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OTEZLA
Arthritis/rheumatic disorders
Psoriasis
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Drug Name:

OTEZLA Rx

Generic Name and Formulations:
Apremilast 10mg, 20mg, 30mg; tabs.

Company:
Celgene Corp

Therapeutic Use:

Indications for OTEZLA:

Active psoriatic arthritis.

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.

Warnings/Precautions:

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. Renal impairment. Pregnancy (Cat.C). Nursing mothers.

Interactions:

Concomitant strong CYP450 inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin): not recommended.

Pharmacological Class:

Phosphodiesterase 4 (PDE4) inhibitor.

Adverse Reactions:

Diarrhea, nausea, headache, upper respiratory tract infection, vomiting, nasopharyngitis, upper abdominal pain; weight loss, depression.

Note:

Register pregnant patients exposed to Otezla by calling (877) 311-8972.

How Supplied:

Tabs 30mg—60; 2-week starter pack—13+14; 28-day starter pack—13+42; Carton—2x14

Indications for OTEZLA:

Moderate-to-severe plaque psoriasis, in adults who are candidates for phototherapy or systemic therapy.

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.

Warnings/Precautions:

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. Renal impairment. Pregnancy (Cat.C). Nursing mothers.

Interactions:

Concomitant strong CYP450 inducers (eg, rifampin, phenobarbital, carbamazepine, phenytoin): not recommended.

Pharmacological Class:

Phosphodiesterase 4 (PDE4) inhibitor.

Adverse Reactions:

Diarrhea, nausea, headache, upper respiratory tract infection, vomiting, nasopharyngitis, upper abdominal pain; weight loss, depression.

Note:

Note: Register pregnant patients exposed to Otezla by calling (877) 311-8972.

How Supplied:

Tabs 30mg—60; 2-week starter pack—13+14; 28-day starter pack—13+42; Carton—2x14

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