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THE SAFETY OF BRUKINSA
Combined Adverse Reactions (ARs) in ≥10% of Patients With MCL (N=118)1 | Pooled Safety Population (N=1550)*2 | |||
|---|---|---|---|---|
| Adverse Reaction | All Grades (%) | Grade ≥3 (%) | All Grades (%) | Grade ≥3 (%) |
| Upper respiratory tract infection | 39 | 0 | 39 | 2 |
| Rash | 36 | 0 | 28 | 0.9 |
| Diarrhea | 23 | 0.8 | 19 | 2 |
| Pneumonia | 15 | 10 | 20 | 11 |
| Musculoskeletal pain | 14 | 3.4 | 30 | 2 |
| Bruising | 14 | 0 | 23 | 0.1 |
| Constipation | 13 | 0 | 13 | 0.3 |
| Hypertension | 12 | 3.4 | 14 | 7 |
| Cough | 12 | 0 | 19 | 0.1 |
| Hemorrhage | 11 | 3.4 | 30 | 4 |
| Urinary tract infection | 11 | 0.8 | 13 | 2 |
Select Laboratory Abnormalities† (≥20%) in Patients With MCL | ||
|---|---|---|
| Laboratory Parameter | Percent Of Patients (N=118) | |
| All Grades (%) | Grade 3 or 4 (%) | |
| Hematologic abnormalities | ||
| Neutrophils decreased | 45 | 20 |
| Platelets decreased | 40 | 7 |
| Hemoglobin decreased | 27 | 6 |
| Lymphocytosis‡ | 41 | 16 |
| Chemistry abnormalities | ||
| Blood uric acid increased | 29 | 2.6 |
| ALT increased | 28 | 0.9 |
| Bilirubin increased | 24 | 0.9 |
No patients discontinued due to neutropenia and 2 patients had febrile neutropenia. Patients on study received growth factor support as needed.2
ARs of Special Interest in the Pooled Safety Population (N=1550)*2 | ||
|---|---|---|
| Adverse Reaction | Percent of Patients (N=1550) | |
| All Grades (%) | Grade ≥3 (%) | |
| Fatigue | 17 | 1 |
| Headache | 11 | 0.4 |
| Arthralgia | 14 | 0.7 |
| Myalgia | 4 | 0.4 |
| Atrial fibrillation and flutter | 4 | 2 |
In the (N=1550) pooled safety population, the most common adverse reactions, including laboratory abnormalities, in ≥30% of patients included neutrophil count decreased (42%), upper respiratory tract infection (39%), platelet count decreased (34%), hemorrhage (30%), and musculoskeletal pain (30%).1
*Chronic lymphocytic leukemia, Waldenström’s macroglobulinemia, mantle cell lymphoma, follicular lymphoma, marginal zone lymphoma, hairy cell leukemia, diffuse large B-cell lymphoma, and Richter’s transformation.2
†Based on laboratory measurements.
‡Asymptomatic lymphocytosis is a known effect of BTK inhibition.
The overall safety profile was unchanged at 35 months.1,3
Most ARs occurred during the early stage of BRUKINSA treatment. There were no additional cases of:
- Atrial fibrillation
- Atrial flutter
- Grade ≥3 cardiac ARs
With 35.3 months of follow-up, the most common (≥20%) TEAEs observed were decreased neutrophil count (46.5%), upper respiratory tract infection (38.4%), rash (36.0%), decreased white blood cell count (33.7%), and decreased platelet count (32.6%); most were Grade 1/2 events.
The prevalence of neutropenia with any grade or Grade ≥3 decreased after the first year; no Grade ≥3 neutropenia occurred after 18 months.
No new TEAEs led to treatment discontinuation or dose reduction during the longer follow-up time.
Dose reductions
due to ARs1
0.8
(1/118)
of patients
Discontinuation
rate due to ARs1
7
(8/118)
of patients
Median duration of treatment:
17.5 months (range: 0.2-33.9 months)2
ALT=alanine aminotransferase; ARs=adverse reactions; BTK=Bruton's tyrosine kinase; MCL=mantle cell lymphoma; R/R=relapsed/refractory; TEAEs=treatment-emergent adverse events.
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.
