AKEEGA® (niraparib/abiraterone acetate) HCP

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Important Safety Information Medical Inquiries Prescribing Information

AKEEGA® offers a well-characterized, consistent, and manageable safety profile¹

ADVERSE REACTIONS

Consistent safety established in 2 phase 3, double-blind, placebo-controlled clinical trials comparing AKEEGA® vs standard of care (SoC*)¹

In patients with BRCA2 mutations:

of patients remained on AKEEGA® without discontinuing due to adverse reactions¹

of patients did not need a dose reduction with AKEEGA®¹

Adverse reactions >20% in AKEEGA®–treated patients with a difference of ≥5% vs SoC* (BRCA2 m subgroup)¹

	AKEEGA® + P (n=162)		Placebo + AAP (n=161)
Adverse Reaction	All Grades %	Grade 3-4 %	All Grades %	Grade 3-4 %
Hypertension^a	51	31	36	19
Musculoskeletal pain^a	45	6	58	4.3
Constipation	41	0	17	0.6
Nausea	30	0	17	0
Fatigue^a	39	4.3	29	3.1
Respiratory tract infection^a	23	0.6	13	0.6
Arrhythmia^a	23	3.7	9	2.5

^aIncludes multiple similar terms.

^*SoC = abiraterone acetate + prednisone.

Select laboratory abnormalities >20% that worsened from baseline in patients
who received AKEEGA® (BRCA2 m subgroup)¹

	AKEEGA® + P (n=162)^a		Placebo + AAP (n=161)^a
Laboratory Abnormality	All Grades %	Grade 3-4 %	All Grades %	Grade 3-4 %
Decreased hemoglobin	74	29	53	1.9
Decreased lymphocyte count	59	20	37	13
Decreased neutrophil count	49	10	19	3.1
Decreased platelet count	41	4.9	23	0.6
Decreased potassium	38	9	29	10
Increased creatinine	30	1.3	16	2.5
Increased ALP	28	0.6	24	3.1
Increased ASP	24	1.3	33	2.5
Increased blood bilirubin	22	0	11	0

*The denominator used to calculate the rate varied from 160 to 161 for placebo + AAP and 159 to 162 for AKEEGA^® + P based on the number of patients with a baseline value and at least one post-treatment value.¹

AKEEGA® flexible
once-daily dosing

Learn how your patients can access AKEEGA®

AAP, abiraterone acetate + prednisone; ALP, alkaline phosphatase; AST, aspartate aminotransferase; BRCA2m, BRCA2 gene-mutated; BRCAm, BRCA gene-mutated; mCSPC, metastatic castration-sensitive prostate cancer; SoC, standard of care; WBC, white blood cell.

Reference:

AKEEGA^® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.

AKEEGA®Safety in mCSPC

AKEEGA® offers a well-characterized, consistent, and manageable safety profile1

Consistent safety established in 2 phase 3, double-blind, placebo-controlled clinical trials comparing AKEEGA® vs standard of care (SoC*)1

In patients with BRCA2 mutations:

Adverse reactions >20% in AKEEGA®–treated patients with a difference of ≥5% vs SoC* (BRCA2 m subgroup)1

Select laboratory abnormalities >20% that worsened from baseline in patients who received AKEEGA® (BRCA2 m subgroup)1

AKEEGA®Safety
in mCSPC

AKEEGA® offers a well-characterized, consistent, and manageable safety profile¹

Consistent safety established in 2 phase 3, double-blind, placebo-controlled clinical trials comparing AKEEGA® vs standard of care (SoC*)¹

Adverse reactions >20% in AKEEGA®–treated patients with a difference of ≥5% vs SoC* (BRCA2 m subgroup)¹

Select laboratory abnormalities >20% that worsened from baseline in patients
who received AKEEGA® (BRCA2 m subgroup)¹