OTEZLA 10mg, 20mg & 30mg Tablets/Film-coated

What is OTEZLA 10mg, 20mg & 30mg

OTEZLA is the brand name for Apremilast, a prescription oral medication used primarily for managing inflammatory autoimmune conditions. It is commonly prescribed for:

• Psoriatic arthritis – to reduce joint pain, swelling, and tenderness.
• Moderate to severe plaque psoriasis – especially in patients who are candidates for systemic therapy or phototherapy.
• Oral ulcers associated with Behçet’s disease.

OTEZLA is a targeted therapy that helps modulate the immune system by inhibiting an enzyme involved in the inflammatory process, thus reducing symptoms without causing global immune suppression like other immunosuppressants.

The tablets are film-coated and come in three strengths: 10 mg, 20 mg, and 30 mg. The starter pack includes a titration schedule to help reduce the risk of gastrointestinal side effects during initiation.

How to use OTEZLA 10mg, 20mg & 30mg

OTEZLA is taken orally and should be used exactly as prescribed. To minimize side effects, it is started on a titration schedule over the first 5 days.

• 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
• Day 4: 20 mg in the morning and 20 mg in the evening
• Day 5: 20 mg in the morning and 30 mg in the evening
• Day 6 onward: 30 mg twice daily

Tablets can be taken with or without food and should be swallowed whole with water. Do not crush, split, or chew the tablets. Consistent use at the same time each day helps maintain stable blood levels and improve efficacy.

Mode of Action OTEZLA 10mg, 20mg & 30mg

Apremilast, the active ingredient in OTEZLA, is a selective phosphodiesterase 4 (PDE4) inhibitor. This enzyme is involved in the breakdown of cyclic adenosine monophosphate (cAMP), a messenger that regulates inflammation.

• By inhibiting PDE4, Apremilast increases intracellular cAMP levels.
• This elevation leads to a reduction in the production of pro-inflammatory cytokines such as TNF-α, IL-17, and IL-23.
• At the same time, it promotes the production of anti-inflammatory cytokines like IL-10.

This dual regulation modulates immune activity without broadly suppressing immune function, offering a safer profile compared to traditional systemic immunosuppressants.

OTEZLA 10mg, 20mg & 30mg Interactions OTEZLA 10mg, 20mg & 30mg

OTEZLA has a relatively low potential for drug interactions, but some drugs may impact its efficacy or increase side effects:

• Strong CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin, St. John's wort): Can significantly decrease OTEZLA blood levels and reduce its effectiveness.
• Medications for depression (e.g., SSRIs or SNRIs): While no direct interactions, concurrent use should be monitored as OTEZLA may impact mood.
• Immunosuppressants or biologics: Combined use hasn’t been extensively studied; caution is advised due to cumulative immunomodulation.
• Antibiotics or antifungals: Some may inhibit or induce liver enzymes that affect OTEZLA metabolism, although the impact is usually minimal.

Always inform your healthcare provider about all medications, supplements, or herbal remedies you are taking before starting OTEZLA.

Dosage of OTEZLA 10mg, 20mg & 30mg

After the initial titration period (Days 1–5), the standard maintenance dosage is:

• 30 mg twice daily (morning and evening)

Renal impairment: For patients with severe renal impairment (creatinine clearance <30 mL/min), the recommended dose is:

• 30 mg once daily, after titration

Dosage adjustments are not usually necessary for mild-to-moderate liver or kidney dysfunction. Follow the prescribing physician’s instructions carefully, especially during the initial 5-day dose escalation phase to minimize gastrointestinal side effects.

Possible side effects of OTEZLA 10mg, 20mg & 30mg

While generally well tolerated, OTEZLA may cause side effects in some patients. Most are mild to moderate and occur early in treatment.

• Common:
  • Diarrhea
  • Nausea
  • Headache
  • Upper respiratory tract infection
• Less Common:
  • Weight loss
  • Fatigue
  • Depression or mood changes
• Rare but serious:
  • Severe allergic reactions
  • Suicidal thoughts (monitoring is advised, especially in those with a history of depression)

Report any unusual or persistent side effects to a healthcare professional immediately.

OTEZLA 10mg, 20mg & 30mg Contraindications OTEZLA 10mg, 20mg & 30mg

OTEZLA is contraindicated or should be used with caution in certain patients:

• Known hypersensitivity to Apremilast or any component of the formulation.
• Severe uncontrolled depression or psychiatric illness: Use may worsen mood or behavior in susceptible individuals.
• Pregnancy: Not recommended unless clearly needed; animal studies have shown potential risks.
• Severe renal impairment: Dosage adjustment is needed; close monitoring is essential.

Always consult your healthcare provider to assess risk versus benefit, particularly if you have preexisting health conditions or are on multiple medications.

Storage of OTEZLA 10mg, 20mg & 30mg

Proper storage helps maintain the medication’s potency and safety.

• Store at a controlled room temperature: 20°C to 25°C (68°F to 77°F).
• Keep in original blister packaging or bottle to protect from moisture and light.
• Do not store in the bathroom or refrigerator.
• Keep out of reach of children and pets.
• Do not use after the expiration date printed on the package.

For expired or unused medication, consult a pharmacist about safe disposal methods.