Novartis Pharmaceuticals Corporation

59 Route 10

East Hanover, NJ 07936

 

 

Appendix 8:
Patient Information Form
(Bisphosphonates and ONJ)

 

 

Zometa® (zoledronic acid) Injection

and

Aredia® (pamidronate disodium) Injection

Submitted:  February 1, 2005

 

 

Oncologic Drugs Advisory Committee Meeting

March 4, 2005

 

Property of Novartis Pharmaceuticals Corporation
All rights reserved
Available for public disclosure without redaction

 

 

 

Patient Demographics

Date of Birth:

 

 

 

 

day

month

year

Age

Gender:

£Male                              £ Female

 

Adverse Event Report:

 

 

Drug Information

Drug Name

Therapy Dates

Indication(s)

Dosing at time of event

From

To

Dose

Formulation

Frequency

Aredia

 

 

 

 

 

 

Zometa

 

 

 

 

 

 

 

Oral Surgeon/ Dentist:

Name/Title:

 

Address:

 

 

Telephone:

 

Oncologist:

Name/Title:

 

Address:

 

 

Telephone:

 

Other Healthcare Professional:

Name/Title:

 

Address:

 

 

Telephone:

 

 



General Medical History / Medical Conditions / Medical Procedures

 

 

List relevant medical history, medical conditions, and medical procedures with special attention to the following (use page 4 for dental history and page 6 for cancer history):

 

Vascular disorders (e.g., injury, vessel compression)                                £No  £Yes (specify below)

 

Coagulation disorders (e.g, DVT, embolism, hemophilia)                            £No  £Yes (specify below)

 

Metabolic / Endocrine disorders (including Diabetes)                                 £No  £Yes (specify below)

 

Alcoholism                                                                                            £No  £Yes (specify below)

 

Anemia                                                                                                 £No  £Yes (specify below)

 

Asthma / Lung Disease                                                                          £No  £Yes (specify below)

 

Autoimmune / Rheumatoid Disease                                                         £No  £Yes (specify below)

 

Smoking                                                                                               £No  £Yes (specify below)

 

Chronic Renal Failure                                                                             £No  £Yes (specify below)

 

 

History / Condition / Procedure

Date

Ongoing problem?

 

 

 

 

Yes

No

 

 

 

 

Yes

No

 

 

 

 

Yes

No

 

 

 

 

Yes

No

 

 

 

 

Yes

No

 

 

 

 

Yes

No

 

 

 

 

Yes

No

 

 

 

 

Yes

No

 

 

 

 

Yes

No

 

‘Background’ Medications – Including Bisphosphonate Use

(within 24 Months prior to diagnosis of Osteonecrosis)

List medications with special attention to the following (use page 5 for dental medications and page 7 for oncology medications):

Corticosteroids                                                  £No  £Yes (specify below)

 

Pamidronate / Aredia®                                                                                £No  £Yes (specify below)

 

Zoledronic acid / Zometa®                                                                      £No  £Yes (specify below)

 

Other Bisphosphonates                                      £No  £Yes (specify below)

Medication

Dose & Regimen

Indication

Date Started

Date Stopped

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



Dental History / Dental Conditions

Please list relevant dental history and dental conditions with special attention to the following:

 

Dental conditions (e.g., dental & sinus infections, mucositis,oral complications due to chemotherapy)

                                                £No  £Yes (specify below)

 

Dental Procedures (e.g., dental extractions, maxillofacial  surgeries

                                                £No  £Yes (specify below))

 

History of trauma or fractures of the Jaw (include trauma due to dental bridgework, dentures, etc.)

                                                £No  £Yes (specify below)

 

History / Medical condition

Date of Diagnosis / Procedure

Ongoing problem?

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

 

Yes

No

 

Osteonecrosis of the Jaw: Diagnosis & Treatment

(if multiple dates of diagnosis are present, this page may be photocopied for additional use)

Diagnosis (type of osteonecrosis)

 

Date of Diagnosis

 

Anatomical Site(s)

 

Concurrent Factors

(e.g., tooth extraction, other dental procedures)

 

Method of Diagnosis

£ Clinical

£ Imaging (specify)

£ Biopsy (specify)

£ Other (specify)

Treatment

 

Date(s) of Treatment

 

Outcome

£ Resolved (specify date)

£ Treatment ongoing     £ Unknown

 

Dental Medications & Treatments

Please list current dental medication/treatments with special attention to the following:

Use of anesthetics in dental procedures (especially those with                £No £Yes (specify below)

vasoconstrictors)

Antibiotics                                                                                          £No £Yes (specify below)

Medication/Treatment

Dose & Regimen

Indication

Date Started

Date Stopped

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 



Cancer Diagnosis

Type of Cancer (Include Staging Details)

Date of Diagnosis

 

 

 

 

 

 

 

Radiation Therapy

£None  £Yes (specify below)

Location

Dose & Regimen

Indication

Date Started

Date Stopped

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Oncology Medications

(within 24 Months prior to diagnosis of Osteonecrosis)

List oncology medications with special attention to the following:

Chemotherapy               £No  £Yes (specify below)

Corticosteroids              £No  £Yes (specify below)

Medication

Dose & Regimen

Indication

Date Started

Date Stopped

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Healthcare Professional reporter information

 

Name ____________________________ Specialty__________________________

 

Signature__________________________  Date_____________________________

 

Prepared by_________________________________