Egrifta SV (Tesamorelin) - Subcutaneous

What Is Egrifta SV?

Egrifta SV (tesamorelin) is a prescription medication used to treat lipodystrophy (abnormal fat changes) in people with human immunodeficiency virus (HIV). Egrifta SV is not a weight-loss medication and should not be used to treat obesity.

Egrifta SV is a growth hormone releasing factor (GHRF). It attaches to certain receptors (binding sites) of the pituitary gland in the brain. This attachment encourages the gland to make and release naturally-occurring growth hormone.

Growth hormone interacts with different receptors on numerous cells, including fat cells. Growth hormone may relieve HIV-related lipodystrophy symptoms by lowering the amount of fat in your body.

Egrifta SV is available as a powder. After it's mixed with sterile water, Egrifta SV is given as a subcutaneous (under the skin) injection.

What Is Egrifta SV Used For?

Egrifta SV is a prescription medication used to treat HIV-related lipodystrophy. Lipodystrophy is a condition of abnormal fat changes or fat distribution. Fat may build up in certain body areas and thin out in other body parts.

This condition might be due to the HIV infection or the medications used for HIV. The exact cause, however, isn't clearly understood. Compared to past HIV medications, there is a lower risk of lipodystrophy with the newer HIV medicine options. So, this side effect is less of a concern for people who are recently starting their HIV treatment.

HIV is a condition that affects around 1.4 million people in the United States (U.S.)—with more than 10% of them being unaware of their HIV status.

HIV is a virus that attacks your immune system (the body's defense system). If you have HIV, you might only experience flu-like symptoms during the first few weeks of infection. Without treatment, however, HIV can cause acquired immunodeficiency syndrome (AIDS). AIDS is the late stage of HIV infection when your immune system is so weak that you may have trouble fighting off infections.

How to Take Egrifta SV

Carefully read the directions and packaging label on the containers. In general, however, keep the following information in mind.

• Egrifta SV is injected subcutaneously (under the skin) of your stomach once daily.
• Don't always inject in the exact same spot of your stomach. You will need to rotate your injection sites to different stomach areas.
• Don't inject into skin areas with scars, bruises, or hard bumps.
• Don't inject into the belly button or within 2 inches (in) of your belly button.
• Only mix the Egrifta SV powder with sterile water that was in the injection box.
• Immediately use the Egrifta SV solution after mixing. Don't save it for future use.
• Don't refrigerate or freeze the Egrifta SV solution mixture.
• Don't share an Egrifta SV syringe with another person, even if the needle is changed.

The following are directions on how to prepare the Egrifta SV solution mixture:

1. Clean your hands with soap and water.
2. Take the caps off the Egrifta SV powder and sterile water vials.
3. Use alcohol swabs to clean the Egrifta SV powder and sterile water vials.
4. The injection box has a 1-inch (in) 20-gauge needle with a protective cap. Turn it clockwise (right) to firmly connect it to the 1 milliliter (mL) syringe.
5. Carefully remove the cap protecting the needle of your syringe.
6. Push the needle through the rubber stopper of the sterile water vial.
7. Turn the sterile water vial with the inserted syringe upside down.
8. Slowly pull the plunger back until the black tip reaches the 0.5-milliliter mark.
9. Without moving the plunger, pull your syringe to remove the needle from the rubber stopper of the sterile water vial.
10. Now, push the needle at an angle through the rubber stopper of the Egrifta SV powder vial.
11. Slowly push the plunger down to transfer the sterile water into the Egrifta SV powder vial. Try to have the sterile fall down along the inside wall of the Egirfta powder vial. Don't inject the sterile water directly onto the powder.
12. Pull the syringe to remove the needle from the rubber stopper of the Egirfta vial.
13. Throw away the sterile water vial and your syringe with the attached needle into one of the following containers: a red biohazard (sharps) container, a hard plastic container (e.g., a detergent bottle), or a metal container (e.g., an empty coffee can).
14. Gently roll the Egrifta SV solution mixture in your hands for 30 seconds. Don't shake the mixture.
15. Inspect the Egrifta SV solution mixture. It should appear clear and colorless. There shouldn't be any particles present.
16. If the Egifta mixture is cloudy and discolored with particles, don't use it. Call your pharmacist or healthcare provider for assistance. You can also reach out to the manufacturer at 1-833-238-4372.

After you prepared the Egrifta SV solution mixture, the following are additional steps to inject the medication.

1. In the injection box, there's another 1-inch 20-gauge needle with a protective cap. Turn it clockwise (right) to firmly connect it to a new 1-milliliter syringe.
2. Carefully remove the cap protecting the needle of your syringe. Don't throw this cap away.
3. Push the needle through the rubber stopper of the Egrifta SV solution vial.
4. Turn the Egrifta SV solution vial with the inserted syringe upside down.
5. Slowly pull the plunger back until the black tip reaches near the 0.4-milliliter mark.
6. Without moving the plunger, pull your syringe to remove the needle from the rubber stopper of the Egirfta solution vial.
7. Place the protective needle cap on a clean and flat surface. Without touching the needle, carefully hold the syringe and slide the needle back into the cap.
8. Make sure that the cap is snapped shut to completely cover the needle.
9. Carefully remove the needle by turning it counterclockwise (left).
10. Throw away the needle and the Egrifta SV vial into one of the containers mentioned in step 13 for the Egrifta SV mixture preparation directions.
11. In the injection box, there is a 1/2-in 30 gauge needle with a protective cap. Turn it clockwise (right) to firmly connect it to the syringe that has about 0.4 milliliters of the Egrifta SV solution.
12. Use an alcohol swab to clean your injection site.
13. Allow the site to dry.
14. Carefully remove the cap protecting the needle of your syringe.
15. If you notice any air bubbles, gently tap the syringe a few times to move the air bubbles to the top of your syringe—which is near the needle.
16. Move the plunger in or out to remove the air bubbles, and adjust the plunger until the black tip is at the 0.35-milliliter mark.
17. With one hand, gently pinch a fold of skin at your injection site.
18. Using your other hand, hold the syringe with the needle at a 90-degree angle to your injection site.
19. Continue to pinch your fold of skin while inserting the needle into your injection site.
20. Gently stop pinching the fold of your skin while pushing the plunger of your syringe until there is no more medication left in your syringe.
21. Remove the needle from your skin at a 90-degree angle.
22. If you notice any bleeding, use a piece of gauze to gently press down on your injection site for 30 seconds.
23. Throw away your syringe with the attached needle in one of the containers mentioned in step 13 for the Egrifta SV mixture preparation directions. For additional information on how to appropriately and legally throw away your syringes and needles, talk with your pharmacist.
    

Storage

When you receive Egrifta SV from the pharmacy, keep everything in the original boxes until you're ready to use the medication.

Protect Egrifta SV from light. Also, place Egrifta SV at 77 degrees Fahrenheit (F)—with a short-term safety storage range of 59 degrees to 86 degrees F. As for the sterile water vial, syringes, and needles, you can store these items between 68 degrees to 77 degrees F. Considering these temperatures, room temperature should usually be okay.

To be safe, you can use a locked cabinet or closet to keep your medication out of the reach of children and pets.

If you plan to travel with Egrifta SV, get familiar with your final destination's regulations. Checking with the U.S. embassy or consulate might be a helpful resource. In general, however, be sure to make a copy of your Egrifta SV prescription. If possible, keep your medication in its original container from your pharmacy with your name on the label. If you have any questions about traveling with your medicine, be sure to ask your pharmacist or healthcare provider.

You can also ask your pharmacist or healthcare provider about the best ways to dispose of your medications. The FDA's website is a potentially helpful resource to know where and how to discard all unused and expired drugs. You can also find disposal boxes in your area.

Off-Label Uses

There's currently no off-label uses for Egrifta SV.

What are the Side Effects of Egrifta SV?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Common side effects of Egrifta SV may include:

• Injection site itchiness
• Injection site redness
• Joint stiffness
• Muscle aches and pain
• Pain in your extremities (e.g., arms, legs, hands, feet)
• Swelling in your extremities
  

Severe Side Effects

Serious side effects and their symptoms may include:

• Severe allergic reaction: If you have a severe allergic reaction to Egrifta SV, you may experience symptoms of rash, swelling, and breathing difficulties.
• Cancer risk: If you take Egrifta SV, you might develop cancer or have your cancer come back. If you suspect you have cancer, talk with your healthcare provider.
• Injection site reactions: While injection site reactions—like itchiness and redness—are common, these side effects may become severe and excessive.
• Risk of death in critically ill people: Egrifta may increase your risk of death if you have a critical illness, such as a severe lung condition. This increased risk is also linked to people critically ill from trauma, open-heart operation, or stomach surgery.
• Fluid retention: Egrifta SV raises your likelihood of fluid retention. This can lead to swelling that causes symptoms of joint stiffness and pain. You may also notice carpal tunnel syndrome symptoms, which may include numbness or pain in your hands and wrists.
• High blood sugar: Egrifta SV is linked to high blood sugar levels. This may increase your risk for diabetes.
• High insulin-like growth factor 1 (IGF-1) levels: Egrifta SV is linked to high IGF-1 hormone levels. The long-term effects of persistently high IGF-1 amounts are unclear. Your healthcare provider will monitor your IGF-1 levels.

Get medical help right away if you develop any of these serious side effects. Call 911 if your symptoms feel life-threatening.

Long-Term Side Effects

Egirfta's long-term side effects are likely similar to many of the medication's severe side effects.

• Cancer risk
• Carpal tunnel syndrome
• Diabetes
• Joint stiffness and pain
• Persistently high IGF-1 levels
• Risk of death in critically ill people

Dosage: How Much Egrifta SV Should I Take?

Modifications

The following modifications (changes) should be kept in mind when using Egrifta SV:

Severe allergic reaction: Avoid using Egrifta SV if you have a known allergy to it or any of its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: Fat cells naturally go through changes during pregnancy. Affecting this process with Egrifta SV may lead to negative effects on the unborn fetus. Therefore, Egrifta SV isn't recommended during pregnancy.

Discuss with your healthcare provider if you plan to become pregnant or are pregnant. Your healthcare provider will help you weigh the benefits and risks of taking Egrifta SV during your pregnancy.

Breastfeeding: We don't know if Egrifta SV is present in human breast milk. We also don't know about the effects and safety of Egrifta SV on nursing infants.

Breastfeeding, however, isn't recommended to limit the chances of HIV passing onto an HIV-negative baby. Avoiding breastfeeding may also prevent treatment-resistant HIV in HIV-positive babies.

Talk with your healthcare provider if you plan to breastfeed. Your healthcare provider can help you weigh the benefits and harms of taking Egrifta SV while nursing. They can also discuss the different ways available to feed your baby.

Adults over 65: Clinical studies haven't included a large enough number of people in this age group to see whether they respond differently from younger adults.

Children: There is limited safety and effectiveness information about Egrifta SV in children. Egrifta SV may cause children to experience excessive growth in height.

Kidney or liver problems: Egrifta SV been studied in people with kidney or liver problems.

Critically ill people: If you develop a critical illness (e.g., severe lung condition, open-heart procedure, stomach surgery), your healthcare provider may discontinue Egirfta.

People with high IGF-1 levels: If you consistently have high IGF-1 levels while on Egifta, your healthcare provider may stop this treatment.

Missed Dose

If you accidentally forgot your Egrifta SV dose, inject the medication as soon as you remember. If it's already close to your next scheduled dose, however, then skip the missed dose and inject Egrifta SV at your next scheduled dosing time. Don't try to double up to make up for the missed dose.

Try to find ways that work for you to help yourself remember to routinely keep your appointments and take your medication. If you miss too many doses, Egrifta SV might be less effective at treating your condition.

Overdose: What Happens If I Take Too Much Egrifta?

There is limited information available about Egrifta SV overdose.

If you think that you're experiencing an overdose or life-threatening symptoms, however, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn’t Take Egrifta?

Before taking Egrifta SV, talk with your healthcare provider if any of the following applies to you.

• Severe allergic reaction: If you have a severe allergic reaction to Egrifta SV or any of its components (ingredients), your healthcare provider wouldn't recommend it for you.
• Active cancer: Egrifta SV may raise your risk of cancer. If you actively have cancer, Egrifta SV isn't an ideal option for you.
• Pregnancy: Egrifta SV may affect normal fat cell changes during your pregnancy. This might negatively affect the unborn fetus. Therefore, Egrifta SV isn't recommended during pregnancy. If you have additional questions or concerns, your healthcare provider can help you weigh the benefits and risks of Egrifta SV during pregnancy.
• Breastfeeding: In general, breastfeeding should be avoided to prevent HIV from passing onto HIV-negative babies. Nursing should also be avoided to limit treatment-resistant HIV in HIV-positive infants. Discuss with your healthcare provider about the benefits and harms of taking Egrifta SV while nursing.
• Children: There is no effectiveness or safety information about Egrifta SV in children.
• Adults over 65: There isn't enough information to compare differences in response to Egrifta SV between older and younger adults.
• Critically ill people: Egrifta SV can increase the risk of death in people who are critically ill—like from a severe lung infection, an open-heart operation, stomach surgery, or trauma. Therefore, Egrifta SV should be discontinued in critically ill people.
• Hypothalamic-pituitary axis (HPA) problems: The hypothalamus is a structure in your brain, and the pituitary is also a gland in your brain. Egrifta SV is a growth hormone releasing factor (GHRF) that's very similar to the naturally-occurring growth hormone releasing hormone (GHRH) from the hypothalamus. GHRF works by encouraging the pituitary gland to make more growth hormone (GH). Egrifta SV might not work as well if you have HPA problems, such as low-functioning pituitary gland, pituitary tumor, or pituitary surgery.

What Other Medications Interact With Egrifta?

Use caution when taking Egrifta SV with the following medications:

Cytochrome P450 (CYP450) medications: CYP450 is a family of proteins that are responsible for breaking down medications. Many of these proteins are located in the liver.

Egrifta SV works by encouraging the pituitary gland to make and release growth hormone (GH). GH may affect some CYP450 activity levels, which may affect how quickly other medications are broken down. As a result, your healthcare provider may need to adjust the doses of your other medications.

Steroids: Egrifta SV encourages the release of GH. GH can block steroids from turning into their active form, which is cortisol. Cortisol is a naturally-occurring hormone. Combining steroids with Egrifta SV may lower the effectiveness of steroids. Therefore, your healthcare provider may need to increase your steroid dose.

For more detailed information about medication interactions with Egrifta SV, talk with your pharmacist or healthcare provider.

And be sure to talk with your healthcare provider about any other medicines that you take or plan to take, including over-the-counter, nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

Presently, Egrifta SV is the only growth hormone release factor (GHRF) that's used to treat abnormal fat changes or distribution in people with HIV.

How Can I Stay Healthy While Taking Egrifta?

If you're taking Egrifta, chances are HIV-related lipodystrophy (abnormal fat changes) has been negatively affecting your quality of life. You may have tried different approaches or treatments. While living with HIV does have its challenges, there are ways to help improve your quality of life. Refer below for some general tips to support your health:

• Take HIV-related medications as recommended by your healthcare provider.
• Keep up with labs and appointments with your healthcare provider.
• Learn more about HIV.
• Share with your loved ones about your HIV status when you are ready. While this is a difficult step, it's important to build your social support network.
• Stop smoking. HIV+ smokers are more likely to have heart disease and cancer compared to the general public.
• Routinely exercising lowers your heart disease risk and bone loss.
• Practice safer sex to limit the spread of HIV.
• Stay up to date with your vaccines.
• Consider support groups or working with a mental health professional to help you find coping strategies that change the way you think, feel, react, or respond to living with HIV.