Amjevita Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled syringe—1 (20mg, 40mg), 2 (40mg); Single-dose prefilled SureClick autoinjector (40mg)—1, 2
Manufacturer
Generic Availability
Amjevita Indications
Indications
To reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in adults with moderately to severely active rheumatoid arthritis (RA); may be used alone or with methotrexate (MTX) or other non-biologic DMARDs. To reduce signs/symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients ≥2yrs of age; may be used alone or with MTX. To reduce signs/symptoms, inhibit progression of structural damage, and improve physical function in adults with active psoriatic arthritis (PsA); may be used alone or with non-biologic DMARDs. To reduce signs/symptoms of active ankylosing spondylitis (AS) in adults.
Amjevita Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: 40mg every other week. May use with MTX, DMARDs, glucocorticoids, NSAIDs, and/or analgesics. RA (without MTX): may increase to 40mg every week or 80mg every other week.
Children
RA, PsA, AS: <18yrs: not established. JIA: <2yrs or <10kg: not established. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. 2–17yrs (15–<30kg): 20mg every other week; (≥30kg): 40mg every other week. May use with MTX, glucocorticoids, NSAIDs, and/or analgesics.
Amjevita Contraindications
Not Applicable
Amjevita Boxed Warnings
Boxed Warning
Amjevita Warnings/Precautions
Warnings/Precautions
Amjevita Pharmacokinetics
See Literature
Amjevita Interactions
Interactions
Amjevita Adverse Reactions
Adverse Reactions
Amjevita Clinical Trials
See Literature
Amjevita Note
Not Applicable
Amjevita Patient Counseling
See Literature
Amjevita Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled syringe—1 (20mg, 40mg), 2 (40mg); Single-dose prefilled SureClick autoinjector (40mg)—1, 2
Manufacturer
Generic Availability
Amjevita Indications
Indications
For moderately to severely active Crohn's disease (CD) in adults and pediatric patients ≥6yrs of age. For moderately to severely active ulcerative colitis (UC) in adults.
Limitations of Use
UC: not established in patients who have lost response to or were intolerant to TNF blockers.
Amjevita Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. Initially 160mg on Day 1 (given in 1 day or divided over 2 days), followed by 80mg on Day 15. On Day 29, start maintenance of 40mg every other week. May continue aminosalicylates, corticosteroids, azathioprine, 6-MP or MTX. UC: only continue if evidence of clinical remission by 8 weeks.
Children
<6yrs: not established. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥6yrs: (17–<40kg): initially 80mg on Day 1, then 40mg on Day 15. On Day 29, start maintenance of 20mg every other week; (≥40kg): initially 160mg on Day 1 (given in 1 day or divided over 2 days), then 80mg on Day 15. On Day 29, start maintenance of 40mg every other week.
Amjevita Contraindications
Not Applicable
Amjevita Boxed Warnings
Boxed Warning
Amjevita Warnings/Precautions
Warnings/Precautions
Amjevita Pharmacokinetics
See Literature
Amjevita Interactions
Interactions
Amjevita Adverse Reactions
Adverse Reactions
Amjevita Clinical Trials
See Literature
Amjevita Note
Not Applicable
Amjevita Patient Counseling
See Literature
Amjevita Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled syringe—1 (20mg, 40mg), 2 (40mg); Single-dose prefilled SureClick autoinjector (40mg)—1, 2
Manufacturer
Generic Availability
Amjevita Indications
Indications
Amjevita Dosage and Administration
Adult
Children
Amjevita Contraindications
Not Applicable
Amjevita Boxed Warnings
Boxed Warning
Amjevita Warnings/Precautions
Warnings/Precautions
Amjevita Pharmacokinetics
See Literature
Amjevita Interactions
Interactions
Amjevita Adverse Reactions
Adverse Reactions
Amjevita Clinical Trials
See Literature
Amjevita Note
Not Applicable
Amjevita Patient Counseling
See Literature