This is info is just for curious types, nothing of concern or worry for us Bes users.
-Most injectables have some means for preserving. Refrigerating is a 1st line of defense. For Besremi there is confusing info on whether and what type of preservative beyond keeping it cold Besremi uses. In the FDA label it says there isn't any: "BESREMi (ropeginterferon alfa-2b-njft) injection is a sterile, preservative-free..."
-In both labels Bes contains a good sized portion of Benzyl Alcohol, I smell it quite well when I use Bes: "Each prefilled syringe delivers 1 mL of solution containing 500 mcg of ropeginterferon alfa-2b-njft and benzyl alcohol(10 mg), glacial acetic acid (0.05 mg)"
-Benzyl is a preservative in injectables, specifically for multi dosing: "Benzyl alcohol (α-hydroxytoluene) is an aromatic alcohol used as an antimicrobial preservative at concentrations ranging from 0.9% to 2.0% in many multidose medication vials..."
We'll disregard that scary word "toluene" in there, benzyl is a consumable compound from my searching. But a lot of concern comes up relating to babies and benzyl.
Benzyl is a type of preservative that prevents growth of bacteria but doesn't actively kill it.
Glacial acetic acid in there is also a type of preservative. So there are two "preservatives"
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My take:
-US FDA or consumers like to see "no preservative" and FDA lets benzyl pass as not being one maybe because it only prevents growth and does not reverse it.
-Euro doesn't care what it's called and just lists it. But they do presumably rely on these unmentioned preservatives for their multi-dose syringe procedure.
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So if you open the syringe cap, it should be well protected from growing any bacteria in the air that it might be exposed to. I expect clear answers here from the authorities would be scarce.
Written by
EPguy
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It seems that "preservative-free" may be a bit like the food labels (Natural" and "organic." the FDA is responsible for both food and drug labels. Seems there is a bit of similarity in process.
Same situation with Pegasys interferon - it contains Benzyl alcohol - yet is considered preservative free, so most patients and pharmacists advise patients to not reuse vials or syringes. But hundreds of patients have been reusing them for up to 15 years, including myself, without any deterioration in drug efficacy or bacterial infection consequences.
All this brings up the obvious question, which ingredient would trigger a listing of "preservative".
Here is a report that looked into the matter. IFN is a protein product. It's clear that our med in fact contains a well known preservative by the common sense definition. I'm glad to have it in there but as Aldebaran25 says here, more openness would be good:
"It was revealed that phenol and benzyl alcohol are the two most common antimicrobial preservatives used in peptide and protein products"
It's strange that really bad ingredients keep getting named, phenol and toluene. These are all carcinogenics/toxins. Somehow in these uses they must not be.
In my own ignorance I imagine that having a ready made injectable approved without it containing any preservative at all is probably pretty much impossible. What annoys is the lack of transparency in addressing things for what they really are and instead pandering eternally to the marketing gods.
Inactive ingredients: benzyl alcohol, glacial acetic acid, polysorbate 80, sodium acetate, sodium chloride, Water for Injection.
From the EMA/Europa site:
6. Contents of the pack and other information
What Besremi contains
- The active substance is ropeginterferon alfa-2b.
Each pre-filled pen of 0.5 mL solution contains 250 micrograms of ropeginterferon alfa-2b as measured on a protein basis, corresponding to 500 micrograms/mL.
- The other ingredients are sodium chloride, polysorbate 80, benzyl alcohol, anhydrous sodium acetate, glacial acetic acid, and water for injections. For benzyl alcohol and sodium, see section 2 “Besremi contains benzyl alcohol” and “Besremi contains sodium”."
From Section 2:
"Besremi contains benzyl alcohol
This medicine contains 5 mg benzyl alcohol in each 0.5 mL. Benzyl alcohol may cause allergic reactions.
Ask your doctor or pharmacist for advice:
- if you are pregnant or breast-feeding.
- if you have a liver or kidney disease.
This is because large amounts of benzyl alcohol can build-up in your body and may cause side effects (called “metabolic acidosis”).
Besremi contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’."
I agree with all of the comments above from EPguy and commenters, and in addition, there is this about the other ingredients:
"Polysorbate 80 is used in both cosmetic formulations and as an emulsifying and stabilizing additive in the food manufacturing process"- which if you think about it, isn't a stabilizer also in a sense at least- a preservative?
...and:
"What is Sodium acetate (anhydrous) （CH3COONa)?
Acetic acid has been said to prevent bacteria cultivation and therefore has been used not only to add sour taste but to preserve food.
Sodium acetate is a food additive obtained by neutralization of acetic acid. When used as a food additive, sodium acetate can be indicated by its group name, substance name, or abbreviated name according to the purpose of use.
Keep the pH level of food within the appropriate level--> pH regulator
Improve taste by adding or enhancing sour taste--> Souring agent
Improve taste by adding or controlling taste--> Seasoning (Organic acid)
Other purposes (shelf-life extension, combined use with preservative, etc.)"
Since it's unlikely that we're interested in the taste of Besremi, I have to think that the reason for sodium acetate's inclusion in it is the "other purposes" above.- i.e., a preservative.
Good details. I think Polysorbate 80 is to keep the solution smooth and mixed. It's like soap (surfactant) that keeps things dissolved. (My college chemical engineering resurfacing a bit)
Sodium acetate seems to be a Ph controller (acetic acid is neutralized) that allows the separate preservatives to work as intended.
Considering the odor and list order of Bes, I suspect the benzyl is doing the heavy lifting.
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