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EGRIFTA- tesamorelin kit


  1. Patient Information
  2. Do Not Take Egrifta If You:
  3. About All Of Your Medical Conditions, Including If You:
  4. How Should I Use Egrifta?
  5. Egrifta?
  6. May Cause Serious Side Effects, Including:
  7. Stop Using Egrifta And Get Emergency Help Right Away If You Have Any Of The Following Symptoms:
  8. The Most Common Side Effects Of Egrifta Include:
  9. How Should I Store Egrifta 2 Mg Vial?
  10. Active Ingredient:
  11. Inactive Ingredients:
  12. Read Before Opening Box:
  13. Contents Of Injection Box:
  14. 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 20

Distributed 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/vial

This 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

    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
    technologies

    EGRIFTAis 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
EGRIFTA
2 mg/vial and the patient Instructions for Use.
You will also need theINJECTION BOXit contains syringes
and other materials needed to administerEGRIFTA.

Protect
from light

Store up to
25 C (77 F)

Theratechnologies

EGRIFTAis a registered trademark
of Theratechnologies Inc.

30 vials

Principal Display Panel - 2 mg Box Label (New Formulation)

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 - 10 ml Bottles Box Label (New Formulation)

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 F

For subcutaneous injection only

Each vial contains 2 mg of tesamorelin

Single-Dose Vial - Discard unused Portion

Distributed by Theratechnologies Inc.

Principal Display Panel - 2 mg Vial Label (New Formulation)

EGRIFTA
tesamorelin kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:62064-041
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62064-041-301 in 1 BOX; Type 1: Convenience Kit of Co-Package07/01/2019
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 130 VIAL15 mL
Part 230 BOTTLE300 mL
Part 1 of 2
EGRIFTA
tesamorelin injection, powder, lyophilized, for solution
Product Information
Route of AdministrationSUBCUTANEOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TESAMORELIN ACETATE(UNII: LGW5H38VE3) (TESAMORELIN - UNII:MQG94M5EEO)TESAMORELIN2 mg in 0.5 mL
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITE (white to off-white )Score
ShapeSize
FlavorImprint Code
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
10.5 mL in 1 VIAL; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02250507/01/2019
Part 2 of 2
STERILE WATER
water injection
Product Information
Route of AdministrationSUBCUTANEOUS
Inactive Ingredients
Ingredient NameStrength
WATER(UNII: 059QF0KO0R)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
130 in 1 TRAY
110 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01880107/14/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02250507/01/2019
Labeler -Theratechnologies Inc. (252017520)

Revised: 12/2018document Id: 

a2509913-6b13-4c99-a0fe-b904078a2745Set id: 57d892a0-1fe1-4f30-8ef1-0b57e8a2b786Version: 2Effective Time: 20181218Theratechnologies Inc.



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