Side Effects of Zinbryta, an FDA-approved MS Drug, Need to Be Considered Too

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Editor’s Note: The opinions expressed in this blog post are not the opinions of Multiple Sclerosis News Today. Our MS Blog series offers patient experts to engage in patient-focused topics that are meant to spark discussion and debate in the Multiple Sclerosis community. The opinions of our bloggers are entirely their own, and any perspectives are not intended as medical advice.

Would you agree to be treated with an MS disease-modifying therapy that has been developed to help you but has side effects that could, maybe only rarely but still could, lead to serious illness or even death?

It’s just like the vaccination of young children. There, the debate about whether to vaccinate or not in is an easy decision for health authorities and the vast majority of healthcare professionals. But there is a significant minority of concerned parents and some professionals who are not convinced. Well, that’s something of an understatement — they are opposed to forced vaccinations. They want to be able to choose.

In our case, we MS patients do have the right to choose and that decision is a personal one.

I was diagnosed with MS in 2002 but have never been prescribed any medicines, and so have never faced that decision. The decision is whether or not to take them and put the possible side effects out of my head, or instead decline the drugs because of what might just happen.

Now, another new drug has been approved by the U.S. Food and Drug Administration (FDA) for use as a disease-modifying therapy for adults with relapsing-remitting MS. Approval for use in other countries will depend on their individual practices and procedures.

The new drug is called Zinbryta (daclizumab, Biogen and AbbVie). It is taken by subcutaneous, or under-the-skin, injection every four weeks.

In a Phase 3 trial, Zinbryta was shown, after nearly three years, to reduce annual relapse rates by 45% and to significantly reduce disease activity observed on MRI scans.

Safety Profile

Because of its safety profile, the prescribing information indicates that the use of Zinbryta should generally be reserved for people who have had an inadequate response to two or more MS therapies.

Whoa, hold on just a minute. Its safety profile? Just what are they trying not to say here? With that thought in my mind, I decided to look at the side effects.

shutterstock_369367799The prescribing information includes a boxed warning about the potential for severe liver injury, including life-threatening and fatal events. For “fatal events,” read “death.”

It also highlights other important risks of Zinbryta treatment, including inflammation of the colon (non-infectious colitis), skin reactions, and enlargement of lymph nodes (lymphadenopathy). Additional warnings include hypersensitivity reactions (anaphylaxis or angioedema), increased risk of infections, and symptoms of depression and/or suicidal thoughts. As if people with MS are not depressed already!

Zinbryta will only be available from certified prescribers, and patients will be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program. This is to ensure that ongoing periodic monitoring will be maintained to detect potential problems. The most common side effects were skin rash and elevated liver enzymes. Serious infections also occurred. In people treated with Zinbryta compared to Avonex, there was an increased incidence of serious infections (4% versus 2%), serious skin reactions, elevated liver enzymes and liver injury, gastrointestinal disorders, and depression.

Having considered all this, and given Zinbryta its approval, the FDA recommends that healthcare professionals perform blood tests to monitor an individual’s liver function prior to starting Zinbryta, as well as monthly before each dose, and for up to six months after the last dose.

So, now you know. If you have relapsing-remitting MS, Zinbryta might well be the very best treatment for you. But you need to know the downsides, too — the worst of which is death. Well, I suppose that’s one cure for multiple sclerosis.

Zinbryta is a trademark of Biogen and AbbVie. Avonex is a registered trademark of Biogen.

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.


Lenny Kushman, CNMT, ARRT(R)(CT) avatar

Lenny Kushman, CNMT, ARRT(R)(CT)

There are many drugs available to MS patients that carry much more serious health warnings. An example being Tysabri and Tecfidera, both which have a chance of PML. A debilitating brain disorder. Both medications have been proven very successful in reducing exacerbations, active lesions, as proven by MRIs, and reversing to some extent the side effects of MS. Prescribing Neurologists are cautious to do preprescibing labs, follow up labs every six months, and MRIs annually. Drug manufacturers are proactive in their responsibility towards patient safety, to the point of including any and all possible side effects in their patient inserts with all their medications. I think that if you're going to write an informative blog regarding MS medications, you have to give both sides of the story in its entirety.
I have MS since 1993, diagnosed with RRMS. I was treated with all the injectable MS meds at one time or another. My physical and cognitive capabilities got worse over the course of the next 16 years. When the "NEW" course of medications became available i.e. oral, and IV injectables, I was started on one of them, (I must include that not all MS patients have the same response to the same medictions.). I was started on Tysabri. In my individual case, fortunately my cognitive issues were resolved, I no longer needed my cane or walker. If not for the continued efforts of the pharmaceutical companies continued research to find medications to arrest the affects of this dibilatating disease, non of us would have any hope other than God's intervention in ever having any relief.
I do not, nor have I ever worked for any pharmaceutical company, research firm, or in any way have associated with the marketing of any MS altering medications.

Matt Allen G avatar

Matt Allen G

I completly agree with Lenny, I did tysabri for about two years before developing a neutralizing antibody. Then I did lemtrada and now we are looking at Zinbryta. Even Tylenol has some pretty serious possible side effects because if it happens to one patient they have to list it. I am more interested in what the common side effects are.

Mozee Montana avatar

Mozee Montana

Wow, it is always interesting to hear stories from real life
I hope they all fine now!
It`s always hard to come face to face with such problems. But how harder it is now, the easier will be later.


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