Alymsys Side Effects

Generic name: bevacizumab

Medically reviewed by Drugs.com. Last updated on Dec 9, 2024.

Note: This document provides detailed information about Alymsys.

Applies to bevacizumab: intravenous solution Side Effects associated with bevacizumab. Some dosage forms listed on this page may not apply specifically to the brand name Alymsys.

Applies to bevacizumab: intravenous solution.

Precautions

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 (the active ingredient contained in Alymsys) together with cancer medicines containing anthracycline if you have heart failure.

Serious side effects of Alymsys

Along with its needed effects, bevacizumab 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 while taking bevacizumab:

Other side effects of Alymsys

Some side effects of bevacizumab 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:

For healthcare professionals

Applies to bevacizumab: intravenous solution.

Gastrointestinal adverse events

• Very common (10% or more): Abdominal pain (up to 61%), vomiting (up to 52%), anorexia (up to 43%), constipation (up to 40%), diarrhea (up to 34%), stomatitis (up to 32%), dyspepsia (up to 24%), gastrointestinal hemorrhage (up to 24%), flatulence (up to 19%)
• Common (1% to 10%): Dry mouth, colitis, constipation, nausea
• Very rare (less than 0.01%): TE fistula, upper aerodigestive tract hemorrhage
• Frequency not reported: Intestinal obstruction, intestinal necrosis, mesenteric venous occlusion, ileus, anastomotic ulceration, gastrointestinal perforation and wound dehiscence (complicated by intra-abdominal abscesses), tracheoesophageal fistulae^[Ref]

All three TE fistulas occurred during the bevacizumab maintenance phase of the study in the context of persistent esophagitis. Additionally, six other cases of TE fistula have been reported in other lung and esophageal cancer studies using bevacizumab and chemotherapy alone or with concurrent radiation treatment.

The incidence of gastrointestinal perforation (gastrointestinal perforation, fistula formation, and/or intraabdominal abscess) in patients with colorectal cancer and in patients with non-small cell lung cancer (NSCLC) receiving bevacizumab was 2.4% and 0.9%, respectively.^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (up to 34%), hypotension (up to 15%)
• Common (1% to 10%): Deep vein thrombosis, congestive heart failure
• Frequency not reported: Arterial thromboembolic events (including cerebrovascular accident (stroke), myocardial infarction, transient ischemic attack, angina), fatal arterial thrombotic events, cerebral ischemia, supraventricular tachycardia, both serious and non-serious hemorrhagic events^[Ref]

Risk factors for the development of arterial thromboembolic events have included a history of arterial thromboembolism prior to bevacizumab exposure, age 65 years and above, and bevacizumab therapy. These events have occurred at a higher rate in these high-risk groups.

In one study, the rate of congestive heart failure (defined as NCI-CTC grade 3 and 4) in the bevacizumab plus paclitaxel arm was 2.2% versus 0.3% in the control arm. Among patients receiving anthracyclines, the rate of CHF was 3.8% for bevacizumab treated patients and 0.6% for patients receiving paclitaxel alone. Congestive heart failure occurred in six of 44 (14%) patients with relapsed acute leukemia (a non-FDA approved indication) receiving bevacizumab and concurrent anthracyclines in a single arm study. The safety of continuation or resumption of bevacizumab in patients with cardiac dysfunction has not been studied.^[Ref]

Nervous system

• Very common (10% or more): Dizziness (up to 26%), sensory neuropathy (24%)
• Common (1% to 10%): Confusion, abnormal gait, CNS hemorrhage, cerebrovascular ischemia
• Rare (less than 0.1%): Brain-capillary leak syndrome (reversible posterior hyponatremia
• Frequency not reported: Dysgeusia^[Ref]

hypertensive encephalopathy

RPLS is a neurological disorder associated with hypertension, fluid retention, and cytotoxic effects of immunosuppressive drugs on the vascular endothelium. The syndrome can present with headache, seizure, lethargy, confusion, blindness and other visual and neurologic disturbances. Mild to severe hypertension may be present, but is not necessary for diagnosis. The onset of symptoms has been reported to occur from sixteen hours to one year after initiation of bevacizumab. Magnetic resonance imaging is necessary to confirm the diagnosis of RPLS.^[Ref]

Hematologic

• Very common (10% or more): Leukopenia (37%), neutropenia (21%)
• Common (1% to 10%): Thrombocytopenia
• Frequency not reported: Hemorrhagic events, pancytopenia, febrile neutropenia, decreased hemoglobin, anemia, prothrombin time prolongations, infection with severe neutropenia^[Ref]

Hepatic

• Postmarketing reports: Gallbladder perforation

Metabolic

• Very common (10% or more): Hyperglycemia (up to 26%), hypomagnesemia (up to 24%), hyponatremia (up to 19%), hypoalbuminemia (16%), weight loss (up to 16%), hypokalemia (up to 16%)
• Common (1% to 10%): Bilirubinemia
• Frequency not reported: Increased blood potassium, decreased blood phosphorus, increased blood alkaline phosphatase^[Ref]

Musculoskeletal

• Very common (10% or more): Myalgia (up to 15%)
• Common (1% to 10%): Bone pain, back pain
• Postmarketing reports: Osteonecrosis of the jaw^[Ref]

Genitourinary

• Frequency not reported: Ureteral stricture^[Ref]

Respiratory

• Very common (10% or more): Upper respiratory infection (up to 47%), severe or fatal hemoptysis (up to 31%), epistaxis (up to 35%), dyspnea (up to 26%)
• Frequency not reported: Pulmonary hypertension, fatal pulmonary hemorrhage, nasal septum perforation
• Common (1% to 10%): Voice alteration^[Ref]

Patients with recent hemoptysis (greater than or equal to 1/2 tsp of red blood) should not receive bevacizumab.

In study 6, four of 13 (31%) bevacizumab-treated patients with squamous cell histology and two of 53 (4%) bevacizumab-treated patients with histology other than squamous cell, experienced serious or fatal pulmonary hemorrhage as compared to none of the 32 (0%) patients receiving chemotherapy alone. In study 5, the rate of pulmonary hemorrhage requiring medical intervention for the paclitaxel, carboplatin, plus bevacizumab arm was 2.3% (10 of 427) compared to 0.5% (2 of 441) for the paclitaxel plus carboplatin alone arm. There were seven deaths due to pulmonary hemorrhage reported by investigators in the paclitaxel, carboplatin, plus bevacizumab arm as compared to one in the paclitaxel plus carboplatin alone arm. Generally, these serious hemorrhagic events presented as major or massive hemoptysis without a history of minor hemoptysis during bevacizumab therapy.^[Ref]

Renal

• Very common (10% or more): Proteinuria (up to 36%)
• Uncommon (0.1% to 1%): Nephrotic syndrome^[Ref]

Kidney biopsy of six patients with proteinuria showed findings consistent with thrombotic microangiopathy.

In study 5, patients age 65 and older receiving carboplatin, paclitaxel, and bevacizumab had a greater relative risk for proteinuria as compared to younger patients.^[Ref]

Dermatologic

• Very common (10% or more): Alopecia (up to 32%)
• Common (1% to 10%): Rash/desquamation, skin ulcer
• Frequency not reported: Exfoliative dermatitis, skin discoloration
• Postmarketing reports: Necrotizing fasciitis^[Ref]

Ocular

• Very common (10% or more): Lacrimation increased
• Postmarketing reports: Cases of serious ocular adverse reactions have been reported following unapproved intravitreal use of this drug compounded from vials approved for IV administration. These reactions included infectious endophthalmitis, intraocular inflammation such as sterile endophthalmitis, uveitis and vitreitis, retinal detachment, retinal pigment epithelial tear, intraocular pressure increased, intraocular hemorrhage (such as vitreous hemorrhage or retinal hemorrhage and conjunctival hemorrhage). Some of these reactions have resulted in various degrees of visual loss, including permanent blindness.^[Ref]

It has been suggested that reduction in macular edema after treatment may have resulted in anatomic changes at the fovea and may have triggered the visual hallucinations.^[Ref]

Other

• Very common (10% or more): Asthenia (up to 74%), pain (up to 62%), fatigue (up to 80%), headache (up to 37%), peripheral edema (up to 22%), taste disorder (up to 9%)
• Common (1% to 10%): Infection with an unknown ANC
• Uncommon (0.1% to 1%): Nongastrointestinal fistula formation, infection without neutropenia
• Frequency not reported: Mesenteric venous occlusion, syncope, dehydration, somnolence, polyserositis, polyserositis^[Ref]

Immunologic

• Frequency not reported: Sepsis, wound healing complications, urinary tract infection, positive assays for treatment-emergent anti-bevacizumab^[Ref]

See also:

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Further information

Alymsys side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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