Only IMBRUVICA® offers convenience through simplicity of a once-a-day single tablet that can be taken at home[1]
The recommended dose of IMBRUVICA® in patients with CLL
- IMBRUVICA® should be taken until disease progression or until it is no longer tolerated by the patient[1]
- Patients can take IMBRUVICA® at home approximately at the same time each day[1]
- IMBRUVICA® can be taken with medicinal products that increase stomach pH such as proton pump inhibitors[1]
Most patients preferred tablet treatment over infusion, injection or combinations, primarily driven by the lower impact on daily life.[2]*
Most patients receiving tablet-only treatment were highly compliant and were more satisfied than those on infusion or combination treatment.[2]†‡
Guideline updates due to the COVID-19 pandemic highlight that home-based treatments are preferable and caution the use of a CD20[3][4]
Dosing guidance
- IMBRUVICA® should be taken once a day with a glass of water approximately at the same time each day[1]
- Tablets should be swallowed whole and should not be broken or chewed[1]
Avoid the use of the following with IMBRUVICA® treatment:[1]
- Warfarin
- Vitamin K antagonists
- Fish oil
- Vitamin E preparations
- Grapefruit juice
- Seville oranges
- St. John’s Wort preparations
Dose modifications
CYP3A4 inhibitors
Moderate CYP3A4 inhibitors: IMBRUVICA® dose should be reduced to 280 mg once-a-day if used concomitantly with moderate CYP3A4 inhibitors[1]
Strong 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[1]
Surgery
IMBRUVICA® should be withheld at least 3–7 days pre- and post-surgery, depending on the type of surgery and the risk of bleeding[1]
Dosing considerations
Use with proton-pump inhibitors (PPIs)
Medicinal products that increase stomach pH (e.g., PPIs) have been used without restrictions in pivotal clinical studies[1]
Dose adjustments for AEs
No IMBRUVICA® dose adjustment required with Grade 1 or 2 AEs[1]
Managing Grade 3 or 4 AEs
Step 1: Withhold IMBRUVICA®
Perform appropriate investigations and interventions[1][5]
Anticoagulant/antiplatelet therapy should be reviewed and, where appropriate, stopped[5]
Step 2: Restart IMBRUVICA®
Once the AE has resolved to Grade 1 or baseline (recovery), IMBRUVICA® may be restarted at the starting dose recommended in the Summary of Product Characteristics, with reassessment if the AE reoccurs[1]
Dose modification after recovery[1]
Grade 3 or 4 AE occurrence | Dose modification |
|---|---|
Grade 3 or 4 AE occurrence 1st | Dose modification Restart at 420 mg daily |
Grade 3 or 4 AE occurrence 2nd | Dose modification Restart at 280 mg daily |
Grade 3 or 4 AE occurrence 3rd | Dose modification Restart at 140 mg daily |
Grade 3 or 4 AE occurrence 4th | Dose modification Discontinue IMBRUVICA® |
Anticoagulants and antiplatelet agents
Anticoagulants and antiplatelet agents can be used with IMBRUVICA®[1]
Anticoagulants and/or antiplatelet agents were used in approximately 50% of patients with CLL in IMBRUVICA® trials[6][7]
Expert panel recommendations:[5]
Anticoagulants: Novel oral anticoagulants are the most appropriate therapy[5]
Antiplatelet agents: IMBRUVICA® can be given but close monitoring is required; consider the risk of concomitant antiplatelet therapy to the individual patient[5]
Risk of bleeding may be increased in patients taking anticoagulants or antiplatelet agents[1][8]
Atrial fibrillation (AF)
IMBRUVICA® is not contraindicated in patients with a prior history of AF[1]
Most AF events in trials were manageable and resolved quickly[8]
- Events were managed with standard therapies[8]§
- Median time to AF resolution was 3 days[8]¶
- Not all patients with AF will require anticoagulation treatment based on risk assessment[5]
- 85.2% of patients with a prior history of AF and 90.5% of patients with a prior history of hypertension did not develop AF[8]
Expert panel recommendations:[5]
Prior history of AFand the potential for developing AF should not deter physicians from considering IMBRUVICA® for their patients[5]
All patients should be given a thorough cardiovascular assessment before starting IMBRUVICA® and be regularly monitored by a physical examination during treatment.[5]
IMBRUVICA® treatment should be withheld temporarily in patients who develop Grade ≥3 AF[5]
AF should be managed with the advice of a cardiologist[5]
The dose of IMBRUVICA® should not be reduced unless there is a clinically important reason[5]
Alternative treatment options to IMBRUVICA® should be considered for patients with pre-existing AF who require anticoagulation therapy[1]
For full information on dosing considerations, please see IMBRUVICA® Summary of Product Characteristics.
Dosing in special populations
Elderly
No specific dose adjustment is required for elderly patients (aged ≥65 years).[1]
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 are no data in patients with severe renal impairment or patients on dialysis.[1]
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. For patients with moderate liver impairment (Child-Pugh class B), the recommended dose is 140 mg daily.[1]
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).[1]
Severe cardiac disease
Patients with severe cardiovascular disease were excluded from IMBRUVICA® clinical studies.[1]
Children
The safety and efficacy of IMBRUVICA® in children and adolescents aged 0 to 18 years have not been established. No data are available.[1]
Explore the predictable long-term
safety profile of IMBRUVICA®
Learn more about tried and tested use of IMBRUVICA®
across a number of studies
Back to IMBRUVICA® in CLL
*All respondents (n=247). 5% preferred injection, 6% infusion and 19% combination therapy. Patients whose latest treatment did not involve tablet (n=44), 64% preferred tablet only, 5% preferred injection, 9% infusion, 23% combination therapy.[2]
†Respondents who have received tablets (either they have only ever received tablet treatment or their latest treatment includes tablets [n=74]).[2]
‡Respondents who have received each treatment most recently (all treated n=137; infusion only n=41 [satisfaction rating 7/10]; tablet only n=39 [satisfaction rating 9/10]; any combination n=36 [satisfaction rating 8/10]).[2]
§During 4 clinical trials in patients with CLL/SLL or MCL, the most frequently used agents were digoxin (22.4%), bisoprolol (20.4%) and amiodarone (16.3%).[8]
¶There was a wide variation in how long events lasted (assessed at a median follow-up of 16.6 months).[8]
AE=adverse event; CD20=cluster of differentiate 20; CLL=chronic lymphocytic leukaemia; MCL=mantle cell lymphoma; PPI=proton pump inhibitor; SLL=small lymphocytic lymphoma.
| Adverse events should be reported. Reporting an adverse event will help J&J monitor the safety of all our healthcare products for the benefit of patients and consumers. It is important to report adverse events, even if it is a known adverse event, as this provides valuable information for monitoring product safety, allowing J&J to provide up-to-date information in the Summary of Product Characteristics and product information leaflets. For Adverse Events or safety related issues on J&J products, please approach the mailbox PVNEMA@ITS.JNJ.COM or Tel: +961 1 518769/ +961 1 518775 |
