Adalimumab PI

Question 1

What’s the generic name of Humira

Answer 1

Adalimumab

Question 2

Humira has a box warning why

Answer 2

Due to potential serious infections and malignancy

Question 3

What Serious infections should be of precaution

Answer 3

• 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 HUMIRA 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 HUMIRA.
• Monitor all patients for active TB during treatment, even if initial
latent TB test is negative

Question 4

What Serious malignancy should be of precaution

Answer 4

• 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 occurred in adolescent and young
adults with inflammatory bowel disease treated with TNF blockers
including HUMIRA

Question 5

WHAT ARE RECENT MAJOR CHANGES TO THE PI

Answer 5

Indications and Usage, Uveitis (1.10) 09/2018
Indications and Usage, Hidradenitis Suppurativa (1.9) 10/2018
Dosage and Administration, Juvenile Idiopathic Arthritis or
Pediatric Uveitis (2.2) 09/2018
Dosage and Administration, Hidradenitis Suppurativa (2.7) 10/2018

Question 6

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

Answer 6

• Rheumatoid Arthritis (RA) (1.1)
• Juvenile Idiopathic Arthritis (JIA) (1.2)
• Psoriatic Arthritis (PsA) (1.3)
• Ankylosing Spondylitis (AS) (1.4)
• Adult Crohn’s Disease (CD) (1.5)
• Pediatric Crohn’s Disease (1.6)
• Ulcerative Colitis (UC) (1.7)
• Plaque Psoriasis (Ps) (1.8)
• Hidradenitis Suppurativa (HS) (1.9)
• Uveitis (UV) (1.10)

Question 7

How is Humira use for Rheumatoid Arthritis

Answer 7

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.

Question 8

How is Humira use for Juvenile Idiopathic Arthritis (JIA)

Answer 8

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.

Question 9

How is Humira use for Psoriatic Arthritis (PsA)

Answer 9

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

Question 10

How is Humira use for Ankylosing Spondylitis (AS)

Answer 10

Ankylosing Spondylitis (AS) (1.4): Reducing signs and symptoms in adult
patients with active AS.

Question 11

How is Humira used for Adult Crohn’s Disease (CD)

Answer 11

Adult Crohn’s Disease (CD) (1.5): Reducing signs and symptoms and
inducing and maintaining clinical remission in adult patients with
moderately to severely active Crohn’s disease who have had an inadequate
response to conventional therapy. Reducing signs and symptoms and
inducing clinical remission in these patients if they have also lost response
to or are intolerant to infliximab.

Question 12

How is Humira use for Pediatric Crohn’s Disease

Answer 12

Pediatric Crohn’s Disease (1.6): Reducing signs and symptoms and
inducing and maintaining clinical remission in patients 6 years of age and
older with moderately to severely active Crohn’s disease who have had an
inadequate response to corticosteroids or immunomodulators such as
azathioprine, 6-mercaptopurine, or methotrexate.

Question 13

How is Humira use for Ulcerative Colitis (UC)

Answer 13

Ulcerative Colitis (UC) (1.7): Inducing and sustaining clinical remission in
adult patients with moderately to severely active ulcerative colitis who have
had an inadequate response to immunosuppressants such as corticosteroids,
azathioprine or 6-mercaptopurine (6-MP). The effectiveness of HUMIRA
has not been established in patients who have lost response to or were
intolerant to TNF blockers.

Question 14

How is Humira use for Plaque Psoriasis

Answer 14

Plaque Psoriasis (Ps) (1.8): The 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.

Question 15

How is Humira use for Hidradenitis Suppurativa

Answer 15

Hidradenitis Suppurativa (HS) (1.9): The treatment of moderate to severe
hidradenitis suppurativa in patients 12 years of age and older.

Question 16

How is Humira use for Uveitis (UV)

Answer 16

Uveitis (UV) (1.10): The treatment of non-infectious intermediate,
posterior, and panuveitis in adults and pediatric patients 2 years of age and
older.

Question 17

What is the dosage and administration for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis (2.1):

Answer 17

40 mg every other week.
• Some patients with RA not receiving methotrexate may benefit from
increasing the frequency to 40 mg every week.

Question 18

What is the dosage and administration for Juvenile Idiopathic Arthritis or Pediatric Uveitis (2.2)

Answer 18

Juvenile Idiopathic Arthritis or Pediatric Uveitis (2.2):
• 10 kg (22 lbs) to <15 kg (33 lbs): 10 mg every other week
• 15 kg (33 lbs) to < 30 kg (66 lbs): 20 mg every other week
• ≥ 30 kg (66 lbs): 40 mg every other week

Question 19

What is the dosage and administration for Adult Crohn’s Disease and Ulcerative Colitis (2.3, 2.5):

Answer 19

Adult Crohn’s Disease and Ulcerative Colitis (2.3, 2.5):
• Initial dose (Day 1): 160 mg
• Second dose two weeks later (Day 15): 80 mg
• Two weeks later (Day 29): Begin a maintenance dose of 40 mg every
other week.
• For patients with Ulcerative Colitis only: Only continue HUMIRA in
patients who have shown evidence of clinical remission by eight weeks
(Day 57) of therapy.

Question 20

What is the dosage and administration for Pediatric Crohn’s Disease (2.4)

Answer 20

Pediatric Crohn’s Disease (2.4):
• 17 kg (37 lbs) to < 40 kg (88 lbs):
• Initial dose (Day 1): 80 mg
• Second dose two weeks later (Day 15): 40 mg
• Two weeks later (Day 29): Begin a maintenance dose of 20 mg
every other week.

• ≥ 40 kg (88 lbs):
• Initial dose (Day 1): 160 mg
• Second dose two weeks later (Day 15): 80 mg
• Two weeks later (Day 29): Begin a maintenance dose of 40 mg
every other week

Question 21

What is the dosage and administration for Adult Uveitis (2.6)

Answer 21

Plaque Psoriasis or Adult Uveitis (2.6):
• 80 mg initial dose, followed by 40 mg every other week starting one week
after initial dose.

Question 22

What is the dosage and administration Hidradenitis Suppurativa (2.7)

Answer 22

Hidradenitis Suppurativa (2.7):
• Adults:
          • Initial dose (Day 1): 160 mg
          • Second dose two weeks later (Day 15): 80 mg
          • Third (Day 29) and subsequent doses: 40 mg every week.
• Adolescents (12 years and older) ≥60 kg (132 lbs):
           • Initial dose (Day 1): 160 mg
           • Second dose two weeks later (Day 15): 80 mg
           • Third (Day 29) and subsequent doses: 40 mg every week.
• Adolescents (12 years and older) 30 kg (66 lbs) to <60 kg (132 lbs):
           • Initial dose (Day 1): 80 mg
           • Second (Day 8) and subsequent doses: 40 mg every other week.

Question 23

Humira DOSAGE FORMS AND STRENGTHS

Answer 23

• Injection: 80 mg/0.8 mL in a single-dose prefilled pen (HUMIRA Pen) (3)
• Injection: 80 mg/0.8 mL in a single-dose prefilled glass syringe (3)
• Injection: 40 mg/0.8 mL in a single-dose prefilled pen (HUMIRA Pen) (3)
• Injection: 40 mg/0.4 mL in a single-dose prefilled pen (HUMIRA Pen) (3)
• Injection: 40 mg/0.8 mL in a single-dose prefilled glass syringe (3)
• Injection: 40 mg/0.4 mL in a single-dose prefilled glass syringe (3)
• Injection: 20 mg/0.4 mL in a single-dose prefilled glass syringe (3)
• Injection: 20 mg/0.2 mL in a single-dose prefilled glass syringe (3)
• Injection: 10 mg/0.2 mL in a single-dose prefilled glass syringe (3)
• Injection: 10 mg/0.1 mL in a single-dose prefilled glass syringe (3)
• Injection: 40 mg/0.8 mL in a single-dose glass vial for institutional use only
(3)

Question 24

WARNINGS AND PRECAUTIONS

Answer 24

• Serious infections: Do not start HUMIRA during an active infection. If an
infection develops, monitor carefully, and stop HUMIRA if infection
becomes serious (5.1)
• Invasive fungal infections: For patients who develop a systemic illness on
HUMIRA, 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 HUMIRA-treated
patients than in controls (5.2)
• Anaphylaxis or serious allergic reactions may occur (5.3)
• Hepatitis B virus reactivation: Monitor HBV carriers during and several
months after therapy. If reactivation occurs, stop HUMIRA and begin antiviral 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 HUMIRA (5.6)
• Heart failure: Worsening or new onset, may occur (5.8)
• Lupus-like syndrome: Stop HUMIRA if syndrome develops (5.9)

Question 25

ADVERSE REACTIONS

Answer 25

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

Question 26

What is the Mechanism of Action of Humira

Answer 26

Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell
surface TNF receptors