ASH Clinical News September 2015 | Page 5

B:16.75”
T:16.25”
S:14.625”

eported (< 1%) in patients
ransaminases. Monitor liver
ate.

54 (14%)

5 (1%)

39 (10%)

2 (1%)

Pneumoniaa

54 (14%)

35 (9%)

43 (11%)

27 (7%)

Hypokalemia

78 (20%)

22 (6%)

35 (9%)

12 (3%)

Hypocalcemia

55 (14%)

10 (3%)

39 (10%)

5 (1%)

Hyperglycemia

43 (11%)

18 (5%)

33 (9%)

15 (4%)

88 (22%)

3 (1%)

73 (19%)

3 (1%)

43 (11%)

7 (2%)

37 (10%)

4 (1%)

63 (16%)

6 (2%)

50 (13%)

8 (2%)

Metabolism and Nutrition Disorders

remic Syndrome (TTP/HUS)

eported in patients who received
Discontinue Kyprolis if TTP/
HUS is excluded, Kyprolis may
n patients previously experiencing

Musculoskeletal and Connective Tissue Disorders
Muscle Spasms

S)

gnant woman based on its
o adequate and well-controlled

ve and can be found the Warning
de cardiac toxicities, acute kidney
dyspnea, hypertension, venous
c toxicity and hepatic failure,

g conditions, adverse reaction
ectly compared with rates in the
s observed in medical practice.

127 (33%)

47 (12%)

7%)

115 (30%)

89 (23%)

%)

75 (19%)

39 (10%)

105 (27%)

12 (3%)

1 (0%)

46 (12%)

0

Dyspneac

70 (18%)

9 (2%)

58 (15%)

6 (2%)

45 (12%)

5 (1%)

53 (14%)

5 (1%)

Embolic and Thrombotic Events,
Venousd

49 (13%)

16 (4%)

22 (6%)

9 (2%)

Hypertensione

41 (11%)

12 (3%)

15 (4%)

4 (1%)

Vascular Disorders

KRd = Kyprolis, lenalidomide, and low-dose dexamethasone; Rd = lenalidomide and low-dose
dexamethasone
a
Pneumonia includes preferred terms of pneumonia, bronchopneumonia
b
Peripheral neuropathies NEC includes preferred terms under HLT peripheral neuropathies NEC
c
Dyspnea includes preferred terms of dyspnea, dyspnea exertional
d
Embolic and thrombotic events, venous include preferred terms in MedDRA SMQ narrow scope
search of embolic and thrombotic events, venous.
e
Hypertension includes preferred terms of hypertension, hypertensive crisis, hypertensive emergency

Laboratory Abnormalities

KRd
(N = 392)

Rd
(N = 389)

182 (46%)

119 (31%)

Decreased Absolute Neutrophil Count

152 (39%)

140 (36%)

Decreased Phosphorus

122 (31%)

106 (27%)

Decreased Platelets

101 (26%)

59 (15%)

Decreased Total White Blood Cell Count

97 (25%)

71 (18%)

Decreased Hemoglobin

58 (15%)

68 (18%)

Decreased Potassium

41 (11%)

23 (6%)

KRd = KYPROLIS, lenalidomide, and low-dose dexamethasone; Rd = lenalidomide and low-dose
dexamethasone

Post-marketing Experience

1 (0%)

DRUG INT T