Apremilast Hexal: Uses, Dosage & Side Effects
A phosphodiesterase 4 (PDE4) inhibitor used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, and oral ulcers associated with Behçet's disease
Apremilast Hexal is a prescription medication containing the active substance apremilast, a selective phosphodiesterase 4 (PDE4) inhibitor. It is used to treat moderate to severe chronic plaque psoriasis in adults who have not responded to, have a contraindication to, or are intolerant of conventional systemic therapies. It is also indicated for active psoriatic arthritis and oral ulcers associated with Behçet's disease. Apremilast works by modulating the immune response rather than broadly suppressing it, offering a unique oral treatment option that does not require routine laboratory monitoring.
Quick Facts
Key Takeaways
- Apremilast Hexal is an oral PDE4 inhibitor that reduces inflammation by modulating immune mediators involved in psoriasis and psoriatic arthritis.
- The standard maintenance dose is 30 mg taken twice daily, reached through a gradual 5-day titration schedule to minimize gastrointestinal side effects.
- Gastrointestinal symptoms (diarrhea, nausea) are the most common side effects and typically improve within the first few weeks of treatment.
- Unlike many systemic therapies for psoriasis, apremilast does not require routine blood count or liver function monitoring.
- Patients should be monitored for depression, suicidal ideation, and unexplained weight loss during treatment.
What Is Apremilast Hexal and What Is It Used For?
Quick Answer: Apremilast Hexal is an oral immunomodulatory medication that selectively inhibits the enzyme phosphodiesterase 4 (PDE4). It is prescribed for moderate to severe plaque psoriasis, active psoriatic arthritis, and oral ulcers associated with Behçet's disease in adults.
Apremilast Hexal contains the active substance apremilast, which belongs to a class of medications known as phosphodiesterase 4 (PDE4) inhibitors. PDE4 is an enzyme found primarily in immune and inflammatory cells. By blocking this enzyme, apremilast increases intracellular levels of cyclic adenosine monophosphate (cAMP), which in turn reduces the production of pro-inflammatory cytokines such as tumor necrosis factor-alpha (TNF-α), interleukin-23 (IL-23), interleukin-17 (IL-17), and interferon-gamma (IFN-γ), while simultaneously increasing anti-inflammatory mediators like interleukin-10 (IL-10).
This dual mechanism of dampening inflammatory signals and boosting anti-inflammatory ones makes apremilast effective in conditions driven by immune dysregulation. Unlike traditional immunosuppressants that broadly suppress the immune system, apremilast acts as an immunomodulator, meaning it fine-tunes the immune response rather than shutting it down entirely. This distinction has practical implications for patients, as it is associated with a lower risk of serious infections and does not require the same level of laboratory monitoring as medications like methotrexate or ciclosporin.
Approved Indications
Apremilast Hexal is approved by the European Medicines Agency (EMA) and equivalent regulatory authorities worldwide for the following conditions:
- Plaque Psoriasis: Treatment of moderate to severe chronic plaque psoriasis in adult patients who have failed to respond to, who have a contraindication to, or who are intolerant of other systemic therapies, including ciclosporin, methotrexate, or psoralen and ultraviolet-A (PUVA) light therapy.
- Psoriatic Arthritis (PsA): Treatment of active psoriatic arthritis in adult patients who have had an inadequate response or intolerance to a prior disease-modifying antirheumatic drug (DMARD) therapy, either alone or in combination with DMARDs.
- Behçet's Disease: Treatment of adult patients with oral ulcers associated with Behçet's disease who are candidates for systemic therapy. This indication has been approved by the FDA and is available in certain countries.
How It Works
The therapeutic mechanism of apremilast centers on its selective inhibition of PDE4. This enzyme is the predominant phosphodiesterase expressed in inflammatory cells, including T cells, monocytes, macrophages, neutrophils, and dendritic cells. When PDE4 is inhibited, intracellular cAMP levels rise, which activates protein kinase A (PKA). PKA then phosphorylates transcription factors such as CREB (cAMP response element-binding protein) and inhibits NF-κB signaling, leading to a cascade that reduces the expression of inflammatory genes.
In psoriasis, this translates to reduced keratinocyte proliferation and decreased inflammatory infiltrate in the skin. In psoriatic arthritis, apremilast reduces synovial inflammation and joint damage progression. Clinical trials (ESTEEM 1 and ESTEEM 2 for psoriasis; PALACE 1-4 for psoriatic arthritis) have demonstrated statistically significant improvements in disease activity scores compared with placebo.
After oral administration, apremilast is well absorbed with an absolute bioavailability of approximately 73%. Peak plasma concentrations are reached within about 2.5 hours. The drug undergoes extensive metabolism by both cytochrome P450 (CYP) and non-CYP pathways, with CYP3A4 being the major CYP enzyme involved. The terminal elimination half-life is approximately 6 to 9 hours, supporting twice-daily dosing.
What Should You Know Before Taking Apremilast Hexal?
Quick Answer: Before starting apremilast, inform your doctor about any history of depression, suicidal thoughts, kidney disease, or pregnancy. Apremilast is not recommended during pregnancy and should be used with caution in patients with severe renal impairment.
Contraindications
Apremilast Hexal must not be used if you have a known hypersensitivity to apremilast or any of the excipients in the formulation. Additionally, apremilast should not be used during pregnancy. Women of childbearing potential must use effective contraception during treatment and must have a negative pregnancy test before starting therapy.
Apremilast is contraindicated in pregnancy. Animal studies have shown reproductive toxicity including increased embryo-fetal loss at clinically relevant exposures. Women of childbearing potential must use effective contraception during treatment. If pregnancy occurs during treatment, apremilast must be discontinued immediately.
Warnings and Precautions
Several important precautions should be observed before and during treatment with Apremilast Hexal:
- Psychiatric Disorders: Cases of depression, suicidal ideation, and suicidal behavior have been reported in patients taking apremilast. Patients and caregivers should be advised to notify the prescriber of any new or worsening depression, suicidal thoughts, or other mood changes. The risks and benefits of continuing treatment should be carefully evaluated if such events occur. Patients with a pre-existing history of psychiatric disorders should be carefully assessed before starting therapy.
- Body Weight: Weight loss has been observed during treatment. Body weight should be monitored regularly, particularly in patients who are underweight at baseline. If unexplained or clinically significant weight loss occurs (typically defined as more than 5% of body weight), consideration should be given to discontinuing treatment.
- 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. The initial dose titration schedule should also be modified, using only the morning doses during the titration period.
- Lactose Intolerance: Film-coated tablets may contain lactose as an excipient. Patients with rare hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
- Underweight Patients: Patients with a body mass index (BMI) below 18 should be closely monitored because of the risk of additional weight loss.
Pregnancy and Breastfeeding
Apremilast is contraindicated during pregnancy. Preclinical studies in animals demonstrated developmental toxicity, including increased embryo-fetal loss and decreased fetal weight at doses within the clinical exposure range. There is insufficient data on the use of apremilast in pregnant women. Women of childbearing potential should use effective contraception to prevent pregnancy during treatment. A pregnancy test is recommended before initiating therapy.
It is unknown whether apremilast or its metabolites are excreted in human breast milk. A risk to the breastfed infant cannot be excluded, and a decision must be made whether to discontinue breastfeeding or discontinue therapy, taking into account the importance of the medicine to the mother.
Children and Adolescents
The safety and efficacy of apremilast in children and adolescents under 18 years of age have not been established. No data are available, and therefore apremilast should not be used in this age group.
No dose adjustment is required for elderly patients, patients with mild to moderate renal impairment, or patients with hepatic impairment. However, patients over 75 years of age have limited clinical trial data, and careful monitoring is advisable.
How Does Apremilast Hexal Interact with Other Drugs?
Quick Answer: Apremilast has few clinically significant drug interactions. The most important interaction is with strong CYP3A4 inducers (e.g., rifampicin, carbamazepine, phenytoin), which can reduce apremilast's effectiveness. It can generally be used safely alongside methotrexate and other DMARDs.
Apremilast is primarily metabolized by cytochrome P450 3A4 (CYP3A4) and also undergoes non-CYP-mediated metabolism through glucuronidation, sulfation, and other pathways. Because of its diverse metabolic routes, the drug is less susceptible to interactions from any single pathway inhibitor. However, substances that strongly induce CYP3A4 can significantly decrease apremilast plasma levels and potentially reduce its therapeutic effect.
In clinical pharmacology studies, co-administration of apremilast with the potent CYP3A4 inducer rifampicin resulted in a 72% decrease in the area under the curve (AUC) of apremilast. This magnitude of reduction is likely to result in loss of clinical efficacy, and therefore concomitant use of strong CYP3A4 inducers with apremilast is not recommended.
Major Interactions
| Interacting Drug | Effect | Recommendation |
|---|---|---|
| Rifampicin | Reduces apremilast AUC by 72% via CYP3A4 induction | Concomitant use not recommended |
| Phenobarbital | Strong CYP3A4 inducer; expected to significantly reduce apremilast levels | Concomitant use not recommended |
| Carbamazepine | Strong CYP3A4 inducer; expected to significantly reduce apremilast levels | Concomitant use not recommended |
| Phenytoin | Strong CYP3A4 inducer; expected to significantly reduce apremilast levels | Concomitant use not recommended |
| St. John's Wort (Hypericum perforatum) | Herbal CYP3A4 inducer; may reduce apremilast levels | Avoid concomitant use |
Minor or No Clinically Significant Interactions
Pharmacokinetic studies have demonstrated that the following medications do not have clinically significant interactions with apremilast:
| Co-administered Drug | Notes |
|---|---|
| Methotrexate | No clinically significant interaction; can be used concomitantly |
| Oral contraceptives | No effect on pharmacokinetics of ethinylestradiol or norgestimate |
| Ketoconazole (CYP3A4 inhibitor) | Minimal increase in apremilast AUC (36%); no dose adjustment needed |
| Topical therapies | Can be used with topical corticosteroids, vitamin D analogs, and emollients |
| NSAIDs | No interaction expected; commonly co-prescribed in psoriatic arthritis |
One of the advantages of apremilast over some other systemic treatments is its relatively limited drug interaction profile. Unlike many biologics or conventional DMARDs, apremilast does not significantly affect the metabolism of most commonly prescribed medications. However, always inform your doctor about all prescription and over-the-counter medicines, herbal supplements, and vitamins you are taking.
What Is the Correct Dosage of Apremilast Hexal?
Quick Answer: The recommended maintenance dose is 30 mg taken orally twice daily, approximately 12 hours apart. Treatment begins with a 5-day dose titration schedule using the starter pack to reduce gastrointestinal side effects. No dose adjustment is needed for elderly patients or those with mild to moderate renal impairment.
Apremilast Hexal is administered orally and should be swallowed whole with water. Tablets should not be crushed, split, or chewed. The medication can be taken with or without food, although taking it with a meal may help reduce gastrointestinal symptoms in some patients.
Initial Dose Titration
To minimize gastrointestinal adverse events (particularly diarrhea and nausea), apremilast therapy begins with a 5-day titration schedule. This gradual dose escalation allows the body to adjust to the medication:
| Day | Morning Dose | Evening Dose |
|---|---|---|
| Day 1 | 10 mg | None |
| Day 2 | 10 mg | 10 mg |
| Day 3 | 10 mg | 20 mg |
| Day 4 | 20 mg | 20 mg |
| Day 5 | 20 mg | 30 mg |
| Day 6 onwards | 30 mg | 30 mg |
Adults
Standard Maintenance Dose
The recommended maintenance dose is 30 mg taken orally twice daily, approximately 12 hours apart (e.g., morning and evening). Treatment should be continued as long as clinical benefit is maintained. In clinical trials for psoriasis, treatment response was assessed at 16 weeks. Patients who have not shown a therapeutic response by week 24 should be re-evaluated and the need for continued treatment reconsidered.
Severe Renal Impairment
Adjusted Dose for Renal Impairment
For patients with severe renal impairment (creatinine clearance <30 mL/min), the dose should be reduced to 30 mg once daily. During the initial titration, only the morning doses from the standard schedule should be administered. No dose adjustment is needed for patients with mild or moderate renal impairment.
Elderly
Elderly Patients
No dose adjustment is required in elderly patients. However, clinical experience in patients over 75 years of age is limited. As elderly patients may be more susceptible to gastrointestinal adverse events, careful monitoring during the titration period is advisable.
Children
Pediatric Use
Apremilast Hexal is not recommended for use in children and adolescents under 18 years of age. Safety and efficacy have not been established in this population, and no pediatric dosing data are available.
Missed Dose
If a dose is missed, it should be taken as soon as possible. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the next dose should be taken at the regular time. Do not take a double dose to make up for a missed dose. Continue with the regular dosing schedule.
Overdose
Apremilast has been studied at doses up to 100 mg daily (50 mg twice daily) without evidence of dose-limiting toxicities. In the event of overdose, the patient should be monitored for signs and symptoms of adverse effects, and appropriate symptomatic and supportive treatment should be given. There is no specific antidote for apremilast overdose. Due to the drug being approximately 68% protein-bound, dialysis is unlikely to be an efficient method of removal.
Many patients find it helpful to use a pill organizer or smartphone alarm to maintain the twice-daily dosing schedule. Taking the medication at consistent times each day helps maintain stable blood levels and may improve treatment outcomes.
What Are the Side Effects of Apremilast Hexal?
Quick Answer: The most common side effects of apremilast are gastrointestinal symptoms (diarrhea and nausea), which typically occur in the first two weeks and resolve with continued treatment. Upper respiratory tract infections and headaches are also common. Serious but rare side effects include depression, suicidal ideation, and severe hypersensitivity reactions.
Like all medicines, Apremilast Hexal can cause side effects, although not everybody gets them. The safety profile of apremilast has been well-characterized through large clinical trial programs involving thousands of patients treated for up to 5 years. The most frequently reported adverse reactions are gastrointestinal in nature, particularly during the first two weeks of treatment, and generally diminish in severity and frequency with continued use. The 5-day dose titration schedule was specifically designed to reduce these initial gastrointestinal symptoms.
It is important to understand that the frequencies reported below are based on pooled data from controlled clinical trials. Individual experiences may vary, and many patients complete treatment without significant side effects.
Very Common
May affect more than 1 in 10 people
- Diarrhea (particularly in the first 2 weeks of treatment)
- Nausea (particularly in the first 2 weeks of treatment)
Common
May affect up to 1 in 10 people
- Upper respiratory tract infections (common cold, sinusitis, nasopharyngitis)
- Headache and tension headache
- Migraine
- Vomiting
- Dyspepsia (indigestion)
- Frequent bowel movements
- Upper abdominal pain
- Decreased appetite
- Back pain
- Fatigue
- Weight decrease
- Bronchitis
- Cough
Uncommon
May affect up to 1 in 100 people
- Gastrointestinal hemorrhage (including rectal bleeding)
- Rash, urticaria (hives)
- Depression
- Suicidal ideation
- Insomnia
Rare
May affect up to 1 in 1,000 people
- Severe hypersensitivity reactions (angioedema, severe rash)
- Suicidal behavior
- Stevens-Johnson syndrome (very rare post-marketing reports)
Contact your doctor immediately or go to the nearest emergency department if you experience: signs of a severe allergic reaction (swelling of the face, lips, tongue or throat, difficulty breathing, severe skin rash), new or worsening symptoms of depression, thoughts of self-harm or suicide, severe abdominal pain with bloody diarrhea, or unexplained significant weight loss.
Gastrointestinal Effects in Detail
Diarrhea and nausea are the most commonly reported side effects and deserve special attention. In the pivotal clinical trials (ESTEEM 1 and 2 for psoriasis; PALACE 1-4 for psoriatic arthritis), diarrhea was reported in approximately 17-19% of patients receiving apremilast compared to 6-8% of placebo patients. Nausea occurred in approximately 15-17% of apremilast patients versus 6-7% of placebo patients.
These gastrointestinal symptoms have several important characteristics: they occur predominantly during the first two weeks of therapy, they are typically mild to moderate in severity, they usually resolve spontaneously with continued treatment, and the gradual dose titration schedule significantly reduces their incidence and severity. In clinical trials, the discontinuation rate due to gastrointestinal adverse events was low (approximately 1.5-2% of patients).
Weight Monitoring
Body weight should be monitored regularly during treatment with apremilast. In clinical trials, approximately 10% of patients experienced weight loss of 5-10% of body weight, and about 2% experienced weight loss exceeding 10%. Most weight loss occurred in the first 6 months of treatment. If unexplained or clinically significant weight loss occurs, the treating physician should evaluate the need for treatment continuation. This is particularly important in underweight patients (BMI <18).
Psychiatric Effects
Post-marketing surveillance and clinical trial data have identified a signal for psychiatric adverse events, including depression and, rarely, suicidal ideation and behavior. In the controlled clinical trials, depression was reported in approximately 1.0% of apremilast patients versus 0.8% of placebo patients. While the absolute risk is low, patients and their caregivers should be advised to report any changes in mood, feelings of hopelessness, or thoughts of self-harm to their healthcare provider immediately. Patients with a history of depression or psychiatric disorders should be carefully evaluated before starting treatment, and the benefit-risk balance should be reassessed if such symptoms develop.
How Should You Store Apremilast Hexal?
Quick Answer: Store Apremilast Hexal below 30°C in its original packaging to protect it from light and moisture. Keep out of reach of children. Do not use after the expiry date printed on the packaging.
Proper storage of medications is essential to maintain their effectiveness and safety. Apremilast Hexal film-coated tablets should be stored at temperatures not exceeding 30°C (86°F). The tablets should be kept in their original packaging (blister pack or bottle) to protect them from moisture and light, both of which can degrade the active substance over time.
Do not use Apremilast Hexal after the expiry date which is stated on the carton and blister or bottle after "EXP". The expiry date refers to the last day of that month. Do not store in a bathroom or other humid environment, as moisture can compromise tablet integrity.
Keep this medicine out of the sight and reach of children. The starter pack, in particular, contains tablets of different strengths (10 mg, 20 mg, and 30 mg) and should be stored securely to prevent accidental ingestion by children.
Do not throw away medicines via household waste or wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures help protect the environment and ensure safe disposal.
What Does Apremilast Hexal Contain?
Quick Answer: The active substance is apremilast, available in 10 mg, 20 mg, and 30 mg film-coated tablets. The inactive ingredients include typical pharmaceutical excipients such as microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, and a film coating.
Active Ingredient
Each film-coated tablet contains one of the following amounts of the active substance:
- 10 mg tablet: Contains 10 mg of apremilast
- 20 mg tablet: Contains 20 mg of apremilast
- 30 mg tablet: Contains 30 mg of apremilast (maintenance dose)
Inactive Ingredients (Excipients)
The tablets contain the following inactive ingredients, which serve various pharmaceutical functions:
Tablet core: Microcrystalline cellulose (filler/binder), lactose monohydrate (filler), croscarmellose sodium (disintegrant), and magnesium stearate (lubricant).
Film coating: The film coat contains polyvinyl alcohol, titanium dioxide (E171), macrogol (polyethylene glycol), talc, and iron oxide pigments. The different tablet strengths are distinguished by color: the 10 mg tablets are pink, the 20 mg tablets are brown, and the 30 mg tablets are beige. These color differences help patients correctly identify the appropriate tablets during the titration period.
Apremilast Hexal tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine. The amount of lactose per tablet is small and is unlikely to cause symptoms in patients with common lactose intolerance.
Tablet Appearance
| Strength | Color | Shape |
|---|---|---|
| 10 mg | Pink | Round, biconvex film-coated tablet |
| 20 mg | Brown | Oval, biconvex film-coated tablet |
| 30 mg | Beige | Oval, biconvex film-coated tablet |
The starter pack (initiation pack) typically contains tablets of all three strengths arranged according to the 5-day titration schedule, along with maintenance 30 mg tablets. This packaging is designed to guide patients through the titration period and reduce the risk of dosing errors. After completing the titration, patients should continue with 30 mg tablets only, taken twice daily.
Frequently Asked Questions
Apremilast Hexal is a PDE4 inhibitor used to treat moderate to severe plaque psoriasis in adults who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies such as methotrexate, ciclosporin, or PUVA. It is also approved for active psoriatic arthritis in adults who have had an inadequate response to a prior DMARD, and for oral ulcers associated with Behçet's disease.
For psoriasis, clinical improvement is typically observed within 4 to 6 weeks, with maximal response seen at approximately 16 weeks. For psoriatic arthritis, some improvement may be noticed within 2 to 4 weeks, but full assessment of response generally occurs at 16 to 24 weeks. It is important to continue treatment as prescribed, as the full therapeutic benefit takes time to develop.
Yes, weight loss has been reported in some patients taking apremilast. In clinical trials, about 10% of patients experienced weight loss of 5-10% of body weight, and approximately 2% had weight loss exceeding 10%. Body weight should be monitored regularly, particularly in underweight patients. If unexplained or clinically significant weight loss occurs, treatment may need to be discontinued.
No, unlike many other systemic treatments for psoriasis and psoriatic arthritis (such as methotrexate, ciclosporin, or biologics), apremilast does not require routine blood count, liver function, or kidney function monitoring. This is one of its practical advantages. However, a pregnancy test is required before initiating treatment in women of childbearing potential, and body weight should be monitored periodically.
Apremilast is classified as an immunomodulator rather than a traditional immunosuppressant. It works by inhibiting PDE4, which modulates the balance between pro-inflammatory and anti-inflammatory mediators. Unlike biologics that target specific immune molecules (e.g., TNF-α, IL-17, IL-23), apremilast has a broader but milder immunomodulatory effect. In clinical trials, the rates of serious infections, opportunistic infections, and malignancies were not significantly increased compared with placebo.
There is no specific contraindication to moderate alcohol consumption while taking apremilast. No formal drug interaction study with alcohol has been conducted. However, alcohol may worsen gastrointestinal side effects such as nausea and diarrhea, particularly during the initial titration period. Additionally, alcohol can have dehydrating effects and may exacerbate psoriasis in some individuals. Patients should discuss alcohol consumption with their healthcare provider.
References
- European Medicines Agency (EMA). Otezla (apremilast) – Summary of Product Characteristics. Updated 2025. Available at: www.ema.europa.eu
- U.S. Food and Drug Administration (FDA). Otezla (apremilast) – Prescribing Information. Updated 2024. Available at: www.accessdata.fda.gov
- 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.
- Paul C, Cather J, Girdtler R, et al. Apremilast, an oral phosphodiesterase 4 inhibitor, in patients with moderate to severe plaque psoriasis: Results of a Phase III, Randomized, Controlled Trial (ESTEEM 2). Br J Dermatol. 2015;173(6):1387-1399.
- 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 Behçet's syndrome. N Engl J Med. 2019;381(20):1918-1928.
- Joint AAD-NPF Guidelines of Care for the Management and Treatment of Psoriasis with Systemic Nonbiologic Therapies. J Am Acad Dermatol. 2023;88(4):835-876.
- 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.
- Smith CH, Yiu ZZN, Bale T, et al. British Association of Dermatologists guidelines for biologic therapy for psoriasis 2020: a rapid update. Br J Dermatol. 2020;183(4):628-637.
- World Health Organization (WHO). Model List of Essential Medicines – 23rd list, 2023. Geneva: World Health Organization; 2023.
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