Otezla Tablets / Film-coated
Apremilast
"Apremilast 27 tablets [4 x 10 mg tablets, 4 x 20 mg tablets and 19 x 30 mg tablets]"
Celgene Europe Ltd
| Pack size | 27 Tablets [4 x 10mg Tablets, 4 x 20mg Tablets and 19 x 30mg Tablets] |
|---|---|
| Dispensing mode | POM |
| Source | UK |
| Agent | CITY MEDICAL STORE |
| Retail Price | 1981.50 AED |
Available as:
Indications
Otezla Tablets / Film-coated is used for:
Active psoriatic arthritis, moderate to severe plaque psoriasis
Adult Dose
Active psoriatic arthritis, moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate.
To reduce risk of gastrointestinal symptoms, titrate to recommended dose of 30 mg twice daily according to the following schedule:
Day 1: 10 mg in morning
Day 2: 10 mg in morning and 10 mg in evening
Day 3: 10 mg in morning and 20 mg in evening
Day 4: 20 mg in morning and 20 mg in evening
Day 5: 20 mg in morning and 30 mg in evening
Day 6 and thereafter: 30 mg twice daily
Hepatic impairment: No dosage adjustment required
Child Dose
Renal Dose
Severe renal impairment (CrCl <30 mL/min): Reduce dose to 30 mg PO qDay
Mild-to-moderate renal impairment: No dosage adjustment required
Administration
To reduce risk of GI symptoms associated with initial therapy, titrate to recommended dose (30 mg PO BID) according to the dosage schedules listed above
Can be administered without regard to meals
Swallow tablet whole; do not crush, split, or chew
Contra Indications
Known hypersensitivity to apremilast.
Precautions
Apremilast is associated with an increase in adverse reactions of depression. Before using, evaluate patient for history of depression and/or suicidal thoughts or behavior.
Weight decrease of 5-10% of body weight. Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of Apremilast.
Lactation: Unknown if distributed in human breast milk; caution required
Pregnancy-Lactation
Pregnancy
Available pharmacovigilance data use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes, but data are extremely limited
Based on findings from animal reproduction studies, may increase the risk for fetal loss
Lactation
There are no data on the presence of apremilast in human milk, the effects on the breastfed infant, or the effects on milk production
Detected in the milk of lactating mice
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed infant or from the underlying maternal condition
Interactions
Coadministration with strong CYP inducers (eg, rifampin, carbamazepine, phenobarbital phenytoin) may occur and result in a loss of efficacy of apremilast; therefore, coadministration is not recommended.
Adverse Effects
Side effects of Apremilast :
1-10%
Diarrhea (7.7-9.3%), Nausea (7.4-8.9%), Headache (4.8-5.9%), Upper respiratory tract infection (0.6-3.9%), Vomiting (0.8-3.2%), Nasopharyngitis (0.2-2.6%), Upper abdominal pain (0.6-2%)
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 in psoriatic arthritis patients and psoriasis patients is not well defined.
Note
Otezla "Apremilast 27 tablets [4 x 10 mg tablets, 4 x 20 mg tablets and 19 x 30 mg tablets]" Tablets / Film-coated manufactured by Celgene Europe Ltd. Its generic name is Apremilast. Otezla is availble in United Arab Emirates.
Farmaco UAE drug index information on Otezla Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.