Multiple Sclerosis: What You Need to Know

(BPT) - Multiple sclerosis (MS) affects more than 2.3 million people worldwide, with at least 400,000 living in the United States, yet there are still many misconceptions and questions surrounding the disease. To help shed some light on this chronic, unpredictable and often debilitating disease, here are three key facts everyone should know:

MS can affect anyone

Statistically, MS impacts more than two to three times more women than men – but no one is excluded. MS occurs across genders, ethnicities and ages, and can also be influenced by certain environmental factors.

Phoenix, AZ, resident Ali Garzuzi was shocked when she was diagnosed with relapsing-remitting MS (RMS) in 2012, explaining, “I had heard of MS before, but I didn’t have a family history so I wasn’t worried. I didn’t think it was something that could happen to me.”

MS is different for everyone

MS and its symptoms – which can include fatigue, numbness or tingling, walking or balance issues, weakness and vision problems – vary from person to person. People living with MS could experience all or none of these symptoms depending on the progression of the disease.

There are also varying types of MS, including relapsing-remitting, which is the most common form of the disease, secondary-progressive, primary-progressive and progressive-relapsing.

“I experienced sensations of tingling and numbness in my hands and fingers for a long time before I was diagnosed with RMS, but never associated it with MS,” recalled Ali. “Education became a really important part of my process. The more I learned about my diagnosis, symptoms and treatment options that were available to me, the more prepared I felt to face my disease.”

Treatment options are available for relapsing forms of MS

In less than two decades, RMS has gone from being an essentially untreatable disease to one with multiple medications available. In addition to intravenous and injectable options, there are oral therapies like Tecfidera® (dimethyl fumarate) to consider.

Ali is among the more than 135,000 people globally that are taking TECFIDERA. She shared her personal treatment experience: “I’ve worked with my doctor since ‘Day 1’ to treat my RMS and welcomed the opportunity to be treated with an oral therapy. Now, my regimen includes taking TECFIDERA, which is proven to reduce relapses and slow disability progression.”

Individual results with TECFIDERA will vary. Talk to your doctor or visit www.TECFIDERA.com to learn more.

Indication

Tecfidera® (dimethyl fumarate) is indicated for the treatment of patients with relapsing forms of multiple sclerosis.

Important Safety Information

TECFIDERA is contraindicated in patients with known hypersensitivity to dimethyl fumarate or any of the excipients of TECFIDERA. TECFIDERA can cause anaphylaxis and angioedema after the first dose or at any time during treatment. Patients experiencing signs and symptoms of anaphylaxis and angioedema (which have included difficulty breathing, urticaria, and swelling of the throat and tongue) should discontinue TECFIDERA and seek immediate medical care.

A fatal case of progressive multifocal leukoencephalopathy (PML) occurred in a patient who received TECFIDERA. PML is an opportunistic viral infection of the brain caused by the JC virus (JCV) that typically only occurs in patients who are immunocompromised, and that usually leads to death or severe disability. The symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes. At the first sign or symptom suggestive of PML, withhold TECFIDERA and perform an appropriate diagnostic evaluation.

TECFIDERA may decrease lymphocyte counts; in clinical trials there was a mean decrease of ~30% in lymphocyte counts during the first year which then remained stable. Four weeks after stopping TECFIDERA, mean lymphocyte counts increased but not to baseline. Six percent of TECFIDERA patients and <1% of placebo patients had lymphocyte counts <0.5x10⁹/L. TECFIDERA has not been studied in patients with pre-existing low lymphocyte counts.

There was no increased incidence of serious infections observed in patients with lymphocyte counts <0.8x10⁹/L or 0.5x10⁹/L in controlled trials, although one patient in an extension study developed PML in the setting of prolonged lymphopenia (lymphocyte counts predominantly <0.5x10⁹/L for 3.5 years). In controlled and uncontrolled clinical trials, 2% of patients experienced lymphocyte counts <0.5 x 10⁹/L for at least six months. In these patients, the majority of lymphocyte counts remained <0.5x10⁹/L with continued therapy. A complete blood count including lymphocyte count should be obtained before initiating treatment, after 6 months, every 6 to 12 months thereafter and as clinically indicated. Consider treatment interruption if lymphocyte counts <0.5 x 10⁹/L persist for more than six months and follow lymphocyte counts until lymphopenia is resolved. Consider withholding treatment in patients with serious infections until resolved. Decisions about whether or not to restart TECFIDERA should be based on clinical circumstances.

TECFIDERA may cause flushing (e.g. warmth, redness, itching, and/or burning sensation). 40% of patients taking TECFIDERA reported flushing which was mostly mild to moderate in severity. Three percent of patients discontinued TECFIDERA for flushing and <1% had serious flushing events that led to hospitalization. Taking TECFIDERA with food may reduce flushing. Alternatively, administration of non-enteric coated aspirin prior to dosing may reduce the incidence or severity of flushing.

TECFIDERA may cause gastrointestinal (GI) events (e.g., nausea, vomiting, diarrhea, abdominal pain, and dyspepsia). Four percent of TECFIDERA patients and <1% placebo patients discontinued due to GI events. The incidence of serious GI events was 1%. The most common adverse reactions associated with TECFIDERA versus placebo are flushing (40% vs 6%) and GI events: abdominal pain (18% vs 10%), diarrhea (14% vs 11%), nausea (12% vs 9%).

Elevations in hepatic transaminases have been reported. A transient increase in mean eosinophil counts was seen during the first two months. TECFIDERA should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Encourage patients who become pregnant while taking TECFIDERA to enroll in the TECFIDERA pregnancy registry by calling 1-866-810-1462 or visiting www.TECFIDERApregnancyregistry.com.

Please see the attached full Prescribing Information and Patient Information for additional important safety information.