Deepika vegiraju at 09:16, 21 February 2022

2022-02-21T09:16:51Z

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== '''What is Tesamorelin?''' ==

* Tesamorelin ('''EGRIFTA SV''') is '''a growth hormone releasing factor''' (GHRF) analog used in the treatment of [[visceral]] [[adiposity]] in [[human immunodeficiency virus]] (HIV) infected patients with [[lipodystrophy]].

[[File:Tesamorelin.svg|thumb|Tesamorelin]]

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== '''What are the uses of this medicine?''' ==

* Tesamorelin (EGRIFTA SV) is an injectable prescription medicine used to reduce the excess stomach-area (abdominal) fat in [[HIV]]-infected adult patients with [[lipodystrophy]]. EGRIFTA SV is a [[Growth hormone releasing factor|growth hormone-releasing factor]] (GHRF).

'''Limitations of use:'''
* The long-term safety of EGRIFTA SV on the heart and blood vessels ([[cardiovascular]]) is not known.
* EGRIFTA SV is not for weight loss management.
* It is not known whether taking EGRIFTA SV helps improve how well you take (compliance with) [[antiretroviral]] medicines.
* EGRIFTA SV is not recommended to be used in children with open or closed bone growth plates ([[epiphyses]]).

== '''How does this medicine work?''' ==

* Tesamorelin (tes" a moe rel' in) is '''a synthetic 44 [[amino acid]] [[polypeptide]] analogue of [[Growth hormone-releasing hormone (GHRH)|growth hormone releasing hormone]] (GHRH)'''.
* The '''N terminal portion of the molecule has been modified''' to improve its stability and pharmacokinetics in comparison to native GHRH.
* Tesamorelin '''activates GHRH receptors in the pituitary''' which '''leads to synthesis and release of [[growth hormone]]''' that acts on multiple cells of the body including [[hepatocytes]] where it '''stimulates production of insulin like growth factor-1 (IGF-1)'''.
* '''IGF-1 mediates many of the effects of growth hormone''', which in the liver include growth, inhibition of programmed cell death, glucose update and [[lipolysis]].
* Serum IGF-1 levels tend to be low in patients with obesity, diabetes and particularly in those with [[lipodystrophy]].
* Tesamorelin was evaluated and found to be effective in decreasing [[visceral]] [[adiposity]] in patients with lipodystrophy associated with antiretroviral therapy of [[human immunodeficiency virus]] (HIV) infection.

== '''Who Should Not Use this medicine ?''' ==

This medicine cannot be used in patients who:
* 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 SV.
* are allergic to tesamorelin or any of the ingredients in EGRIFTA SV.
* are pregnant or plan to become pregnant.

== '''What drug interactions can this medicine cause?''' ==

* Monitor patients for potential interactions when administering EGRIFTA SV in combination with other drugs known to be metabolized by CYP450 liver enzymes.
* EGRIFTA SV stimulates GH production; therefore, patients receiving [[glucocorticoid]] replacement for previously diagnosed [[hypoadrenalism]] may require an increase in maintenance or stress doses following initiation of EGRIFTA SV.

== '''Is this medicine FDA approved?''' ==

* Tesamorelin was approved for use in the United States as therapy to reduce excess abdominal fat in HIV-infected patients with antiviral therapy-related lipodystrophy in 2010.
* Tesamorelin is also being evaluated as therapy of [[insulin resistance]], [[obesity]] and nonalcoholic [[fatty liver]].

== '''How should this medicine be used?''' ==

'''Recommended dosage:'''
* The dose of EGRIFTA SV is 1.4 mg (0.35 mL of the reconstituted solution) injected subcutaneously once daily.

'''Administration:'''
* Use EGRIFTA SV exactly as your healthcare provider tells you to use it.
* Inject EGRIFTA SV 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 SV into scar tissue, bruises or your belly button.
* Do not share your EGRIFTA SV 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.
* Use only the diluent provided, Sterile Water for Injection, USP, to reconstitute EGRIFTA SV.
* Reconstitute one vial of lyophilized powder with 0.5 mL of diluent. Mix by rolling the vial gently in your hands for 30 seconds. Do not shake.
* Inspect the reconstituted vial visually for particulate matter and discoloration. Use only if the solution is clear, colorless and without particulate matter.
* Administer 0.35 mL of EGRIFTA SV immediately following reconstitution and throw away any unused solution and diluent.

== '''What are the dosage forms and brand names of this medicine?''' ==

This medicine is available in fallowing doasage form:
* As EGRIFTA SV for injection 2 mg single-dose vial with a diluent of 10 mL of Sterile Water for Injection, USP

This medicine is available in fallowing brand namesː
* '''EGRIFTA SV'''

=='''What side effects can this medication cause?'''==

The most common side effects of this medicine include:
* pain in legs and arms
* muscle pain

EGRIFTA SV may cause serious side effects, including:
* increase risk of new cancer in HIV positive patients or your cancer coming back (reactivation)
* increased levels of your [[Insulin-like growth factor (IGF)|insulin-like growth factor-1]] (IGF-1)
* fluid retention
* increase in blood sugar (glucose) or [[diabetes]]
* serious allergic reaction
* injection site reactions
* increased risk of death in people who have critical illnesses

==''' What special precautions should I follow?''' ==

* Carefully consider the decision to start treatment with EGRIFTA SV based on the increased background risk of malignancies in [[HIV]]-positive patients. Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA SV. Discontinue EGRIFTA SV if there is any evidence of recurrent [[malignancy]].
* EGRIFTA SV stimulates GH production and increases serum IGF-1, a growth factor. The effects of prolonged elevations in IGF-1 levels are unknown. Monitor IGF-1 levels during EGRIFTA SV therapy. Consider discontinuing in patients with persistent elevations.
* Fluid [[retention]] may occur during EGRIFTA SV therapy and is thought to be related to the induction of GH secretion.
* EGRIFTA SV treatment can result in [[glucose intolerance]]. Evaluate glucose prior to and during therapy.
* [[Hypersensitivity]] reactions occurred in 4% of patients treated with EGRIFTA. Advise patients to seek immediate medical attention and discontinue treatment if suspected.
* EGRIFTA SV treatment may cause [[injection site reactions]], including injection site [[erythema]], [[pruritus]], pain, irritation, and [[bruising]]. Rotate injection sites to different areas of the abdomen to decrease injection site reactions.
* Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental [[trauma]], or those with [[acute respiratory failure]] has been reported. Consider discontinuation in critically ill patients.

== '''What to do in case of emergency/overdose?''' ==

* {{overdose}}

== '''Can this medicine be used in pregnancy?''' ==

* EGRIFTA SV is contraindicated in pregnant women because modifying [[visceral]] [[adipose tissue]] offers no benefit in pregnant women and could result in fetal harm.
* If EGRIFTA SV is used during pregnancy, or if the patient becomes pregnant while taking it, discontinue EGRIFTA SV.

=='''Can this medicine be used in children?'''==

* The safety and effectiveness of EGRIFTA SV in pediatric patients have not been established.

== '''What are the active and inactive ingredients in this medicine?''' ==

* '''Active ingredient:''' tesamorelin acetate
* '''Inactive ingredients:''' mannitol, sucrose, histidine, polysorbate 20

== '''Who manufactures and distributes this medicine?''' ==

* '''Distributed by:''' [[Theratechnologies Inc]]., Montréal, Québec, Canada
* EGRIFTA SV™ is a trademark of Theratechnologies Inc.

== '''What should I know about storage and disposal of this medication?''' ==

* You will be given two boxes from the pharmacy when you get your prescription of EGRIFTA SV:
* Store the 2 mg EGRIFTA SV vials in the Medication Box they come in, at room temperature between 68°F to 77°F (20°C to 25°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 SV vials out of the light.
* After mixing, use EGRIFTA SV right away. Throw away any unused EGRIFTA SV after mixing.
* Do not store, freeze or refrigerate EGRIFTA SV 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 SV after the expiration date (EXP) printed on the carton and vial labels.

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[[Category:Growth hormone secretagogues]]
[[Category:Growth hormone-releasing hormone receptor agonists]]
[[Category:HIV/AIDS]]
[[Category:Merck brands]]
[[Category:Peptides]]
[[Category:Recombinant proteins]]
[[Category:World Anti-Doping Agency prohibited substances]]

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Tesamorelin - Revision history

Deepika vegiraju at 09:16, 21 February 2022