OTEZLA 30mg Tablets/Film-coated

What is OTEZLA 30mg

OTEZLA 30mg is a film-coated oral tablet containing the active substance Apremilast. It is classified as a phosphodiesterase 4 (PDE4) inhibitor and is commonly prescribed for:

• Moderate to severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy.
• Active psoriatic arthritis to reduce signs and symptoms in adults.
• Oral ulcers associated with Behçet’s Disease in adults.

Unlike biologics, OTEZLA is not an immunosuppressant or injectable. It works by modulating inflammatory pathways at a cellular level without directly affecting immune cell populations. Its oral formulation makes it a convenient alternative to injectable therapies for chronic inflammatory diseases.

OTEZLA is marketed in various dosage strengths, but the 30mg tablet is the maintenance dose used after an initial titration period to reduce the risk of gastrointestinal side effects.

How to use OTEZLA 30mg

Proper usage of OTEZLA 30mg is crucial to ensure effectiveness and reduce potential side effects:

• Initial Dose Titration: The first 5 days involve a titration period, gradually increasing the dosage to minimize side effects like nausea or diarrhea.
• Maintenance Dose: After titration, the recommended dose is 30mg twice daily (morning and evening), taken at approximately the same times each day.
• With or Without Food: OTEZLA can be taken with or without meals.
• Do Not Crush or Split: The tablets should be swallowed whole with water. Do not break, chew, or crush the tablets.
• Missed Dose: If a dose is missed, take it as soon as remembered. If it is close to the next scheduled dose, skip the missed dose. Do not double the dose.

Patients should be regularly monitored for changes in weight, mood, and signs of depression. Consult your healthcare provider before stopping the medication abruptly.

Mode of Action OTEZLA 30mg

Apremilast, the active component of OTEZLA 30mg, is a selective PDE4 (phosphodiesterase 4) inhibitor. Its mechanism of action involves:

• Inhibition of PDE4 enzyme: PDE4 is an intracellular enzyme that breaks down cyclic adenosine monophosphate (cAMP).
• Increased intracellular cAMP levels: This results in the downregulation of pro-inflammatory mediators such as TNF-alpha, IL-17, and IL-23.
• Modulation of immune response: It reduces excessive immune activity without broadly suppressing immune cells, providing targeted anti-inflammatory effects.

Unlike traditional immunosuppressive drugs, Apremilast does not compromise the overall immune system, making it a safer option for long-term use in chronic inflammatory conditions. The therapeutic effects are gradual and may take several weeks to become noticeable.

OTEZLA 30mg Interactions OTEZLA 30mg

OTEZLA has a defined interaction profile that needs careful consideration:

• Strong CYP3A4 Inducers: Medications such as rifampin, carbamazepine, phenytoin, and St. John’s Wort may reduce the effectiveness of OTEZLA by increasing its metabolism.
• CYP3A4 Inhibitors: While these may increase Apremilast levels, clinical consequences are generally minimal.
• Other Immunosuppressants: Combining with other DMARDs or biologics (like methotrexate, adalimumab) should be done with caution and under medical supervision.
• NSAIDs and corticosteroids: Generally safe to use concurrently, but dosage adjustments may be needed based on patient response.
• Live vaccines: Use with caution, as the immune modulation may affect vaccine efficacy.

Always inform your healthcare provider of all prescription, OTC, and herbal products you're using to prevent unwanted interactions.

Dosage of OTEZLA 30mg

The dosage regimen of OTEZLA 30mg includes an initial titration phase followed by a maintenance phase:

• Titration Schedule (Days 1–5):
  • Day 1: 10 mg in the morning
  • Day 2: 10 mg in the morning and evening
  • Day 3: 10 mg in the morning and 20 mg in the evening
  • Day 4: 20 mg twice daily
  • Day 5: 20 mg in the morning and 30 mg in the evening
• Maintenance Dose (Day 6 onwards): 30 mg taken twice daily.

This schedule helps reduce the incidence of gastrointestinal discomfort. The tablets should be swallowed whole with water, with or without food. Dose adjustments may be necessary for patients with renal impairment (creatinine clearance <30 mL/min), in which case 30 mg once daily may be recommended.

Possible side effects of OTEZLA 30mg

While OTEZLA is generally well tolerated, some individuals may experience side effects:

• Very Common (>10%):
  • Diarrhea
  • Nausea
  • Headache
• Common (1–10%):
  • Upper respiratory tract infections
  • Fatigue
  • Weight loss
  • Back pain
• Uncommon or Rare:
  • Depression or mood changes
  • Allergic reactions (rash, pruritus, facial swelling)
  • Increased risk of infections

Any signs of mood alterations, suicidal thoughts, or significant weight loss should be reported to a healthcare provider immediately.

OTEZLA 30mg Contraindications OTEZLA 30mg

OTEZLA 30mg is contraindicated in the following cases:

• Known Hypersensitivity: To Apremilast or any excipient in the formulation.
• Severe Renal Impairment: In patients with creatinine clearance <30 mL/min, unless adjusted.
• Pregnancy: OTEZLA is not recommended due to potential fetal risks. Women of childbearing potential should use effective contraception.
• Breastfeeding: Not advised as safety data in lactation is insufficient.
• Major depressive disorder: Use with caution in individuals with a history of psychiatric disorders due to risk of mood changes or suicidal ideation.

Always consult with a healthcare professional before initiating treatment to ensure patient suitability and safety.

Storage of OTEZLA 30mg

Proper storage ensures the medicine maintains its effectiveness and safety:

• Temperature: Store below 30°C (86°F) in a cool, dry place.
• Original Packaging: Keep in the original blister pack until time of use to protect from moisture and light.
• Keep Away from Children: Store out of reach and sight of children to prevent accidental ingestion.
• Do Not Use After Expiry: Discard any unused medication after the expiration date printed on the packaging.

Do not dispose of medications in wastewater or household trash. Follow local guidelines for safe disposal of pharmaceuticals.