Apremilast
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Phosphodiesterase 4 Inhibitor
Controlled Drug Substance
No
Apremilast
Summary
Apremilast is used to treat psoriatic arthritis, plaque psoriasis, and oral ulcers associated with Behcet's Disease.
Apremilast works by inhibiting an enzyme called phosphodiesterase 4 (PDE4), which reduces the production of inflammatory chemicals in the body. This helps lower inflammation and relieve symptoms like joint pain, swelling, and skin lesions.
For adults, the recommended maintenance dose is 30 mg twice daily. For children aged 6 years and older with moderate to severe plaque psoriasis, the dose is based on weight. Apremilast is taken orally.
Common side effects of Apremilast include diarrhea, nausea, headache, vomiting, infections, mood changes, and weight loss.
Apremilast should be used with caution during pregnancy and breastfeeding. It should not be taken with certain medications due to potential interactions. People with an allergy to apremilast should not take the medicine. Elderly patients may be more susceptible to side effects.
Indications and Purpose
How does Apremilast work?
Apremilast works by inhibiting an enzyme called phosphodiesterase 4 (PDE4), which reduces the production of inflammatory chemicals in the body. This helps lower inflammation, relieving symptoms like joint pain, swelling, and skin lesions in conditions such as psoriasis and psoriatic arthritis.
Is Apremilast effective?
Yes, Apremilast is effective for many people in managing conditions like psoriasis and psoriatic arthritis. It helps reduce inflammation, improve joint symptoms, and decrease the severity of skin plaques. While results vary, many patients notice improvement within 2–16 weeks of consistent use. Always follow your doctor’s guidance for the best outcomes.
What is Apremilast?
Apremilast is a pill that helps treat a condition called psoriatic arthritis, which causes painful and swollen joints. It works by increasing the amount of a chemical in the body called cAMP. This chemical helps reduce inflammation and pain in the joints.
Directions for Use
For how long do I take Apremilast?
Apremilast is used up to 5 years in patients with psoriasis, psoriatic arthritis, or Behçet's syndrome for long term treatment.
How do I dispose of Apremilast?
If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.
How do I take Apremilast?
You can take Apremilast with or without food. Swallow the tablets whole. Do not crush, split, or chew them.
How long does it take for Apremilast to start working?
Apremilast typically starts showing noticeable effects within 2 to 4 weeks, but for some conditions, like psoriatic arthritis or plaque psoriasis, it may take up to 16 weeks to achieve full benefits. Regular use as prescribed is essential to see optimal results. Always consult your doctor if improvement seems delayed.
How should I store Apremilast?
Apremilast should be stored at room temperature, away from moisture and heat, typically between 68°F to 77°F (20°C to 25°C). Keep it in its original container, tightly closed, and out of reach of children. Do not store it in the bathroom or near sources of heat or humidity.
What is the usual dose of Apremilast?
For adults with psoriatic arthritis, plaque psoriasis, or Behçet's Disease, the recommended maintenance dose is 30 mg twice daily after a 5-day titration period. For children aged 6 years and older with moderate to severe plaque psoriasis, the dose is based on weight: 30 mg twice daily for those weighing at least 50 kg, and 20 mg twice daily for those weighing 20 kg to less than 50 kg.
Warnings and Precautions
Can Apremilast be taken safely while breastfeeding?
Apremilast should be used with caution while breastfeeding, as it’s unclear if it passes into breast milk. It's best to consult your doctor before taking Apremilast while breastfeeding to weigh potential risks and benefits.
Can Apremilast be taken safely while pregnant?
Apremilast is not recommended during pregnancy unless necessary, as its safety is not well established. If you're pregnant or planning to get pregnant, consult your doctor to weigh the risks and benefits.
Can I take Apremilast with other prescription drugs?
If you take Apremilast with strong CYP450 inducers (such as rifampin, phenobarbital, carbamazepine, phenytoin), the amount of Apremilast in your body will decrease. This can make Apremilast less effective. Therefore, it's not recommended to take Apremilast with these medications.
Does Apremilast have adverse effects?
Adverse effects are unwanted or harmful effects that can occur with medication use. For Apremilast, common adverse effects include diarrhea, nausea, headache, and weight loss. These are generally mild but can be bothersome. Rare but serious adverse effects may include severe allergic reactions or mood changes, which require immediate medical attention. It's important to report any new or worsening symptoms to your healthcare provider and consult them before stopping the medication.
Does Apremilast have any safety warnings?
Apremilast comes with safety warnings, including the risk of depression and suicidal thoughts. It's important to monitor mood changes and report any feelings of depression or suicidal thoughts to your doctor immediately. Weight loss is another concern, so regular weight checks are advised. Allergic reactions, though rare, can occur, so watch for symptoms like rash, itching, or swelling. Always inform your healthcare provider about any new symptoms or concerns while taking Apremilast.
Is Apremilast addictive?
Apremilast is not known to be addictive or habit-forming. There is no evidence to suggest that it causes physical or psychological dependence. Therefore, you don't need to worry about addiction when taking this medication. However, it's always important to follow your healthcare provider's instructions and report any unusual symptoms or concerns you may have while using Apremilast.
Is Apremilast safe for the elderly?
Apremilast can generally be used by elderly patients, but they may be more susceptible to side effects, such as gastrointestinal issues or infections. Dose adjustments are typically not necessary, but careful monitoring is recommended. Always consult a doctor to assess the individual risks and ensure safe use.
Is it safe to drink alcohol while taking Apremilast?
Most people tolerate Apremilast well, and occasional alcoholic drinks should not affect the way this medicine works. There are no well-established interactions between Apremilast and alcohol that would interfere with the medication's effectiveness or cause harm. However, it's always wise to consume alcohol in moderation and be mindful of how your body reacts. If you notice any unusual symptoms, consult your healthcare provider for guidance.
Is it safe to exercise while taking Apremilast?
Most people tolerate Apremilast well, and it should not limit your ability to exercise. There is no information suggesting that this medicine causes symptoms that would limit exercise capacity, physical strength, or endurance. However, if you experience any unusual symptoms during physical activity, such as dizziness or fatigue, take precautions and consult your healthcare provider for advice. It's always a good idea to listen to your body and adjust your exercise routine as needed.
Is it safe to stop Apremilast?
Apremilast is typically used for long-term management of chronic conditions like psoriasis or psoriatic arthritis. Stopping it abruptly may lead to a return of symptoms or worsening of the condition. There are no known withdrawal symptoms, but it's crucial to consult your doctor before stopping the medication. They can guide you on how to safely discontinue use if necessary, ensuring that your condition remains managed effectively.
What are the most common side effects of Apremilast?
Side effects are unwanted effects that can occur with medication use. Common side effects of Apremilast include diarrhea, nausea, headache, upper respiratory tract infection, and weight loss. These effects are generally mild and may go away over time. It's important to remember that new symptoms can occur when starting any new medicine, and they may not always be related to the medication. Always speak to your healthcare provider before stopping any medicine, as they can help determine the cause of symptoms and provide guidance.
Who should avoid taking Apremilast?
People with an allergy to apremilast or other ingredients in the medicine should not take the medicine. Some people may have allergic reactions, including hives and swelling of the face, lips, tongue, or throat.People 65 and older and those taking certain medications that can cause dehydration or low blood pressure may be at higher risk of problems from severe diarrhea, nausea, or vomiting.The most common side effects of apremilast are diarrhea, nausea, headache, and vomiting.
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