Large orange arrow and smaller gray arrows with sky background representing patient choice in treatment options for RMS

RMS patients reconsidering their DMT due to insurance coverage?

As generic DMTs begin to enter the RMS market, some of your patients may need help choosing a treatment that offers convenient dosing,* demonstrated efficacy, a well-established safety profile, and patient support offerings.1,2

Consider MAVENCLAD, the first and only short-course* oral therapy for RMS.1

DMT = disease modifying therapy; RMS = relapsing multiple sclerosis

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SERVICE REQUEST FORM

MAVENCLAD® (cladribine) is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS.

Limitations of Use: MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of its safety profile.

WELL-ESTABLISHED SAFETY PROFILE

View our well-characterized safety and tolerability profile, which has more than 17 years of evaluation in clinical trials, follow-ups, and real-world experience3

CONVENIENT DOSING & PROVEN EFFICACY

Discover the convenient dosing schedule of MAVENCLAD, as well as our proven efficacy in treating relapses and lesions1,2

MAVENCLAD & THE IMMUNE SYSTEM

Learn about the proposed MAVENCLAD mechanism of action (MOA), including information about continuous vs non-continuous immunosuppression

PATIENT CASE STUDIES

Explore real-world case studies about patients who started taking MAVENCLAD, provided by healthcare providers from around the world

PATIENT SUPPORT OFFERINGS

Are your patients reconsidering their DMT due to insurance coverage changes? Learn about what MAVENCLAD can offer, such as our patient and financial support programs

SERVICE REQUEST FORM

Get more info about our Service Request Form, which enables you to prescribe MAVENCLAD and sign your patients up for one-on-one support services

Well-established Safety Profile

MAVENCLAD has a well-characterized safety and tolerability profile based on more than 17 years of clinical, observational, and real-world experience in MS.3 View the full MAVENCLAD safety story here.

Chart of adverse reactions in CLARITY clinical trial for MAVENCLAD® (cladribine)
Adverse reactions in CLARITY with an incidence of ≥5% for MAVENCLAD and higher than placebo1
Discontinuation rate due to adverse reactions

In the pivotal trial, 3.5% of patients receiving MAVENCLAD discontinued treatment due to ARs vs 2.1% of patients receiving placebo.2

The most common ARs with an incidence of >20% reported in CLARITY were upper respiratory tract infection, headache, and lymphopenia. In clinical studies, 11% of MAVENCLAD patients had hypersensitivity ARs, compared with 7% of placebo patients.1

AR = adverse reaction; MS = multiple sclerosis

Icon related to cases of progressive multifocal leukoencephalopathy (PML) reported in up to 8 years of safety follow-up with patients with MS treated with MAVENCLAD® (cladribine). See Full Prescribing & Safety Info, including BOXED WARNING.

Cases of progressive multifocal leukoencephalopathy (PML) have been reported in up to 8 years of safety follow-up with patients with MS treated with MAVENCLAD

In patients treated with parenteral cladribine for oncological indications, cases of PML have been reported in the postmarketing setting1

>83,000 MAVENCLAD RMS PATIENTS
treated with no reported cases of PML3
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Convenient Dosing & Proven Efficacy
Convenient Dosing

MAVENCLAD is the first and only short-course oral therapy with no more than 10 treatment days a year for 2 years1*

MAVENCLAD is eliminated from the body 1 week after administration,1,4 while the efficacy of MAVENCLAD is sustained beyond active dosing.2

*Screening and monitoring should be performed before, during, and after treatment. Each treatment week, taken about a month apart, consists of 1 or 2 MAVENCLAD pills a day for 4 or 5 days (dosing depends on weight) in a row.

Proven Efficacy

Only MAVENCLAD can deliver proven efficacy over 96 weeks with a maximum of 10 treatment days a year for 2 years1,2*  View the full MAVENCLAD efficacy story here.

T1-Gd+1,2†

Reduction in median number of T1-Gd+ lesions†P<0.001

Relative reduction in mean number of T1-Gd+ lesions† at 96 weeks

86%

vs placebo

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Active T21,2†

Reduction in median number of active T2 lesions†P<0.001

Relative reduction in mean number of active T2 lesions† at 96 weeks

73%

vs placebo

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MAVENCLAD demonstrated proven efficacy across MRI endpoints

The mean relative reduction reflects that not all patients had lesions. At 96 weeks, 57/433 (13.2%) patients in the MAVENCLAD group had T1-Gd+ lesions vs 226/437 (51.7%) patients in the placebo group. At 96 weeks, 166/433 (38.3%) patients in the MAVENCLAD group had active T2 lesions vs 313/437 (71.6%) patients in the placebo group.2,3

†P-value for imaging measurement was based on a nonparametric analysis-of-covariance model on ranked data with fixed effects for study group and region and the number of T1-GD+ lesions at baseline as a covariate.

ARR = annualized relapse rate; CI = confidence interval; MRI = magnetic resonance imaging; T1-Gd+ = T1-weighted gadolinium-enhancing

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PROPOSED MOA & THE IMMUNE SYSTEM

The proposed mechanism of action (MOA) by which MAVENCLAD exerts its therapeutic effects in patients with MS is not fully understood.

MAVENCLAD selectively depletes B cells—and, to a lesser extent, T cells—while leaving the innate immune system relatively intact. After 2 months, most immune cells begin to recover towards normal levels.5*

Post hoc analysis, percentage of patients who had median ALC at Grade 1 lymphopenia or within normal limits†‡:

WEEK 13 OF YEAR 1
  • Normal to grade 1:
    82.2%
  • Grade 2: 16.4%
  • Grade 3: 1.3%
  • Grade 4: 0.0%
1
WEEK 48 OF YEAR 1
  • Normal to grade 1:
    89.1%
  • Grade 2: 10.9%
  • Grade 3: 0.0%
  • Grade 4: 0.0%
2
WEEK 12 OF YEAR 2
  • Normal to grade 1:
    64.5%
  • Grade 2: 28.9%
  • Grade 3: 6.7%
  • Grade 4: 0.0%
3
WEEK 48 OF YEAR 2
  • Normal to grade 1:
    88.3%
  • Grade 2: 10.4%
  • Grade 3: 1.3%
  • Grade 4: 0.0%
4

Methods: Longitudinal lymphocyte data based on pooled analyses of the CLARITY and CLARITY Extension trials, and from patients in those studies followed in the PREMIERE registry. CD19+ B cells, CD4+ T cells, and CD8+ T cells were quantified in a subset of patients using flow cytometry. Thresholds for CD19+ B cells and CD8+ T cells were based on values used in studies of DMTs for MS. The threshold for CD4+ T cells was based on the value used for initiating ART in patients with HIV.

Limitations: This data includes bridging intervals between CLARITY, CLARITY EXT, and PREMIERE, during which lymphocyte counts were not monitored. Patients receiving IFN-beta as rescue therapy (n=11) were not excluded or censored.

Neuroinflammatory cells linked to MS are depleted for up to 12 months after MAVENCLAD treatment1,5,6

B cells

In MS, can produce antibodies that lead to myelin damage6 and present antigen to activate T cells7

CD4+ helper T cells

In MS, do not function correctly and are widely implicated as proinflammatory cells8

CD8+ cytotoxic T cells

In MS, contribute to central nervous system inflammation and damage8

MAVENCLAD has a mild-to-moderate effect on neutrophils and monocytes.5,9,10 With MAVENCLAD, median counts of natural killer cells, monocytes, and CD8+ cytotoxic T cells remained within the normal range throughout the treatment period.5,9-11

MAGNIFY-MS‖: Quantitative B cell changes were observed in patients with highly active MS taking MAVENCLAD, including sustained decrease of memory B cells, and maintenance of regulatory B cells, following each treatment course12

Study Limitations

  • MAGNIFY-MS was a Phase IV, open-label, single-arm, multicenter study
  • The primary endpoint of MAGNIFY-MS was to determine the onset of action of MAVENCLAD in patients with highly active relapsing MS#
  • The data presented here is a post-hoc analysis based on a poster that has not yet been peer-reviewed

Due to the study limitations listed above, no definitive conclusions of efficacy can be drawn from these results and no treatment decisions should be made from these data.

*

Pooled data from CLARITY, CLARITY EXT, and PREMIERE.

†

Data were derived from a post hoc analysis of the 2 courses in patients receiving MAVENCLAD in CLARITY.

‡

Percentages were calculated as a proportion of all patients with laboratory values at each time point. A total of 1.7% of patients (3/176) experienced ≥1 episode of grade 4 lymphopenia at any time point during the entire trial period.

§

MAVENCLAD/placebo were administered as 2 courses separated by 1 year (a maximum of 20 days of treatment). Each course consisted of 2 treatment weeks: 1 at the beginning of the first month and 1 at the beginning of the second month. Data from patients randomized to placebo in CLARITY or who received a cumulative dose of MAVENCLAD for 2 years in CLARITY or CLARITY EXT were included. Any relevant follow-up in CLARITY EXT and PREMIERE was also reported.

‖

MAGNIFY-MS was a Phase IV, open-label, single-arm, multicenter, 2-year study to determine the onset of action of MAVENCLAD, as measured by combined unique active lesions. These data illustrate the longitudinal evaluation of peripheral blood immune cells in patients receiving MAVENCLAD. Patients with highly active relapsing MS (n = 270) received 2 courses of active treatment (week 1 and week 5 of year 1, week 1 and week 5 of year 2).

Median percentage change from baseline.

#

Highly active relapsing MS was defined by having 1 relapse in the previous year and ≥1 T1-Gd+ lesion, or ≥9 T2 lesions, while on therapy with other DMTs, or ≥2 relapses in the previous year, whether on DMT treatment or not.

ALC = absolute lymphocyte count; ART = antiretroviral therapy;  BL = baseline; IFN = interferon;  LLN = lower limit of normal; MOA = mechanism of action;  MS = multiple sclerosis; Q = quartile;  T1-Gd+ = T1-weighted gadolinium-enhancing

While some DMTs continuously deplete B cells while on treatment,

MAVENCLAD allows for B cell recovery between dosing intervals and is therefore not a continuous immunosuppressant2

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Patient Case Studies

Explore real-world case studies about patients who switched to MAVENCLAD.

Patient from Sarasota, Florida

Meet a patient concerned about chronic immunosuppression and intolerant to infusions

Female in her late 50s

Concerned about chronic immunosuppression

Discontinued 2 high-efficacy infusion DMTs due to intolerability

Patient from Phoenix, Arizona

Learn about a patient with a high level of disability and disease activity

Male in his mid-40s

High level of disability

Diagnosed 18 years ago

Patient from Reno, Nevada

Meet an active patient that had an inadequate response to previous infusion therapy

Female in her late 20s

Discontinued infusion therapy due to side effects

Considering having a child but is willing to wait for at least 20 months to get pregnant

Patient from Durham, North Carolina

Learn about a patient who discontinued oral therapy due to side effects and JCV status

Female in her early 40s

Discontinued an oral therapy due to side effects

JCV positive

JCV = John Cunningham virus

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Patient Support Offerings

MS LifeLines® Patient and Financial Support Programs. Visit MS LifeLines here.

FINANCIAL ASSISTANCE FOR ELIGIBLE* PATIENTS

Co-pay for eligible* patients

Eligible patients with insurance may pay as little as $0 co-pay or co-insurance for MAVENCLAD. MS LifeLines® also offers other assistance programs, including free medication, to help eligible patients gain access to MAVENCLAD.

*Some limitations are required by law. Patients covered by federal or state healthcare programs, including Medicare and Medicaid, are not eligible for assistance. This program is open to residents of the US and Puerto Rico with relapsing forms of multiple sclerosis who are starting MAVENCLAD therapy or presently taking MAVENCLAD.

MS LifeLines® financial support specialists can help:

  • Verify patient insurance benefits to determine coverage and understand how much money they may have to pay for their medication (out-of-pocket expenses)
  • Provide information about MS LifeLines® financial assistance options and help determine if patients qualify
  • Work with specialty pharmacies to facilitate treatment and help coordinate treatment delivery

MS LIFELINES® NURSES ARE THERE FOR YOUR PATIENTS

MS LifeLines® nurses can:

  • Help patients with treatment during their 2 years on MAVENCLAD
  • Send patients treatment reminders by email or text if needed
  • Provide tips and MS education to help manage certain symptoms
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Service Request Form

Get more info about our Service Request Form (SRF), which enables you to prescribe MAVENCLAD and sign your patients up for one-on-one support services. Download the SRF here.

Electronic Resources

There are a number of electronic resources that help with prescribing and managing MAVENCLAD prescription, including:

  • the MS LifeLines Pro™ portal, where you can manage all EMD Serono RMS prescriptions in one place, start a patient prescription, sign up to receive timely updates and alerts, and more. Register at the link above or by calling 1-877-447-3243
  • iAssist
  • CoverMyMeds

You can also prescribe MAVENCLAD directly using an SRF. Just print it, fill it out, and fax it to 1-866-227-3242 to get started. Completing this form with your patient also gives them the ability to sign up for one-on-one support services provided by MS LifeLines®.

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References: 1. MAVENCLAD [prescribing information]. Rockland, MA: EMD Serono, Inc.; 2022. 2. Giovannoni G, Comi G, Cook S, et al; for the CLARITY Study Group. N Engl J Med. 2010;362(5):416-426. 3. Data on file. EMD Serono, Inc. 4. Hallare J, Gerriets V. Half Life. [Updated 2023 Jun 20]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK554498/ 5. Comi G, Cook S, Giovannoni G, et al. Mult Scler Relat Disord. 2019;29:168-174. 6. Disanto G, Morahan JM, Barnett MH, et al. Neurology. 2012;78(11):823-832. 7. Krumbholz M, Derfuss T, Hohlfeld R, et al. Nat Rev Neurol. 2012:8(11):613-623. 8. Dendrou CA, Fugger L, Friese MA. Nat Rev Immunol. 2015;15(9):545-558. 9. Baker D, Herod SS, Alvarez-Gonzalez C, et al. Neurol Neuroimmunol Neuroinflamm. 2017;4(4):e360. 10. Sorensen PS, Dangond F, Hiking C, et al. Poster presented at: Third Annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2018 [P061]; February 1-3, 2018; San Diego, CA. 11. Rieckmann P, Comi G, Cook S, et al. Poster presented at: 25th Congress of ECTRIMS: September 9-12, 2009; Dusseldorf, Germany. 12. Wiendl H, Schmierer K, Hodgkinson S, et al. Poster presented at AAN 2021 Congress; April 17-22, 2021.

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Important Safety Information

WARNING: MALIGNANCIES and RISK OF TERATOGENICITY
  • Treatment with MAVENCLAD may increase the risk of malignancy. MAVENCLAD is contraindicated in patients with current malignancy. In patients with prior malignancy or with increased risk of malignancy, evaluate the benefits and risks of the use of MAVENCLAD on an individual patient basis. Follow standard cancer screening guidelines in patients treated with MAVENCLAD.
  • MAVENCLAD is contraindicated for use in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception because of the potential for fetal harm. Malformations and embryolethality occurred in animals. Exclude pregnancy before the start of treatment with MAVENCLAD in females of reproductive potential. Advise females and males of reproductive potential to use effective contraception during MAVENCLAD dosing and for 6 months after the last dose in each treatment course. Stop MAVENCLAD if the patient becomes pregnant.
CONTRAINDICATIONS
  • Patients with current malignancy.
  • Pregnant women, and women and men of reproductive potential who do not plan to use effective contraception during and for 6 months after the last dose in each treatment course. May cause fetal harm.
  • Patients infected with human immunodeficiency virus (HIV).
  • Patients with active chronic infections (e.g., hepatitis or tuberculosis).
  • Patients with a history of hypersensitivity to cladribine.
  • Women intending to breastfeed on a MAVENCLAD treatment day and for 10 days after the last dose.
WARNINGS AND PRECAUTIONS
  • Malignancies: Treatment with MAVENCLAD may increase the risk of malignancy. After the completion of 2 treatment courses, do not administer additional MAVENCLAD treatment during the next 2 years. In clinical studies, patients who received additional MAVENCLAD treatment within 2 years after the first 2 treatment courses had an increased incidence of malignancy. The risk of malignancy with reinitiating MAVENCLAD more than 2 years after the completion of 2 treatment courses has not been studied. Follow standard cancer screening guidelines in patients treated with MAVENCLAD.
  • Risk of Teratogenicity: MAVENCLAD may cause fetal harm when administered to pregnant women. In females of reproductive potential, exclude pregnancy before initiation of each treatment course of MAVENCLAD and prevent by the use of effective contraception during MAVENCLAD dosing and for at least 6 months after the last dose of each treatment course. Women who become pregnant during treatment with MAVENCLAD should discontinue treatment.
  • Lymphopenia: MAVENCLAD causes a dose-dependent reduction in lymphocyte count. Concomitant use of MAVENCLAD with hematotoxic drugs may increase the risk of adverse reactions because of the additive hematological effects. Monitor lymphocyte counts before, during, and after treatment.
  • Infections: Serious, including life-threatening or fatal, infections have occurred. MAVENCLAD reduces the body's immune defense, and an increased risk of infections has been observed in patients receiving MAVENCLAD. Infections occurred in 49% of MAVENCLAD-treated patients compared to 44% of patients treated with placebo in clinical studies; serious or severe infections occurred in 2.4% of MAVENCLAD- treated patients and 2.0% of placebo-treated patients. The most frequent serious infections included herpes zoster and pyelonephritis. Fungal infections were observed, including cases of coccidioidomycosis. Single fatal cases of tuberculosis and fulminant hepatitis B were reported in the clinical program.
    • Screen patients for active and latent infections (tuberculosis, hepatitis B or C). Delay treatment until infection is fully resolved or controlled.
    • Vaccinate patients who are seronegative for varicella zoster virus (VZV) prior to treatment. Vaccinate patients who are seropositive to VZV with recombinant, adjuvanted zoster vaccine either prior to or during treatment, including when their lymphocyte counts are less than or equal to 500 cells per microliter.
    • Administer anti-herpes prophylaxis in patients with lymphocyte counts less than 200 cells per microliter. Monitor for infections.
    • Progressive multifocal leukoencephalopathy (PML) has been reported in patients treated with parenteral cladribine for oncologic indications. No case of PML has been reported in clinical studies of cladribine in patients with MS. Obtain a baseline magnetic resonance imaging (MRI) within 3 months before initiating the first treatment course of MAVENCLAD. At the first sign of PML, withhold MAVENCLAD and perform an evaluation.
    • Administer all immunizations (except as noted for VZV) according to immunization guidelines prior to starting MAVENCLAD. Administer live-attenuated or live vaccines at least 4 to 6 weeks prior to starting MAVENCLAD due to risk of infection.
  • Hematologic Toxicity: In addition to lymphopenia, decreases in other blood cells and hematological parameters have been reported with MAVENCLAD in clinical studies. Obtain complete blood count (CBC) with differential including lymphocyte count before and during treatment, periodically thereafter, and when clinically indicated.
  • Graft-versus-Host Disease with Blood Transfusions: Transfusion-associated graft-versus-host disease has been observed rarely after transfusion of nonirradiated blood in patients treated with cladribine for non-MS treatment indications. In patients who require blood transfusion, irradiation of cellular blood components is recommended.
  • Liver Injury: In clinical studies, 0.3% of MAVENCLAD-treated patients had liver injury (serious or causing treatment discontinuation) compared to 0 placebo patients. Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to treatment. Discontinue MAVENCLAD if clinically significant liver injury is suspected.
  • Hypersensitivity: If a hypersensitivity reaction is suspected, discontinue MAVENCLAD therapy. Do not use MAVENCLAD in patients with a history of hypersensitivity to cladribine.
  • Cardiac Failure: In clinical studies, one MAVENCLAD-treated patient experienced life-threatening acute cardiac failure with myocarditis, which improved after approximately one week. Cases of cardiac failure have also been reported with parenteral cladribine used for treatment indications other than multiple sclerosis. Instruct patients to seek medical advice if they experience symptoms of cardiac failure (e.g., shortness of breath, rapid or irregular heartbeat, swelling).

Adverse Reactions: The most common adverse reactions (incidence of >20%) are upper respiratory tract infection, headache, and lymphopenia.

Drug Interactions: Concomitant use with immunosuppressive or myelosuppressive drugs and some immunomodulatory drugs (e.g., interferon beta) is not recommended and may increase the risk of adverse reactions. Acute short-term therapy with corticosteroids can be administered. Monitor for additive effects on the hematological profile with use of hemotoxic drugs. Avoid concomitant use of antiviral and antiretroviral drugs. Avoid concomitant use of BCRP or ENT/CNT inhibitors as they may alter bioavailability of MAVENCLAD.

Use in Specific Populations: Studies have not been performed in pediatric, or elderly patients >65 years, pregnant or breastfeeding women. Use in patients with moderate to severe renal or hepatic impairment is not recommended.

To report SUSPECTED ADVERSE REACTIONS, contact EMD Serono, Inc. at 1-800-283-8088 ext. 5563 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING, for additional information.

Important Safety Information
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