APREMILAST

Background and Date of Approval

Apremilast received United States Food and Drug Administration (FDA) approval on 21 March 2014.

Uses

Apremilast treats moderate to severe plaque psoriasis, a chronic autoimmune skin condition characterized by red, itchy, and scaly patches. It is also indicated for the management of active psoriatic arthritis.

How is it administered?

Apremilast is administered orally in the form of tablets. It is taken orally with or without food, as directed by a healthcare professional. The recommended starting dosage and any necessary dose adjustments are determined based on the specific condition being treated and the patient's response to the medication.

Side Effects

Common side effects 0f Apremilast may include gastrointestinal disturbances such as diarrhea, nausea, vomiting, headache, upper respiratory tract infections, and fatigue. Some patients may also experience weight loss, decreased appetite, and back pain. More severe side effects can include depression, mood changes, and suicidal thoughts. Additionally, allergic reactions like rash and swelling may occur.

Warnings

Some patients taking Apremilast have reported experiencing depression, suicidal thoughts, or changes in mood. It can cause gastrointestinal disturbances such as diarrhea, nausea, and vomiting. This medication may lead to weight loss.

Precautions

It is essential to monitor for any signs of mood changes and promptly report them to a healthcare provider. Patients should be cautious and report any severe or persistent gastrointestinal symptoms to their healthcare provider. Patients should monitor their weight regularly, and significant or unexplained weight loss should be reported to a healthcare provider.

Word of Advice

Exercise caution if you have a history of depression or mood disorders before taking Apremilast. Report any changes in mood or behaviour to your healthcare provider. Monitor for gastrointestinal effects including diarrhoea or nausea, and maintain adequate hydration. Inform your doctor if you experience severe or persistent symptoms. Monitor your weight while taking Apremilast, as it may cause weight loss. Report any significant or unexplained weight changes to your healthcare provider. Watch for signs of infection such as fever or persistent cough, and report any concerns to your doctor without delay. Avoid live vaccinations while on this medication, as they may affect your immune response. Consult your healthcare provider before receiving any vaccines. Use with caution if you have a history of liver or kidney problems, and adhere to your doctor's instructions for regular monitoring. Seek immediate medical attention if you notice any signs of allergic reactions such as rash or swelling. Adhere to the prescribed dosage. Consult your healthcare provider before taking it. Be aware of potential side effects and communicate any concerns promptly.

References

Amgen Ltd, Electronic medicines compendium (EMC), [Revised on30 Jun 2021] [Accessed on 19th Oct 2023], https://www.medicines.org.uk/emc/product/3648/smpc#gref Amgen Inc, US Food and Drug Administration, [Revised on Dec 2021 ] [Accessed on 19th 2023], https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205437s011lbl.pdf

Frequently Asked Questions

What should I do if I miss a dose of Apremilast?

If you miss a dose of Apremilast, take it as soon as you remember unless it is almost time for your next dose. In that case, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for the missed one.

How long does it take for Apremilast to work?

The response to Apremilast can vary among individuals. Some patients may start noticing improvements in their symptoms within a few weeks, while others may take longer. It is essential to continue taking the medication as your healthcare provider prescribes.

What should I do if I experience severe side effects while taking Apremilast?

Consult your healthcare provider immediately if you experience severe or persistent side effects, such as allergic reactions, gastrointestinal issues, or mood changes after taking Apremilast. They can guide whether any adjustments to the treatment plan are necessary.

Can Apremilast be taken with food?

Apremilast can be taken with or without food, as directed by your healthcare provider. It is essential to follow the specific instructions in the medication guide or as your doctor advises.

How often do I need to see my healthcare provider while taking Apremilast?

Regular follow-up appointments with your healthcare provider are important to monitor your response to Apremilast and assess for potential side effects or complications. The frequency of these visits will be determined based on your treatment plan and health status.

Can Apremilast be used in patients with a history of mental health issues?

Apremilast should be used cautiously in patients with a history of depression, mood disorders, or suicidal thoughts. Discussing your medical history thoroughly with your healthcare provider before starting this medication is essential.

Available Brands 11

Written By: Muskan Patel, M.Pharm

Reviewed By: Dr. Vishwa Patel, MBBS