INDICATIONS

KEVZARA is indicated for treatment of adult patients with:
  • moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
  • polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.
Prescribing Information

Intended for US Payer Audience

Read Important Safety Information, including Boxed WARNING

FDA APPROVED

To treat adult patients with polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

APPROVAL
 PRESS RELEASE
In the management of Rheumatoid Arthritis...

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CLINICAL VALUE

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ILLUMINATING
THE EVIDENCE

Targeted MOA that
inhibits the effects
of chronically elevated
IL-6

  • IL-6 is a pro-inflammatory cytokine produced by a variety of cell types, including local production by synovial and endothelial cells in joints affected by inflammatory processes such as RA1
  • KEVZARA, an IL-6Ri, specifically targets and binds with a high affinity to both soluble and membrane-bound IL-6 receptors, thereby inhibiting IL-6 signaling1,2
OBSERVED EFFECTS
OF SARILUMAB BASED
ON PHARMACODYNAMIC STUDIES1

The clinical significance of these findings is unknown.

*Following single-dose SC administration of sarilumab in patients with RA, absolute neutrophil
counts decreased to the nadir between 3 and 4 days and thereafter recovered toward baseline.1

A ROBUST CLINICAL
PROGRAM SPANNING MTX-IR
and TNF-IR POPULATIONS

Adult patients with moderately
to severely active RA, diagnosed
based on ACR criteria

MTX IR AND TNF-IR
PATIENT POPULATIONS

Two Pivotal, Randomized,
Double-Blind, Placebo-
controlled Studies
HEAD-TO-HEAD
SUPERIORITY STUDY AS A
MONOTHERAPY
VS ADALIMUMAB

Monotherapy Study
(not included in KEVZARA USPI)

Long-term SAFETY
AND EFFICACY data IN RA

Open-label extension (OLE) study limitations and additional study context

  • These data are not included in the US Prescribing Information
LONG-TERM SAFETY ANALYSIS

This was a comprehensive safety analysis from pooled studies of patients who received at least 1 dose of sarilumab in combination with DMARD(s) as of last data analysis on January 15, 2018.4

LONG-TERM EFFICACY ANALYSIS
Efficacy assessments in this analysis did not include all of the primary endpoints from the placebo-controlled period of the pivotal trials analyzed.

For analysis of no radiographic progression, linear extrapolation was used to impute missing data. Patients with missing data after the imputation were considered progressors.4

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ACCOUNT DIRECTOR

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Given the limitations and context
described above, caution should
be used in interpreting these data.

ECONOMIC VALUE

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economic value:

Exposing the
bottom line

COMPETITIVELY PRICED
amongst RA products*

These products are not therapeutically equivalent and not interchangeable. This only reflects the wholesale acquisition cost and not overall cost.

These products vary in their efficacy and safety, and they have different active ingredients. There are no data from clinical trials that provide differences in efficacy and safety and dosing as they relate to overall product costs. In addition, the quantities of a drug product a patient will require during treatment will vary.

Trademarks are the property of their respective owners.

*Costs approximated based on annual WAC prices as of April 2022; subject to change.5

REDUCTIONS IN CRP
LEVELS at Consistent
q2W Dosing FOR RA

  • The recommended dose of KEVZARA is 200 mg Q2W as an SC injection1
  • KEVZARA can be used with or without MTX or other conventional DMARD(s).
    Dosing of MTX and other conventional DMARDs may vary1
  • Reduce the dose to 150 mg Q2W for the management of neutropenia,
    thrombocytopenia, and elevated liver enzymes1
  • KEVZARA initiation is not recommended in patients with an ANC <2000 per mm3,
    platelet count <150,000 per mm3, or ALT or AST >1.5x ULN1

Predictable budget impact

KEVZARA IS THE ONLY IL-6
INHIBITOR THAT DOES NOT
EXPERIENCE DOSE
ESCALATION

In a pharmacy claims
analysis from the Optum
Clinformatics database,
of patients prescribed
ACTEMRA…6*

Q2W PATIENTS

48%
OF PATIENTS
WERE INITIALLY
PRESCRIBED
Q2W DOSING

51%
OF PATIENTS
INITIALLY
PRESCRIBED
Q2W DOSING
ESCALATED
TO Q2

QW PATIENTS

51%
OF PATIENTS WERE INITIALLY
PRESCRIBED QW DOSING

BLENDED UTILIZATION

IN TOTAL, 75%
EITHER INITIATED OR ESCALATED
TO THE HIGHER WEEKLY DOSE

actemra dose
ESCALATION can almost
double projected costs

KEVZARA Recommended Dose: 200 mg Q2W as an SC injection1
  • Reduce the dose to 150 mg Q2W for the management of neutropenia, thrombocytopenia, and elevated liver enzymes

Funding for this study was provided by Sanofi and Regeneron Pharmaceuticals.

These products are not therapeutically equivalent and not interchangeable. This only reflects the wholesale acquisition cost and not overall cost.

These products vary in their efficacy and safety, and they have different active ingredients. There are no data from clinical trials that provide differences in efficacy and safety and dosing as they relate to overall product costs. In addition, the quantities of a drug product a patient will require during treatment will vary.

Trademarks are the property of their respective owners.

* Based on a retrospective claims analysis from pharmacy claims data obtained from the Optum Clinformatics database between July 1, 2016, and January 15, 2021. The ACTEMRA SC Blended Rate was calculated utilizing claims data from this analysis with 75% of patients having been prescribed or escalated to QW dosing and 25% of patients having been prescribed or maintained Q2W dosing.6

STUDIED IN
COST-EFFECTIVENESS
ANALYSIS VS MARKET LEADER

  • KEVZARA has been studied in a cost-effectiveness analysis as a monotherapy vs adalimumab monotherapy7*
  • KEVZARA as a monotherapy has been studied vs adalimumab monotherapy in an analysis of the
    incremental cost per effectively treated patient    8†

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COST-EFFECTIVENESS DATA
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ACCOUNT DIRECTOR

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*Funding for this research was contributed to by the Institute for Clinical and Economic Review.7

†Funding for this study was provided by Sanofi and Regeneron Pharmaceuticals.8

Intended for use with payers, formulary committees, or other similar entities for purposes of population-based
drug selection, coverage, and/or reimbursement decision-making, pursuant to FD&C Act Section 502(a).

PRACTICAL VALUE

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SURPASSING THE EXPECTED

pre-filled syringe

Open distribution networks. Patient support programs. Button-free
pen and pre-filled syringe must be refrigerated at 36-46°F but that can be kept
at room temperature (<77°F) for up to 14 days, if needed1

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SPECIALTY PHARMACIES*

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INTO KEVZARA DOSING
AND ADMINISTRATION

*Sanofi and Regeneron Pharmaceuticals, Inc. do not recommend any particular specialty pharmacy.
However, health plans may recommend or mandate a particular pharmacy.

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ACCOUNT DIRECTOR
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INDICATIONS

KEVZARA is indicated for treatment of adult patients with:

  • moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs).
  • polymyalgia rheumatica (PMR) who have had an inadequate response to corticosteroids or who cannot tolerate corticosteroid taper.

IMPORTANT SAFETY
INFORMATION

WARNING: RISK OF SERIOUS
INFECTIONS

Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Avoid use of KEVZARA in patients with an active infection.

Reported infections include:

  • Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before KEVZARA use and during therapy. Treatment for latent infection should be initiated prior to KEVZARA use.
  • Invasive fungal infections, such as candidiasis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
  • Bacterial, viral and other infections due to opportunistic pathogens.

Closely monitor patients for signs and symptoms of infection during treatment with KEVZARA. If a serious infection develops, interrupt KEVZARA until the infection is controlled.

Consider the risks and benefits of treatment with KEVZARA prior to initiating therapy in patients with chronic or recurrent infection.

CONTRAINDICATION

Do not use KEVZARA in patients with known hypersensitivity to sarilumab or any of the inactive ingredients.

WARNINGS AND PRECAUTIONS

  • Infections. Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving immunosuppressive agents including KEVZARA. The most frequently observed serious infections with KEVZARA included pneumonia and cellulitis. Among opportunistic infections, TB, candidiasis, and pneumocystis were reported with KEVZARA.
    • Hold treatment with KEVZARA if a patient develops a serious infection or an opportunistic infection.
    • Patients with latent TB should be treated with standard antimycobacterial therapy before initiating KEVZARA. Consider anti-TB therapy prior to initiation of KEVZARA in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent TB but having risk factors for TB infection.
    • Consider the risks and benefits of treatment prior to initiating KEVZARA in patients who have: chronic or recurrent infection, a history of serious or opportunistic infections, underlying conditions that may predispose them to infection, been exposed to TB, or lived in or traveled to areas of endemic TB or endemic mycoses.
    • Viral reactivation has been reported with immunosuppressive biologic therapies. Cases of herpes zoster were observed in clinical studies with KEVZARA.
  • Laboratory Abnormalities. Treatment with KEVZARA was associated with decreases in absolute neutrophil counts (including neutropenia), and platelet counts; and increases in transaminase levels and lipid parameters (LDL, HDL cholesterol, and/or triglycerides). Increased frequency and magnitude of these elevations were observed when potentially hepatotoxic drugs (e.g., MTX) were used in combination with KEVZARA. Assess neutrophil count, platelet count, and ALT/AST levels prior to initiation with KEVZARA. Monitor these parameters 4 to 8 weeks after start of therapy and every 3 months thereafter. Assess lipid parameters 4 to 8 weeks after start of therapy, then at 6 month intervals.
  • Gastrointestinal Perforation. GI perforation risk may be increased with concurrent diverticulitis or concomitant use of NSAIDs or corticosteroids. Gastrointestinal perforations have been reported in clinical studies, primarily as complications of diverticulitis. Promptly evaluate patients presenting with new onset abdominal symptoms.
  • Immunosuppression. Treatment with immunosuppressants may result in an increased risk of malignancies. The impact of treatment with KEVZARA on the development of malignancies is not known but malignancies have been reported in clinical studies.
  • Hypersensitivity Reactions. Hypersensitivity reactions have been reported in association with KEVZARA. Hypersensitivity reactions that required treatment discontinuation were reported in 0.3% of patients in controlled RA trials. Injection site rash, rash, and urticaria were the most frequent hypersensitivity reactions. Advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. If anaphylaxis or other hypersensitivity reaction occurs, stop administration of KEVZARA immediately. Do not administer KEVZARA to patients with known hypersensitivity to sarilumab.
  • Active Hepatic Disease and Hepatic Impairment. Treatment with KEVZARA is not recommended in patients with active hepatic disease or hepatic impairment, as treatment with KEVZARA was associated with transaminase elevations.
  • Live Vaccines. Avoid concurrent use of live vaccines during treatment with KEVZARA due to potentially increased risk of infections. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving KEVZARA.

ADVERSE REACTIONS

  • For Rheumatoid Arthritis: The most common serious adverse reactions were infections. The most frequently observed serious infections included pneumonia and cellulitis. The most common adverse reactions (occurred in at least 3% of patients treated with KEVZARA + DMARDs) are neutropenia, increased ALT, injection site erythema, upper respiratory infections, and urinary tract infections.
  • For Polymyalgia Rheumatica: Serious adverse reactions of neutropenia occurred in 2 patients (3.4%) in the KEVZARA group compared to none in the placebo group. The proportion of patients with serious infections was similar in the KEVZARA group (5.1%) compared to the placebo group (5.2%). The common adverse reactions occurring in ≥5% of patients treated with KEVZARA were neutropenia, leukopenia, constipation, rash pruritic, myalgia, fatigue, and injection site pruritus.

DRUG INTERACTIONS

  • Exercise caution when KEVZARA is co-administered with CYP substrates with a narrow therapeutic index (e.g. warfarin or theophylline), or with CYP3A4 substrates (e.g. oral contraceptives or statins) as there may be a reduction in exposure which may reduce the activity of the CYP3A4 substrate.
  • Elevated interleukin-6 (IL-6) concentration may down-regulate CYP activity such as in patients with RA and hence increase drug levels compared to subjects without RA. Blockade of IL-6 signaling by IL-6Rα antagonists such as KEVZARA might reverse the inhibitory effect of IL-6 and restore CYP activity, leading to altered drug concentrations.

USE IN SPECIFIC POPULATIONS

  • KEVZARA should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus. Because monoclonal antibodies could be excreted in small amounts in human milk, the benefits of breastfeeding and the potential adverse effects on the breastfed child should be considered along with the mother’s clinical need for KEVZARA.
  • Use caution when treating the elderly.

Advise patients to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Please click here for full Prescribing Information, including Boxed WARNING.

ACR, American College of Rheumatology; ALT, alanine transaminase; AST, aspartate transaminase; BID, twice a day; CRP, C-reactive protein; DMARD, disease-modifying antirheumatic drug; IL, interleukin; IL-6Ri, interleukin-6 receptor inhibitor; MOA, mechanism of action; MTX, methotrexate; MTX-IR, methotrexate inadequate response; Q2W, every other week; QD; once a day; QW, once a week; RA, rheumatoid arthritis; SC, subcutaneous; TNFi, tumor necrosis factor inhibitor; TNF-IR, tumor necrosis factor inadequate response; USPI, US Prescribing Information; WAC, wholesale acquisition cost.

IMPORTANT SAFETY
INFORMATION

WARNING: RISK OF SERIOUS INFECTIONS
Patients treated with KEVZARA are at increased risk for developing serious infections that may lead to hospitalization or death. Opportunistic infections have also been reported in patients receiving KEVZARA. Most patients who developed infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
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