US-MULT-230356
40 mg
Every Other Week
Ankylosing Spondylitis: HUMIRA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.
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.
SELECT DOSE TYPE
SELECT WEIGHT
Induction Dose (Pediatric Crohn's Disease Starter Pack)
HUMIRA Pen 80 mg/0.8 mL
NDC: 0074‑0124‑03
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 Pen 40 mg/0.4 mL
NDC: 0074-0554-02
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.
*The number of doses per month will vary throughout the year depending on which calendar day a patient begins treatment.
HUMIRA Pen 80 mg/0.8 mL (1)
HUMIRA Pen 40 mg/0.4 mL (2)
NDC: 0074-1539-03
*The number of doses per month will vary throughout the year depending on which calendar day a patient begins treatment.
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
HUMIRA Prefilled Syringe 10 mg/0.1 mL
NDC: 0074-0817-02
10 mg
Every Other Week
HUMIRA Prefilled Syringe 20 mg/0.2 mL
NDC: 0074-0616-02
20 mg
Every Other Week
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.
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: 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: 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: 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
*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
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.
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
*Administered as two 80‑mg injections in 1 day or as one 80‑mg injection per day for 2 consecutive days.
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.
Uveitis: HUMIRA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adults.
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
10 mg
Every Other Week
HUMIRA Prefilled Syringe 20 mg/0.2 mL
NDC: 0074-0616-02
20 mg
Every Other Week
40 mg
Every Other Week
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
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: 1. with chronic or recurrent infection, 2. who have been exposed to TB, 3. with a history of opportunistic infection, 4. who resided in or traveled in regions where mycoses are endemic, 5. with underlying conditions that may predispose them to 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. Postmarketing 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 of these patients had received treatment with azathioprine or 6-mercaptopurine 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.
HYPERSENSITIVITY
HEPATITIS B VIRUS REACTIVATION
NEUROLOGIC REACTIONS
HEMATOLOGIC REACTIONS
CONGESTIVE HEART FAILURE
AUTOIMMUNITY
IMMUNIZATIONS
ADVERSE REACTIONS
Please see Full Prescribing Information.
US-HUM-210183
Reference:
US-HUM-220513