Pronunciation:

be-va-SIZ-yoo-mab - maly

Brand Names:

• Alymsys

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Bevacizumab

Uses of This Medicine:

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

Bevacizumab-maly injection is also used together with other medicines (eg, 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 a type of brain tumor called glioblastoma that keeps coming back (recurrent).

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

Bevacizumab-maly injection also used in combination with other medicines (eg, paclitaxel, pegylated liposomal doxorubicin, topotecan) to treat platinum-resistant recurrent (cancer that keeps coming back) epithelial ovarian, fallopian tube, or primary peritoneal cancer in patients who have received 2 previous treatments.

Bevacizumab-maly is an antineoplastic that helps the body fight cancer. It prevents the growth of certain types of blood vessels to cancer cells. This helps decrease the growth of cancer cells by starving them of the nutrients they need to grow.

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

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

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

Children—

Appropriate studies have not been performed on the relationship of age to the effects of bevacizumab-maly injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bevacizumab-maly injection in the elderly. However, elderly patients are more likely to have age-related heart or blood vessel problems, which may require caution in patients receiving bevacizumab-maly injection.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bacillus of Calmette and Guerin Vaccine, Live
• Dengue Tetravalent Vaccine, Live
• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rubella Virus Vaccine, Live
• Smallpox Monkeypox Vaccine
• Typhoid Vaccine
• Varicella Virus Vaccine
• Yellow Fever Vaccine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live
• Adenovirus Vaccine Type 7, Live
• Cholera Vaccine
• Ebola Zaire Vaccine, Live
• Influenza Virus Vaccine, Live
• Rotavirus Vaccine, Live

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

• Hemoptysis (coughing up blood), recent history of—Should not be used in patients with this condition.

Proper Use of This Medicine:

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-maly 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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely and at regular visits to make sure that 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 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-maly together with cancer medicines containing anthracycline, especially if you have heart failure.

Side Effects of This Medicine:

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

Check with your doctor or nurse immediately 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, spams, or twitching seizures

nausea

nervousness

pain, redness, or swelling in the arm or leg

pain in the rectum

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

sweating

swelling of the face, ankles, hands, feet, or lower legs

swelling or inflammation of the mouth

swollen glands

tingling of the hands or feet

trembling

trouble breathing

trouble in 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

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

cracked lips

cracks in the skin

difficulty in moving

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

swollen joints

tearing of the eyes

tingling of hands and feet

ulceration of the skin

Other side effects not listed may also occur 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.