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Prescribing Information

What are the benefits and risks of Avastin for ovarian cancer (OC)?

Avastin® (bevacizumab), in combination with carboplatin and paclitaxel, followed by Avastin alone, is used for the treatment of patients with advanced (Stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgery.

Avastin is used with chemotherapy to treat 2 different types of recurrent ovarian cancer: platinum-sensitive and platinum-resistant.

Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than two prior chemotherapy treatments.

Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (psOC).

What is advanced (stage III or IV) ovarian cancer?

Advanced (stage III or IV) ovarian cancer is generally cancer that has not been treated with chemotherapy or other medicines before. Avastin is given after surgery along with chemotherapy for advanced ovarian cancer.

The benefits of Avastin therapy in advanced (stage III or IV) ovarian cancer

In a clinical study, Avastin, when taken with carboplatin and paclitaxel (chemotherapy) followed by Avastin alone, was shown to extend the length of time people with advanced ovarian cancer lived without their tumors growing or spreading, compared with chemotherapy alone (18.2 months vs 12.0 months).

When patients took Avastin with carboplatin and paclitaxel (chemotherapy) followed by Avastin alone instead of chemotherapy alone:

Benefits and safety of Avastin® (bevacizumab) therapy in Ovarian Cancer (OC)

Individual results may vary.

What is the difference between platinum-sensitive and platinum-resistant cancers?

Recurrent ovarian cancer is cancer that has come back some time after first treatment with platinum-based chemotherapy. Cancer that comes back within 6 months following first treatment is called platinum-resistant, and cancer that comes back more than 6 months after initial treatment is referred to as platinum-sensitive.

Platinum-sensitve time to progression graph

The benefits of Avastin therapy in platinum-sensitive ovarian cancer

In clinical studies, when women with platinum-sensitive ovarian cancer took Avastin with chemotherapy (either in combination with carboplatin and paclitaxel or in combination with carboplatin and gemcitabine) instead of chemotherapy alone:

Benefits and safety of Avastin® (bevacizumab) therapy in platinum-sensitive Ovarian Cancer (OC)

Individual results may vary.

The benefits of Avastin therapy in platinum-resistant ovarian cancer

In clinical studies, when women with platinum-resistant ovarian cancer took Avastin with chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan) instead of chemotherapy alone:

Benefits and safety of Avastin® (bevacizumab) therapy in platinum-sensitive Ovarian Cancer (OC)

More than 50% of patients who initially responded were still responding at: 9.4 months vs. 5.4 months.

Individual results may vary.

What are the side effects of Avastin in advanced (stage III or IV) ovarian cancer?

See the table below for common severe to life-threatening (grade 3 or 4) side effects that increased by 2% or more in patients who added Avastin to carboplatin and paclitaxel (chemotherapy) followed by Avastin alone or who added Avastin to carboplatin and paclitaxel (chemotherapy) followed by placebo compared to chemotherapy alone.

Side effects of Avastin® (bevacizumab) stage III or IV ovarian cancer

Talk to your doctor about the benefits and risks of Avastin. To learn about the possible side effects of taking Avastin, visit the Side Effects page.

What are the side effects of Avastin in psOC?

In one study, the most common severe to life-threatening side effects that increased by 2% or more in people who received Avastin plus carboplatin and gemcitabine (chemotherapy) compared to those who received placebo plus chemotherapy or vice versa (refer to the last 2 rows of the table) were:

Side effects of Avastin® (bevacizumab) in psOC table 1

Talk to your doctor about the benefits and risks of Avastin. To learn about the possible side effects of taking Avastin, visit the Side Effects page.

What are the side effects of Avastin in psOC?

In a separate study, the most common severe to life-threatening side effects that increased by 2% or more in people who received Avastin plus carboplatin and paclitaxel (chemotherapy) compared to those who received chemotherapy were:

Side effects of Avastin® (bevacizumab) in psOC table 2

Talk to your doctor about the benefits and risks of Avastin. To learn about the possible side effects of taking Avastin, visit the Side Effects page.

What are the side effects of Avastin in prOC?

The most common severe to life-threatening side effects that increased by 2% or more in people who received Avastin plus chemotherapy (compared with those receiving chemotherapy alone) were:

Side effects of Avastin® (bevacizumab) in psOC table 3

Talk to your doctor about the benefits and risks of Avastin. To learn about the possible side effects of taking Avastin, visit the Side Effects page.

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Important Safety Information & Indication

Indication

Ovarian Cancer (OC)

Avastin, in combination with carboplatin and paclitaxel, followed by Avastin alone, is used for the treatment of patients with advanced (Stage III or IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgery.
Avastin, in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than two prior chemotherapy treatments.
Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (psOC).

Possible serious side effects

Everyone reacts differently to Avastin therapy. So, it's important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Your doctor will stop treatment if any serious side effects occur. Be sure to contact your health care team if there are any signs of these side effects.

  • GI perforation. A hole that develops in your stomach or intestine. Symptoms include pain in your abdomen, nausea, vomiting, constipation, or fever
  • Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
  • Wounds that don't heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgical wounds are fully healed
  • Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If you recently coughed up blood or had serious bleeding, be sure to tell your doctor
  • Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
  • Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
  • Infusion-related reactions. These were uncommon with the first dose (less than 3% of patients). 0.4% of patients had severe reactions. Infusion-related reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, serious allergic reactions, chest pain, headache, tremors, and excessive sweating. Your doctor or nurse will monitor you for signs of infusion-related reactions
  • Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, chest pain, and your heart may become too weak to pump blood to other parts of your body (congestive heart failure). These can sometimes be fatal
  • Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness

Side effects seen most often

In clinical studies across different types of cancer, some patients experienced the following side effects:

  • High blood pressure
  • Too much protein in the urine
  • Nosebleeds
  • Bleeding
  • Back pain
  • Headache
  • Taste change
  • Dry skin
  • Inflammation of the skin
  • Inflammation of the nose
  • Watery eyes

Avastin is not for everyone

Talk to your doctor if you are:

  • Undergoing surgery. Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed
  • Pregnant or think you are pregnant. Data have shown that Avastin may harm your unborn baby. Use birth control while on Avastin. If you stop Avastin, you should keep using birth control for 6 months before trying to become pregnant
  • Planning to become pregnant. Taking Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children
  • Breastfeeding. Breastfeeding while on Avastin may harm your baby, therefore, women should not breastfeed during and for 6 months after taking Avastin

For more information about your treatment or condition, talk to your doctor.

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Product Information for additional important safety information.