The past few weeks we have been discussing the various types of treatments for multiple sclerosis including injectable medications and oral medications. This week we will be discussing infusion medications. There are only four medications in this category, two of which have been approved just recently, Tysabri, Novantrone, Lemtrada and Ocrevus. Let’s take a closer look at each of them.
Tysabri is a monoclonal antibody that is designed to prevent damaging immune cells from entering the bloodstream and crossing the blood brain barrier into the brain and spinal cord. It was approved by the FDA in 2004 for the use in MS. Tysabri is considered an immuno suppressant medication, and should not be used in combination with any other medications that affect the immune system. It is given via infusion once a month at a hospital, local infusion center or doctors office. Usually the infusion itself takes around an hour, then the individual must be observed for an hour afterwards to make sure there are no complications or reactions to the medication. Tysabri is usually considered when other medications have been tried and have not been successful.
There is a very serious, but rare, risk of taking tysabri (and other immno suppressant medications), PML. PML (Progressive multifocal leukoencephalopathy) is a potentially fatal brain infection that can be caused by the JC virus. If you are taking other medications that suppress your immune system, have been taking tysabri for a longer period of time (over two years), or test positive for the JC virus, your risk of getting PML increases. While taking tysabri, you will be monitored every six months via blood test for the JC virus. PML can be tricky to spot, as the symptoms are very similar to symptoms of MS. Clumsiness, vision changes, weakness on one side of the body, personality changes and problems with cognition (thinking, memory and orientation leading to confusion). If you ever experience some of the symptoms and think you may have PML, it is important that you call your doctor immediately.
Other side effects of tysabri can include headache, fatigue, chest/abdominal discomfort, diarrhea, depression, rash and joint pain. Tysabri can also cause liver damage which can be monitored and detected by blood tests. Just another reason to be keeping up with regular appointments and blood work.
Although there are many warnings and potential side effects, many patients have reviewed this medication and called it “liquid gold”. They find it has helped with their symptoms immensely.
Novantrone is an antineoplastic (anti-cancer) medication that is a DNA reactive agent, meaning it causes damage to DNA. It was approved by the FDA in 2000 for the use in MS. Novantrone works by stopping the proliferation of B cells and T cells and macrophages, which all play a role in the immune response that is thought to be involved in MS. It is indicated for people with secondary progressive MS, progressive relapsing MS or worsening relapsing remitting MS. Novantrone is given via infusion that takes 5-15 minutes. Due to potential damage to your heart, you shouldn’t take more than 140mg in your lifetime, this will limit your treatment to 2-3 years.
Before starting to take Novantrone, you’ll have a heart test that will look for a problem called “left ventricular ejection fraction (LVEF)”. If you have a clinically significant reduction or a 50% reduction in LVEF, you should not take Novantrone. Also, if your neutrophill count is below 1500 cells/mm you shouldn’t take it. Novantrone will clear more slowly from your body if your liver function is impaired, as well. Therefore you will need to be tested for proper liver function prior to starting Novantrone.
Common side effects from Novantrone can include nausea, temporary hair thinning, temporary blue-green urine, urinary tract and airway infections, uneven heart rate, weight gain and chest pain/tightness. More serious side effects can include heart disease, liver damage and therapy-related acute leukemia (TRAL).
Lemtrada is a monoclonal antibody that focuses on CD52 (a protein on the surface of immune cells) and causes depletion of lymphocytes. It was approved by the FDA in 2014 for the use in MS. Originally, it was used and approved at a much higher dose for the treatment of chronic lymphocytic leukemia. It’s ability to target immune cells lead scientist to test its potential as a treatment for MS. Lemtrada is given by infusion for five consecutive days at first, then three consecutive days a year later.
There are serious side effects associated with Lemtrada. A rare bleeding condition, a rare kidney condition, life-threatening infusion reactions, increased risk of cancers and autoimmune thyroid disorders. Yikes!!
More common and less severe side effects include rash, headache, fever, nasal congestion, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, hives, itching, thyroid gland disorders, fungal infection, pain in joints, extremities and back, diarrhea, sinusitis, sore mouth and throat, tingling, dizziness, abdominal pain, flushing and vomiting.
Prior to starting the medication, an individual should be vaccinated for varicella, their thyroid function should be tested and then monitored every three months, they should receive a full CBC and urinalysis once a month until 48 months after last infusion and they should have a skin exam yearly to monitor for melanoma.
Ocrevus is the newest medication on the scene. It was approved by the FDA in early 2017 for the use in primary progressive MS, and is the first medication to be approved for primary progressive MS. Ocrevus is a monoclonal antibody that targets CD20 positive B lymphocytes. These lymphocytes contribute to nerve damage in MS. Ocrevus is given via infusion in a infusion center or doctors office. The initial dose is split up over two weeks. In the first infusion 300 mg is infused then two weeks later another 300 mg. Each of these infusions takes at least 2 1/2 hours. After the first two doses, you will get one infusion every six months which will take at least 3 1/2 hours. Prior to your first dose you will need to be screened for hepatitis B.
As with the other medications, there are many potential side effects. Fatigue, coughing, fever, shortness of breath, nausea, headache or all possible. Infusion related reactions may occur as well. These may include throat irritation, headache, flushing, mild fever or rash. During clinical trials several individuals developed abnormal growths of tissue, the links between these growths and the medication are still not known.
It is clear that these medications are very strong. Many of them include the caveat of “try others first”. When deciding on one of these medications, it is a very individual decision. You can talk to as many people as you want, but in the end, how the medication will affect you comes down to your body and your biology. You’ll never truly know how something will work, or not work, until you try it.
I’ve been on tysabri for just over two years. Before starting the medication I read numerous patient reviews. It seemed like one person loved it then the next hated it and this continued for pages and pages. I finally realize that I just needed to try it for myself. When I first started it, after I would have an infusion I would be exhausted, like spend the rest of the day on the couch and do nothing exhausted. As the infusions went on, the exhaustion lessened. Eventually I got to the point where I am now. I can walk into the infusion center get my infusion and then go on with my day, *almost* like nothing happened.