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Yusimry Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled pen, single-dose prefilled syringe—2
Manufacturer
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.
Yusimry Indications
Indications
To reduce signs/symptoms, induce major clinical response, inhibit progression of structural damage, and improve physical function in moderately to severely active rheumatoid arthritis (RA); may be used alone or with methotrexate (MTX) or 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.
Yusimry 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 frequency to 40mg once weekly 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 (≥30kg): 40mg every other week. May use with MTX, glucocorticoids, NSAIDs, and/or analgesics.
Yusimry Contraindications
Not Applicable
Yusimry Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Yusimry 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. Elderly. Pregnancy. Nursing mothers.
Yusimry Pharmacokinetics
Absorption
-
Average absolute bioavailability: 64%.
-
Mean time to reach maximum concentration: 5.5 days (131 ± 56 hours).
-
Maximum serum concentration: 4.7 ± 1.6 mcg/mL.
Distribution
-
Distribution volume (Vss) ranged from 4.7 to 6.0 L.
Elimination
-
Half-life: approxiamtely 2 weeks (range: 10–20 days).
-
Systemic clearance: approximately 12 mL/hr.
Yusimry 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.
Yusimry 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.
Yusimry Clinical Trials
See Literature
Yusimry Note
Not Applicable
Yusimry Patient Counseling
See Literature
Yusimry Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled pen, single-dose prefilled syringe—2
Manufacturer
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.
Yusimry Indications
Indications
In moderately to severely active Crohn's disease (CD) in adults and pediatric patients ≥6yrs of age. In 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.
Yusimry 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: discontinue in those without evidence of clinical remission by 8 weeks of therapy.
Children
UC: not established. CD: <6yrs (or <40kg): not established. Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. ≥6yrs (≥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.
Yusimry Contraindications
Not Applicable
Yusimry Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Yusimry 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. Elderly. Pregnancy. Nursing mothers.
Yusimry Pharmacokinetics
Absorption
-
Average absolute bioavailability: 64%.
-
Mean time to reach maximum concentration: 5.5 days (131 ± 56 hours).
-
Maximum serum concentration: 4.7 ± 1.6 mcg/mL.
Distribution
-
Distribution volume (Vss) ranged from 4.7 to 6.0 L.
Elimination
-
Half-life: approxiamtely 2 weeks (range: 10–20 days).
-
Systemic clearance: approximately 12 mL/hr.
Yusimry 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.
Yusimry 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.
Yusimry Clinical Trials
See Literature
Yusimry Note
Not Applicable
Yusimry Patient Counseling
See Literature
Yusimry Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled pen, single-dose prefilled syringe—2
Manufacturer
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.
Yusimry Indications
Indications
Moderate to severe hidradenitis suppurativa in adults.
Yusimry 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.
Yusimry Contraindications
Not Applicable
Yusimry Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Yusimry 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. Elderly. Pregnancy. Nursing mothers.
Yusimry Pharmacokinetics
Absorption
-
Average absolute bioavailability: 64%.
-
Mean time to reach maximum concentration: 5.5 days (131 ± 56 hours).
-
Maximum serum concentration: 4.7 ± 1.6 mcg/mL.
Distribution
-
Distribution volume (Vss) ranged from 4.7 to 6.0 L.
Elimination
-
Half-life: approxiamtely 2 weeks (range: 10–20 days).
-
Systemic clearance: approximately 12 mL/hr.
Yusimry 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.
Yusimry 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.
Yusimry Clinical Trials
See Literature
Yusimry Note
Not Applicable
Yusimry Patient Counseling
See Literature
Yusimry Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled pen, single-dose prefilled syringe—2
Manufacturer
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.
Yusimry Indications
Indications
Non-infectious intermediate, posterior and panuveitis in adults.
Yusimry Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. Initially 80mg, followed by 40mg every other week starting one week after initial dose.
Children
Not established.
Yusimry Contraindications
Not Applicable
Yusimry Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Yusimry 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. Elderly. Pregnancy. Nursing mothers.
Yusimry Pharmacokinetics
Absorption
-
Average absolute bioavailability: 64%.
-
Mean time to reach maximum concentration: 5.5 days (131 ± 56 hours).
-
Maximum serum concentration: 4.7 ± 1.6 mcg/mL.
Distribution
-
Distribution volume (Vss) ranged from 4.7 to 6.0 L.
Elimination
-
Half-life: approxiamtely 2 weeks (range: 10–20 days).
-
Systemic clearance: approximately 12 mL/hr.
Yusimry 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.
Yusimry 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.
Yusimry Clinical Trials
See Literature
Yusimry Note
Not Applicable
Yusimry Patient Counseling
See Literature
Yusimry Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Single-dose prefilled pen, single-dose prefilled syringe—2
Manufacturer
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.
Yusimry 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.
Yusimry Dosage and Administration
Adult
Inject SC into thigh or abdomen; rotate inj sites; supervise 1st dose. Initially 80mg, followed by 40mg every other week starting one week after initial dose. Use beyond 1yr has not been evaluated.
Children
Not established.
Yusimry Contraindications
Not Applicable
Yusimry Boxed Warnings
Boxed Warning
Serious infections. Malignancy.
Yusimry 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. Elderly. Pregnancy. Nursing mothers.
Yusimry Pharmacokinetics
Absorption
-
Average absolute bioavailability: 64%.
-
Mean time to reach maximum concentration: 5.5 days (131 ± 56 hours).
-
Maximum serum concentration: 4.7 ± 1.6 mcg/mL.
Distribution
-
Distribution volume (Vss) ranged from 4.7 to 6.0 L.
Elimination
-
Half-life: approxiamtely 2 weeks (range: 10–20 days).
-
Systemic clearance: approximately 12 mL/hr.
Yusimry 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.
Yusimry 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.
Yusimry Clinical Trials
See Literature
Yusimry Note
Not Applicable
Yusimry Patient Counseling
See Literature
