Adalimumab (Humira)

Trade Name : Humira

AbbVie Inc.

KIT

Strength

Delivery Process

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Adalimumab (Humira) which is also known as Humira and Manufactured by AbbVie Inc.. It is available in strength of per ml. Read more

Adalimumab (Humira) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

No data

SERIOUS INFECTIONS
Patients treated with HUMIRA are at increased risk for developing serious infections that may lead to hospitalization or death . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.
Discontinue HUMIRA if a patient develops a serious infection or sepsis.
Reported infections include:
Carefully consider the risks and benefits of treatment with HUMIRA prior to initiating therapy in patients with chronic or recurrent infection.
Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HUMIRA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy .
MALIGNANCY
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including HUMIRA . Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including HUMIRA. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine or 6-mercaptopurine (6u2013MP) concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants .
WARNING: SERIOUS INFECTIONS AND MALIGNANCY
See full prescribing information for complete boxed warning.
SERIOUS INFECTIONS n ):
MALIGNANCY :

HUMIRA is a tumor necrosis factor (TNF) blocker indicated for treatment of:

Rheumatoid Arthritis (RA) :
Juvenile Idiopathic Arthritis (JIA) :
Psoriatic Arthritis (PsA) :
Ankylosing Spondylitis (AS) :
Adult Crohnu2019s Disease (CD) :
Pediatric Crohnu2019s Disease :
Ulcerative Colitis (UC) :
Plaque Psoriasis (Ps) :
Hidradenitis Suppurativa (HS) :
Uveitis (UV) :

HUMIRA is administered by subcutaneous injection.
Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis :
Juvenile Idiopathic Arthritis or Pediatric Uveitis :
Adult Crohn's Disease and Ulcerative Colitis , :
Pediatric Crohnu2019s Disease :
Plaque Psoriasis or Adult Uveitis :
Hidradenitis Suppurativa :

HUMIRA is a clear and colorless solution available as:

Injection: 80 mg/0.8 mL in a single-dose prefilled pen (HUMIRA Pen) n
Injection: 80 mg/0.8 mL in a single-dose prefilled glass syringe n
Injection: 40 mg/0.8 mL in a single-dose prefilled pen (HUMIRA Pen) n
Injection: 40 mg/0.4 mL in a single-dose prefilled pen (HUMIRA Pen) n
Injection: 40 mg/0.8 mL in a single-dose prefilled glass syringe n
Injection: 40 mg/0.4 mL in a single-dose prefilled glass syringe n
Injection: 20 mg/0.4 mL in a single-dose prefilled glass syringe n
Injection: 20 mg/0.2 mL in a single-dose prefilled glass syringe n
Injection: 10 mg/0.2 mL in a single-dose prefilled glass syringe n
Injection: 10 mg/0.1 mL in a single-dose prefilled glass syringe n
Injection: 40 mg/0.8 mL in a single-dose glass vial for institutional use only n

None.
None n n

No data

Serious infections:
Invasive fungal infections:
Malignancies:
Anaphylaxis or serious allergic reactions
Hepatitis B virus reactivation:
Demyelinating disease:
Cytopenias, pancytopenia:
Heart failure:
Lupus-like syndrome:

The most serious adverse reactions described elsewhere in the labeling include the following:
Most common adverse reactions (incidence >10%): infections (e.g. upper respiratory, sinusitis), injection site reactions, headache and rash n n n
To report SUSPECTED ADVERSE REACTIONS, contact AbbVie Inc. at 1-800-633-9110 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

No data

Abatacept:
Anakinra:
Live vaccines:

No data

Doses up to 10 mg/kg have been administered to patients in clinical trials without evidence of dose-limiting toxicities. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment instituted immediately.

Adalimumab is a tumor necrosis factor blocker. Adalimumab is a recombinant human IgG1 monoclonal antibody created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons.
HUMIRA (adalimumab) injection is supplied as a sterile, preservative-free solution for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (HUMIRA Pen), as a single-dose, 1 mL prefilled glass syringe, or as a single-dose institutional use vial. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of HUMIRA is clear and colorless, with a pH of about 5.2.
Each 80 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (80 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (80 mg), mannitol (33.6 mg), polysorbate 80 (0.8 mg), and Water for Injection, USP.
Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (40 mg), mannitol (16.8 mg), polysorbate 80 (0.4 mg), and Water for Injection, USP.
Each 40 mg/0.8 mL prefilled syringe, prefilled pen, or single-dose institutional use vial delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of HUMIRA contains adalimumab (40 mg), citric acid monohydrate (1.04 mg), dibasic sodium phosphate dihydrate (1.22 mg), mannitol (9.6 mg), monobasic sodium phosphate dihydrate (0.69 mg), polysorbate 80 (0.8 mg), sodium chloride (4.93 mg), sodium citrate (0.24 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.
Each 20 mg/0.2 mL prefilled syringe delivers 0.2 mL (20 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (20 mg), mannitol (8.4 mg), polysorbate 80 (0.2 mg), and Water for Injection, USP.
Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of HUMIRA contains adalimumab (20 mg), citric acid monohydrate (0.52 mg), dibasic sodium phosphate dihydrate (0.61 mg), mannitol (4.8 mg), monobasic sodium phosphate dihydrate (0.34 mg), polysorbate 80 (0.4 mg), sodium chloride (2.47 mg), sodium citrate (0.12 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.
Each 10 mg/0.1 mL prefilled syringe delivers 0.1 mL (10 mg) of drug product. Each 0.1 mL of HUMIRA contains adalimumab (10 mg), mannitol (4.2 mg), polysorbate 80 (0.1 mg), and Water for Injection, USP.
Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of HUMIRA contains adalimumab (10 mg), citric acid monohydrate (0.26 mg), dibasic sodium phosphate dihydrate (0.31 mg), mannitol (2.4 mg), monobasic sodium phosphate dihydrate (0.17 mg), polysorbate 80 (0.2 mg), sodium chloride (1.23 mg), sodium citrate (0.06 mg) and Water for Injection, USP. Sodium hydroxide is added as necessary to adjust pH.

No data

Long-term animal studies of HUMIRA have not been conducted to evaluate the carcinogenic potential or its effect on fertility.

No data

No data

HUMIRA (adalimumab) is supplied as a preservative-free, sterile, clear and colorless solution for subcutaneous administration. The following packaging configurations are available.
Storage and Stability
Do not use beyond the expiration date on the container. HUMIRA must be refrigerated at 36u00b0F to 46u00b0F (2u00b0C to 8u00b0C). DO NOT FREEZE. Do not use if frozen even if it has been thawed.
Store in original carton until time of administration to protect from light.
If needed, for example when traveling, HUMIRA may be stored at room temperature up to a maximum of 77u00b0F (25u00b0C) for a period of up to 14 days, with protection from light. HUMIRA should be discarded if not used within the 14-day period. Record the date when HUMIRA is first removed from the refrigerator in the spaces provided on the carton and dose tray.
Do not store HUMIRA in extreme heat or cold.

See FDA-approved patient labeling (Medication Guide and Instructions for Use).
Patient Counseling
Provide the HUMIRA u201cMedication Guideu201d to patients or their caregivers, and provide them an opportunity to read it and ask questions prior to initiation of therapy and prior to each time the prescription is renewed. If patients develop signs and symptoms of infection, instruct them to seek medical evaluation immediately.
Advise patients of the potential benefits and risks of HUMIRA.
Instructions on Injection Technique
Inform patients that the first injection is to be performed under the supervision of a qualified health care professional. If a patient or caregiver is to administer HUMIRA, instruct them in injection techniques and assess their ability to inject subcutaneously to ensure the proper administration of HUMIRA n
For patients who will use the HUMIRA Pen, tell them that they:
Instruct patients to dispose of their used needles and syringes or used Pen in a FDA-cleared sharps disposal container immediately after use. Instruct patients that if they do not have a FDA-cleared sharps disposal container, they may use a household container that is made of a heavy-duty plastic, can be closed with a tight-fitting and puncture-resistant lid without sharps being able to come out, upright and stable during use, leak-resistant, and properly labeled to warn of hazardous waste inside the container.
Instruct patients that when their sharps disposal container is almost full, they will need to follow their community guidelines for the correct way to dispose of their sharps disposal container. Instruct patients that there may be state or local laws regarding disposal of used needles and syringes. Refer patients to the FDAu2019s website at http://www.fda.gov/safesharpsdisposal for more information about safe sharps disposal, and for specific information about sharps disposal in the state that they live in.
Instruct patients not to dispose of their used sharps disposal container in their household trash unless their community guidelines permit this. Instruct patients not to recycle their used sharps disposal container.
AbbVie Inc.
North Chicago, IL 60064, U.S.A.
US License Number 1889
03-C434/20063590 03/2020

No data

INSTRUCTIONS FOR USE
HUMIRA (Hu-MARE-ah)
(adalimumab)
40 MG/0.8 ML
SINGLE-DOSE PEN
Do not
IMPORTANT:
See the section below called .
Gather the Supplies for Your Injection
If more comfortable, take your HUMIRA Pen out of the refrigerator before injecting to allow the liquid to reach room temperature. remove the gray cap (Cap #1) or the plum-colored cap (Cap #2) while allowing it to reach room temperature. warm HUMIRA in any other way (for example, warm it in a microwave or in hot water).
If you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist. The figure below shows what the HUMIRA Pen looks like. See Figure A.
Figure A
Check the carton, dose tray, and HUMIRA Pen
1. Make sure the name HUMIRA appears on the carton, dose tray, and HUMIRA Pen label.
2. and your doctor or pharmacist if:
See the section at the end of this Instructions for Use.
3. Hold the Pen with the gray cap (Cap # 1) pointed down.
4. Make sure the amount of liquid in the Pen is at the fill line or close to the fill line seen through the window. This is the full dose of HUMIRA that you will inject. See Figure B.
5. If the Pen does not have the full amount of liquid, . Call your pharmacist.
Figure B
6. Turn the Pen over and hold the Pen with the gray cap (Cap # 1) pointed up. See Figure C.
7. Check the solution through the windows on the side of the Pen to make sure the liquid is clear and colorless. your HUMIRA Pen if the liquid is cloudy, discolored, or if it has flakes or particles in it. Call your pharmacist. It is normal to see one or more bubbles in the window.
Figure C
Choose the Injection Site
8. Wash and dry your hands well.
9. Choose an injection site on:
Prepare the Injection Site
10. Wipe the injection site with an alcohol prep (swab) using a circular motion.
Preparing the HUMIRA Pen
11. n
12. Hold the middle of the Pen (gray body) with one hand so that you are not touching the gray cap (Cap # 1) or the plum-colored cap (Cap # 2). Turn the Pen so that the gray cap (Cap # 1) is pointing up. See Figure E.
Figure E
13. With your other hand, pull the gray cap (Cap # 1) straight off (do not twist the cap). Make sure the small needle cover of the syringe has come off with the gray cap (Cap # 1). See Figure F.
14. Throw away the gray cap (Cap # 1).
Figure F
15. Remove the plum-colored cap (Cap # 2) from the bottom of the Pen by pulling it straight off (do not twist the cap). The Pen is now activated. Throw away the plum-colored cap (Cap # 2).
The plum-colored activator button:
Figure G
Figure H
Position the Pen and Inject HUMIRA
16. Position the Pen:
Figure I
17. Place the white end of the Pen straight () and flat against the raised area of your skin that you are squeezing. Place the Pen so that it will not inject the needle into your fingers that are holding the raised skin. See Figure J.
Figure J
18. Inject HUMIRA
Figure L
19. When the injection is finished, slowly pull the Pen from your skin. The white needle sleeve will move to cover the needle tip. See Figure M.
20. Throw away (dispose of) your used HUMIRA Pen in a sharps disposal container right away after use. See the sectionn
21. Keep a record of the dates and location of your injection sites. To help you remember when to take HUMIRA, you can mark your calendar ahead of time.
How should I dispose of the used HUMIRA Pen?
How should I store HUMIRA?
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
AbbVie Inc.
North Chicago, IL 60064, U.S.A.
US License Number 1889
03-C413/20063421
Revised: 03/2020

No data

No data

INSTRUCTIONS FOR USE
HUMIRA (Hu-MARE-ah)
(adalimumab)
40 MG/0.8 ML, 20 MG/0.4 ML AND 10 MG/0.2 ML
SINGLE-DOSE PREFILLED SYRINGE
Do not
Gather the Supplies for Your Injection
If more comfortable, take your HUMIRA prefilled syringe out of the refrigerator before injecting to allow the liquid to reach room temperature. remove the needle cover while allowing it to reach room temperature. warm HUMIRA in any other way (for example, warm it in a microwave or in hot water).
If you do not have all the supplies you need to give yourself an injection, go to a pharmacy or call your pharmacist.
The figure below shows what a prefilled syringe looks like. See Figure A.
Figure A
Check the carton, dose tray, and prefilled syringe
1. Make sure the name HUMIRA appears on the dose tray and prefilled syringe label.
2. and your doctor or pharmacist if:
See the section at the end of this Instructions for Use.
Choose the Injection Site
3. Wash and dry your hands well.
4. Choose an injection site on:
Prepare the Injection Site
5. Wipe the injection site with an alcohol prep (swab) using a circular motion.
6. Do touch this area again before giving the injection. Allow the skin to dry before injecting. Do not fan or blow on the clean area.
Prepare the Syringe and Needle
7. Check the fluid level in the syringe:
Figure D
8. The top of the liquid may be curved. If the syringe does not have the correct amount of liquid, . Call your pharmacist.
9. Remove the needle cover:
10. Turn the syringe so the needle is facing up and hold the syringe at eye level with one hand so you can see the air in the syringe. Using your other hand, slowly push the plunger in to push the air out through the needle. See Figure F.
Figure F
Position the Prefilled Syringe and Inject HUMIRA
Position the Syringe
11. Hold the body of the prefilled syringe in one hand between the thumb and index finger. Hold the syringe in your hand like a pencil. See Figure G.
Figure G
Figure H
Inject HUMIRA
12. Using a quick, dart-like motion, insert the needle into the squeezed skin at about a . See Figure I.
Figure I
If blood appears in the syringe:
If no blood appears in the syringe:
13. Throw away the used prefilled syringe and needle in a sharps disposal container right away after use. See n
14. Keep a record of the dates and location of your injection sites. To help you remember when to take HUMIRA, you can mark your calendar ahead of time.
How should I dispose of used prefilled syringes and needles?
How should I store HUMIRA?
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured by:
AbbVie Inc.
North Chicago, IL 60064, U.S.A.
US License Number 1889
03-C441/20063653
Revised: 03/2020

No data

NDC 0074-0124-03
STARTER PACK FOR
CROHNu2019S DISEASE,
ULCERATIVE COLITIS,
HIDRADENITIS SUPPURATIVA
3 SINGLE-DOSE PREFILLED PENS
HUMIRAn
adalimumab
80 mg/0.8 mL
FOR SUBCUTANEOUS USE ONLY
80mg/0.8 ml
29 GAUGE NEEDLE
EACH STERILE SINGLE-DOSE PREFILLED PEN CONTAINS:
Adalimumab..............80 mg
Mannitol.................33.6 mg
Polysorbate 80.........0.8 mg
Water for injection, USP
Sodium hydroxide added as necessary to adjust pH.
Contains no preservatives.
No U.S. standard of potency.
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle Cover for syringe is not made with natural rubber latex.
Carton contains:
The entire carton is to be dispensed as a unit.
Do not accept if seal is broken or missing.
Return to pharmacy if dose tray seal is broken or missing.
HUMIRA.COM
Rx only
abbvie
NDC 0074-0124-73
NOT FOR SALE
STARTER PACK FOR
CROHNu2019S DESEASE,
ULCERATIVE COLITIS,
HIDRADENITIS SUPPURATIVA
3 SINGLE-DOSE PREFILLED PENS
HUMIRAn
adalimumab
80 mg/0.8 mL
FOR SUBCUTANEOUS USE ONLY
80 mg/0.8 ml
29 GAUGE NEEDLE
EACH STERILE SINGLE-DOSE PREFILLED PEN CONTAINS:
Adalimumab..............80 mg
Mannitol.................33.6 mg
Polysorbate 80.........0.8 mg
Water for injection, USP
Sodium hydroxide added as necessary to adjust pH.
Contains no preservatives.
No U.S. standard of potency.
ATTENTION PHYSICIAN: Each patient is required to receive the enclosed Medication Guide.
Needle Cover for syringe is not made with natural rubber latex.
Carton contains:
The entire carton is to be dispensed as a unit.
Do not accept if seal is broken or missing.
Return to physcian if dose tray seal is broken or missing.
HUMIRA.COM
Rx only
abbvie
NDC 0074-1539-03
PSORIASIS/UVEITIS
STARTER PACK
3 SINGLE-DOSE PREFILLED PENS
HUMIRAn
adalimumab
ONE 80 mg/0.8 mL
TWO 40 mg/0.4 mL
FOR SUBCUTANEOUS USE ONLY
80 mg/0.8 ml
40 mg/0.4 ml
29 GAUGE NEEDLE
EACH 80 mg/0.8 mL STERILE SINGLE-DOSE PREFILLED PEN CONTAINS:
Adalimumab..............80 mg
Mannitol.................33.6 mg
Polysorbate 80..........0.8 mg
Water for injection, USP
EACH 40 mg/0.4 mL STERILE SINGLE-DOSE PREFILLED PEN CONTAINS:
Adalimumab..............40 mg
Mannitol.................16.8 mg
Polysorbate 80..........0.4 mg
Water for injection, USP
Contains no preservatives.
No U.S. standard of potency.
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle cover for syringe is not made with natural rubber latex.
Carton Contains:
The entire carton is to be dispensed as a unit.
Do not accept if seal is broken or missing.
Store in carton until time of administration.
Return to pharmacy if dose tray seal is broken or missing.
HUMIRA.COM
Rx only
abbvie
NDC 0074-0817-02
2 SINGLE-DOSE PREFILLED SYRINGES
HUMIRAn
adalimumab
10 mg/0.1 mL
FOR SUBCUTANEOUS USE ONLY
10 mg/0.1 mL
29 GAUGE NEEDLE
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle cover for syringe is not made with natural rubber latex. The entire carton is to be dispensed as a unit.
Return to pharmacy if dose tray seal is broken or missing.
THIS CARTON CONTAINS:
HUMIRA.com
Rx only
abbvie
NDC 0074-0616-02
2 SINGLE-DOSE PREFILLED SYRINGES
HUMIRAn
adalimumab
20 mg/0.2 mL
FOR SUBCUTANEOUS USE ONLY
20 mg/0.2 mL
29 GAUGE NEEDLE
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle cover for syringe is not made with natural rubber latex. The entire carton is to be dispensed as a unit.
Return to pharmacy if dose tray seal is broken or missing.
THIS CARTON CONTAINS:
Rx only
HUMIRA.com
abbvie
NDC 0074-3799-02
2 Single-Dose Prefilled Syringes
HUMIRAn
adalimumab
40 mg/0.8 mL Syringe
FOR SUBCUTANEOUS USE ONLY
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle Cover for Syringe May Contain Dry Natural Rubber.
The entire carton is to be dispensed as a unit.
Return to pharmacy if dose tray seal is broken or missing.
This carton contains:
www.HUMIRA.com
Rx only
abbvie
NDC 0074-3799-03
Pediatric Starter Pack
FOR PEDIATRIC PATIENTS < 40 kg
HUMIRAn
adalimumab
NDC 0074-3799-71
NOT FOR SALE
2 Single-Dose Prefilled Syringes
HUMIRAn
adalimumab
40 mg/0.8 mL Syringe
FOR SUBCUTANEOUS USE ONLY
ATTENTION PHYSICIAN: Each patient is required to receive the enclosed Medication Guide.
Needle Cover for Syringe May Contain Dry Natural Rubber.
The entire carton is to be dispensed as a unit.
Return to physician if dose tray seal is broken or missing.
This carton contains:
www.HUMIRA.com
Rx only
abbvie
NDC 0074-9374-02
2 Single-Dose Prefilled Syringes
HUMIRAn
adalimumab
20 mg/0.4 mL Syringe
FOR SUBCUTANEOUS USE ONLY
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle Cover for Syringe May Contain Dry Natural Rubber.
The entire carton is to be dispensed as a unit. Return to pharmacy if dose tray seal is broken or missing.
This carton contains:
www.HUMIRA.com
Rx only
abbvie
NDC 0074-9374-71
NOT FOR SALE
2 Single-Dose Prefilled Syringes
HUMIRAn
adalimumab
20 mg/0.4 mL Syringe
FOR SUBCUTANEOUS USE ONLY
ATTENTION PHYSICIAN: Each patient is required to receive the enclosed Medication Guide.
Needle Cover for Syringe May Contain Dry Natural Rubber.
The entire carton is to be dispensed as a unit. Return to physician if dose tray seal is broken or missing.
This carton contains:
www.HUMIRA.com
Rx only
abbvie
NDC 0074-4339-02
2 SINGLE-DOSE PREFILLED PENS
HUMIRA PEN
adalimumab
40 mg/0.8 mL
FOR SUBCUTANEOUS USE ONLY
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle Cover for Syringe May Contain Dry Natural Rubber.
The entire carton is to be dispensed as a unit.
Return to pharmacy if dose tray seal is broken or missing.
This carton contains:
www.Humira.com
Rx only
abbvie
NDC 0074-4339-06
Starter Package for - Crohnu2019s Disease, - Ulcerative Colitis, or - Hidradenitis Suppurativa
HUMIRA PEN
(adalimumab)
40 mg/0.8 mL
FOR SUBCUTANEOUS USE ONLY
6 Single-Dose Prefilled Pens
Each Sterile Single-DosePrefilled Pen contains:
Adalimumab................................................. 40 mg
Sodium chloride...........................................4.93 mg
Monobasic sodium phosphate dihydrate........0.69 mg
Dibasic sodium phosphate dihydrate.............1.22 mg
Sodium citrate.............................................0.24 mg
Citric acid monohydrate...............................1.04 mg
Mannitol.......................................................9.6 mg
Polysorbate 80..............................................0.8 mg
Water for injection
Sodium hydroxide added as necessary to adjust pH.
Contains no preservatives.
No U.S. standard of potency.
Medication Guide for patient enclosed.
Needle Cover for Syringe May Contain Dry Natural Rubber.
Carton contains 6 dose trays (each containing 1 single-dose prefilled pen with 1/2 inch length fixed needle), 6 alcohol preps, 1 Package Insert, 1 Medication Guide and Instructions for Use.
The entire carton is to be dispensed as a unit.
Do not accept if seal is broken or missing.
Return to pharmacy if dose tray seal is broken or missing.
www.HUMIRA.com
Rx only
abbvie
NDC 0074-4339-07
Psoriasis/Uveitis/AdolescentHidradenitis Suppurativa Starter Package
4 Single-DosePrefilled Pens
HUMIRA PEN
adalimumab
40 mg/0.8 mL
FOR SUBCUTANEOUS USE ONLY
Each Sterile Single-DosePrefilled Pen Contains:
Adalimumab.................................................40 mg
Sodium chloride.........................................4.93 mg
Monobasic sodium phosphate dihydrate.......0.69 mg
Dibasic sodium phosphate dihydrate............1.22 mg
Sodium citrate............................................0.24 mg
Citric acid monohydrate..............................1.04 mg
Mannitol......................................................9.6 mg
Polysorbate 80.............................................0.8 mg
Water for injection.
Sodium hydroxide added as necessary to adjust pH.
Contains no preservatives.
No U.S. standard of potency.
Medication Guide for patient enclosed.
Needle Cover for Syringe May Contain Dry Natural Rubber.
Carton Conatins:
The entire carton is to be dispensed as a unit.
Do not accept if seal is broken or missing.
Return to pharmacy if dose tray seal is broken or missing.
www.HUMIRA.com
Rx only
abbvie
NDC 0074-4339-71
NOT FOR SALE
2 SINGLE-DOSE PREFILLED PENS
HUMIRA PEN
adalimumab
40 mg/0.8 mL
FOR SUBCUTANEOUS USE ONLY
ATTENTION PHYSICIAN: Each patient is required to receive the enclosed Medication Guide.
Needle Cover for Syringe May Contain Dry Natural Rubber.
The entire carton is to be dispensed as a unit.
Return to physician if dose tray seal is broken or missing.
This carton contains:
www.HUMIRA.com
Rx only
abbvie
NDC 0074-4339-73
NOT FOR SALE
Starter Package for - Crohnu2019s Disease, - Ulcerative Colitis, or - Hidradenitis Suppurativa
HUMIRA PEN
(adalimumab)
40 mg/0.8 mL
FOR SUBCUTANEOUS USE ONLY
6 Single-Dose Prefilled Pens
Each Sterile Single-DosePrefilled Pen Contains:
Adalimumab.................................................40 mg
Sodium chloride.........................................4.93 mg
Monobasic sodium phosphate dihydrate.......0.69 mg
Dibasic sodium phosphate dihydrate............1.22 mg
Sodium citrate............................................0.24 mg
Citric acid monohydrate..............................1.04 mg
Mannitol......................................................9.6 mg
Polysorbate 80.............................................0.8 mg
Water for injection.
Sodium hydroxide added as necessary to adjust pH.
Contains no preservatives.
No U.S. standard of potency.
Medication Guide for patient enclosed.
Needle Cover for Syringe May Contain Dry Natural Rubber.
Carton contains 6 dose trays (each containing1 single-dose prefilled pen with 1/2 inch lengthfixed needle), 6 alcohol preps, 1 Package Insert,1 Medication Guide and Instructions for Use.
The entire carton is to be dispensed as a unit.
Do not accept if seal is broken or missing.
Return to physician if dose tray seal is broken or missing.
www.HUMIRA.com
Rx only
abbvie
NDC 0074-3797-01
Humira Adalimumab
40 mg/0.8mL
Single-Use Vial
NDC 0074-6347-02
2 Single-Dose Prefilled Syringes
HUMIRAn
adalimumab
10 mg/0.2 mL
FOR SUBCUTANEOUS USE ONLY
Please see package insert for full prescribing information.
This carton contains:
Medication Guide for patient enclosed.
Needle Covers for Syringe May Contain Dry Natural Rubber.
Carton contains 2 dose trays, 2 alcohol preps, 1 package insert, 1 Medication Guide and Instructions for Use.
Each dose tray contains 1 single-dose prefilled syringe with 1/2 inch length fixed needle.
The entire carton is to be dispensed as a unit.
Return to pharmacy if dose tray seal is broken or missing.
www.HUMIRA.com
Rx only
abbvie
NDC 0074-0243-02
2 SINGLE-DOSE PREFILLED SYRINGES
40 mg/0.4 mL
29 GAUGE NEEDLE
HUMIRAn
adalimumab
40 mg/0.4 mL
FOR SUBCUTANEOUS USE ONLY
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle cover for syringe is not made with natural rubber latex. The entire carton is to be dispensed as a unit.
Return to pharmacy if dose tray seal is broken or missing.
THIS CARTON CONTAINS:
HUMIRA.com
Rx only
abbvie
NDC 0074-0554-01
1 SINGLE-DOSE PREFILLED PEN
29 GAUGE NEEDLE
HUMIRA
adalimumab
40 mg/0.4 mL
FOR SUBCUTANEOUS USE ONLY
ATTENTION PHARMACIST: Each patient is requiredto receive the enclosed Medication Guide.
The entire carton is to be dispensed as a unit.
Return to pharmacy if dose tray seal is broken or missing.
THIS CARTON CONTAINS:
HUMIRA.COM
Rx only
abbvie
NDC 0074-0554-02
2 SINGLE-DOSE PREFILLED PENS
HUMIRAn
adalimumab
40 mg/0.4 mL
FOR SUBCUTANEOUS USE ONLY
40 mg/0.4 mL
29 GAUGE NEEDLE
ATTENTION PHARMACIST: Each patient is requiredto receive the enclosed Medication Guide.
The entire carton is to be dispensed as a unit.
Return to pharmacy if dose tray seal is broken or missing.
THIS CARTON CONTAINS:
HUMIRA.COM
Rx only
abbvie
NDC 0074-0554-04
Psoriasis/Uveitis/Adolescent Hidradenitis Suppurativa Starter Package
4 Single-UsePrefilled Pens
HUMIRAn
adalimumab
40 mg/0.4 mL
FOR SUBCUTANEOUS USE ONLY
Each Sterile Single-UsePrefilled Pen Contains:
Adalimumab..................................................40 mg
Mannitol.......................................................16.8 mg
Polysorbate 80..............................................0.4 mg
Water for injection.
Contains no preservatives.
No U.S. standard of potency.
Medication Guide for patient enclosed.
Carton contains:
The entire carton is to be dispensed as a unit.
Do not accept if seal is broken or missing.
Return to pharmacy if dose tray sealis broken or missing.
www.HUMIRA.com
Rx only
abbvie
NDC 0074-0554-06
Starter Package for - Crohnu2019s Disease, - Ulcerative Colitis, or - Hidradenitis Suppurativa
HUMIRAn
adalimumab
40 mg/0.4 mL
FOR SUBCUTANEOUS USE ONLY
6 Single-Use Prefilled Pens
Each Sterile Single-UsePrefilled Pen Contains:
Adalimumab..................................................40 mg
Mannitol.......................................................16.8 mg
Polysorbate 80..............................................0.4 mg
Water for injection.
Contains no preservatives.
No U.S. standard of potency.
Rx only
Medication Guide for patient enclosed.
Carton contains 6 dose trays (each containing1 single-use prefilled pen with 29 gauge1/2 inch length fixed needle), 6 alcohol preps,1 package insert, 1 Medication Guide, andInstructions for Use.
The entire carton is to be dispensed as a unit.
Do not accept if seal is broken or missing.
Return to pharmacy if dose tray seal is broken or missing.
www.HUMIRA.com
abbvie
NDC 0074-0554-74
NOT FOR SALE
1 SINGLE-DOSE PREFILLED PEN
29 GAUGE NEEDLE
HUMIRAn
adalimumab
40 mg/0.4 mL
FOR SUBCUTANEOUS USE ONLY
ATTENTION PHYSICIAN: Each patient is requiredto receive the enclosed Medication Guide.
The entire carton is to be dispenses as a unit.
Return to physician if dose tray seal is broken or missing.
THIS CARTON CONTAINS:
HUMIRA.COM
Rx only
abbvie
NDC 0074-2540-01
1 SINGLE-DOSE PREFILLED SYRINGE
HUMIRAn
adalimumab
80 mg/0.8 mL
FOR SUBCUTANEOUS USE ONLY
80 mg/0.8 mL
29 GAUGE NEEDLE
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle cover for syringe is not made with natural rubber latex. The entire carton is to be dispensed as a unit.
Return to pharmacy if dose tray seal is broken or missing.
THIS CARTON CONTAINS:
HUMIRA.com
Rx only
abbvie
NDC 0074-2540-03
PEDIATRIC CROHNu2019S DISEASE
STARTER PACK
FOR PEDIATRIC PATIENTS u226540 kg
3 SINGLE-DOSE PREFILLED SYRINGES
HUMIRAn
adalimumab
80 mg/0.8 mL
FOR SUBCUTANEOUS USE ONLY
80 mg/0.8 mL
29 GAUGE NEEDLE
Each 80 mg/0.8 mL STERILE SINGLE-DOSE PREFILLED SYRINGE CONTAINS:
Adalimumab..................................................80 mg
Mannitol.......................................................33.6 mg
Polysorbate 80..............................................0.8 mg
Water for injection, USP
Contains no preservatives
No U.S. standard of potency
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle cover for syringe is not made with natural rubber latex.
Carton Contains:
The entire carton is to be dispensed as a unit.
Do not accept if seal is broken or missing.
Return to pharmacy if dose tray seal is broken or missing.
HUMIRA.com
Rx only
abbvie
NDC 0074-0067-02
PEDIATRIC CROHNu2019S DISEASE
STARTER PACK
FOR PEDIATRIC PATIENTS < 40 kg
80 mg/0.8 mL
40 mg/0.4 mL
29 GAUGE NEEDLE
2 SINGLE-DOSE PREFILLED SYRINGES
HUMIRAn
adalimumab
One 80 mg/0.8 mL
One 40 mg/0.4 mL
FOR SUBCUTANEOUS USE ONLY
EACH 80 mg/0.8 mL STERILE SINGLE-DOSE PREFILLED SYRINGE CONTAINS
Adalimumab..................................................80 mg
Mannitol.......................................................33.6 mg
Polysorbate 80..............................................0.8 mg
Water for injection, USP
EACH 40 mg/0.4 mL STERINE SINGLE-DOSE PREFILLED SYRINGE CONTAINS:
Adalimumab..................................................40 mg
Mannitol.......................................................16.8 mg
Polysorbate 80..............................................0.4 mg
Water for injection, USP
Contains no preservatives.
No U.S. standard of potency.
ATTENTION PHARMACIST: Each patient is required to receive the enclosed Medication Guide.
Needle cover for syringe is not made with natural rubber latex.
Carton Contains:
The entire carton is to be dispensed as a unit.
Do not accept if seal is broken or missing.
Return to pharmacy if dose tray seal is broken or missing.
HUMIRA.com
Rx only
abbvie

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Adalimumab (Humira)

Trade Name : Humira

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Adalimumab (Humira)

Trade Name : Humira

KIT

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

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QUICK LINKS

CONTACT US

Can’t find what
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