Product image of Otezla (Apremilast) supplied by GNH India

Otezla

Active Ingredient:
Apremilast
Origin:
EU

Otezla (Apremilast)

Apremilast, the active ingredient in Otezla, is a phosphodiesterase‑4 (PDE‑4) inhibitor presented as a tablet for oral use. It is indicated for the treatment of certain chronic inflammatory skin conditions in adult patients. GNH India supplies Otezla as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

GNH India supplies Otezla as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Amgen Europe B.V.

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Indications & Clinical Uses

Otezla is a phosphodiesterase‑4 inhibitor used in the management of inflammatory skin disorders.

  • Plaque psoriasis: reduces skin lesions and improves quality of life.
  • Psoriatic arthritis: alleviates joint pain and swelling while slowing disease progression.
  • Oral ulcers associated with Behçet’s disease: decreases frequency and severity of ulcer episodes.

How It Works

  • Apremilast selectively inhibits the intracellular enzyme phosphodiesterase‑4, leading to increased intracellular cyclic adenosine monophosphate (cAMP). Elevated cAMP modulates the expression of inflammatory mediators, decreasing pro‑inflammatory cytokines such as TNF‑α, IL‑17 and IL‑23 while enhancing anti‑inflammatory pathways, which collectively reduces inflammation in target tissues.

Side Effects

Adverse reactions reported with apremilast are generally mild to moderate and reflect its immunomodulatory activity.

Common Side Effects

  • Diarrhea: typically transient and resolves with continued therapy.
  • Nausea: may occur early in treatment.
  • Headache: often mild and improves over time.
  • Upper respiratory tract infection: common viral symptoms.
  • Weight loss: modest reduction observed in some patients.
  • Insomnia: occasional difficulty falling asleep.

Serious or Rare Side Effects

  • Depression or suicidal ideation: monitor mood changes.
  • Severe allergic reactions: signs include rash, swelling, or breathing difficulty.
  • Pancreatitis: rare abdominal pain with elevated enzymes.
  • Severe infections: opportunistic infections in immunocompromised patients.
  • Hepatotoxicity: abnormal liver function tests.
  • Cardiovascular events: rare cases of myocardial infarction reported.

Precautions & Warnings

When prescribing apremilast, clinicians should consider several safety aspects.

  • Pregnancy: limited data; use only if potential benefit outweighs risk.
  • Breastfeeding: unknown safety; weigh benefits against potential infant exposure.
  • Renal impairment: dose adjustment may be required in severe dysfunction.
  • Hepatic impairment: monitor liver enzymes regularly.
  • History of depression: assess mental health before initiation.
  • Store at ambient temperature: keep below 25°C, retain original packaging, and protect from moisture.

Avoid Interactions

Apremilast may interact with other medicines, requiring attention to avoid reduced efficacy or increased toxicity.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine) may lower apremilact levels.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole) may increase exposure, raising side‑effect risk.

Moderate Interactions (Monitor Closely)

  • Warfarin: may require INR monitoring.
  • Methotrexate: additive immunosuppressive effect.
  • Digoxin: potential increase in serum concentrations.
  • Oral contraceptives: monitor for reduced efficacy.
  • Antacids containing aluminum or magnesium: may affect absorption.

Frequently Asked Questions

  

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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