Patient information: uses, side effects, how to take - Egrifta Sv

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 Patient Information has been approved by the U.S. Food and Drug Administration Revised: 03/2025

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^TM3 mL Syringes with needle attached (clear cap), for weekly mixing
33 sterile BD SafetyGlide^TMsyringes 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^TM3 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^TM3 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 1½ 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 1½ 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^TMsyringe 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^TMsyringe 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 pushing the plunger up to remove air and excess liquid from the syringe (See Figure AJ). Some resistance may be felt when pushing the plunger.

No air pockets should be left.

Note: This is your recommended daily dose of EGRIFTA WR: 1.28 mg (0.16 mL).

Step 37: Safely place the orange needle cap on the needle. (See Figure AK)

Step 38: Keep the mixed EGRIFTA WR vial for the next Daily Injections in the Medication Box at room temperature up to 77°F (25°C). (See Figure AL)

Injecting EGRIFTA WR

Step 39: Choose an injection site on the stomach area (abdomen) that is at least 2 inches (5 cm) away from your belly button. (See the green area in Figure AM)

Do not inject into your belly button, nor on areas with scar tissue, bruises or on any hard bumps from previous injections.
Rotate the site for each injection. This may help prevent bruising or irritation.

Step 40: Clean the injection site with a new alcohol swab and let it dry. (See Figure AN)

Step 41: Remove the orange needle cap and throw it away (discard). (See Figure AO)

Do not touch the needle.
Do not move the plunger.

Step 42: Pinch a fold of skin at your cleaned injection site between your thumb and fingers. (See Figure AP)

Step 43: Insert the needle straight into the skin. (See Figure AQ)

Step 44: Remove your hand from the pinched area of skin, while keeping the needle in the skin. (See Figure AR)

Step 45: Push the plunger all the way down until all the medicine in the syringe has been injected under the skin. (See Figure AS)

Step 46: Pull the needle out. (See Figure AT)

Step 47: Hold the syringe and carefully slide up the white safety needle shield along the needle until you hear a "click". (See Figure AU)

Step 48: Throw away (discard) the syringe with the needle attached into the sharps container. (See Figure AV)

Step 49: If there is bleeding at the injection site, use gauze to apply pressure and apply an adhesive bandage if necessary.

For the next Daily Injection (Day 2 to Day 7) go directly to step 24 of this Instructions for Use.

Throw away (discard) the EGRIFTA WR vial after it has been used for 7 Daily Injections (DAY 1 TO DAY 7).

Disposing of EGRIFTA WR

Do not recap the needle with the needle cap after you inject EGRIFTA WR.
Throw away (discard) the EGRIFTA WR vial after it has been used for 7 Daily Injections (DAY 1 TO DAY 7).
Throw away (discard) the Bacteriostatic Water for Injection bottle after 28 days of use.
Put your used EGRIFTA WR needles and syringes in an 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 an 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 FDAs website at: https://www.fda.gov/safesharpsdisposal.
Do not throw away (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.
If you have any questions, call your healthcare provider, or you can call toll free at 1-833-23THERA (1-833-238-4372) for more information.

Manufactured by: Theratechnologies Inc., 2015 Peel Street, Suite 1100, Montréal, Québec, Canada H3A 1T8

Revised: March 2025

EGRIFTA WR is a trademark of Theratechnologies Inc.

Egrifta Sv: Uses, Side Effects and Dosage