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A once-a-day, single tablet that can be taken at home[1]
The recommended dose of IMBRUVICA® in patients with WM is one 420 mg once daily.[1]
- Patients can take IMBRUVICA® at home with no dose escalation[1]
- IMBRUVICA® should be taken until disease progression or until it is no longer tolerated by the patient[1]
• IMBRUVICA® should be taken once a day with a glass of water approximately at the same time each day
• Tablets should be swallowed whole and should not be broken or chewed
• IMBRUVICA® must not be taken with grapefruit juice or Seville oranges
• Use of preparations containing St. John’s Wort is contraindicated in patients taking IMBRUVICA®
• IMBRUVICA® dose should be reduced to 280 mg once a day if used concomitantly with moderate CYP3A4 inhibitors
• IMBRUVICA® dose should be reduced to 140 mg once a day OR withheld for up to 7 days if used concomitantly with strong CYP3A4 inhibitors
• IMBRUVICA® should be withheld at least 3–7 days pre- and post-surgery, depending on the type of surgery and the risk of bleeding
• Medicinal products that increase stomach pH (e.g., proton pump inhibitors) have been used without restrictions in the pivotal clinical studies
• Anticoagulants and antiplatelet agents can be used with IMBRUVICA®†
Dosing in special populations[1]
Elderly
No specific dose adjustment is required for elderly patients (aged ≥65 years).
Renal impairment
No specific clinical studies have been conducted in patients with renal impairment. Patients with mild or moderate renal impairment were treated in IMBRUVICA® clinical studies. No dose adjustment is needed for patients with mild or moderate renal impairment (>30 mL/min creatinine clearance). Hydration should be maintained and serum creatinine levels monitored periodically.
Administer IMBRUVICA® to patients with severe renal impairment (<30 mL/min creatinine clearance) only if the benefit outweighs the risk and monitor patients closely for signs of toxicity. There is no data in patients with severe renal impairment or patients on dialysis.
Hepatic impairment
IMBRUVICA® is metabolised in the liver. In a hepatic impairment study, data showed an increase in IMBRUVICA® exposure. For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 280 mg daily (2 capsules). For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily (1 capsule).
Monitor patients for signs of IMBRUVICA® toxicity and follow dose modification guidance as needed. It is not recommended to administer IMBRUVICA® to patients with severe hepatic impairment (Child-Pugh class C).
Severe cardiac disease
Patients with severe cardiovascular disease were excluded from IMBRUVICA® clinical studies.
Paediatric population
The safety and efficacy of IMBRUVICA® in children and adolescents aged 0 to 18 years have not been established. No data are available.
This content is intended for Healthcare Professionals only. IMBRUVICA® is licensed in the following indications:
- IMBRUVICA® as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).
- IMBRUVICA® as a single agent or in combination with rituximab or obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
- IMBRUVICA® as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.
- IMBRUVICA® as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemoimmunotherapy.
- IMBRUVICA® in combination with rituximab is indicated for the treatment of adult patients with WM.
Prescribing information may vary depending on approval in each country. Therefore, before prescribing any product, always refer to local materials such as the prescribing information and/or the Summary of Product Characteristics.
*For full information about dosing considerations and contraindications, please see the IMBRUVICA® Summary of Product Characteristics.
†Use of either anticoagulants or antiplatelet agents concomitantly with IMBRUVICA® increases the risk of major bleeding. A higher risk for major bleeding was observed with anticoagulants than with antiplatelet agents. Consider the risks and benefits of anticoagulant or antiplatelet therapy when co-administered with IMBRUVICA®. Monitor for signs and symptoms of bleeding.[1]
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