Arthritis/rheumatic disorders:
Indications for: OTEZLA
Active psoriatic arthritis.
Adult Dosage:
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 Dosage:
<18yrs: not established.
OTEZLA 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 Classification:
Phosphodiesterase 4 (PDE4) inhibitor.
OTEZLA Interactions:
Concomitant strong CYP450 inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin): not recommended.
Adverse Reactions:
Diarrhea, nausea, headache, upper respiratory tract infection, vomiting, upper abdominal pain; weight loss, depression, hypersensitivity reactions.
Note:
Register pregnant patients exposed to Otezla by calling (877) 311-8972.
Generic Drug Availability:
NO
How Supplied:
Tabs 30mg—60, 500; 2-week starter pack—13+14; 28-day starter pack—13+42; Carton—2x14
Oral inflammation/ulcers:
Indications for: OTEZLA
Oral ulcers associated with Behcet's Disease.
Adult Dosage:
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 Dosage:
<18yrs: not established.
OTEZLA 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 Classification:
Phosphodiesterase 4 (PDE4) inhibitor.
OTEZLA Interactions:
Concomitant strong CYP450 inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin): not recommended.
Adverse Reactions:
Diarrhea, nausea, headache, upper respiratory tract infection, vomiting, upper abdominal pain; weight loss, depression, hypersensitivity reactions.
Note:
Register pregnant patients exposed to Otezla by calling (877) 311-8972.
Generic Drug Availability:
NO
How Supplied:
Tabs 30mg—60, 500; 2-week starter pack—13+14; 28-day starter pack—13+42; Carton—2x14
Psoriasis:
Indications for: OTEZLA
In adults with plaque psoriasis who are candidates for phototherapy or systemic therapy.
Adult Dosage:
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 Dosage:
<18yrs: not established.
OTEZLA 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 Classification:
Phosphodiesterase 4 (PDE4) inhibitor.
OTEZLA Interactions:
Concomitant strong CYP450 inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin): not recommended.
Adverse Reactions:
Diarrhea, nausea, headache, upper respiratory tract infection, vomiting, upper abdominal pain; weight loss, depression, hypersensitivity reactions.
Note:
Register pregnant patients exposed to Otezla by calling (877) 311-8972.
Generic Drug Availability:
NO
How Supplied:
Tabs 30mg—60, 500; 2-week starter pack—13+14; 28-day starter pack—13+42; Carton—2x14
