4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in...

17
4 mg daily dose 4 mg daily dose Rx only 4 mg daily dose NDC 62856-704-30 NDC 62856-704-30 Rx only 30 Day Supply 4 mg daily dose 4 mg daily-dose carton containing 6 cards (five 4 mg capsules per card) 30 Day Supply Take one “Daily Dose” of 4 mg each day 203976 Each daily dose consists of 1 capsule: one 4 mg capsule (total dose 4 mg). Each capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate. See package insert for dosage information. Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Dosing Instructions: Take one daily dose: one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor. P PUSH PUSH Push through black half circle. 1. Turn card over and peel tab to expose foil. 2. Turn card over and push on END of plastic blister to dispense. 3. Take one 4 mg capsule once daily ® ® ® ® Distributed by: Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4)

Transcript of 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in...

Page 1: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

4 m

g da

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ose

4 mg daily dose

Rx only

4 mg daily dose

NDC 62856-704-30NDC 62856-704-30

Rx only

30 D

ay S

uppl

y

4 mg daily dose

4 mg daily-dose carton containing 6 cards (five 4 mg capsules per card)

30 Day Supply

Take one “Daily Dose” of 4 mg each day

203976

Each daily dose consists of 1 capsule: one 4 mg capsule (total dose 4 mg). Each capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinibmesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

Take one 4 mg capsule once daily

®

®

®

®

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

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Page 2: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

8 m

g da

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ose

203972

Rx only NDC 62856-708-30NDC 62856-708-30

Rx only

8 mg daily dose

30 D

ay S

uppl

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8 mg daily dose

8 mg daily-dose carton containing 6 cards (ten 4 mg capsules per card)

30 Day Supply

Take one “Daily Dose” of 8 mg each day

®

®

®

Take two 4 mg capsules once daily

8 mg daily dose

Each daily dose consists of 2 capsules: two 4 mg capsules (total dose 8 mg). Each capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: two 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

®

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

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Page 3: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

10 m

g da

ily d

ose

10 mg daily dose

Rx only

10 mg daily dose

NDC 62856-710-30NDC 62856-710-30

Rx only

30 D

ay S

uppl

y

10 mg daily dose

10 mg daily-dose carton containing 6 cards (five 10 mg capsules per card)

30 Day Supply

Take one “Daily Dose” of 10 mg each day

203974

Each daily dose consists of 1 capsule: one 10 mg capsule (total dose 10 mg). Each capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinibmesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: one 10 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

Take one 10 mg capsule once daily

®

®

®

®

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

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Page 4: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

203970

Rx only NDC 62856-712-30NDC 62856-712-30

Rx only

12 mg daily dose

12 mg daily-dose carton containing 6 cards (fifteen 4 mg capsules per card)

30 Day Supply

12 m

g da

ily d

ose

30 D

ay S

uppl

y

12 mg daily dose

Take one “Daily Dose” of 12 mg each day

12 mg daily dose

Each daily dose consists of 3 capsules: three 4 mg capsules (total dose 12 mg). Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: three 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

®

®

®

®

Take three 4 mg capsules once daily

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

INSIDE TOP FLAP PRINTING

UNVARNISHED LOT/EXP AREA

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Page 5: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

14 m

g da

ily d

ose

203966

Rx only NDC 62856-714-30NDC 62856-714-30

Rx only

14 mg daily dose

30 D

ay S

uppl

y

14 mg daily dose

14 mg daily-dose carton containing 6 cards (five 10 mg capsules and five 4 mg capsules per card)

30 Day Supply

Take one “Daily Dose” of 14 mg each day

14 mg daily dose

Each daily dose consists of 2 capsules: one 10 mg capsule and one 4 mg capsule (total dose 14 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: one 10 mg capsule and one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

®

®

®

®

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

Take one 10 mg capsule and one4 mg capsule together once daily

INSIDE TOP FLAP PRINTING

UNVARNISHED LOT/EXP AREA

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(b) (4)

Page 6: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

Each daily dose consists of 3 capsules: one 10 mg capsule and two 4 mg capsules (total dose 18 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: one 10 mg capsule and two 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

203968

Rx only NDC 62856-718-30NDC 62856-718-30

Rx only

18 mg daily dose

18 mg daily-dose carton containing 6 cards (five 10 mg capsules and ten 4 mg capsules per card)

30 Day Supply

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

18 mg daily dose

18 m

g da

ily d

ose

30 D

ay S

uppl

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18 mg daily dose

Take one “Daily Dose” of 18 mg each day

®

®

®

®

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

Take one 10 mg capsule and two4 mg capsules together once daily

INSIDE TOP FLAP PRINTING

UNVARNISHED LOT/EXP AREA

123245

1 2 3 2 4 5

(b) (4)

Page 7: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

20 m

g da

ily d

ose

203964

Rx only NDC 62856-720-30NDC 62856-720-30

Rx only

20 mg daily dose

30 D

ay S

uppl

y

20 mg daily dose

20 mg daily-dose carton containing 6 cards (ten 10 mg capsules per card)

30 Day Supply

Take one “Daily Dose” of 20 mg each day

20 mg daily dose

Each daily dose consists of 2 capsules: two 10 mg capsules (total dose 20 mg). Each capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: two 10 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

®

®

®

®

Take two 10 mg capsules once daily

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

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(b) (4)

Page 8: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

203962

Rx only NDC 62856-724-30NDC 62856-724-30

Rx only

24 mg daily dose

24 mg daily-dose carton containing 6 cards (ten 10 mg capsules and five 4 mg capsules per card)

30 Day Supply

24 m

g da

ily d

ose

30 D

ay S

uppl

y

24 mg daily dose

Take one “Daily Dose” of 24 mg each day

24 mg daily dose

Each daily dose consists of 3 capsules: two 10 mg capsules and one 4 mg capsule (total dose 24 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: two 10 mg capsules and one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

®

®

®

®

Take two 10 mg capsules and one4 mg capsule together once daily

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

123251

1 2 3 2 5 1

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UNVARNISHED LOT/EXP AREA

(b) (4)

Page 9: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

DailyDose

DailyDose

DailyDose

DailyDose

DailyDose

Each 5 Day Card containsten 4 mg capsules

NDC 62856-708-05

Rx onlyNDC 62856-708-05

Rx only

8 mg daily dose

LENV

IMA

(le

nvat

inib

) cap

sule

s

NDC

628

56-7

08-0

2039

77

8 mg daily doseTake both capsules at the same time daily

Take both capsules at the same time daily

Take both capsules at the same time daily

Take both capsules at the same time daily

Take both capsules at the same time daily

Each daily dose consists of 2 capsules: two 4 mg capsules (total dose 8 mg). Each capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: two 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

Record StartDate

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

4 mg4 mg

4 mg4 mg

®

®

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

Take two 4 mg capsules once daily

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Page 10: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

DailyDose

DailyDose

DailyDose

DailyDose

DailyDose

Record StartDate

___________

Each 5 Day Card containsfive 4 mg capsules

NDC 62856-704-05

Rx onlyNDC 62856-704-05

Rx only

LENV

IMA

(le

nvat

inib

) cap

sule

s

NDC

628

56-7

04-0

4 mg daily dose

2039

75

Take one capsule at the same time daily

Take one capsule at the same time daily

Take one capsule at the same time daily

Take one capsule at the same time daily

Take one capsule at the same time daily

4 mg daily dose

Each daily dose consists of 1 capsule: one 4 mg capsule (total dose 4 mg). Each capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinibmesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

4 mg4 mg

Take one 4 mg capsule once daily

®®

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

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Page 11: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

DailyDose

DailyDose

DailyDose

DailyDose

DailyDose

Record StartDate

___________

Each 5 Day Card containsfive 10 mg capsules

NDC 62856-710-05

Rx onlyNDC 62856-710-05

Rx only

LENV

IMA

(le

nvat

inib

) cap

sule

s

NDC

628

56-7

10-0

10 mg daily dose

2039

73

Take one capsule at the same time daily

Take one capsule at the same time daily

Take one capsule at the same time daily

Take one capsule at the same time daily

Take one capsule at the same time daily

10 mg daily dose

10 mg10 mg

Each daily dose consists of 1 capsule: one 10 mg capsule (total dose 10 mg). Each capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinibmesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: one 10 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.Take one 10 mg capsule once daily

®®

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

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Page 12: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

4 mg4 mg

4 mg4 mg

4 mg4 mgNDC 62856-712-05

Rx onlyNDC 62856-712-05

Rx only

DailyDose

DailyDose

DailyDose

DailyDose

DailyDose

12 mg daily dose

LENV

IMA

(le

nvat

inib

) cap

sule

s

NDC

628

56-7

12-0

2039

69

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Record StartDate

Each 5 Day Card containsfifteen 4 mg capsules

®12 mg daily dose

Each daily dose consists of 3 capsules: three 4 mg capsules (total dose 12 mg). Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: three 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

®

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

Take three 4 mg capsules once daily

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Page 13: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

DailyDose

DailyDose

DailyDose

DailyDose

DailyDose

Each 5 Day Card containsfive 10 mg capsules

and five 4 mg capsules

NDC 62856-714-05

Rx onlyNDC 62856-714-05

Rx only

14 mg daily dose

LENV

IMA

(le

nvat

inib

) cap

sule

s

NDC

628

56-7

14-0

2039

71

14 mg daily doseTake both capsules at the same time daily

Take both capsules at the same time daily

Take both capsules at the same time daily

Take both capsules at the same time daily

Take both capsules at the same time daily

Each daily dose consists of 2 capsules: one 10 mg capsule and one 4 mg capsule (total dose 14 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: one 10 mg capsule and one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

Record StartDate

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

4 mg10 mg10 mg 4 mg

®

®

Take one 10 mg capsule and one4 mg capsule together once daily

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

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(b) (4)

Page 14: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

NDC 62856-718-05

Rx onlyNDC 62856-718-05

Rx only

DailyDose

DailyDose

DailyDose

DailyDose

DailyDose

18 mg daily dose

LENV

IMA

(le

nvat

inib

) cap

sule

s

NDC

628

56-7

18-0

2039

67

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Record StartDate

_

Each 5 Day Card containsfive 10 mg capsules

and ten 4 mg capsules

4 mg10 mg10 mg 4 mg

4 mg4 mg

®

Each daily dose consists of 3 capsules: one 10 mg capsule and two 4 mg capsules (total dose 18 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinibequivalent to 4.90 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15 - 30°C (59 - 86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: one 10 mg capsule and two 4 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

18 mg daily dose

®

Take one 10 mg capsule and two4 mg capsules together once daily

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

1232

44

(b) (4)

Page 15: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

DailyDose

DailyDose

DailyDose

DailyDose

DailyDose

20 mg daily dose

Record StartDate

___________

Each 5 Day Card containsten 10 mg capsules

NDC 62856-720-05

Rx onlyNDC 62856-720-05

Rx only

LENV

IMA

(le

nvat

inib

) cap

sule

s

NDC

628

56-7

20-0

2039

63

20 mg daily dose

Take both capsules at the same time daily

Take both capsules at the same time daily

Take both capsules at the same time daily

Take both capsules at the same time daily

Take both capsules at the same time daily

Each daily dose consists of 2 capsules: two 10 mg capsules (total dose 20 mg). Each capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: two 10 mg capsules at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

10 mg10 mg

10 mg10 mg

®

®

Take two 10 mg capsules once daily

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

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(b) (4)

Page 16: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

NDC 62856-724-05

Rx onlyNDC 62856-724-05

Rx only

DailyDose

DailyDose

DailyDose

DailyDose

DailyDose

24 mg daily dose

LENV

IMA

(le

nvat

inib

) cap

sule

s

NDC

628

56-7

24-0

2039

65

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Take all three capsules at the same time daily

Record StartDate

Each 5 Day Card containsten 10 mg capsules

and five 4 mg capsules

4 mg10 mg 10 mg10 mg10 mg 4 mg

®24 mg daily dose

Each daily dose consists of 3 capsules: two 10 mg capsules and one 4 mg capsule (total dose 24 mg). Each 10 mg capsule contains 10 mg of lenvatinib equivalent to 12.25 mg of lenvatinib mesylate. Each 4 mg capsule contains 4 mg of lenvatinib equivalent to 4.90 mg of lenvatinib mesylate.

See package insert for dosage information.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Dosing Instructions:Take one daily dose: two 10 mg capsules and one 4 mg capsule at the same time once daily, with or without food. Continue to take every day until instructed otherwise by your doctor.

P

PUSH

PUSH

Push through blackhalf circle.

1. Turn card over andpeel tab to exposefoil.

2. Turn card over and pushon END of plastic blisterto dispense.

3.

®

Take two 10 mg capsules and one4 mg capsule together once daily

Distributed by:Eisai Inc., Woodcliff Lake, NJ 07677Made in Japan

1232

50

(b) (4)

Page 17: 4 mg daily dose - Food and Drug Administration · Eisai Inc., Woodcliff Lake, NJ 07677 Made in Japan 123247 123247 INSIDE TOP FLAP PRINTING UNVARNISHED LOT/EXP AREA (b) (4) 8 mg daily

Ramesh Digitally signed by Ramesh Raghavachari Date: 4/23/2020 02:05:02PMRaghavachari GUID: 502d0913000029f375128b0de8c50020