Can Aubagio cause PML as a side effect?
Key Points
- No, progressive multifocal leukoencephalopathy (PML) is not listed as a side effect for Aubagio (teriflunomide) in the manufacturer’s package insert. Aubagio is a treatment used for multiple sclerosis.
- Progressive multifocal leukoencephalopathy is a rare and often fatal infection of the brain that is caused by the John Cunningham (JC) virus.
- In addition to a weakened immune system from disease, medications that suppress the immune system can activate PML.
In 2012, the FDA approved Aubagio (teriflunomide), a once-daily, oral treatment used in patients with relapsing forms of multiple sclerosis (MS).
Aubagio is classified as a pyrimidine synthesis inhibitor and immunomodulator with anti-inflammatory properties. It works in MS by decreasing inflammation, lowering the number of white blood cells in the central nervous system, and protecting the nerves.
In studies, it has shown significant effect in reducing MS disease activity, including reducing relapses, slowing the progression of physical disability, and reducing the number of brain lesions.
The most common side effects with Aubagio include:
- elevated liver enzymes
- alopecia (hair loss)
- diarrhea
- influenza
- nausea
- paresthesia
What is PML?
Progressive multifocal leukoencephalopathy (PML) is a rare, often fatal infection of the brain that is caused by the John Cunningham (JC) virus.
In addition to a weakened immune system from disease, medications that suppress the immune system and treat autoimmune diseases can activate PML. These drugs include immunosuppressants to prevent rejection of organ transplants, multiple sclerosis (MS) agents, cancer treatments, and medicines for autoimmune diseases like lupus.
Many people acquire the JC virus in childhood with no symptoms, but a weakened immune system often activates the virus and allows it to multiply. Roughly half of the world's population are infected with the virus by the time they reach age 20, although most have no symptoms.
Some drugs used to treat MS or other autoimmune diseases can activate PML as a side effect.
What are the risk factors for PML?
- cancer (immune suppression such as in leukemia or lymphoma)
- HIV/AIDS
- organ transplant
- drugs that alter the immune system function (immune modulators)
- autoimmune disorders such as systemic lupus erythematosus (lupos)
Related questions
- Does Aubagio cause weight gain or loss?
- Who makes Aubagio and where is it made?
- Does Aubagio help with fatigue?
What are the symptoms of PML?
There is a wide range of symptoms for PML, and they can progress over days to weeks, leading to disability and frequently death:
- loss of coordination or clumsiness loss of language ability, speaking or understanding speech (aphasia/dysphasia)
- memory loss (dementia)
- confusion
- vision problems, blurred vision
- weakness of the legs and arms that progresses
- personality changes
Which MS drugs can cause PML?
Patients with autoimmune conditions are at risk for PML. This includes diseases such as multiple sclerosis, rheumatoid arthritis, and systemic lupus erythematosus (lupus). Many of these patients are treated with biological therapies that can reactivate the JC virus.
MS drugs that warn about progressive multifocal leukoencephalopathy (PML) in their package insert include:
- alemtuzumab (Lemtrada)
- bafiertam (monomethyl fumarate)
- cladribine (Mavenclad)
- dimethyl fumarate (Tecfidera)
- diroximel fumarate (Vumerity)
- fingolimod (Gilenya)
- natalizumab (Tysabri)
- ocrelizumab (Ocrevus)
- ozanimod (Zeposia)
- rituximab (Rituxan)
- siponimod (Mayzent)
Other drugs associated with PML include immunosuppressants to prevent rejection of organ transplants, cancer treatments, and medicines for autoimmune diseases like lupus. Healthcare providers should monitor patients at risk for clinical symptoms or MRI findings that may suggest PML. MRI findings may be apparent before clinical signs or symptoms.
Bottom Line
- PML is a rare and often fatal infection of the brain and central nervous system that is caused by the John Cunningham (JC) virus.
- Progressive multifocal leukoencephalopathy (PML) is not listed as a side effect for Aubagio (teriflunomide) in the product label.
- Other multiple sclerosis drugs that have been linked with PML include: dimethyl fumarate (Tecfidera), fingolimod (Gilenya), natalizumab (Tysabri), ocrelizumab (Ocrevus), and rituximab (Rituxan), among others.
This is not all the information you need to know about Aubagio (teriflunomide) for safe and effective use. Review the full Aubagio information here, and discuss this information with your doctor or other health care provider.
References
- Aubagio (terifluamide) [Package Insert]. Revised Sept. 2019. Genzyme Corp. Canbridge, MA. Accessed June 12, 2020 at http://products.sanofi.us/Aubagio/aubagio.html
- Alstadhaug KB, Myhr KM, Rinaldo CH. Progressive multifocal leukoencephalopathy. Progredierende multifokal leukoencefalopati. Tidsskr Nor Laegeforen. 2017;137(23-24):10.4045/tidsskr.16.1092. Published 2017 Dec 12. doi:10.4045/tidsskr.16.1092
- Progressive Multifocal Leukoencephalopathy (PML). Cleveland Clinic. Accessed June 12, 2020 at https://my.clevelandclinic.org/health/articles/6101-progressive-multifocal-leukoencephalopathy-pml
Read next
Should I take Aubagio in the morning or night?
It does not matter if you take Aubagio in the morning or at night. But you must take it at around the same time each day. So if you decide to take your Aubagio in the morning, then take it every morning. If you decide to take it at night then take it every night. If you experience fatigue, tiredness, or weakness with Aubagio, you may find it better to take it at night. Continue reading
How long can you live with multiple sclerosis?
Multiple sclerosis (MS) is not generally considered life-threatening and most people will live a normal life-span. One study has found that the average life expectancy for people with MS is 76 years of age. In 2019, the U.S. life-expectancy averaged 78.8 years, but in 2020 it declined to 77.3 years, primarily due to the COVID pandemic. Many people with MS may live for 25 to 35 years or longer after their diagnosis. Continue reading
What are the early signs of multiple sclerosis?
Some of the early signs of multiple sclerosis (MS) include weakness or numbness in one or more limbs; tremor or abnormal, uncoordinated movements while walking; slurred speech, or dizziness; double vision or the painful loss of vision in one eye; or long-lasting fatigue. Continue reading
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