of increased pressure in the brain include headache, nausea, vomiting, and vision problems. Call your childs doctor if your child has these symptoms. Your doctor can check to see if increased pressure in the brain is present. If your child has increased pressure in the brain, your childs doctor may reduce or stop IPLEX^� treatment for a time. IPLEX^� treatment may be started again after the pressure is gone.

· A hip bone problem called slipped capital femoral epiphysis. This happens when the upper end of the leg bone (femur) slips apart. Get medical attention for your child right away if your child develops a limp, or has hip or knee pain.

· Worsened curve of the spine (scoliosis). If your child has scoliosis, your child will need to be checked regularly for an increase in the curve of the spine.

· Allergic reactions. Your child may have a mild or serious allergic reaction to IPLEX^�. Call your childs doctor right away if your child gets a rash or hives. Get medical help right away if your child has trouble breathing or goes into shock.

· IPLEX^� can cause reactions at the injection site including:

· redness

· pain

· increase of fat

· lumps under the skin

· slight hair growth

Injection site reactions can be avoided by changing the injection site at each injection ("injection site rotation").

Call your child's doctor if your child has side effects that bother them, or do not go away.

These are not all the side effects of IPLEX^Ã?. Ask your childs doctor or pharmacist for more information.

· IPLEX^� should be kept frozen at all times until you are ready to use it.

· IPLEX^� will be shipped by a national pharmacy. The pharmacy will use a national overnight shipping service and deliver IPLEX^� directly to you or to your doctors office. During the shipment of IPLEX^� to you or your doctor, it will be kept on dry ice so it stays frozen.

· Store IPLEX^Ã? in your freezer at -4° F (-20° C) or colder for no more than 2 months. Do not use IPLEX^Ã? that has been stored in your freezer for longer than 2 months.

· Do not store IPLEX^� in your home freezer if contents thaw during the defrost cycle. The medicine may not work.

· Once IPLEX^� thaws, use it within 1 hour.

· Do not use IPLEX^� if it thaws and stays at room temperature for longer than 1 hour. The medicine may not work.

· If you do not use IPLEX^� within 2 hours after you have removed it from the freezer, discard the vial because it may not work.

· Keep IPLEX^� and all medicines out of reach of children.

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not give IPLEX^Ã? to your child for a condition for which it was not prescribed. Do not give your child more IPLEX^Ã? than your doctor prescribed. Do not give IPLEX^Ã? to another person besides your child. It may harm them.

This leaflet summarizes the most important information about IPLEX^Ã?. If you would like more information, talk to your childs doctor. You can also ask your childs doctor or pharmacist for information that is written for health professionals. More information about IPLEX^Ã? is available by contacting Insmed Incorporated.

Insmed Incorporated 4851
Lake Brook Drive
Glen Allen, VA 23058
804-565-3079
www.insmed.com

Active ingredient: mecasermin rinfabate

Inactive ingredients: sodium acetate, sodium chloride

IPLEX^Ã? should be administered using sterile disposable syringes and needles. The syringes should be of small enough volume that the prescribed dose can be withdrawn from the vial with reasonable accuracy.

1. When you are ready to use IPLEX^Ã?, take it out of the freezer and thaw it at room temperature for 45 minutes.

2. Once IPLEX^Ã? reaches room temperature, use it within 1 hour.

3. Swirl the vial of IPLEX^Ã? in a gentle, circular motion to help mix it.

Do not shake the vial.

4. Make sure IPLEX^Ã? is at room temperature when you give the injection.

1. Wash your hands with soap and water or a rubbing alcohol-based gel or foam hand sanitizer product.

2. Check to make sure the IPLEX^Ã? in the vial is clear and colorless or slightly yellow. Do not use it if it's cloudy or the wrong color. Contact the national pharmacy who sent you your IPLEX^Ã? for instructions on how to return and obtain replacement of IPLEX^Ã?.

3. Remove the cap on top of the vial. Do not remove the rubber stopper.

4. Wipe the top of the vial with an alcohol swab.

5. Use a new needle and syringe each time you give an injection.

6. Pull out the plunger on the syringe to draw air into the syringe up to the line that matches the prescribed dose of IPLEX^Ã?. Put the needle through the rubber top of the vial and push the plunger of the syringe to inject air into the vial.

7. Leave the syringe in the vial and turn both upside down.

8. Hold the syringe and vial tightly in one hand.

9. Make sure the tip of the needle is in the IPLEX^Ã? liquid.

10. With your free hand, pull the plunger back to get the prescribed dose of IPLEX^Ã? into the syringe.

11. Before you take the needle out of the vial, check the syringe for air bubbles. If there are bubbles, hold the vial and syringe with the needle straight up and tap the side of the syringe until the bubbles float to the top. Push the bubbles out with the plunger and if necessary, draw IPLEX^Ã? back in until you have the right amount.

12. Take the needle out of the vial. Do not let the needle touch anything.

13. Recap the needle as directed by your doctor to help prevent accidental injury while preparing the site for injection.

14. You are ready now to inject.

1. Choose a place on your childs body for the injection. Do not inject IPLEX^Ã? into skin areas that are tender, black and blue (bruised), red, hard, or have an increase in fat. Inject IPLEX^Ã? just below the skin on your child's stomach area (abdomen), buttock, upper leg (thigh), or upper arm. Never inject IPLEX^Ã? into a vein. Always remember to choose a different site for each injection. You should give the new injection at least 1 inch from the old ones.

2. Use rubbing alcohol or soap and water to clean the skin where you are going to inject your child. The injection site should be dry before you inject.

3. Pinch the skin and stick the needle straight in the way your doctor or nurse showed you.

4. Release the skin.

5. Slowly push in the plunger of the syringe all the way. Make sure to inject all the IPLEX^Ã? in the syringe.

6. Leave the needle in the skin for about 10 seconds.

7. Pull the needle straight out and press very lightly on the place of the injection with a cotton ball for a few seconds.

8. Throw away the needle and syringe in the special container your healthcare provider told you to use. Do not put needles and syringes in the trash. Never reuse needles and syringes. Never share needles.

Always throw away any unused IPLEX^Ã?.

Bookmark this page: