Brand Name	Generic Name	Route of Administration	Dosing	Frequency	Mechanism of Action	Indication	Efficacy Data	Common Adverse Events	Serious Adverse Effects	Monitoring	Pregnancy  Considerations
Avonex ¹ ²	Interferon β-1a	Intramuscular Injection	7.5 mcg week 1, 15 mcg week 2, 22.5 mcg week 3, then remain at 30 mcg, beginning at week 4	Once Weekly	The mechanism of action of Interferon β in MS ihas not yet been elucidated.	Interferon β is approved in patients with relapsing forms of MS to slow accumulation of physical disability and decrease frequency of clinical exacerbation.    Avonex (Interferon β-1a), Betaseron (Interferon β-1b), and Extavia (Interferon β-1b) are all indicated for CIS.	Patients with relapsing forms of MS were given either 30 mcg intramuscular (IM) injection of Avonex (Interferon β-1a) or placebo once weekly over 2 years. Patients with chronic progressive forms of MS were excluded. Time to progression in disability was substantially longer in the Avonex (Interferon β-1a) group. Other endpoints in favor of Avonex (Interferon β-1a) are mean change in Expanded Disability Status Scale (EDSS) from study entry to end of study, number of exacerbations in subset completing 2 years, annual exacerbation rate, and percentage of exacerbation-free patients. Magnetic resonance imaging (MRI) endpoints were all in favor of Avonex (Interferon β-1a) over placebo, and included mean annual number of Gd-enhancing lesions, and mean annual percentage change in T2 lesion volume.  A second study included patients with isolated demyelinating event with lesions typical of MS upon brain MRI. Time to development of second exacerbation was observed substantially later in the Avonex (Interferon β-1a) group as opposed to placebo. Changes in favor of Avonex (Interferon β-1a) over placebo included change from baseline in T2 volume of lesions at 18 months, number of new or enlarging T2 lesions at 18 months, and number of Gd-enhancing lesions at 6 months.	Flu-like symptoms post-injection, depression, irritability, hallucinations, confusion, easy bleeding, liver enzyme abnormalities, gastrointestinal upset, bradycardia, tachyarrhythmia, increased risk of infection, abnormal thyroid function	Depression, suicide, psychotic disorders, hepatic injury, anaphylaxis, congestive heart failure (CHF), decreased peripheral blood counts, thrombotic microangiopathy, seizures, autoimmune disorders, laboratory tests. Additionally, menstrual irregularities have also been reported.	Monitoring of CBC with differential, WBC count, platelet count, blood chemistry, and LFTs is recommended at 1, 3 and 6 months following initiation of therapy, and then periodically after as clinically necessary.  Flu-like symptoms  (Premedication with analgesics or antipyretics on treatment days may aid in mitigating flu-like symptoms associated with Interferon beta use.)  Injection site reactions,  signs and symptoms of depression and suicidal tendencies  bleeding,   hepatic injury symptoms,  hypersesitivity reaction,  infections,  new onset autoimmune disorder,  thyroid function tests (every 6 months in history of thyroid dysfunction, or as clinically necessary),  new onset cardiovascular disease,  signs of thrombotic microangiopathy (new-onest hypertension, thrombocytopenia, renal impairment)	Pregnancy Catergory C   Interferon β-1a should only be used during pregnancy only if potential benefits outweigh potential risk to the fetus. No teratogenic effects seen in animal studies.  Small amounts of interferon Beta 1a in the form of Avonex have been found to be excreted into breast milk ²⁷
Rebif  ³ ⁴		Subcutaneous Injection	22 mcg prescribed dose titration: 4.4 mcg on weeks 1 and 2 ,injected using 8.8 mcg syringe, 11 mcg on weeks 3 and 4, injected using a 22 mcg syringe, and week 5 and on, inject 22 mcg with autoinjector or 22 mcg syringe  44 mcg prescribed dose titration, using full syringe or autoinjector: 8.8 mcg on weeks 1 and 2, 22 mcg on week 3 and 4, 44mcg weeks 5 and on.	Three Times Weekly			Study 1 included patients with relapsing forms of MS who were randomized to Rebif (Interferon β-1a) 22 mcg, Rebif (Interferon β-1a) 44 mcg or placebo given 3 times weekly over 2 years. Both Rebif (Interferon β-1a) groups had substantially less exacerbations per patient vs placebo group. Time to onset of progression in disability sustained for 3 months was substantially longer in Rebif  (Interferon β-1a) treated patients vs placebo. Differences between Rebif (Interferon β-1a) 22 mcg and 44 mcg groups in endpoints were not clinically meaningful. Median time to first exacerbation, percent of exacerbation-free patients at 2 years, median percent change of magnetic resonance imaging (MRI) T2 lesion area at 2 years, and median number of active lesions per patient per scan were all substantially in favor of either Rebif (Interferon β-1a) group over placebo.    In a study comparing RRMS patients randomized to either Avonex (Interferon β-1a) 30 mcg intramuscular (IM) injection weekly, or Rebif  (Interferon β-1a) 44 mcg 3 times weekly over 48 weeks showed a substantially greater percentage of relapse-free patients at 24 and 48 weeks compared with Avonex (Interferon β-1a).  Patients with secondary progressive MS were excluded from both studies.	Injection site reaction, flu-like symptoms, urinary tract infection (UTI), abdominal pain, depression, elevation of liver enzymes, hematologic abnormalities, decreased peripheral blood counts, visual disturbance	Hepatic injury, depression and suicide, seizures, anaphylaxis, injection site reactions, laboratory tests, decreased peripheral blood counts, thrombotic microangiopathy, autoimmune disorders
Plegridy  ⁵ ⁶			First Dose= 63 mcg (orange pen)  Second Dose= 94 mcg (blue pen)  Third Dose and on= 125 mcg (grey pen)	Every 14 Days			Plegridy (Interferon β-1a) was studied in patients with relapsing forms of MS, who were randomized to either 125mcg of Plegridy (Interferon β-1a) or placebo, given once every 14 days for 48 weeks. Plegridy (Interferon β-1a) showed significantly lower annualized relapse rates, significant reduction in the proportion of patients with relapses, significant reduction in patients with disability progression, significant reduction in mean number of new or newly enlarging T2 hyperintense lesions, and significantly lessGd-enhancing lesions, as compared to placebo.  Progressive forms of MS were excluded.	Injection site reactions, flu-like symptoms, pyrexia, headache, myalgia, chills, asthenia, arthralgia	Hepatic injury, depression and suicide, seizures, anaphylaxis, injection site reactions, CHF, decreased peripheral blood counts, thrombotic microangiopathy, autoimmune disorders
Betaseron ⁷ ⁸	Interferon β-1b		Inject 0.0625 mg (0.25 mL) on weeks 1 and 2;  0.125 mg (0.5mL) on weeks 3 and 4;  0.187 5mg (0.75mL) on weeks 5 and 6;  week 7 and on 0.25 mg (1 mL)	Every Other Day			The 2 year BETASERON (Interferon β-1b) RRMS study used both Betaseron (Interferon β-1b) 0.05 mg and 0.25 mg, but substantial difference in endpoints vs placebo were seen with Betaseron (Interferon β-1b) 0.25 mg and not often with Betaseron (Interferon β-1b) 0.05 mg. Betaseron (Interferon β-1b) 0.25 mg showed substantial differences in primary and secondary endpoints when compared with placebo, such as annual exacerbation rate, exacerbation frequency per patient, and percent change in MRI lesion area at endpoint.  Two studies are outlined in the prescribing information, specifically  involving patients with Secondary Progressive MS.  Progression of disability using Expanded Disability Status Scale (EDSS) was primary endpoint; substantial increase in time to progression with Betaseron (Interferon β-1b) vs placebo was appreciated. Study 3 did not elucidate significant differences between treatment and placebo groups in regards to progression of disability.  Annual relapse rates were substantially different in both studies with Betaseron (Interferon β-1b) in comparison with placebo.	Injection site reaction, lymphopenia, flu-like symptoms, myalgia, leukopenia, neutropenia, increased liver enzymes, headache, hypertonia, pain, rash, insomnia, abdominal pain, and asthenia	Hepatic injury, anaphylaxis, depression and suicide, congestive heart failure (CHF), injection site necrosis, leukopenia, thrombotic microangiopathy, flu-like symptom complex, and seizure		Pregnancy Category C    Four spontaneous abortions occurred in the BETASERON (Interferon β-1b) RRMS trial.    Betaseron (Interferon β-1b) should only be used during pregnancy if potential benefits outweigh potential risks to the fetus.
Extavia ⁹ ¹⁰			Inject 0.0625 mg (0.25 mL) on weeks 1 and 2;  0.125 mg (0. 5mL) on weeks 3 and 4;  0.1875 mg (0.75 mL) on weeks 5 and 6;  week 7 and on 0.25 mg (1 mL)	Every Other Day
Glatopa ¹¹ ¹²	Glatiramer acetate	Subcutaneous  Injection	20 mg/mL (1 mL dose)  No titration necessary	Once Daily	The exact mechanism  by which glatiramer acetate exerts its therapeutic effect in MS is not fully understood, but is thought to act by modifying immune processes that are believed to be responsibe for the pathogenesis of MS.	Glatiramer acetate is indicated for patients with relapsing forms of MS, and is also indicated in treatment of clinically isolated syndrome (CIS).	Glatiramer acetate 20 mg/mL given once daily was used in the following studies:  Study 1 in the Copaxone (glatiramer acetate) prescribing information was performed specifically with RRMS patients. Glatiramer acetate had a substantial difference versus placebo in mean relapse frequency and reduction in relapse rate compared with prestudy.  Another study with RRMS patients found substantially fewer T1 Gd-enhancing lesions over 9 months with Copaxone (glatiramer acetate) 20 mg/mL vs placebo.  Further studies including patients with one, singular demyelinating event with lesions noted upon magnetic resonance imaging (MRI) were randomized to either Copaxone (glatiramer acetate) or placebo. Time to development of a second exacerbation was delayed substantially in the Copaxone (glatiramer acetate) group, compared with placebo.  Efficacy with use of Copaxone (glatiramer acetate) 40 mg/mL 3 times weekly was shown in study 5; RRMS patients were given either Copaxone (glatiramer acetate) 40 mg/mL 3 times weekly or placebo. Copaxone (glatiramer acetate) was substantially more efficacious than placebo in reduction of the number of confirmed relapses over 12 months, reduction in cumulative number of new or enlarging t2 lesions at months 6 amd 12, and cumulative number of enhancing lesions on T1-weighted images at months 6 and 12.	Injection site reactions, vasodilation, rash, dyspnea, and chest pain; also, anxiety, diaphoresis, immunogenicity, infection, and weakness	Post-injection reactions, chest pain, lipoatrophy or necrosis near injection site, and potential effects on immune response	Monitor for post-injection site reactions    (Symptoms can include flushing, chest tightness, dyspnea, and palpitations)	Pregnancy Category B    No adverse effects observed in animal studies; no adequate or well-controlled studies involving pregnant women.
Copaxone ¹³ ¹⁴			20 mg/mL (1 mL dose)  No titration necessary	Once Daily
			40 mg/mL (1 mL dose)  No titration necessary	3 Times Weekly
Novantrone ¹⁵ ¹⁶	Mitoxantrone	Intravenous  Infusion	12 mg/m2 infused over 5-15 minutes every 3 months  (maximum lifetime cumulative dose: 140 mg/m2; discontinue use with  left ventricular ejection fraction [LVEF]  < 50% or clinically significant reduction in LVEF)	Every 3 Months	Mitoxantrone is an antineoplastic anthracenedione shown in vitro to inhibit B cell, T cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, tumor necrosis factor-α (TNFα), and interleukin-2 (IL-2).	Mitoxantrone is indicated for patients with MS who are classified as secondary (chronic) progressive, progressive relapsing, or worsening RRMS, in mitigating neurological disability and/or frequency of clinical relapse. It is not indicated for patients with primary progressive MS.	Efficacy of Mitoxantrone was studied in patients with secondary progressive or progressive relapsing forms of MS; Patients received either 12mg/m2 or 5mg/m2 of Mitoxantrone every 3 months for 2 years. Mitoxantrone 12mg/m2 showed a significant difference in primary endpoints vs placebo. These endpoints include: mean EDSS change and mean ambulation index change (from baseline to 24 months), mean number of relapses per patient requiring corticosteroid treatment (adjusted for discontinuation), and median number of months to first relapse requiring corticosteroid treatment  A second study included patients with SPMS or worsening RRMS with residual neurological deficit between relapses, who also developed one new Gd-enhancing MRI lesion during the 2-month screening period. Patients either received 1g of IVmethylprednisolone (IVMP) or received 12mg/m2 of IV Mitoxantrone plus 1g of IVMP.for 6 months, evaluated monthly. N=43. Patients receiving combination of Mitoxantrone and IVMP had significantly less new Gd-enhancing lesionson MRI at 6 months, significant mean reduction in EDSS, significant mean annualized relapse rate (per patient), and significantly less patients with relapse.	Nausea, vomiting, alopecia (mild hair thinning), menstrual irregularities, infection, stomatitis, arrhythmia, diarrhea, urine abnormality, electrocardiography (ECG) abnormality, constipation, back pain, headache, laboratory abnormalities (GGT, SGOT, SGPT, anemia, granulocytopenia, leukopenia)	Cardiotoxic risk increses with successive doses;  Secondary acute myelogenous leukemia,  myelosuppression,  extravasation at infusion site,  hypersensitivity reaction	Baseline left ventricular ejection fraction (LVEF) and yearly LVEF monitoring post-discontinuation of novantrone;  Liver function tests (LFTs) and blood cell monitoring before each infusion (Hgb, white blood cell [WBC], and Platelets);  Do not administer with a neutrophil count less than 1500 cells/mm3	Pregnancy Category D    Women who are of reproductive potential should use effective contraception during therapy and have a pregnancy test with results known prior to each dose of Mitoxantrone.    Mitoxantrone may cause fetal harm if administered during pregnancy. Mitoxantrone has shown fetal harm in animal studies.  Infertility and amenorrhea have been reported in women with MS using Mitoxantrone.  Mitoxantrone is known to be excreted into breast milk at substantial concentrations up to 28 days after last dose.
Tysabri ¹⁷ ¹⁸	Natalizumab	Intravenous Infusion	300 mg in 100 mL NS infused over 1 hour	Once Monthly	The mechanism by which natalizumab exerts its therapeutic effect in MS is unknown. Natalizumab may be effective due to blockade of interaction of α4-integrin expressed by inflammatory cells with VCAM-1 on vascular endothelial cells, and with CS-1 and/or osteopontin expressed by parenchymal cells in the brain.	Natalizumab is indicated as monotherapy for patients with relapsing forms of MS.	Natalizumab is a monoclonal antibody with superior efficacy in reducing relapsing rates, gadolinium-enhancing lesions, and disease progression  Two studies investigated onset of sustained increase in disability in MS patients; both studies included patients already treated with at least one agent.    Study MS1 patients received Natalizumab 300mg or placebo once monthly.  Percentage with sustained increase in disability was significantly in favor of placebo over Natalizumab. Annual relapse rate was significantly lower in Natalizumab group than with placebo group. new or newly enlarging T2 hyperintense lesions, as well as percentage of patients with Gd-enhancing lesions were all significantly less in Natalizumab group vs placebo group.	Infusion and hypersensitivity reactions, infections, depression, headache, fatigue, arthralgia, Infection, gastroenteritis, vaginitis, extremity pain, diarrhea, abdominal discomfort, cholelithiasis, arthralgia, rash, labratory test abnormalities	Herpes, encephalitus, and meningitis,  hepatotoxicity,  hypersensitivity reaction,  immunosuppression/ infection Risk of progressive multifocal leukoencephalopathy (PML) or PML caused by John Cunningham polyomavirus (JCV) Factors of increased PML Risk: Positive for JCV antibodies, Use of specific immunosuppressive drugs, > 2 years of Natalizumab use	Hepatotoxicity (elevated serum transaminases, bilirubin);  Patient should be monitored during and 1 hour following infusion for hypersensitivity reaction;  persistent antibody-positivity    MS TOUCH program to monitor for cases of PML, and necessary to prescribe Natalizumab  Baseline MRI brain scan should also be obtained for comparison if PML is suspected	Pregnancy Category C    Natalizumab should only be used during pregnancy when the potential benefit outweighs the potential risk to the fetus.  Natalizumab has been detected in human breast milk.
Lemtrada ¹⁹ ²⁰	Alemtuzumab	Intravenous infusion	First Course: 12 mg/day on 5 consecutive days, infused over 4 hours  Second Course: 12 mg/day on 3 consecutive days 12 months after first treatment course	5 doses in year 1;  3 doses in consecutive years	The mechanism by which Alemtuzumab exerts its therapeutic effect in MS has not yet been elucidated. Alemtuzumab is thought to work by binding to certain immune cells , resulting in antibody-dependent cellular cytolysis and complement-mediated lysis.	Alemtuzumab is the most recently approved disease-modifying MS medication, and due to safety profile, is reserved for patients with inadequate responses to 2 or more MS medications.	Alemtuzumab is a monoclonal antibody with superior efficacy to Interferon β-1a in relducing relapse rates.    In one study, patients with RRMS were given 2 courses of Alemtuzumab and clinical outcome measures were annualized relapse rate over 2 years, time to confirmed disability progression, and percentage of relapse-free patients at 2 years. Patients included must have previously relapsed on either Interferon β-1a or glatiramer acetate therapy; patients were randomized to Alemtuzumab or Interferon β-1a therapy (44 mcg given 3 times weekly). These outcomes were substantially lower in the Alemtrada group, compared with Interferon β-1a therapy. There was no substantial difference in T2 lesion volume from baseline.    In Study 2, RRMS patients were given either Interferon β-1a 44 mcg 3 times weekly or 2 courses of Alemtuzumab. Annualized relapse rate was substantially lower in the Alemtuzumab group vs the Interferon β-1a group. However, there was no substantial difference among groups in regard to time to confirmed disability, progression, and for change in T2 lesion volume.	Headache, rash, pyrexia, nasopharyngitis, nausea, UTI, fatigue, insomnia, infection, herpes viral infection, urticaria, pruritis, thyroid gland disorders, fungal infection, arthralgia, extremity pain, diarrhea, sinusitis, oropharyngeal pain, paresthesia, dizziness, abdominal pain, flushing, and vomiting, infusion reactions, increased risk of malignancy, risk of autoimmune thyroid disorders, increased risk of herpes infection vs Interferon β, vaccination interactions	Immune thrombocytopenia, Anti-glomerular basement membrane disease, malignancy,  glomerular nephropathies, autoimmune cytopenias, human papillomavirus (HPV), tuberculosis, pneumonitis	Infusion reactions: pretreat and monitor up to 2 hours post-infusion  CBC with differential, serum creatinine, and urinalysis (once monthly until 48 months after last infusion)  Thyroid function tests prior to initiation, and then every 3 months until 48 months after the last infusion.  Baseline and yearly skin exams for melanoma  There is a LEMTRADA REMS program.    Pretreat with corticosteroids for the first 3 days of each treatment course, prior to Alemtuzumab infusion.  Monitor vital signs before and periodically throughout infusion.	Pregnancy Category C    Women of childbearing potential should use effective contraception during and following 4 months after discontinuation of Alemtuzumab.    Alemtuzumab use during pregnancy should be used only if the potential benefit outweighs the potential risk to the fetus.    Alemtuzumab may be excreted into human breast milk.
Gilenya ²¹  ²²	Fingolimod	PO	0.5 mg capsule	Once Daily	Fingolimod binds to sphingosine 1-phosphate receptor modulators (SIP) receptors on the lymphocyte surface, thereby depleting CD4+ and CD8+ cells. The exact mechanism by which Fingolimod exerts its therapeutic effect in MS is not known, but may involve reduction of lymphocyte migrationinto the central nevous system (CNS).	Fingolimod is indicated in patients with relapsing forms of MS to reduce frequency of clinical exacerbation and to delay accumulation of physical disability.	Fingolimod has been shown to be superior to Interferon β-1a in reduction of relapse rate.    Patients with RRMS were given placebo, Fingolimod 0.5 mg daily, or 1.25 mg daily for up to 24 months. Fingolimod 1.25 mg did not result in additional benefit over the 0.5 mg Fingolimod dose. Annualized relapse rate was substantially lower, and percentage of patients without relapse was substantially higher in the Fingolimod 0.5 mg group vs the placebo group. Magnetic resonance imaging (MRI) endpoints of mean number of new or newly enlarging T2 lesions and mean T1 Gd-enhancing lesions were also substantially lower in the Fingolimod 0.5 mg group vs placebo.    Another study involved patients with RRMS who were randomized to treatment with either Fingolimod 0.5 mg, Fingolimod 1.25 mg, or Interferon β-1a 30 mcg intramuscular (IM) injection once weekly. Again, Fingolimod 1.25 mg showed no additional benefit vs Fingolimod 0.5 mg. Annualized relapse rates were substantially lower for patients receiving Fingolimod 0.5 mg vs the Interferon β-1a group. The number of new or newly enlarging T2 lesions over 12 months, along with the mean number of T1 Gd-enhancing lesions at month 12 were both substantially lower with either strength of Fingolimod when compared with Interferon β-1a.	Headache, liver transaminase elevation, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in extremities	Bradyarrhythmia, atrioventricular block, infection, multifocal leukoencephalopathy (PML), posterior reversible encephalopathy syndrome (PRES), macular edema, respiratory effects, liver injury	First Dose: observe for bradycardia for at least 6 hours after first dose.  Obtain electrocardiography (ECG) at baseline and again at the end of observation period. If bradycardia occurs, monitor until resolution. Patients with certain heart conditions should be monitored overnight.    Monitor for infection during and 2 months after discontinuation of Fingolimod.  Monitor for PML   and posterior reversible encephalopathy syndrome (PRES)  Obtain complete blood count (CBC) and liver function tests (LFTs) before initiating treatment  Risk of macular edema: examine fundus before and 3-4 months following treatment initiation.	Pregnancy Category C    Women of childbearing potential should use effective contraception during and up to 2 months after discontinuation of Fingolimod.    Fingolimod may cause fetal harm based on animal data.    It is not known if this medication is excreted into human breast milk
Aubagio ²³ ²⁴	Teriflunomide	PO	7 mg and 14 mg tablets	Once Daily	Teriflunomide is a dihydro-orotate dehydrogenase inhibitor, and its exact mechanism to produce therapeutic effect in MS is unknown, but may involve a reduction in activated lymphocytes in the central nervous system (CNS).	Teriflunomide is indicated in patients with relapsing forms of MS.	Both strengths of Teriflunomide reduced annual relapse rates, lesion volume, and gadolinium-enhancing lesions vs placebo. Teriflunomide 14 mg dose reduced relative risk of disability progression.    In one study, patients with either RRMS or a progressive form of MS were given either Teriflunomide 7 mg, Teriflunomide 14 mg, or placebo. There was a statistically meaningful reduction in annualized relapse rates for patients receiving Teriflunomide in either strength vs placebo. In the Teriflunomide 14 mg group, there was a substantial reduction in relative risk of disability progression compared with placebo. Patients in both Teriflunomide groups had substantially lower change in T2 and T1 hyperintense lesions, as well as fewer Gd-enhancing lesions vs placebo.    A patient population of 98% RRMS and 2% progressive forms of MS were administered either Teriflunomide 7 mg, Teriflunomide 14 mg, or placebo. Substantial differences in favor of either Teriflunomide strength over placebo was seen with annualized relapse rate and disability progression.    Another study observed magnetic resonance imaging (MRI) endpoints in patients with relapsing forms of MS given placebo, Teriflunomide 7 mg, or Teriflunomide 14 mg. The mean number of active lesions per MRI brain scan were substantially lower in both Teriflunomide groups vs placebo.	Headache; diarrhea; nausea; hair thinning or loss; increase in ALT	Hepatotoxicity,  Bone marrow effects, Immunosupression,  Risk of malignancy,  Peripheral neuropathy,  Respiratory effects,  Skin reactions,  increased blood pressure	Transaminase and bilirubin levels (within 6 months of initiation of Aubagio);  ALT (at least monthly for 6 months);  Complete blood count (CBC) (6 months prior to initiation),  Tuberculosis screening prior to initiation.      Drug levels can be detected in serum up to 2 years after discontinuation of Aubagio: elimination of aubagio may be accelerated by administering activated charcoal or cholestyramine.	Pregnancy Category X    Black Box Warning of Risk for Teratogenicity;  Contraindicated use in women of childbearing potential who are not using effective contraception.    It is not known whether teriflunomide is excreted into human breast milk. Teriflunomide is detected in human semen; Men wishing to father a child should discontinue aubagio and undergo accelerated elimination procedure until Teriflunomide plasma concentration is less than 0.02 mg/L
Tecfidera ²⁵ ²⁶	Dimethyl fumarate	PO	120 mg capsules twice daily for 7 days; then 240mg twice daily.  Temporary dose reduction to 120mg twice daily may be administered if the patient cannot tolerate 240mg twice daily due to gastrointestinal ADE. Within 4 weeks, 240mg BID should be resumed.	Twice Daily	The mechanism by which Dimethyl fumarate exerts its therapeutic effect in MS is unknown.	Dimethyl fumarate is indicated for patients with relapsing forms of MS.	Patients with RRMS were given dimethyl fumarate 240 mg twice daily, dimethyl fumarate 240 mg 3 times a day, or placebo for up to 2 years. Dimethyl fumarate dosed 3 times daily showed no benefit over twice daily dosing. Dimethyl fumarate was statistically superior to placebo in the following endpoints: proportion of relapse, annualized relapse rate, proportion with disability progression, mean number of T2 lesions over 2 yeas, percentage of patients with no new or no newly enlarging lesions, number of Gd-enhancing lesions, and mean number of new T1 hypointense lesions over 2 years.    A second study with identical endpoints as above randomized relapsing MS patients to receive dimethyl fumarate 240 mg twice daily, dimethyl fumarate 240 mg 3 times daily, an open-label comparator, or placebo. Dimethyl fumarate 240 mg twice daily was statistically superior to placebo in all endpoints except relative risk reduction in the proportion with disability progression.	Flushing, and typically transient gastrointestinal side effects such as abdominal pain, diarrhea, and nausea	Anaphylaxis and angioedema, Progressive multifocal leukoencephalopathy (PML) risk,  lymphopenia risk	Complete blood count (CBC) before initiation of therapy,  Liver function tests (LFTs) periodically.    Flushing can be reduced by taking aspirin 30 minutes prior to tecfidera dose, and taking tecfidera dose with food.	Pregnancy Category C   Dimethyl fumarate may cause fetal harm based on animal data.    It is not known if this medication is excreted into human breast milk. Exercise caution when administering Dimethyl fumarate to nursing women.
1. Avonex [package insert]. Cambridge (MA): Biogen Idec Inc; 1996				2 Avonex In: Lexi-drugs online [Internet]. Hudson (OH): Lexicomp, Inc.; 2015 [updated 10 Dec 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
3. Rebif [package insert]. Rockland (MA): EMD Serono, Inc; 1996				4. Rebif In: Lexi-drugs online [Internet]. Hudson (OH): Lexicomp, Inc.; 2015 [updated 10 Dec 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
5. Plegridy [package insert]. Cambridge (MA): Biogen Idec Inc; 2014				6. Plegridy In: Lexi-drugs online  [Internet]. Hudson (OH): Lexicomp, Inc.; 2015 [updated 8 Dec 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
7. Betaseron [package insert]. Germany: Bayer Pharmaceuticals Inc; 1993				8. Betaseron In: Lexi-drugs online [Internet]. Hudson (OH): Lexicomp, Inc.; 2015 [updated 25 Nov 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
9. Extavia [package insert]. East Anover (NJ): Novartis; 1993				10. Extavia In: Lexi-drugs online  [Internet].  Hudson (OH): Lexicomp, Inc.; 2015 [updated 25 Nov 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
11. Glatopa [package insert]. Princeton (NJ): Sandoz Inc.; 1996				12. Glatopa In: Lexi-drugs online [Internet].  Hudson (OH): Lexicomp, Inc.; 2015 [updated 14 Oct 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
13. Copaxone [package insert]. North Wales (PA): TEVA Pharmaceuticals USA Inc.; 1996				14. Copaxone In: Lexi-drugs online  [Internet]. Hudson (OH): Lexicomp, Inc.; 2015 [updated 14 Oct 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
15. Novantrone [package insert]. Rockland (MA): EMD Serono Inc.; 2008				16. Novantrone In: Lexi-drugs online [ [Internet]. Hudson (OH): Lexicomp, Inc.; 2015 [updated 19 Nov 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
17. Tysabri [package insert]. Cambridge (MA): Biogen Idec Inc.; 2004				18. Tysabri In: Lexi-drugs online [Internet]. Hudson (OH): Lexicomp, Inc.; 2015 [updated 13 Nov 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
19. Lemtrada [package insert]. Cambridge (MA): Genzyme Corporation; 2001				20. Lemtrada In: Lexi-drugs online [Internet]. Hudson (OH): Lexicomp, Inc.; 2015 [updated 1 Dec 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
21. Gilenya [package insert]. East Anover (NJ): Novartis; 2010				22. Gilenya In: Lexi-drugs online [Internet].  Hudson (OH): Lexicomp, Inc.; 2015 [updated 10 Dec 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
23. Aubagio [package insert]. Cambridge (MA): Genzyme Corporation; 2012				24. Aubagio In: Lexi-drugs online [ [Internet]. Hudson (OH): Lexicomp, Inc.; 2015 [updated 1 Dec 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
25. Tecfidera [package insert]. Cambridge (MA): Biogen Inc.; 2013				26. Tecfidera In: Lexi-drugs online [Internet].  Hudson (OH): Lexicomp, Inc.; 2015 [updated 9 Oct 2015; cited 10 Dec 2015]. Available from: http://online.lexi.com.
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