Tesamorelin

Generic name: tesamorelin
Brand names: Egrifta, Egrifta SV
Dosage form: subcutaneous powder for injection (1 mg; 2 mg)
Drug class: Growth hormones

Medically reviewed by  A Ras MD.

What is tesamorelin used for?

Tesamorelin is used to lower belly fat in patients with HIV.

Description

EGRIFTA SV contains tesamorelin (as the acetate salt), a human growth hormone-releasing factor (GRF) analog. The peptide precursor of tesamorelin acetate is produced synthetically and is comprised of the 44 amino acid sequence of human GRF. 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:

Structural Formula

EGRIFTA SV 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 SV contains 2 mg of tesamorelin acetate and the following inactive ingredients: 20 mg mannitol, USP, 10 mg sucrose, NF, 0.78 mg histidine, USP and 0.05 mg polysorbate 20, NF.

Mechanism of Action

In vitro, tesamorelin binds and stimulates human GRF receptors with similar potency as the endogenous GRF .

Growth hormone-releasing factor (GHRF), also known as growth hormone-releasing hormone (GHRH), is a hypothalamic peptide that acts on the pituitary somatotroph cells to stimulate the synthesis and pulsatile release of endogenous growth hormone (GH), which is both anabolic and lipolytic. GH exerts its effects by interacting with specific receptors on a variety of target cells, including chondrocytes, osteoblasts, myocytes, hepatocytes, and adipocytes, resulting in a host of pharmacodynamic effects. Some, but not all these effects, are primarily mediated by IGF-1 produced in the liver and in peripheral tissues.

Before taking tesamorelin, tell your doctor:

  • If you are allergic to tesamorelin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
  • If you have had any of these health problems: Cancer, head injury or radiation to the head, pituitary tumor, pituitary surgery, or problems with the pituitary gland.
  • If you are pregnant or may be pregnant. Do not take tesamorelin if you are pregnant.
  • If you are breast-feeding. Do not breast-feed while you take tesamorelin.

This is not a list of all drugs or health problems that interact with tesamorelin.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take tesamorelin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take tesamorelin?

  • Tell all of your health care providers that you take tesamorelin. This includes your doctors, nurses, pharmacists, and dentists.
  • If you have cancer or a tumor or have ever had cancer or a tumor, talk with your doctor. The chance of cancer or tumor growth is raised with tesamorelin. The chance of new tumors may also be raised in some patients.
  • High blood sugar has happened with tesamorelin. This includes diabetes that is new or worse.
  • Check your blood sugar as you have been told by your doctor.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Do not share this product with another person. This includes any needles or syringes, even if the needle has been changed. Sharing may pass infections from one person to another. This includes infections you may not know you have.

How is tesamorelin best taken?

Use tesamorelin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • It is given as a shot into the fatty part of the skin in the belly area.
  • If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
  • Do not give into skin that is bruised or scarred. Do not give into the belly button.
  • Move the site where you give the shot with each shot.
  • Wash your hands before and after use.
  • This medicine needs to be mixed before use. Follow how to mix as you were told by the doctor.
  • Do not shake.
  • Use right away after mixing.
  • Throw away any part of the opened vial not used after the shot is given.
  • Do not use if the solution is cloudy, leaking, or has particles.
  • Do not use if solution changes color.
  • Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

What are the side effects of tesamorelin that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
  • A fast heartbeat.
  • Dizziness or passing out.
  • Flushing.
  • Shortness of breath.
  • Pain or numbness in the hands or wrist.
  • A burning, numbness, or tingling feeling that is not normal.
  • Irritation where the shot is given.
  • Bleeding, itching, pain, redness, or swelling where the shot is given.
  • This medicine may cause you to swell or keep fluid in your body. Tell your doctor if you have swelling, weight gain, or trouble breathing.

What are some other side effects of tesamorelin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Pain in arms or legs.
  • Muscle or joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out tesamorelin?

  • Some brands of tesamorelin need to be stored in a refrigerator. Some brands of tesamorelin need to be stored at room temperature. If you have questions about how to store tesamorelin, talk with your pharmacist.
  • Store in the original container to protect from light.
  • Store sterile water box at room temperature.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

Principal Display Panel – Medication Box

  • MEDICATION BOX
  • (Box 1 of 2)
  • NDC 62064-241-30
  • 2 mg/vial
  • Rx only
  • EGRIFTA SV
  • tesamorelin for injection
  • For subcutaneous injection only
  • EGRIFTA SV 2 mg/vial FormulationDoseMixing
    Instructions, and Storage conditions are
    different than the EGRIFTA 1 mg/vial Formulation.
  • Important: Refer to Patient Instructions for Use
  • Use only 1 vial of EGRIFTA SV 2 mg to
    prepare the recommended dose of 1.4 mg
    (0.35 mL of the reconstituted solution).
  • READ BEFORE OPENING BOX:
  • This is the MEDICATION BOX – it contains 30 vials of
    EGRIFTA SV 
    ​2 mg/vial and the Patient Instructions for Use.
    You will also need the INJECTION BOX for EGRIFTA SV 
    it contains syringes and other materials needed for
    reconstitution and administration.
  • Protect from light. Keep it in original box.
  • Store at room
    temperature up
    to 77°F (25°C).
  • THERA
    technologies
  • EGRIFTA SV is a trademark
    of Theratechnologies Inc.
  • 30 vials

Principal Display Panel - Medication Box

 

Principal Display Panel – Injection Box

  • INJECTION BOX (Box 2 of 2)
  • For use only with EGRIFTA SV™ 2 mg/vial
    (tesamorelin for injection)
  • For mixing,
    refer to Patient
    Instructions for Use
    included in the
    EGRIFTA SV 2 mg/vial
    Medication Box.
  • Rx only
  • READ BEFORE OPENING BOX
  • This is your INJECTION BOX for EGRIFTA SV (tesamorelin for injection) 2 mg/vial.
  • This box contains sterile syringes, Sterile Water for Injection USP, and materials
    needed for injecting EGRIFTA SV.
  • Note this INJECTION BOX does NOT contain your EGRIFTA SV 2 mg/vial medication.
  • Before removing contents, make sure you also have the
    EGRIFTA SV 2 mg/vial MEDICATION BOX.
  • Contents of INJECTION BOX:
  • a) 30 single-dose, 10 mL bottles of Sterile Water for Injection
  • b) 60 sterile 1mL syringes
  • c) 60 sterile 1″ 20-gauge needles, used for mixing
  • d) 30 sterile ½” 30-gauge needles, used for injection
  • Store at
    controlled room
    temperature
    20°C to 25°C
    (68°F to 77°F)
  • Made in USA
  • Distributed by Theratechnologies Inc., Montréal Québec, H3A 1T8, Canada
  • THERA
    technologies
  • EGRIFTA SV is a trademark of Theratechnologies Inc.

Principal Display Panel - Injection Box

 

 

Principal Display Panel – 2 mg Vial Label

  • Refer to Instructions for Use
  • 2 mg/vial
  • EGRIFTA SV
  • tesamorelin for injection
  • Rx only
  • STERILE
  • Store up
    to 77°F
  • For subcutaneous injection only
  • Each vial contains 2 mg of tesamorelin acetate
  • Single-Dose Vial – Discard Unused Portion
  • Distributed by Theratechnologies Inc.

Principal Display Panel - 2 mg Vial Label

 

SRC: NLM .

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