NDC Code(s) : 55513-840-01, 55513-840-02, 55513-841-01, 55513-841-02, 55513-841-00, 55513-843-01, 55513-843-00, 55513-842-01
Packager : Amgen Inc

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AIMOVIGerenumab-aooe INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-840
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERENUMAB(UNII: I5I8VB78VT)
(ERENUMAB - UNII:I5I8VB78VT) 		ERENUMAB70 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETATE ION(UNII: 569DQM74SC)1.5 mg in 1 mL
SUCROSE(UNII: C151H8M554)73 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55513-840-011 in 1 CARTON 22/05/2018
11 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:55513-840-022 in 1 CARTON 22/05/2018
21 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761077 05/22/2018
AIMOVIGerenumab-aooe INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-841
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERENUMAB(UNII: I5I8VB78VT)
(ERENUMAB - UNII:I5I8VB78VT) 		ERENUMAB70 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETATE ION(UNII: 569DQM74SC)1.5 mg in 1 mL
SUCROSE(UNII: C151H8M554)73 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55513-841-011 in 1 CARTON 22/05/2018
11 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:55513-841-022 in 1 CARTON 22/05/2018
21 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
3NDC:55513-841-002 in 1 CARTON 22/05/2018
31 mL in 1 SYRINGE, GLASS Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761077 05/22/2018
AIMOVIGerenumab-aooe INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-843
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERENUMAB(UNII: I5I8VB78VT)
(ERENUMAB - UNII:I5I8VB78VT) 		ERENUMAB140 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETATE ION(UNII: 569DQM74SC)2 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
SUCROSE(UNII: C151H8M554)65 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55513-843-011 in 1 CARTON 15/03/2019
11 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
2NDC:55513-843-001 in 1 CARTON 15/03/2019
21 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761077 03/15/2019
AIMOVIGerenumab-aooe INJECTION, SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-842
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ERENUMAB(UNII: I5I8VB78VT)
(ERENUMAB - UNII:I5I8VB78VT) 		ERENUMAB140 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACETATE ION(UNII: 569DQM74SC)2 mg in 1 mL
POLYSORBATE 80(UNII: 6OZP39ZG8H)0.1 mg in 1 mL
SUCROSE(UNII: C151H8M554)65 mg in 1 mL
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:55513-842-011 in 1 CARTON 15/03/2019
11 mL in 1 SYRINGE Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA761077 03/15/2019

LABELER - Amgen Inc(039976196)

PRINCIPAL DISPLAY PANEL

AMGEN®

1 x 70 mg/mL Prefilled Syringe
NDC 55513-840-01
Rx Only

aimovig®
(erenumab-aooe)
Injection

70
mg/mL

70 mg/mL

Single-dose Prefilled Syringe

For Subcutaneous Use Only

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original
carton to protect from light. Do Not Freeze. Do Not Shake.

Before injecting, allow AIMOVIG to sit
at room temperature for at least 30 minutes
with cap on, protected from direct sunlight.

Keep out of the sight and reach of children.

For more information, go to Aimovig.com or
call 1-800-77-AMGEN (1-800-772-6436).

CAUTION, Prior to use,
read the enclosed
Instructions for Use for
administration information
and see package insert for
full Prescribing
Information

Do Not Reuse

Not made with
natural rubber latex

PRINCIPAL DISPLAY PANEL - 70 mg/mL Syringe Carton

PRINCIPAL DISPLAY PANEL

1 x 70 mg/mL Prefilled Autoinjector
NDC 55513-841-01

aimovig®
(erenumab-aooe)
Injection

70
mg/mL

Aimovig.com/demo

70 mg/mL

Prefilled Autoinjector

For Subcutaneous Use Only

Store carton in refrigerator at 36°F to 46°F (2°C to 8°C).

Do Not Freeze or Shake.

Store in Carton to Protect from Light. Discard Any
Unused Portion.

Keep out of the sight and reach of children.

Not made with natural rubber latex

No U.S. standard of potency

CAUTION, Consult
Accompanying Documents

Do not re-use

Refrigerate
until ready
to use

Rx Only

AMGEN

PRINCIPAL DISPLAY PANEL - 70 mg/mL Autoinjector Carton

PRINCIPAL DISPLAY PANEL

1 x 70 mg/mL Prefilled Autoinjector
NDC 55513-841-00

aimovig®
(erenumab-aooe)
Injection

70
mg/mL

Aimovig.com/demo

70 mg/mL

Not for Sale

Prefilled Autoinjector

For Subcutaneous Use Only

Store carton in refrigerator at 36°F to 46°F (2°C to 8°C).

Do Not Freeze or Shake.

Store in Carton to Protect from Light. Discard Any
Unused Portion.

Keep out of the sight and reach of children.

Not made with natural rubber latex

No U.S. standard of potency

CAUTION, Consult
Accompanying Documents

Do not re-use

Refrigerate
until ready
to use

Rx Only

AMGEN

PRINCIPAL DISPLAY PANEL - 70 mg/mL Autoinjector Carton - Not for Sale

PRINCIPAL DISPLAY PANEL

1 x 140 mg/mL Prefilled Autoinjector
NDC 55513-843-01

aimovig®
(erenumab-aooe)
Injection

140
mg/mL

Aimovig.com/demo

140 mg/mL

Prefilled Autoinjector

For Subcutaneous Use Only

Store carton in refrigerator at 36°F to 46°F (2°C to 8°C).

Do Not Freeze or Shake.

Store in Carton to Protect from Light. Discard Any
Unused Portion.

Keep out of the sight and reach of children.

Not made with natural rubber latex

No U.S. standard of potency

CAUTION, Consult
Accompanying Documents

Do not re-use

Refrigerate
until ready
to use

Rx Only

AMGEN

PRINCIPAL DISPLAY PANEL - 140 mg/mL Autoinjector Carton

PRINCIPAL DISPLAY PANEL

1 x 140 mg/mL Prefilled Autoinjector
NDC 55513-843-00

aimovig®
(erenumab-aooe)
Injection

140
mg/mL

Aimovig.com/demo

140 mg/mL

Prefilled Autoinjector

Not for Sale

For Subcutaneous Use Only

Store carton in refrigerator at 36°F to 46°F (2°C to 8°C).

Do Not Freeze or Shake.

Store in Carton to Protect from Light. Discard Any
Unused Portion.

Keep out of the sight and reach of children.

Not made with natural rubber latex

No U.S. standard of potency

CAUTION, Consult
Accompanying Documents

Do not re-use

Refrigerate
until ready
to use

Rx Only

AMGEN

PRINCIPAL DISPLAY PANEL - 140 mg/mL Autoinjector Carton - Not for Sale

PRINCIPAL DISPLAY PANEL

AMGEN®

1 x 140 mg/mL Prefilled Syringe
NDC 55513-842-01
Rx Only

aimovig®
(erenumab-aooe)
Injection

140
mg/mL = 1
dose

140 mg/mL

Single-dose Prefilled Syringe

For Subcutaneous Use Only

Store refrigerated at 2°C to 8°C (36°F to 46°F) in original
carton to protect from light. Do Not Freeze. Do Not Shake.

Before injecting, allow AIMOVIG to sit at
room temperature for at least 30 minutes
with cap on, protected from direct sunlight.

Keep out of the sight and reach of children.

For more information, go to Aimovig.com or
call 1-800-77-AMGEN (1-800-772-6436).

CAUTION, Prior to use,
read the enclosed
Instructions for Use for
administration information
and see package insert for
full Prescribing Information

Do Not Reuse

Not made with
natural rubber latex

PRINCIPAL DISPLAY PANEL - 140 mg/mL Syringe Carton