Types of Oral Therapies
Tecfidera, generic name dimethyl fumarate, is FDA-approved to help control relapsing forms of Multiple Sclerosis (MS). This medication was known as BG-12 during research and development. Tecfidera is an oral pill that must be taken twice per day to be effective. It has some known risks including lowering the number of white blood cells. White blood cells are involved in the disease process of MS but also have other immune functions such as fighting infections. Prior to starting this medication, we prefer that you have baseline blood tests and a new MRI of the brain for baseline comparison. As this is a new medication, other risks may be discovered and we should be notified of any new health conditions. We ask that you avoid alcohol intake during the first month of Tecfidera use. Do not start this medication while you have an active infection.
What Should Be Done About Current MS Disease Modifying Treatments?
Unless otherwise instructed, we encourage you to stay on your current treatment until you receive your medication, as many insurance companies are limiting access to this new medication requiring the submission of information and appeals to insurance companies in efforts for them to authorize payment for this medication for you. We would greatly appreciate your patience in this matter.
If you are currently on a disease modifying therapy:
- If you are on an interferon (Avonex, Plegridy, Betaseron, Rebif, or Extavia) or glatiramer acetate (Copaxone), it is okay to start the medication the day your next injection would be due.
- If you are on fingolimod (Gilenya), we prefer that you be off of this medication for 1 month prior to starting Tecfidera and also ask that your blood work is reviewed as showing an adequate number of white blood cells. If your white blood cell count is low, we may ask that you delay starting until repeat blood work shows acceptable levels of white blood cells.
- If you are on natalizumab (Tysabri), we may ask that you be off of this medication for 3 months (or more) prior to starting Tecfidera. Discuss your start date with us.
- If you are on methotrexate, we prefer that you be off of this medication for 6 weeks prior to starting Tecfidera.
- If you are on azathioprine (Imuran) or mycophenolate mofetil (CellCept), we prefer that you be off of this medication for 6 weeks prior to starting Tecfidera.
Starting your medication:
Once you receive the medication, we will usually start as outlined below.
- Take 1 of the 120 mg capsule with supper for the first two nights
- Swallow Tecfidera whole. Do not crush, chew, or sprinkle capsule contents on food.
- If you develop side effects, such as gastrointestinal symptoms or flushing and itching, see advice below. If side effects are severe, do not continue the medication without discussing with us. If side effects are mild, continue as below.
- If you tolerate this without significant side effects, we ask that you increase to one 120 mg capsule with breakfast and one 120 mg with supper for 6 days.
- If you are tolerating the medication adequately, increase to the higher dose 240 mg capsule twice per day.
Please make sure you are scheduled for regular follow-up appointments to help us assess how well your MS is controlled and to help maintain your safety while on this medication.
We recommend checking blood tests around 3 months after you have started taking Tecfidera. If you do not have prescriptions for labs, please call your nurse.
We also recommend a follow up appointment within 6 months with your physician or our physician assistant, Ryan Orie. Please call (412) 692-4920 and follow prompts for scheduling.
Notify us if any new health conditions are diagnosed or new symptoms arise.
Potential Side Effects:
Tecfidera may cause significant side effects and we hope that starting and taking it will be easier with a titrating dose as outlined above. Some of the more common side effects relate to the gastrointestinal tract (nausea, indigestion, cramps, stomach pain, vomiting, or diarrhea). Other common side effects may include your skin turning red (flushing) or itching. Most of these symptoms should decrease or resolve the longer you take the medication.
Flushing or itching:
If you experience flushing or itching, we may recommend taking aspirin if you do not have a contraindication such as having a bleeding disorder, being on blood thinning or anticoagulant medications, or having trouble with ulcers or gastritis. If you are allowed aspirin and experience flushing or itching, you may take a single 81 mg of enteric coated aspirin daily with food. If flushing continues, you may increase to two 81 mg aspirin and, if needed, a regular full size 325 mg aspirin. Do not exceed this dose of aspirin without talking with us. Most people will be able to stop the aspirin after a month or so. If you need to continue it, you should let all your doctors know you are on regular aspirin.
Nausea, upset stomach, vomiting:
To lessen the risk of nausea and vomiting, we suggest taking Tecfidera with food. If needed, take the over-the-counter medicine Pepto Bismol (liquid) at the suggested dose. If no better, we may also suggest trying ginger, which may be found at many stores that sell supplements. If nausea continues, we may prescribe an anti-nausea medicine such as Zofran 4 mg taken up to three times daily. If nausea is severe, a form of this medication can be dissolved under the tongue to make sure it is absorbed even with bad nausea and vomiting. Please call if this is not helpful as we may have other options.
Cramps or Diarrhea:
For cramps and diarrhea, we suggest taking Pepto Bismol liquid. If no better, we may prescribe Bentyl (dicyclomine) or other medications.
If Side Effects Are Severe:
If any or all of the above symptom(s) remain severe despite the above measures, you should call our office so that more of the 120 mg capsule can be ordered. We may then have you restart with the lower dose, 120 mg size twice daily, and continue for one month. If you tolerate this dosage after one month, we may have you increase the dosage to 240 mg twice daily.
If You Miss a Dose:
If you miss or skip a dose, do not double up on the next dose. Simply skip that dose and return to the next scheduled dose. For example, if you miss the breakfast dose, do not take two (480 mg) with supper. Take one with supper and take the next breakfast dose as scheduled.
Call (412) 648-6761 or message through MyUPMC if you have any questions.
Prior Authorization Information
Each insurance company has different medical documentation requirements for authorization of the medication. Each insurance company provides authorization for this medication for different time frames. EXAMPLES: UPMC approves for 6 months initially and, if stability or improvement occurs, they will then allow us to request reauthorization on a yearly basis. Highmark approves for 12 months initially. Some insurance plans approve for only 3 months at a time. We ask that you find out your insurance company requirements for authorization and let us know when authorization and reauthorization is required. Please provide this information to us in a timely manner, as it takes up to 1-3 weeks to have a medication authorized due to the volume of medication we must authorize for all of our patients.
There are insurance companies that will not approve this medication until you have tried several other disease modifying medications. If you change insurances and you are on Tecfidera, refills will most likely require a reauthorization at that time. Please call our front desk to provide your new insurance information if it is not a UPMC plan. The number to call to change your insurance is (412) 692-4920 and press number 1. You must also inform our MS team of your specialty pharmacy, as each insurance plan contracts with a particular specialty pharmacy. Your specialty pharmacy may change at the time of insurance renewal; though, your insurance may not change.
MOST INSURANCES REQUIRE LAB WORK AT A MINIMUM OF EVERY SIX MONTHS. We cannot reauthorize your medication without this. Please make sure you have your lab work drawn in a timely manner.
Should you and your provider determine that treatment with Fingolimod (Gilenya) as disease-modifying therapy for multiple sclerosis is the best choice for your condition, this therapy requires that you undergo a significant number of both laboratory and diagnostics evaluations. Your physician or nurse will provide you with all of the necessary prescriptions for these tests; however, this is also a guide as to what testing needs to be completed as well as the frequency of testing. Directions for scheduling tests are also included. We ask that you use UPMC facilities to have testing completed and to use UPMC or Quest lab facilities so that we are able to access your results quickly and efficiently—this helps us to serve you better and prevents delays in you receiving your treatment. If you do not use a UPMC facility due to preference or to insurance limitations, it is your responsibility to complete these tests and to have the results sent to us. We can provide you with Release of Information forms so that you can make sure the tests are sent to us when you use an outside facility.
The blood work requirements and purpose of each test are listed below. These labs must be drawn prior to starting Gilenya.
- Complete blood count with differential/and lymphocyte subsets—this test provides important information about the kinds and numbers of cells in the blood, especially red and white blood cells and platelets to evaluate your body blood counts as well as possibility and risk of infection. CBC with diff. is to be completed prior to starting therapy, 2 weeks after start, and then every 3 months. Lymphocyte subsets are drawn at 2 weeks and every 4 weeks thereafter until stable.
- Hepatic function panel—a group of 7 tests which evaluate liver function for injury, infection, and inflammation. This is to be completed prior to starting therapy and every 3 months.
- Hemoglobin A1C—evaluates blood sugar level over a period of months. Testing is to be completed before initiating treatment and every year.
- HIV—this test is a marker for the AIDs virus. This must be done prior to starting therapy.
- HCG—blood pregnancy test for all women of child-bearing age. Must be completed by woman before starting therapy.
- Varicella zoster virus antibody—used to assess immunity of the chicken pox or shingles vaccine. If you do not demonstrate immunity, you may be at higher risk of developing this infection. Your physician may prescribe the vaccine prior to initiating therapy. If you receive the vaccine, you will need to wait 3 months to initiate therapy so that you have immunity.
There are also diagnostic tests that must be done prior to beginning Gilenya which include:
- MRI brain with and without contrast—this should be done at baseline and repeated yearly.
- 12-lead EKG (Electrocardiogram)—Gilenya has side effects, which can affect the heart rate and cardiac system so this must be done prior to starting therapy. If these results are abnormal, you will be required to see a cardiologist. This test can be completed Monday through Friday at Montefiore Hospital on the 5th floor diagnostic testing area. You do not need to schedule an appointment. An EKG will also be completed after the 6-hour observation period.
- Pulmonary Function Test (PFT)—Gilenya has side effects that may involve the respiratory system, so this must be done prior to starting therapy. If the results are abnormal at baseline, your doctor may recommend that you follow up with a pulmonologist before beginning medication. PFTs are required on a yearly basis.
You can call to schedule this test:
Comprehensive Lung Center
Falk Medical Building 4th floor
3601 Fifth Ave.
Pittsburgh, PA 15213
- Complete eye exam including Optical Coherence Tomography (OCT, a noninvasive, noncontact, transpupillary imaging study). As Gilenya can cause visual disturbances, a complete eye exam as well as an OCT test must be done prior to initiating therapy. The OCT should be repeated after 3 months and then yearly.
You may schedule this test at UPMC:
UPMC Eye Center
Eye & Ear Institute
203 Lothrop St.
Pittsburgh, PA 15213
Please request to be seen by Dr. Islam Zaydan on the same day to have your eye exam (for your convenience).
- Dermatologic Exam—You must have a complete skin exam within the previous six months by a dermatologist. This must be done yearly.
You can call to schedule an appointment:
Falk Medical Building 5th floor
3601 Fifth Ave.
Pittsburgh, PA 15213
Prior to initiating therapy, you will be scheduled with the physician to review all results. Should all results be within normal limits, you will then be scheduled to receive your first dose (on a Monday through Thursday only). Your medication will be delivered directly to the office, and you will come in to the office on the day you are to receive your first dose. You must have someone accompany you to the office for your first dose, as you will not be permitted to drive home. You may be seen briefly by your doctor to ensure that you have completed all of the necessary testing and are medically cleared to take your medication. Once this has been determined, you will be brought to the Infusion Center to receive your medication. The nurses will monitor your heart rate and blood pressure prior to administering your medication and at least every two hours (more frequently, if needed). You will be closely observed for at least six hours after you receive your medication. Please note, you should bring lunch as well as activities, as you will not be permitted to leave the Infusion Center during the observation period (you must be directly observed throughout the six-hour period). If your heart rate and blood pressure remain within normal ranges, you will be sent home after the six-hour observation period. If you experience side effects from the medication or changes in heart rate or blood pressure, you may be asked to report to the Infusion Center the following day to receive your next dose. If you experience a major side effect or change in vital signs, you will be taken to the Presbyterian University Hospital Emergency Department. As you will also need an EKG after the 6-hour period, you should plan on being here for at least 7 hours on the observation day.
Please feel free to contact our nurses with any questions or concerns.