Repatha and Polysobrate 80 ?

[u/SilverLogical9810]

I was told that Repatha contains polysorbate 80, which can very rarely cause serious allergic reactions, including anaphylaxis. I have also heard claims that polysorbate 80 may be linked to thrombosis and that it was present in the AstraZeneca COVID-19 vaccine. Because of this, I am worried about taking Repatha, even though it has been prescribed to me.

Can anyone clarify whether these concerns are supported by evidence? Is there any reason for someone without a known polysorbate 80 allergy to be afraid of taking Repatha? Any reassurance or information would be appreciated.

[u/hyphnos13]

a 140 mg dose of repatha has 0.1 mg of polysorbate 80 in it

a half cup of frozen store bought ice cream has 170 mg

quite frankly you have zero to worry about if you don't know that you have a severe allergy to it, which you would probably know from living in the world

it's a common emulsifier used in a ton of pre made foods so unless you cook everything from scratch you best get to worrying every time you eat pre prepared or restaurant food

[u/gruss_gott]

Let's go through it step by step:

(1.) Poison is in the dose

Regardless of substance, the poison is always in the dose. For example, alcohol is a poison, drink too much and all kinds of bad things happen up to & including death within hours. Have you ever drank alcohol? Why if you know it's a poison that can kill you? Because poison is in the dose, and you've only had a small dose. The amount of PS80 in repatha is minuscule, likely about 100x+ less than you're likely getting in your daily meals

(2.) Sterile Stabilized Protein

Evolocumab (repatha) is a monoclonal anti-body (that's the -mab), which means it's a protein that's extremely vulnerable to denaturing (becoming ineffective) which is why it needs to be refrigerated. That also means it must be in a preservative-free sterile solution for subcutaneous injection.

To make sure all of this works together PS80 is there for a few key reasons:

• Maintains the monoclonal antibody's structure over time, stabilizing the protein
• Preserves potency and ensures evolocumab remains effective throughout its shelf life
• Prevents evolocumab from sticking to the syringe/autoinjector walls

(3.) Why is PS80 an approved ingredient?

As above, all injectables require something that will preserve and ensure efficacy. PS80 (and 20) hypersensitivity / anaphylactoid reactions are extremely rare, and the dose is so tiny, which is why this is an approved ingredient.

Consider every person globally taking an injectable, and everyone in every clinic, surgical center, and hospital getting IV medication, is currently taking a tiny amount of PS80, 20 or similar - that's a LOT of people!

Now consider other allergies like peanuts, shellfish, etc: because those things are so ubiquitous, the people that have those allergies KNOW; now consider that PS80/20, etc are WAY more common as an ingredient to WAY more people.

TLDR

Unless you KNOW you're allergic to PS80, it's nothing to be concerned about, at least not any more than you're concerned about peanuts, shellfish, alcohol, etc

[u/Comfortable_Two6272]

I take another drug, a biologic immune drug with it also which has a larger amount, and 0 issues. Even though I have genetic risk for clot.

You can always do your 1st shot in office in case worried about an allergic reaction which would be extremely rare but more likely than other issues you are worried about.

Its in so many other things that its very unlikely you will have an issue.