BRUKINSA patients can call the myBeiGene® patient support program to talk to a dedicated nurse: 1-833-BEIGENE (1-833-234-4363)
DOSING SCHEDULE FOR BRUKINSA + OBINUTUZUMAB1,2
Maximum total duration of obinutuzumab: ~30 months (maximum 20 doses)2
Flexibility to tailor the schedule to your patients
ONCE DAILY
Consider for patients with compliance concerns or for those who prefer taking their medication once a day
320 mg daily dose
(four 80-mg capsules once daily)
TWICE DAILY
Consider for patients who take other twice-daily medications to maintain a consistent dosing schedule
320 mg daily dose
(two 80-mg capsules AM
and two 80-mg capsules PM)
In Cycle 1, 100 mg obinutuzumab could be administered on Day 1 and 900 mg on Day 2 at investigator discretion in ROSEWOOD (Study 212).1
Refer to obinutuzumab Prescribing Information for additional dosing and administration information.
recommended dosage for
severe hepatic impairment1,3,4
- Adjust dose to 80 mg twice daily
- No dose adjustment needed for mild to moderate hepatic impairment
Although the safety of BRUKINSA has not been evaluated in patients with severe hepatic impairment, there is no caution to avoid use in these patients.
Straightforward dose modification
- Simply reduce the number of BRUKINSA capsules
- Ability to reduce the dose in small increments
- Rates of dose reductions (0.8%-11%) were low across BRUKINSA studies
No dose exchanges needed
- BRUKINSA does not require a new prescription or dose exchange for dose reductions
- Can be taken with or without food. Can be taken with a high-fat meal—BRUKINSA drug concentration (AUC) is not affected
- Advise patients to swallow capsules whole with water—do not open, break, or chew capsules
- If a dose of BRUKINSA is missed, it should be taken as soon as possible with a return to the normal schedule the following day
BRUKINSA should be taken until disease progression or unacceptable toxicity.
AUC=area under the concentration-time curve; BTKi=Bruton’s tyrosine kinase inhibitor; FL=follicular lymphoma; R/R=relapsed/refractory.
DOWNLOAD GUIDE TO DOSING AND ADMINISTRATION OF BRUKINSAProton pump inhibitors
Including, but not limited to:
- Omeprazole
- Esomeprazole
- Lansoprazole
H2-receptor antagonists
Including, but not limited to:
- Famotidine
- Ranitidine
- Nizatidine
Anticoagulants
- Heparins
- Direct thrombin inhibitors
- Factor Xa inhibitors
- Vitamin K antagonists
Antiplatelets
- Aspirin
- P2Y12 inhibitors
- Phosphodiesterase inhibitors
- PAR-1 antagonists
BRUKINSA was allowed to be coadministered in clinical trials with antiplatelets and anticoagulants (as long as INR was ≤1.5 and aPTT ≤1.5 x ULN).5-7
Coadministration of BRUKINSA with antiplatelet or anticoagulant medications may increase the risk of hemorrhage. Monitor for signs and symptoms of bleeding.1
≥Grade 3 events requiring dose modifications
- Grade 3 or Grade 4 febrile neutropenia
- Platelet count decreased to 25,000-50,000/mm3 with significant bleeding
- Neutrophil count decreased to <500/mm3*
- Platelet count decreased to <25,000/mm3*
- Severe or life-threatening non-hematological toxicities†
*Lasting more than 10 consecutive days.
†Evaluate the benefit-risk before resuming treatment at the same dosage for Grade 4 non-hematological toxicity.
aPTT=activated partial thromboplastin time; INR=International Normalized Ratio; PAR-1=protease-activated receptor 1; ULN=upper limit of normal.
IMPORTANT SAFETY INFORMATION
What should I tell my healthcare provider before taking BRUKINSA?
Before taking BRUKINSA, tell your healthcare provider about all of your medical conditions, including if you:
- have bleeding problems.
- have had recent surgery or plan to have surgery. Your healthcare provider may stop BRUKINSA for any planned medical, surgical, or dental procedure.
- have an infection.
- have or had heart rhythm problems.
- have high blood pressure.
- have liver problems, including a history of hepatitis B virus (HBV) infection.
- are pregnant or plan to become pregnant. BRUKINSA can harm your unborn baby. If you are able to become pregnant, your healthcare provider may do a pregnancy test before starting treatment with BRUKINSA.
- Females should avoid getting pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.
- Males should avoid getting female partners pregnant during treatment and for 1 week after the last dose of BRUKINSA. You should use effective birth control (contraception) during treatment and for 1 week after the last dose of BRUKINSA.
- are breastfeeding or plan to breastfeed. It is not known if BRUKINSA passes into your breast milk. Do not breastfeed during treatment with BRUKINSA and for 2 weeks after the last dose of BRUKINSA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking BRUKINSA with certain other medications may affect how BRUKINSA works and can cause side effects.
What are the possible side effects of BRUKINSA?
BRUKINSA may cause serious side effects, including:
- Bleeding problems (hemorrhage). Bleeding problems are common with BRUKINSA, and can be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs or symptoms of bleeding, including:
- blood in your stools or black stools (looks like tar)
- pink or brown urine
- unexpected bleeding, or bleeding that is severe or you cannot control
- vomit blood or vomit that looks like coffee grounds
- cough up blood or blood clots
- increased bruising
- dizziness
- weakness
- confusion
- change in speech
- headache that lasts a long time
- Infections that can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, or flu-like symptoms.
- Decrease in blood cell counts (white blood cells, platelets, and red blood cells). Your healthcare provider should do blood tests during treatment with BRUKINSA to check your blood counts.
- Second primary cancers. New cancers have happened in people during treatment with BRUKINSA, including cancers of the skin or other organs. Your healthcare provider will check you for other cancers during treatment with BRUKINSA. Use sun protection when you are outside in sunlight.
- Heart rhythm problems (atrial fibrillation, atrial flutter, and ventricular arrhythmias) that can be serious and may lead to death. Tell your healthcare provider if you have any of the following signs or symptoms:
- your heartbeat is fast or irregular
- feel lightheaded or dizzy
- pass out (faint)
- shortness of breath
- chest discomfort
- Liver problems. Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with BRUKINSA. Your healthcare provider will do blood tests to check your liver before and during treatment with BRUKINSA. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.
The most common side effects of BRUKINSA include:
- decreased white blood cell count
- decreased platelet count
- upper respiratory tract infection
- bleeding
- muscle, bone, or joint pain
These are not all the possible side effects of BRUKINSA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is BRUKINSA?
BRUKINSA is a prescription medicine used to treat adults with:
- Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- Waldenström’s macroglobulinemia (WM).
- Mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.
- Marginal zone lymphoma (MZL) when the disease has come back or did not respond to treatment and who have received at least one certain type of treatment.
- Follicular lymphoma (FL), in combination with the medicine obinutuzumab, when the disease has come back or did not respond to treatment and who have received at least two prior treatments.
It is not known if BRUKINSA is safe and effective in children.
Please see full Prescribing Information including Patient Information.
