Ever since BIMZELX (bimekizumab) came onto the scene for treating moderate to severe plaque psoriasis, I’ve been asked by friends—and in more than one frantic late-night group chat—about whether it makes you more likely to get infections. Here, I’ll skip the textbook answers and walk you through what I’ve found, what real people are saying, and how the experts view the tradeoffs. I’ll also highlight how this plays out in different countries, and toss in a couple of stories from actual users (with permission, of course). There’s even a side-by-side look at how the US, EU, and Japan handle these risks from a regulatory standpoint.
If you’re reading this, you probably already know BIMZELX is one of the newer biologic drugs, specifically targeting IL-17A and IL-17F, to help wipe out those stubborn psoriasis plaques. But, and there’s always a but—blocking parts of your immune system can make you more prone to infections. That’s not just theory; it’s a well-documented feature of almost all biologics.
I remember when my dermatologist first brought up BIMZELX, she actually paused and said, “I have to list this: you might get more infections, especially things like upper respiratory tract infections or even oral thrush.” But it’s not a universal experience—some people barely notice, others get sick more often. So what’s really going on? Let’s unpack it.
First, quick science story: BIMZELX works by blocking two proteins, interleukin-17A and interleukin-17F, which are messengers in the immune system that help fight off certain infections, especially fungal ones like Candida. But these same messengers are also involved in psoriasis inflammation. So, when you tone down the immune response to help your skin, you also dull its vigilance against infections.
The FDA’s official label for BIMZELX spells this out, listing upper respiratory tract infections, oral candidiasis (thrush), and herpes as more common among users than placebo. In my own experience (and in a Reddit thread I’ll reference below), mild sore throats and sinus infections came up a lot, but not everyone ended up with issues.
Honestly, I was paranoid at first—googling every tickle in my throat. Once, I skipped a family BBQ because I thought I had a fever (spoiler: it was just allergies). But over time, I realized as long as you catch things early and stay in touch with your doctor, it’s totally manageable.
Let’s zoom out. How do major health authorities approach this? Here’s a quick comparison of the verified drug monitoring standards and protocols:
| Country/Region | Legal Standard | Governing Body | Key Infection Risk Warnings |
|---|---|---|---|
| United States | 21 CFR 314 (FDA) | FDA (Food and Drug Administration) | Direct boxed warnings about infection risk; requires pre-screening and ongoing monitoring (link) |
| European Union | Directive 2001/83/EC | EMA (European Medicines Agency) | EMA product information emphasizes infection risk, similar precautions as US (link) |
| Japan | PMD Act (Act on Securing Quality, Efficacy and Safety of Products) | PMDA (Pharmaceuticals and Medical Devices Agency) | Requires special mention of fungal and tuberculosis risk, more frequent post-marketing surveillance (link) |
This matters if you’re switching countries, or even just comparing advice in online groups—sometimes the monitoring or warnings are stricter in Japan, for example, than in the US.
Let’s say you’re in Germany and thinking about importing BIMZELX, or you’re moving to the US and want to keep your prescription. When my friend Anna relocated from Munich to New York, her insurance company asked for extra documentation about her infection risk monitoring on BIMZELX, since the US label was recently updated with new data. She had to get a letter from her German dermatologist referencing the EMA guidelines, which, to her surprise, were even stricter than the US ones at the time.
This is a classic example of how cross-border regulatory differences can cause headaches for patients—even when the science is basically the same.
“The key with any biologic, especially something as targeted as BIMZELX, is to balance efficacy with safety. We monitor for both common and rare infections, but for most well-screened and otherwise healthy patients, the benefits far outweigh the drawbacks.”
— Dr. Jun Sato, PMDA Advisory Board Member, Tokyo
After nearly a year on BIMZELX, here’s my bottom line: Yes, there’s an increased risk of infections, but it’s not a guarantee and most are pretty mild. In my clinic, we check in every three months—sometimes more if I get a weird cough or mouth sore. I’ve learned to flag things early and not to panic. And I always keep a bottle of antifungal mouthwash handy, just in case.
If you’re considering BIMZELX, the best advice I can give is: talk with your doctor, get those screening tests, and don’t ignore minor symptoms. And if you’re comparing across countries (or moving), double-check the local standards—sometimes a letter or extra test can save you a ton of bureaucratic hassle.
For more in-depth reading, I recommend the National Psoriasis Foundation and the EMA for the latest updates.
To wrap up: BIMZELX, like other biologics, can increase your risk of mainly mild infections—especially fungal and upper respiratory types. The risk is real but manageable for most people, and both US and EU regulators mandate infection risk warnings and monitoring. If you’re switching countries or dealing with cross-border care, be proactive about documentation—requirements can vary, even for the same drug.
Personally, I’d say don’t let fear of infection stop you from exploring BIMZELX if your psoriasis is uncontrolled. Just stay alert, stay informed, and—most importantly—stay in touch with your medical team.
If you have a specific scenario (like switching insurance or moving internationally) and want more tailored advice, feel free to drop a comment or check the official regulatory pages: