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 USA 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.

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.

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.

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.

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.