0

 

  Vomiting  

21 (13%)

 

0

 

0

Vascular disorders 

    

  Hypertension (includes secondary hypertension)  

59 (35%) 

 

46 (27%) 

 

0

 

Infections  

    

  Lower respiratory tract infections (includes pneumonia, pneumonia bacterial, pneumonia pneumococcal, pneumonia fungal, pneumonia viral, pneumocystis jiroveci pneumonia, bronchopulmonary aspergillosis and lung infection)  

35 (21%) 

 

20 (12%) 

 

3 (2%)

 

Skin and subcutaneous tissue disorders 

    

  Rash (includes exfoliative skin reactions)  

26 (15%) 

 

2 (1%)

 

1 (<1%)

 

Additional adverse drug reactions reported at a frequency of <10% in patients with follicular lymphoma and other hematologic malignancies include pneumonitis (9%), mucosal inflammation (8%), and paresthesia and dysesthesia (7%).

 

Table 3: Treatment-emergent Laboratory Abnormalities in ≥20% of Patients and ≥4% of Grade ≥3 Treated with ALIQOPA 

Laboratory Parameter 

 

Copanlisib Monotherapy N = 168* 

 

 

Any Grade** 

 

n (%) 

 

Grade 3** 

 

n (%) 

 

Grade 4** 

 

n (%) 

Hematology abnormalities 

 

Decreased hemoglobin

 

Lymphocyte count decreased

 

White blood cell decreased

 

Platelet count decreased

 

Neutrophil count decreased

 

130 (78%)

 

126 (78%)

 

118 (71%)

 

109 (65%)

 

104 (63%)

 

7 (4%)

 

43 (27%)

 

30 (18%)

 

11 (7%)

 

20 (12%)

 

0

 

4 (2%)

 

3 (2%)

 

3 (2%)

 

25 (15%)

 

Serum chemistry abnormalities 

 

Hyperglycemia

 

Hypertriglyceridemia

 

Hypophosphatemia

 

Hyperuricemia

 

Serum lipase increased

 

160 (95%)

 

74 (58%)

 

72 (44%)

 

42 (25%)

 

34 (21%)

 

72 (43%)

 

6 (5%)

 

24 (15%)

 

40 (24%)

 

11 (7%)

 

9 (5%)

 

0

 

0

 

2 (1%)

 

2 (1%)

 

*Denominator for each laboratory parameter may vary based on number of patients with specific numeric laboratory values available. 

 

**NCI-CTCAE v4.03

 

7 DRUG INTERACTIONS 

 

7.1 Effect of Other Drugs on Copanlisib 

 

Strong CYP3A Inducers