DISEASE -MODIFYING
THERAPIES FOR MS
Updated July 2021. Please visit nationalMSsociety.org/DMT for the most current version of this publication.
Although a cure for MS has not yet been discovered, a number of medications (also called disease modifying therapies, or DMTs) have been approved to treat MS. Permanent damage to the central nervous system (or CNS, which is made up of the brain, spinal cord and optic nerves) can occur early in the disease, even when a person has no symptoms and feels well. Early and ongoing treatment with DMTs may help prevent permanent damage in the CNS. Research has demonstrated the DMTs for relapsing forms of MS reduce the frequency and severity of MS relapses, reduce the development of new areas of damage in the CNS and slow the accumulation of disability. Disease modifying therapies don’t generally improve everyday symptoms. Many symptoms of MS can be managed using other types of medications and non- medication strategies. Combining DMT use, symptom management and a healthy lifestyle is the optimal strategy for managing MS.
Working with your healthcare provider to find the best choice for you The decision to take a DMT should be a shared decision made jointly between you and your healthcare provider. Each person’s body or disease can respond to DMTs differently, and the DMT that is the best option for one person may not be the best for another person. In addition, a DMT that adequately controls your disease today may not do so in the future and you may need to change to a different DMT. Also make sure your provider knows what other health conditions and medications (including vitamins and supplements) you take as that can affect which DMTs are safe for you.
Help with DMT costs Learn more about patient assistance programs to help with the cost of each DMT at nationalMSsociety.org/assistanceprograms. For additional information, connect to an MS Navigator at 1-800-344-4867 or [email protected].
Understanding US Food and Drug Administration (FDA) warnings The chart below summarizes the side effects, warnings and precautions listed for each DMT in the FDA required prescribing information. In some instances, a warning is printed in a black box in the prescribing information to call attention to serious or life-threatening risks. All black box warnings are in bold font in the column outlining the ‘Side effects and warnings’ in the chart.
Disease-Modifying Therapies for MS | National MS Society 1 Each DMT can cause a serious allergic reaction, and some make it unsafe for you to receive certain vaccines while you’re taking them. Prior to starting any DMT, talk with your healthcare provider about any vaccines you should get or have recently received. Each DMT requires some safety monitoring. Talk with your healthcare provider about the monitoring that is required for the DMT you are taking and be consistent with it.
None of the DMTs are approved by the FDA for women who are pregnant or plan to become pregnant, or who are breastfeeding. It is important for women to discuss their plans for pregnancy with their healthcare provider so that they can decide together the best and safest treatment plan.
Disease-Modifying Therapies for MS | National MS Society 2 Important information
Injectable treatments
Treatment Dose/Route of Side effects and warnings (chemical name) Administration (black box warnings are noted in bold)
Manufacturer Pregnancy, FDA indications family planning & breastfeeding
Avonex® 30 mcg intramuscular Most common side effects: (interferon beta-1a) (into a large muscle) headache, flu-like symptoms (chills, fever, muscle injection once weekly pain, fatigue, weakness), injection site pain and Biogen inflammation Pregnancy: Data do not Approval: 1996 US, for suggest a clear Possible serious side effects: the treatment of relationship between • Depression, suicidal thoughts, hallucinations or relapsing forms of use and major other behavioral health problems multiple sclerosis, congenital • Liver problems, or worsening of liver problems which include clinically malformations, but including liver failure and death isolated syndrome, may cause fetal harm relapsing-remitting based on animal data • Heart problems, including heart failure disease (RRMS) and • Blood problems, including low red and white blood active secondary cell and platelet counts progressive disease, in • Injury to small blood vessels, red blood cells and adults. platelets (thrombotic microangiopathy), that can sometimes lead to death • Autoimmune diseases—easy bleeding or bruising, thyroid gland problems and autoimmune hepatitis
Read the medication guide for a comprehensive overview of side effects and risks associated with this medication
Disease-Modifying Therapies for MS | National MS Society 3 Injectable treatments
Treatment Dose/Route of Side effects and warnings (chemical name) Administration (black box warnings are noted in bold)
Manufacturer Pregnancy, FDA indications family planning & breastfeeding
Betaseron® 0.25 mg subcutaneous Most common side effects: (interferon beta-1b) (under the skin) Flu-like symptoms (chills, fever, muscle pain, fatigue, injection every other weakness) following injection, headache, injection site Bayer Healthcare day reactions (swelling redness, pain), injection site skin Pharmaceuticals Inc. breakdown, low white blood cell count, insomnia, Pregnancy: May cause abdominal pain, increased liver enzymes Approval for RRMS: fetal harm based on 1993 US; 1995 CAN animal data Possible serious side effects: Approval for SPMS: • Liver problems including liver failure 1995 CAN for the • Depression or suicidal thoughts treatment of relapsing forms of multiple • Heart problems or worsening heart problems sclerosis, which • Injury to small blood vessels, red blood cells and include clinically platelets (thrombotic microangiopathy), sometimes isolated syndrome, leading to death relapsing-remitting • Lupus erythematosus, an autoimmune disease disease (RRMS) and • Injection site problems including serious skin active secondary reactions and severe skin damage (necrosis) progressive disease, in adults. Read the medication guide for a comprehensive overview of side effects and risks associated with this medication.
Disease-Modifying Therapies for MS | National MS Society 4 Injectable treatments
Treatment Dose/Route of Side effects and warnings (chemical name) Administration (black box warnings are noted in bold)
Manufacturer Pregnancy, FDA indications family planning & breastfeeding
Copaxone® 20 mg subcutaneous Most common side effects: (glatiramer acetate) (under the skin) Injection site reactions (redness, pain, swelling), Teva Neuroscience injection every day, or flushing, shortness of breath, rash, chest pain 40 mg subcutaneous Approval: 1996 US; injection three times Possible serious side effects: 1997 CAN per week • Damage to the fatty tissue under the skin (lipoatrophy) and, rarely, death of skin tissue Therapeutic Pregnancy: Available (necrosis) equivalent to human data are not • Liver problems, including liver failure Copaxone: Glatiramer sufficient to support Acetate conclusions about drug-associated risk Read the Copaxone medication guide for a Mylan Pharmaceuticals for major birth defects comprehensive overview of side effects and risks Approval: 2017 US, for and miscarriage associated with this medication. the treatment of relapsing forms of Read the Mylan glatiramer acetate medication guide multiple sclerosis, for 20 mg and the medication guide for which include clinically 40 mg. isolated syndrome, relapsing-remitting disease (RRMS) and active secondary progressive disease, in adults.
Disease-Modifying Therapies for MS | National MS Society 5 Injectable treatments
Treatment Dose/Route of Side effects and warnings (chemical name) Administration (black box warnings are noted in bold)
Manufacturer Pregnancy, FDA indications family planning & breastfeeding
Extavia® 0.25 mg subcutaneous Most common side effects: (interferon beta-1b) (under the skin) flu-like symptoms (chills, fever, muscle pain, fatigue, injection every other weakness) following injection, headache, injection site Novartis day reactions (swelling redness, pain), injection site Pharmaceuticals skin breakdown, low white blood cell count, insomnia, Pregnancy: May cause abdominal pain, increased liver enzymes Approval: 2009 US; fetal harm based on 2009 CAN, for the animal data Possible serious side effects: treatment of relapsing • Liver problems including liver failure forms of multiple • Depression or suicidal thoughts sclerosis, which include clinically • Injury to small blood vessels, red blood cells and isolated syndrome, platelets (thrombotic microangiopathy), which can relapsing-remitting be fatal disease (RRMS) and • Worsening heart problems active secondary progressive disease, in Read the medication guide for a comprehensive adults. overview of side effects and risks associated with this medication.
Glatopa® 20 mg subcutaneous Most common side effects: (glatiramer acetate, (under the skin) Injection site reactions (redness, pain, swelling), generic equivalent injection every day, or flushing, shortness of breath, rash, chest pain of Copaxone) 40 mg subcutaneous injection three times Possible serious side effects: Sandoz – a Novartis per week • Damage to the fatty tissue under the skin company (lipoatrophy) and, rarely, death of skin tissue Pregnancy: Available (necrosis) Approval: 2015 US, for human data are not • Liver problems the treatment of sufficient to support relapsing forms of conclusions about multiple sclerosis, drug-associated risk Read the medication guide for a comprehensive which include clinically for major birth defects overview of side effects and risks associated with isolated syndrome, and miscarriage this medication. relapsing-remitting disease (RRMS) and active secondary progressive disease, in adults.
Disease-Modifying Therapies for MS | National MS Society 6 Injectable treatments
Treatment Dose/Route of Side effects and warnings (chemical name) Administration (black box warnings are noted in bold)
Manufacturer Pregnancy, FDA indications family planning & breastfeeding
Kesimpta® 20 mg subcutaneous Most common side effects: (ofatumumab) (under the skin) Upper respiratory tract infection, headache, injection- injection at weeks 0, 1 related and injection-site reactions Novartis and 2, followed by 20 mg once monthly Possible serious side effects: Approval: 2020 US, for starting at week 4 • Hepatitis B virus (HBV) reactivation the treatment of • Infections relapsing forms of Pregnancy: May cause multiple sclerosis, fetal harm based on • A decrease in some types of antibodies which include clinically animal data (immunoglobulins) isolated syndrome, relapsing-remitting Read the medication guide for a comprehensive disease (RRMS) and overview of side effects and risks associated with this active secondary medication. progressive disease, in adults. Plegridy® 63 mcg subcutaneous Most common side effects: (pegylated (under the skin) or Flu-like symptoms (chills, fever, muscle pain, fatigue, interferonbeta-1a) intramuscular (into a weakness, headache, itching), injection site reactions large muscle) injection (swelling, redness, pain) Biogen on day 1, 94 mcg on day 15, and 125 mcg Possible serious side effects: Approval: 2014 US, for on day 29 and every 14 • Liver problems or worsening of liver problems, the treatment of days thereafter including liver failure and death relapsing forms of • Depression or suicidal thoughts multiple sclerosis, Pregnancy: Data do not which include clinically suggest a clear • Seizures isolated syndrome, relationship between • Injection site reactions, including severe skin relapsing-remitting use and major damage (necrosis) disease (RRMS) and congenital • Heart problems, including congestive heart failure active secondary malformations, but • Blood problems and changes in your blood tests progressive disease, in may cause fetal harm adults. based on animal data. • Injury to small blood vessels, red blood cells and platelets (thrombotic microangiopathy), sometimes leading to death • Autoimmune diseases—easy bleeding or bruising, thyroid gland problems and autoimmune hepatitis
Read the medication guide for a comprehensive overview of side effects and risks associated with this medication.
Disease-Modifying Therapies for MS | National MS Society 7 Injectable treatments
Treatment Dose/Route of Side effects and warnings (chemical name) Administration (black box warnings are noted in bold)
Manufacturer Pregnancy, FDA indications family planning & breastfeeding
Rebif® 22 mcg or 44 mcg Most common side effects: (interferon beta-1a) subcutaneous (under Flu-like symptoms (chills, fever, muscle pain, fatigue, the skin) injection weakness, headache), injection site reactions (redness, EMD Serono, Inc / three times per week pain, swelling) Pfizer, Inc Pregnancy: Data do not Possible serious side effects: Approval: 1998 US; suggest a clear • Behavioral health problems including depression 2002 CAN, for the relationship between and suicidal thoughts treatment of relapsing use and major • Liver problems or worsening of liver problems forms of multiple congenital including liver failure sclerosis, which malformations, but include clinically may cause fetal harm • Injection site problems, including skin damage isolated syndrome, based on animal data. (necrosis) relapsing-remitting • Low blood cell counts disease (RRMS) and • Injury to small blood vessels, red blood cells and active secondary platelets (thrombotic microangiopathy) progressive disease, in • Seizures adults.
Read the medication guide for a comprehensive overview of side effects and risks associated with this medication.
Disease-Modifying Therapies for MS | National MS Society 8
Oral treatments
Treatment (chemical Dose/Route of Side effects and warnings (black name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Aubagio® 7 mg or 14 mg pill by Most common side effects: (teriflunomide) Sanofi mouth once daily Headache, hair thinning, diarrhea, nausea, abnormal liver tests Genzyme Pregnancy: Contraindicated for use in Possible serious side effects: Approval: 2012 US; 2013 pregnant women and in • Serious liver problems, including liver CAN, for the treatment of females of reproductive failure, that can be life-threatening relapsing forms of multiple potential who are not • Decrease in white blood cell count and sclerosis, which include using effective more frequent infections clinically isolated syndrome, contraception because of relapsing-remitting disease the potential for fetal • Numbness and tingling in the hands or feet (RRMS) and active secondary harm. Females should not that is different from MS symptoms progressive disease, in take if they are pregnant • High blood pressure adults. or plan to become • Serious skin reactions that may lead to pregnant. Males should death not take if their partner plans to becomes Read the medication guide for a pregnant. Effective birth comprehensive overview of side effects and control should be used by risks associated with this medication. males and females if either partner is taking Aubagio or still has Aubagio in their blood. Aubagio can remain in the blood for up to 2 years after stopping taking it. A healthcare provider can prescribe medication to lower Aubagio blood levels more quickly.
Disease-Modifying Therapies for MS | National MS Society 9 Oral treatments
Treatment (chemical Dose/Route of Side effects and warnings (black name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Bafiertam™ 95 mg capsule by mouth Most common side effects: (monomethyl fumarate) twice daily for 7 days and Flushing, abdominal pain, diarrhea and 190 mg twice a day nausea Banner Life Sciences thereafter Possible serious side effects: Approval: 2013 US, for the Pregnancy: May cause fetal • Herpes zoster (shingles) and other serious treatment of relapsing forms harm based on animal data infections of multiple sclerosis, which • Decreases in white blood count include clinically isolated syndrome, relapsing- • Serious liver problems that may lead to remitting disease (RRMS) death and active secondary • Progressive multifocal progressive disease, in leukoencephalopathy (PML), a rare brain adults. infection that usually leads to death or severe disability, has been reported in people taking medications that are chemically similar to Bafiertam
Read the medication guide for a comprehensive overview of side effects and risks associated with this medication.
Disease-Modifying Therapies for MS | National MS Society 10 Oral treatments
Treatment (chemical Dose/Route of Side effects and warnings (black name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Gilenya® 0.5 mg capsule by mouth Most common side effects: (fingolimod) once daily for adults and Headache, flu, diarrhea, back pain, abnormal children weighing greater liver tests, sinusitis, abdominal pain, pain in Novartis Pharmaceuticals than 40 kg or 0.25 mg once extremities, cough daily by mouth for children Approval: 2010 US; weighing less than or equal Possible serious side effects: 2011 CAN, for the treatment to 40 kg • Infections that may cause death. Do not of relapsing forms of receive any live vaccines during or for 2 multiple sclerosis, which Pregnancy: May cause fetal months after stopping treatment. Children include clinically isolated harm based on animal data. need to have completed their vaccination syndrome, relapsing- Females who can become schedule before starting treatment with remitting disease (RRMS) pregnant should use Gilenya and active secondary effective birth control • Progressive multifocal leukoencephalopathy progressive disease, in during treatment and for 2 (PML), a rare brain infection that usually patients 10 years and older. months after stopping leads to death or severe disability • A vision problem called macular edema that cause some of the same symptoms as an MS vision attack (optic neuritis). Having diabetes or having had inflammation of the eye (uveitis) may increase this risk • Swelling and narrowing of the blood vessels in your brain called Posterior Reversible Encephalopathy Syndrome (PRES) has happened rarely in adults may lead to stroke if left untreated • Shortness of breath • Severe worsening of multiple sclerosis symptoms after stopping treatment • Increased blood pressure • Types of skin cancer called basal cell carcinoma and melanoma • Relapses with tumefactive demyelinating lesions (tumefactive MS), either during treatment or after stopping treatment
Disease-Modifying Therapies for MS | National MS Society 11 Oral treatments
Treatment (chemical Dose/Route of Side effects and warnings (black name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Mavenclad® Tablet given by mouth in Most common side effects: (cladribine) two treatment courses, Respiratory infection, headache, low white once per year for two years. blood cell count EMD Serono, Inc. Each treatment course has two cycles, which are 4-5 Possible serious side effects: Approval: 2019 US; 2017 days long and about one • Increased risk of cancer (malignancy); CAN for the treatment of month apart. The exact do not take if you have cancer relapsing forms of MS, to dose will depend on your • Serious infections such as TB, hepatitis B or include relapsing-remitting weight C, and shingles (herpes zoster). Fatal cases disease and active secondary of TB and hepatitis happened during progressive disease, in Pregnancy: clinical studies adults. Because of its safety Contraindicated for use in profile, use is generally pregnant women and in • Liver problems recommended for those who women and men of • Complications with blood transfusions have had an inadequate reproductive potential response to, or are unable to who do not plan to use Read the medication guide for a tolerate, an alternate drug effective contraception comprehensive overview of side effects and indicated for the treatment because of the risk of fetal risks associated with this medication. of MS. harm
It is not known if Mavenclad passes into your breast milk. Do not breastfeed on the days, on which you take Mavenclad and for 10 days after the last dose.
Disease-Modifying Therapies for MS | National MS Society 12 Oral treatments
Treatment (chemical Dose/Route of Side effects and warnings (black name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Mayzent® Increases each day over 4-5 Most common side effects: (siponimod) days to the ongoing Headache, high blood pressure, abnormal (maintenance) dose of a liver tests Novartis Pharmaceuticals 1mg or 2 mg pill by mouth once daily. Your healthcare Possible serious side effects: Approval: 2019 US, provider will do a blood • Infections that may cause death for the treatment of test to determine whether • A vision problem called macular edema that relapsing forms of multiple you will take the 1 mg or cause some of the same symptoms as an MS sclerosis, which include 2mg maintenance dose and vision attack (optic neuritis). Having clinically isolated syndrome, give you specific diabetes or having had inflammation of the relapsing-remitting disease instructions for increasing eye (uveitis) may increase this risk (RRMS) and active secondary the dose each day to reach progressive disease, in the maintenance dose. • Slow heart rate (bradycardia or adults. bradyarrhythmia), especially after the first Pregnancy: May cause fetal dose harm based on animal data. • New or worsening shortness of breath, Tell your healthcare including during sleep provider right away if you • Types of skin cancer called basal cell become pregnant while carcinoma, melanoma and squamous cell taking Mayzent or if you carcinoma become pregnant within 10 days after stopping Read the medication guide for a Mayzent. Females taking comprehensive overview of side effects and Mayzent should use risks associated with this medication. effective birth control during treatment and for 10 days after stopping Mayzent.
Disease-Modifying Therapies for MS | National MS Society 13 Oral treatments
Treatment (chemical Dose/Route of Side effects and warnings (black name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Ponvory™ (ponesimod) 2mg pill by mouth on day Most common side effects: one, increased Upper respiratory tract infection, high blood Janssen Pharmaceuticals, Inc. incrementally to a pressure, abnormal liver tests maintenance dose of 20mg Approval: 2021 US; for the on day 15 taken once daily Possible serious side effects: treatment of relapsing forms thereafter. Your healthcare • Infections that may cause death of multiple sclerosis, which provider will give you • Slow heart rate (bradycardia or include clinically isolated specific instructions for bradyarrhythmia), especially after the first syndrome, relapsing- increasing the dose each dose remitting disease (RRMS) day to reach the and active secondary maintenance dose. • New or worsening shortness of breath, progressive disease, in including during sleep adults. Pregnancy: May cause fetal • Types of skin cancer called basal cell harm based on animal data. carcinoma, melanoma and squamous cell Women of childbearing carcinoma potential should use • A vision problem called macular edema. effective contraception to Having diabetes or having had avoid pregnancy during and inflammation of the eye (uveitis) may for 1 week after stopping increase this risk treatment. • Serious side effects when used with some medications
Read the medication guide (scroll to page 10) for a comprehensive overview of side effects and risks associated with this medication.
Disease-Modifying Therapies for MS | National MS Society 14 Oral treatments
Treatment (chemical Dose/Route of Side effects and warnings (black name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Tecfidera® 120 mg capsule by mouth Most common side effects: (dimethyl fumarate) twice daily for one week, Flushing (sensation of heat or itching and a followed by 240 mg capsule blush on the skin), gastrointestinal issues Biogen twice daily thereafter (nausea, diarrhea, abdominal pain)
Approval: 2013 US; 2013 Pregnancy: May cause fetal Possible serious side effects: CAN, for the treatment of harm based on animal data • Progressive multifocal relapsing forms of multiple leukoencephalopathy (PML), a rare brain sclerosis, which include infection that usually leads to death or clinically isolated syndrome, severe disability relapsing-remitting disease • Herpes zoster (shingles) and other (RRMS) and active secondary infections progressive disease, in adults. • Decreases in white blood cell counts • Liver problems
Read the medication guide for a comprehensive overview of side effects and risks associated with this medication.
Disease-Modifying Therapies for MS | National MS Society 15 Oral treatments
Treatment (chemical Dose/Route of Side effects and warnings (black name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Vumerity® 231 mg capsule by mouth Most common side effects: (diroximel fumarate) twice daily for one week, Flushing (redness, itching, rash) and stomach followed by two 231 mg problems (nausea, vomiting, diarrhea, Biogen capsules taken twice daily stomach pain, indigestion) thereafter Approval: 2013 US, for the Possible serious side effects: treatment of relapsing forms Pregnancy: May cause fetal • Progressive multifocal of multiple sclerosis, which harm based on animal data leukoencephalopathy (PML), a rare brain include clinically isolated infection that usually leads to death or syndrome, relapsing- severe disability remitting disease (RRMS) • Decreases in white blood cell count and active secondary progressive disease, in • Liver problems adults. • Herpes zoster (shingles) and other serious infections
Read the medication guide for a comprehensive overview of side effects and risks associated with this medication.
Disease-Modifying Therapies for MS | National MS Society 16 Oral treatments
Treatment (chemical Dose/Route of Side effects and warnings (black name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Zeposia® 0.23 mg capsule by mouth Most common side effects: (ozanimod) once daily for days 1-4, Upper respiratory tract infections, elevated followed by 0.46 mg once liver enzymes, low blood pressure when you Bristol Myers Squibb daily for days 5-7, then stand up (orthostatic hypotension), painful increased to 0.92 mg once and frequent urination (signs of urinary tract Approval: 2020 US, for the daily on day 8 and infection), back pain and high blood pressure treatment of relapsing forms thereafter. of multiple sclerosis, which Possible serious side effects: include clinically isolated Pregnancy: May cause fetal • Slow heart rate (bradyarrhythmia) when syndrome, relapsing- harm based on animal data. starting treatment remitting disease (RRMS) Females who can become • Serious infections that can be life- and active secondary pregnant should use threatening and cause death progressive disease, in effective birth control adults. • Breathing problems • A vision problem called macular edema that cause some of the same symptoms as an MS vision attack (optic neuritis). Having diabetes or having had inflammation of the eye (uveitis) may increase this risk • Interaction with some medications
Read the medication guide for a comprehensive overview of side effects and risks associated with this medication.
Disease-Modifying Therapies for MS | National MS Society 17
Intravenous infusion treatments
Treatment Dose/Route of Side effects and warnings (black (chemical name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
® Lemtrada 12 mg per day intravenous Most common side effects: (alemtuzumab) Sanofi infusion (a needle placed in Rash, headache, fever, nasal congestion, your vein) for five nausea, urinary tract infection, fatigue, Genzyme consecutive days, followed insomnia, upper respiratory tract infection, by 12 mg per day on three herpes viral infections, hives, itching, thyroid Approval: 2014 US; 2014 consecutive days one year gland disorders, fungal infection, pain in CAN, for the treatment of later joints, extremities and back, diarrhea, relapsing forms of multiple vomiting, flushing. sclerosis, to include Pregnancy: May cause fetal relapsing remitting disease harm Infusion reactions (including nausea, hives, and active secondary itching, insomnia, chills, flushing, fatigue, progressive disease, in shortness of breath, changes in the sense of adults. Because of taste, indigestion, dizziness, pain) are also Lemtrada’s safety profile, common while the medication is being the FDA recommends that administered and for 24 hours or more after this medication generally the infusion is over be reserved for people who have had an inadequate Possible serious side effects: response to two or more • Serious, sometimes fatal autoimmune MS therapies. and kidney problems • Serious and life-threatening infusion reactions • Serious and life-threatening stroke • Increased risk of certain cancers (malignancies) • Inflammation of the liver • Overactivity of the immune system (hemophagogytic lymphohistiocytosis) that can be fatal • A decrease in some types of blood cells • Increased risk of serious infections • Progressive multifocal leukoencephalopathy (PML), a rare brain infection that usually leads to death or severe disability • Blood clotting problems • Bleeding disorders • Thyroid disorders
Disease-Modifying Therapies for MS | National MS Society 18 Intravenous infusion treatments
Treatment Dose/Route of Side effects and warnings (black (chemical name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Read the medication guide for a comprehensive overview of side effects and risks associated with this medication.
Novantrone® 12 mg/m² intravenous Most common side effects: (mitoxantrone) infusion (a needle placed in Nausea, hair loss, menstrual change, upper your vein) every 3 months. respiratory infection, urinary tract infection, Available only as a generic Lifetime cumulative dose mouth sores, irregular heartbeat, diarrhea, medication limit of approximately 8–12 constipation, back pain, sinusitis, headache, doses over 2–3 years (140 blue-green urine Approval: 2000 US for mg/m2) reducing neurologic Possible serious side effects: disability and/or the Pregnancy: May cause fetal • Secondary acute myeloid leukemia (AML), frequency of clinical harm when administered to a type of cancer, has been reported relapses in patients with a pregnant woman • Cardiotoxicity, specifically heart failure that secondary (chronic) can be fatal, that increases with the number progressive, progressive of treatments relapsing, or worsening relapsing-remitting multiple sclerosis (i.e., Novantrone is rarely prescribed for MS. Read patients whose neurologic the medication guide for a comprehensive status is significantly overview of side effects and risks associated with this medication. abnormal between relapses)
Disease-Modifying Therapies for MS | National MS Society 19 Intravenous infusion treatments
Treatment Dose/Route of Side effects and warnings (black (chemical name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
® Ocrevus 600 mg intravenous Most common side effects: (ocrelizumab) infusion (a needle placed in Infusion reactions (most commonly itchy your vein) every 6 months skin, rash, throat irritation, flushed face or Genentech (a member of (first dose: 300 mg on day fever, headache), which in rare instances may the Roche Group) one and 300 mg 2 weeks be life-threatening; increased risk of later) infections, including respiratory tract Approval: 2017 US; 2013 infections and herpes infections CAN, for the treatment of Pregnancy: May cause fetal relapsing forms of multiple harm based on animal data Possible serious side effects: sclerosis in adults, which • Infections, including hepatitis B include clinically isolated reactivation that may cause serious liver syndrome, relapsing- problems including death remitting disease (RRMS) • Weakened immune system and active secondary progressive disease, and • Risk of cancers (malignancies) including primary progressive MS in breast cancer adults. Read the medication guide for a comprehensive overview of side effects and risks associated with this medication.
Disease-Modifying Therapies for MS | National MS Society 20 Intravenous infusion treatments
Treatment Dose/Route of Side effects and warnings (black (chemical name) Administration box warnings are noted in bold)
Manufacturer FDA Pregnancy, family indications planning & breastfeeding
Tysabri® 300 mg intravenous Most common side effects: (natalizumab) infusion (a needle placed in Headache, fatigue, joint pain, chest your vein) once every 28 discomfort, urinary tract infection, lower Biogen days. Must take place in an respiratory tract infection, gastroenteritis, approved infusion facility vaginitis, depression, pain in extremity, Approval: 2004 US, as a abdominal discomfort, diarrhea, and rash monotherapy (not in Pregnancy: May cause fetal combination with any other harm based on animal data Possible serious side effects: MS disease-modifying • Progressive multifocal treatment or other immune leukoencephalopathy (PML), a rare suppressant drugs) for the brain infection that usually leads to treatment of relapsing death or severe disability. Risk of forms of MS, to include getting PML is higher if you have been clinically isolated infected by the John Cunningham Virus syndrome, relapsing- (JCV), have been on Tysabri for a long remitting disease, and time, or have received certain medicines active secondary that can weaken your immune system progressive disease, in • Herpes infections that may increase the adults. risk of getting an infection of the brain or the covering of the brain and spinal cord (encephalitis or meningitis) • Weakened immune system and higher risk of infections • Liver damage • Low blood platelet counts
Read the medication guide for a comprehensive overview of side effects and risks associated with this medication.
Disease-Modifying Therapies for MS | National MS Society 21 Aubagio® is a registered trademark of Genzyme Corporation. Avonex® is a registered trademark of Biogen Idec. BafiertamTM is a trademark of Banner Life Sciences. Betaseron® is a registered trademark of Bayer Schering Pharma Aktiengesellschaft. Copaxone® is a registered trademark of Teva Pharmaceutical Industries Ltd. Extavia® is a registered trademark of Novartis AG Corporation. Gilenya® is a registered trademark of Novartis AG Corporation. Glatopa® is a registered trademark of Novartis AG Corporation. Kesimpta® is a registered trademark of Novartis AG Corporation. Lemtrada® is a registered trademark of Genzyme Corporation. Mayzent® is a registered trademark of Novartis AG Corporation. Mavenclad® is a registered trademark of EMD Serono, Inc. Ocrevus® is a registered trademark of Genentech. Plegridy® is a registered trademark of Biogen. PonvoryTM is a trademark of Janssen Pharmaceuticals, Inc. Rebif® is a registered trademark of EMD Serono, Inc. Tecfidera® is a registered trademark of Biogen. Tysabri® is a registered trademark of Biogen. Vumerity® is a registered trademark of Biogen. Zeposia® is a registered trademark of Bristol Myers Squibb.
Disease-Modifying Therapies for MS | National MS Society 22
The National Multiple Sclerosis Society is proud to be a source of information about multiple sclerosis. Our comments are based on professional advice, published experience and expert opinion, but do not represent individual therapeutic recommendations or prescriptions. For specific information and advice, consult your physician.
Early and ongoing treatment with an FDA-approved therapy can make a difference for people with multiple sclerosis. Learn about your options by talking to your healthcare professional and contacting the Society at nationalMSsociety.org or 1-800-344-4867.
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