DISEASE-MODIFYING THERAPIES FOR MS - National Multiple Sclerosis ...
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
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 contactus@nmss.org. 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 3Injectable 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 4Injectable 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 5Injectable 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 6Injectable 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 7Injectable 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 8Oral 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 9Oral 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 10Oral 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 11Oral 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 12Oral 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 13Oral 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 14Oral 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 15Oral 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 16Oral 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 17Intravenous 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 18Intravenous 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
overview of side effects and risks associated
status is significantly
with this medication.
abnormal between
relapses)
Disease-Modifying Therapies for MS | National MS Society 19Intravenous 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 20Intravenous 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 21Aubagio® 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. The Society publishes many other resources about various aspects of MS. Visit nationalMSsociety.org/brochures or call 1-800-344-4867. About the National Multiple Sclerosis Society Founded in 1946, the National MS Society is a nationwide organization leading the global charge to create a world free of MS. As a movement by and for people affected by MS, the Society brings together people of diverse backgrounds to turn their passion and power into real results. Through the support of generous donors and members in the MS community, the Society funds cutting-edge research, drives change through advocacy, facilitates professional education, and provides programs and services to help all people affected by MS live their best lives. Connect to learn more and get involved: nationalMSsociety.org, Facebook, Twitter, Instagram, YouTube or 1-800-344-4867. nationalMSsociety.org For information: 1-800-344-4867 © 2021 National MS Society. All rights reserved. services_dseseMdfyngThrpies_pub_07-21
You can also read
