Alymsys (Bevacizumab Intravenous)

Generic name: Bevacizumab
Drug class: VEGF/VEGFR inhibitors

Usage of Alymsys (Bevacizumab Intravenous)

Bevacizumab injection is given with other medicines to treat patients with metastatic (cancer that has spread) carcinoma of the colon or rectum. This medicine is also used to treat a certain type of metastatic lung cancer called nonsquamous, non-small cell lung cancer, and a certain type of brain tumor called glioblastoma that keeps coming back (recurrent).

Bevacizumab injection is 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. This medicine is also used in combination with other medicines (eg, paclitaxel, pegylated liposomal doxorubicin, topotecan, carboplatin and paclitaxel, or carboplatin and gemcitabine followed by Avastin® alone) to treat patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer with or without having previous surgery.

Bevacizumab injection is also used together with atezolizumab to treat a type of liver cancer called hepatocellular carcinoma (HCC) that has spread throughout the body (metastatic) or cannot be removed by surgery (unresectable) in patients who have not received other cancer medicines by mouth or injection.

Bevacizumab is a substance that helps the body fight cancer. It prevents the growth of certain types of blood vessels to cancer cells. This helps to decrease the growth of cancer cells by starving the cells of nutrients that are needed to grow.

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

Alymsys (Bevacizumab Intravenous) side effects

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

bleeding gums

body aches or pain

burning, tingling, numbness, or pain in the hands, arms, feet, or legs

chest pain, discomfort, or tightness

chills

cloudy urine

cough

cracks in the skin

decreased urine output

difficult or labored breathing

dilated neck veins

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

ear congestion

fever

irregular breathing

irregular heartbeat

lack or loss of strength

lightheadedness

loss of appetite

loss of heat from the body

loss of voice

mood changes

nervousness

pain

pain, redness, or swelling in the arm or leg

painful or difficult urination

pinpoint red spots on the skin

pounding in the ears

rapid breathing

redness of the skin

runny or stuffy nose

seizures

sensation of pins and needles

slow or fast heartbeat

sore throat

sores on the skin

sores, ulcers, or white spots on the lips or in the mouth

stabbing pain

sunken eyes

sweating

swelling of the face, fingers, feet, or lower legs

swelling or inflammation of the mouth

swollen glands

thirst

trouble breathing

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood or material that looks like coffee grounds

watery or bloody diarrhea

weight gain

wrinkled skin

yellow skin

Less common

Bone pain

difficulty with swallowing

fainting

severe constipation

severe vomiting

stomach pain or tenderness

Rare

Back pain

blisters

blurred vision

confusion

dizziness

drowsiness

headache

increased thirst

loss of consciousness

muscle pain or cramps

open sores

pale skin

Incidence not known

Bloody mucus or unexplained nosebleeds

constipation

diarrhea

heartburn

heavy jaw feeling

high fever

hoarseness

indigestion

loosening of a tooth

nausea

pain, swelling, or numbness in the mouth or jaw

stomach cramping or burning

stomach pain, usually after eating a meal

sudden weakness in the arms or legs

sudden, severe chest pain

unexplained bleeding or bruising

unusual tiredness or weakness

voice changes

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

Belching

bloody nose

change in taste or bad unusual or unpleasant (after) taste

change in walking and balance

clumsiness or unsteadiness

dry mouth

excess flow of tears

hair loss

stomach discomfort or upset

thinning of the hair

weight loss

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.

Before taking Alymsys (Bevacizumab Intravenous)

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.

Pediatric

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

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bevacizumab 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 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.

Interactions with 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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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.

Relate drugs

How to use Alymsys (Bevacizumab Intravenous)

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 have to stay in place for at least 30 to 90 minutes every 2 or 3 weeks. Your doctor will decide how many treatments you will need.

Bevacizumab 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.

Warnings

It is very important that your doctor check your progress 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.

Using 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 it at least 28 days before or after having surgery and until the wound has healed enough.

Bevacizumab 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 right away 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 chance of having bleeding problems. Tell your doctor right away if you start to notice any signs of bleeding.

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

Your blood pressure might get too high while you are receiving 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.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Bevacizumab 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 together with cancer medicines containing anthracycline if you have heart failure.

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