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 (PDE4) inhibitor presented as a 30 mg tablet for oral use. It is indicated for the treatment of plaque psoriasis and psoriatic arthritis in adult patients, acting as an immunomodulatory agent to reduce inflammatory activity.

GNH India supplies Otezla as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide, providing reliable access to EU‑market medicines for qualified healthcare providers across multiple regions and regulatory environments, with consistent quality and traceability.

Manufacturer / TM Owner

Amgen Europe B.V.

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Indications & Clinical Uses

Apremilast is used to manage inflammatory skin and joint disorders within the psoriasis and psoriatic arthritis disease spectrum.

  • Plaque psoriasis (moderate to severe): improves skin clearance and reduces lesion severity.
  • Psoriatic arthritis: alleviates joint pain, swelling and improves functional ability.
  • Combined psoriatic disease: provides benefit for patients experiencing both skin and joint manifestations.

How It Works

  • Apremilast selectively inhibits the intracellular enzyme phosphodiesterase‑4 (PDE4). By blocking PDE4, the drug prevents the breakdown of cyclic adenosine monophosphate (cAMP), leading to elevated cAMP levels in immune cells. The increased cAMP modulates downstream signaling, resulting in reduced production of pro‑inflammatory cytokines such as TNF‑α, IL‑17 and IL‑23, and enhanced anti‑inflammatory mediators, thereby attenuating the inflammatory response characteristic of psoriasis and psoriatic arthritis.

Side Effects

Apremilast may cause a range of adverse reactions, which are generally categorized by frequency and severity.

Common Side Effects

  • Nausea: mild to moderate stomach upset.
  • Diarrhea: loose stools, often transient.
  • Headache: mild tension‑type headaches.
  • Upper respiratory tract infection: cold‑like symptoms.
  • Weight loss: modest decrease in body weight.
  • Depressed mood: occasional feelings of sadness.

Serious or Rare Side Effects

  • Severe depression or suicidal ideation: requires immediate medical attention.
  • Allergic reactions: rash, pruritus, or angioedema.
  • Pancreatitis: abdominal pain with elevated enzymes.
  • Severe infections: opportunistic infections in immunocompromised patients.

Precautions & Warnings

When prescribing Apremilast, clinicians should consider several precautionary measures to ensure safe use.

  • Pregnancy: category B, use only if benefit outweighs risk.
  • Breastfeeding: limited data, weigh benefits versus potential exposure.
  • Renal impairment: dose adjustment may be required in severe renal dysfunction.
  • Hepatic impairment: monitor liver function tests periodically.
  • Depression: assess for history of depression or suicidal thoughts before initiating therapy.
  • Store at ambient temperature: keep tablets below 25 °C in the original container, protect from moisture and light.

Avoid Interactions

Apremilast can interact with other medicines, affecting its efficacy or safety profile.

Major Interactions (Avoid)

  • Strong CYP3A4 inducers (e.g., rifampin, carbamazepine): may reduce apremilast plasma concentrations.
  • Strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin): may increase apremilast exposure.

Moderate Interactions (Monitor Closely)

  • Anticoagulants (warfarin): monitor INR as apremilast may affect metabolism.
  • Methotrexate: observe for additive hepatotoxicity.
  • Diuretics: monitor electrolytes as apremilast may influence renal clearance.
  • Live vaccines: consider timing as immunomodulation may affect vaccine response.

Frequently Asked Questions

Otezla contains the active ingredient apremilast and is prescribed for adult patients with moderate to severe plaque psoriasis and for those with active psoriatic arthritis. It helps reduce skin lesions, joint inflammation, and improves overall disease control.

Apremilast selectively inhibits the enzyme phosphodiesterase‑4 (PDE4), which raises intracellular cAMP levels. Elevated cAMP modulates immune cell signaling, decreasing the production of pro‑inflammatory cytokines such as TNF‑α, IL‑17 and IL‑23, thereby dampening the inflammatory processes underlying psoriasis and psoriatic arthritis.

The dosage of Otezla is individualized by the prescribing clinician. Typically, treatment begins with a titration schedule to reach the target dose of 30 mg taken twice daily, but the exact regimen is determined based on patient tolerance, renal function, and clinical response.

Apremilast is classified as pregnancy category B, indicating that animal studies have not shown risk but there are no adequate human studies. It should be used during pregnancy only if the potential benefit justifies the potential risk. Limited data are available for breastfeeding; a risk‑benefit assessment should be performed by the healthcare provider.

To request Otezla, submit an enquiry on the product page at gnhindia.com specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements) and the necessary import documentation.

The primary alternatives to apremilast are biologic agents such as TNF‑α inhibitors or IL‑17 inhibitors. Unlike biologics, Otezla is an oral small‑molecule therapy, which avoids injections and may have a different safety profile, but biologics often provide higher efficacy in severe disease. Choice depends on disease severity, patient preference, comorbidities and cost considerations.

Store Otezla tablets at ambient temperature, preferably below 25 °C, in the original blister pack to protect from moisture and light. Keep the container tightly closed and out of reach of children. Do not refrigerate or freeze the tablets.

Otezla is taken orally as a tablet. Patients should swallow each tablet whole with water, typically twice daily after a titration period. It may be taken with or without food, but consistent administration with respect to meals helps maintain steady drug levels.

Serious risks include severe depression, suicidal thoughts or behavior, and rare cases of pancreatitis. Patients should be monitored for mood changes, abdominal pain, and signs of infection. Immediate medical attention is required if any of these serious adverse events occur.

Otezla is contraindicated in individuals with known hypersensitivity to apremilast or any tablet excipients. Caution is advised for patients with severe hepatic impairment, uncontrolled depression, or a history of suicidal ideation. It should also be avoided in patients taking strong CYP3A4 inducers without appropriate dose adjustments.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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