Apremilast

Apremilast instructions

Common name: Apremilast

Trade name: OTEZLA

All names: Apremilast, Apremilast, Apores, OT EZLA, MPRILA

Indications:

Adult patients with active psoriatic arthritis

Psoriasis

Dosage:

To reduce the risk of gastrointestinal symptoms, follow the schedule below Titrate to the recommended dose of 30 mg twice daily.

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

Fourth Day: 20 mg in the morning, 20 mg in the evening

Day 5: 20 mg in the morning, 30 mg in the evening

Day 6 and beyond: 30 mg twice daily

Severe renal impairment dose :

The recommended dose is 30 mg once daily

For initial dose titration, titrate only using the morning schedule listed in Table 1 and skip the afternoon dose

Adverse Reactions:

Psoriatic Arthritis: The most common adverse reactions (≥5%) are diarrhea, nausea, and headache.

Psoriasis: The most common adverse reactions (≥5%) were diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache.

Contraindications:

Known hypersensitivity to the prodrugs or any excipients in the formulation

Precautions:

Diarrhea, nausea, and vomiting: If a patient develops severe diarrhea, nausea, or vomiting, consider reducing the OTEZLA dose or discontinuing the drug.

Depression: Advise patients, their caregivers, and families to be aware of the emergence or worsening of depression, suicidal thoughts, or other changes in mood and to contact their health care provider if such changes occur. Carefully weigh the risks and benefits of treatment with OTEZLA in patients with a history of depression and/or suicidal thoughts or behaviors.

Weight loss: Monitor your weight regularly. If unexplained or clinically significant weight loss occurs, assess for weight loss and consider discontinuing OTEZLA

Storage:

Seal and store at 15-30°C

Mechanism of Action:

Apremilast works differently from other types of oral systemic medications for psoriasis in that it affects the entire immune system. Instead, Apremilast works by specifically targeting a certain molecule in immune system cells that is involved in causing inflammation, an enzyme called phosphodiesterase 4 (PDE4). By affecting the inflammatory process within cells, Apremilast reduces the activity in the immune system that causes chronic inflammation and plaque formation, thereby reducing skin flaking and scaling.

Safety and efficacy:

On March 21, 2014, the U.S. Food and Drug Administration (FDA) approved apremilast for the treatment of adults with active PsA.

The safety and efficacy of Apremilast, a phosphodiesterase-4 (PDE-4) inhibitor, were evaluated in three clinical trials involving 1,493 patients with active and active psoriatic arthritis (PsA). Patients treated with Apremilast tablets showed improvements in signs and symptoms of PsA, including tender and swollen joints, and physical function compared with placebo.