Apremilast Sandoz
Phosphodiesterase 4 (PDE4) inhibitor for psoriasis and psoriatic arthritis
Quick facts about Apremilast Sandoz
Key takeaways about Apremilast Sandoz
- Oral alternative to injections: Apremilast is taken as a tablet twice daily, offering a convenient alternative to injectable biologic therapies for psoriasis and psoriatic arthritis
- Gradual dose build-up: Treatment starts with a 5-day dose titration to reduce gastrointestinal side effects, reaching the maintenance dose of 30 mg twice daily on Day 6
- No routine blood monitoring required: Unlike methotrexate or cyclosporine, apremilast does not require regular blood tests, though weight monitoring is recommended
- Most common side effects are temporary: Diarrhea and nausea typically occur in the first 2 weeks and usually resolve within 4 weeks of continued treatment
- Results take time: Maximum benefit for skin psoriasis is usually seen after 16 to 24 weeks of continuous treatment
What Is Apremilast Sandoz and What Is It Used For?
Apremilast Sandoz is a selective phosphodiesterase 4 (PDE4) inhibitor that reduces inflammation by increasing levels of cyclic AMP (cAMP) inside immune cells. It is approved for treating moderate to severe plaque psoriasis, active psoriatic arthritis, and oral ulcers in Behcet's disease.
Apremilast Sandoz belongs to a class of medications known as PDE4 inhibitors. Phosphodiesterase 4 is an enzyme found primarily in immune and inflammatory cells. By blocking this enzyme, apremilast increases intracellular levels of cyclic adenosine monophosphate (cAMP), a signaling molecule that plays a key role in regulating inflammation. This leads to a reduction in pro-inflammatory mediators such as tumor necrosis factor-alpha (TNF-alpha), interleukin-17 (IL-17), and interleukin-23 (IL-23), while simultaneously increasing anti-inflammatory mediators such as interleukin-10 (IL-10).
Apremilast Sandoz is a generic formulation of apremilast, originally marketed under the brand name Otezla. As a generic medication, it contains the same active substance in the same pharmaceutical form and has demonstrated bioequivalence to the originator product through rigorous regulatory evaluation by the European Medicines Agency (EMA). This means patients can expect the same therapeutic effects and safety profile as the original brand.
The mechanism of action of apremilast is distinct from that of biologic therapies (such as TNF inhibitors or IL-17 inhibitors) because it works intracellularly rather than targeting specific extracellular cytokines. This broad intracellular modulation of the inflammatory cascade makes it effective across multiple inflammatory conditions while maintaining a favorable safety profile that does not require routine laboratory monitoring for immunosuppression.
Approved indications
Apremilast Sandoz is approved for the following conditions in adults:
- Moderate to severe plaque psoriasis: For patients who have not responded to, have a contraindication to, or are intolerant of other systemic therapies including cyclosporine, methotrexate, or psoralen plus ultraviolet A (PUVA) phototherapy
- Active psoriatic arthritis: Either alone or in combination with disease-modifying antirheumatic drugs (DMARDs), in patients who have had an inadequate response or intolerance to prior DMARD therapy
- Oral ulcers associated with Behcet's disease: For adult patients who are candidates for systemic therapy
How effective is apremilast?
Clinical evidence from the ESTEEM (psoriasis) and PALACE (psoriatic arthritis) clinical trial programs has demonstrated significant efficacy. In the ESTEEM trials, approximately 33% of patients with moderate to severe plaque psoriasis achieved a 75% reduction in Psoriasis Area and Severity Index (PASI 75) at week 16, compared to about 5% with placebo. For psoriatic arthritis, the PALACE trials showed that approximately 40% of patients achieved an ACR20 response (20% improvement in American College of Rheumatology criteria) at week 16. In Behcet's disease, the BCT-002 trial demonstrated a significant reduction in the number and pain of oral ulcers.
What Should You Know Before Taking Apremilast Sandoz?
Before starting Apremilast Sandoz, inform your doctor about any history of depression or suicidal thoughts, kidney problems, lactose intolerance, or if you are pregnant or planning to become pregnant. Apremilast should not be used during pregnancy, and women of childbearing potential must use effective contraception.
While apremilast has a favorable safety profile compared to many other immunomodulatory therapies, there are important considerations your healthcare provider should be aware of before initiating treatment. A thorough medical history and assessment of current medications are essential to ensure safe and effective use of this medication.
Contraindications
Apremilast Sandoz is contraindicated in the following situations:
- Hypersensitivity: Do not take apremilast if you are allergic to apremilast or any of the other ingredients (excipients) in the tablet
- Pregnancy: Apremilast must not be used during pregnancy. Animal studies have demonstrated developmental toxicity at doses above therapeutic levels
Warnings and Precautions
Your doctor should evaluate the following before prescribing Apremilast Sandoz:
- Depression and suicidal ideation: Cases of depression, suicidal ideation, and suicidal behavior have been reported in clinical trials and post-marketing experience. Patients and caregivers should be advised to report any worsening of depression, suicidal thoughts, or other mood changes to their healthcare provider. If new or worsening psychiatric symptoms develop, the benefits and risks of continuing treatment should be reassessed
- Body weight: Weight should be monitored regularly during treatment. Unexplained or clinically significant weight loss should be evaluated, and discontinuation of treatment should be considered. In clinical trials, weight loss of 5-10% was observed in approximately 10% of patients
- Severe renal impairment: In patients with severe renal impairment (creatinine clearance less than 30 mL/min), the dose of apremilast should be reduced to 30 mg once daily (instead of twice daily). No dose adjustment is needed for mild or moderate renal impairment
- Lactose intolerance: Apremilast Sandoz tablets contain lactose. Patients with rare hereditary conditions of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medication
- Gastrointestinal disorders: Patients with a history of severe gastrointestinal conditions should use apremilast with caution, as diarrhea, nausea, and vomiting are common side effects, particularly during the initial weeks of treatment
Pregnancy and Breastfeeding
Apremilast Sandoz should not be used during pregnancy. Preclinical studies in animals have shown reproductive toxicity, including embryo loss and reduced fetal weight at doses above therapeutic exposure levels. Women of childbearing potential should use effective contraception during treatment. A pregnancy test is recommended before starting therapy. If pregnancy is suspected or confirmed during treatment, the medication should be stopped immediately and the patient should consult her healthcare provider.
It is unknown whether apremilast or its metabolites are excreted in human breast milk. Because of the potential for adverse effects on the nursing infant, a decision must be made whether to discontinue breastfeeding or to discontinue the drug, taking into account the importance of the medication to the mother. Animal studies have shown that apremilast is present in the milk of lactating mice.
Tell your doctor immediately if you experience any of the following during treatment with Apremilast Sandoz: new or worsening feelings of depression, suicidal thoughts, unexplained significant weight loss, or severe diarrhea that does not resolve. These may require medical assessment and possible discontinuation of treatment.
How Does Apremilast Sandoz Interact with Other Drugs?
The most important drug interaction with Apremilast Sandoz involves strong CYP3A4 enzyme inducers (such as rifampicin, phenobarbital, carbamazepine, and phenytoin), which can significantly reduce apremilast blood levels and diminish its effectiveness. St. John's Wort should also be avoided. No dose adjustment is needed when combining apremilast with methotrexate or other common DMARDs.
Apremilast is primarily metabolized by the cytochrome P450 enzyme CYP3A4, with minor contributions from CYP1A2 and CYP2A6. This metabolic pathway means that drugs which strongly induce CYP3A4 can accelerate the breakdown of apremilast, reducing its blood levels and potentially diminishing therapeutic effectiveness. Understanding these interactions is crucial for safe and effective treatment.
Importantly, apremilast does not significantly inhibit or induce cytochrome P450 enzymes at therapeutic concentrations. This means it is unlikely to affect the blood levels of most other medications you may be taking. Clinical pharmacokinetic studies have confirmed that apremilast does not interact with common medications such as methotrexate, oral contraceptives (ethinylestradiol/norgestimate), ketoconazole, or midazolam.
Major Interactions
The following medications can significantly reduce apremilast levels and should be avoided:
| Drug | Type | Effect | Recommendation |
|---|---|---|---|
| Rifampicin | Strong CYP3A4 inducer | Reduces apremilast exposure by approximately 72% | Avoid co-administration |
| Phenobarbital | Strong CYP3A4 inducer | Significantly reduces apremilast blood levels | Avoid co-administration |
| Carbamazepine | Strong CYP3A4 inducer | Significantly reduces apremilast blood levels | Avoid co-administration |
| Phenytoin | Strong CYP3A4 inducer | Significantly reduces apremilast blood levels | Avoid co-administration |
| St. John's Wort | Herbal CYP3A4 inducer | May significantly reduce apremilast blood levels | Avoid co-administration |
Minor Interactions and Safe Combinations
The following commonly used medications have been studied and shown to have no clinically significant interactions with apremilast:
- Methotrexate: No pharmacokinetic interaction. Can be used together for psoriatic arthritis without dose adjustment for either drug
- Oral contraceptives: Apremilast does not affect the efficacy of combined oral contraceptive pills (ethinylestradiol/norgestimate)
- Ketoconazole: Co-administration with the strong CYP3A4 inhibitor ketoconazole increased apremilast exposure by approximately 36%, which is not considered clinically relevant. No dose adjustment is needed
- Topical psoriasis treatments: Apremilast can be safely used alongside topical corticosteroids, vitamin D analogues, and other topical treatments
- NSAIDs and analgesics: No known interactions with common pain relievers such as ibuprofen, naproxen, or paracetamol (acetaminophen)
Always inform your healthcare provider about all prescription and over-the-counter medications, herbal supplements (especially St. John's Wort), and vitamins you are taking before starting Apremilast Sandoz. Although apremilast has relatively few drug interactions, your doctor can best assess potential risks with a complete picture of your medication regimen.
What Is the Correct Dosage of Apremilast Sandoz?
The maintenance dose of Apremilast Sandoz is 30 mg taken orally twice daily, approximately 12 hours apart. Treatment begins with a 5-day dose titration schedule starting at 10 mg once daily on Day 1 and gradually increasing to the full dose of 30 mg twice daily from Day 6 onward. This gradual increase helps reduce gastrointestinal side effects.
Apremilast Sandoz is administered as an oral tablet that can be taken with or without food. The tablets should be swallowed whole and should not be crushed, split, or chewed. Adhering to the initial dose titration schedule is important for tolerability, as it significantly reduces the incidence and severity of gastrointestinal side effects such as diarrhea and nausea.
Adults
The recommended dose titration schedule for all approved indications is as follows:
| Day | Morning Dose | Evening Dose | Total Daily Dose |
|---|---|---|---|
| Day 1 | 10 mg | - | 10 mg |
| Day 2 | 10 mg | 10 mg | 20 mg |
| Day 3 | 10 mg | 20 mg | 30 mg |
| Day 4 | 20 mg | 20 mg | 40 mg |
| Day 5 | 20 mg | 30 mg | 50 mg |
| Day 6+ | 30 mg | 30 mg | 60 mg (maintenance) |
After the titration period, the maintenance dose is 30 mg twice daily for all three approved indications (plaque psoriasis, psoriatic arthritis, and Behcet's disease oral ulcers). Treatment can be continued long-term as long as clinical benefit is maintained. For psoriasis, treatment response should be evaluated after 24 weeks; if no improvement is seen, treatment should be reconsidered.
Children
Apremilast Sandoz is not approved for use in children and adolescents under 18 years of age. The safety and efficacy of apremilast in the pediatric population have not been established. There are currently no data available to support dosing recommendations in this age group.
Elderly
No dose adjustment is required for elderly patients based on age alone. Clinical trials included patients aged 65 years and older, and no overall differences in safety or efficacy were observed compared to younger adults. However, as with all medications in elderly patients, renal function should be assessed, and the dose should be reduced if severe renal impairment is present (creatinine clearance less than 30 mL/min).
Missed Dose
If you miss a dose of Apremilast Sandoz, take the missed dose as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are unsure about what to do, consult your pharmacist or doctor.
Overdose
Apremilast has been studied at doses up to 100 mg daily (50 mg twice daily) in healthy volunteers without dose-limiting toxicities. In the event of an overdose, patients should be monitored for signs or symptoms of adverse effects and given appropriate supportive treatment as needed. There is no specific antidote for apremilast. Due to its extensive protein binding, dialysis is unlikely to be effective for removal of apremilast from the body. If you suspect an overdose, contact your local poison control center or seek emergency medical attention.
Patients with severe renal impairment (creatinine clearance below 30 mL/min) should take the reduced maintenance dose of 30 mg once daily (rather than twice daily). The initial dose titration schedule should use only the morning doses for Days 1 through 3, then proceed to 20 mg once daily on Days 4 and 5, and 30 mg once daily from Day 6 onward.
What Are the Side Effects of Apremilast Sandoz?
The most common side effects of Apremilast Sandoz are gastrointestinal symptoms, particularly diarrhea (affecting up to 17% of patients) and nausea (up to 17%), which are usually most pronounced during the first 2 weeks and typically resolve within 4 weeks. Other common side effects include upper respiratory tract infections, headache, and decreased appetite. The initial dose titration schedule is designed to minimize these effects.
Like all medicines, Apremilast Sandoz can cause side effects, although not everybody gets them. The overall safety profile of apremilast is well characterized from extensive clinical trial data involving more than 4,000 patients across psoriasis, psoriatic arthritis, and Behcet's disease studies, as well as substantial post-marketing experience since its original approval in 2014.
The gastrointestinal side effects of apremilast are the most commonly reported and are the primary reason for the initial dose titration schedule. These effects are thought to result from the PDE4 inhibitory mechanism itself, as PDE4 is expressed in gastrointestinal smooth muscle and secretory cells. The gradual dose escalation over 5 days allows the body to adapt to the medication and significantly reduces the incidence and severity of nausea and diarrhea.
Most side effects are mild to moderate in severity and tend to decrease over the first few weeks of treatment. In clinical trials, the discontinuation rate due to adverse events was approximately 5-7% for apremilast versus 4-5% for placebo, indicating that the medication is generally well tolerated.
Very Common (affects more than 1 in 10 people)
- Diarrhea (up to 17% of patients, usually resolves within 4 weeks)
- Nausea (up to 17% of patients, usually resolves within 4 weeks)
- Upper respiratory tract infections (including common cold, nasopharyngitis)
- Headache and tension headache
Common (affects 1 in 10 to 1 in 100 people)
- Decreased appetite and weight loss
- Vomiting
- Dyspepsia (indigestion, stomach discomfort)
- Frequent bowel movements
- Upper abdominal pain
- Back pain
- Fatigue
- Insomnia
- Migraine
- Cough
- Bronchitis
Uncommon (affects 1 in 100 to 1 in 1,000 people)
- Allergic skin reactions (rash, urticaria)
- Gastrointestinal hemorrhage (bleeding in the digestive tract)
- Depression
- Suicidal ideation
Rare (affects fewer than 1 in 1,000 people)
- Severe allergic reactions (angioedema)
- Suicidal behavior (reported in post-marketing surveillance)
- Stevens-Johnson syndrome (reported very rarely in post-marketing experience)
Stop taking Apremilast Sandoz and seek immediate medical attention if you experience: severe allergic reactions with swelling of the face, lips, tongue, or throat; difficulty breathing; severe skin reactions; or new or worsening thoughts of self-harm or suicide. Contact your doctor promptly if you experience persistent severe diarrhea, unexplained significant weight loss, or signs of depression.
How Should You Store Apremilast Sandoz?
Store Apremilast Sandoz at room temperature below 30°C (86°F) in the original packaging to protect from light and moisture. Keep the tablets in their blister pack until ready to take them. Do not use the tablets after the expiry date printed on the packaging.
Proper storage of medications is essential to maintain their effectiveness and safety throughout the treatment period. Apremilast Sandoz tablets should be stored according to the following guidelines to ensure optimal pharmaceutical quality:
- Temperature: Store below 30°C (86°F). Do not refrigerate or freeze the tablets
- Light protection: Keep the tablets in the original blister packaging to protect them from light
- Moisture protection: Store in a dry place. Do not transfer tablets to a pill organizer for extended periods
- Expiry date: Do not use the medicine after the expiry date stated on the blister and carton. The expiry date refers to the last day of that month
- Disposal: Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment
- Keep out of reach: Keep all medicines out of the sight and reach of children
The starter pack typically contains tablets of different strengths (10 mg, 20 mg, and 30 mg) for the initial titration period. Each tablet strength is clearly labeled and color-coded to help prevent dosing errors during the titration phase. After the initial titration, patients will continue with 30 mg tablets only.
What Does Apremilast Sandoz Contain?
Each Apremilast Sandoz film-coated tablet contains apremilast as the active substance (available in 10 mg, 20 mg, and 30 mg strengths) along with inactive ingredients including lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and a film coating.
Understanding the complete composition of your medication is important, particularly if you have known allergies or intolerances to specific pharmaceutical excipients. Below is a detailed breakdown of the ingredients in Apremilast Sandoz tablets:
Active ingredient
The active substance is apremilast. Each film-coated tablet contains either 10 mg, 20 mg, or 30 mg of apremilast, depending on the tablet strength.
Inactive ingredients (excipients)
The tablet core contains the following inactive ingredients:
- Lactose monohydrate: Used as a filler/diluent. Patients with rare hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine
- Microcrystalline cellulose: Used as a binder and filler
- Croscarmellose sodium: Used as a disintegrant to help the tablet break down in the gastrointestinal tract
- Magnesium stearate: Used as a lubricant during the manufacturing process
The film coating contains hypromellose, titanium dioxide (E171), iron oxide pigments (for color differentiation between strengths), lactose monohydrate, and triacetin. The different tablet strengths are distinguished by their color and size to facilitate correct identification during the titration period.
The 10 mg tablet is typically pink and diamond-shaped, the 20 mg tablet is brown and diamond-shaped, and the 30 mg tablet is beige and diamond-shaped. Each tablet is debossed with the strength on one side for easy identification. Always verify the tablet strength before taking your dose, particularly during the initial titration period when you will be using tablets of different strengths.
Frequently Asked Questions About Apremilast Sandoz
Apremilast Sandoz is used to treat three main conditions in adults: moderate to severe plaque psoriasis (when other systemic treatments have been inadequate, contraindicated, or not tolerated), active psoriatic arthritis (alone or in combination with DMARDs), and oral ulcers associated with Behcet's disease. It works by inhibiting the enzyme PDE4, which plays a key role in inflammation. It is not a biologic medication but rather a small molecule immunomodulator taken as an oral tablet.
Some patients may notice initial improvement within 2 to 4 weeks of reaching the full maintenance dose. However, the maximum clinical benefit for psoriasis is typically observed after 16 to 24 weeks of continuous treatment. For psoriatic arthritis, joint improvements may be apparent within 16 weeks. If no meaningful improvement is seen after 24 weeks, your doctor may reassess whether to continue treatment. It is important to take the medication consistently as prescribed and not to discontinue it prematurely because you do not see immediate results.
The most frequently reported side effects are diarrhea and nausea, each affecting up to about 17% of patients. These gastrointestinal effects are typically most pronounced during the first 2 weeks of treatment and usually resolve within 4 weeks as the body adjusts to the medication. The initial 5-day dose titration schedule is specifically designed to minimize these effects. Other common side effects include upper respiratory tract infections, headache, decreased appetite, vomiting, back pain, and fatigue. Most side effects are mild to moderate in severity.
Yes, Apremilast Sandoz can be safely used in combination with methotrexate for the treatment of psoriatic arthritis. Clinical trials specifically evaluated this combination and found no significant pharmacokinetic interactions between the two drugs. No dose adjustment is needed for either medication when used together. This combination may provide additional benefit for patients with psoriatic arthritis who have not achieved adequate disease control with either medication alone.
No, Apremilast Sandoz should not be used during pregnancy. Animal studies have shown developmental toxicity at doses above therapeutic exposure. Women of childbearing potential should use effective contraception during treatment, and a pregnancy test is recommended before starting therapy. If you become pregnant while taking apremilast, stop the medication immediately and contact your healthcare provider. It is also unknown whether apremilast passes into breast milk, so breastfeeding is not recommended during treatment.
Apremilast Sandoz is a generic version of Otezla, manufactured by Sandoz. Both contain the same active ingredient (apremilast) in the same strengths (10 mg, 20 mg, 30 mg) and the same dosage form (film-coated tablets). Generic medications are required to demonstrate bioequivalence to the original product, meaning they deliver the same amount of active substance at the same rate. Apremilast Sandoz has been approved by the EMA after meeting all regulatory requirements for quality, safety, and efficacy. The main difference is typically the price, as generic medications are generally more affordable than originator brands.
Apremilast works differently from traditional immunosuppressants. Rather than broadly suppressing the immune system, it modulates the inflammatory response by increasing intracellular cAMP levels, which reduces the production of pro-inflammatory cytokines while increasing anti-inflammatory mediators. Unlike biologic therapies or conventional immunosuppressants like cyclosporine, apremilast has not been associated with an increased risk of serious infections, opportunistic infections, or malignancies in clinical trials. This is one reason why routine blood monitoring for immunosuppression is not required during treatment.
References and Medical Sources
All information in this article is based on the following peer-reviewed sources and official drug information:
- European Medicines Agency (EMA). Otezla (apremilast) - Summary of Product Characteristics. Last updated 2025. Available at: ema.europa.eu
- Papp K, Reich K, Leonardi CL, et al. Apremilast, an oral phosphodiesterase 4 (PDE4) inhibitor, in patients with moderate to severe plaque psoriasis: Results of a phase III, randomized, controlled trial (Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis [ESTEEM] 1). J Am Acad Dermatol. 2015;73(1):37-49.
- Kavanaugh A, Mease PJ, Gomez-Reino JJ, et al. Treatment of psoriatic arthritis in a phase 3 randomised, placebo-controlled trial with apremilast, an oral phosphodiesterase 4 inhibitor (PALACE 1). Ann Rheum Dis. 2014;73(6):1020-1026.
- Hatemi G, Mahr A, Ishigatsubo Y, et al. Trial of Apremilast for Oral Ulcers in Behcet's Syndrome. N Engl J Med. 2019;381(20):1918-1928.
- Menter A, Strober BE, Kaplan DH, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. J Am Acad Dermatol. 2019;80(4):1029-1072.
- Gossec L, Baraliakos X, Kerschbaumer A, et al. EULAR recommendations for the management of psoriatic arthritis with pharmacological therapies: 2023 update. Ann Rheum Dis. 2024;83(6):706-719.
- U.S. Food and Drug Administration (FDA). Otezla (apremilast) prescribing information. Available at: fda.gov
- World Health Organization (WHO). WHO Model List of Essential Medicines - 23rd List (2023). Geneva: WHO; 2023.
Medical Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, consisting of board-certified specialists in dermatology, rheumatology, and clinical pharmacology. Our team follows strict editorial standards based on the GRADE framework for evidence assessment.
Medical Writers
Licensed physicians with expertise in dermatology, rheumatology, and pharmacology. All medical content is based on current international guidelines and peer-reviewed evidence.
Medical Reviewers
Independent specialist physicians who verify medical accuracy, assess evidence quality, and ensure compliance with EMA, FDA, and WHO guidelines.
Evidence Level: 1A (based on systematic reviews and randomized controlled trials) | Guideline Sources: EMA SmPC, FDA Label, AAD-NPF, EULAR | Last Fact-Checked: | Conflict of Interest: None. No pharmaceutical funding.