Vegzelma (Intravenous)

Bevacizumab-adcd injection is given with other medicines to treat patients with metastatic carcinoma of the colon or rectum (cancer that has spread).

Bevacizumab-adcd injection is also used with other medicines (for example, carboplatin and paclitaxel) to treat nonsquamous, non-small cell lung cancer (NSCLC) that has spread, come back, or cannot be removed by surgery. It is also used to treat glioblastoma, a type of brain tumor that keeps coming back (recurrent).

Bevacizumab-adcd injection is also used with other medicines (for example, interferon alfa) to treat patients with metastatic kidney cancer. It is also used with other medicines (for example, paclitaxel and cisplatin, or paclitaxel and topotecan) to treat patients with cervical cancer that is ongoing, keeps coming back, or has spread to other parts of the body.

Bevacizumab-adcd injection is also used with other medicines (for example, paclitaxel, pegylated liposomal doxorubicin, topotecan, carboplatin and paclitaxel, or carboplatin and gemcitabine followed by Vegzelma™ alone) to treat platinum-resistant recurrent (cancer that keeps coming back) or stage 3 or 4 epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have had 2 previous treatments or with or without surgery.

Bevacizumab-adcd is an antineoplastic that helps the body fight cancer. It prevents the growth of certain blood vessels to cancer cells, which helps reduce the growth of cancer cells by depriving them of the nutrients they need to grow.

This medicine should only be given by or under the immediate supervision of your doctor.

It is very important that your doctor checks your progress closely and at regular visits to ensure this medicine is working properly. Blood and urine tests are needed to check for unwanted effects. Be sure to keep all appointments. You may be taught how to check your blood pressure at home.

Receiving this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy while you are receiving this medicine and for at least 6 months after the last dose. If you think you have become pregnant while receiving this medicine, tell your doctor right away.

Receiving this medicine may increase the risk of ovarian failure. Talk with your doctor if you plan to have children. Some women receiving this medicine have become infertile (unable to have children).

This medicine can cause stomach or bowel perforation (tear or hole), including blockage. Check with your doctor right away if you have severe stomach pain, constipation, fever, nausea, or vomiting.

This medicine may also increase your risk of having a serious condition called tracheoesophageal fistula (an abnormal opening in one or more places between the esophagus and the trachea). Tell your doctor right away if you start having trouble swallowing, coughing, or choking while eating, trouble breathing, or chest pain or discomfort while you are receiving this medicine.

This medicine may affect the way your body heals. Make sure any doctor who treats you knows that you are receiving this medicine. You may need to stop receiving this medicine at least 28 days before and after having surgery.

This medicine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
• Check with your doctor immediately if you start to cough up blood or if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
• Avoid contact sports or other situations where bruising or injury could occur.

This medicine may increase your risk of developing blood clots. Check with your doctor right away if you have swelling and pain in your arms, legs, or stomach, chest pain, trouble breathing, loss of sensation, confusion, or problems with muscle control or speech.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

This medicine may increase your chance of having a brain condition called posterior reversible encephalopathy syndrome (PRES). Check with your doctor right away if you start having chest pain, sudden and severe headaches, fainting spells, seizures, unusual drowsiness, confusion, or problems with vision, speech, or walking while you are receiving this medicine.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chills or shaking, dizziness, trouble breathing, itching or rash, lightheadedness or fainting after receiving this medicine.

Do not receive bevacizumab-adcd together with cancer medicines containing anthracycline, especially if you have heart failure.

In deciding to use a medicine, you and your doctor need to consider the risks of the medicine against the benefits it may provide. Here are some important points to think about for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done to see how age affects the use of bevacizumab-adcd injection in children. Safety and effectiveness for this age group have not been established.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the use of bevacizumab-adcd injection. However, older patients are more likely to have heart or blood vessel issues related to age, which may require caution when using bevacizumab-adcd injection.

Breast Feeding

There are not enough studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines can be used together even if an interaction might happen. In these situations, your doctor may need to adjust the dose or take other precautions. Be sure to tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food due to possible interactions. Drinking alcohol or using tobacco with some medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how this medicine is used. Tell your doctor if you have any other medical issues, especially:

• Angina (severe chest pain) or
• Bleeding problems or
• Blood clots or
• Diabetes or
• Esophagus problems or
• History of heart attack or
• Heart failure or
• Hypertension (high blood pressure) or
• Kidney problems or
• Liver problems or
• Protein in the urine or
• Stomach or bowel problems (e.g., blockage, fistula, perforation) or
• History of stroke or
• Problems with wound healing—Use with caution. May make these conditions worse.

• Recent history of hemoptysis (coughing up blood)—Should not be used in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do, you may need medical attention.

Check with your doctor or nurse right away if any of the following side effects occur:

More common

• Black, tarry stools
• Bladder pain
• Bloating or swelling of the face, arms, hands, lower legs, or feet
• Bloody nose
• Bloody or cloudy urine
• Blurred vision
• Burning, numbness, tingling, or painful sensations
• Burning, painful, or difficult urination
• Changes in patterns and rhythms of speech
• Chest pain
• Chills
• Coma
• Confusion
• Cough or hoarseness
• Decreased urine output
• Dizziness
• Drowsiness
• Dry mouth
• Fever
• Flushed, dry skin
• Frequent urge to urinate
• Fruit-like breath odor
• Headache
• Increased hunger
• Increased thirst
• Increased urination
• Loss of appetite
• Lower back or side pain
• Mood or mental changes
• Muscle pain, cramps, spasms, or twitching seizures
• Nausea
• Nervousness
• Numbness or tingling in the hands, feet, or lips
• Pain, redness, or swelling in the arm or leg
• Pain in the rectum
• Pain or tenderness around the eyes and cheekbones
• Pale skin
• Pelvic pain
• Pounding in the ears
• Rapid weight gain
• Slow or fast heartbeat
• Slurred speech
• Sore throat
• Sores, ulcers, or white spots on the lips or in the mouth
• Stomach pain or cramps
• Stuffy or runny nose
• Sweating
• Swelling of the face, ankles, hands, feet, or lower legs
• Swollen glands
• Tingling of the hands or feet
• Trembling
• Trouble breathing
• Trouble speaking
• Unsteadiness or awkwardness
• Unusual bleeding or bruising
• Unusual tiredness or weakness
• Unusual weight gain or loss
• Vomiting
• Weakness in the arms, hands, legs, or feet
• Weakness or heaviness of the legs

Less common

• Fainting

Incidence not known

• Bloody mucus or unexplained nosebleeds
• Constipation
• Diarrhea
• Heartburn
• Heavy jaw feeling
• Indigestion
• Loosening of a tooth
• Pain, swelling, or numbness in the mouth or jaw
• Problems with vision, speech, or walking
• Stomach cramping or burning
• Vomiting of blood or material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Back pain
• Bad, unusual, or unpleasant (after) taste
• Burning, numbness, tingling, or painful sensations
• Cracked lips
• Cracks in the skin
• Difficulty in moving
• Discoloration of the fingernails or toenails
• Joint pain
• Lack or loss of strength
• Loss of heat from the body
• Muscle aches or stiffness
• Redness, swelling, or pain of the skin
• Scaling of skin on the hands and feet
• Swelling or inflammation of the mouth
• Swollen joints
• Tearing of the eyes
• Tingling of hands and feet
• Ulceration of the skin
• Unsteadiness or awkwardness
• Voice changes
• Weakness in the arms, hands, legs, or feet

Other side effects not listed may also happen in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Vegzelma

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Bevacizumab

Find detailed information on biosimilars for this medication.

Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will need to stay in place for at least 30 to 90 minutes.

Bevacizumab-adcd is often given together with other cancer medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your doctor to help you plan a way to remember to take your medicines at the right times.

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