Amjevita

— THERAPEUTIC DISORDERS TREATED —
  • Arthritis/rheumatic disorders
  • Colorectal disorders
  • Psoriasis

Amjevita Generic Name & Formulations

General Description

Adalimumab-atto 20mg/0.4mL, 40mg/0.8mL; soln for SC inj; preservative-free.

Pharmacological Class

Tumor necrosis factor (TNF) blocker.

How Supplied

Single-dose prefilled syringe—1 (20mg, 40mg), 2 (40mg); Single-dose prefilled SureClick autoinjector (40mg)—1, 2

Manufacturer

Generic Availability

NO

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

Serious infections. Malignancy.

Amjevita Warnings/Precautions

Warnings/Precautions

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Latex allergy. Elderly. Pregnancy. Nursing mothers.

Amjevita Pharmacokinetics

See Literature

Amjevita Interactions

Interactions

Avoid live vaccines. Concomitant other biologic DMARDs (eg, abatacept or anakinra) or other TNF blockers: not recommended. Concomitant immunosuppressants may increase risk of infection. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose of these drugs.

Amjevita Adverse Reactions

Adverse Reactions

Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, neurological events, antibody formation, lupus-like syndrome.

Amjevita Clinical Trials

See Literature

Amjevita Note

Not Applicable

Amjevita Patient Counseling

See Literature

Amjevita Generic Name & Formulations

General Description

Adalimumab-atto 20mg/0.4mL, 40mg/0.8mL; soln for SC inj; preservative-free.

Pharmacological Class

Tumor necrosis factor (TNF) blocker.

How Supplied

Single-dose prefilled syringe—1 (20mg, 40mg), 2 (40mg); Single-dose prefilled SureClick autoinjector (40mg)—1, 2

Manufacturer

Generic Availability

NO

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

Serious infections. Malignancy.

Amjevita Warnings/Precautions

Warnings/Precautions

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Latex allergy. Elderly. Pregnancy. Nursing mothers.

Amjevita Pharmacokinetics

See Literature

Amjevita Interactions

Interactions

Avoid live vaccines. Concomitant other biologic DMARDs (eg, abatacept or anakinra) or other TNF blockers: not recommended. Concomitant immunosuppressants may increase risk of infection. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose of these drugs.

Amjevita Adverse Reactions

Adverse Reactions

Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, neurological events, antibody formation, lupus-like syndrome.

Amjevita Clinical Trials

See Literature

Amjevita Note

Not Applicable

Amjevita Patient Counseling

See Literature

Amjevita Generic Name & Formulations

General Description

Adalimumab-atto 20mg/0.4mL, 40mg/0.8mL; soln for SC inj; preservative-free.

Pharmacological Class

Tumor necrosis factor (TNF) blocker.

How Supplied

Single-dose prefilled syringe—1 (20mg, 40mg), 2 (40mg); Single-dose prefilled SureClick autoinjector (40mg)—1, 2

Manufacturer

Generic Availability

NO

Amjevita Indications

Indications

Moderate to severe chronic plaque psoriasis in adults who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

Amjevita Dosage and Administration

Adult

Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥18yrs: initially 80mg, followed by 40mg every other week starting one week after initial dose.

Children

<18yrs: not established.

Amjevita Contraindications

Not Applicable

Amjevita Boxed Warnings

Boxed Warning

Serious infections. Malignancy.

Amjevita Warnings/Precautions

Warnings/Precautions

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, viral, invasive fungal [treat empirically if develops], or other pathogens). Active infections: do not initiate therapy. Chronic or history of recurring infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test/treat latent TB and HBV infection prior to initiating therapy. Monitor closely if new infection, active TB (even if initial latent test is negative), reactivation of HBV, or blood dyscrasias occurs; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, or hematological abnormality develops. Lymphoma and other malignancies. CHF (monitor). Immunosuppression. Discontinue if lupus-like syndrome with antibody formation or serious hypersensitivity reaction occurs. Central or peripheral nervous system demyelinating disorders; consider discontinuing if develops. Pediatric patients: follow up on current immunizations before starting therapy; consider risks/benefits prior to vaccinating exposed infants in utero. Latex allergy. Elderly. Pregnancy. Nursing mothers.

Amjevita Pharmacokinetics

See Literature

Amjevita Interactions

Interactions

Avoid live vaccines. Concomitant other biologic DMARDs (eg, abatacept or anakinra) or other TNF blockers: not recommended. Concomitant immunosuppressants may increase risk of infection. Concomitant CYP450 substrates with narrow therapeutic index (eg, warfarin, cyclosporine, theophylline); monitor and adjust dose of these drugs.

Amjevita Adverse Reactions

Adverse Reactions

Inj site reactions, infections (may be serious), headache, nausea, rash, abdominal pain; rare: malignancies (eg, lymphoma; esp children), blood dyscrasias, neurological events, antibody formation, lupus-like syndrome.

Amjevita Clinical Trials

See Literature

Amjevita Note

Not Applicable

Amjevita Patient Counseling

See Literature