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IPLEX™ (mecasermin rinfabate [rdna origin] injection)
(“eye-plex”)
(mecasermin rinfabate [rDNA origin] injection)

Read the Patient Information leaflet that comes with IPLEX™ (mecasermin rinfabate [rdna origin] injection) before starting your child's IPLEX (mecasermin rinfabate [rdna origin] injection) 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 child's condition or treatment.

What is IPLEX (mecasermin rinfabate [rdna origin] injection) ?

IPLEX (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) should not be used in place of growth hormone. IPLEX (mecasermin rinfabate [rdna origin] injection) is not for other causes of growth failure.

IPLEX (mecasermin rinfabate [rdna origin] injection) is not for children less than 3 years old or adults with primary IGF-1 deficiency.

Who should not take IPLEX (mecasermin rinfabate [rdna origin] injection) ?

Your child should not take IPLEX (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) . Check with your child's doctor if you are not sure. See “What are the Ingredients in IPLEX (mecasermin rinfabate [rdna origin] injection) ?”

What should I tell my child's doctor before my child starts IPLEX (mecasermin rinfabate [rdna origin] injection) ?

Tell your child's doctor about all of your child's 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 child's doctor if your child takes insulin or other medicines for diabetes. A dose change may be needed for these medicines.

How should my child use IPLEX (mecasermin rinfabate [rdna origin] injection) ?

• IPLEX (mecasermin rinfabate [rdna origin] injection) 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 child's doctor or nurse should teach you how to inject IPLEX (mecasermin rinfabate [rdna origin] injection) . Do not give your child IPLEX (mecasermin rinfabate [rdna origin] injection) unless you understand all of the instructions.
• Use IPLEX (mecasermin rinfabate [rdna origin] injection) exactly as prescribed for your child. Your child's doctor will tell you how much IPLEX (mecasermin rinfabate [rdna origin] injection) you should give your child. The doctor may change the dose over time.
• Inject IPLEX (mecasermin rinfabate [rdna origin] injection) once a day before a meal at the same time every day, either in the morning or in the evening.
• Inject IPLEX (mecasermin rinfabate [rdna origin] injection) just below the skin in your child's upper leg (thigh), stomach area (abdomen), upper outer buttock, or upper arm. Change the injection site for each injection (“rotate the injection site”).
• Never inject IPLEX (mecasermin rinfabate [rdna origin] injection) into a vein.
• Skip your child's dose of IPLEX (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) .
• Only use IPLEX (mecasermin rinfabate [rdna origin] injection) if the liquid is clear, and either colorless or slightly yellow. Do not inject IPLEX (mecasermin rinfabate [rdna origin] injection) if the liquid is cloudy. Contact the national pharmacy who sent you your IPLEX (mecasermin rinfabate [rdna origin] injection) for instructions on how to return and obtain replacement of IPLEX (mecasermin rinfabate [rdna origin] injection) .

What are possible side effects of IPLEX (mecasermin rinfabate [rdna origin] injection) ?

IPLEX (mecasermin rinfabate [rdna origin] injection) may cause the following side effects, some of which can be serious.

• Low blood sugar (hypoglycemia). IPLEX (mecasermin rinfabate [rdna origin] injection) may lower your child's blood sugar levels the way insulin does. Do not give your child IPLEX (mecasermin rinfabate [rdna origin] injection) 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 your child's doctor has found the right dose for your child.
    
    Before beginning treatment with IPLEX (mecasermin rinfabate [rdna origin] injection) , your child's 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 child's 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 (mecasermin rinfabate [rdna origin] injection) 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 child's doctor will explain how to do this.
• Enlarged tonsils. IPLEX (mecasermin rinfabate [rdna origin] injection) may enlarge your child's 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 child's doctor if your child gets any of these symptoms. Your child's doctor should do regular exams to check your child's tonsils.
• Increased pressure in the brain (intracranial hypertension). Signs of increased pressure in the brain include headache, nausea, vomiting, and vision problems. Call your child's doctor if your child has these symptoms. Your child's doctor can check to see if increased pressure in the brain is present. If your child has increased pressure in the brain, your child's doctor may reduce or stop IPLEX (mecasermin rinfabate [rdna origin] injection) treatment for a time. IPLEX (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) . Call your child's 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 (mecasermin rinfabate [rdna origin] injection) 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 possible side effects of IPLEX (mecasermin rinfabate [rdna origin] injection) . Ask your child's doctor or pharmacist for more information.

How should I store IPLEX (mecasermin rinfabate [rdna origin] injection) ?

• IPLEX (mecasermin rinfabate [rdna origin] injection) should be kept frozen at all times until you are ready to use it.
• IPLEX (mecasermin rinfabate [rdna origin] injection) will be shipped by a national pharmacy. The pharmacy will use a national overnight shipping service and deliver IPLEX (mecasermin rinfabate [rdna origin] injection) directly to you or to your doctor's office. During shipment of IPLEX (mecasermin rinfabate [rdna origin] injection) to you or your child's doctor, it will be frozen.
• Store IPLEX (mecasermin rinfabate [rdna origin] injection) in your home freezer at -15. 5°C to -1. 5°C (4.1°F to 29.3°F ) for no more than 5 months. Do not use IPLEX (mecasermin rinfabate [rdna origin] injection) that has been stored in your freezer for longer than 5 months.
• Use IPLEX (mecasermin rinfabate [rdna origin] injection) within 12 hours after the vial has been removed from the freezer.
• If you do not use IPLEX (mecasermin rinfabate [rdna origin] injection) within 12 hours after you have removed it from the freezer, discard the vial because it may not work.
• When a freezer is unavailable, a dose of IPLEX (mecasermin rinfabate [rdna origin] injection) (stored for up to 3 months in a home freezer) can be stored at refrigerator temperature for up to 5 days. Use IPLEX (mecasermin rinfabate [rdna origin] injection) within 2 hours after the vial is removed from the refrigerator.
• Keep IPLEX (mecasermin rinfabate [rdna origin] injection) and all medicines out of reach of children.

General information about IPLEX (mecasermin rinfabate [rdna origin] injection)

Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not give IPLEX (mecasermin rinfabate [rdna origin] injection) to your child for a condition for which it was not prescribed. Do not give your child more IPLEX (mecasermin rinfabate [rdna origin] injection) than your doctor prescribed. Do not give IPLEX (mecasermin rinfabate [rdna origin] injection) to another person besides your child. It may harm them.

This leaflet summarizes the most important information about IPLEX (mecasermin rinfabate [rdna origin] injection) . If you would like more information, talk to your child's doctor. You can also ask your child's doctor or pharmacist for information that is written for health professionals. More information about IPLEX (mecasermin rinfabate [rdna origin] injection) is available by contacting Insmed Incorporated.

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

What are the Ingredients in IPLEX (mecasermin rinfabate [rdna origin] injection) ?

Active ingredient: mecasermin rinfabate

Inactive ingredients: sodium acetate, sodium chloride

INSTRUCTIONS FOR USE

IPLEX (mecasermin rinfabate [rdna origin] injection) 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.

Preparing IPLEX (mecasermin rinfabate [rdna origin] injection) for use:

1. When you are ready to use IPLEX (mecasermin rinfabate [rdna origin] injection) , take it out of the freezer and thaw by warming the vial in your hand for approximately 2 minutes.
2. Use IPLEX (mecasermin rinfabate [rdna origin] injection) within 12 hours after the vial is removed from the freezer.
3. When the vial of IPLEX (mecasermin rinfabate [rdna origin] injection) is at room temperature, swirl the vial in a gentle, circular motion to help mix it.
   Do not shake the vial.
4. Make sure IPLEX (mecasermin rinfabate [rdna origin] injection) is at room temperature when you give the injection.

Preparing the dose:

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 (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) for instructions on how to return and obtain replacement of IPLEX (mecasermin rinfabate [rdna origin] injection) .

3. Remove the protective cap from the top of the vial. Do not touch the rubber vial stopper. The stopper is clean. If the stopper is touched by anything, you must clean it with an antiseptic or alcohol swab before use.

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

5. Pull out the plunger on the syringe to draw air into the syringe up to the line that matches the prescribed dose of IPLEX (mecasermin rinfabate [rdna origin] injection) . Put the needle through the rubber top of the vial and push the plunger of the syringe to inject air into the vial.

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

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

8. Make sure the tip of the needle is in the IPLEX (mecasermin rinfabate [rdna origin] injection) liquid.

9. With your free hand, pull the plunger back to get the prescribed dose of IPLEX (mecasermin rinfabate [rdna origin] injection) into the syringe.

10. 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 (mecasermin rinfabate [rdna origin] injection) back in until you have the right amount.

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

12. Recap the needle as directed by your child's doctor to help prevent accidental injury while preparing the site for injection.

13. You are ready now to inject.

Injecting IPLEX (mecasermin rinfabate [rdna origin] injection) :

1. Choose a place on your child's body for the injection. Do not inject IPLEX (mecasermin rinfabate [rdna origin] injection) into skin areas that are tender, black and blue (bruised), red, hard, or have an increase in fat. Inject IPLEX (mecasermin rinfabate [rdna origin] injection) just below the skin on your child's stomach area (abdomen), upper outer buttock, upper leg (thigh), or upper arm. Never inject IPLEX (mecasermin rinfabate [rdna origin] injection) 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 child's 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 (mecasermin rinfabate [rdna origin] injection) 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 (mecasermin rinfabate [rdna origin] injection) .

Last reviewed on RxList: 3/2/2009
This monograph has been modified to include the generic and brand name in many instances.