Tesamorelin Dosage Chart: One Approved Indication, One Population
Tesamorelin is approved as EGRIFTA SV under BLA 022505. Unlike most compounds here, a dosage chart for it restates a real label. What that label covers, and what it does not.
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A tesamorelin dosage chart is unusual on this site, because for once there is an approved label behind the numbers rather than a rodent study and a conversion nobody should make.
The compound is approved by the FDA as EGRIFTA, latterly EGRIFTA SV, under biologics licence application BLA 022505 held by Theratechnologies, supplied as a prescription powder for reconstitution. That single fact changes what the arithmetic on this page means.
What an approved label adds to the arithmetic
Every reconstitution calculation on this site is exact: labelled mass divided by diluent volume gives concentration, and volume drawn times concentration gives the amount in the syringe. The arithmetic is never the weak link.
The weak link is the target. For an unapproved compound there is no established quantity for the calculation to land on, so the exactness is decorative. Here there is one, because a regulator reviewed a trial programme and authorised specific quantities.
There is a second gain. An approved product carries a labelled mass somebody is accountable for, so the numerator in the calculation is verified rather than asserted. Material sold as a research chemical does not, which is why the same arithmetic on a research vial inherits whatever error the label carries.
The indication is one line, and it is narrow
The approved indication reads: reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
The same section carries a limitation of use stating that long-term cardiovascular safety has not been established, and directing prescribers to weigh risk and benefit in patients who have not had a reduction in visceral adipose tissue.
| What the label fixes | Value |
|---|---|
| Approval | FDA, BLA 022505 (Theratechnologies) |
| Marketed as | EGRIFTA, latterly EGRIFTA SV |
| Population | HIV-infected adults with lipodystrophy |
| Outcome | Reduction of excess abdominal fat |
| Stated limitation | Long-term cardiovascular safety not established |
| Form | Prescription powder for reconstitution |
Roughly 24 studies are registered under the name on ClinicalTrials.gov.
Where a chart stops being a restatement
A tesamorelin dosage chart that restates approved quantities alongside the indication they were approved for is reporting. The provenance is genuine and better than anything available for the unapproved compounds covered elsewhere on this site.
A chart that carries the same quantities with no population attached has changed what it is claiming without changing a single digit. The figures were established in HIV-associated lipodystrophy for reduction of visceral fat. Applied to general body composition they become an extrapolation, and extrapolation in a table is indistinguishable from reporting unless the table says so.
That is the one thing to check on any chart for this compound, and it is not a number.
Frequently Asked Questions
Is tesamorelin an approved drug?expand_more
Yes. It is approved by the FDA and marketed as EGRIFTA, latterly EGRIFTA SV, under BLA 022505 held by Theratechnologies.
What is the approved indication?expand_more
Reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. The label also states that long-term cardiovascular safety has not been established.
Does an approved label make the reconstitution arithmetic more reliable?expand_more
It makes the inputs more reliable. The arithmetic is exact either way, but an approved product carries a labelled mass somebody is accountable for, where a research chemical carries a seller's claim.
Can approved quantities be applied to a different goal?expand_more
Not without leaving what the authorisation covers. The quantities were established in one population for one endpoint, and the approval is attached to that pairing.
How much research exists?expand_more
Around 24 studies are registered on ClinicalTrials.gov under the name, which is substantial relative to most compounds covered here.
References & Citations
- [1]
FDA Drugs@FDA. EGRIFTA / EGRIFTA SV (tesamorelin), BLA 022505, Theratechnologies. Prescription powder; indication and limitations of use as stated on the approved label.View source →
- [2]
ClinicalTrials.gov. Studies registered under the term tesamorelin.View source →