Oral Therapies | Multiple Sclerosis Care Center

Types of Oral Therapies

Tecfidera(dimethyl fumarate) , Vumerity (diroximel fumarate) and Bafiertam (monomethyl fumarate)

Prior to this medication you will be required to obtain “prestaging labs” to better estimate your potential risks of this or other medications.

Tecfidera, generic name (dimethyl fumarate), Vumerity (diroximel fumarate) and Bafiertam (monomethyl fumarate), are FDA-approved to help control relapsing forms of Multiple Sclerosis (MS). Tecfidera , Vumerity and Bafiertam are oral medications usually taken twice daily. They have 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.

To safely stay on these medications, you will be required to obtain blood tests, CBC and CMP every 3 months.

MRI will be required prior to initiation of Tecfidera, Vumerity or Bafiertam and 6 months after start, then usually once yearly.

If you are currently on a disease modifying therapy:

Your provider will advise you on how to switch therapies most effectively but please see below for common recommendations.

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, azathioprine (Imuran) or mycophenolate mofetil (CellCept) we prefer that you be off these medications for 6 weeks prior to starting Tecfidera, Vumerity or Bafiertam.

Starting your medication:

Tecfidera: Take one of the 120 mg capsule with supper for the first two nights. 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. Swallow Tecfidera (Dimethyl fumarate) whole. Do not crush, chew, or sprinkle capsule contents on food.
If side effects are severe, do not continue the medication without discussing with us. If side effects are mild, see side effect management section below..

Vumerity: Take one of the 231mg capsules by mouth twice daily for 7 days. If you tolerate this without significant side effects, take two 231mg capsules twice daily for a total of 462mg twice daily. Swallow Vumerity (diroximel fumarate) whole. Do not crush, chew, or sprinkle capsule contents on food. If side effects are severe, do not continue the medication without discussing with us. If side effects are mild, see side effect management section below.

Bafiertam: Take one 95mg capsule twice daily for 7 days. If you tolerate this without significant side effects, take two 95mg capsules twice daily for a total dose of 190mg twice daily. Swallow Bafiertam (monomethyl fumarte) whole. Do not crush, chew, or sprinkle capsule contents on food. If side effects are severe, do not continue the medication without discussing with us. If side effects are mild, see side effect management section below.

Side effect management:

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:

Take one 81mg enteric coated aspirin daily IF you have no contraindications such as a bleeding disorder, being on blood thinning or anticoagulant medications, or having trouble with ulcers or gastritis. 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:

Take your oral medication with food. We can provide anti-nausea medication if needed ondansetron (Zofran) which can be taken up to 3 times daily.

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 we can discuss your symptoms. We may be able to offer other methods for side effect management or alter the dose of your medication.

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.

Call (412) 641-6600 or message through MyUPMC if you have any questions.

For more information please visit the following websites:

Vumerity: https://www.vumerity.com

Tecfidera: https://www.nationalmssociety.org/Treating-MS/Medications/Tecfidera%E2%84%A2

Bafiertam: https://www.bafiertam.com

Gilenya (fingolimod), Mayzent (Siponimod), Zeposia (ozanimod), and Ponvory (pomesimod)

Gilenya (fingolimod), Mayzent (Siponimod), Zeposia (ozanimod), and Ponvory (pomesimod) are oral medications used to treat relapsing remitting multiple Sclerosis. It typically used when other medications have failed. Due to the way these medications work, extra observation is needed to initiate this medication and yearly evaluations with dermatology, and ophthalmology are required. Once your provider orders this medication and submits the appropriate forms, you will receive a call from a staff member at the Gilenya Go program (when starting Gilenya) to schedule first dose monitoring. Ponvory does not require first dose monitoring for most patients, however the need for monitoring will be discussed by your provider. Zeposia does not require first dose observation. Mayzent does not require first dose observation in most patients however certain patients with heart conditions may require a first dose observation.

More on the Gilenya Go program can be accessed here.

More information on Ponvory can be accessed via this website: www.ponvory.com

More information on Zeposia can be accessed via this website: www.zeposia.com

More information on Mayzent can be accessed via this website: www.mayzent.com

Prior to starting Gilenya, Mayzent, Zeposia or Ponvory:

Prior to this medication you will be required to obtain “prestaging labs” to better estimate your potential risks of this or other medications.

MRI Brain is required for a baseline evaluation.
12-lead EKG (Electrocardiogram): due to side effects of Gilenya that can affect the heart rate and rhythm, this test must be completed prior to taking your first dose. If there are any abnormalities, you will be required to see a cardiologist. EKG will be repeated 6 hours AFTER you start this medication through the Gilenya Go program. This may also be necessary for Zeposia, Ponvory, and/or Mayzent.
Ophthalmology evaluation: due to the potential for macular edema which can cause vision issues, a baseline eye exam is required. An OCT (optical coherence tomography) should be completed prior to starting Gilenya, Mayzent, Zeposia or Ponvory, 3 months after staring the medication and then yearly.
- UPMC Eye Center
  Eye & Ear Institute
  203 Lothrop St.
  Pittsburgh, PA 15213
  Phone: 412-647-2200
Dermatology evaluation: Gilenya, Mayzent, Zeposia and Ponvory can place you at higher risk for skin cancer. As such you need to make an appointment with a dermatologist 6 months after starting this therapy and continue with yearly skin examinations.
- Falk Medical Building 5th floor
- 3601 Fifth Ave.
- Pittsburgh, PA 15213412-647-4200

OR you can call 1-833-500-0581 to find a dermatologist at a UPMC facility near you

Pulmonary function testing (PFTs) provided by a pulmonologist may be done prior to starting therapy as Gilenya can affect the respiratory system. PFTs should be repeated yearly.
- Comprehensive Lung Center
  Falk Medical Building 4th floor
  3601 Fifth Ave.
  Pittsburgh, PA 15213
  Phone: 412-648-6161
In order to safely stay on this medication, you are required to obtain blood work (CMP, CBC and lymphocyte subset panel) every 3 months
MRI will be required prior to initiation of Gilenya, Mayzent, Zeposia or Ponvory and, usually 6 months after start, then once yearly.

“Rebound” risk with Gilenya:

When changing medication therapy from Gilenya (or any disease modifying medication in Multiple Sclerosis) patients are at risk of “relapse” (a new neurological deficit or worsening of established deficits >24 hours) usually related to a new or enlarging demyelinating lesion. This is an increased risk when stopping Gilenya, and in some cases, can be significant. The rate of rebound is not truly known; however, one study documented a 10%-25% possibility, typically increased within the first 6 months of discontinuation of therapy. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6858914/

Your provider will discuss the reasons for discontinuing this medication and the risks/benefits associated with this recommendation. You are to contact our office with any new or worsening symptoms or any questions or concerns. There are treatment options available for rebound, however, response to treatment varies.

Aubagio

Prior to this medication you will be required to obtain “prestaging labs” to better estimate your potential risks of this or other medications.

Aubagio (teriflunomide) is an oral medication for treatment of relapsing/remitting MS and active secondary progressive MS.

Aubagio is provided in a 7mg or 14mg oral tablet once daily
- This medication can interact with other medications so be sure to advise your provider of all medications you may be taking.
- This medication can cause birth defects and should be used with caution in those wishing to conceive (both women and men).
- Due to the impact on the immune system, Aubagio can increase your risk of infection.

Side Effects:

Common side effects of Aubagio include headache, diarrhea, nausea, alopecia (hair loss) and increase in liver enzymes.

You will be required to obtain lab work (CMP, CBC at minimum) every 6 months while on Aubagio.
MRI will be required prior to initiation of Aubagio and 6 months after start, then once yearly.

More information on Aubagio is available at: https://www.aubagio.com

Cladribine (Mavenclad)

Prior to this medication you will be required to obtain “prestaging labs” to better estimate your potential risks of this or other medications.

Mavenclad is an oral medication indicated for relapsing/remitting MS who have failed at least one prior therapy. Mavenclad is provided weight based therefore a current weight is required. Each treatment is divided into 2 treatment cycles: you will be prescribed the correct weight-based dose per day for up to 5 days the first month then the correct weight based dose for up to 5 days the second month.

After finishing your first 2 treatments you do not take any further doses for one year. After one year, you would start the second course of treatment, similar to year one.

This medication needs to be swallowed whole with or without good, each dose at least 3 hours apart from other medications. Limiting contact with skin is recommended.

Side effects:

upper respiratory infections
headache
hematologic toxicity

Warnings:

increased risk of malignancy (cancer). Routine age related cancer screening is recommended.
caution with blood transfusions (due to potential of graft vs host disease)
caution in both male and female patients with conception as it may cause birth defects
discuss all medications with your provider as to prevent drug interactions

This medication requires routine blood work: CBC, CMP, Lymphocyte subset panel at 2 months, 6 months after start of treatment and every 6 months for 2 years following initiation of treatment.