ABRILADA™ Highlights

(adalimumab-afzb)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ABRILADA safely and effectively. See full prescribing information for ABRILADA.

ABRILADA™ (adalimumab-afzb) injection, for subcutaneous use
Initial U.S. Approval: 2019

ABRILADA (adalimumab-afzb) is biosimilar* to HUMIRA (adalimumab).

WARNING: SERIOUS INFECTIONS and MALIGNANCY

See full prescribing information for complete boxed warning.

SERIOUS INFECTIONS (5.1, 6.1):

•
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.
•
Discontinue ABRILADA if a patient develops a serious infection or sepsis during treatment.
•
Perform test for latent TB; if positive, start treatment for TB prior to starting ABRILADA.
•
Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

MALIGNANCY (5.2):

•
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.
•
Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

RECENT MAJOR CHANGES

Indications and Usage, Hidradenitis Suppurativa (1.8)

06/2023

Indications and Usage, Uveitis (1.9)

08/2023

Dosage and Administration, Plaque Psoriasis or Adult Uveitis (2.5)

08/2023

Dosage and Administration, Hidradenitis Suppurativa (2.6)

06/2023

Warnings and Precautions, Malignancies (5.2)

08/2023

Warnings and Precautions, Neurologic Reactions (5.5)

08/2023

INDICATIONS AND USAGE

ABRILADA is a tumor necrosis factor (TNF) blocker indicated for:

•
Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
•
Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
•
Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
•
Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS.
•
Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
•
Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients.
Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
•
Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
•
Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients.
•
Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

DOSAGE AND ADMINISTRATION

•
Administer by subcutaneous injection (2)

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis (2.1):

•
Adults: 40 mg every other week.
•
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis (2.2):

Pediatric Weight
2 Years of Age and Older

Recommended Dosage

10 kg (22 lbs) to less than 15 kg (33 lbs)

10 mg every other week

15 kg (33 lbs) to less than 30 kg (66 lbs)

20 mg every other week

30 kg (66 lbs) and greater

40 mg every other week

Crohn's Disease (2.3):

•
Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29.
•
Pediatric Patients 6 Years of Age and Older:

Pediatric Weight

Recommended Dosage

Days 1 and 15

Starting on Day 29

17 kg (37 lbs) to less than 40 kg (88 lbs)

Day 1: 80 mg
Day 15: 40 mg

20 mg every other week

40 kg (88 lbs) and greater

Day 1: 160 mg (single dose or split over two consecutive days)
Day 15: 80 mg

40 mg every other week

Ulcerative Colitis (2.4):

•
Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57).

Plaque Psoriasis or Adult Uveitis (2.5):

•
Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.

Hidradenitis Suppurativa (2.6):

•
Adults:
•
Day 1: 160 mg (given in one day or split over two consecutive days).
•
Day 15: 80 mg.
•
Day 29 and subsequent doses: 40 mg every week or 80 mg every other week.

DOSAGE FORMS AND STRENGTHS

Injection:

•
Single-dose prefilled pen (ABRILADA Pen): 40 mg/0.8 mL (3)
•
Single-dose prefilled glass syringe: 40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL (3)
•
Single-dose glass vial for institutional use only: 40 mg/0.8 mL (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Serious Infections: Do not start ABRILADA during an active infection. If an infection develops, monitor carefully, and stop ABRILADA if infection becomes serious. (5.1)
•
Invasive Fungal Infections: For patients who develop a systemic illness on ABRILADA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. (5.1)
•
Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls. (5.2)
•
Anaphylaxis or Serious Hypersensitivity Reactions may occur. (5.3)
•
Hepatitis B Virus Reactivation: Monitor hepatitis B virus (HBV) carriers during and several months after therapy. If reactivation occurs, stop ABRILADA and begin anti-viral therapy. (5.4)
•
Demyelinating Disease: Exacerbation or new onset, may occur. (5.5)
•
Cytopenias, Pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping ABRILADA. (5.6)
•
Heart Failure: Worsening or new onset, may occur. (5.8)
•
Lupus-Like Syndrome: Stop ABRILADA if syndrome develops. (5.9)

ADVERSE REACTIONS

Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache, and rash. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Abatacept: Increased risk of serious infection. (5.1, 5.11, 7.2)
•
Anakinra: Increased risk of serious infection. (5.1, 5.7, 7.2)
•
Live vaccines: Avoid use with ABRILADA. (5.10, 7.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.


*
Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of ABRILADA has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

Revised: 1/2024

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Health Professional Information

Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ABRILADA safely and effectively. See full prescribing information for ABRILADA.

ABRILADA™ (adalimumab-afzb) injection, for subcutaneous use
Initial U.S. Approval: 2019

ABRILADA (adalimumab-afzb) is biosimilar* to HUMIRA (adalimumab).

WARNING: SERIOUS INFECTIONS and MALIGNANCY

See full prescribing information for complete boxed warning.

SERIOUS INFECTIONS (5.1, 6.1):

•
Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.
•
Discontinue ABRILADA if a patient develops a serious infection or sepsis during treatment.
•
Perform test for latent TB; if positive, start treatment for TB prior to starting ABRILADA.
•
Monitor all patients for active TB during treatment, even if initial latent TB test is negative.

MALIGNANCY (5.2):

•
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.
•
Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have occurred in adolescent and young adults with inflammatory bowel disease treated with TNF blockers including adalimumab products.

RECENT MAJOR CHANGES

Indications and Usage, Hidradenitis Suppurativa (1.8)

06/2023

Indications and Usage, Uveitis (1.9)

08/2023

Dosage and Administration, Plaque Psoriasis or Adult Uveitis (2.5)

08/2023

Dosage and Administration, Hidradenitis Suppurativa (2.6)

06/2023

Warnings and Precautions, Malignancies (5.2)

08/2023

Warnings and Precautions, Neurologic Reactions (5.5)

08/2023

INDICATIONS AND USAGE

ABRILADA is a tumor necrosis factor (TNF) blocker indicated for:

•
Rheumatoid Arthritis (RA) (1.1): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA.
•
Juvenile Idiopathic Arthritis (JIA) (1.2): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.
•
Psoriatic Arthritis (PsA) (1.3): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA.
•
Ankylosing Spondylitis (AS) (1.4): reducing signs and symptoms in adult patients with active AS.
•
Crohn's Disease (CD) (1.5): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older.
•
Ulcerative Colitis (UC) (1.6): treatment of moderately to severely active ulcerative colitis in adult patients.
Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers.
•
Plaque Psoriasis (Ps) (1.7): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.
•
Hidradenitis Suppurativa (HS) (1.8): treatment of moderate to severe hidradenitis suppurativa in adult patients.
•
Uveitis (UV) (1.9): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

DOSAGE AND ADMINISTRATION

•
Administer by subcutaneous injection (2)

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis (2.1):

•
Adults: 40 mg every other week.
•
Some patients with RA not receiving methotrexate may benefit from increasing the dosage to 40 mg every week or 80 mg every other week.

Juvenile Idiopathic Arthritis (2.2):

Pediatric Weight
2 Years of Age and Older

Recommended Dosage

10 kg (22 lbs) to less than 15 kg (33 lbs)

10 mg every other week

15 kg (33 lbs) to less than 30 kg (66 lbs)

20 mg every other week

30 kg (66 lbs) and greater

40 mg every other week

Crohn's Disease (2.3):

•
Adults: 160 mg on Day 1 (given in one day or split over two consecutive days); 80 mg on Day 15; and 40 mg every other week starting on Day 29.
•
Pediatric Patients 6 Years of Age and Older:

Pediatric Weight

Recommended Dosage

Days 1 and 15

Starting on Day 29

17 kg (37 lbs) to less than 40 kg (88 lbs)

Day 1: 80 mg
Day 15: 40 mg

20 mg every other week

40 kg (88 lbs) and greater

Day 1: 160 mg (single dose or split over two consecutive days)
Day 15: 80 mg

40 mg every other week

Ulcerative Colitis (2.4):

•
Adults: 160 mg on Day 1 (given in one day or split over two consecutive days), 80 mg on Day 15 and 40 mg every other week starting on Day 29. Discontinue in patients without evidence of clinical remission by eight weeks (Day 57).

Plaque Psoriasis or Adult Uveitis (2.5):

•
Adults: 80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.

Hidradenitis Suppurativa (2.6):

•
Adults:
•
Day 1: 160 mg (given in one day or split over two consecutive days).
•
Day 15: 80 mg.
•
Day 29 and subsequent doses: 40 mg every week or 80 mg every other week.

DOSAGE FORMS AND STRENGTHS

Injection:

•
Single-dose prefilled pen (ABRILADA Pen): 40 mg/0.8 mL (3)
•
Single-dose prefilled glass syringe: 40 mg/0.8 mL, 20 mg/0.4 mL, 10 mg/0.2 mL (3)
•
Single-dose glass vial for institutional use only: 40 mg/0.8 mL (3)

CONTRAINDICATIONS

None. (4)

WARNINGS AND PRECAUTIONS

•
Serious Infections: Do not start ABRILADA during an active infection. If an infection develops, monitor carefully, and stop ABRILADA if infection becomes serious. (5.1)
•
Invasive Fungal Infections: For patients who develop a systemic illness on ABRILADA, consider empiric antifungal therapy for those who reside or travel to regions where mycoses are endemic. (5.1)
•
Malignancies: Incidence of malignancies was greater in adalimumab-treated patients than in controls. (5.2)
•
Anaphylaxis or Serious Hypersensitivity Reactions may occur. (5.3)
•
Hepatitis B Virus Reactivation: Monitor hepatitis B virus (HBV) carriers during and several months after therapy. If reactivation occurs, stop ABRILADA and begin anti-viral therapy. (5.4)
•
Demyelinating Disease: Exacerbation or new onset, may occur. (5.5)
•
Cytopenias, Pancytopenia: Advise patients to seek immediate medical attention if symptoms develop, and consider stopping ABRILADA. (5.6)
•
Heart Failure: Worsening or new onset, may occur. (5.8)
•
Lupus-Like Syndrome: Stop ABRILADA if syndrome develops. (5.9)

ADVERSE REACTIONS

Most common adverse reactions (>10%) are: infections (e.g. upper respiratory, sinusitis), injection site reactions, headache, and rash. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

•
Abatacept: Increased risk of serious infection. (5.1, 5.11, 7.2)
•
Anakinra: Increased risk of serious infection. (5.1, 5.7, 7.2)
•
Live vaccines: Avoid use with ABRILADA. (5.10, 7.3)

See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.


*
Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of ABRILADA has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.

Revised: 1/2024
Medication Guide

Health Professional Information

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