Amjevita

— THERAPEUTIC CATEGORIES —
  • Arthritis/rheumatic disorders
  • Colorectal disorders
  • Miscellaneous dermatological conditions
  • Miscellaneous ocular agents
  • Psoriasis
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Amjevita Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Adalimumab-atto 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Tumor necrosis factor (TNF) blocker.

    How Supplied

    Single-dose prefilled syringe—1 (10mg, 20mg, 40mg, 80mg), 2 (40mg, 80mg); Single-dose prefilled SureClick autoinjector (40mg, 80mg)—1, 2

    Manufacturer

    Amgen, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement.

    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 (10–<15kg): 10mg every other week; (15–<30kg): 20mg every other week; (≥30kg): 40mg every other week. May use with MTX, glucocorticoids, NSAIDs, and/or analgesics. 

    Administration

    Carefully inspect for particulate matter and discoloration before use. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

    Nursing Considerations

    Carefully inspect for particulate matter and discoloration before use. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

    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

    Absorption

    Average absolute bioavailiabity (after a single 40 mg dose): 64%.

    Mean time to reach maximum concentration (after a single 40 mg dose): 5.5 days (131 ± 56 hours).

    Maximum serum concentration (after a single 40 mg dose): 4.7 ± 1.6 mcg/mL.

    Distribution

    Distribution volume ranged from 4.7–6.0 L.

    Elimination

    Systemic clearance: ~12 mL/hr.

    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

    Legal Class

    Rx

    General Description

    Adalimumab-atto 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Tumor necrosis factor (TNF) blocker.

    How Supplied

    Single-dose prefilled syringe—1 (10mg, 20mg, 40mg, 80mg), 2 (40mg, 80mg); Single-dose prefilled SureClick autoinjector (40mg, 80mg)—1, 2

    Manufacturer

    Amgen, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement.

    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.

    Administration

    Carefully inspect for particulate matter and discoloration before use. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

    Nursing Considerations

    Carefully inspect for particulate matter and discoloration before use. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

    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

    Absorption

    Average absolute bioavailiabity (after a single 40 mg dose): 64%.

    Mean time to reach maximum concentration (after a single 40 mg dose): 5.5 days (131 ± 56 hours).

    Maximum serum concentration (after a single 40 mg dose): 4.7 ± 1.6 mcg/mL.

    Distribution

    Distribution volume ranged from 4.7–6.0 L.

    Elimination

    Systemic clearance: ~12 mL/hr.

    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

    Legal Class

    Rx

    General Description

    Adalimumab-atto 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Tumor necrosis factor (TNF) blocker.

    How Supplied

    Single-dose prefilled syringe—1 (10mg, 20mg, 40mg, 80mg), 2 (40mg, 80mg); Single-dose prefilled SureClick autoinjector (40mg, 80mg)—1, 2

    Manufacturer

    Amgen, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement.

    Amjevita Indications

    Indications

    Moderate to severe hidradenitis suppurativa.

    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 week or 80mg every other week.

    Children

    Not established.

    Administration

    Carefully inspect for particulate matter and discoloration before use. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

    Nursing Considerations

    Carefully inspect for particulate matter and discoloration before use. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

    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

    Absorption

    Average absolute bioavailiabity (after a single 40 mg dose): 64%.

    Mean time to reach maximum concentration (after a single 40 mg dose): 5.5 days (131 ± 56 hours).

    Maximum serum concentration (after a single 40 mg dose): 4.7 ± 1.6 mcg/mL.

    Distribution

    Distribution volume ranged from 4.7–6.0 L.

    Elimination

    Systemic clearance: ~12 mL/hr.

    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

    Legal Class

    Rx

    General Description

    Adalimumab-atto 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Tumor necrosis factor (TNF) blocker.

    How Supplied

    Single-dose prefilled syringe—1 (10mg, 20mg, 40mg, 80mg), 2 (40mg, 80mg); Single-dose prefilled SureClick autoinjector (40mg, 80mg)—1, 2

    Manufacturer

    Amgen, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement.

    Amjevita Indications

    Indications

    Non-infectious intermediate, posterior and panuveitis in adults.

    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.

    Administration

    Carefully inspect for particulate matter and discoloration before use. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

    Nursing Considerations

    Carefully inspect for particulate matter and discoloration before use. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

    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

    Absorption

    Average absolute bioavailiabity (after a single 40 mg dose): 64%.

    Mean time to reach maximum concentration (after a single 40 mg dose): 5.5 days (131 ± 56 hours).

    Maximum serum concentration (after a single 40 mg dose): 4.7 ± 1.6 mcg/mL.

    Distribution

    Distribution volume ranged from 4.7–6.0 L.

    Elimination

    Systemic clearance: ~12 mL/hr.

    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

    Legal Class

    Rx

    General Description

    Adalimumab-atto 10mg/0.2mL, 20mg/0.2mL, 20mg/0.4mL, 40mg/0.4mL, 40mg/0.8mL, 80mg/0.8mL; soln for SC inj; preservative-free.

    Pharmacological Class

    Tumor necrosis factor (TNF) blocker.

    How Supplied

    Single-dose prefilled syringe—1 (10mg, 20mg, 40mg, 80mg), 2 (40mg, 80mg); Single-dose prefilled SureClick autoinjector (40mg, 80mg)—1, 2

    Manufacturer

    Amgen, Inc.

    Generic Availability

    NO

    Mechanism of Action

    Adalimumab binds specifically to TNF-alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement.

    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. Use beyond 1yr has not been evaluated.

    Children

    <18yrs: not established.

    Administration

    Carefully inspect for particulate matter and discoloration before use. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

    Nursing Considerations

    Carefully inspect for particulate matter and discoloration before use. Rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard.

    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

    Absorption

    Average absolute bioavailiabity (after a single 40 mg dose): 64%.

    Mean time to reach maximum concentration (after a single 40 mg dose): 5.5 days (131 ± 56 hours).

    Maximum serum concentration (after a single 40 mg dose): 4.7 ± 1.6 mcg/mL.

    Distribution

    Distribution volume ranged from 4.7–6.0 L.

    Elimination

    Systemic clearance: ~12 mL/hr.

    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

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