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Otezla Generic Name & Formulations
Legal Class
Rx
General Description
Apremilast 10mg, 20mg, 30mg; tabs.
Pharmacological Class
Phosphodiesterase 4 (PDE4) inhibitor.
How Supplied
Tabs 30mg—60, 500; 2-week starter pack—13+14; 28-day starter pack—13+42; Carton—2×14
Manufacturer
Generic Availability
NO
Mechanism of Action
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action is not well defined.
Otezla Indications
Indications
Active psoriatic arthritis.
Otezla Dosage and Administration
Adult
Swallow whole. Initially titrate over 5 days. Starting on Day 1: 10mg in the AM. Day 2: 10mg in AM and 10mg in PM. Day 3: 10mg in AM and 20mg in PM. Day 4: 20mg in AM and 20mg in PM. Day 5: 20mg in AM and 30mg in PM. Following on Day 6 and thereafter: 30mg twice daily (AM & PM). Severe renal impairment (CrCl <30mL/min): reduce to 30mg once daily; for initial titration, use only AM dose schedule and skip PM doses.
Children
<18yrs: not established.
Otezla Contraindications
Not Applicable
Otezla Boxed Warnings
Not Applicable
Otezla Warnings/Precautions
Warnings/Precautions
Discontinue if serious hypersensitivity reactions develop. Risk of severe diarrhea, nausea, and vomiting; monitor patients susceptible to complications (eg, elderly, volume depleted, hypotension); consider reducing dose or suspending therapy if occurs. History of depression and/or suicidal thoughts or behaviors; monitor for clinical worsening or other mood changes. Monitor weight regularly; evaluate and consider discontinuing if unexplained or significant weight loss occurs. Severe renal impairment. Pregnancy. Nursing mothers.
Otezla Pharmacokinetics
Absorption
Absolute bioavailability: ~73%.
Distribution
Plasma protein bound: ~68%. Mean apparent volume of distribution (Vd): 87 L.
Elimination
Renal (58%), fecal (39%). Half-life: 6–9 hours.
Otezla Interactions
Interactions
Concomitant strong CYP450 inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin): not recommended.
Otezla Adverse Reactions
Adverse Reactions
Diarrhea, nausea, headache, upper respiratory tract infection, vomiting, upper abdominal pain; weight loss, depression, hypersensitivity reactions.
Otezla Clinical Trials
See Literature
Otezla Note
Notes
Register pregnant patients exposed to Otezla by calling (877) 311-8972.
Otezla Patient Counseling
See Literature
Otezla Generic Name & Formulations
Legal Class
Rx
General Description
Apremilast 10mg, 20mg, 30mg; tabs.
Pharmacological Class
Phosphodiesterase 4 (PDE4) inhibitor.
How Supplied
Tabs 30mg—60, 500; 2-week starter pack—13+14; 28-day starter pack—13+42; Carton—2×14
Manufacturer
Generic Availability
NO
Mechanism of Action
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action is not well defined.
Otezla Indications
Indications
Oral ulcers associated with Behcet's Disease.
Otezla Dosage and Administration
Adult
Swallow whole. Initially titrate over 5 days. Starting on Day 1: 10mg in the AM. Day 2: 10mg in AM and 10mg in PM. Day 3: 10mg in AM and 20mg in PM. Day 4: 20mg in AM and 20mg in PM. Day 5: 20mg in AM and 30mg in PM. Following on Day 6 and thereafter: 30mg twice daily (AM & PM). Severe renal impairment (CrCl <30mL/min): reduce to 30mg once daily; for initial titration, use only AM dose schedule and skip PM doses.
Children
<18yrs: not established.
Otezla Contraindications
Not Applicable
Otezla Boxed Warnings
Not Applicable
Otezla Warnings/Precautions
Warnings/Precautions
Discontinue if serious hypersensitivity reactions develop. Risk of severe diarrhea, nausea, and vomiting; monitor patients susceptible to complications (eg, elderly, volume depleted, hypotension); consider reducing dose or suspending therapy if occurs. History of depression and/or suicidal thoughts or behaviors; monitor for clinical worsening or other mood changes. Monitor weight regularly; evaluate and consider discontinuing if unexplained or significant weight loss occurs. Severe renal impairment. Pregnancy. Nursing mothers.
Otezla Pharmacokinetics
Absorption
Absolute bioavailability: ~73%.
Distribution
Plasma protein bound: ~68%. Mean apparent volume of distribution (Vd): 87 L.
Elimination
Renal (58%), fecal (39%). Half-life: 6–9 hours.
Otezla Interactions
Interactions
Concomitant strong CYP450 inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin): not recommended.
Otezla Adverse Reactions
Adverse Reactions
Diarrhea, nausea, headache, upper respiratory tract infection, vomiting, upper abdominal pain; weight loss, depression, hypersensitivity reactions.
Otezla Clinical Trials
See Literature
Otezla Note
Notes
Register pregnant patients exposed to Otezla by calling (877) 311-8972.
Otezla Patient Counseling
See Literature
Otezla Generic Name & Formulations
Legal Class
Rx
General Description
Apremilast 10mg, 20mg, 30mg; tabs.
Pharmacological Class
Phosphodiesterase 4 (PDE4) inhibitor.
How Supplied
Tabs 30mg—60, 500; 2-week starter pack—13+14; 28-day starter pack—13+42; Carton—2×14
Manufacturer
Generic Availability
NO
Mechanism of Action
Apremilast is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels. The specific mechanism(s) by which apremilast exerts its therapeutic action is not well defined.
Otezla Indications
Indications
In adults with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Otezla Dosage and Administration
Adult
Swallow whole. Initially titrate over 5 days. Starting on Day 1: 10mg in the AM. Day 2: 10mg in AM and 10mg in PM. Day 3: 10mg in AM and 20mg in PM. Day 4: 20mg in AM and 20mg in PM. Day 5: 20mg in AM and 30mg in PM. Following on Day 6 and thereafter: 30mg twice daily (AM & PM). Severe renal impairment (CrCl <30mL/min): reduce to 30mg once daily; for initial titration, use only AM dose schedule and skip PM doses.
Children
<18yrs: not established.
Otezla Contraindications
Not Applicable
Otezla Boxed Warnings
Not Applicable
Otezla Warnings/Precautions
Warnings/Precautions
Discontinue if serious hypersensitivity reactions develop. Risk of severe diarrhea, nausea, and vomiting; monitor patients susceptible to complications (eg, elderly, volume depleted, hypotension); consider reducing dose or suspending therapy if occurs. History of depression and/or suicidal thoughts or behaviors; monitor for clinical worsening or other mood changes. Monitor weight regularly; evaluate and consider discontinuing if unexplained or significant weight loss occurs. Severe renal impairment. Pregnancy. Nursing mothers.
Otezla Pharmacokinetics
Absorption
Absolute bioavailability: ~73%.
Distribution
Plasma protein bound: ~68%. Mean apparent volume of distribution (Vd): 87 L.
Elimination
Renal (58%), fecal (39%). Half-life: 6–9 hours.
Otezla Interactions
Interactions
Concomitant strong CYP450 inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin): not recommended.
Otezla Adverse Reactions
Adverse Reactions
Diarrhea, nausea, headache, upper respiratory tract infection, vomiting, upper abdominal pain; weight loss, depression, hypersensitivity reactions.
Otezla Clinical Trials
See Literature
Otezla Note
Notes
Register pregnant patients exposed to Otezla by calling (877) 311-8972.
Otezla Patient Counseling
See Literature
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