Brand Name
Otezla
Generic Name
Apremilast
View Brand Information FDA approval date: February 26, 2020
Classification: Phosphodiesterase 4 Inhibitor
Form: Tablet, Kit
What is Otezla (Apremilast)?
OTEZLA, an inhibitor of phosphodiesterase 4 , is indicated for the treatment of: Adult patients with active psoriatic arthritis.
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A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)
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Brand Information
Otezla (apremilast)
1DOSAGE FORMS AND STRENGTHS
OTEZLA is available as diamond-shaped, film-coated tablets in the following dosage strengths:
- 10-mg pink tablet engraved with "APR" on one side and "10" on the other side
- 20-mg brown tablet engraved with "APR" on one side and "20" on the other side
- 30-mg beige tablet engraved with "APR" on one side and "30" on the other side
OTEZLA XR is available as 75 mg round, biconvex, pink, film-coated extended-release tablets with "APR 75" printed in black on one side and a hole or indentation on either side of the tablet, which may or may not be visible.
2CONTRAINDICATIONS
OTEZLA/OTEZLA XR is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation
3ADVERSE REACTIONS
The following adverse reactions are described elsewhere in the labeling:
- Hypersensitivity
- Diarrhea, Nausea, and Vomiting
- Depression
- Weight Decrease
- Drug Interactions
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
4DESCRIPTION
The active ingredient in OTEZLA/OTEZLA XR tablets is apremilast. Apremilast drug substance is non-hygroscopic. Apremilast drug substance is practically insoluble in water and slightly soluble in alcohol.
Apremilast is a phosphodiesterase 4 (PDE4) inhibitor. Apremilast is known chemically as
The chemical structure is:
OTEZLA (apremilast) tablets are supplied in 10 mg, 20 mg, and 30 mg strengths for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: croscarmellose sodium, iron oxide red, iron oxide yellow (20 and 30 mg only), iron oxide black (30 mg only), lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.
OTEZLA XR (apremilast) extended-release tablets are supplied in a 75 mg strength for oral administration. Each tablet contains apremilast as the active ingredient and the following inactive ingredients: cellulose acetate, colloidal silicon dioxide, ferrosoferric oxide, hydroxypropyl methylcellulose acetate succinate, hypromellose, iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polyethylene oxide, sodium chloride, titanium dioxide.
5HOW SUPPLIED/STORAGE AND HANDLING
OTEZLA is available as diamond-shaped, film-coated tablets in the following dosage strengths: 10 mg pink tablet engraved with "APR" on one side and "10" on the other side; 20 mg brown tablet engraved with "APR" on one side and "20" on the other side; 30 mg beige tablet engraved with "APR" on one side and "30" on the other side.
Tablets are supplied in the strengths and package configurations listed in Table 14.
OTEZLA XR is available as 75 mg round, biconvex, pink, film-coated extended-release tablets with "APR 75" printed in black on one side and a hole or indentation on either side of the tablet, which may or may not be visible.
Tablets are supplied in the strengths and package configurations listed in Table 15.
6PATIENT COUNSELING INFORMATION
- Administration Instructions
Instruct patients to take OTEZLA/OTEZLA XR only as prescribed [see . Advise patients to take OTEZLA/OTEZLA XR with or without food. Instruct patients to swallow tablets whole and not to crush, split, or chew prior to swallowing [see . - Hypersensitivity
Inform patients that hypersensitivity reactions can occur following administration of OTEZLA/OTEZLA XR. Instruct patients to contact their healthcare provider if they experience symptoms of an allergic reaction [see . - Diarrhea, Nausea, and Vomiting
Advise patients of the potential complications of severe diarrhea, nausea, or vomiting and instruct them to contact their healthcare provider if they experience these adverse reactions, especially if the patient is 65 years of age or older [see . - Depression
Inform patients that treatment with OTEZLA/OTEZLA XR is associated with an increased incidence of depression. Advise patients, their caregivers, and families of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider [see . - Weight Decrease
Inform patients that treatment with OTEZLA/OTEZLA XR is associated with potential weight loss. Instruct patients or caregivers to have their or their child's weight monitored regularly and, if unexplained or clinically significant weight loss occurs, to contact their healthcare provider for evaluation of the weight loss [see . - Pregnancy
Advise pregnant patients and patients of reproductive potential of the potential risk to a fetus. Advise patients to inform their prescriber of a known or suspected pregnancy [see . - Residual Tablet Shell
Patients receiving OTEZLA XR may notice an inert tablet shell passing in the stool or via colostomy. Patients should be informed that the active medication has already been absorbed by the time the patient sees the inert tablet shell.
7PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
NDC 55513-137-60
Otezla
30 mg
Rx Only
8PRINCIPAL DISPLAY PANEL - 28 Day Treatment Initiation Pack
NDC 55513-369-55
Otezla
28 Day
This pack contains the following
Four - 10 mg tablets
55 TABLETS
Rx Only
AMGEN
9PRINCIPAL DISPLAY PANEL - 14 Day Treatment Initiation Pack - 55513-485-95
NDC 55513-485-95
Otezla
14 Day
SAMPLE - NOT FOR SALE
This pack contains the following
Four - 10 mg tablets
27 TABLETS
Rx Only
AMGEN
10PRINCIPAL DISPLAY PANEL - 14 Day Treatment Initiation Pack - 55513-485-96
NDC 55513-485-96
14 Day Treatment
SAMPLE - NOT FOR SALE
Each pack contains the following for titration
Rx Only
AMGEN
Otezla
11PRINCIPAL DISPLAY PANEL - 60 Tablet Bottle Label
NDC 55513-497-60
Otezla
20 mg
Rx Only
60 Tablets
12PRINCIPAL DISPLAY PANEL - 28 Day Treatment Initiation Pack - 55513-508-55
NDC 55513-508-55
Otezla
28 Day
This pack contains the following
Four - 10 mg tablets
55 TABLETS
Rx Only
AMGEN
13PRINCIPAL DISPLAY PANEL - 14 Day Treatment Initiation Pack - 55513-996-95
NDC 55513-996-95
14 Day Treatment
SAMPLE - NOT FOR SALE
Each pack contains the following for titration over
Rx Only
AMGEN
Otezla
14PRINCIPAL DISPLAY PANEL - 14 Day Treatment Initiation Pack - 55513-996-96
NDC 55513-996-96
Otezla
14 Day
SAMPLE - NOT FOR SALE
This pack contains the following
Four - 10 mg tablets
27 TABLETS
Rx Only
AMGEN
15PRINCIPAL DISPLAY PANEL - 75 mg Tablet Bottle Label
Once-daily
Otezla XR™
75 mg
Rx Only
16PRINCIPAL DISPLAY PANEL - 28 Day Treatment Initiation Pack - 55513-516-41
NDC 55513-516-41
Otezla
10 mg, 20 mg, 30 mg
Otezla XR™
75 mg
28 Day
This pack contains the following for titration
Four - 10 mg tablets
Contains a total of 41 tablets.
Rx Only
