Special Warning : אזהרת שימוש

4.4 Special warnings and precautions for use

Diarrhea, nausea, and vomiting

There have been post-marketing 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 may be at a higher risk of complications. If patients develop severe diarrhea, 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 and depression. Instances of suicidal ideation and behavior, including suicide, have been observed in patients with or without history of depression (see section 4.8). 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 behavior 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.

Severe renal impairment
Apremilast should be dose reduced to 30 mg once daily in patients with severe renal impairment (see sections 4.2 and 5.2).

Underweight patients
Patients who are underweight 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.

Lactose content
Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

Effects on Driving

4.7 Effects on ability to drive and use machines

Apremilast has no or negligible influence on the ability to drive and use machines.