HEMLIBRA® (emicizumab-kxwh) Dosing and Administration Guide · Sample dosing chart overview...

Calculate Dose Loading Dose Maintenance Dose Safety

DOSING GUIDE

Please see the HEMLIBRA full Prescribing Information for additional Important Safety Information, including Boxed WARNING.

IndicationHEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors.

Important Safety InformationBoxed WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM

Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur.

For adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors

Visit HEMLIBRAcalculator.com to access the HEMLIBRA Dosing Calculator

Navigate this Dosing Guide using the buttons below:

For HCP and Pharmacy Audiences


The below steps provide guidance that may help with calculating the recommended loading and maintenance dose of HEMLIBRA and determining the vial(s) you may provide according to the patient’s weight. This is not intended to replace your independent clinical judgment.

Calculate the patient dose in mg

Choose the appropriate vial combinations

Calculate the total volume of HEMLIBRA needed in mL

STEP 1

STEP 2

STEP 3

Loading Dose Weeks 1-4

Maintenance Dose OptionsWeeks 5+

Vial concentration

mg of HEMLIBRA

Volume of HEMLIBRA in mL needed to inject ÷

Patient weight

(kg)

once weekly (QW) dose (3 mg/kg)

Total mg of HEMLIBRA

neededx x= =

=

Calculating the recommended dose of HEMLIBRA

QW

If combining the 30 mg/mL vial with vials of different concentrations (60 mg/0.4 mL, 105 mg/0.7 mL, and/or 150 mg/mL) consider the following approach:1. Take the labeled dose from the higher-concentration vial(s) first 2. Subtract the mg used from the higher-concentration vial(s) from the total mg of HEMLIBRA dose 3. Use the remaining mg to calculate the mL from the 30 mg/mL vial

60-mg, 105-mg, and/or 150-mg vialsare the same concentration (150 mg/mL)

and may be combined in the same syringe

30-mg vials (30 mg/mL)should not be combined with the 60-mg, 105-mg,

and/or 150-mg vials in the same syringe

2

once weekly (QW)dose (1.5 mg/kq)

OR

OR

Patient weight

(kg)

Total mg of HEMLIBRA neededonce every 2 weeks

(Q2W) dose (3 mg/kg)

once every 4 weeks (Q4W) dose (6 mg/kg)


Do not combine HEMLIBRA vials of different concentrations in a single injection.


The dosing charts on the following pages are intended to provide examples of the dose and vial(s) you may provide according to the patient’s weight. Confirm all calculations before use. These examples are for illustration purposes. Genentech makes no claims as to the accuracy of the information contained herein. The information provided is not a substitute for clinical judgment. Neither Genentech, nor any other party involved in preparation or publication of this dosing guide, shall be liable to you or others for any decisions made or actions taken by you or others in reliance of this information.

Sample dosing chart overview

Patient Weight Total

Dose (mg)

Total Volume

(mL)

Number of Vials (Recommended Volume)Number of Syringes

Vial Strength/Volume (Concentration)

lb kg 30 mg/mL (30 mg/mL)

60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe

Find the patient’s weight

in lb

Find the patient’s weight in kg

Tells you the total mg of HEMLIBRA

needed based on

the patient’s weight

Tells you the total

volume of HEMLIBRA in mL the

patient will inject for

each dose

Provides recommendation of vials, as well as recommended volume, based on configuration

Tells you which syringe sizes may be used

to administer the full dose of HEMLIBRA

3

Visit HEMLIBRAcalculator.com to access the HEMLIBRA Dosing Calculator

Example HEMLIBRA dose calculations

Example 1 (without combining concentrations): Maintenance dose for 40-kg patient using Q2W dosing

Example 2 (combining concentrations): Maintenance dose for 45-kg patient using QW dosing

Step 1: 40 kg x 3 mg/kg = 120 mg of HEMLIBRA needed for a Q2W maintenance dose

Step 2: For a 120-mg maintenance dose, two 60-mg (purple) vials will provide the correct dose

Step 3: 120 mg of HEMLIBRA ÷ 60 mg/0.40 mL = 0.80 mL of HEMLIBRA needed to inject

Step 1: 45 kg x 1.5 mg/kg = 67.5 mg of HEMLIBRA needed for a QW maintenance dose

Step 2: For a 67.5-mg maintenance dose, one 60-mg (purple) vial and one 30-mg (blue) vial will provide the correct dose

Step 3: • Take the labeled dose from the higher-concentration vial (60 mg/0.4 mL)• Subtract the mg used from the higher-concentration vial (60 mg/0.4 mL)

from the total mg of HEMLIBRA dose (67.5 mg)• Use the remaining mg (7.5 mg) to calculate the remaining mL from the

30-mg vial: 7.5 mg of HEMLIBRA ÷ 30 mg/mL = 0.25 mL of HEMLIBRA needed to inject

• Discard the remaining volume of HEMLIBRA


Note: Discard any unused solution in the vial after each use. The recommended dosage volume is based on drawing from the higher-concentration vial(s) first when using vials of different concentrations. Calculated dosage volume may vary depending on the choice of vial combination and volume drawn from each vial. Refer to the HEMLIBRA Dosing Calculator at HEMLIBRAcalculator.com for additional dosing support.


Dose (mg)

Total Volume

(mL)

Number of Vials (Recommended Volume) Number of SyringesVial Strength/Volume (Concentration)


60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe


6.6 3 9.0 0.30 1 (0.30) 1

8.8 4 12.0 0.40 1 (0.40) 1

11.0 5 15.0 0.50 1 (0.50) 1 1 1 1

13.2 6 18.0 0.60 1 (0.60) 1

15.4 7 21.0 0.70 1 (0.70) 1

17.6 8 24.0 0.80 1 (0.80) 1

19.8 9 27.0 0.90 1 (0.90) 1

22.0 10 30.0 1.00 1 (1.00) 1

24.2 11 33.0 0.22 1 (0.22) 1

26.4 12 36.0 0.24 1 (0.24) 1

28.6 13 39.0 0.26 1 (0.26) 1

30.8 14 42.0 0.28 1 (0.28) 1

33.0 15 45.0 0.30 1 (0.30) 1

35.2 16 48.0 0.32 1 (0.32) 1

37.4 17 51.0 0.34 1 (0.34) 1

39.6 18 54.0 0.36 1 (0.36) 1

41.8 19 57.0 0.38 1 (0.38) 1

44.0 20 60.0 0.40 1 (0.40) 1

46.2 21 63.0 0.50 1 (0.10) 1 (0.40) 2

48.4 22 66.0 0.60 1 (0.20) 1 (0.40) 2

50.6 23 69.0 0.70 1 (0.30) 1 (0.40) 2

52.8 24 72.0 0.80 1 (0.40) 1 (0.40) 2

55.0 25 75.0 0.90 1 (0.50) 1 (0.40) 2

57.2 26 78.0 1.00 1 (0.60) 1 (0.40) 2

59.4 27 81.0 1.10 1 (0.70) 1 (0.40) 2

61.6 28 84.0 1.20 1 (0.80) 1 (0.40) 2

63.8 29 87.0 1.30 1 (0.90) 1 (0.40) 2

66.0 30 90.0 1.40 1 (1.00) 1 (0.40) 2

68.2 31 93.0 0.62 3 1 (0.62) 3 1

70.4 32 96.0 0.64 1 (0.64) 1

4

HEMLIBRA loading dose:(Weeks 1-4) (3 mg/kg)

Loading Dose

Do not combine HEMLIBRA vials of different concentrations in a single injection. If the total volume of HEMLIBRA is greater than 2 mL, multiple injections will be needed.


Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



72.6 33 99.0 0.66 1 (0.66) 1

74.8 34 102.0 0.68 1 (0.68) 1

77.0 35 105.0 0.70 1 (0.70) 1 1

79.2 36 108.0 0.72 2 (0.72) 1

81.4 37 111.0 0.74 2 (0.74) 1

83.6 38 114.0 0.76 2 (0.76) 1

85.8 39 117.0 0.78 2 (0.78) 1

88.0 40 120.0 0.80 2 (0.80) 1

90.2 41 123.0 1.30 1 (0.60) 1 (0.70) 2

92.4 42 126.0 1.40 1 (0.70) 1 (0.70) 2

94.6 43 129.0 1.50 1 (0.80) 1 (0.70) 2

96.8 44 132.0 1.60 1 (0.90) 1 (0.70) 2

99.0 45 135.0 1.70 1 (1.00) 1 (0.70) 2

101.2 46 138.0 0.92 1 (0.92) 1

103.4 47 141.0 0.94 1 (0.94) 1

105.6 48 144.0 0.96 1 (0.96) 1

107.8 49 147.0 0.98 1 (0.98) 1

110.0 50 150.0 1.00 1 (1.00) 1

112.2 51 153.0 1.02 1 (0.32) 1 (0.70) 1

114.4 52 156.0 1.04 1 (0.34) 1 (0.70) 1

116.6 53 159.0 1.06 1 (0.36) 1 (0.70) 1

118.8 54 162.0 1.08 1 (0.38) 1 (0.70) 1

121.0 55 165.0 1.10 1 (0.40) 1 (0.70) 1

123.2 56 168.0 1.12 3 (1.12) 1

125.4 57 171.0 1.14 3 (1.14) 1

127.6 58 174.0 1.16 3 (1.16) 1

129.8 59 177.0 1.18 3 (1.18) 1

132.0 60 180.0 1.20 3 (1.20) 1

134.2 61 183.0 1.70 1 (0.60) 1 (0.40) 1 (0.70) 1 1

136.4 62 186.0 1.80 1 (0.70) 1 (0.40) 1 (0.70) 1 1

5

HEMLIBRA loading dose:(Weeks 1-4) (3 mg/kg) (cont’d)

Loading Dose



Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



138.6 63 189.0 1.90 1 (0.80) 1 (0.40) 1 (0.70) 1 1

140.8 64 192.0 2.00 1 (0.90) 1 (0.40) 1 (0.70) 1 1

143.0 65 195.0 2.10 1 (1.00) 1 (0.40) 1 (0.70) 1 1 1

145.2 66 198.0 1.32 2 (1.32) 1

147.4 67 201.0 1.34 2 (1.34) 1

149.6 68 204.0 1.36 2 (1.36) 1

151.8 69 207.0 1.38 2 (1.38) 1

154.0 70 210.0 1.40 2 (1.40) 1

156.2 71 213.0 1.42 2 (0.72) 1 (0.70) 1

158.4 72 216.0 1.44 2 (0.74) 1 (0.70) 1

160.6 73 219.0 1.46 2 (0.76) 1 (0.70) 1

162.8 74 222.0 1.48 2 (0.78) 1 (0.70) 1

165.0 75 225.0 1.50 2 (0.80) 1 (0.70) 1

167.2 76 228.0 1.52 4 (1.52) 1

169.4 77 231.0 1.54 4 (1.54) 1

171.6 78 234.0 1.56 4 (1.56) 1

173.8 79 237.0 1.58 4 (1.58) 1

176.0 80 240.0 1.60 4 (1.60) 1

178.2 81 243.0 1.62 1 (0.62) 1 (1.00) 1

180.4 82 246.0 1.64 1 (0.64) 1 (1.00) 1

182.6 83 249.0 1.66 1 (0.66) 1 (1.00) 1

184.8 84 252.0 1.68 1 (0.68) 1 (1.00) 1

187.0 85 255.0 1.70 1 (0.70) 1 (1.00) 1

189.2 86 258.0 1.72 2 (0.72) 1 (1.00) 1

191.4 87 261.0 1.74 2 (0.74) 1 (1.00) 1

193.6 88 264.0 1.76 2 (0.76) 1 (1.00) 1

195.8 89 267.0 1.78 2 (0.78) 1 (1.00) 1

198.0 90 270.0 1.80 2 (0.80) 1 (1.00) 1

200.2 91 273.0 1.82 3 (1.12) 1 (0.70) 3 1

202.4 92 276.0 1.84 3 (1.14) 1 (0.70) 1

6


Loading Dose



Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



204.6 93 279.0 1.86 3 (1.16) 1 (0.70) 1

206.8 94 282.0 1.88 3 (1.18) 1 (0.70) 1

209.0 95 285.0 1.90 1 3 (1.20) 1 (0.70) 1 1

211.2 96 288.0 1.92 2 (1.92) 1

213.4 97 291.0 1.94 2 (1.94) 1

215.6 98 294.0 1.96 2 (1.96) 1

217.8 99 297.0 1.98 2 (1.98) 1

220.0 100 300.0 2.00 2 (2.00) 1

222.2 101 303.0 2.02 3 (2.02) 1 1

224.4 102 306.0 2.04 3 (2.04) 1 1

226.6 103 309.0 2.06 3 (2.06) 1 1

228.8 104 312.0 2.08 3 (2.08) 1 1

231.0 105 315.0 2.10 3 (2.10) 1 1

233.2 106 318.0 2.12 2 (0.72) 2 (1.40) 1 1

235.4 107 321.0 2.14 2 (0.74) 2 (1.40) 1 1

237.6 108 324.0 2.16 2 (0.76) 2 (1.40) 1 1

239.8 109 327.0 2.18 2 (0.78) 2 (1.40) 1 1

242.0 110 330.0 2.20 2 (0.80) 2 (1.40) 1 1

244.2 111 333.0 2.22 4 (1.52) 1 (0.70) 1 1

246.4 112 336.0 2.24 4 (1.54) 1 (0.70) 1 1

248.6 113 339.0 2.26 4 (1.56) 1 (0.70) 1 1

250.8 114 342.0 2.28 4 (1.58) 1 (0.70) 1 1

253.0 115 345.0 2.30 4 (1.60) 1 (0.70) 1 1

255.2 116 348.0 2.32 1 (0.32) 2 (2.00) 1 1

257.4 117 351.0 2.34 1 (0.34) 2 (2.00) 1 1

259.6 118 354.0 2.36 1 (0.36) 2 (2.00) 1 1

261.8 119 357.0 2.38 1 (0.38) 2 (2.00) 1 1

264.0 120 360.0 2.40 1 (0.40) 2 (2.00) 1 1

266.2 121 363.0 2.42 3 1 (0.32) 3 (2.10) 3 1 1

268.4 122 366.0 2.44 1 (0.34) 3 (2.10) 1 1

7


Loading Dose



Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



270.6 123 369.0 2.46 1 (0.36) 3 (2.10) 1 1

272.8 124 372.0 2.48 1 (0.38) 3 (2.10) 1 1

275.0 125 375.0 2.50 1 1 (0.40) 3 (2.10) 1 1 1

277.2 126 378.0 2.52 4 (1.52) 1 (1.00) 1 1

279.4 127 381.0 2.54 4 (1.54) 1 (1.00) 1 1

281.6 128 384.0 2.56 4 (1.56) 1 (1.00) 1 1

283.8 129 387.0 2.58 4 (1.58) 1 (1.00) 1 1

286.0 130 390.0 2.60 4 (1.60) 1 (1.00) 1 1

288.2 131 393.0 2.62 1 (0.62) 2 (2.00) 1 1

290.4 132 396.0 2.64 1 (0.64) 2 (2.00) 1 1

292.6 133 399.0 2.66 1 (0.66) 2 (2.00) 1 1

294.8 134 402.0 2.68 1 (0.68) 2 (2.00) 1 1

297.0 135 405.0 2.70 1 (0.70) 2 (2.00) 1 1

299.2 136 408.0 2.72 2 (0.72) 2 (2.00) 1 1

301.4 137 411.0 2.74 2 (0.74) 2 (2.00) 1 1

303.6 138 414.0 2.76 2 (0.76) 2 (2.00) 1 1

305.8 139 417.0 2.78 2 (0.78) 2 (2.00) 1 1

308.0 140 420.0 2.80 2 (0.80) 2 (2.00) 1 1

310.2 141 423.0 2.82 2 (0.72) 3 (2.10) 1 1

312.4 142 426.0 2.84 2 (0.74) 3 (2.10) 1 1

314.6 143 429.0 2.86 2 (0.76) 3 (2.10) 1 1

316.8 144 432.0 2.88 2 (0.78) 3 (2.10) 1 1

319.0 145 435.0 2.90 2 (0.80) 3 (2.10) 1 1

321.2 146 438.0 2.92 3 (2.92) 1 1

323.4 147 441.0 2.94 3 (2.94) 1 1

325.6 148 444.0 2.96 3 (2.96) 1 1

327.8 149 447.0 2.98 3 (2.98) 1 1

330.0 150 450.0 3.00 3 (3.00) 1 1

8


Loading Dose



Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



6.6 3 4.5 0.15 1 (0.15) 1

8.8 4 6.0 0.20 1 (0.20) 1

11.0 5 7.5 0.25 1 (0.25) 1

13.2 6 9.0 0.30 1 (0.30) 1

15.4 7 10.5 0.35 1 (0.35) 1 1 1

17.6 8 12.0 0.40 1 (0.40) 1

19.8 9 13.5 0.45 1 (0.45) 1 1 1

22.0 10 15.0 0.50 1 (0.50) 1

24.2 11 16.5 0.55 1 (0.55) 1

26.4 12 18.0 0.60 1 (0.60) 1

28.6 13 19.5 0.65 1 (0.65) 1 1

30.8 14 21.0 0.70 1 (0.70) 1

33.0 15 22.5 0.75 1 (0.75) 1

35.2 16 24.0 0.80 1 (0.80) 1

37.4 17 25.5 0.85 1 (0.85) 1 1

39.6 18 27.0 0.90 1 (0.90) 1

41.8 19 28.5 0.95 1 (0.95) 1

44.0 20 30.0 1.00 1 (1.00) 1

46.2 21 31.5 0.21 1 (0.21) 1

48.4 22 33.0 0.22 1 (0.22) 1

50.6 23 34.5 0.23 1 (0.23) 1

52.8 24 36.0 0.24 1 (0.24) 1

55.0 25 37.5 0.25 1 (0.25) 1

57.2 26 39.0 0.26 1 (0.26) 1

59.4 27 40.5 0.27 1 (0.27) 1

61.6 28 42.0 0.28 1 (0.28) 1

63.8 29 43.5 0.29 1 (0.29) 1

66.0 30 45.0 0.30 1 (0.30) 1

68.2 31 46.5 0.31 1 (0.31) 1

70.4 32 48.0 0.32 1 (0.32) 1

HEMLIBRA QW maintenance dose chart: (Weeks 5+) (1.5 mg/kg)

9 Maintenance Dose

QW Q2W Q4W

Click to view dosing options

QW=once weekly; Q2W=once every 2 weeks; Q4W=once every 4 weeks.



Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



72.6 33 49.5 0.33 1 (0.33) 1

74.8 34 51.0 0.34 1 (0.34) 1

77.0 35 52.5 0.35 1 (0.35) 1

79.2 36 54.0 0.36 1 (0.36) 1

81.4 37 55.5 0.37 1 1 (0.37) 1 1

83.6 38 57.0 0.38 1 (0.38) 1

85.8 39 58.5 0.39 1 1 (0.39) 1 1

88.0 40 60.0 0.40 1 (0.40) 1

90.2 41 61.5 0.45 1 (0.05) 1 (0.40) 2

92.4 42 63.0 0.50 1 (0.10) 1 (0.40) 2

94.6 43 64.5 0.55 1 (0.15) 1 (0.40) 1 2

96.8 44 66.0 0.60 1 (0.20) 1 (0.40) 2

99.0 45 67.5 0.65 1 (0.25) 1 (0.40) 2

101.2 46 69.0 0.70 1 (0.30) 1 (0.40) 2

103.4 47 70.5 0.75 1 (0.35) 1 (0.40) 1 2

105.6 48 72.0 0.80 1 (0.40) 1 (0.40) 2

107.8 49 73.5 0.85 1 (0.45) 1 (0.40) 2

110.0 50 75.0 0.90 1 (0.50) 1 (0.40) 2

112.2 51 76.5 0.95 1 (0.55) 1 (0.40) 2

114.4 52 78.0 1.00 1 (0.60) 1 (0.40) 2

116.6 53 79.5 1.05 1 (0.65) 1 (0.40) 2

118.8 54 81.0 1.10 1 (0.70) 1 (0.40) 2

121.0 55 82.5 1.15 1 (0.75) 1 (0.40) 2

123.2 56 84.0 1.20 1 (0.80) 1 (0.40) 2

125.4 57 85.5 1.25 1 (0.85) 1 (0.40) 2

127.6 58 87.0 1.30 1 (0.90) 1 (0.40) 2

129.8 59 88.5 1.35 1 (0.95) 1 (0.40) 2

132.0 60 90.0 1.40 1 (1.00) 1 (0.40) 2

134.2 61 91.5 0.61 1 (0.61) 1

136.4 62 93.0 0.62 1 (0.62) 1

10

HEMLIBRA QW maintenance dose chart: (Weeks 5+) (1.5 mg/kg) (cont’d)

Maintenance Dose

QW Q2W Q4W





Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



138.6 63 94.5 0.63 1 (0.63) 1

140.8 64 96.0 0.64 1 (0.64) 1

143.0 65 97.5 0.65 1 (0.65) 1

145.2 66 99.0 0.66 1 (0.66) 1

147.4 67 100.5 0.67 1 1 1 (0.67) 1

149.6 68 102.0 0.68 1 (0.68) 1

151.8 69 103.5 0.69 1 1 1 (0.69) 1

154.0 70 105.0 0.70 1 (0.70) 1

156.2 71 106.5 0.71 2 (0.71) 1

158.4 72 108.0 0.72 2 (0.72) 1

160.6 73 109.5 0.73 2 (0.73) 1 1

162.8 74 111.0 0.74 2 (0.74) 1

165.0 75 112.5 0.75 2 (0.75) 1

167.2 76 114.0 0.76 2 (0.76) 1

169.4 77 115.5 0.77 2 (0.77) 1 1

171.6 78 117.0 0.78 2 (0.78) 1

173.8 79 118.5 0.79 2 (0.79) 1

176.0 80 120.0 0.80 2 (0.80) 1

178.2 81 121.5 1.25 1 (0.55) 1 (0.70) 1 2

180.4 82 123.0 1.30 1 (0.60) 1 (0.70) 1 2

182.6 83 124.5 1.35 1 (0.65) 1 (0.70) 1 2

184.8 84 126.0 1.40 1 (0.70) 1 (0.70) 1 2

187.0 85 127.5 1.45 1 (0.75) 1 (0.70) 1 2

189.2 86 129.0 1.50 1 (0.80) 1 (0.70) 1 2

191.4 87 130.5 1.55 1 (0.85) 1 (0.70) 1 2

193.6 88 132.0 1.60 1 (0.90) 1 (0.70) 1 2

195.8 89 133.5 1.65 1 (0.95) 1 (0.70) 1 2

198.0 90 135.0 1.70 1 (1.00) 1 (0.70) 1 2

200.2 91 136.5 0.91 1 (0.91) 1

202.4 92 138.0 0.92 1 (0.92) 1

11 Maintenance Dose

QW Q2W Q4W






Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



204.6 93 139.5 0.93 1 (0.93) 1

206.8 94 141.0 0.94 1 (0.94) 1

209.0 95 142.5 0.95 1 (0.95) 1

211.2 96 144.0 0.96 1 (0.96) 1

213.4 97 145.5 0.97 1 1 1 (0.97) 1

215.6 98 147.0 0.98 1 (0.98) 1

217.8 99 148.5 0.99 1 1 1 (0.99) 1

220.0 100 150.0 1.00 1 (1.00) 1

222.2 101 151.5 1.01 1 (0.31) 1 (0.70) 1

224.4 102 153.0 1.02 1 (0.32) 1 (0.70) 1

226.6 103 154.5 1.03 1 (0.33) 1 (0.70) 1

228.8 104 156.0 1.04 1 (0.34) 1 (0.70) 1

231.0 105 157.5 1.05 1 (0.35) 1 (0.70) 1

233.2 106 159.0 1.06 1 (0.36) 1 (0.70) 1

235.4 107 160.5 1.07 1 (0.37) 1 (0.70) 1 1

237.6 108 162.0 1.08 1 (0.38) 1 (0.70) 1

239.8 109 163.5 1.09 1 (0.39) 1 (0.70) 1

242.0 110 165.0 1.10 1 (0.40) 1 (0.70) 1

244.2 111 166.5 1.11 3 (1.11) 1

246.4 112 168.0 1.12 3 (1.12) 1

248.6 113 169.5 1.13 3 (1.13) 1

250.8 114 171.0 1.14 3 (1.14) 1

253.0 115 172.5 1.15 3 (1.15) 1

255.2 116 174.0 1.16 3 (1.16) 1

257.4 117 175.5 1.17 3 (1.17) 1

259.6 118 177.0 1.18 3 (1.18) 1

261.8 119 178.5 1.19 3 (1.19) 1

264.0 120 180.0 1.20 3 (1.20) 1

266.2 121 181.5 1.65 1 (0.55) 1 (0.40) 1 (0.70) 1 1

268.4 122 183.0 1.70 1 (0.60) 1 (0.40) 1 (0.70) 1 1

12 Maintenance Dose

QW Q2W Q4W






Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



270.6 123 184.5 1.75 1 (0.65) 1 (0.40) 1 (0.70) 1 1

272.8 124 186.0 1.80 1 (0.70) 1 (0.40) 1 (0.70) 1 1

275.0 125 187.5 1.85 1 (0.75) 1 (0.40) 1 (0.70) 1 1

277.2 126 189.0 1.90 1 (0.80) 1 (0.40) 1 (0.70) 1 1

279.4 127 190.5 1.95 1 (0.85) 1 (0.40) 1 (0.70) 1 1 1

281.6 128 192.0 2.00 1 (0.90) 1 (0.40) 1 (0.70) 1 1

283.8 129 193.5 2.05 1 (0.95) 1 (0.40) 1 (0.70) 1 1 1

286.0 130 195.0 2.10 1 (1.00) 1 (0.40) 1 (0.70) 1 1

288.2 131 196.5 1.31 2 (1.31) 1

290.4 132 198.0 1.32 2 (1.32) 1

292.6 133 199.5 1.33 2 (1.33) 1

294.8 134 201.0 1.34 2 (1.34) 1

297.0 135 202.5 1.35 2 (1.35) 1

299.2 136 204.0 1.36 2 (1.36) 1

301.4 137 205.5 1.37 2 (1.37) 1 1

303.6 138 207.0 1.38 2 (1.38) 1

305.8 139 208.5 1.39 2 (1.39) 1

308.0 140 210.0 1.40 2 (1.40) 1

310.2 141 211.5 1.41 2 (0.71) 1 (0.70) 1

312.4 142 213.0 1.42 2 (0.72) 1 (0.70) 1

314.6 143 214.5 1.43 2 (0.73) 1 (0.70) 1

316.8 144 216.0 1.44 2 (0.74) 1 (0.70) 1

319.0 145 217.5 1.45 2 (0.75) 1 (0.70) 1

321.2 146 219.0 1.46 2 (0.76) 1 (0.70) 1

323.4 147 220.5 1.47 2 (0.77) 1 (0.70) 1

325.6 148 222.0 1.48 2 (0.78) 1 (0.70) 1

327.8 149 223.5 1.49 2 (0.79) 1 (0.70) 1

330.0 150 225.0 1.50 2 (0.80) 1 (0.70) 1

13 Maintenance Dose

QW Q2W Q4W






Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



6.6 3 9.0 0.30 1 (0.30) 1

8.8 4 12.0 0.40 1 (0.40) 1

11.0 5 15.0 0.50 1 (0.50) 1 1 1 1

13.2 6 18.0 0.60 1 (0.60) 1

15.4 7 21.0 0.70 1 (0.70) 1

17.6 8 24.0 0.80 1 (0.80) 1

19.8 9 27.0 0.90 1 (0.90) 1

22.0 10 30.0 1.00 1 (1.00) 1

24.2 11 33.0 0.22 1 (0.22) 1

26.4 12 36.0 0.24 1 (0.24) 1

28.6 13 39.0 0.26 1 (0.26) 1

30.8 14 42.0 0.28 1 (0.28) 1

33.0 15 45.0 0.30 1 (0.30) 1

35.2 16 48.0 0.32 1 (0.32) 1

37.4 17 51.0 0.34 1 (0.34) 1

39.6 18 54.0 0.36 1 (0.36) 1

41.8 19 57.0 0.38 1 (0.38) 1

44.0 20 60.0 0.40 1 (0.40) 1

46.2 21 63.0 0.50 1 (0.10) 1 (0.40) 2

48.4 22 66.0 0.60 1 (0.20) 1 (0.40) 2

50.6 23 69.0 0.70 1 (0.30) 1 (0.40) 2

52.8 24 72.0 0.80 1 (0.40) 1 (0.40) 2

55.0 25 75.0 0.90 1 (0.50) 1 (0.40) 2

57.2 26 78.0 1.00 1 (0.60) 1 (0.40) 2

59.4 27 81.0 1.10 1 (0.70) 1 (0.40) 2

61.6 28 84.0 1.20 1 (0.80) 1 (0.40) 2

63.8 29 87.0 1.30 1 (0.90) 1 (0.40) 2

66.0 30 90.0 1.40 1 (1.00) 1 (0.40) 2

68.2 31 93.0 0.62 3 1 (0.62) 3 1

70.4 32 96.0 0.64 1 (0.64) 1

14

HEMLIBRA Q2W maintenance dose chart: (Weeks 5+) (3 mg/kg)

Maintenance Dose

QW Q2W Q4W





Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



72.6 33 99.0 0.66 1 (0.66) 1

74.8 34 102.0 0.68 1 (0.68) 1

77.0 35 105.0 0.70 1 (0.70) 1 1

79.2 36 108.0 0.72 2 (0.72) 1

81.4 37 111.0 0.74 2 (0.74) 1

83.6 38 114.0 0.76 2 (0.76) 1

85.8 39 117.0 0.78 2 (0.78) 1

88.0 40 120.0 0.80 2 (0.80) 1

90.2 41 123.0 1.30 1 (0.60) 1 (0.70) 2

92.4 42 126.0 1.40 1 (0.70) 1 (0.70) 2

94.6 43 129.0 1.50 1 (0.80) 1 (0.70) 2

96.8 44 132.0 1.60 1 (0.90) 1 (0.70) 2

99.0 45 135.0 1.70 1 (1.00) 1 (0.70) 2

101.2 46 138.0 0.92 1 (0.92) 1

103.4 47 141.0 0.94 1 (0.94) 1

105.6 48 144.0 0.96 1 (0.96) 1

107.8 49 147.0 0.98 1 (0.98) 1

110.0 50 150.0 1.00 1 (1.00) 1

112.2 51 153.0 1.02 1 (0.32) 1 (0.70) 1

114.4 52 156.0 1.04 1 (0.34) 1 (0.70) 1

116.6 53 159.0 1.06 1 (0.36) 1 (0.70) 1

118.8 54 162.0 1.08 1 (0.38) 1 (0.70) 1

121.0 55 165.0 1.10 1 (0.40) 1 (0.70) 1

123.2 56 168.0 1.12 3 (1.12) 1

125.4 57 171.0 1.14 3 (1.14) 1

127.6 58 174.0 1.16 3 (1.16) 1

129.8 59 177.0 1.18 3 (1.18) 1

132.0 60 180.0 1.20 3 (1.20) 1

134.2 61 183.0 1.70 1 (0.60) 1 (0.40) 1 (0.70) 3 1 1

136.4 62 186.0 1.80 1 (0.70) 1 (0.40) 1 (0.70) 1 1

15

HEMLIBRA Q2W maintenance dose chart: (Weeks 5+) (3 mg/kg) (cont’d)

Maintenance Dose

QW Q2W Q4W





Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



138.6 63 189.0 1.90 1 (0.80) 1 (0.40) 1 (0.70) 1 1

140.8 64 192.0 2.00 1 (0.90) 1 (0.40) 1 (0.70) 1 1

143.0 65 195.0 2.10 1 (1.00) 1 (0.40) 1 (0.70) 1 1 1

145.2 66 198.0 1.32 2 (1.32) 1

147.4 67 201.0 1.34 2 (1.34) 1

149.6 68 204.0 1.36 2 (1.36) 1

151.8 69 207.0 1.38 2 (1.38) 1

154.0 70 210.0 1.40 2 (1.40) 1

156.2 71 213.0 1.42 2 (0.72) 1 (0.70) 1

158.4 72 216.0 1.44 2 (0.74) 1 (0.70) 1

160.6 73 219.0 1.46 2 (0.76) 1 (0.70) 1

162.8 74 222.0 1.48 2 (0.78) 1 (0.70) 1

165.0 75 225.0 1.50 2 (0.80) 1 (0.70) 1

167.2 76 228.0 1.52 4 (1.52) 1

169.4 77 231.0 1.54 4 (1.54) 1

171.6 78 234.0 1.56 4 (1.56) 1

173.8 79 237.0 1.58 4 (1.58) 1

176.0 80 240.0 1.60 4 (1.60) 1

178.2 81 243.0 1.62 1 (0.62) 1 (1.00) 1

180.4 82 246.0 1.64 1 (0.64) 1 (1.00) 1

182.6 83 249.0 1.66 1 (0.66) 1 (1.00) 1

184.8 84 252.0 1.68 1 (0.68) 1 (1.00) 1

187.0 85 255.0 1.70 1 (0.70) 1 (1.00) 1

189.2 86 258.0 1.72 2 (0.72) 1 (1.00) 1

191.4 87 261.0 1.74 2 (0.74) 1 (1.00) 1

193.6 88 264.0 1.76 2 (0.76) 1 (1.00) 1

195.8 89 267.0 1.78 2 (0.78) 1 (1.00) 1

198.0 90 270.0 1.80 2 (0.80) 1 (1.00) 1

200.2 91 273.0 1.82 3 (1.12) 1 (0.70) 3 1

202.4 92 276.0 1.84 3 (1.14) 1 (0.70) 1

16 Maintenance Dose

QW Q2W Q4W






Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



204.6 93 279.0 1.86 3 (1.16) 1 (0.70) 1

206.8 94 282.0 1.88 3 (1.18) 1 (0.70) 1

209.0 95 285.0 1.90 1 3 (1.20) 1 (0.70) 1 1

211.2 96 288.0 1.92 2 (1.92) 1

213.4 97 291.0 1.94 2 (1.94) 1

215.6 98 294.0 1.96 2 (1.96) 1

217.8 99 297.0 1.98 2 (1.98) 1

220.0 100 300.0 2.00 2 (2.00) 1

222.2 101 303.0 2.02 3 (2.02) 1 1

224.4 102 306.0 2.04 3 (2.04) 1 1

226.6 103 309.0 2.06 3 (2.06) 1 1

228.8 104 312.0 2.08 3 (2.08) 1 1

231.0 105 315.0 2.10 3 (2.10) 1 1

233.2 106 318.0 2.12 2 (0.72) 2 (1.40) 1 1

235.4 107 321.0 2.14 2 (0.74) 2 (1.40) 1 1

237.6 108 324.0 2.16 2 (0.76) 2 (1.40) 1 1

239.8 109 327.0 2.18 2 (0.78) 2 (1.40) 1 1

242.0 110 330.0 2.20 2 (0.80) 2 (1.40) 1 1

244.2 111 333.0 2.22 4 (1.52) 1 (0.70) 1 1

246.4 112 336.0 2.24 4 (1.54) 1 (0.70) 1 1

248.6 113 339.0 2.26 4 (1.56) 1 (0.70) 1 1

250.8 114 342.0 2.28 4 (1.58) 1 (0.70) 1 1

253.0 115 345.0 2.30 4 (1.60) 1 (0.70) 1 1

255.2 116 348.0 2.32 1 (0.32) 2 (2.00) 1 1

257.4 117 351.0 2.34 1 (0.34) 2 (2.00) 1 1

259.6 118 354.0 2.36 1 (0.36) 2 (2.00) 1 1

261.8 119 357.0 2.38 1 (0.38) 2 (2.00) 1 1

264.0 120 360.0 2.40 1 (0.40) 2 (2.00) 1 1

266.2 121 363.0 2.42 3 1 (0.32) 3 (2.10) 3 1 1

268.4 122 366.0 2.44 1 (0.34) 3 (2.10) 1 1

17 Maintenance Dose

QW Q2W Q4W






Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



270.6 123 369.0 2.46 1 (0.36) 3 (2.10) 1 1

272.8 124 372.0 2.48 1 (0.38) 3 (2.10) 1 1

275.0 125 375.0 2.50 1 1 (0.40) 3 (2.10) 1 1 1

277.2 126 378.0 2.52 4 (1.52) 1 (1.00) 1 1

279.4 127 381.0 2.54 4 (1.54) 1 (1.00) 1 1

281.6 128 384.0 2.56 4 (1.56) 1 (1.00) 1 1

283.8 129 387.0 2.58 4 (1.58) 1 (1.00) 1 1

286.0 130 390.0 2.60 4 (1.60) 1 (1.00) 1 1

288.2 131 393.0 2.62 1 (0.62) 2 (2.00) 1 1

290.4 132 396.0 2.64 1 (0.64) 2 (2.00) 1 1

292.6 133 399.0 2.66 1 (0.66) 2 (2.00) 1 1

294.8 134 402.0 2.68 1 (0.68) 2 (2.00) 1 1

297.0 135 405.0 2.70 1 (0.70) 2 (2.00) 1 1

299.2 136 408.0 2.72 2 (0.72) 2 (2.00) 1 1

301.4 137 411.0 2.74 2 (0.74) 2 (2.00) 1 1

303.6 138 414.0 2.76 2 (0.76) 2 (2.00) 1 1

305.8 139 417.0 2.78 2 (0.78) 2 (2.00) 1 1

308.0 140 420.0 2.80 2 (0.80) 2 (2.00) 1 1

310.2 141 423.0 2.82 2 (0.72) 3 (2.10) 1 1

312.4 142 426.0 2.84 2 (0.74) 3 (2.10) 1 1

314.6 143 429.0 2.86 2 (0.76) 3 (2.10) 1 1

316.8 144 432.0 2.88 2 (0.78) 3 (2.10) 1 1

319.0 145 435.0 2.90 2 (0.80) 3 (2.10) 1 1

321.2 146 438.0 2.92 3 (2.92) 1 1

323.4 147 441.0 2.94 3 (2.94) 1 1

325.6 148 444.0 2.96 3 (2.96) 1 1

327.8 149 447.0 2.98 3 (2.98) 1 1

330.0 150 450.0 3.00 3 (3.00) 1 1

18 Maintenance DoseMaintenance Dose

QW Q2W Q4W






Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



Maintenance Dose

QW Q2W Q4W

6.6 3 18 0.60 1 (0.60) 1

8.8 4 24 0.80 1 (0.80) 1

11.0 5 30 1.00 1 (1.00) 1 1 1 1

13.2 6 36 0.24 1 (0.24) 1

15.4 7 42 0.28 1 (0.28) 1

17.6 8 48 0.32 1 (0.32) 1

19.8 9 54 0.36 1 (0.36) 1

22.0 10 60 0.40 1 (0.40) 1

24.2 11 66 0.60 1 (0.20) 1 (0.40) 2

26.4 12 72 0.80 1 (0.40) 1 (0.40) 2

28.6 13 78 1.00 1 (0.60) 1 (0.40) 2

30.8 14 84 1.20 1 (0.80) 1 (0.40) 2

33.0 15 90 1.40 1 (1.00) 1 (0.40) 2

35.2 16 96 0.64 1 (0.64) 1

37.4 17 102 0.68 1 (0.68) 1

39.6 18 108 0.72 2 (0.72) 1

41.8 19 114 0.76 2 (0.76) 1

44.0 20 120 0.80 2 (0.80) 1

46.2 21 126 1.40 1 (0.70) 1 (0.70) 2

48.4 22 132 1.60 1 (0.90) 1 (0.70) 2

50.6 23 138 0.92 1 (0.92) 1

52.8 24 144 0.96 1 (0.96) 1

55.0 25 150 1.00 1 (1.00) 1

57.2 26 156 1.04 1 (0.34) 1 (0.70) 1

59.4 27 162 1.08 1 (0.38) 1 (0.70) 1

61.6 28 168 1.12 3 (1.12) 1

63.8 29 174 1.16 3 (1.16) 1

66.0 30 180 1.20 3 (1.20) 1

68.2 31 186 1.80 1 (0.70) 1 (0.40) 1 (0.70) 3 1 1

70.4 32 192 2.00 1 (0.90) 1 (0.40) 1 (0.70) 1 1


19





Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



72.6 33 198 1.32 2 (1.32) 1

74.8 34 204 1.36 2 (1.36) 1

77.0 35 210 1.40 2 (1.40) 1 1

79.2 36 216 1.44 2 (0.74) 1 (0.70) 1

81.4 37 222 1.48 2 (0.78) 1 (0.70) 1

83.6 38 228 1.52 4 (1.52) 1

85.8 39 234 1.56 4 (1.56) 1

88.0 40 240 1.60 4 (1.60) 1

90.2 41 246 1.64 1 (0.64) 1 (1.00) 1

92.4 42 252 1.68 1 (0.68) 1 (1.00) 1

94.6 43 258 1.72 2 (0.72) 1 (1.00) 1

96.8 44 264 1.76 2 (0.76) 1 (1.00) 1

99.0 45 270 1.80 2 (0.80) 1 (1.00) 1

101.2 46 276 1.84 3 (1.14) 1 (0.70) 1

103.4 47 282 1.88 3 (1.18) 1 (0.70) 1

105.6 48 288 1.92 2 (1.92) 1

107.8 49 294 1.96 2 (1.96) 1

110.0 50 300 2.00 2 (2.00) 1

112.2 51 306 2.04 3 (2.04) 1 1

114.4 52 312 2.08 3 (2.08) 1 1

116.6 53 318 2.12 2 (0.72) 2 (1.40) 1 1

118.8 54 324 2.16 2 (0.76) 2 (1.40) 1 1

121.0 55 330 2.20 2 (0.80) 2 (1.40) 1 1

123.2 56 336 2.24 4 (1.54) 1 (0.70) 1 1

125.4 57 342 2.28 4 (1.58) 1 (0.70) 1 1

127.6 58 348 2.32 1 (0.32) 2 (2.00) 1 1

129.8 59 354 2.36 1 (0.36) 2 (2.00) 1 1

132.0 60 360 2.40 1 (0.40) 2 (2.00) 1 1

134.2 61 366 2.44 1 (0.34) 3 (2.10) 3 1 1

136.4 62 372 2.48 1 (0.38) 3 (2.10) 1 1

20 Maintenance Dose

QW Q2W Q4W






Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



138.6 63 378 2.52 4 (1.52) 1 (1.00) 1 1

140.8 64 384 2.56 4 (1.56) 1 (1.00) 1 1

143.0 65 390 2.60 1 4 (1.60) 1 1 (1.00) 1 1

145.2 66 396 2.64 1 (0.64) 2 (2.00) 1 1

147.4 67 402 2.68 1 (0.68) 2 (2.00) 1 1

149.6 68 408 2.72 2 (0.72) 2 (2.00) 1 1

151.8 69 414 2.76 2 (0.76) 2 (2.00) 1 1

154.0 70 420 2.80 2 (0.80) 2 (2.00) 1 1

156.2 71 426 2.84 2 (0.74) 3 (2.10) 1 1

158.4 72 432 2.88 2 (0.78) 3 (2.10) 1 1

160.6 73 438 2.92 3 (2.92) 1 1

162.8 74 444 2.96 3 (2.96) 1 1

165.0 75 450 3.00 3 (3.00) 1 1

167.2 76 456 3.04 3 (2.04) 1 (1.00) 2

169.4 77 462 3.08 3 (2.08) 1 (1.00) 2

171.6 78 468 3.12 1 (0.32) 4 (2.80) 2

173.8 79 474 3.16 1 (0.36) 4 (2.80) 2

176.0 80 480 3.20 1 (0.40) 4 (2.80) 2

178.2 81 486 3.24 3 (1.14) 3 (2.10) 2

180.4 82 492 3.28 3 (1.18) 3 (2.10) 2

182.6 83 498 3.32 1 (0.32) 3 (3.00) 2

184.8 84 504 3.36 1 (0.36) 3 (3.00) 2

187.0 85 510 3.40 1 (0.40) 3 (3.00) 2

189.2 86 516 3.44 5 (3.44) 2

191.4 87 522 3.48 5 (3.48) 2

193.6 88 528 3.52 2 (0.72) 4 (2.80) 2

195.8 89 534 3.56 2 (0.76) 4 (2.80) 2

198.0 90 540 3.60 2 (0.80) 4 (2.80) 2

200.2 91 546 3.64 1 (0.64) 3 (3.00) 2

202.4 92 552 3.68 1 (0.68) 3 (3.00) 2

21 Maintenance Dose

QW Q2W Q4W






Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



204.6 93 558 3.72 4 (2.72) 1 (1.00) 2

206.8 94 564 3.76 4 (2.76) 1 (1.00) 2

209.0 95 570 3.80 1 1 4 (2.80) 1 (1.00) 2

211.2 96 576 3.84 1 (0.34) 5 (3.50) 2

213.4 97 582 3.88 1 (0.38) 5 (3.50) 2

215.6 98 588 3.92 4 (3.92) 2

217.8 99 594 3.96 4 (3.96) 2

220.0 100 600 4.00 4 (4.00) 2

222.2 101 606 4.04 3 (2.04) 2 (2.00) 1 2

224.4 102 612 4.08 3 (2.08) 2 (2.00) 1 2

226.6 103 618 4.12 6 (4.12) 1 2

228.8 104 624 4.16 6 (4.16) 1 2

231.0 105 630 4.20 6 (4.20) 1 2

233.2 106 636 4.24 3 (1.14) 3 (2.10) 1 (1.00) 1 2

235.4 107 642 4.28 3 (1.18) 3 (2.10) 1 (1.00) 1 2

237.6 108 648 4.32 1 (0.32) 4 (4.00) 1 2

239.8 109 654 4.36 1 (0.36) 4 (4.00) 1 2

242.0 110 660 4.40 1 (0.40) 4 (4.00) 1 2

244.2 111 666 4.44 1 (0.34) 3 (2.10) 2 (2.00) 1 2

246.4 112 672 4.48 1 (0.38) 3 (2.10) 2 (2.00) 1 2

248.6 113 678 4.52 1 (0.32) 6 (4.20) 1 2

250.8 114 684 4.56 1 (0.36) 6 (4.20) 1 2

253.0 115 690 4.60 1 (0.40) 6 (4.20) 1 2

255.2 116 696 4.64 1 (0.64) 4 (4.00) 1 2

257.4 117 702 4.68 1 (0.68) 4 (4.00) 1 2

259.6 118 708 4.72 2 (0.72) 4 (4.00) 1 2

261.8 119 714 4.76 2 (0.76) 4 (4.00) 1 2

264.0 120 720 4.80 2 (0.80) 4 (4.00) 1 2

266.2 121 726 4.84 3 3 7 (4.84) 3 1 2

268.4 122 732 4.88 7 (4.88) 1 2

22 Maintenance Dose

QW Q2W Q4W






Dose (mg)

Total Volume

(mL)



60 mg/0.4 mL (150 mg/mL)

105 mg/0.7 mL (150 mg/mL)

150 mg/mL (150 mg/mL)

1 mL Syringe

2 or 3 mL Syringe



270.6 123 738 4.92 5 (4.92) 1 2

272.8 124 744 4.96 5 (4.96) 1 2

275.0 125 750 5.00 1 1 1 5 (5.00) 1 2

277.2 126 756 5.04 3 (2.04) 3 (3.00) 3

279.4 127 762 5.08 3 (2.08) 3 (3.00) 3

281.6 128 768 5.12 3 (1.12) 4 (4.00) 3

283.8 129 774 5.16 3 (1.16) 4 (4.00) 3

286.0 130 780 5.20 3 (1.20) 4 (4.00) 3

288.2 131 786 5.24 1 (0.34) 7 (4.90) 3

290.4 132 792 5.28 1 (0.38) 7 (4.90) 3

292.6 133 798 5.32 1 (0.32) 5 (5.00) 3

294.8 134 804 5.36 1 (0.36) 5 (5.00) 3

297.0 135 810 5.40 1 (0.40) 5 (5.00) 3

299.2 136 816 5.44 5 (3.44) 2 (2.00) 3

301.4 137 822 5.48 5 (3.48) 2 (2.00) 3

303.6 138 828 5.52 8 (5.52) 3

305.8 139 834 5.56 8 (5.56) 3

308.0 140 840 5.60 8 (5.60) 3

310.2 141 846 5.64 1 (0.64) 5 (5.00) 3

312.4 142 852 5.68 1 (0.68) 5 (5.00) 3

314.6 143 858 5.72 2 (0.72) 5 (5.00) 3

316.8 144 864 5.76 2 (0.76) 5 (5.00) 3

319.0 145 870 5.80 2 (0.80) 5 (5.00) 3

321.2 146 876 5.84 7 (4.84) 1 (1.00) 3

323.4 147 882 5.88 7 (4.88) 1 (1.00) 3

325.6 148 888 5.92 6 (5.92) 3

327.8 149 894 5.96 6 (5.96) 3

330.0 150 900 6.00 6 (6.00) 3

23 Maintenance Dose

QW Q2W Q4W






Important Safety Information

IndicationHEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A with or without factor VIII inhibitors.

Important Safety InformationBoxed WARNING: THROMBOTIC MICROANGIOPATHY and THROMBOEMBOLISM Cases of thrombotic microangiopathy and thrombotic events were reported when on average a cumulative amount of >100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) was administered for 24 hours or more to patients receiving HEMLIBRA prophylaxis. Monitor for the development of thrombotic microangiopathy and thrombotic events if aPCC is administered. Discontinue aPCC and suspend dosing of HEMLIBRA if symptoms occur. Warnings and PrecautionsThrombotic Microangiopathy (TMA) and Thromboembolism Associated With HEMLIBRA and aPCCIn clinical trials, TMA was reported in 0.8% of patients (3/391) and thrombotic events were reported in 0.5% of patients (2/391). In patients who received at least one dose of aPCC, TMA was reported in 8.1% of patients (3/37) and thrombotic events were reported in 5.4% of patients (2/37). Patients with TMA presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13.Consider the benefits and risks if aPCC must be used in a patient receiving HEMLIBRA prophylaxis. Monitor for the development of TMA and/or thromboembolism when administering aPCC. Immediately discontinue aPCC and interrupt HEMLIBRA prophylaxis if clinical symptoms, imaging, or laboratory findings consistent with TMA and/or thromboembolism occur, and manage as clinically indicated. Consider the benefits and risks of resuming HEMLIBRA prophylaxis following complete resolution of TMA and/or thrombotic events on a case-by-case basis.Laboratory Coagulation Test Interference HEMLIBRA affects intrinsic pathway clotting-based laboratory tests, including activated clotting time (ACT); activated partial thromboplastin time (aPTT); and all assays based on aPTT, such as one-stage, factor VIII (FVIII) activity. Therefore, intrinsic pathway clotting-based coagulation laboratory test results in patients who have been treated with HEMLIBRA prophylaxis should not be used to monitor HEMLIBRA activity, determine dosing for factor replacement or anti-coagulation, or measure FVIII inhibitor titers. Results affected by HEMLIBRA: aPTT; Bethesda assays (clotting-based) for FVIII inhibitor titers; one-stage, aPTT-based single-factor assays; aPTT-based Activated Protein C Resistance (APC-R); ACT.Results unaffected by HEMLIBRA: Bethesda assays (bovine chromogenic) for FVIII inhibitor titers; thrombin time (TT); one-stage, prothrombin time (PT)-based single-factor assays; chromogenic-based single-factor assays other than FVIII (see Drug Interactions for FVIII chromogenic activity assay considerations); immuno-based assays (ie, ELISA, turbidimetric methods); genetic tests of coagulation factors (eg, Factor V Leiden, Prothrombin 20210).Most Common Adverse ReactionsThe most common adverse reactions (incidence ≥10%) are injection site reactions, headache, and arthralgia.Adverse ReactionsCharacterization of aPCC Treatment in Pooled Clinical Trials There were 130 instances of aPCC treatment in 37 patients, of which 13 instances (10%) consisted of on average a cumulative amount of >100 U/kg/24 hours of aPCC for 24 hours or more; 2 of the 13 were associated with thrombotic events and 3 of the 13 were associated with TMA. No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.Injection Site Reactions In total, 85 patients (22%) reported injection site reactions (ISRs). All ISRs observed in HEMLIBRA clinical trials were reported as mild to moderate intensity and 93% resolved without treatment. The commonly reported ISR symptoms were injection site erythema (11%), injection site pruritus (4%), and injection site pain (4%).Other Less Common (<1%) Reactions Rhabdomyolysis was reported in 2 adult patients with asymptomatic elevations in serum creatinine kinase without associated renal or musculoskeletal symptoms. In both instances, the event occurred following an increase in physical activity.Drug InteractionsClinical experience suggests that a drug interaction exists with HEMLIBRA and aPCC.Pregnancy, Lactation, Females and Males of Reproductive PotentialWomen of childbearing potential should use contraception while receiving HEMLIBRA. It is not known whether HEMLIBRA can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HEMLIBRA should be used during pregnancy only if the potential benefit for the mother outweighs the risk to the fetus. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for HEMLIBRA and any potential adverse effects on the breastfed child from HEMLIBRA or from the underlying maternal condition.You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

HEMLIBRA® is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.The HEMLIBRA logo is a registered trademark of Chugai Pharmaceutical Co., Ltd., Tokyo, Japan.The Genentech logo is a registered trademark of Genentech, Inc.©2020 Genentech USA, Inc. All rights reserved. M-US-00003108(v1.0) 03/20


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HEMLIBRA® (emicizumab-kxwh) Dosing and Administration Guide · Sample dosing chart overview...

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Transcript of HEMLIBRA® (emicizumab-kxwh) Dosing and Administration Guide · Sample dosing chart overview...