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Apremilast Accord is a brand name for Apremilast. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Psoriatic arthritis Apremilast Accord, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1). Psoriasis…
Verbatim from this product's EMA label. Tap a section to expand.
Treatment with Apremilast Accord should be initiated by specialists experienced in the diagnosis and treatment of psoriasis, psoriatic arthritis or Behçet’s disease. Posology Adult patients with psoriatic arthritis, psoriasis, or Behçet’s disease The recommended dose of apremilast for adult patients is 30 mg taken orally twice daily.
An initial titration schedule is required as shown below in table 1. Table 1. Dose titration schedule for adult patients Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM AM PM 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg Paediatric patients with moderate to severe plaque psoriasis The recommended dose of apremilast for paediatric patients 6 years of age and older with moderate to severe plaque psoriasis is based on body weight.
The recommended dose of apremilast is 20 mg taken orally twice daily for paediatric patients who weigh from 20 kg to less than 50 kg, and 30 mg taken orally twice daily for paediatric patients who weigh at least 50 kg, following the initial titration schedule shown below in table 2.
4 Table 2. Dose titration schedule for paediatric patients Body weight Day 1 Day 2 Day 3 Day 4 Day 5 Day 6 & thereafter AM AM PM AM PM AM PM AM PM AM PM 20 kg to less than 50 kg 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 20 mg 50 kg or more 10 mg 10 mg 10 mg 10 mg 20 mg 20 mg 20 mg 20 mg 30 mg 30 mg 30 mg All indications (psoriasis in adults and children, psoriatic arthritis, Behçet’s disease) No re-titration is required after initial titration.
The recommended twice daily apremilast dose should be taken approximately 12 hours apart (morning and evening), with no food restrictions. If patients miss a dose, the next dose should be taken as soon as possible. If it is close to the time for their next dose, the missed dose should not be taken and the next dose should be taken at the regular time.
During pivotal trials the greatest improvement was observed within the first 24 weeks of treatment for PsA and PSOR and within the first 12 weeks of treatment for BD. If a patient shows no evidence of therapeutic benefit after this time period, treatment should be reconsidered.
The patient's response to treatment should be evaluated on a regular basis. 2). Patients with renal impairment Adult patients with psoriatic arthritis, psoriasis, or Behçet’s disease No dose adjustment is needed in adult patients with mild and moderate renal impairment.
9%). 2%) and are mostly mild to moderate in severity. 7%) and are mostly mild to moderate in severity. The gastrointestinal adverse reactions generally occurred within the first 2 weeks of treatment and usually resolved within 4 weeks.
3). Tabulated list of adverse reactions The adverse reactions observed in adult patients treated with apremilast are listed below by system organ class (SOC) and frequency for all adverse reactions. Within each SOC and frequency grouping, adverse reactions are presented in order of decreasing seriousness.
The adverse drug reactions were determined based on data from the apremilast clinical development programme and post-marketing experience in adult patients. The frequencies of adverse drug reactions are those reported in the apremilast arms of the four Phase III studies in PsA (n = 1,945 or the two Phase III studies in PSOR (n = 1184), and in the phase III study in BD (n = 207).
The highest frequency from either data pool is represented in table 3. Frequencies are defined as: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1 000 to < 1/100); rare (≥ 1/10 000 to < 1/1 000); not known (cannot be estimated from the available data).
Table 3. Summary of adverse reactions in psoriatic arthritis (PsA), psoriasis (PSOR) and Behçet’s disease (BD) System Organ Class Frequency Adverse reaction Infections and infestations Very common Upper respiratory tract infectiona Common Bronchitis Nasopharyngitis* Immune system disorders Uncommon Hypersensitivity Metabolism and nutrition disorders Common Decreased appetite* Psychiatric disorders Common Insomnia Depression Uncommon Suicidal ideation and behaviour 8 System Organ Class Frequency Adverse reaction Anxiety Mood altered Nervous system disorders Very common Headache*,a Common Migraine* Tension headache* Respiratory, thoracic, and mediastinal disorders Common Cough Gastrointestinal disorders Very common Diarrhoea* Nausea* Common Vomiting* Dyspepsia Frequent bowel movements Upper abdominal pain* Gastroesophageal reflux disease Uncommon Gastrointestinal haemorrhage Skin and subcutaneous tissue disorders Uncommon Rash Urticaria Not known Angioedema Musculoskeletal and connective tissue disorders Common Back pain* General disorders and administration site conditions Common Fatigue Investigations Uncommon Weight decrease *At least one of these adverse reactions was reported as serious a Frequency reported as common in PSA and PSOR Description of selected adverse reactions Psychiatric disorders In clinical studies and post-marketing experience, uncommon cases of suicidal ideation and behaviour, were reported, while completed suicide was reported post-marketing.
Diarrhoea, nausea, and vomiting There have been post-marketing reports of severe diarrhoea, nausea, and vomiting associated with the use of apremilast. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalised.
Patients 65 years of age or older may be at a higher risk of complications. If patients develop severe diarrhoea, nausea, or vomiting, discontinuation of treatment with apremilast may be necessary. Psychiatric disorders Apremilast is associated with an increased risk of psychiatric disorders such as insomnia, anxiety, altered mood, and depression.
8). The risks and benefits of starting or continuing treatment with apremilast should be carefully assessed if patients report previous or existing psychiatric symptoms or if concomitant treatment with other medicinal products likely to cause psychiatric events is intended.
Patients and caregivers should be instructed to notify the prescriber of any changes in behaviour or mood and of any suicidal ideation. If patients suffered from new or worsening psychiatric symptoms, or suicidal ideation or suicidal attempt is identified, it is recommended to discontinue treatment with apremilast.
2). 2). Underweight patients Patients who are underweight and paediatric patients who have a borderline to low body mass index at the start of treatment should have their body weight monitored regularly. In the event of unexplained and clinically significant weight loss, these patients should be evaluated by a medical practitioner and discontinuation of treatment should be considered.
6 Excipients warning: Lactose Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose- galactose malabsorption should not take this medicinal product. Sodium This medicinal product contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
1. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The dose of apremilast should be reduced to 30 mg once daily in adult patients with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockcroft-Gault equation). 2). Paediatric patients with moderate to severe psoriasis No dose adjustment is needed in paediatric patients 6 years of age and older with mild or moderate renal impairment.
In paediatric patients 6 years of age and older with severe renal impairment (creatinine clearance of less than 30 mL per minute estimated by the Cockroft–Gault equation), dose adjustment is recommended. The apremilast dose should be reduced to 30 mg once daily for paediatric patients who weigh at least 50 kg and to 20 mg once daily for paediatric patients who weigh 20 kg to less than 50 kg.
For initial dose titration in these groups, it is recommended that apremilast be titrated using only the AM schedule listed in table 2 above for the appropriate body weight category and the PM doses be skipped. 2). Paediatric population 5 The safety and efficacy of apremilast have not been established in children with moderate to severe plaque psoriasis below the age of 6 years or with a body weight less than 20 kg, or in other paediatric indications.
No data are available. Method of administration Apremilast Accord is for oral use. The film-coated tablets should be swallowed whole, and can be taken either with or without food.
4). Body weight loss Patient weight was measured routinely in clinical studies. 99 kg. 7% of the patients receiving apremilast had observed weight loss greater than 10%. None of these patients had overt clinical consequences resulting from weight loss.
1% of patients treated with apremilast discontinued due to adverse reaction of weight decreased. 52 kg. 8% of the patients receiving apremilast had observed weight loss greater than 10%. None of these patients had overt clinical consequences from weight loss.
None of the patients discontinued the study due to adverse reaction of weight decreased. 4 for patients who are underweight at beginning of treatment. 4). Patients with hepatic impairment The safety of apremilast was not evaluated in PsA, PSOR or BD patients with hepatic impairment.
Patients with renal impairment In the PsA, PSOR or BD clinical studies, the safety profile observed in patients with mild renal impairment was comparable to patients with normal renal function. The safety of apremilast was not evaluated in PsA, PSOR or BD patients with moderate or severe renal impairment in the clinical studies.
Paediatric patients The safety of apremilast was assessed in a 52-week clinical trial in paediatric patients 6 to 17 years of age with moderate to severe plaque psoriasis (SPROUT study). The safety profile of apremilast observed during the study was consistent with the safety profile previously established in adult patients with moderate to severe plaque psoriasis.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.