Possible Side Effects of Avastin and Carboplatin and Paclitaxel (Chemotherapy) in the Treatment of Advanced NSCLC

People receiving Avastin plus carboplatin and paclitaxel (chemotherapy) for their advanced NSCLC may experience some of the following serious side effects.

In some cases, the following side effects have been fatal.

Serious or fatal severe bleeding in the lungs was seen in 4% of people with non-squamous NSCLC receiving Avastin plus chemotherapy
One person (1.2% of people) with advanced NSCLC that spread to the central nervous system and had radiation and surgery more than 4 weeks before starting Avastin therapy had mild bleeding in the central nervous system
More people who received Avastin plus chemotherapy experienced severe to life- threatening stroke or heart problems than people who received chemotherapy alone
Severe to life-threatening blood clots in the veins of the body occurred in more people who received Avastin plus chemotherapy than those who received chemotherapy alone
Life-threatening reduced white blood cell counts were seen in more people (26.2% in total) who received Avastin plus carboplatin and paclitaxel (chemotherapy) than those who received carboplatin and paclitaxel (chemotherapy) alone
- Fever with reduced white cell counts was also seen in more people (5.4% in total) who received Avastin plus carboplatin and paclitaxel (chemotherapy)
- Infections with severe or life-threatening reduced white blood cell counts were seen in 19 (4.5% in total) people who received Avastin plus carboplatin and paclitaxel (chemotherapy), of which 3 were fatal
- During the first 6 cycles of treatment, serious infections, including pneumonia, reduced white blood cell counts with fever, catheter infections, and wound infections were seen more often in people who received Avastin plus carboplatin and paclitaxel (chemotherapy)
Too much protein in the urine that was life-threatening to fatal was seen in 3% of people receiving Avastin plus carboplatin and paclitaxel (chemotherapy)

If you experience serious side effects, your doctor may temporarily or permanently stop your treatment with Avastin.

More people who received Avastin plus carboplatin and paclitaxel (chemotherapy) for advanced NSCLC experienced side effects than people who received carboplatin and paclitaxel (chemotherapy) alone. These side effects included reduced white blood cell counts, tiredness, high blood pressure, infection without reduced white blood cell counts, blood clots in the veins of the body, fever with reduced white blood cell counts, inflammation of the lungs, infection with severe or life-threatening reduced white blood cell counts, low sodium levels in the blood that could lead to seizure or coma, headache, and too much protein in the urine
Some different side effects you may experience are associated with the carboplatin and paclitaxel (chemotherapy) part of your treatment. These include anemia (lowered red blood cell counts), aching joints and muscles, numbness and tingling in fingers and toes, bruising, nausea, vomiting, hair loss, mouth and lip sores, and diarrhea

If any of the above side effects occur, your doctor can help you manage them.

Who should not receive Avastin?

Avastin therapy may not be appropriate for certain people with advanced NSCLC. If any of the following conditions apply to you, talk to your doctor to find out if Avastin is appropriate for you.

Avastin should not be given to people who are allergic (hypersensitive) to it or any of its ingredients
Avastin may cause problems in getting pregnant
If you are pregnant or thinking about becoming pregnant, talk with your doctor about the potential risks
- Before starting Avastin, talk with your doctor about the potential risk of Avastin to the fetus
- If you become pregnant while receiving Avastin, talk with your doctor about the potential danger to the fetus and/or the potential risk of losing the pregnancy
- If you stop treatment with Avastin, talk with your doctor about the possible continued effects the therapy may have on the fetus
You should use effective birth control methods while receiving Avastin and for at least 6 months after you finish receiving Avastin
Nursing mothers should not breast-feed while receiving Avastin, or for a period of time after treatment is finished
You should not receive Avastin prior to having elective surgery
Avastin should not be given for at least 28 days after major surgery and until the surgical wound is fully healed
The safety and effectiveness of Avastin in children have not been evaluated

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Indication

Avastin, in combination with carboplatin and paclitaxel (chemotherapy), is approved by the FDA for first-line treatment of people newly diagnosed with a common form of NSCLC (unresectable, locally advanced, recurrent, or metastatic non-squamous, non-small cell lung cancer).

Serious Side Effects

Avastin can result in the development of a potentially serious, and sometimes fatal, side effect called gastrointestinal (GI) perforation. GI perforation is the development of a hole in the stomach, small intestine, or large intestine. Symptoms may include abdominal pain, nausea, vomiting, constipation, and fever. Avastin therapy should be stopped if GI perforation occurs.

Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Stop Avastin for at least 28 days before voluntary surgery. Do not start Avastin for at least 28 days after surgery and until the surgical wound is fully healed. Avastin therapy should be stopped in patients who experience slow or incomplete wound healing.

Treatment with Avastin can result in serious and sometimes fatal bleeding. This includes coughing up blood, bleeding in the stomach, vomiting blood, bleeding in the brain, nosebleeds, and vaginal bleeding. People who have recently coughed up blood or have serious bleeding should not receive Avastin.

Please click here for additional important safety information.

Indication

Avastin, in combination with carboplatin and paclitaxel (chemotherapy), is approved by the FDA for first-line treatment of people newly diagnosed with a common form of NSCLC (unresectable, locally advanced, recurrent, or metastatic non-squamous, non-small cell lung cancer).

Possible Serious Side Effects and Additional Important Safety Information

What is the most important safety information I should know about Avastin?

Avastin can result in the development of a potentially serious, and sometimes fatal, side effect called gastrointestinal (GI) perforation. GI perforation is the development of a hole in the stomach, small intestine, or large intestine. Symptoms may include abdominal pain, nausea, vomiting, constipation, and fever. Avastin therapy should be stopped if GI perforation occurs.

Treatment with Avastin can lead to slow or incomplete wound healing (for example, when a surgical incision has trouble healing or staying closed). In some cases, this event resulted in fatality. Stop Avastin for at least 28 days before voluntary surgery. Do not start Avastin for at least 28 days after surgery and until the surgical wound is fully healed. Avastin therapy should be stopped in patients who experience slow or incomplete wound healing.

Treatment with Avastin can result in serious and sometimes fatal bleeding. This includes coughing up blood, bleeding in the stomach, vomiting blood, bleeding in the brain, nosebleeds, and vaginal bleeding. People who have recently coughed up blood or have serious bleeding should not receive Avastin.

What are the additional possible serious side effects of Avastin?

Serious side effects with Avastin include:

The formation of an abnormal passage from parts of the body to another part, sometimes fatal. Stop Avastin therapy if this occurs
Stroke or heart problems, which can be fatal. Heart problems include blood clots, mini-stroke, heart attack, and chest pain. Stop Avastin therapy if these occur
Too much protein in the urine, which may lead to kidney problems, sometimes fatal. Your doctor will monitor your protein level and may stop Avastin therapy if your level is too high
High blood pressure. Your doctor will monitor your blood pressure and may start you on medications to control your blood pressure. Temporarily stop Avastin if not controlled with medications. Avastin should be stopped if blood pressure severely spikes or if disturbance of the brain from high blood pressure occurs
Nervous system and vision disturbances. Symptoms may include high blood pressure, headache, seizure, sluggishness, confusion, and blindness. Stop Avastin therapy if these symptoms occur
Infusion reactions. These may include high blood pressure or severe high blood pressure that may lead to stroke, difficulty breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headaches, tremors, and excessive sweating. Stop Avastin therapy if severe infusion reactions occur

What are the most common side effects of Avastin?

The most common side effects of Avastin that occurred at >10% and at least twice the control rate include nosebleeds, headache, high blood pressure, inflammation of the nose, too much protein in the urine, taste change, dry skin, rectal bleeding, tear production disorder, back pain, and inflammation of the skin.

What should I do if I am pregnant or thinking of becoming pregnant?

You should not take Avastin while you are pregnant. If you stop Avastin, you should use a contraceptive for at least 6 months after your last dose before attempting to become pregnant.

What should I tell my health care provider before taking Avastin?

Avastin therapy may not be appropriate for certain people. Talk to your doctor if you:

Are pregnant or think you may be pregnant, or are planning to become pregnant. Based on animal data, Avastin may harm the fetus
Are breast-feeding. Avastin may pass into your breast milk
Are undergoing surgery. Avastin should not be given for at least 28 days after surgery and until the surgical wound is fully healed
Are under the age of 18. The safety and efficacy of Avastin in children have not been evaluated

Please see full Product Information, including Serious Side Effects, for additional important safety information.