Manufacturer Theratechnologies Inc.
Effective date 2025-03-31
Label type HUMAN PRESCRIPTION DRUG LABEL
Version 1
Source full-release
Hydrated at 2026-05-31 21:37:30
Key Label Information#
Uses
1 INDICATIONS AND USAGE
EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA WR has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR.
4 CONTRAINDICATIONS
Warnings
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
Directions And Dosage
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
For injection: 11.6 mg of tesamorelin as a white to off-white lyophilized powder in a single-patient-use vial for reconstitution and a diluent of 30 mL of multiple-dose Bacteriostatic Water for Injection, USP.
Other Label Information
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied EGRIFTA WR (tesamorelin) for injection is supplied as a white to off-white lyophilized powder in a 11.6 mg single-patient-use vial with a 30 mL multiple-dose bottle of Bacteriostatic Water for Injection, USP, as diluent. EGRIFTA WR (NDC 62064-381-04) is available in a package comprised of two boxes, containing 4 (four) 11.6 mg single-patient-use vials of EGRIFTA WR in the Medication Box and 1 (one) multiple-dose 30 mL bottles of Bacteriostatic Water for Injection, USP, diluent with a 28-day supply of disposable syringes, needles and alcohol swabs in the Injection Box. Storage and Handling Store EGRIFTA WR 11.6 mg vial at room temperature at 20°C to 25°C (68°F to 77°F) in the original box to protect from light; excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store the Injection box (containing Bacteriostatic Water for Injection, syringes, needles and alcohol swabs) at room temperature at 20°C to 25°C (68°F to 77°F). Do not freeze.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel - Medication Box Rx only MEDICATION BOX (Box 1 of 2) NDC 62064-381-04 4 vials EGRIFTA WR TM (tesamorelin) for injection 11.6 mg/vial For Subcutaneous Use Single-patient-use vial Sterile lyophilized powder New Formulation, Dose, Mixing Instructions, and Storage One (1) mixed EGRIFTA WR vial provides daily doses for seven (7) days EGRIFTA WR and EGRIFTA SV are not substitutable. THERA technologies
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel - Injection Box INJECTION BOX (Box 2 of 2) For use only with EGRIFTA WR TM (tesamorelin) for injection 11.6 mg/vial (NDC 62064-381-04) New Formulation, Dose Mixing Instructions, and Storage One (1) mixed EGRIFTA WR vial provides daily doses for seven (7) days READ BEFORE OPENING BOX This INJECTION BOX does NOT contain your EGRIFTA WR (tesamorelin) for injection 11.6 mg/vial. Make sure you also have the EGRIFTA WR 11.6 mg/vial MEDICATION BOX. CONTENTS OF INJECTION BOX: - 1 Instructions for Use and Patient Information - 1 multiple-dose, 30 mL bottle of Bacteriostatic Water for Injection - 4 sterile BD PlastipakTM 3 mL syringes with needle attached - 33 sterile BD SafetyGlideTM syringes with needle attached - 1 box of 100 alcohol swabs EGRIFTA WR and EGRIFTA SV are not substitutable. For Weekly Mixing and Daily Injection, refer to Instructions for Use. Store at room temperature at 20°C to 25°C (68°F to 77°F). Rx only THERA technologies
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel - 11.6 mg Vial Label EGRIFTA WRTM (tesamorelin) for injection 11.6 mg/vial NDC 62064-381-01 Rx only STERILE Store at 20°C to 25°C (68°F to 77°F). For Subcutaneous Use Single-patient-use vial The daily recommended dose is 1.28 mg (0.16 mL). Mfd. by Theratechnologies Inc. US License No. 2091
Label Images#
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY SPL version 2719316 EGRIFTA WR 11.6 MG Injection PSN 1 2719314 tesamorelin 11.6 MG Injection PSN 1 2719316 tesamorelin 11.6 MG Injection [Egrifta] SBD 1 2719314 tesamorelin 11.6 MG Injection SCD 1 2719316 Egrifta 11.6 MG Injection SY 1 2719314 tesamorelin 11.6 MG (as tesamorelin acetate 11.9 MG) Injection SY 1
DailyMed Pharmacologic Classes#
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62064-381-04 EGRIFTA WR 1 in 1 BOX KIT 1 1
DailyMed Billing Units#
Products#
EGRIFTA WR tesamorelin BACTERIOSTATIC WATER
NDC Codes#
Ingredients#
Complete SPL Sections#
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
EGRIFTA WR is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA WR has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA WR is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA WR.
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
For injection: 11.6 mg of tesamorelin as a white to off-white lyophilized powder in a single-patient-use vial for reconstitution and a diluent of 30 mL of multiple-dose Bacteriostatic Water for Injection, USP.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following important adverse reactions are also described elsewhere in the labeling: Increased risk of neoplasms [see Warnings and Precautions ( 5.1 )] Elevated IGF-1 levels [see Warnings and Precautions ( 5.2 )] Fluid retention [see Warnings and Precautions ( 5.3 )] Glucose intolerance or diabetes mellitus [see Warnings and Precautions ( 5.4 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] Injection site reactions [see Warnings and Precautions ( 5.6 )]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
11 DESCRIPTION
DESCRIPTION SECTION
Tesamorelin is a human growth hormone-releasing factor (GRF) analog produced synthetically. It is comprised of the 44 amino acid sequence of human GRF and a hexenoyl moiety, a C6 chain with a double bond at position 3, attached to the tyrosine residue at the N-terminal part of the molecule. Tesamorelin is prepared as an acetate salt. The molecular formula of tesamorelin acetate is C 221 H 366 N 72 O 67 S • x C 2 H 4 O 2 (x ≈ 7) and its molecular weight (as free base equivalent) is 5135.9 Da. The structural formula of tesamorelin acetate is: EGRIFTA WR (tesamorelin) for injection is a sterile, white to off-white, preservative-free lyophilized powder for subcutaneous injection. Each single-patient-use vial of EGRIFTA WR contains tesamorelin 11.6 mg (equivalent to approximately 11.9 mg of tesamorelin acetate) and the following inactive ingredients: 145 mg hydroxypropyl betadex, 43.5 mg mannitol. Hydrochloric acid and/or sodium hydroxide may be used to adjust the pH. The pH of EGRIFTA WR is between 4.5 and 7.4. After reconstitution with 1.3 mL of Bacteriostatic Water for Injection, USP, resultant concentration is 8 mg/mL and the solution is clear and colorless. Bacteriostatic Water for Injection, USP contains benzyl alcohol as preservative.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
The safety and effectiveness of EGRIFTA WR (11.6 mg/vial formulation) has been established based on adequate and well controlled studies with EGRIFTA (1 mg/vial formulation), as well as a demonstration of comparable bioavailability between the 1.28 mg EGRIFTA WR dose (11.6 mg/vial formulation) and the 2 mg EGRIFTA dose (1 mg/vial formulation) [see Clinical Pharmacology ( 12.3 )] . Two multicenter, randomized, double-blind, placebo-controlled studies were conducted in HIV-infected patients with lipodystrophy and excess abdominal fat (abdominal lipohypertrophy). Study 1 and Study 2 consisted of a 26-week Main Phase and a 26-week Extension Phase, respectively. Main inclusion criteria were age 18 to 65 years, a waist circumference ≥95 cm (37.4 inches) and a waist-to-hip ratio ≥0.94 for men and ≥94 cm (37.0 inches) and ≥0.88 for women, respectively, and fasting blood glucose (FBG)
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
How Supplied EGRIFTA WR (tesamorelin) for injection is supplied as a white to off-white lyophilized powder in a 11.6 mg single-patient-use vial with a 30 mL multiple-dose bottle of Bacteriostatic Water for Injection, USP, as diluent. EGRIFTA WR (NDC 62064-381-04) is available in a package comprised of two boxes, containing 4 (four) 11.6 mg single-patient-use vials of EGRIFTA WR in the Medication Box and 1 (one) multiple-dose 30 mL bottles of Bacteriostatic Water for Injection, USP, diluent with a 28-day supply of disposable syringes, needles and alcohol swabs in the Injection Box. Storage and Handling Store EGRIFTA WR 11.6 mg vial at room temperature at 20°C to 25°C (68°F to 77°F) in the original box to protect from light; excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. Store the Injection box (containing Bacteriostatic Water for Injection, syringes, needles and alcohol swabs) at room temperature at 20°C to 25°C (68°F to 77°F). Do not freeze.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling ( Patient Information and Instructions 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 [see Warnings and Precautions ( 5.1 )]. Elevated IGF-1 Levels Inform patients that treatment with EGRIFTA WR increases IGF-1 levels and that they will need periodic monitoring of their IGF-1 levels [see Warnings and Precautions ( 5.2 )]. Fluid Retention Inform patients that treatment with EGRIFTA WR may cause fluid retention, resulting in adverse reactions including edema, arthralgia, and carpal tunnel syndrome [see Warnings and Precautions ( 5.3 )]. Glucose Intolerance or Diabetes Mellitus Inform patients that treatment with EGRIFTA WR may result in glucose intolerance or diabetes mellitus. Advise patients that they will need to be monitored to see if impaired glucose tolerance or diabetes mellitus develops, and that if they have pre-existing diabetes mellitus, they may need adjustments to their anti-diabetic medications [see Warnings and Precautions ( 5.4 )]. Hypersensitivity Reactions Inform patients that hypersensitivity reactions (e.g., rash, urticaria) may occur during treatment with EGRIFTA WR. Advise patients to seek prompt medical attention and to immediately discontinue treatment with EGRIFTA WR if a reaction occurs [see Warnings and Precautions ( 5.5 )]. Injection Site Reactions Inform patients that injection site reactions may occur with EGRIFTA WR, including injection site erythema, pruritus, pain, irritation, and bruising. Advise patients to rotate the site of injection to reduce the risk of injection site reactions [see Warnings and Precautions ( 5.6 )]. Pregnancy Advise women to discontinue EGRIFTA WR if pregnancy occurs, as the drug offers no known benefit to pregnant women and could result in fetal harm [see Contraindications ( 4 ) and Use in Specific Populations ( 8.1 )]. Lactation Because of both the potential for HIV-1 infection transmission and serious adverse reactions in nursing infants, mothers receiving EGRIFTA WR should be instructed not to breastfeed [see Use in Specific Populations ( 8.2 )] . Administration Counsel patients that they should never share an EGRIFTA WR syringe with another person, even if the needle is changed. Sharing of syringes or needles between patients may pose a risk of transmission of infection.
SPL PATIENT PACKAGE INSERT SECTION
SPL PATIENT PACKAGE INSERT SECTION
PATIENT INFORMATION EGRIFTA WR TM (tesamorelin) for injection for subcutaneous use 11.6 mg/vial Read the Patient Information that comes with EGRIFTA WR before you start to take EGRIFTA WR 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 WR? EGRIFTA WR is a prescription medicine used to reduce the excess stomach-area (abdominal) fat in HIV-infected adult patients with lipodystrophy. EGRIFTA WR is a growth hormone-releasing factor (GHRF). The long-term safety of EGRIFTA WR on the heart and blood vessels (cardiovascular) is not known. EGRIFTA WR is not for weight loss management. It is not known whether taking EGRIFTA WR helps improve how well you take (compliance with) antiretroviral medicines. It is not known if EGRIFTA WR is safe and effective in children. EGRIFTA WR is not recommended to be used in children with open or closed bone growth plates (epiphyses). Who should not use EGRIFTA WR? Do not use EGRIFTA WR if you: have a pituitary gland tumor, have had pituitary gland surgery, have other problems related to your pituitary gland, or have had radiation treatment to your head or a head injury. have active cancer. Any previous cancer should be inactive, and any previous cancer treatment should be complete before starting EGRIFTA WR. are allergic to tesamorelin or any of the ingredients in EGRIFTA WR. See the end of this leaflet for a complete list of ingredients in EGRIFTA WR. are pregnant or plan to become pregnant. EGRIFTA WR can harm your unborn baby. If you become pregnant, stop using EGRIFTA WR and talk with your healthcare provider. What should I tell my healthcare provider before using EGRIFTA WR? Before using EGRIFTA WR, 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 WR may develop or may have worsening eye problems. have scheduled heart or stomach surgery. have breathing problems. are breastfeeding or plan to breastfeed. It is not known if EGRIFTA WR 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 using EGRIFTA WR. 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 WR? Read the detailed Instructions for Use that comes with EGRIFTA WR before you start using it. Your healthcare provider will show you how to inject EGRIFTA WR. Use EGRIFTA WR exactly as your healthcare provider tells you to use it. Inject EGRIFTA WR under the skin (subcutaneously) of your stomach-area (abdomen). Change (rotate) the injection site on your stomach-area with each dose. Do not inject EGRIFTA WR into scar tissue, bruises or your belly button. There are two EGRIFTA formulations (EGRIFTA WR and EGRIFTA SV) with different recommended dosages. EGRIFTA WR and EGRIFTA SV are not substitutable. Do not share your EGRIFTA WR 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 WR? EGRIFTA WR may cause serious side effects, including: increase risk of new cancer in HIV positive patients or your cancer coming back (reactivation). Stop using EGRIFTA WR if 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 WR. swelling (fluid retention). EGRIFTA WR can cause swelling in some parts of your body. Call your healthcare provider if you have swelling, an increase in joint pain or pain or numbness in your hands or wrist (carpal tunnel syndrome). Joint pain and swelling of your arms, hands, legs and feet are common side effects of EGRIFTA WR, but may sometimes be serious. increase in blood sugar (glucose) or diabetes. Your healthcare provider will check your blood sugar before you start taking EGRIFTA WR and during your treatment with EGRIFTA WR. serious allergic reaction. Some people using EGRIFTA WR may have an allergic reaction. Stop using EGRIFTA WR and get emergency medical 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 ○ itching ○ swelling of your face or throat ○ feeling of faintness or fainting ○ reddening or flushing of the skin injection site reactions. Injection site reactions are a common side effect of EGRIFTA WR but may sometimes be serious.Change (rotate) your injection site to help lower your risk for injection site reactions. Call your healthcare provider for medical advice if you have any of the following symptoms around the area of the injection site: ○ redness ○ irritation ○ swelling ○ itching ○ bruising or 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 WR include: • pain in legs and arms • muscle pain These are not all the possible side effects of EGRIFTA WR. 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 toll-free at 1-833-23THERA (1-833-238-4372). How should I store EGRIFTA WR 11.6 mg vials, Bacteriostatic Water for Injection, syringes, needles and alcohol swabs? You will be given two boxes (Medication Box and Injection Box) from the pharmacy when you get your prescription of EGRIFTA WR: Store the 11.6 mg EGRIFTA WR vials in the Medication Box they come in, at room temperature between 68°F to 77°F (20°C to 25°C). Store the Bacteriostatic Water for Injection, syringes, needles and alcohol swabs that come in the Injection Box at room temperature between 68°F to 77°F (20°C to 25°C). Keep EGRIFTA WR vials out of the light. Do not freeze. After mixing and injecting on the first day, keep the EGRIFTA WR vial in your Medication Box, at room temperature at 20°C to 25°C (68°F to 77°F). Throw away (discard) any unused EGRIFTA WR vial 7 days after mixing . Throw away (discard) any Bacteriostatic Water for Injection left in the bottle 28 days after first use . Do not use EGRIFTA WR after the expiration date (EXP) printed on the carton and vial labels. Keep EGRIFTA WR and all medicines out of the reach of children. General information about the safe and effective use of EGRIFTA WR. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EGRIFTA WR for a condition for which it was not prescribed. Do not give EGRIFTA WR 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 WR that is written for health professionals. What are the ingredients in EGRIFTA WR? Active ingredient: tesamorelin (as an acetate salt) Inactive ingredients: hydrochloric acid, hydroxypropyl betadex, mannitol, sodium hydroxide EGRIFTA WR does not contain any preservative. Bacteriostatic Water for Injection contains benzyl alcohol as preservative. Manufactured by Theratechnologies Inc., 2015 Peel Street, Suite 1100, Montréal, Québec, Canada H3A 1T8 US License No. 2091 for Theratechnologies Inc. For more information about EGRIFTA WR, go to www.EGRIFTAWR.com or call toll-free at 1-833-23THERA (1-833-238-4372). This ...
INSTRUCTIONS FOR USE SECTION
INSTRUCTIONS FOR USE SECTION
INSTRUCTIONS FOR USE EGRIFTA WR TM (tesamorelin) for injection for subcutaneous use Note: This Instructions for Use contains information on how to mix and inject the EGRIFTA WR 11.6 mg vial. Read and follow the steps for weekly mixing and daily injection of EGRIFTA WR 11.6 mg vial. Your healthcare provider should show you how to mix and inject 11.6 mg vial before you inject it for the first time. Ask your healthcare provider if you have any questions. Important Information You Need to Know Before Injecting EGRIFTA WR 11.6 mg vial For subcutaneous injection only (inject directly under the skin). There are two EGRIFTA formulations (EGRIFTA WR and EGRIFTA SV) with different recommended dosages. EGRIFTA WR and EGRIFTA SV are not substitutable. The recommended daily dose of EGRIFTA WR is 1.28 mg (0.16 mL). One (1) EGRIFTA WR 11.6 mg vial must be mixed with 1.3 mL of the Bacteriostatic Water for Injection to prepare for 7 doses [for 7 consecutive daily injections (Day 1 to Day 7) of treatment]. Do not share your syringe or needles with other people. You may give other people a serious infection or get a serious infection from them. Do not use a syringe or needle more than 1 time. If supplies are missing, damaged, or expired; or if you have any questions at any time during the mixing or the injection of EGRIFTA WR, call your pharmacist or toll-free at 1-833-23THERA (1-833-238-4372). Storing EGRIFTA WR Store the Medication Box at room temperature between 68°F to 77°F (20°C to 25°C) and keep the EGRIFTA WR vials out of the light. Store the Injection Box at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze or refrigerate EGRIFTA WR after it has been mixed with the Bacteriostatic Water for Injection. Keep EGRIFTA WR and all medicines out of the reach of children. Box Content Medication Box Supplies for 28 days: 4 single-patient use EGRIFTA WR 11.6 mg vials ( mix only 1 vial per week as per weekly mixing ) Injection Box Supplies for 28 days: 1 multiple-dose, 30 mL bottle of Bacteriostatic Water for Injection (to be used for weekly mixing) 4 sterile BD Plastipak TM 3 mL Syringes with needle attached (clear cap), for weekly mixing 33 sterile BD SafetyGlide TM syringes with needle attached (orange cap), for daily injection 1 box of 100 alcohol swabs Weekly Mixing (Day 1) Getting Started For Weekly Mixing of EGRIFTA WR, follow steps 1 through 23. For Daily Injection (Day 1 to Day 7), follow steps 24 through 49. Step 1: Use a well-lit, clean, and flat surface as a working area. Step 2: Take out the following: (See Figure B ) One (1) vial of EGRIFTA WR 11.6 mg One (1) 30 mL bottle of Bacteriostatic Water for Injection One (1) BD Plastipak TM 3 mL Syringe with needle attached (clear cap) for Weekly Mixing One (1) alcohol swab Sharps disposal container Step 3: Wash and dry your hands well. (See Figure C ) Step 4: Inspect the compact powder in the EGRIFTA WR vial. It should be white to off-white. (See Figure D ) Do not use the vial if the powder is discolored or has particles in it. Get a new vial, and call your healthcare provider, pharmacist, or contact toll free at 1-833-23THERA (1-833-238-4372). Step 5: Check the expiration dates (EXP) on the: (See Figure E ) 1) EGRIFTA WR vial label 2) Bacteriostatic Water for Injection bottle Do not use if expired. Step 6: Remove the plastic caps from the vial and the bottle . (See Figure F ) Step 7: Clean the top of both the vial and the bottle with an alcohol swab (See Figure G ). Throw away (discard) the alcohol swab after use. Preparing to Mix EGRIFTA WR Step 8: Take a BD Plastipak TM 3 mL Syringe with needle attached (clear cap) out of its packaging. (See Figure H ) Step 9: Pull the protective clear needle cap straight off and throw it away (discard) (See Figure I ). Make sure the needle is tightly screwed to the syringe. Do not twist the needle cap. Step 10: Pull down the plunger to reach the 11⁄2 mark (1.5 mL) on the syringe to fill it with air. (See Figure J ) Step 11: Insert the needle straight into the top of the Bacteriostatic Water for Injection bottle. (See Figure K ) Step 12: Turn the bottle and syringe upside down. (See Figure L ) Step 13: Push the plunger all the way up (See Figure M ). Some resistance may be felt. Step 14: Pull down the plunger slowly to reach the 11⁄2 mark (1.5 mL) on the syringe. A visible air pocket and tiny air bubbles in the syringe are normal. (See Figure N ) Step 15: Turn the bottle right side up and remove the needle. (See Figure O ) Step 16: Place the syringe upright and tap it with your finger to force any large air bubbles to rise to the top. (See Figure P ) Step 17: Push the plunger up slowly to remove 0.2 mL of excess water and air out of the syringe and align the top rim of the plunger to the 1.3 mL mark. Some water should come out of the needle. (See Figure Q ) If you have less than 1.3 mL, repeat step 10 to step 17 until 1.3 mL of water is in the syringe. Step 18: Put the Bacteriostatic Water for Injection bottle back in the Injection box for the next Weekly Mixing . (See Figure R ) Throw away (discard) the Bacteriostatic Water for Injection bottle after 28 days of use. Record the date of first use of the Bacteriostatic Water for Injection bottle as indicated on the back side of the Injection Box. The mixing and injection tracker provided inside the injection box can also be used to record this information. Mixing EGRIFTA WR Step 19: Insert the needle straight into the top of the EGRIFTA WR vial . (See Figure S ) Step 20: Push the plunger down until the syringe is completely empty. While keeping the plunger down, remove the needle from the vial. (See Figure T ) Step 21: Throw away (discard) the syringe and needle in the sharps container. (See Figure U ) Step 22: Move the vial in a circle (swirl) to mix all the powder and liquid. (See Figure V ) Do not shake the vial. Step 23: Let the vial rest for a few seconds until the layer of foam separates and the solution becomes clear and colorless, with no particles in it. (See Figure W ) Do not use the vial if after a few seconds the solution looks cloudy, is discolored, or has particles in it. Get another vial, and call your healthcare provider, pharmacist, or contact toll free at 1-833-23THERA (1-833-238-4372). Daily Injection (DAY 1 TO DAY 7) Preparing to Inject EGRIFTA WR Step 24: For daily injection of EGRIFTA WR (step 24 through step 49), you will need: (See Figure X ) One (1) mixed and clear solution of EGRIFTA WR ( prepared during the Weekly Mixing ) One (1) BD SafetyGlide TM syringe with needle attached (orange cap) for injection Two (2) alcohol swabs One (1) sterile gauze pad One (1) adhesive bandage Sharps disposal container Step 25: Wash and dry your hands well. (See Figure Y ) Step 26: Clean the top of the EGRIFTA WR vial with an alcohol swab (See Figure Z ). Throw away (discard) the alcohol swab after use. Step 27: Take a BD SafetyGlide TM syringe with needle attached (orange cap) out of its packaging. (See Figure AA ) Step 28: Twist the orange needle cap to clearly see the graduated markings on the syringe, if needed. (See Figure AB ) Step 29: Pull the orange needle cap straight off and keep it aside. (See Figure AC ) Do not touch the needle. Step 30: Insert the needle carefully and straight into the top of the vial to avoid bending the needle. (See Figure AD ) If you bend the needle, use a new syringe. Step 31: Turn the vial and syringe upside down. (See Figure AE ) Step 32: Pull down the plunger slowly to reach the 18 mark (0.18 mL) . (See Figure AF ) If you do not have enough liquid in the syringe, repeat step 30 and step 31 . Step 33: Turn the vial right side up and remove the needle. (See Figure AG ) Step 34: Place the syringe upright and tap it with your finger to force any air bubbles to rise to the top. (See Figure AH ) Step 35: Hold the plunger rod half-way to carefully adjust the volume in step 36 . (See Figure AI ) Step 36: Adjust the plunger to reach exactly the 16 mark (0.16 mL) by slowly pushi...
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel - Medication Box Rx only MEDICATION BOX (Box 1 of 2) NDC 62064-381-04 4 vials EGRIFTA WR TM (tesamorelin) for injection 11.6 mg/vial For Subcutaneous Use Single-patient-use vial Sterile lyophilized powder New Formulation, Dose, Mixing Instructions, and Storage One (1) mixed EGRIFTA WR vial provides daily doses for seven (7) days EGRIFTA WR and EGRIFTA SV are not substitutable. THERA technologies
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel - Injection Box INJECTION BOX (Box 2 of 2) For use only with EGRIFTA WR TM (tesamorelin) for injection 11.6 mg/vial (NDC 62064-381-04) New Formulation, Dose Mixing Instructions, and Storage One (1) mixed EGRIFTA WR vial provides daily doses for seven (7) days READ BEFORE OPENING BOX This INJECTION BOX does NOT contain your EGRIFTA WR (tesamorelin) for injection 11.6 mg/vial. Make sure you also have the EGRIFTA WR 11.6 mg/vial MEDICATION BOX. CONTENTS OF INJECTION BOX: - 1 Instructions for Use and Patient Information - 1 multiple-dose, 30 mL bottle of Bacteriostatic Water for Injection - 4 sterile BD PlastipakTM 3 mL syringes with needle attached - 33 sterile BD SafetyGlideTM syringes with needle attached - 1 box of 100 alcohol swabs EGRIFTA WR and EGRIFTA SV are not substitutable. For Weekly Mixing and Daily Injection, refer to Instructions for Use. Store at room temperature at 20°C to 25°C (68°F to 77°F). Rx only THERA technologies
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Principal Display Panel - 11.6 mg Vial Label EGRIFTA WRTM (tesamorelin) for injection 11.6 mg/vial NDC 62064-381-01 Rx only STERILE Store at 20°C to 25°C (68°F to 77°F). For Subcutaneous Use Single-patient-use vial The daily recommended dose is 1.28 mg (0.16 mL). Mfd. by Theratechnologies Inc. US License No. 2091
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