Bayer Nubeqa Patient nmCRPC Brochure

CHOOSING NUBEQA

POSSIBLE SIDE EFFECTS WITH NUBEQA

NUBEQA may cause fertility problems in males, which may affect their ability to father children. Talk to your healthcare provider if you have concerns about fertility. COMMON SIDE EFFECTS WITH NUBEQA The most common side effects of hormone therapy + NUBEQA vs hormone therapy* alone are: • Increase in liver function tests (AST increased; 23% vs 14% on hormone therapy alone) • Decreased white blood cells (neutropenia; 20% vs 9% on hormone therapy alone) • Feeling more tired than usual (16% vs 11% on hormone therapy alone) • Increase in liver function tests (bilirubin increased; 16% vs 7% on hormone therapy alone) • Pain in arm, leg, hand, or foot (6% vs 3% on hormone therapy alone) • Rash (4% vs 1.4% on hormone therapy alone) Overall, serious side effects with NUBEQA were moderately higher than those with hormone therapy alone. • Serious side effects happened in 25% of men who added NUBEQA to hormone therapy compared with 20% who took hormone therapy alone • Serious side effects that happened in 1% or more of men who added NUBEQA to their hormone therapy included: not being able to urinate completely, pneumonia, and blood in the urine

Sometimes side effects can cause a person to stop treatment when another treatment is added. IN A CLINICAL STUDY, THE TOLERABILITY PROFILE OF NUBEQA ENABLED MOST PATIENTS TO STAY ON THERAPY There was no difference in the percentage of men (9%) who permanently stopped treatment due to side effects between those who took hormone therapy* + NUBEQA and those who took hormone therapy alone. That means that most men (more than 90%) did not permanently stop taking NUBEQA due to side effects, similar to men who took hormone therapy alone. • Side effects that caused men to permanently stop taking NUBEQA were heart failure (0.4%) and death (0.4%) 13% of men had to stop taking NUBEQA and then start it again because of side effects. • The most common side effects that caused men to stop taking NUBEQA and then start it again were high blood pressure (hypertension; 0.6%), diarrhea (0.5%), and pneumonia (0.5%) 6% of men taking NUBEQA had to reduce their dosage because of side effects. • The most common side effects that caused men to reduce their dosage included fatigue (0.7%), high blood pressure (hypertension; 0.3%), and nausea (0.3%) TALK TO YOUR DOCTOR ABOUT THE MEDICINES YOU ARE TAKING Although NUBEQA has a limited potential to interfere with other medicines, it may interfere with some medicines you are taking. So be sure to tell your doctor about all the medicines you are taking, including over-the-counter medicines and supplements.

*Hormone therapy includes drug treatments or surgery that lowers testosterone.

IN A CLINICAL TRIAL

When NUBEQA was added to hormone therapy, MOST MEN (84%) DID NOT REPORT FEELING MORE TIRED THAN USUAL

(Men who did feel more tired than usual: 16% vs 11% on hormone therapy alone)

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