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ANC greater than 1000 | Maintain current dosage of KEVZARA. |
ANC 500–1000 | Hold treatment with KEVZARA until ANC greater than 1000. KEVZARA can then be resumed at 150 mg every two weeks and increased to 200 mg every two weeks as clinically appropriate. |
ANC less than 500 | Discontinue KEVZARA. |
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50,000–100,000 | Hold treatment with KEVZARA until platelets greater than 100,000. KEVZARA can then be resumed at 150 mg every two weeks and increased to 200 mg every two weeks as clinically appropriate. |
Less than 50,000 | If confirmed by repeat testing, discontinue KEVZARA. |
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ALT greater than ULN to 3 times ULN or less | Consider dosage modification of concomitant DMARDs as clinically appropriate. |
ALT greater than 3 times ULN to 5 times ULN or less | Hold treatment with KEVZARA until ALT less than 3 times ULN. KEVZARA can then be resumed at 150 mg every two weeks and increased to 200 mg every two weeks as clinically appropriate. |
ALT greater than 5 times ULN | Discontinue KEVZARA. |
Placebo + DMARD N=579 |
KEVZARA 150 mg + DMARD N=579 |
KEVZARA 200 mg + DMARD N=582 |
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ULN = Upper Limit of Normal | |||
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Greater than ULN to 3 times ULN or less | 15% | 27% | 30% |
Greater than 3 times ULN to 5 times ULN | 0% | 1% | 1% |
Greater than 5 times ULN | 0% | 0.7% | 0.2% |
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Greater than ULN to 3 times ULN or less | 25% | 38% | 43% |
Greater than 3 times ULN to 5 times ULN | 1% | 4% | 3% |
Greater than 5 times ULN | 0% | 1% | 0.7% |
Preferred Term | Placebo + DMARD (N=579) |
KEVZARA 150 mg + DMARD (N=579) |
KEVZARA 200 mg + DMARD (N=582) |
---|---|---|---|
Neutropenia | 0.2% | 7% | 10% |
Alanine aminotransferase increased | 2% | 5% | 5% |
Injection site erythema | 0.9% | 5% | 4% |
Injection site pruritus | 0.2% | 2% | 2% |
Upper respiratory tract infection | 2% | 4% | 3% |
Urinary tract infection | 2% | 3% | 3% |
Hypertriglyceridemia | 0.5% | 3% | 1% |
Leukopenia | 0% | 0.9% | 2% |
Percentage of Patients | ||||||
---|---|---|---|---|---|---|
Study 1 | Study 2 | |||||
Placebo + MTX N=398 |
KEVZARA 150 mg + MTX N=400 |
KEVZARA 200 mg + MTX N=399 |
Placebo + DMARD(s) N=181 |
KEVZARA 150 mg + DMARD(s) N=181 |
KEVZARA 200 mg + DMARD(s) N=184 |
|
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||||||
|
34.7% | 54.0% | 64.9% | 37.6% | 54.1% | 62.5% |
Difference from placebo, (95% CI) |
19.4% (12.6%, 26.1%) |
30.2% (23.6%, 36.8%) |
16.6% (6.7%, 26.5%) |
25.3% (15.7%, 34.8%) |
||
|
33.4% | 58.0% | 66.4% | 33.7% | 55.8% | 60.9% |
Difference from placebo, (95% CI) |
24.6% (18.0%, 31.3%) |
33.0% (26.5%, 39.5%) |
22.1% (12.6%, 31.6%) |
27.4% (17.7%, 37.0%) |
||
|
31.7% | 53.5% | 58.6% | |||
Difference from placebo, (95% CI) |
21.9% (15.2%, 28.5%) |
27.0% (20.5%, 33.6%) |
NA |
NA |
NA |
|
|
||||||
|
12.3% | 26.5% | 36.3% | 13.3% | 30.4% | 33.2% |
Difference from placebo, (95% CI) |
14.2% (8.9%, 19.6%) |
24.1% (18.4%, 29.8%) |
17.1% (9.2%, 25.1%) |
20.1% (12.0%, 28.3%) |
||
|
16.6% | 37.0% | 45.6% | 18.2% | 37.0% | 40.8% |
Difference from placebo, (95% CI) |
20.4% (14.5%, 26.3%) |
29.1% (23.0%, 35.1%) |
18.8% (10.2%, 27.4%) |
22.8% (14.0%, 31.6%) |
||
|
18.1% | 40.0% | 42.9% | |||
Difference from placebo, (95% CI) |
21.9% (15.8%, 28.0%) |
24.8% (18.7%, 30.9%) |
NA |
NA |
NA |
|
|
||||||
|
4.0% | 11.0% | 17.5% | 2.2% | 13.8% | 14.7% |
Difference from placebo, (95% CI) |
7.0% (3.4%, 10.6%) |
13.5% (9.4%, 17.7%) |
11.6% (6.2%, 17.0%) |
12.5% (7.1%, 17.9%) |
||
|
7.3% | 19.8% | 24.8% | 7.2% | 19.9% | 16.3% |
Difference from placebo, (95% CI) |
12.5% (7.8%, 17.1%) |
17.5% (12.6%, 22.5%) |
12.7% (6.1%, 19.3%) |
9.2% (2.8%, 15.7%) |
||
|
9.0% | 24.8% | 26.8% | |||
Difference from placebo, (95% CI) |
15.7% (10.6%, 20.8%) |
17.8% (12.6%, 23.0%) |
NA |
NA |
NA |
|
|
||||||
Responders |
3.0% | 12.8% | 14.8% | NA |
NA |
NA |
Difference from placebo, (95% CI) |
9.7% (6.1%, 13.4%) |
11.8% (7.9%, 15.6%) |
||||
|
||||||
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||||||
Percentage of patients | 4.8% | 18.0% | 23.1% | 3.9% | 17.1% | 17.9% |
Difference from placebo (95% CI) |
13.3% (9.0%, 17.5%) |
18.3% (13.7%, 23.0%) |
13.3% (7.3%, 19.3%) |
14.1% (8.0%, 20.3%) |
||
|
||||||
Percentage of patients | 10.1% | 27.8% | 34.1% | 7.2% | 24.9% | 28.8% |
Difference from placebo (95% CI) |
17.7% (12.5%, 23.0%) |
24.0% (18.5%, 29.5%) |
17.7% (10.5%, 24.9%) |
21.7% (14.3%, 29.1%) |
Figure 1: Percent of ACR20 Response by Visit for Study 1 (Adults with Moderately to Severely Active RA) |
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|
Study 1 | Study 2 | |||||
---|---|---|---|---|---|---|
Component means (range/units) | Placebo + MTX (N=398) |
KEVZARA 150 mg + MTX (N=400) |
KEVZARA 200 mg + MTX (N=399) |
Placebo + DMARD(s) (N=181) |
KEVZARA 150 mg + DMARD(s) (N=181) |
KEVZARA 200 mg + DMARD(s) (N=184) |
|
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Baseline | 26.80 | 27.21 | 26.50 | 29.42 | 27.66 | 29.55 |
Week 12 | 16.25 | 12.88 | 11.78 | 19.18 | 13.38 | 13.10 |
Change from baseline | -10.51 | -14.42 | -14.94 | -9.79 | -14.11 | -15.92 |
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Baseline | 16.68 | 16.60 | 16.77 | 20.21 | 19.60 | 19.97 |
Week 12 | 9.66 | 7.50 | 6.79 | 12.50 | 8.82 | 8.28 |
Change from baseline | -7.02 | -9.03 | -10.12 | -7.25 | -10.77 | -10.89 |
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Baseline | 63.71 | 65.48 | 66.71 | 71.57 | 71.02 | 74.86 |
Week 12 | 49.25 | 41.47 | 36.93 | 54.77 | 43.45 | 41.66 |
Change from baseline | -14.45 | -23.73 | -29.77 | -16.12 | -27.95 | -32.77 |
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Baseline | 62.86 | 63.43 | 63.59 | 68.39 | 68.10 | 67.76 |
Week 12 | 39.25 | 31.32 | 28.47 | 43.73 | 33.65 | 30.18 |
Change from baseline | -23.63 | -31.85 | -34.84 | -24.60 | -34.92 | -36.92 |
|
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Baseline | 63.70 | 64.43 | 66.49 | 68.77 | 67.71 | 70.89 |
Week 12 | 49.37 | 41.52 | 38.05 | 53.67 | 41.99 | 41.74 |
Change from baseline | -13.92 | -22.88 | -28.39 | -15.05 | -26.05 | -28.83 |
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Baseline | 1.61 | 1.63 | 1.69 | 1.80 | 1.72 | 1.82 |
Week 12 | 1.34 | 1.15 | 1.13 | 1.49 | 1.23 | 1.33 |
Change from baseline | -0.27 | -0.47 | -0.57 | -0.29 | -0.50 | -0.49 |
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Baseline | 20.46 | 22.57 | 22.23 | 26.02 | 23.60 | 30.77 |
Week 12 | 19.61 | 9.24 | 3.30 | 21.72 | 9.21 | 4.58 |
Change from baseline | -0.58 | -13.59 | -18.31 | -3.39 | -14.24 | -25.91 |
Study 1 | |||
---|---|---|---|
Placebo + MTX (N=398) |
KEVZARA 150 mg + MTX (N=400) |
KEVZARA 200 mg + MTX (N=399) |
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Mean change | 2.78 | 0.90 | 0.25 |
LS |
-1.88 (-2.74, -1.01) | -2.52 (-3.38, -1.66) | |
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Mean change | 1.46 | 0.42 | 0.05 |
LS |
-1.03 (-1.53, -0.53) | -1.40 (-1.90, -0.90) | |
|
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Mean change | 1.32 | 0.47 | 0.20 |
LS |
-0.85 (-1.34, -0.35) | -1.12 (-1.61, -0.63) |
Study 1 | Study 2 | |||||
---|---|---|---|---|---|---|
Week 16 | Week 12 | |||||
Placebo + MTX (N=398) |
KEVZARA 150 mg + MTX (N=400) |
KEVZARA 200 mg + MTX (N=399) |
Placebo + DMARD(s) (N=181) |
KEVZARA 150 mg + DMARD(s) (N=181) |
KEVZARA 200 mg + DMARD(s) (N=184) |
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-0.30 | -0.54 | -0.58 | -0.29 | -0.50 | -0.49 |
|
-0.24 (-0.31, -0.16) |
-0.26 (-0.34, -0.18) |
-0.20 (-0.32, -0.09) |
-0.21 (-0.33, -0.10) |
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42.5% | 53.8% | 57.4% | 35.9% | 47% | 51.1% |
Strength | Package Size | NDC Number |
---|---|---|
150 mg/1.14 mL | 2 syringes per pack | 0024-5908-01 |
200 mg/1.14 mL | 2 syringes per pack | 0024-5910-01 |
Strength | Package Size | NDC Number |
---|---|---|
150 mg/1.14 mL | 2 pre-filled pens per pack | 0024-5920-01 |
200 mg/1.14 mL | 2 pre-filled pens per pack | 0024-5922-01 |
MEDICATION GUIDE KEVZARA® (KEV-za-ra) (sarilumab) injection, for subcutaneous use |
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This Medication Guide has been approved by the U.S. Food and Drug Administration | Revised: April 2018 | ||
KEVZARA can cause serious side effects including:
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KEVZARA is an injectable prescription medicine called an Interleukin-6 (IL-6) receptor blocker. KEVZARA is used to treat adults with moderately to severely active rheumatoid arthritis (RA) after at least one other medicine called a disease modifying antirheumatic drug (DMARD) has been used and did not work well or could not be tolerated. |
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Do not use KEVZARA if you are allergic to sarilumab or any of the ingredients in KEVZARA. See the end of this Medication Guide for a complete list of ingredients in KEVZARA. |
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Especially tell your healthcare provider if you use:
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KEVZARA can cause serious side effects, including:
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You may also report side effects to sanofi-aventis at 1-800-633-1610. |
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Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use KEVZARA for a condition for which it was not prescribed. Do not give KEVZARA to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider or pharmacist for information about KEVZARA that was written for health professionals. |
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Active Ingredient SANOFI Manufactured by: sanofi-aventis U.S. LLC Bridgewater, NJ 08807, A SANOFI COMPANY U.S. License # 1752. Marketed by: sanofi-aventis U.S. LLC (Bridgewater, NJ 08807) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591) KEVZARA® is a registered trademark of Sanofi Biotechnology ©2018 Regeneron Pharmaceuticals, Inc. / sanofi-aventis U.S. LLC For more information, go to www.KEVZARA.com or call 1-844-KEVZARA (1-844-538-9272). |
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