ABEVMY

for guidance on dose adjustments. • Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) ABEVMY, in combination with carboplatin/paclitaxel chemotherapy regimen, is indicated for treatment of patients with unresectable advanced, metastatic or recurrent non-squamous non- small cell lung cancer.

• Platinum-Sensitive Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer ABEVMY, in combination with carboplatin and gemcitabine is indicated for the treatment of patients with first recurrence platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancer.

These patients should not have received prior VEGF-targeted therapy including ABEVMY. The effectiveness of bevacizumab in platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer is based on an improvement of progression-free survival in patients who had first recurrence after 6 months of platinum-based chemotherapy.

No overall survival benefit was demonstrated with bevacizumab. • Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer ABEVMY, in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin is indicated for the treatment of patients with recurrent, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens.

These patients should not have received prior VEGF-targeted therapy including ABEVMY. The effectiveness of bevacizumab in platinum-resistant recurrent epithelial ovarian, fallopian tube or ABEVMY (bevacizumab for injection) Page 5 primary peritoneal cancer is based on a study in patients with disease progression within < 6 months from the most recent platinum-based chemotherapy, with a minimum of 4 platinum therapy cycles completed.

A statistically significant improvement in progression-free survival was seen. No overall survival benefit was demonstrated with bevacizumab. • Malignant Glioma (WHO Grade IV) – Glioblastoma ABEVMY, in combination with lomustine, is indicated for the treatment of patients with glioblastoma after relapse or disease progression, following prior therapy.

4 CLINICAL TRIALS – REFERENCE BIOLOGIC DRUG for information). 3 Pediatrics section). 4 Geriatrics section. 2 CONTRAINDICATIONS ABEVMY is contraindicated in patients who are hypersensitive to this drug, Chinese hamster ovary cell products or other recombinant human or humanised antibodies or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Eye Disorders ABEVMY is not formulated and has not been authorized for intravitreal use. Local and systemic adverse events have been reported in the post-market setting with unauthorized intravitreal use of bevacizumab (see 7 WARNINGS AND PRECAUTIONS, General).

Gastrointestinal Perforations ABEVMY administration can result in the development of gastrointestinal perforation in some instances resulting in fatality. e. was not correlated to duration of exposure). The typical presentation was reported as abdominal pain associated with symptoms such as constipation and vomiting.

Gastrointestinal perforation should be included in the differential diagnosis of patients on ABEVMY presenting with abdominal pain. 2%. 7% in platinum- resistant ovarian cancer studies. The incidence of gastrointestinal perforation in patients receiving irinotecan/bolus 5- fluorouracil/leucovorin with bevacizumab was 2%.

ABEVMY therapy should be permanently discontinued in patients with gastrointestinal perforation (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal and 8 ADVERSE REACTIONS, Gastrointestinal). Wound Healing Complications ABEVMY administration can result in wound dehiscence, in some instances resulting in fatality.

ABEVMY therapy should be permanently discontinued in patients with wound dehiscence requiring medical intervention. ABEVMY should be discontinued at least 28 days prior to elective surgery. ABEVMY therapy should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed (see 7 WARNINGS AND PRECAUTIONS, Peri-Operative Considerations, Wound Healing).

Hemorrhage Severe or fatal hemorrhage, including hemoptysis, gastrointestinal bleeding, central nervous systems (CNS) hemorrhage, epistaxis, and vaginal bleeding occurred up to five-fold more frequently in patients receiving bevacizumab.

3 Pediatrics section). 4 Geriatrics section. 2 CONTRAINDICATIONS ABEVMY is contraindicated in patients who are hypersensitive to this drug, Chinese hamster ovary cell products or other recombinant human or humanised antibodies or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. ABEVMY is contraindicated in patients with untreated Central Nervous System (CNS) metastases (see 7 WARNINGS AND PRECAUTIONS and

ABEVMY is contraindicated in patients who are hypersensitive to this drug, Chinese hamster ovary cell products or other recombinant human or humanised antibodies or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.

For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. ABEVMY is contraindicated in patients with untreated Central Nervous System (CNS) metastases (see 7 WARNINGS AND PRECAUTIONS and 8 ADVERSE REACTIONS).