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Apremilast: Brands, Price & Uses in Bangladesh
Apremilast is a phosphodiesterase-4 (PDE4) inhibitor approved for the following conditions: Active psoriatic arthritis in adult patients (FDA-approved, established use).
About Apremilast
Indications of Apremilast
Apremilast is a phosphodiesterase-4 (PDE4) inhibitor approved for the following conditions:
- Active psoriatic arthritis in adult patients (FDA-approved, established use).
- Moderate-to-severe plaque psoriasis in adult and pediatric patients (6 years and older, weighing at least 20 kg) who are candidates for phototherapy or systemic therapy (FDA-approved, established use).
- Oral ulcers associated with Behçet's disease in adult patients (FDA-approved, established use).
Apremilast may also be used off-label, under specialist supervision, for other inflammatory conditions such as certain forms of oral lichen planus, though evidence for such uses is limited and this is not an approved indication.
Dosage & Administration of Apremilast
| Indication | Regimen |
|---|---|
| Psoriatic arthritis / Plaque psoriasis / Behçet's disease oral ulcers (adults) | Titrate over 5 days starting at 10 mg once daily, increasing by 10 mg/day increments, to reach a maintenance dose of 30 mg twice daily from Day 6 onward. |
| Severe renal impairment (CrCl <30 mL/min) | Titrate using the morning schedule only (skip evening doses) to a maintenance dose of 30 mg once daily. |
Tablets should be swallowed whole with or without food. Do not split, crush, or chew tablets. If a dose is missed, it should be taken as soon as possible unless it is close to the next scheduled dose; doses should not be doubled. Because gastrointestinal side effects are more common during the initial titration period, the step-wise dose escalation schedule must be followed exactly as prescribed and should not be skipped, even after a missed dose (consult the prescriber for guidance on resuming titration).
Side Effects of Apremilast
The most common adverse reactions associated with Apremilast, particularly during the initial titration period, include:
- Diarrhea (often early and self-limiting)
- Nausea
- Headache (including tension headache)
- Upper respiratory tract infection
- Vomiting
- Weight loss
Less common but clinically important effects include depression and mood changes, and rare hypersensitivity reactions such as angioedema. See Precautions and Warnings for further detail on depression/suicidal ideation risk and weight loss monitoring.
Contraindications of Apremilast
Apremilast is contraindicated in patients with known hypersensitivity to apremilast or to any component of the formulation.
Frequently Asked Questions about Apremilast
What is Apremilast used for?
Apremilast is used to treat active psoriatic arthritis, moderate-to-severe plaque psoriasis in candidates for phototherapy or systemic therapy, and oral ulcers associated with Behçet's disease in adults; it is also approved for plaque psoriasis in children 6 years and older weighing at least 20 kg.
Why do I need to start with a low dose of Apremilast and increase it gradually?
The dose of Apremilast is titrated upward over 5 days to reduce the likelihood and severity of gastrointestinal side effects such as nausea and diarrhea, which are more common when treatment is started at the full maintenance dose. Follow the titration schedule provided by your physician or pharmacist exactly.
Can Apremilast cause depression?
Yes. Treatment with Apremilast has been associated with an increased risk of depression, including new or worsening depression and, rarely, suicidal thoughts. Tell your physician immediately, or seek emergency care, if you or a caregiver notice mood changes, anxiety, or thoughts of self-harm while taking Apremilast, especially if you have a prior history of depression.
Does Apremilast cause weight loss?
Unexplained weight loss has been reported with Apremilast. Your physician will monitor your body weight periodically during treatment, and you should report any significant or unexplained weight loss promptly, as it may require evaluation or discontinuation of the medicine.
Can I take Apremilast with rifampin or other seizure medicines like carbamazepine or phenytoin?
No. Strong CYP3A4 inducers such as rifampin, carbamazepine, phenytoin, phenobarbital, and St. John's Wort significantly reduce blood levels of Apremilast and can cause it to lose effectiveness. Combining these medicines with Apremilast is not recommended; tell your physician about all medicines you take.
Is Apremilast safe during pregnancy or breastfeeding?
Data on Apremilast use in pregnancy are limited, so it should be used during pregnancy only if clearly needed and if the potential benefit outweighs the potential risk to the fetus. It is not known if Apremilast passes into breast milk, so consult your physician before breastfeeding while taking this medicine.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.