- Patient Information
- Do Not Take Egrifta If You:
- About All Of Your Medical Conditions, Including If You:
- How Should I Use Egrifta?
- Egrifta?
- May Cause Serious Side Effects, Including:
- Stop Using Egrifta And Get Emergency Help Right Away If You Have Any Of The Following Symptoms:
- The Most Common Side Effects Of Egrifta Include:
- How Should I Store Egrifta 2 Mg Vial?
- Active Ingredient:
- Inactive Ingredients:
- Read Before Opening Box:
- Contents Of Injection Box:
- Revised: 12/2018document Id:
Patient Information ⮝
Advise the patient to read the FDA-approved patient labeling (Patient InformationandInstructions for Use).
Increased Risk of Malignancy
Inform patients about the increased background risk of malignancies in HIV-positive patients and for patients with a history of neoplasms, inform them about the risk of malignancy reoccurrence[
Do Not Take Egrifta If You: ⮝
- have pituitary gland tumor, pituitary gland surgery, other problems related to your pituitary gland, or have had a head injury.
- have active cancer. Any previous cancer should be inactive and any previous cancer treatment should be complete before starting EGRIFTA.
- are allergic to tesamorelin or any of the ingredients in EGRIFTA.
Before using EGRIFTA, tell your healthcare provider
About All Of Your Medical Conditions, Including If You: ⮝
- have or have had cancer.
- have problems with your blood sugar or diabetes. Some people with diabetes who use EGRIFTA may develop or may have worsening eye problems.
- have scheduled heart or stomach surgery.
- 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 mothersnotbreastfeed 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.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How Should I Use Egrifta? ⮝
- Read the detailed Instructions for Usethat comes with EGRIFTA before you start using it. Your healthcare provider will show you how to inject EGRIFTA.
- Use EGRIFTA exactly as your healthcare provider tells you to use it.
- Inject EGRIFTA under the skin (subcutaneously) of your belly (abdomen).
- Change (rotate) the injection site on your belly (abdomen) with each dose. Do not inject EGRIFTA into scar tissue, bruises or your belly button.
- Do not share your EGRIFTA syringe or needles with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
What are the possible side effects of
Egrifta? ⮝
EGRIFTA
May Cause Serious Side Effects, Including: ⮝
- may increase risk of new cancer in HIV positive patients or your cancer coming back (reactivation).Stop using EGRIFTA if you have any cancer symptoms come back.
- increased levels of your insulin-like growth factor-1 (IGF-1).Your healthcare provider will do blood tests to check your IGF-1 levels while you are taking EGRIFTA.
- 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 blood sugar (glucose) or diabetes.Your healthcare provider will check your blood sugar from time to time.
- 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
shortness of breath or trouble breathing
hives
fast heartbeat
swelling of your face or throat
feeling of faintness or fainting
- 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
irritation
swelling
itching
bleeding
pain
rash
- increased risk of death in people who have critical illnesses because of heart or stomach surgery, trauma or serious breathing (respiratory) problems has happened when taking certain amounts of growth hormone.
The Most Common Side Effects Of Egrifta Include: ⮝
joint pain
pain in legs and arms
swelling in your legs
muscle pain
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. You may report side effects to FDA at 1-800- FDA-1088.
You may also report side effects to THERA patient supportTMtoll-free at 1-833-23THERA (1-833-238-4372).
How Should I Store Egrifta 2 Mg Vial? ⮝
- EGRIFTA comes in two boxes given to you by the pharmacy.
Store the Medication Box of 2 mg EGRIFTA vials at room temperature between 68 F to 77 F (20 C to 25 C).
Store the Injection Box of Sterile Water for Injection, syringes and needles at room temperature between 68 F to 77 F (20 C to 25 C).- Keep EGRIFTA vials in the box and out of the light.
- After mixing, use EGRIFTA right away and throw away any unused EGRIFTA.
- Do not store, freeze or refrigerate after EGRIFTA has been mixed with the sterile water.
- Throw away the used bottle of Sterile Water for Injection.
- Do not use EGRIFTA after the expiration date printed on the carton and vial labels.
Keep EGRIFTA and all medicines out of the reach of children.
General information about the safe and effective use ofEGRIFTA
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.
You can ask your healthcare provider or pharmacist for information about EGRIFTA that is written for healthcare professionals.
Active Ingredient: ⮝
tesamorelin
Inactive Ingredients: ⮝
mannitol, sucrose, histidine, polysorbate 20Distributed by: Theratechnologies Inc., Montr al, Qu bec, Canada H3A 1T8
For more information about EGRIFTA, go towww.EGRIFTA.comor contact toll-free at 1-833-23THERA (1-833-238-4372).
This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 11/2018
Instructions for Use
EGRIFTA(eh-GRIF-tuh)
(tesamorelin for injection)
for subcutaneous use
2mg/vialThis Instructions for Use (IFU) contains step-by-step information on how to use the2 mg vialof EGRIFTA.Each 2 mg vialof EGRIFTA must be mixed with0.5 mL ofthe Sterile Water for Injectionprovided in the Injection Box given to you by the pharmacy.You only need oneEGRIFTA 2 mgvial from the Medication Boxto complete your dose. The recommendeddose is 1.4 mg (0.35 mL).
Be sure that you read, understand, and follow this IFU 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 IFU 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 )
Figure F
Step 5: Roll the vial gently in your hands for 30 seconds, until the Sterile Water and EGRIFTA powder are mixed well. Donotshake the vial. (
You should inject EGRIFTA into the skin on your belly (abdomen). (
- Do notrecap the needle or remove the needle from the syringe after you inject EGRIFTA.
- Put your used EGRIFTA needles and syringes in a FDA-cleared sharps disposal container right away after use.Do not throw away (dispose of) loose needles and syringes in your household trash.
- If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- made of a heavy-duty plastic,
- can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out,
- upright and stable during use,
- leak-resistant, and
- properly labeled to warn of hazardous waste inside the container.
- When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and pens. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at:http://www.fda.gov/safesharpsdisposal.
- Do notdispose of your used sharps disposal container in your household trash unless your community guidelines permit this.Do notrecycle your used sharps disposal container.
- 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.
- Keep the sharps container away from children and pets.
If you have any questions,call your healthcare provider. You can call THERA patient supportTMtoll-free 1-833-23THERA (1-833-238-4372) or visit the EGRIFTAwebsite at:www.EGRIFTA.comfor more information.
How do I store EGRIFTA 2 mg vial?
- EGRIFTA comes in two boxes given to you by the pharmacy:
- Store the Medication Box of 2 mg EGRIFTA vials at room temperature between 68 F to 77 F (20 C to 25 C).
- Store the Injection Box of Sterile Water for Injection, syringes and needles at room temperature between 68 F to 77 F (20 C to 25 C).
- Keep EGRIFTA vials in the box and out of the light.
- After mixing, use EGRIFTA right away and throw away any unused EGRIFTA.
- Do not store, freeze or refrigerate EGRIFTA after it has been mixed with the sterile water.
- Throw away the used bottle of Sterile Water for Injection.
- Do not use EGRIFTA after the expiration date printed on the carton and vial labels.
General information about the safe and effective use of EGRIFTA.
Keep EGRIFTA and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Thera
technologiesEGRIFTAis a registered trademark of Theratechnologies Inc.
Distributed by: Theratechnologies Inc., Montr al, Qu bec, Canada H3A 1T8
Revised: 11/2018
Principal Display Panel - 2 mg Box Label (New Formulation)
MEDICATION BOX
(Box 1 of 2)
NDC 62064-041-30
2 mg/vial
Rx only
EGRIFTA
tesamorelin for injection
New Formulation
Refer to Patient Instructions for Use
For subcutaneous injection only
Read Before Opening Box: ⮝
This is theMEDICATION BOXit contains 30 vials of
EGRIFTA2 mg/vial and the patient Instructions for Use.
You will also need theINJECTION BOXit contains syringes
and other materials needed to administerEGRIFTA.Protect
from lightStore up to
25 C (77 F)Theratechnologies
EGRIFTAis a registered trademark
of Theratechnologies Inc.30 vials
Principal Display Panel - 10 ml Bottles Box Label (New Formulation)
INJECTION BOX(Box 2 of 2)
For use only withEGRIFTA2 mg/vial
(tesamorelin for injection)New Formulation
For mixing,
refer to Patient
Instructions for Use
included in the
EGRIFTA2 mg/vial
Medication Box.Rx only
READ BEFORE OPENING BOX
This is your INJECTION BOX forEGRIFTA(tesamorelin for injection) 2 mg/vial.
This box contains sterile syringes, Sterile Water for Injection USP, and materials
needed for injectingEGRIFTA.Note this INJECTION BOX does NOT contain yourEGRIFTA2 mg/vial medication.
Before removing contents,make sure you also have the
EGRIFTA2 mg/vial MEDICATION BOX.
Contents Of Injection Box: ⮝
a) 30 single-dose, 10 mL bottles of Sterile Water for Injection
b) 60 sterile 1-mL syringes
c) 60 sterile individual 1" 20-gauge needles, used for mixing
d) 30 sterile individual " 30-gauge needles, used for injection
Store at
controlled room
temperature
20 C to 25 C
(68 F to 77 F)Made in USA
Distributed by Theratechnologies Inc., Montr al, Qu bec, H3A 1T8, Canada
Theratechnologies
EGRIFTAis a registered trademark of Theratechnologies Inc.
Principal Display Panel - 2 mg Vial Label (New Formulation)
Refer to Instructions for Use
2 mg/vial
EGRIFTA
tesamorelin for injection
Rx only
STERILE
Store at
up to 77 FFor subcutaneous injection only
Each vial contains 2 mg of tesamorelin
Single-Dose Vial - Discard unused Portion
Distributed by Theratechnologies Inc.
EGRIFTA
tesamorelin kit
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62064-041
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62064-041-30 1 in 1 BOX; Type 1: Convenience Kit of Co-Package 07/01/2019
Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 30 VIAL 15 mL Part 2 30 BOTTLE 300 mL
Part 1 of 2 EGRIFTA
tesamorelin injection, powder, lyophilized, for solution
Product Information Route of Administration SUBCUTANEOUS
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TESAMORELIN ACETATE(UNII: LGW5H38VE3) (TESAMORELIN - UNII:MQG94M5EEO) TESAMORELIN 2 mg in 0.5 mL
Inactive Ingredients Ingredient Name Strength MANNITOL(UNII: 3OWL53L36A) 20 mg in 0.5 mL SUCROSE(UNII: C151H8M554) 10 mg in 0.5 mL HISTIDINE(UNII: 4QD397987E) 0.78 mg in 0.5 mL POLYSORBATE 20(UNII: 7T1F30V5YH) 0.05 mg in 0.5 mL
Product Characteristics Color WHITE (white to off-white ) Score Shape Size Flavor Imprint Code Contains
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 0.5 mL in 1 VIAL; Type 1: Convenience Kit of Co-Package
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022505 07/01/2019
Part 2 of 2 STERILE WATER
water injection
Product Information Route of Administration SUBCUTANEOUS
Inactive Ingredients Ingredient Name Strength WATER(UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 30 in 1 TRAY 1 10 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018801 07/14/2014
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA022505 07/01/2019
Labeler -Theratechnologies Inc. (252017520)
Revised: 12/2018document Id: ⮝
a2509913-6b13-4c99-a0fe-b904078a2745Set id: 57d892a0-1fe1-4f30-8ef1-0b57e8a2b786Version: 2Effective Time: 20181218Theratechnologies Inc.