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Egrifta

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Egrifta

Egrifta

PATIENT INFORMATION

EGRIFTA
(eh-GRIF-tuh)
(tesamorelin for injection) for subcutaneous use

Read the Patient Information that comes with EGRIFTA™ before you start to take it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is EGRIFTA™?

  • EGRIFTA™ is an injectable prescription medicine to reduce the excess in abdominal fat in HIV-infected patients with lipodystrophy. EGRIFTA™ contains a growth hormone-releasing factor (GRF).
  • The impact and safety of EGRIFTA™ on cardiovascular health has not been studied.
  • EGRIFTA™ is not indicated for weight loss management.
  • It is not known whether taking EGRIFTA™ helps improve compliance with anti-retroviral medications.
  • It is not known if EGRIFTA™ is safe and effective in children. EGRIFTA™ is not recommended to be used in children.

Who should not use EGRIFTA™?

Do not use EGRIFTA™ if you:

  • have pituitary gland tumor, pituitary gland surgery or other problems related to your pituitary gland
  • have active cancer (either newly diagnosed or recurrent) or are receiving treatment for cancer
  • are allergic to tesamorelin or any of the ingredients in EGRIFTA™ . See the end of this leaflet for a complete list of ingredients in EGRIFTA™
  • are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA™ and talk with your healthcare provider. See "What should I tell my healthcare provider before using EGRIFTA™ ?".

What should I tell my healthcare provider before using EGRIFTA™?

Before using EGRIFTA™ , tell your healthcare provider if you:

  • have or have had cancer
  • have diabetes
  • are breastfeeding or plan to breastfeed. It is not known if EGRIFTA™ passes into your breast milk. The Centers for Disease Control and Prevention (CDC) recommends that HIV-infected mothers not breastfeed to avoid the risk of passing HIV infection to your baby. Talk with your healthcare provider about the best way to feed your baby if you are taking EGRIFTA™
  • have kidney or liver problems
  • have any other medical condition.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. EGRIFTA™ may affect the way other medicines work, and other medicines may affect how EGRIFTA™ works.

Know the medicines you take. Keep a list with you to show your healthcare provider and pharmacist when you get a new medicine.

How should I use EGRIFTA™ ?

  • Read the detailed "Instructions for Use" that comes with EGRIFTA™ before you start using EGRIFTA™ . Your healthcare provider will show you how to inject EGRIFTA™ .
  • Use EGRIFTA™ exactly as prescribed by your healthcare provider.
  • Inject EGRIFTA™ under the skin (subcutaneously) of your stomach area (abdomen).
  • Change (rotate) the injection site on your stomach area (abdomen) with each dose. Do not inject EGRIFTA™ into scar tissue, bruises or your navel.
  • Do not share needles or syringes with other people. Sharing of needles can result in the transmission of infectious diseases, such as HIV.

What are the possible side effects of EGRIFTA™?

EGRIFTA™ may cause serious side effects including:

  • Serious allergic reaction. Some people taking EGRIFTA™ may have an allergic reaction.

Stop using EGRIFTA™ and get emergency help right away if you have any of the following symptoms:

  • a rash over your body
  • hives
  • swelling of your face or throat
  • shortness of breath or trouble breathing
  • fast heartbeat
  • feeling of faintness or fainting

  • Swelling (fluid retention). EGRIFTA™ can cause swelling in some parts of your body. Call your healthcare provider if you have an increase in joint pain, or pain or numbness in your hands or wrist (carpal tunnel syndrome).
  • Increase in glucose (blood sugar) intolerance and diabetes. Your healthcare provider will measure your blood sugar periodically.
  • Injection site reactions. Change (rotate) your injection site to help lower your risk for injection site reactions. Call your healthcare provider for medical advice if you have the following symptoms around the area of the injection site:

  • redness
  • itching
  • pain
  • irritation
  • bleeding
  • rash
  • swelling

The most common side effects of EGRIFTA™ include:

  • joint pain
  • pain in legs and arms
  • swelling in your legs
  • nausea
  • vomiting
  • muscle soreness
  • tingling, numbness and pricking
  • rash
  • itching

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

These are not all the possible side effects of EGRIFTA™ . For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. To report side effects, contact EMD Serono toll-free at 1-800-283-8088 ext. 5563. You may report side effects to FDA at 1-800-FDA-1088.

How do I store EGRIFTA™?

  • EGRIFTA™ has two boxes
    • Store the Medication Box of EGRIFTA™ vials in the refrigerator between 2°C and 8°C (36°F and 46°F).
    • Store the box of Sterile Water for Injection, syringes and needles at room temperature between 20°C to 25°C (68°F to 77°F).
  • Keep EGRIFTA™ vials in Medication Box away from light.
  • Do not freeze.
  • Do not use EGRIFTA™ after the expiration date printed on the carton and vial labels.
  • After mixing, use EGRIFTA™ right away and throw away any unused EGRIFTA™ . Do not store mixed EGRIFTA™ . Also, throw away the used bottle of Sterile Water for Injection.

Keep EGRIFTA™ and all medicines out of the reach of children.

General information about the safe and effective use of EGRIFTA™

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EGRIFTA™ for a condition for which it was not prescribed. Do not give EGRIFTA™ to other people, even if they have the same symptoms you have. It may harm them.

Do not share your EGRIFTA™ syringe with another person, even if the needle is changed. Do not share your EGRIFTA™ needles with another person.

This Patient Information leaflet summarizes the most important information about EGRIFTA™. If you would like more information, talk with your healthcare provider.

You can ask your healthcare provider or pharmacist for information about EGRIFTA™ that is written for healthcare professionals.

For more information about EGRIFTA™, go to www.EGRIFTA.com or contact AXIS Center toll-free at 1-877-714-2947.

What are the ingredients in EGRIFTA™?

Active ingredient: tesamorelin

Inactive ingredients: mannitol and Sterile Water for Injection

Patient Instructions for Use

EGRIFTA™
(eh-GRIF-tuh)
(tesamorelin for injection) for subcutaneous use

Be sure that you read, understand, and follow these Patient Instructions for Use before using EGRIFTA™. Your healthcare provider should show you how to mix and inject EGRIFTA™ before you inject it for the first time. Ask your healthcare provider if you have any questions.

Keep this leaflet in case you need to look at it again later.

Important information for use of EGRIFTA™

  • After mixing EGRIFTA™ with Sterile Water for Injection, it should look clear and colorless, with no particles in it. Do not use EGRIFTA™ if it looks cloudy, discolored, or if you see particles in it. Talk to your healthcare provider if you have any questions.
  • Do not use EGRIFTA™ after the date on the Medication Box and EGRIFTA™ vial.
  • Do not use a syringe or needle more than 1 time.
  • Do not share your EGRIFTA™ needles with another person. Sharing of needles can result in the transmission of infectious diseases, such as HIV. Do not share your EGRIFTA™ syringe with another person, even if the needle is changed.
  • If you are missing any supplies from your Medication Box or Injection Box, or if anything looks damaged call your pharmacist or contact AXIS Center toll-free at 1-877-714-2947 right away.

Preparing for your EGRIFTA™ injection

Step 1: Find a well-lit, clean, and flat surface, such as a table.

Step 2: Gather your supplies:

  • Medication Box that contains 30 EGRIFTA™ powder vials
  • Injection Box that contains the following:
    1. 30 10-mL bottles of Sterile Water for Injection, used for mixing
    2. 30 sterile 3-mL syringes with sterile needle already attached (BD 3 mL Syringe)
    3. 30 individual Vz" 27-gauge injection needles (BD Eclipse™ Injection Needle)
  • Other Supplies Needed
    • Alcohol pads
    • Sterile gauze
    • A "sharps container" or a puncture resistant container for throwing away needles after you are done with them. The container should be made from hard plastic or metal. Make sure it has a lid. You can also put used syringes or empty vials of medicine in the container.

Material included in Injection Box (a, b, c) and Medication Box (d):

Figure A

Material included - Illustration

Step 3: Take out the following from your Injection Box:

  • A Sterile Water for Injection bottle (Figure A, a)
  • A syringe with needle already attached (Figure A, b)
  • A ½" 27-gauge injection needle with pink needle shield (Figure A, c)

Step 4: Take one EGRIFTA™ vial (Figure A, d) from the Medication Box. Put the box with the remaining vials back in the refrigerator right away.

Step 5: Prepare to use your supplies:

  • Wash your hands with soap and water. Dry your hands with a clean towel.
  • Take off the plastic caps from the vials of EGRIFTA™ and Sterile Water bottle.
  • Clean the rubber stopper on top of the vial of EGRIFTA™ and Sterile Water bottle with an alcohol swab.

How to mix EGRIFTA

Step 1: Pick up the syringe with needle attached (Figure A, b), remove the protective cap and insert the needle through the rubber stopper of the bottle of Sterile Water (Figure A, a; see Figure B for illustration). Turn both upside down, and pull back the plunger until the liquid reaches the 2.1 mL mark on the syringe. (See Figure C)

Figure B

Insert the needle through the rubber stopper - Illustration

Figure C

Pull back the plunger until the liquid reaches the 2.1 mL mark - Illustration

Step 2: Take the syringe with needle attached out of the Sterile Water bottle and insert the needle into the EGRIFTA™ vial. Push the plunger in slowly on a slight angle so water goes down the inside wall of the EGRIFTA™ vial instead of directly onto the powder to avoid foaming. (See Figure D)

Figure D

Insert the needle into the EGRIFTA™ vial - Illustration

Step 3: While keeping the syringe with needle attached in the vial and the vial upright, roll the vial gently in your hands for 30 seconds, until the Sterile Water and EGRIFTA™ powder are mixed well. Do not shake the vial. (See Figure E)

Figure E

Roll the vial gently -  Illustration

Step 4: Still keeping the syringe with needle attached in the vial, turn both until the syringe is straight up. Pull down on the syringe until you see just the tip of the needle going through the rubber stopper, then pull back on the plunger until all the liquid inside the vial goes into the syringe. The level of medicine in the syringe should be around the 2.1 mL syringe mark. (See Figure F)

Figure F

Level of medicine in the syringe - Illustration

Step 5: Take the needle out of the vial. (See Figure G)

Figure G

Take the needle out of the vial - Illustration

Step 6: Place the needle cap on its side against a clean flat surface. Without touching the needle, hold the syringe and slide the needle carefully into the protective cap. (See Figure H) Push the cap all the way or until it snaps shut (See Figure I). Do not touch the cap until it covers the needle completely.

Figure H

Slide the needle carefully into the protective cap - Illustration

Figure I

Push the cap all the way - Illustration

Step 7: With the cap on the needle, remove the needle by holding the syringe firmly and twisting the cap counterclockwise (to the left). (See Figure J)

Figure J

Removing the needle - Illustration

Step 8: Place the injection needle (Figure A, c), with its white protective cap in place, onto the syringe. Hold the syringe firmly and twist the cap clockwise (to the right) until it closes securely. (See Figure K)

Figure K

Placing the needle - Illustration

Where do I inject EGRIFTA™?

You should inject EGRIFTA™ into the skin on your stomach (abdomen). (See Figure L)

  • Pick an injection site that is around your belly button to the left or right.
  • Stay away from any area with scar tissue, bruises, reddening, infection, or irritation.
  • Avoid areas with any hard bumps from previous injections.
  • Change your injection site from one day to the next. This may help prevent bruising or irritation. You may want to keep a note of the date and location of each daily injection to help you remember.

Figure L

Pick an injection site - Illustration

How to inject EGRIFTA™

  • Pick up the syringe and pull the cap straight off the injection needle. Do not twist it. (See Figure M)

Figure M

Pull the cap straight off - Illustration

  • Tap the syringe gently with your finger to force any air bubbles to rise to the top. Press the plunger to push bubbles out. (See Figure N)

Figure N

Force any air bubbles to rise to the top - Illustration

  • Clean the injection site you have selected with an alcohol swab and let it dry. Hold the syringe in one hand. Use your other hand to hold a cleaned fold of skin for your injection. Hold the skin between your thumb and fingers. (See Figure O)

Figure O

Hold the skin between your thumb and fingers - Illustration

  • Hold the syringe at a right angle to the skin, like a dart. Push the injection needle into the skin with a quick motion. Most of the needle should go beneath the skin surface. (See Figure P)

Figure P

Most of the needle should go beneath the skin surface - Illustration

  • Remove your hand from the pinched area of skin after the needle goes in. Make sure the needle stays in the skin. (See Figure Q)

Figure Q

Make sure the needle stays in the skin - Illustration

  • Slowly push the plunger all the way down until all of the medicine in the syringe has been injected under the skin.
  • Pull the injection needle out of your skin when the syringe is empty:
  • Be careful to pull it out at the same angle you put it in
  • Flip back the pink needle shield until it snaps, covering the injection needle completely. Keep pressing until you hear a click, that means the injection needle is protected. (See Figure R)

 

Figure R

 

  • Use a piece of sterile gauze to rub the injection site clean. If there is bleeding, apply pressure to the injection site with gauze for 30 seconds. If bleeding continues, apply a bandage to the site.

How should I dispose of the used syringes, needles, bottles and vials?

  • If you accidentally prick another person with a used needle, that person should be informed to contact a healthcare provider right away about the accident.
  • Never reuse or recycle needles or syringes.
  • Never throw used needles, syringes, or the sharps container into the trash.
  • Throw away used syringes, needles, EGRIFTA™ vials and Sterile Water for Injection bottle in a puncture-proof container, sharps container, or a hard container like a coffee can.
  • Speak to your pharmacist or other healthcare provider about the proper disposal of the sharps container and all other used materials. There may be local or state laws about how to throw away used needles and syringes.
  • Keep the sharps container away from children and pets.

If you have any questions, call your healthcare provider. You can call AXIS Center toll-free at 1-877-714-2947 or visit the EGRIFTA™ Web site at: www.EGRIFTA™ .com for more information.

How do I store EGRIFTA™?

EGRIFTA™ has two boxes:

  • Store the Medication Box of EGRIFTA™ vials in the refrigerator between 2°C and 8°C (36°F and 46°F).
  • Store the Injection Box of Sterile Water for Injection, syringes and needles at room temperature between 20ºC to 25ºC (68°F to 77°F).
  • Keep EGRIFTA™ vials away from light.
  • Do not freeze.
  • After mixing, use EGRIFTA™ right away and throw away any unused EGRIFTA™. Do not store mixed EGRIFTA™. Also, throw away the used bottle of Sterile Water for Injection.
  • Do not use EGRIFTA™ after the expiration date printed on the Medication Box and vial labels.

Keep EGRIFTA™ and all medicines out of the reach of children.

Last reviewed on RxList: 12/12/2011
This monograph has been modified to include the generic and brand name in many instances.

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Egrifta - User Reviews

Egrifta User Reviews

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Here is a collection of user reviews for the medication Egrifta sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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