TAKHZYRO (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 2 mL Syringe Carton

NDC 47783-646-01

PREFILLED
SYRINGE

TAKHZYRO®
(lanadelumab-flyo)
injection

300 mg/2 mL (150 mg/mL)

1 single-dose prefilled syringe.
For Subcutaneous use only.

Must be refrigerated, store at 36°F to 46°F (2°C to 8°C)
in the original carton to protect from light. Do not freeze.
Do not shake. Keep out of reach of children.

2 mL
Single-dose syringe Rx Only

PRINCIPAL DISPLAY PANEL -- 2 mL Syringe Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 2 mL Vial Carton

Rx Only
NDC 47783-644-01

TAKHZYRO®
(lanadelumab-flyo)
injection

300 mg/2 mL (150 mg/mL)

Single-dose Vial, for Subcutaneous use only.

2 mL1 single-dose vial.

Takeda

PRINCIPAL DISPLAY PANEL -- 2 mL Vial Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg/mL Syringe Label

NDC 47783-645-01

TAKHZYRO®
(lanadelumab-flyo)
injection

150 mg/mL

For Subcutaneous use only.
Single-dose prefilled syringe
Store refrigerated at 36°F to 46°F (2°C to 8°C).
Takeda Pharmaceuticals U.S.A., Inc. | U.S. License No. 1898

LOT EXP

Rx Only

0757712

PRINCIPAL DISPLAY PANEL -- 150 mg/mL Syringe Label
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 150 mg/mL Syringe Carton

NDC 47783-645-01

PREFILLED
SYRINGE

TAKHZYRO®
(lanadelumab-flyo)
injection

150 mg/mL

Attention: For pediatric use (2 to less than 12 years)

For Subcutaneous use only.
1 single-dose prefilled syringe.

Must be refrigerated, store at 36°F to 46°F (2°C to 8°C)
in the original carton to protect from light. Do not freeze.
Do not shake. Keep out of reach of children.

1 mL
Single-dose syringeRx Only

PRINCIPAL DISPLAY PANEL -- 150 mg/mL Syringe Carton
(click image for full-size original)
TAKHZYRO lanadelumab-flyo solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47783-646
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lanadelumab (lanadelumab) lanadelumab 300 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 10.6 mg in 2 mL
CITRIC ACID MONOHYDRATE 8.2 mg in 2 mL
HISTIDINE 15.6 mg in 2 mL
SODIUM CHLORIDE 10.6 mg in 2 mL
POLYSORBATE 80 0.2 mg in 2 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47783-646-01 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS
1 2 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (47783-646-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761090 02/08/2022
TAKHZYRO lanadelumab-flyo injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47783-644
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lanadelumab (lanadelumab) lanadelumab 300 mg in 2 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE
CITRIC ACID MONOHYDRATE
HISTIDINE
SODIUM CHLORIDE
POLYSORBATE 80
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47783-644-01 1 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS
1 5 mL in 1 VIAL, GLASS This package is contained within the CARTON (47783-644-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761090 08/24/2018
TAKHZYRO lanadelumab-flyo solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:47783-645
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
lanadelumab (lanadelumab) lanadelumab 150 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE 5.3 mg in 1 mL
CITRIC ACID MONOHYDRATE 4.1 mg in 1 mL
HISTIDINE 7.8 mg in 1 mL
SODIUM CHLORIDE 5.3 mg in 1 mL
POLYSORBATE 80 0.1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:47783-645-01 1 SYRINGE, GLASS in 1 CARTON contains a SYRINGE, GLASS
1 1 mL in 1 SYRINGE, GLASS This package is contained within the CARTON (47783-645-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761090 02/03/2023
Labeler — Takeda Pharmaceuticals America, Inc. (039997266)
Establishment
Name Address ID/FEI Operations
Rentschler Biopharma SE 313166479 API MANUFACTURE (47783-646), API MANUFACTURE (47783-644), API MANUFACTURE (47783-645), ANALYSIS (47783-646), ANALYSIS (47783-644), ANALYSIS (47783-645)
Establishment
Name Address ID/FEI Operations
Vetter Pharma-Fertigung GmbH & Co. KG 316126754 MANUFACTURE (47783-646), MANUFACTURE (47783-645), ANALYSIS (47783-646), ANALYSIS (47783-645)
Establishment
Name Address ID/FEI Operations
Catalent Indiana LLC 172209277 MANUFACTURE (47783-644), ANALYSIS (47783-644)

Revised: 02/2023 Takeda Pharmaceuticals America, Inc.

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