Product From for Pazopanib in Advanced Cancer

Medical Information (Mandatory fields)
1. Patient has histological evidence of advanced/metastatic cancer andreceived prior systemic therapy, unless it is considered unsuitable.
2. Patient has not received anti-cancer therapy within 14 days prior to the firstdose of pazopanib AND all toxicities related to prior therapy have resolved
to Grade 1 or less.

☐ YES ☐ NO
☐ YES
☐ NO
☐ NA

3. Patient has adequate bone marrow and coagulation function as shown by:
Lab parameter
Adults (≥18 yrs)
Pediatric & young
adults (< 18 yrs)
Absolute neutrophil count≥ 1.5 × 109/L≥ 1.0 × 109/L(ANC)
Platelets≥ 100 × 109/L≥ 75 × 109/L
Hemoglobin≥ 9.0 g/dL
≥ 8.0 g/dL

☐ YES ☐ NO

4. Patient has adequate liver function as shown by:
LabAdults (≥18 yrs)
Pediatric & young adults
parameter(< 18 yrs)
Total bilirubin ≤ 2.0 mg/dL< 2.5 x ULN (unlessabnormality is due todisease)
ALT< 2.5 x ULN (≤ 5 x ULN in< 2.5 x ULN (unlesspresence of liverabnormality is due tometastases)
disease)AST< 2.5 x ULN (≤ 5 x ULN in
Not applicable
presence of livermetastases)☐ YES ☐ NO

5. Patient has a normal ECG defined as:ParameterAdults (≥18 yrs)

☐ YES ☐ NO

Resting heart rate
QTcF
QTcB

50-90 bpm
Male: < 450 ms
Female: < 460 ms
Not applicable

Pediatric and young
adults (< 18 yrs)
Not applicable< 480 ms
< 480 ms

6. Adults: Patient has serum creatinine < 1.5 mg/dL

7. Patient has clinically normal cardiac function based on the institutional
lower limit of normal (LVEF assessed by MUGA or ECHO) AND no historyof any one or more of the following cardiovascular conditions within the past
6 months?
a. Cardiac angioplasty or stenting;☐ YES☐ NO☐ NA☐ YES ☐ NO

This Form must not be used for reporting any safety information. Safety information must be reported tothe relevant Health Authority according to Local Regulations and to the Novartis Patient Safety Department
as per the MAP Agreement Letter.
Version: 3.0
Effective date: 02 Dec 2019

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Product From for Pazopanib in Advanced Cancerb.
c.
d.
e.
f.

Myocardial infarction;
Unstable angina;
Coronary artery bypass graft surgery;
Symptomatic peripheral vascular disease;
Class III or IV congestive heart failure, as defined by the New YorkHeart Association (NYHA).

8. Pediatric & young adults: Patient with a known history of seizures shouldhave well-controlled seizures and should not be receiving enzyme-inducing
anti-convulsants

☐ YES
☐ NO
☐ NA

9. Patient is woman of childbearing potential and has a negative serum
pregnancy test within 14 days prior to the start of pazopanib

☐ YES
☐ NO
☐ NA

10. Patient has any history of the following cardiac events:a. a cerebrovascular accident at any time in the past;b. a transient ischemic attack in the past 6 months;c. deep venous thrombosis (DVT) in past 6 months;
d. pulmonary embolism in the past 6 months.
Note: Patients with recent DVT who have been treated with therapeuticanti-coagulating agents and remained stable for at least 6 weeks areeligible.
11. Patient has a history of clinically significant gastrointestinal disorders within
28 days prior to beginning pazopanib, including:a. own intraluminal metastatic lesions/s with risk of bleeding;b. other gastrointestinal conditions with increased risk of perforation;c. abdominal fistula;d. gastrointestinal perforation or intra-abdominal abscess.
12. Patient has a history of a Grade 3 hemorrhage within 4 weeks of starting
pazopanib.
13. Patient has poorly controlled hypertension blood pressure as defined below:≥ 140/90 mmHg
AdultsPediatric & young> 95th percentile for age, height, and genderadults
14. Adults: History or clinical evidence of central nervous system (CNS)
metastases.
Note: Patients who have previously-treated CNS metastases (surgery ±radiotherapy, radiosurgery, or gamma knife) AND must meet all 3 of thefollowing criteria:
e. asymptomatic and,f. have has no evidence of active CNS metastases for ≥ 6 months prior totreatment with pazopanib,

☐ YES
☐ NO

☐ YES
☐ NO

☐ YES
☐ NO

☐ YES
☐ NO

☐ YES
☐ NO
☐ NA

This Form must not be used for reporting any safety information. Safety information must be reported tothe relevant Health Authority according to Local Regulations and to the Novartis Patient Safety Department
as per the MAP Agreement Letter.
Version: 3.0
Effective date: 02 Dec 2019Page 2 of 3

Product From for Pazopanib in Advanced Cancerg. have no requirement for steroids or enzyme-inducing anticonvulsants(EIAC)
15. Pediatric & young adults: Patient has moderate to severe renal disease byinstitutional standards for their age.

☐ YES
☐ NO
☐ NA

16. Patient has an uncontrolled infection.

☐ YES

17. Patient has gross metabolic abnormalities.

☐ YES

18. Patient had prior major surgery or trauma within 28 days prior to first dose ofpazopanib AND/OR presence of clinically significant non-healing wound,
fracture, or ulcer.
19. Patient has known immediate or delayed hypersensitivity reaction oridiosyncrasy to drugs chemically related to pazopanib.

☐ NO☐ NO☐ YES☐ NO☐ YES☐ NOThis Form must not be used for reporting any safety information. Safety information must be reported tothe relevant Health Authority according to Local Regulations and to the Novartis Patient Safety Department
as per the MAP Agreement Letter.
Version: 3.0
Effective date: 02 Dec 2019

Page 3 of 3