Aplex Kit

Apremilast, an inhibitor of phosphodiesterase 4 (PDE4), is indicated for the treatment of: Adult patients with: Active psoriatic arthritis Plaque psoriasis who are candidates for phototherapy or systemic therapy Oral ulcers associated with Behçet's Disease Pediatric patients 6 years of age and older with: Active psoriatic arthritis Moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy In the pediatric population, Apremilast is indicated for patients weighing at least 20 kg, and Apremilast is indicated for patients weighing at least 50 kg. Psoriatic Arthritis Apremilast is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 20 kg with active psoriatic arthritis. Apremilast is indicated for the treatment of adult patients and pediatric patients 6 years of age and older and weighing at least 50 kg with active psoriatic arthritis. Plaque Psoriasis Apremilast is indicated for the treatment of adult patients with plaque psoriasis who are candidates for phototherapy or systemic therapy. Apremilast is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 20 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Apremilast is indicated for the treatment of pediatric patients 6 years of age and older and weighing at least 50 kg with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Oral Ulcers Associated with Behçet's Disease Apremilast is indicated for the treatment of adult patients with oral ulcers associated with Behçet's Disease.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Hypersensitivity: Cases of angioedema and anaphylaxis have been reported during post marketing surveillance. Avoid the use of Apremilast in patients with known hypersensitivity to apremilast or to any of the excipients in the formulation. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue Apremilast and institute appropriate therapy Diarrhea, Nausea, and Vomiting: Consider Apremilast dosage reduction or suspension if patients develop severe diarrhea, nausea, or vomiting Depression: Advise patients, their caregivers, and families to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes and if such changes occur to contact their healthcare provider. Carefully weigh risks and benefits of treatment with Apremilast in patients with a history of depression and/or suicidal thoughts or behavior Weight Decrease: Monitor weight regularly. If unexplained or clinically significant weight loss occurs, evaluate weight loss and consider discontinuation of Apremilast Drug Interactions: Use with strong cytochrome P450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended because loss of efficacy may occur Hypersensitivity reactions, including cases of angioedema and anaphylaxis, have been reported during post marketing surveillance. If signs or symptoms of serious hypersensitivity reactions develop during treatment, discontinue Apremilast and institute appropriate therapy. Diarrhea, Nausea, and Vomiting There have been reports of severe diarrhea, nausea, and vomiting associated with the use of Apremilast. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting. Patients who reduced dosage or discontinued Apremilast generally improved quickly. Consider Apremilast dosage reduction or suspension if patients develop severe diarrhea, nausea, or vomiting. Depression Treatment with apremilast is associated with an increased incidence of depression. Before using Apremilast in patients with a history of depression and/or suicidal thoughts or behavior, carefully weigh the risks and benefits of treatment with Apremilast. Advise patients, their caregivers, and families of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and if such changes occur to contact their healthcare provider. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following adverse reactions are described elsewhere in the labeling: Hypersensitivity Diarrhea, Nausea, and Vomiting Depression Weight Decrease Drug Interactions Psoriatic Arthritis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, and headache Plaque Psoriasis: The most common adverse reactions (≥ 5%) are diarrhea, nausea, upper respiratory tract infection, and headache, including tension headache Behçet's Disease: The most common adverse reactions (≥ 10%) are diarrhea, nausea, headache, and upper respiratory tract infection at ( ) or FDA Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Psoriatic Arthritis Clinical Trials Apremilast was evaluated in three multicenter, randomized, double-blind, placebo-controlled trials (PsA-1, PsA-2, and PsA-3) of similar design in adult subjects with active psoriatic arthritis. Across the three trials, there were 1493 subjects randomized equally to placebo, Apremilast 20 mg twice daily or Apremilast 30 mg twice daily. Titration was used over the first 5 days. Placebo subjects whose tender and swollen joint counts had not improved by at least 20% were re-randomized 1:1 in a blinded fashion to either Apremilast 20 mg twice daily or 30 mg twice daily at week 16 while Apremilast subjects remained on their initial treatment. Subjects ranged in age from 18 to 83 years, with an overall median age of 51 years. The majority of the most common adverse reactions presented in Table 3 occurred within the first 2 weeks of treatment and tended to resolve over time with continued dosing. Diarrhea, headache, and nausea were the most commonly reported adverse reactions. The most common adverse reactions leading to discontinuation for subjects taking Apremilast were nausea (1.8%), diarrhea (1.8%), and headache (1.2%). The proportion of subjects with psoriatic arthritis who discontinued treatment due to any adverse reaction was 4.6% for subjects taking Apremilast 30 mg twice daily and 1.2% for placebo-treated subjects. Table 3. Adverse Reactions Reported in ≥ 2% of Adult Subjects with Active Psoriatic Arthritis on Apremilast 30 mg Twice Daily and ≥ 1% than That Observed in Subjects on Placebo up to Day 112 (Week 16) Placebo Apremilast 30 mg BID BID = twice daily. Adverse Reactions Day 1 to 5 (N = 495) n (%) n (%) indicates number of subjects and percent. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.