1 INDICATIONS AND USAGE

EGRIFTA 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 has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue.
• EGRIFTA 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.

2 DOSAGE AND ADMINISTRATION

3 DOSAGE FORMS AND STRENGTHS

EGRIFTA for injection is supplied in a single-dose 1 mg vial as a white to off-white lyophilized powder and a diluent of 10 mL Sterile Water for Injection, USP.

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

6 ADVERSE REACTIONS

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

8 USE IN SPECIFIC POPULATIONS

11 DESCRIPTION

EGRIFTA contains tesamorelin (as the acetate salt), a human growth hormone-releasing factor (hGHRF) analog. The peptide precursor of tesamorelin acetate is produced synthetically and is comprised of the 44 amino acid sequence of human GHRF. Tesamorelin acetate is made by attaching a hexenoyl moiety, a C6 chain with a double bond at position 3, to the tyrosine residue at the N-terminal part of the molecule. The molecular formula of tesamorelin acetate is C221H366N72O67S • x C2H4O2 (x ≈ 7) and its molecular weight (free base) is 5135.9 Daltons. The structural formula of tesamorelin acetate is:

EGRIFTA is a sterile, white to off-white, preservative-free lyophilized powder for subcutaneous injection. After reconstitution with the supplied diluent (Sterile Water for Injection, USP), the solution is clear and colorless. Each single-dose vial of EGRIFTA contains 1 mg of tesamorelin (equivalent to 1.1 mg of tesamorelin acetate) and the following inactive ingredient: 50 mg mannitol, USP.

12 CLINICAL PHARMACOLOGY

13 NONCLINICAL TOXICOLOGY

14 CLINICAL STUDIES

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) <150 mg/dL (8.33 mmol/L). Main exclusion criteria included BMI ≤ 20 kg/m2, type 1 diabetes mellitus, type 2 diabetes mellitus, previous treatment with insulin or with oral hypoglycemic or insulin-sensitizing agents, history of malignancy, and hypopituitarism. Patients were on a stable anti-retroviral regimen for at least 8 weeks prior to randomization. Patients meeting the inclusion/exclusion criteria were randomized in a 2:1 ratio to receive a 2 mg dose of EGRIFTA (1 mg/vial formulation) or placebo subcutaneously daily for 26 weeks. The primary efficacy assessment for each of these studies was the percent change from baseline to Week 26 in visceral adipose tissue (VAT), as assessed by computed tomography (CT) scan at L4-L5 vertebral level. Secondary endpoints included changes from baseline in patient-reported outcomes related to body image, triglycerides, ratio of total cholesterol to HDL cholesterol, IGF-1 levels, and safety parameters. Other endpoints included changes from baseline in waist circumference, abdominal subcutaneous tissue (SAT), trunk fat, and lean body mass. In both studies, EGRIFTA-treated patients completing the 26-week treatment period were re-randomized to blinded therapy with either daily placebo or a 2 mg dose of EGRIFTA (1 mg/vial formulation) for an additional 26-week treatment period (Extension Phase) in order to assess maintenance of VAT reduction and to gather long-term safety data. For inclusion in the Extension Phase studies, subjects must have completed the Main Phase with FBG ≤ 150 mg/dL.

Main Phase (Baseline to Week 26):

Study 1 (NCT 00123253): This study randomized 412 HIV-infected patients with lipodystrophy and excess abdominal fat to receive either a 2 mg dose of EGRIFTA (1 mg/vial formulation) (N=273) or placebo (N=137). At baseline for the two groups combined, mean age was 48 years; 86% were male; 75% were white, 14% were Black/African American, and 8% were Hispanic; mean weight was 90 kg; mean BMI was 29 kg/m2; mean waist circumference was 104 cm; mean hip circumference was 100 cm; mean VAT was 176 cm2; mean CD4 cell count was 606 cells/mm3; 69% had undetectable viral load (<50 copies/mL); and 33.7% randomized to EGRIFTA and 36.6% randomized to placebo had impaired glucose tolerance, while 5.6% randomized to EGRIFTA and 6.7% randomized to placebo had diet-controlled diabetes mellitus. The twenty-six week completion rate in Study 1 was 80%.

Study 2 (NCT 00435136): This study randomized 404 HIV-infected patients with lipodystrophy and excess abdominal fat to receive either a 2 mg dose of EGRIFTA (1 mg/vial formulation) (N=270) or placebo (N=126). At baseline for the two groups combined, mean age was  48 years; 84% were male; 77% were white, 12% were Black/African American, and 9% were Hispanic; mean weight was 88 kg; mean BMI was 29 kg/m2; mean waist circumference was 105 cm; mean hip circumference was 100 cm; mean VAT was 189 cm2; mean CD4 cell count was 592 cells/mm3; 83% had undetectable viral load (<50 copies/mL); and 44% randomized to EGRIFTA and 40% randomized to placebo had impaired glucose tolerance, while 9.3% randomized to EGRIFTA and 10% randomized to placebo had diet-controlled type 2 diabetes mellitus. The twenty-six week completion rate in Study 2 was 74%.

Results for the Main Phases of Studies 1 and 2 are presented in Tables 2 and 3.

Table 2: Changes from Baseline to Week 26 in Visceral Adipose Tissue (cm2) by Treatment Group (Intent-To-Treat Population with Last Observation Carried Forward)

Baseline data are expressed as mean (SD); Change refers to least-squares mean (LSM); CI: confidence interval.
1 Results derived from the statistical model: Ln(VAT Week 26/VAT Baseline) = Ln(VAT Baseline) + treatment group
MAIN PHASE (Baseline-Week 26)
		Study 1		Study 2
		2 mg EGRIFTA (1 mg/vial) (N=273)	Placebo (N=137)	2 mg EGRIFTA (1 mg/vial) (N=270)	Placebo (N=126)
Baseline (cm2)		178 (77)	171 (77)	186 (87)	195 (95)
Change (cm2)		-27	4	-21	-0
Mean treatment difference (95% CI)		-31 (-39,-24)		-21 (-29,-12)
Mean change (%)1		-18	2	-14	-2
Mean treatment difference (95% CI)1		-20 (-24, -15)		-12 (-16, -7)

Table 3: Changes from Baseline to Week 26 in IGF-1, IGFBP-3, Weight, and Waist Circumference by Treatment Group (Intent-To-Treat Population with Last Observation Carried Forward)

Baseline data are expressed as mean (SD); Change refers to least-squares mean (LSM); CI: confidence interval.
MAIN PHASE (Baseline-Week 26)
		Study 1		Study 2
		2 mg EGRIFTA (1 mg/vial) (N=273)	Placebo (N=137)	2 mg EGRIFTA (1 mg/vial) (N=270)	Placebo (N=126)
IGF-1 (ng/mL)	Baseline	161 (59)	168 (75)	146 (66)	149 (59)
	Change	107	-15	108	3
	Mean treatment difference (95% CI)	122 (101, 141)		105 (85, 126)
IGFBP-3 (mg/L)	Baseline	3 (1)	3 (1)	3 (1)	3 (1)
	Change	0.4	-0.2	0.8	-0.0
	Mean treatment difference (95% CI)	0.6 (0.5, 0.8)		0.8 (0.5, 1.0)
Weight (kg)	Baseline	90 (14)	90 (14)	89 (14)	87 (16)
	Change	-0.4	0.0	0.5	0.3
	Mean treatment difference (95% CI)	-0.4 (-1.3, 0.5)		0.2 (-0.7, 1.3)
Waist circumference (cm)	Baseline	104 (10)	105 (9)	105 (9)	105 (9)
	Change	-3 (5)	-1 (4)	-2 (5)	-1 (5)
	Mean treatment difference (95% CI)	-2 (-2.8, -0.9)		-1 (-2.5, -0.3)

At Week 26, treatment with a 2 mg dose of EGRIFTA (1 mg/vial formulation) resulted in a reduction from baseline in mean trunk fat of 1.0 kg in Study 1 and 0.8 kg in Study 2, respectively (compared with an increase of 0.4 kg in Study 1 and of 0.2 kg in Study 2, respectively, in patients receiving placebo).  Treatment with EGRIFTA resulted in an increase from baseline in mean lean body mass of 1.3 kg in Study 1 and of 1.2 kg in Study 2, respectively (compared with a decrease of 0.2 kg in Study 1 and of 0.03 kg in Study 2, respectively, in patients receiving placebo).

Patient Reported Outcomes

Patients rated the degree of distress associated with their belly appearance on a 9-point rating scale that was then transformed to a score from 0 (extremely upsetting and distressing) to 100 (extremely encouraging). A score of 50 indicated neutral (no feeling either way). A positive change from baseline score indicated improvement, i.e., less distress.

The cumulative distribution of response (change from baseline to 26 weeks) is shown in Figure 1 for both treatment groups. A curve shifted to the right on this scale indicates a greater percentage of patients reporting improvement.

Figure 1. Cumulative Distribution of Response for Belly Appearance Distress

Extension Phase (Weeks 26-52):

In the double-blind Extension Phase, patients on a 2 mg dose of EGRIFTA (1 mg/vial formulation) completing the 26-week Main Phase were re-randomized to receive a 2 mg dose of EGRIFTA or placebo.

Study 1 (NCT 00123253)

This study re-randomized 207 HIV-infected patients with lipodystrophy who completed a 2 mg dose of EGRIFTA (1 mg/vial formulation) in the Main Phase to receive either EGRIFTA(N=154) or placebo (N=50) for an additional 26-week duration (3:1 randomization ratio). At baseline (Week 26) for the two groups combined, mean age was  48 years; 88% were male; 78% were white, 12% were Black/African American, and 8% were Hispanic; mean weight was 90 kg; mean BMI was 29 kg/m2; mean waist circumference was 102 cm; mean hip circumference was 100 cm; mean VAT was 145 cm2; mean CD4 cell count was 639 cells/mm3;68% had undetectable viral load (<50 copies/mL); and for those EGRIFTA-treated patients completing the 26-week treatment period that were re-randomized to EGRIFTA (T-T group) or re-randomized to placebo, 37% and  32%, respectively, had impaired glucose tolerance, while 2% re-randomized to EGRIFTA and 6% re-randomized to placebo had diet-controlled type 2 diabetes mellitus. The completion rate for patients randomized into the extension phase of Study 1 was 83%.

Study 2 (NCT 00435136)

This study re-randomized 177 HIV-infected patients with lipodystrophy who completed EGRIFTA treatment in the Main Phase to receive either a 2 mg dose of  EGRIFTA (1 mg/vial formulation) (N=92) or placebo (N=85) for an additional 26-week duration (1:1 randomization ratio). At baseline (Week 26) for the two groups combined, mean age was 48 years; 90% were male; 84% were white, 9% were Black/African American, and 7% were Hispanic; mean weight was 89 kg; mean BMI was 28 kg/m2; mean waist circumference was 105 cm; mean hip circumference was 100 cm; mean VAT was 172 cm2; mean CD4 cell count was  579 cells/mm3; 82% had undetectable viral load (<50 copies/mL); and for those EGRIFTA-treated patients completing the 26-week treatment period that were re-randomized to EGRIFTA (T-T group) or re-randomized to placebo, 49% and 51%, respectively, had impaired glucose tolerance, while 4% re-randomized to EGRIFTA and 13% re-randomized to placebo had diet-controlled diabetes mellitus. The completion rate for patients randomized into the extension phase of Study 2 was 81%.

Results for the Extension Phases of Studies 1 and 2 are presented in Tables 4 and 5.

Table 4: Changes from Week 26 Baseline to Week 52 in Visceral Adipose Tissue (cm2) by Treatment Group (Intent-To-Treat Population with Last Observation Carried Forward)

Week 26 baseline data are expressed as mean (SD). Change refers to least-squares mean (LSM); CI: confidence interval.
1T-T = tesamorelin for Weeks 0-26 and tesamorelin for Weeks 26-52
2T-P = tesamorelin for Weeks 0-26 and placebo for Weeks 26-52
3Results derived from the statistical model: Ln(VAT Week 52/Week 26) = Ln(Week 26 VAT) + treatment group
EXTENSION PHASE (Week 26-52)
	Study 1		Study 2
	T-T1 (Week 26-52) (N=154)	T-P2 (Week 26-52) (N=50)	T-T1 (Week 26-52) (N=92)	T-P2 (Week 26-52) (N=85)
Week 26 (cm2)	145 (72)	144 (72)	166 (89)	177 (88)
Change (cm2)	3	25	-11	24
Mean treatment difference (95% CI)	-22 (-34, -10)		-35 (-48, -22)
Mean change (%)3	0	22	-5	16
Mean treatment difference (95% CI)3	-17 (-24, -10)		-18 (-24, -11)

Figure 2 shows the percent change in VAT from baseline (Week 0) over time until 52 weeks in completer patients.

Figure 2. Percent Change from Baseline in VAT over Time

Data in Figure 2 are expressed as mean values. T-T (tesamorelin to tesamorelin) refers to the group of patients who received tesamorelin for Weeks 0-26 and were re-randomized to tesamorelin for Weeks 26-52. T-P (tesamorelin to placebo) refers to the group of patients who received tesamorelin for Weeks 0-26 and were re-randomized to placebo for Weeks 26-52. P-T (placebo to tesamorelin) refers to the group of patients who received placebo for Weeks 0-26 and were switched to tesamorelin (treated open label) for Weeks 26-52.

Table 5: Changes from Week 26 Baseline to Week 52 in IGF-1, IGFBP-3, Weight, and Waist Circumference by Treatment Group (Intent-To-Treat Population with Last Observation Carried Forward)

Week 26 baseline data are expressed as mean (SD); Change refers to least-squares mean (LSM); CI: confidence interval.
1T-T = tesamorelin for Week 0-26 and tesamorelin for Week 26-52
2T-P = tesamorelin for Week 0-26 and placebo for Week 26-52
EXTENSION PHASE (Weeks 26-52)
		Study 1		Study 2
		T-T1 (Week 26-52) (N=154)	T-P2 (Week 26-52) (N=50)	T-T1 (Week 26-52) (N=92)	T-P2 (Week 26-52) (N=85)
IGF-1 (ng/mL)	Week 26	291 (124)	281 (105)	280 (134)	269 (110)
	Change	-59	-137	-25	-135
	Mean treatment difference (95% CI)	78 (50, 106)		110 (87, 134)
IGFBP-3 (mg/L)	Week 26	3 (1)	3 (1)	3 (1)	3 (1)
	Change	-0.2	-0.5	-0.3	-0.9
	Mean treatment difference (95% CI)	0.3 (-0.0, 0.6)		0.6 (0.3, 0.9)
Weight (kg)	Week 26	89 (14)	92 (17)	89 (13)	90 (14)
	Change	0.2	0.6	-0.5	0.1
	Mean treatment difference (95% CI)	-0.4 (-2, 1)		-0.6 (-2, 1)
Waist circumference (cm)	Week 26	101 (10)	102 (12)	101 (9)	103 (11)
	Change	-0.2	2.4	-1.1	0.2
	Mean treatment difference (95% CI)	-2.6 (-4, -1)		-1.3 (-2, 0)

Patients treated with a 2 mg dose of EGRIFTA (1 mg/vial formulation) for 52 weeks (T-T group) showed no change between Weeks 26 and 52 in mean trunk fat (increase of 0.1 kg in Study 1 and decrease of 0.5 kg in Study 2, respectively, compared with an increase of 1.4 kg in patients in the T-P group in Study 1 and an increase of 1.09 kg in Study 2, respectively) nor was there a change from Week 26 baseline in mean lean body mass (decrease of 0.1 kg in Study 1 and increase of 0.1 kg in Study 2, respectively, compared with a decrease of 1.8 kg in patients in the T-P group in Study 1 and a decrease of 1.7 kg in Study 2, respectively).

16 HOW SUPPLIED/STORAGE AND HANDLING

EGRIFTA for injection is supplied as a white to off-white lyophilized powder in a 1 mg single-dose vial with a diluent of 10 mL vial of Sterile Water for Injection, USP.

EGRIFTA (NDC 62064-011-60) is available in a package comprised of two boxes containing 60 (sixty) 1 mg single-dose vials of EGRIFTA in the Medication Box and a 30 single-dose 10 mL bottles of Sterile Water for Injection, USP diluent with a 30 day supply of disposable syringes, and needles in the Injection Box.

Protect EGRIFTA from light and keep in the original box until time of use. Store EGRIFTA 1 mg/vial at refrigerated temperature, between 2°C to 8°C (36°F to 46°F).  Store the Sterile Water for Injection, USP, syringes and needles at controlled room temperature of 20°C to 25°C (68°F to 77°F).

17 PATIENT COUNSELING INFORMATION

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 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 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 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. Advise patients to seek prompt medical attention and to immediately discontinue treatment with EGRIFTA if a reaction occurs [see Warnings and Precautions (5.5)].

Injection Site Reactions

Inform patients that injection site reactions may occur with EGRIFTA, 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 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 should be instructed not to breastfeed [see Use in Specific Populations (8.2)].

Administration

Counsel patients that they should never share an EGRIFTA 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.

This Patient Information has been approved by the U.S. Food and Drug Administration                                         Revised: 07/2019

Instructions for Use

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

This Instructions for Use contains step-by-step information on how to use the 1 mg vial of EGRIFTA. Two vials of EGRIFTA 1 mg must be mixed with a total of 2.2 mL of the Sterile Water for Injection provided in the Injection Box given to you by the pharmacy. You need two EGRIFTA 1 mg vials from the Medication Box to prepare your dose.  The recommended dose is 2 mg (2 mL).

Be sure that you read, understand, and follow this 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 Instructions for Use in case you need to look at it again later.

Important information for use of EGRIFTA

• Do not use a syringe or needle more than 1 time.
• Do not share your 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. 

• If you are missing any supplies from the boxes given to you by the pharmacy or if any of the supplies look damaged, call your pharmacist or contact THERA patient supportTM toll-free at 1-833-23THERA (1-833-238-4372) 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 60 EGRIFTA 1 mg single-dose vials
• Injection Box that contains the following:
  • 30 single-dose 10 mL bottles of Sterile Water for Injection, used for mixing
  • 30 sterile 3 mL syringes with sterile needle attached
  • 30 1½” 18-gauge sterile needles, used for mixing
  • 30 ½” 27-gauge sterile needles, used for injection
• Other Supplies Needed
  • Two alcohol pads
  • One sterile gauze
  • One adhesive bandage
  • Sharps disposal container or a puncture resistant container for throwing away used needles and syringes after you are done with them. (See “How should I dispose of the used syringes, needles, bottles and vials?”)

For each injection using EGRIFTA 1 mg vial you will need: (See Figure A)

Figure A

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

• One Sterile Water for Injection bottle
• One 3 mL syringe with needle attached
• One 1½" 18-gauge needle used for mixing 
• One ½" 27-gauge needle used for injection 

Step 4: Take 2 vials of EGRIFTA 1 mg 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 both of the EGRIFTA 1 mg vials and the Sterile Water for Injection bottle.
• Clean the rubber stoppers on the top of both of the EGRIFTA 1 mg vials and Sterile Water for Injection bottle with an alcohol pad.

How to mix EGRIFTA 1 mg vial

Step 1: Pick up the 3 mL syringe with the needle attached. Carefully remove the protective needle cap by pulling it straight off. Do not twist the needle cap. 
Insert the needle through the rubber stopper of the Sterile Water for Injection bottle. (See Figure B)

Figure B

Step 2: With the needle still in the Sterile Water for Injection bottle, turn the bottle and syringe upside down.
Pull back the plunger until the Sterile Water reaches the 2.2 mL mark on the syringe. (See Figure C)

Figure C

• Throw away the bottle containing the unused Sterile Water for Injection. (See “How should I dispose of the used syringes, needles, bottles and vials?”)

Step 3: Remove the syringe with needle attached from the Sterile Water bottle.
Insert the needle into the rubber stopper of one of the EGRIFTA 1 mg vials.
With the needle at a slight angle, slowly push the plunger of the syringe all the way down so that the Sterile Water goes down the inside wall of the EGRIFTA 1 mg vial instead of directly onto the powder to avoid foaming. (See Figure D)

Figure D

Step 4: While keeping the syringe with needle attached in the EGRIFTA 1 mg 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

Step 5: With the needle still in the EGRIFTA 1 mg vial, turn the vial and syringe upside down. Pull the syringe back until you see just the tip of the needle going through the rubber stopper.
Pull back on the plunger of the syringe until all of the liquid inside the vial is in the syringe. The medicine should be at around the 2.2 mL mark on the syringe. (See Figure F)

Figure F

Step 6: Remove the needle from the vial. (See Figure G)

Figure G

Step 7: Place the protective needle cap on its side on a clean flat surface. Without touching the needle, hold the syringe and slide the needle carefully into the needle cap. (See Figure H) 

Figure H

Step 8: Push the protective needle cap all the way in or until it snaps shut (See Figure I). Do not touch the needle cap until it covers the needle completely.

Figure I

Step 9: With the protective needle cap securely on the needle, remove the needle by holding the syringe firmly and twisting the needle cap counterclockwise (to the left). (See Figure J)
Throw away the needle. (See "How should I dispose of the used syringes, needles, bottles and vials?")

Figure J

Step 10: Place the 1½" 18-gauge needle to be used for mixing, with its protective needle cap in place, onto the syringe. Hold the syringe firmly and twist the needle cap clockwise (to the right) until it closes securely. (See Figure K)

Figure K

Step 11: Carefully remove the protective needle cap by pulling it straight off. Do not twist the needle cap.
Insert the needle into the rubber stopper of the second EGRIFTA 1 mg vial. With the needle at a slight angle, slowly push the plunger of the syringe all the way down so that the liquid goes down the inside wall of the EGRIFTA vial instead of directly onto the powder to avoid foaming. (see Figure L).

Figure L

Step 12: While keeping the syringe with the needle attached in the EGRIFTA 1 mg 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 M)

Figure M

Note:

• After mixing, the solution 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.
• Call your healthcare provider, pharmacist, or contact THERA patient supportTM toll-free at 1-833-23THERA (1-833-238-4372) right away if the solution is cloudy, discolored, or contains particles.

Step 13: With the needle still in the EGRIFTA 1 mg vial, turn the vial and syringe upside down. Pull the syringe back until you see just the tip of the needle going through the rubber stopper.
Pull back on the plunger of the syringe until all of the liquid inside the vial is in the syringe. The medicine should be at around the 2.2 mL mark on the syringe. (See Figure N)

Figure N

Step 14: Remove the needle from the vial. (See Figure O)

Figure O

Step 15: Place the protective needle cap on its side on a clean flat surface. Without touching the needle, hold the syringe and slide the needle carefully into the needle cap. (See Figure P)

Figure P

Step 16: Push the protective needle cap all the way in or until it snaps shut (See Figure Q). Do not touch the needle cap until it covers the needle completely.

Figure Q

Step 17: With the protective needle cap securely on the needle, remove the needle by holding the syringe firmly and twisting the needle cap counterclockwise (to the left). (See Figure R)
Throw away the needle. (See "How should I dispose of the used syringes, needles, bottles and vials?")

Figure R

Step 18: Place the ½" 27-gauge needle to be used for your injection, with its protective needle cap and pink needle shield in place, onto the syringe. Hold the syringe firmly and twist the needle cap and pink needle shield clockwise (to the right) until it closes securely. (See Figure S)

Figure S

Where do I inject EGRIFTA 1 mg vial?

Inject EGRIFTA into the stomach-area (abdomen). (See Figure T)

• Choose an injection site that is at least 2 inches (5 cm) away from your belly button. (See the shaded area in Figure T)
• Do not inject into areas with scar tissue or bruises.
• Do not inject into your belly button.
• Avoid areas with any hard bumps from previous injections.
• Rotate the site for each injection. This may help prevent bruising or irritation. You may want to write down the date and location of each daily injection to help you remember.
  

  

Figure T

How to inject your 2 mg dose of EGRIFTA

Do not remove the needle cap until you are ready to inject.

Step 1: Hold the syringe with the needle facing up. Pull the pink needle shield down away from the protective needle cap.

Carefully remove the needle cap by pulling it straight off the needle. Do not twist the needle cap. (See Figure U)

Do not touch the needle.

Figure U

Step 2: Tap the syringe gently with your finger to force any air bubbles to rise to the top. Slowly push up on the plunger to remove any air and bubbles and until the medicine in the syringe is at the 2 mL mark of the syringe. (See Figure V)

Figure V

Step 3: Clean the injection site you have selected with an alcohol pad and let it dry. Hold the syringe in one hand. With your other hand, gently pinch a fold of skin at your cleaned injection site. Hold the skin between your thumb and fingers. (See Figure W)

Figure W

Step 4: Hold the syringe at a 90 degree angle to the skin.
With a quick, dart-like motion, insert the needle into the skin. Most of the needle should go beneath the skin. (See Figure X)

Figure X

Step 5: Remove your hand from the pinched area of skin after the needle is inserted. Be careful not to remove the needle from the skin.

Step 6: Slowly push the plunger of the syringe all the way down until all of the medicine in the syringe has been injected. (See Figure Y)

Figure Y

Pull the needle out of your skin. Be careful to pull the needle out at the same angle as it was inserted.

Step 7: While holding the syringe in one hand, gently press the pink needle shield against a hard, flat surface until you hear a “click” and the injection needle is covered by the pink needle shield. (See Figure Z)

Figure Z

• Apply pressure to the injection site with gauze for 30 seconds. If there is bleeding, apply an adhesive bandage to the site.
• Throw away the syringe. (See "How should I dispose of the used syringes, needles, bottles and vials?")

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

• Do not recap 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 syringes. 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 not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
• If another person receives a needle stick with a used needle, that person should be told to contact a healthcare provider right away.
• Keep the sharps container away from children and pets.

How should I store EGRIFTA 1 mg vials, Sterile Water for Injection, syringes and needles?

• You will be given 2 boxes from the pharmacy when you get your prescription of EGRIFTA:
  
  • Store the 1 mg EGRIFTA vials in the Medication Box they come in, in the refrigerator between 36°F to 46°F (2°C to 8°C).
  • Store the Sterile Water for Injection, syringes and needles that come in the Injection Box at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep EGRIFTA vials out of the light.
• After mixing, use EGRIFTA right away. Throw away any unused EGRIFTA after mixing.
• Do not store, freeze or refrigerate EGRIFTA after it has been mixed with the Sterile Water.
• Throw away any Sterile Water for Injection left in the bottle after use.
• Do not use EGRIFTA after the expiration date (EXP) printed on the carton and vial labels.

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

EGRIFTA® is a registered trademark of Theratechnologies Inc.

Distributed by: Theratechnologies Inc., Montréal, Québec, Canada H3A 1T8

Revised: 07/2019

Principal Display Panel - Medication Box

MEDICATION BOX

(Box 1 of 2)

NDC 62064-011-60

1 mg/vial

Rx only

EGRIFTA

tesamorelin for injection

For subcutaneous injection only

EGRIFTA 1 mg/vial Formulation, Dose,
Mixing Instructions, and Storage conditions are different
than the EGRIFTA SV™ 2 mg/vial Formulation.

Important: Refer to Patient Instructions for Use.

Use 2 vials of EGRIFTA 1 mg to prepare the recommended
dose of 2 mg (2 mL of the reconstituted solution).

READ BEFORE OPENING BOX:

This is the MEDICATION BOX – it contains 60 vials of
EGRIFTA 1 mg/vial and the Patient Instructions for Use.

You will also need the INJECTION BOX for EGRIFTA 1 mg/vial –
it contains syringes and other materials needed for reconstitution
and administration.

Protect
from light.
Keep in
original box.

Store
refrigerated
at 2°C to 8°C
(36°F to 46°F)

60 vials

THERAtechnologies

EGRIFTA® is a registered trademark
of Theratechnologies Inc.

EGRIFTA SV™ is a trademark of
Theratechnologies Inc.

Principal Display Panel - Injection Box

INJECTION BOX (Box 2 of 2)

For ​EGRIFTA​ 1 mg/vial (tesamorelin for injection)

For mixing, refer to Patient
Instructions for Use included
in the EGRIFTA® ​1 mg/vial
Medication Box.

Rx Only

READ BEFORE OPENING BOX

This is your INJECTION BOX for EGRIFTA (tesamorelin for injection) 1 mg/vial.
This box contains sterile syringes, Sterile Water for Injection USP, and materialsneeded for injecting EGRIFTA®.

Note this INJECTION BOX does NOT contain your EGRIFTA 1 mg/vial medication.

Before removing contents, make sure you also have the EGRIFTA 1 mg/vial
MEDICATION BOX.

Contents of INJECTION BOX:

a) 30 single-dose, 10 mL bottles of Sterile Water for Injection

b) 30 sterile, 3-mL syringes with needle already attached

c) 30 individual 1½" 18-gauge sterile needles used for mixing

d) 30 individual ½" 27-gauge sterile injection needles

Store at
controlled room
temperature
20°C to 25°C
(68°F to 77°F).

Made in USA

Distributed by Theratechnologies Inc., Montréal, Québec, H3A 1T8, Canada

THERAtechnologies

EGRIFTA® is a registered trademark of Theratechnologies Inc.

EGRIFTA SV™ is a trademark of Theratechnologies Inc.

Principal Display Panel - 1 mg Vial Label

Refer to Instructions for Use

EGRIFTA®

tesamorelin for injection

1 mg/vial

Rx only

STERILE

Store at
36°F to 46°F

For subcutaneous injection only

Each vial contains 1.1 mg of tesamorelin acetate

Single-Dose Vial - Discard Unused Portion

Distributed by Theratechnologies Inc.

XXXXXX