apremilast

(redirected from Otezla)

apremilast

(a-pre-mil-ast),

Otezla

(trade name)

Classification

Therapeutic: antirheumatics
Pharmacologic: temporary class
Pregnancy Category: C

Indications

Treatment of active psoriatic arthritis.

Action

Acts as an inhibitor of phosphodiesterase type 4 (PDE4). Inhibition of PDE4 results in ↑ intracellular levels of cyclic adenosine monophosphate (cAMP).

Therapeutic effects

Decreased severity of psoriatic arthritis with improved joint function.

Pharmacokinetics

Absorption: 73 % absorbed following oral administration.
Distribution: Unknown.
Metabolism and Excretion: Extensively metabolized (mostly by CYP3A4); metabolites are not pharmacologically active. Excreted in urine (58%) and feces (39%) as inactive metabolites; 3% excreted unchanged in urine, 7% in feces.
Half-life: 6–9 hr.

Time/action profile (blood levels†)

ROUTEONSETPEAKDURATION
POunknown2.5 hr 12–24 hr
† Improvement in joint symptoms make take up to 4 mos.

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Concurrent use of P450 enzyme inducers.
Use Cautiously in: History of depression or suicidal ideation; Severe renal impairment (dose reduction required for CCr <30 mL/min); Obstetric: Use during pregnancy only if potential benefits justify potential fetal risks; Lactation: Use caution if breastfeeding; Pediatric: Safe and effective use in children <18 yr has not been established.

Adverse Reactions/Side Effects

Central nervous system

  • depression
  • headache

Gastrointestinal

  • diarrhea
  • nausea
  • upper abdominal pain
  • vomiting

Metabolic

  • weight loss

Interactions

Drug-Drug interaction

Concurrent use of P450 enzyme inducers including carbamazepine, phenobarbital, phenytoin and rifampin may ↓ blood levels and effectiveness; concurrent use should be avoided.

Route/Dosage

Oral (Adults ) Day 1—10 mg in the morning; day 2—10 mg in the morning and 10 mg in the evening; day 3—10 mg in the morning and 20 mg in the evening; day 4—20 mg in the morning and 20 mg in the evening; day 5—20 mg in the morning and 30 mg in the evening; day 6 and thereafter—30 mg in the morning and 30 mg in the evening.

Renal Impairment

Oral (Adults CCr <30 mL/min) Days 1–3—10 in the morning; days 4–5—20 mg in the morning; day 6 and thereafter—30 mg in the morning.

Availability

Tablets: 10 mg, 20 mg, 30 mg

Nursing implications

Nursing assessment

  • Assess pain and range of motion before and periodically during therapy.
  • Monitor mental status for signs and symptoms of depression (orientation, mood behavior) frequently. Assess for suicidal tendencies, especially during early therapy.
  • Obtain weight and BMI initially and periodically during treatment. If clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of therapy.

Potential Nursing Diagnoses

Chronic pain (Indications)
Impaired skin integrity (Indications)
Deficient knowledge, related to medication regimen (Patient/Family Teaching)

Implementation

  • Follow titration guidelines when beginning therapy to minimize GI side effects.
  • Oral: Administer without regard for meals. Swallow tablet whole; do not crush, break, or chew.

Patient/Family Teaching

  • Instruct patient to take apremilast as directed.
  • Advise patient, family and caregivers to look for suicidality, especially during early therapy or dose changes. Notify health care professional immediately if thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, agitation or restlessness, panic attacks, insomnia, new or worse irritability, aggressiveness, acting on dangerous impulses, mania, or other changes in mood or behavior occur.
  • Inform patient of need to monitor weight regularly. Notify health care professional if unexplained or clinically significant weight loss occurs.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Improvement in pain and function in patients with psoriatic arthritis.
Drug Guide, © 2015 Farlex and Partners
References in periodicals archive ?
(NASDAQ: AMGN)'s $13.4-billion deal to buy the psoriasis drug Otezla from Celgene Corporation (NASDAQ: CELG) and Johnson & Johnson (NYSE:JNJ)'s $572-million settlement agreement with the state of Oklahoma in an opioid lawsuit.
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Amgen believes that the Otezla acquisition offers many benefits.
(Alliance News) - Moody's Investors Service on Monday said Amgen Inc's Otezla acquisition is credit negative given the resulting reduction in cash, as well as a "rich multiple".
ENPNewswire-August 27, 2019--Bristol-Myers Squibb Announces Agreement between Celgene and Amgen to Divest OTEZLA for $13.4 Billion
RBC Capital analyst Kennen MacKay raised his price target on Amgen to $206, saying that despite the "sticker shock" of its $13.4B deal for the Otezla franchise, the transaction is expected to be immediately accretive to earnings and fitting well with its existing inflammation and immunology portfolio.
regulators are requiring BMS to sell Celgene's blockbuster psoriasis and psoriatic arthritis drug Otezla.
Based on drug, the dermatology drugs market has been mainly classified into Humira, Remicade, Otezla, Stelara, Enbrel, Cosentyx, Neoral, Taltz, Cubicin, Canesten, Zyvox, Dupixent, Protopic, Valtrex, and Eucrisa.
The Mega M&A news on January third, when BMS announced plans to acquire Celgene in a transaction valued at approximately $74 billion, will result in leading franchises in oncology (in both solid tumors and hematologic malignancies) led by Opdivo and Yervoy as well as Revlimid and Pomalyst; Immunology and Inflammation (led by Orencia and Otezla) and Cardiovascular Disease with Eliquis.
On Monday, Bristol-Myers said that it had agreed to divest one of Celgene's top products, the psoriasis pill Otezla, in order to appease regulators at the U.S.