HUMIRA (adalimumab) Dosing

ADMINISTRATION CONSIDERATIONS1

  • HUMIRA is administered by subcutaneous (SC) injection
  • The first injection should be given under the supervision of a healthcare professional. A patient may self-inject HUMIRA after appropriate training and monitoring by a healthcare professional
  • Prior to initiating HUMIRA and periodically during therapy, patients should be evaluated for active tuberculosis and tested for latent infection
  • In clinical trials, the most common adverse reaction was injection site reactions. 20% of patients treated with HUMIRA developed injection site reactions (erythema and/or itching, hemorrhage, pain, or swelling), compared to 14% of patients receiving placebo. Most were mild and did not necessitate discontinuation
  • Anaphylaxis or serious allergic reactions may occur

ANKYLOSING SPONDYLITIS

Recommended Dose

HUMIRA Prefilled Syringe
40 mg/0.4 mL

NDC: 0074-0243-02

HUMIRA Prefilled Syringe.

40 mg
Every Other Week

OR

HUMIRA Pen
40 mg/0.4 mL

NDC: 0074-0554-02

HUMIRA Pen.

40 mg
Every Other Week

INDICATION1

Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

CROHN’S DISEASE (ADULT)

Induction Dose (Adult Crohn's Disease Starter Pack)
HUMIRA Pen 80 mg/0.8 mL
NDC: 0074-0124-03

2 HUMIRA Pens.

DAY 1*
2 x 80 mg/0.8 mL (160 mg)

HUMIRA Pen.

DAY 15
80 mg/0.8 mL

Maintenance Dose Starting at Day 29
HUMIRA Pen 40 mg/0.4 mL
NDC: 0074-0554-02

HUMIRA Pen.

40 mg/0.4 mL*
Every Other Week

*Administer as two 80-mg injections in 1 day or as one 80-mg injection per day for 2 consecutive days.

  • In a maintenance clinical trial, among patients who were not responsive by Week 12, therapy continued beyond 12 weeks did not result in significantly more responses.

INDICATION1

Crohn's Disease: HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

PEDIATRIC CROHN’S DISEASE

SELECT DOSE TYPE

SELECT WEIGHT


Induction Dose (Pediatric Crohn's Disease Starter Pack)
HUMIRA Prefilled Syringe 80 mg/0.8 mL, 40 mg/0.4 mL
NDC: 0074-0067-02

HUMIRA Prefilled Syringe.

DAY 1
80 mg/0.8 mL

HUMIRA Prefilled Syringe.

DAY 15
40 mg/0.4 mL


Induction Dose (Pediatric Crohn's Disease Starter Pack)
HUMIRA Pen 80 mg/0.8 mL
NDC: 0074‑0124‑03

2 HUMIRA Pens.

DAY 1*
2 x 80 mg/0.8 mL (160 mg)

HUMIRA Pen.

DAY 15
80 mg/0.8 mL

Also available as a syringe, HUMIRA Prefilled Syringe 80 mg/0.8 mL Pediatric Crohn’s Disease Starter Package NDC: 0074-2540-03.

*Administer as two 80-mg injections in 1 day or as one 80-mg injection per day for 2 consecutive days.

SELECT WEIGHT


Maintenance Dose Starting at Day 29
HUMIRA Prefilled Syringe
20 mg/0.2 mL

NDC: 0074-0616-02

HUMIRA Prefilled Syringe.

20 mg/0.2 mL
Every Other Week


Maintenance Dose Starting at Day 29
HUMIRA Pen 40 mg/0.4 mL
NDC: 0074-0554-02

HUMIRA Pen.

40 mg/0.4 mL
Every Other Week
or as a syringe, HUMIRA Prefilled Syringe 40 mg/0.4 mL NDC: 0074‑0243‑02.

INDICATION1

Crohn’s Disease: HUMIRA is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

HIDRADENITIS SUPPURATIVA

Dosing for ADULTS & ADOLESCENTS ≥12 years, ≥60 kg (≥132 lbs)

Initial Doses (HS Starter Pack)
HUMIRA Pen 80 mg/0.8 mL
NDC: 0074-0124-03

2 HUMIRA Pens.

DAY 1

2 x 80 mg (160 mg)

or one 80 mg injection on Days 1 and 2

HUMIRA Pen.

DAY 15

1 x 80 mg

2 Maintenance Doses a Month*

2 HUMIRA Pens.

2 WEEKS LATER (Day 29) CONTINUE WITH

1 x 80 mg Every Other Week

HUMIRA Pen 80 mg/0.8 mL (2 Pens)
NDC: 0074-0124-02

Maintenance Dose Starting at Day 29
HUMIRA Pen 40 mg/0.4 mL
4 maintenance doses a month*

NDC: 0074-0554-02

4 HUMIRA Pens.

2 WEEKS LATER (Day 29) CONTINUE WITH

1 x 40 mg Every Week

 

HUMIRA Pen 40 mg/0.4 mL

NDC: 0074-0554-02

*The number of doses per month will vary throughout the year depending on which calendar day a patient begins treatment.


Dosing for ADOLESCENTS ≥12 years, ≥30 kg (66 lbs) to <60 kg (132 lbs)

Induction Dose (Adolescent HS Starter Pack)

HUMIRA Pen 80 mg/0.8 mL (1)
HUMIRA Pen 40 mg/0.4 mL (2)
NDC: 0074-1539-03

DAY 1

1 x 80 mg

DAY 8

1 x 40 mg

DAY 22

1 x 40 mg


2 Maintenance Doses a Month*

2 WEEKS LATER (Day 36) CONTINUE WITH

1 x 40 mg Every Other Week

HUMIRA Pen 40 mg/0.4 mL
NDC: 0074-0554-02

*The number of doses per month will vary throughout the year depending on which calendar day a patient begins treatment.

INDICATION1

Hidradenitis Suppurativa: HUMIRA is indicated for the treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older.

HS=hidradenitis suppurativa

JUVENILE IDIOPATHIC ARTHRITIS

HUMIRA Prefilled Syringe 10 mg/0.1 mL
NDC: 0074-0817-02

HUMIRA Prefilled Syringe.

10 mg
Every Other Week

HUMIRA Prefilled Syringe 20 mg/0.2 mL
NDC: 0074-0616-02

HUMIRA Prefilled Syringe.

20 mg
Every Other Week

HUMIRA Prefilled Syringe
40 mg/0.4 mL

NDC: 0074-0243-02

HUMIRA Prefilled Syringe.

40 mg
Every Other Week

OR

HUMIRA Pen
40 mg/0.4 mL

NDC: 0074-0554-02

HUMIRA Pen.

40 mg
Every Other Week

HUMIRA has not been studied in patients with polyarticular JIA less than 2 years of age or in patients with a weight below 10 kg.

INDICATION1

Juvenile Idiopathic Arthritis: HUMIRA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

PLAQUE PSORIASIS

Plaque Psoriasis Starter Pack (3 count)
HUMIRA Pen 80 mg/0.8 mL (1)
HUMIRA Pen 40 mg/0.4 mL (2)
NDC: 0074-1539-03

DAY

1

HUMIRA Pen.

80 mg Pen

DAY

8

HUMIRA Pen.

40 mg Pen

DAY

22

HUMIRA Pen.

40 mg Pen


2 Maintenance Doses a Month*

1 x 40 mg Every Other Week

HUMIRA Pen 40 mg/0.4 mL (2 pens)
NDC: 0074-0554-02

Every
Other
Week

Maintenance Dose

HUMIRA Pen.

40 mg Pen
HUMIRA Pen 40 mg/0.4 mL (2)

NDC: 0074-0554-02

INDICATION1

Plaque Psoriasis: HUMIRA is indicated for 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. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

PSORIATIC ARTHRITIS

Recommended Dose

HUMIRA Prefilled Syringe
40 mg/0.4 mL

NDC: 0074-0243-02

HUMIRA Prefilled Syringe.

40 mg
Every Other Week

OR

HUMIRA Pen
40 mg/0.4 mL

NDC: 0074-0554-02

HUMIRA Pen.

40 mg
Every Other Week

INDICATION1

Psoriatic Arthritis: HUMIRA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis.

RHEUMATOID ARTHRITIS

Recommended Dose

HUMIRA Prefilled Syringe
40 mg/0.4 mL

NDC: 0074-0243-02

HUMIRA Prefilled Syringe.

40 mg
Every Other Week

OR

HUMIRA Pen
40 mg/0.4 mL

NDC: 0074-0554-02

HUMIRA Pen.

40 mg
Every Other Week

INDICATION1

Rheumatoid Arthritis: HUMIRA is indicated, alone or in combination with methotrexate or other non-biologic DMARDs, for 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 rheumatoid arthritis.

DMARD=disease-modifying anti-rheumatic drugs

ULCERATIVE COLITIS (ADULT)

Induction Dose (Starter Pack)
HUMIRA Pen 80 mg/0.8 mL
NDC: 0074-0124-03

2 HUMIRA Pens.

DAY 1*
2 x 80 mg/0.8 mL (160 mg)

HUMIRA Pen.

DAY 15
80 mg/0.8 mL

*Administer as two 80‑mg injections in 1 day or as one 80‑mg injection per day for 2 consecutive days.

Maintenance Dose Starting at Day 29
HUMIRA Pen 40 mg/0.4 mL
NDC: 0074-0554-02

HUMIRA Pen.

40 mg/0.4 mL
Every Other Week

  • Discontinue HUMIRA in adult patients without evidence of clinical remission by 8 weeks (Day 57) of therapy.

INDICATION1

Ulcerative Colitis: HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

PEDIATRIC ULCERATIVE COLITIS

SELECT DOSE TYPE

SELECT WEIGHT


Induction Dose
HUMIRA Pen 40 mg/0.4 mL
NDC: 0074-0054-02

2 HUMIRA Pens.

DAY 1
2 x 40 mg/0.4 mL (80 mg)*

HUMIRA Pen.

DAY 8
40 mg/0.4 mL*

HUMIRA Pen.

DAY 15
40 mg/0.4 mL*

*Dose also available as a HUMIRA Prefilled Syringe 40 mg/0.4 mL NDC: 0074‑0243‑02.


Induction Dose
HUMIRA Pen 80 mg/0.8 mL
Pediatric Ulcerative Colitis Starter Pack

NDC: 0074‑0124‑04

2 HUMIRA Pens.

DAY 1*
2 x 80 mg/0.8 mL (160 mg)

HUMIRA Pen.

DAY 8
80 mg/0.8 mL

HUMIRA Pen.

DAY 15
80 mg/0.8 mL

SELECT WEIGHT


Maintenance Dose Starting at Day 29
HUMIRA Pen 40 mg/0.4 mL or HUMIRA Prefilled Syringe 20 mg/0.2 mL
NDC: 0074-0554-02 or NDC: 0074-0616-02

Choose One of 2 Ways to Prescribe

HUMIRA Pen.

40 mg/0.4 mL*
Every Other Week

OR

HUMIRA Prefilled Syringe.

20 mg/0.2 mL
Every Week


Maintenance Dose Starting at Day 29
HUMIRA Pen 80 mg/0.8 mL or 40 mg/0.4 mL
NDC: 0074-0124-02 or NDC: 0074-0554-02

Choose One of 2 Ways to Prescribe

HUMIRA Pen.

80 mg/0.8 mL
Every Other Week


OR

HUMIRA Pen.

40 mg/0.4 mL
Every Week
or HUMIRA Prefilled Syringe 40 mg/0.4 mL
NDC: 0074‑0243‑02

*Administered as two 80‑mg injections in 1 day or as one 80‑mg injection per day for 2 consecutive days.

  • Continue the recommended pediatric dosage in patients who turn 18 years of age and who are well-controlled on their HUMIRA regimen.1

INDICATION1

Ulcerative Colitis: HUMIRA is indicated for the treatment of moderately to severely active ulcerative colitis in adults and pediatric patients 5 years of age and older.

Limitations of Use:
The effectiveness of HUMIRA has not been established in patients who have lost response to or were intolerant to TNF blockers.

NON-INFECTIOUS UVEITIS (ADULT)

Initial Doses (Uveitis Starter Pack)
HUMIRA Pen 80 mg/0.8 mL and 40 mg/0.4 mL
NDC: 0074-1539-03

DAY

1

HUMIRA Pen.

80 mg Pen

DAY

8

HUMIRA Pen.

40 mg Pen

DAY

22

HUMIRA Pen.

40 mg Pen

HUMIRA Prefilled Syringe
40 mg/0.4 mL

NDC: 0074-0243-02

HUMIRA Prefilled Syringe.

40 mg
Every Other Week

OR

HUMIRA Pen
40 mg/0.4 mL

NDC: 0074-0554-02

HUMIRA Pen.

40 mg
Every Other Week

INDICATION1

Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults.

PEDIATRIC NON-INFECTIOUS UVEITIS

The recommended dose of HUMIRA for pediatric patients 2 years of age and older with NI intermediate, posterior, or panuveitis is based on weight as shown below. MTX, glucocorticoids, NSAIDs, and/or analgesics may be continued during treatment with HUMIRA.

HUMIRA Prefilled Syringe 10 mg/0.1 mL
NDC: 0074-0817-02

HUMIRA Prefilled Syringe.

10 mg
Every Other Week

HUMIRA Prefilled Syringe 20 mg/0.2 mL
NDC: 0074-0616-02

HUMIRA Prefilled Syringe.

20 mg
Every Other Week

HUMIRA Prefilled Syringe
40 mg/0.4 mL

NDC: 0074-0243-02

HUMIRA Prefilled Syringe.

40 mg
Every Other Week

OR

HUMIRA Pen
40 mg/0.4 mL

NDC: 0074-0554-02

HUMIRA Pen.

40 mg
Every Other Week

  • HUMIRA has not been studied in patients with pediatric uveitis less than 2 years of age or in patients with a weight below 10 kg

INDICATION1

Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in pediatric patients 2 years of age and older.

MTX=methotrexate; NSAID=nonsteroidal anti-inflammatory drug; NI=non-infectious