Usual Adult Dose for Ankylosing Spondylitis

50 mg subcutaneously once a week

Comments:

• Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during therapy with this drug.
• Doses higher than 50 mg per week are not recommended.

• Rheumatoid arthritis (RA): To reduce symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active RA; this drug can be used alone or in combination with methotrexate (MTX)
• Ankylosing spondylitis (AS): To reduce symptoms in patients with active AS
• Psoriatic arthritis (PsA): To reduce symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with PsA; this drug can be used alone or in combination with methotrexate (MTX)

Usual Adult Dose for Rheumatoid Arthritis

50 mg subcutaneously once a week

Comments:

• Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during therapy with this drug.
• Doses higher than 50 mg per week are not recommended.

• Rheumatoid arthritis (RA): To reduce symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active RA; this drug can be used alone or in combination with methotrexate (MTX)
• Ankylosing spondylitis (AS): To reduce symptoms in patients with active AS
• Psoriatic arthritis (PsA): To reduce symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with PsA; this drug can be used alone or in combination with methotrexate (MTX)

Usual Adult Dose for Psoriatic Arthritis

50 mg subcutaneously once a week

Comments:

• Methotrexate, glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during therapy with this drug.
• Doses higher than 50 mg per week are not recommended.

• Rheumatoid arthritis (RA): To reduce symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active RA; this drug can be used alone or in combination with methotrexate (MTX)
• Ankylosing spondylitis (AS): To reduce symptoms in patients with active AS
• Psoriatic arthritis (PsA): To reduce symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with PsA; this drug can be used alone or in combination with methotrexate (MTX)

Usual Adult Dose for Plaque Psoriasis

50 mg subcutaneously 2 times a week for 3 months (alternatively, starting doses of 25 to 50 mg once a week have been shown to be effective); then 50 mg subcutaneously once a week

Use: For chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

Usual Pediatric Dose for Juvenile Idiopathic Arthritis

2 years and older:

• Less than 63 kg: 0.8 mg/kg subcutaneously once a week
• Greater than or equal to 63 kg: 50 mg subcutaneously once a week
• Maximum dose: 50 mg subcutaneously once a week

• Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.

Usual Pediatric Dose for Plaque Psoriasis

4 years and older:

• Less than 63 kg: 0.8 mg/kg subcutaneously once a week
• Greater than or equal to 63 kg: 50 mg subcutaneously once a week
• Maximum: 50 mg subcutaneously once a week

• Glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics may be continued during treatment with this drug.

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNINGS:
SERIOUS INFECTIONS:

• This drug is associated with an 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.
• This drug should be discontinued if a patient develops a serious infection or sepsis during therapy.
• A test for latent TB should be performed before starting treatment with this drug. If the test is positive, treatment for TB should be started prior to beginning therapy with this drug.
• All patients should be monitored for active TB during treatment, even if the initial latent TB test is negative.

• Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including this drug.

• Patients with, or at risk of, sepsis

• Safety and efficacy for use in polyarticular juvenile idiopathic arthritis has not been established in pediatric patients less than 2 years of age.
• Safety and efficacy for use in plaque psoriasis has not been established in pediatric patients less than 4 years of age.
• Safety and efficacy for use in all other indications has not been established in pediatric patients less than 18 years of age.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug may be injected into the thigh, abdomen or upper arm, at least 3 cm from an old site and not where the skin is tender, bruised, red, or hard.
• Injection sites should be rotated.
• Patients should be instructed and assessed on self-administration techniques and the importance of proper syringe and needle disposal if they are to self-administer.
• Prefilled syringes and auto-injector should be allowed to reach room temperature prior to injection.

• Consult the manufacturer product information.

• Consult the manufacturer product information.

• Infections: Patients should be evaluated before, during, and after treatment.
• Full blood counts should be obtained in patients with a history of blood dyscrasias or symptoms suggestive of blood dyscrasias.
• Periodic skin examinations should be performed in all patients at an increased risk for skin cancer.
• Blood glucose levels should be monitored in diabetic patients.

• Therapy should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or pediatric plaque psoriasis.
• This drug may be used in combination with methotrexate if necessary. No apparent interactions have been documented with concurrent use of glucocorticoids, nonsteroidal anti-inflammatory agents, or analgesics.
• Patients should be instructed to call their doctor immediately if they develop symptoms such as persistent fever, bruising, bleeding, or paleness.
• If possible, pediatric patients should be up to date with all immunizations prior to commencing therapy.
• Patients exposed to the varicella virus should temporarily stop therapy and be considered for prophylactic varicella zoster immune globulin therapy.

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