EGRIFTA (tesamorelin) 1mg Injection

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

EGRIFTA®. The first FDA-approved medicine shown to reduce HIV-related excess belly fat.

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.

PATIENTS: be advised that this product is difficult to obtain in large quantities as EMD-Serono here in Mexico releases no more than 50 vials per patient every 90 days. Therefore minimum purchases are 5 vials, however most purchase 20 or more.

Chemical Name: TESAMORELIN (TES-a-moe-REL-in)

Common uses
Egrifta 1mg Solution is a human growth hormone-releasing factor (GRF) analog used to reduce excess stomach fat in certain HIV-infected patients.

Before using
Some medicines or medical conditions may interact with Egrifta 1mg Solution. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticonvulsants (eg, phenytoin), corticosteroids (eg, prednisone), cyclosporine, or sex hormones (eg, estradiol, testosterone). DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including severe breathing problems (eg, respiratory failure); a serious illness caused by complications from surgery, injury, or trauma; kidney or liver problems; allergies; plans to become pregnant; or breast-feeding. Tell your doctor if you have a history of cancer or non-cancerous growths, or diabetes. USE OF EGRIFTA 1mg SOLUTION IS NOT RECOMMENDED if you have cancer, an underactive pituitary gland, a pituitary gland tumor, or if you have had your pituitary gland removed, pituitary gland surgery, radiation treatment of the head, or head injury. USE OF EGRIFTA 1mg SOLUTION IS NOT RECOMMENDED if you are pregnant. Use of Egrifta 1mg Solution in CHILDREN is not recommended. Discuss with your doctor the risks and benefits of giving Egrifta 1mg Solution to your child. Contact your doctor or pharmacist if you have any questions about taking Egrifta 1mg Solution.

Directions
Follow the directions for using Egrifta 1mg Solution provided by your doctor. An additional patient information leaflet is available with Egrifta 1mg Solution. Ask your doctor, nurse, or pharmacist any questions that you may have about this information. Egrifta 1mg Solution is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Egrifta 1mg Solution at home, a healthcare professional will provide detailed instructions for its appropriate use. Ask any questions that you may have about Egrifta 1mg Solution or giving injections. If the medicine contains particles, is cloudy or discolored, or if the vial is cracked or damaged in any way, do not use it. USE THE PROPER TECHNIQUE TAUGHT TO YOU by your doctor. Inject deep under the skin, NOT into a vein or muscle. BE SURE TO ROTATE YOUR INJECTION SITE on the stomach area with each dose as directed. Do NOT inject Egrifta 1mg Solution into scar tissue, bruises, or the belly button. Do NOT prepare Egrifta 1mg Solution until you are ready to use it. After mixing, use Egrifta 1mg Solution right away and throw away any unused medicine. Do NOT store prepared doses for later use. EGRIFTA 1mg SOLUTION COMES WITH TWO BOXES, one with the medicine and one with solution to mix it with as well as syringes and needles. STORE THE MEDICINE BOX in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do NOT freeze or store in the bathroom. Store in original packaging until just before use, away from heat, moisture, and light. STORE THE BOX WITH THE SOLUTION, SYRINGES, AND NEEDLES at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Do NOT use Egrifta 1mg Solution after its expiration date. KEEP THIS PRODUCT, as well as syringes and needles, out of the reach of children and away from pets. IF YOU MISS A DOSE OF EGRIFTA 1mg SOLUTION, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. DO NOT use 2 doses at once.

Cautions
DO NOT TAKE EGRIFTA 1mg SOLUTION if you have had an allergic reaction to it, to any ingredient in this product, or to mannitol. DO NOT EXCEED THE RECOMMENDED DOSE or use Egrifta 1mg Solution for longer than prescribed without checking with your doctor. Laboratory and/or medical tests, including IGF-I levels and blood sugar levels, may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking Egrifta 1mg Solution. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are taking Egrifta 1mg Solution. THE SAFETY OF LONG-TERM USE OF EGRIFTA 1mg SOLUTION is not known. Contact your doctor if your condition does not improve while you use Egrifta 1mg Solution. EGRIFTA 1mg SOLUTION IS NOT INTENDED to manage weight loss. EGRIFTA 1mg SOLUTION MAY RAISE YOUR BLOOD SUGAR. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. FOR WOMEN: DO NOT use Egrifta 1mg Solution if you are pregnant. It may cause harm to the fetus. AVOID BECOMING PREGNANT while you are taking it. If you become pregnant, stop taking Egrifta 1mg Solution and contact your doctor right away. IT IS NOT KNOWN IF EGRIFTA 1mg SOLUTION IS FOUND IN BREAST MILK. Mothers infected with HIV should not breast-feed. There is a risk of passing the HIV infection or Egrifta 1mg Solution to the baby. IF YOU HAVE DIABETES, Egrifta 1mg Solution may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

Possible side effects
SIDE EFFECTS that may occur while using Egrifta 1mg Solution include nausea, night sweats, stomach upset, trouble sleeping, or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience arm, joint, leg, or muscle pain; burning, numbness, or tingling of the skin; decreased sense of touch; fainting or faintness; fast or irregular heartbeat; mental or mood changes (eg, depression); muscle or joint soreness or stiffness; numbness, pain, or weakness in your wrist, hand, or fingers; redness, swelling, itching, pain, irritation, rash, bleeding, or bruising at the injection site; shortness of breath or trouble breathing; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; confusion; drowsiness; flushing; rapid breathing; fruit-like breath odor). AN ALLERGIC REACTION to Egrifta 1mg Solution is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; flushing; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Drug interactions
Drug interactions can result in unwanted side effects or prevent a medicine from doing its job. Use our drug interaction checker to find out if your medicines interact with each other. 

If you take too much
If overdose is suspected, contact your local poison control center or emergency room immediately.

Additional information
DO NOT SHARE EGRIFTA 1mg SOLUTION with others for whom it was not prescribed. DO NOT USE EGRIFTA 1mg SOLUTION for other health conditions. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when it is full. IF YOU WILL BE USING EGRIFTA 1mg SOLUTION FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.

Do not use EGRIFTA® if you:

• have pituitary gland tumor, pituitary gland surgery or other problems related to your pituitary gland
• have or had a history of active cancer (either newly diagnosed or recurrent)
• are allergic to tesamorelin or any of the ingredients in EGRIFTA® (mannitol or sterile water)
• are pregnant or become pregnant. If you become pregnant, stop using EGRIFTA® and talk with your healthcare provider.

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.

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.

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
• muscle soreness
• tingling, numbness and pricking
• nausea
• vomiting
• rash
• itching

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

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

Call your doctor for medical advice about side effects.

Use:

• 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.

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