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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Brand Name
Alymsys
Generic Name
Bevacizumab-maly
Active Ingredient
BevacizumabCategory
Vascular Endothelial Growth Factor Inhibitor [EPC]
Variants
4
Different strengths and dosage forms
| Strength | Form | Route | NDC |
|---|---|---|---|
| 100 mg/4mL | INJECTION, SOLUTION | INTRAVENOUS | 85006-1754 |
| 400 mg/16mL | INJECTION, SOLUTION | INTRAVENOUS | 85006-1755 |
| 400 mg/16mL | INJECTION, SOLUTION | INTRAVENOUS |
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Alymsys, you must consult a qualified healthcare professional.
| 100 mg/4mL | INJECTION, SOLUTION | INTRAVENOUS | 70121-1754 |
Detailed information about Alymsys
Bevacizumab is a recombinant humanized monoclonal antibody and a Vascular Endothelial Growth Factor (VEGF) inhibitor used to treat various cancers by inhibiting the growth of new blood vessels that feed tumors.
Dosage for Bevacizumab is strictly individualized based on the patient's body weight (mg/kg) and the specific type of cancer being treated. According to clinical guidelines from the National Comprehensive Cancer Network (NCCN), standard regimens include:
Bevacizumab is not FDA-approved for use in pediatric patients. Clinical trials in children with solid tumors have generally failed to show significant efficacy, and there are concerns regarding its impact on developing growth plates (epiphyseal fusion). In some pediatric studies, cases of osteonecrosis (bone death) have been reported. If a physician considers Bevacizumab for a minor, it is typically within the context of a clinical trial or highly specific off-label use for refractory cases.
There are no formal studies of Bevacizumab in patients with kidney disease. However, because monoclonal antibodies are not cleared by the kidneys, dose adjustments are generally not required for mild to moderate renal impairment. Patients with nephrotic syndrome (severe protein loss in urine) should have the drug discontinued.
No formal studies have been conducted in patients with liver impairment. As the liver is not the primary route of elimination for Bevacizumab, dose adjustments based on liver function tests are not typically standardized, though overall clinical status must be monitored.
No overall differences in safety or efficacy were observed between patients older than 65 and younger patients. However, elderly patients are at a statistically higher risk for arterial thromboembolic events (blood clots in the arteries), including stroke and heart attack, while on Bevacizumab.
Bevacizumab is administered as an intravenous infusion by a healthcare professional. It is not self-administered.
Because Bevacizumab is administered on a strict clinical schedule, missing a dose can interfere with the effectiveness of the cancer treatment. If you miss an appointment for your infusion, contact your oncology clinic immediately to reschedule. Your doctor will determine the best timing for the next dose to maintain the therapeutic cycle.
There is no specific antidote for Bevacizumab overdose. In clinical trials, the highest dose tested (20 mg/kg every 2 weeks) was associated with severe headaches in several patients. In the event of an accidental overdose, the patient should be monitored closely for signs of severe hypertension (high blood pressure), gastrointestinal perforation, or hemorrhage. Emergency supportive care should be initiated as needed.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your treatment schedule or skip appointments without medical guidance. Regular blood pressure and urine tests are mandatory during treatment.
Bevacizumab affects the vascular system throughout the body, leading to several common side effects. Patients frequently report:
Bevacizumab is a potent medication that requires vigilant monitoring. Before starting treatment, patients must undergo a thorough cardiovascular and renal assessment. Because Bevacizumab remains in the system for several months, its effects on wound healing and blood pressure can persist long after the last dose. Patients must inform all healthcare providers, including dentists, that they are receiving or have recently received Bevacizumab.
As noted by the FDA, Bevacizumab carries significant risks for Gastrointestinal (GI) Perforation, Wound Healing Complications, and Hemorrhage.
While there are no absolute contraindications for drug-drug combinations listed in the primary labeling, certain combinations are avoided due to extreme toxicity:
Bevacizumab must NEVER be used in the following circumstances:
Bevacizumab is classified as potentially teratogenic (causing birth defects). Based on its mechanism of action, it is expected to inhibit angiogenesis in the fetus, which is critical for normal development. Animal studies have shown that VEGF inhibition leads to malformations, decreased fetal weight, and fetal death.
It is not known if Bevacizumab is excreted in human milk. However, because maternal IgG (the type of antibody Bevacizumab is) is known to be present in breast milk, and the potential for serious adverse reactions in nursing infants is high, women are advised to discontinue breastfeeding during treatment and for at least 6 months following the last dose.
Bevacizumab is a humanized IgG1 monoclonal antibody produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) mammalian cell expression systems. Its primary target is the human vascular endothelial growth factor (VEGF).
At the molecular level, Bevacizumab binds to all soluble isoforms of VEGF-A. By doing so, it sterically hinders the VEGF molecule from binding to its receptors, VEGFR-1 (Flt-1) and VEGFR-2 (KDR), on the surface of endothelial cells. This blockade shuts down the intracellular signaling pathways (such as the MAPK and PI3K pathways) that normally lead to endothelial cell proliferation, migration, and survival. Without these signals, the tumor cannot stimulate the formation of the new blood vessels it requires for growth and metastasis.
The pharmacodynamic effect of Bevacizumab is observed through the reduction of tumor vascularity and interstitial fluid pressure. There is a clear dose-response relationship regarding the inhibition of tumor growth in animal models, though in humans, the relationship between blood levels and clinical response is more complex. The duration of effect is long, matching its 20-day half-life. Tolerance (the drug becoming less effective over time) can occur if the tumor begins to secrete other pro-angiogenic factors, such as Basic Fibroblast Growth Factor (bFGF), to bypass the VEGF blockade.
Common questions about Alymsys
Bevacizumab is primarily used to treat several types of advanced cancers, including metastatic colorectal cancer, non-small cell lung cancer, and glioblastoma. It is also FDA-approved for certain types of kidney, cervical, and ovarian cancers, as well as hepatocellular carcinoma. It works by inhibiting angiogenesis, the process by which tumors grow new blood vessels to supply themselves with nutrients. Typically, it is used in combination with other chemotherapy drugs to improve survival outcomes. Your doctor will determine the specific regimen based on your cancer type and stage.
The most frequently reported side effects include high blood pressure (hypertension), fatigue, and nosebleeds. Many patients also experience headaches, back pain, and a change in their sense of taste. Protein in the urine (proteinuria) is another common occurrence that is monitored through regular lab tests. While many of these are manageable, they require consistent monitoring by your healthcare team. If you experience severe abdominal pain or unusual bleeding, you should contact your doctor immediately.
There is no known direct interaction between alcohol and Bevacizumab that would change the drug's effectiveness. However, alcohol can contribute to dehydration and may worsen certain side effects like headaches or fatigue. It can also put additional strain on the liver, which may be processing other chemotherapy drugs you are taking. It is generally best to limit alcohol consumption during cancer treatment. Always discuss your lifestyle habits with your oncologist to ensure they do not interfere with your specific treatment plan.
No, Bevacizumab is generally not considered safe during pregnancy and is classified as potentially harmful to a developing fetus. Because the drug works by stopping the growth of new blood vessels, it can severely interfere with the normal development of a baby. Women of childbearing age must use effective birth control during treatment and for at least six months after the last dose. Additionally, Bevacizumab can cause ovarian failure, which may lead to permanent infertility in some women. Discuss fertility preservation options with your doctor before starting therapy.
Bevacizumab begins working at the molecular level immediately after the first infusion, but its effects on the tumor are not visible right away. Most patients undergo several cycles of treatment (usually over 2 to 3 months) before an imaging scan, such as a CT or MRI, is performed to assess the tumor's response. The goal of treatment is often to shrink the tumor or stop it from growing further. Your oncologist will use these scans and other clinical markers to determine if the medication is effective for you. Treatment typically continues as long as the cancer is not progressing and side effects are manageable.
You should not stop taking Bevacizumab without consulting your oncologist, as it is part of a carefully timed treatment cycle. However, unlike some medications, there is no physical 'withdrawal' effect if a dose is delayed or stopped. The main risk of stopping treatment is that the cancer may begin to grow or spread more quickly once the anti-angiogenic effect is removed. If you are experiencing severe side effects, your doctor may decide to pause or permanently discontinue the drug. This decision is always based on a careful balance of the drug's benefits versus its risks.
If you miss an appointment for your Bevacizumab infusion, you should contact your oncology clinic as soon as possible to reschedule. Because the drug is given on a specific schedule (usually every 2 or 3 weeks), keeping your appointments is crucial for maintaining a constant level of the drug in your system. Your healthcare provider will adjust your schedule to ensure you receive the correct number of doses. Do not attempt to 'double up' on doses or change your chemotherapy schedule without professional guidance. Consistent dosing is key to the success of the therapy.
Weight gain is not a typical direct side effect of Bevacizumab. In fact, many patients undergoing cancer treatment may experience weight loss due to decreased appetite or the effects of chemotherapy. However, if you notice sudden, rapid weight gain accompanied by swelling in your ankles, feet, or face, you should notify your doctor immediately. This could be a sign of fluid retention, which may indicate heart or kidney problems related to the medication. Your medical team will monitor your weight and fluid status at each visit.
Bevacizumab is almost always taken in combination with other medications, particularly chemotherapy drugs like 5-fluorouracil, paclitaxel, or carboplatin. However, it can interact with certain drugs like sunitinib, which increases the risk of a serious blood disorder. It also increases the risk of heart problems when used with anthracyclines like doxorubicin. You must provide your doctor with a complete list of all prescriptions, over-the-counter drugs, and herbal supplements you are taking. This allows your oncology pharmacist to screen for any potentially dangerous interactions.
Bevacizumab is a biological drug, so it does not have 'generics' in the traditional sense. Instead, it has 'biosimilars,' which are highly similar versions of the original drug (Avastin) that have been FDA-approved for safety and efficacy. Several biosimilars, such as Mvasi (bevacizumab-awwb) and Zirabev (bevacizumab-bvzr), are currently available and may be used interchangeably with the reference product depending on your insurance and hospital formulary. These biosimilars provide the same clinical benefits and have the same side effect profile as the original brand-name drug.
Other drugs with the same active ingredient (Bevacizumab)
> Warning: Stop receiving Bevacizumab and call your doctor immediately or seek emergency care if you experience any of the following:
Prolonged use of Bevacizumab may lead to chronic hypertension, which requires long-term management with antihypertensive medications. There is also a risk of permanent ovarian failure in premenopausal women, potentially leading to infertility. Chronic proteinuria may, in rare cases, lead to permanent kidney damage if not monitored and managed appropriately.
The FDA has issued a 'Black Box Warning' for Bevacizumab due to the following severe risks:
Report any unusual symptoms to your healthcare provider immediately. Early detection of side effects is critical for safe management.
While rare, some patients may experience an infusion reaction. Symptoms include hypertension, shivering, redness of the face, or chest pain. If a reaction occurs, the infusion rate is slowed or stopped, and medications like antihistamines may be given.
Bevacizumab significantly increases the risk of arterial thromboembolic events (ATEs), including myocardial infarction (heart attack) and cerebrovascular accidents (stroke). Patients with a history of these conditions or those over age 65 are at the highest risk. Additionally, the drug can cause or worsen congestive heart failure, particularly in patients who have previously received anthracycline chemotherapy (like doxorubicin).
Proteinuria (protein in the urine) is common. In severe cases, this can progress to nephrotic syndrome. If a 24-hour urine collection shows more than 2 grams of protein, the drug is typically held until levels improve.
To ensure safety, the following monitoring is mandatory:
Bevacizumab itself does not typically cause sedation or dizziness. However, the underlying cancer or the chemotherapy used alongside Bevacizumab may cause fatigue or weakness. Patients should assess their own reaction to the treatment before driving or operating heavy machinery.
There is no direct pharmacological interaction between Bevacizumab and alcohol. However, alcohol can exacerbate dehydration and liver stress, which may be problematic during cancer treatment. Patients should consult their oncologist regarding moderate alcohol consumption.
There is no 'withdrawal syndrome' associated with stopping Bevacizumab. However, the drug must be permanently discontinued if the patient experiences GI perforation, severe hemorrhage, arterial thromboembolism, nephrotic syndrome, or hypertensive crisis. Stopping the drug may allow the tumor to resume angiogenesis, so discontinuation is a major clinical decision.
> Important: Discuss all your medical conditions, especially history of heart disease, high blood pressure, or recent surgeries, with your healthcare provider before starting Bevacizumab.
For each major interaction, the mechanism is typically pharmacodynamic (the drugs have additive effects on the body) rather than pharmacokinetic (the drugs affecting each other's levels). The clinical consequence is usually an increased risk of toxicity (bleeding, heart failure, or bone death). Management strategies involve frequent monitoring, dose delays, or choosing alternative therapies.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking, including over-the-counter pain relievers like ibuprofen, which can affect blood pressure and bleeding risk.
Conditions requiring careful risk-benefit analysis include:
There is no established cross-sensitivity between Bevacizumab and small-molecule VEGF inhibitors (like sunitinib or sorafenib). However, patients who have had a severe reaction to other monoclonal antibodies (like rituximab or trastuzumab) should be monitored more closely for infusion reactions.
> Important: Your healthcare provider will evaluate your complete medical history, including any history of 'mini-strokes' (TIAs) or chronic inflammatory bowel disease, before prescribing Bevacizumab.
Safety and effectiveness in pediatric patients have not been established. In fact, the FDA has noted that Bevacizumab is not approved for use in children. There are significant concerns regarding the drug’s effect on the growth plates of bones. In juvenile animal studies, Bevacizumab caused dysplasia (abnormal development) of the epiphyseal cartilage. Cases of osteonecrosis of the jaw have also been reported in pediatric patients receiving the drug off-label.
Clinical trials included a significant number of patients aged 65 and older. While the overall efficacy was similar to younger patients, the risk of serious side effects is higher in the elderly. Specifically, the risk of arterial thromboembolic events (stroke, heart attack) and severe hypertension is increased. Geriatric patients should be monitored more frequently for cardiovascular symptoms and changes in mental status.
No formal studies have been conducted in patients with pre-existing renal impairment. However, clinical experience suggests that Bevacizumab does not require dose adjustment for mild to moderate kidney disease. The primary concern in this population is the development of drug-induced proteinuria, which may exacerbate underlying renal issues. If a patient develops nephrotic syndrome, the drug must be stopped permanently.
No studies have been conducted in patients with hepatic impairment. Since the liver is not the primary organ for the elimination of monoclonal antibodies (which are cleared via proteolysis), hepatic impairment is not expected to significantly alter the drug's levels. However, because the liver produces many clotting factors, and Bevacizumab affects bleeding risk, these patients require close clinical observation.
> Important: Special populations require individualized medical assessment. Always inform your oncologist if you are planning to become pregnant or have a history of kidney disease.
| Parameter | Value |
|---|---|
| Bioavailability | 100% (Intravenous) |
| Protein Binding | N/A (It is a protein itself) |
| Half-life | ~20 days (Range: 11–50 days) |
| Tmax | Immediate (End of infusion) |
| Metabolism | Systemic Proteolysis |
| Excretion | Not renally/fecally excreted in intact form |
Bevacizumab is the prototypical member of the Vascular Endothelial Growth Factor Inhibitor [EPC] class. Related medications include other VEGF-targeting antibodies like Ramucirumab, and small-molecule tyrosine kinase inhibitors (TKIs) that block the VEGF receptor from the inside, such as Sunitinib, Pazopanib, and Sorafenib.