Bevatas 100mg/4ml

Bevatas is an anti-neoplastic medication which is containing Bevacizumab as an active substance, which is involved in the treatment of various cancers. It is a monoclonal antibody, which target a tumor cell protein known as vascular endothelial growth factor (VEGF). This VEGF is responsible for cancer to form their blood vessels, so they can easily acquire food and oxygen from blood for survival. The treatment involved by interceding with development of blood supply, so it is termed as anti-angiogenesis therapy.

Bevacizumab

Bevatas

100mg/4ml

Intas






Indication of Bevatas

The most important prescribing information of Bevatas is;

Metastatic colorectal cancer:
In this condition, Bevatas should be used in combination with intravenous 5-FU based chemotherapy. This is considered as first or second line therapy. Bevatas is concurrently used with fluoropyrimidine Irinotecan or fluoropyrimidine oxaliplatin based therapy should be used as second line treatment in advanced colon rectal cancer for the patients who are advanced with first line therapy of Bevatas. Bevatas is not a supporting therapy for colon cancer.

Non-squamous non-small cell lung cancer:
Bevatas is used as first line therapy for this condition by combining with carboplatin & paclitaxel.

Recurrent Glioblastoma:
Bevatas is majorly used in this condition

Advanced renal cell cancer:
In this condition, Bevatas should be combined with interferon alfa medicine.

Advanced cervical cancer:
For treating this condition, Bevatas should be concurrently used with paclitaxel & cisplatin or paclitaxel & topotecan.

Epithelial ovarian, fallopian tube or primary peritoneal cancer:
Bevatas should be combined with carboplatin & paclitaxel, followed by Bevatas as a single therapy. In platinum resistance epithelial ovarian, fallopian or peritoneal cancer, Bevatas should be combined with paclitaxel, pegylated liposomal doxorubicin or topotecan. In platinum sensitive recurrent epithelial ovarian, fallopian tube or peritoneal cancer, Bevatas should be combined with carboplatin & paclitaxel or carboplatin & gemcitabine.

Mechanism of action of Bevatas

Bevacizumab is majorly binds to the protein like vascular endothelial growth factor and prevent the interaction of protein to its receptors. The communication of protein with its receptors causes cell production by forming new blood vessels which comes under the process of angiogenesis. Bevacizumab is involved in inhibition of new blood vessel formation leads to death of cancer cells due to loss of oxygen and food.



Pharmacokinetic

The pharmacokinetic of Bevatas is to be linear; the concluded time to reach more than 90% of steady state concentration is 84 days. The median trough concentration of Bevacizumab is 80.3mcg/ml on day 84.

Volume of distribution of Bevacizumab is 2.9L

The drug has been experienced with opsonization for elimination. This may occur through reticuloendothelial system at time of binding to endothelial cells.

The terminal half-life period of Bevacizumab is nearly 20 days. Creatinine clearance value is 0.23 (33)L/day





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Brand Bevatas
Ingredients Bevacizumab
Strength 100mg/4ml
Manufactured Intas
Rating

Dosage regimens and administration of Bevatas

The most important administration factors are, Bevatas should not be used until at least 28 days following surgery and lesion is completely healed.

Advanced colon rectal cancer
Bevatas combined with 5-FU The dose of Bevatas is; The dose of 5mg/kg of Bevatas should be taken for every 2 weeks administered through intravenously in combination with bolus IFL. 10mg/kg of Bevatas should be taken for every 2 weeks administered intravenously by combining with FOLFOX4. The dose of Bevatas is 5mg/kg should be administered intravenously as every 2 weeks or 7.5mg/kg should be given IV for every 3 weeks by combining with fluoropyrimidine Irinotecan or fluoropyrimidine oxaliplatin based chemotherapy regimens.

Non-squamous non-small cell lung cancer
The suggested dose of Bevatas is 15mg/kg should be administered through IV for every 2 weeks by combining with carboplatin & paclitaxel.

Recurrent Glioblastoma
The usual suggested dose of Bevatas is 10mg/kg should be administered IV for every 2 weeks

Advanced renal cell cancer
The usual suggested dose of Bevatas is 10mg/kg should be given intravenously for every 2 weeks by combining with interferon alfa.

Advanced cervical cancer
The advised dose of Bevatas in this condition is 15mg/kg of drug should be given intravenously for every 3 weeks by combining with paclitaxel & cisplatin or by combining with paclitaxel & topotecan.

Epithelial ovarian, fallopian tube, or peritoneal cancer
Therapy of stage III or IV: The usual dose of Bevatas is 15mg/kg IV for every 3 weeks by combining with carboplatin & paclitaxel for period of 6 cycles, continued by Bevatas 15mg/kg for every 3 weeks as a single regimen, for total duration of treatment is 22 cycles.

Therapy of frequent disease

Platinum resistance condition
The prescribed dose of Bevatas is 15mg/kg given IV for every 3 weeks by combining with topotecan (every 3 weeks).

Platinum sensitive
The prescribed dose of Bevatas is 15mg/kg should be given as IV for every 3 weeks, by combining with carboplatin & paclitaxel for period of 6 to 8 cycles, continued by Bevatas 15mg/kg for every 3 weeks as a single regimen. The prescribed dose of Bevatas is 15mg/kg IV for every 3 weeks by combining with carboplatin & gemcitabine for period of 6 to 10 cycles, continue with Bevatas 15mg/kg as a single regimen.

Administration
Bevatas should be administered through intravenous infusion over the period of 90 minutes as first infusion and consecutive infusions may follow over 60 minutes. 100mg of Bevatas containing 4ml solution which is diluted in 100ml of 0.9% sodium chloride solution. Bevatas should not be diluted in dextrose solution. Bevatas should be administered as intravenous site. It should be administered with or without food.

Over dosage

There is no chance of getting over dosage in Bevatas receiving patients, because Bevatas is a cytotoxic drug which is administered only under the supervision of medical oncologist. Bevatas should be used cautiously.

Common side effects

Diarrhea, Nausea, Stomatitis, Fatigue, Arthralgia, Muscle weakness, Pain, Dysarthria, Headache, Dyspnea, Epistaxis, Nasal mucosal disorders, Hypertension, Neutropenia, Mucosal inflammation, Peripheral sensory neuropathy, Palmar plantar erythrodysaesthesia, Contusion, Back pain, Insomnia

The most common adverse effects in Bevatas treatment

GI perforations & fistulae, Surgery and wound healing complications, Hemorrhage, Arterial thromboembolic events, Venous thromboembolic events, Hypertension, Posterior reversible encephalopathy syndrome, Renal damage & Proteinuria, Infusion reactions, Ovarian failure, Congestive heart failure

Precautions

Some warning signs should be taken into consideration: Gastrointestinal perforation, surgery & wound lesions complexity or hemorrhages are the major adverse effect occurs during the treatment with Bevatas injection.

In GI perforation:
Treatment should be discontinued and providing supportive measures

In wound or surgery complications:
Bevatas treatment should be interrupt during the surgery until the wound should be completely healed. Nearly 28 days after & before the surgery, therapy should be withheld.

Hemorrhage:
Severe hemorrhages like GI bleeding, hemoptysis, Hematemesis, CNS hemorrhage, Epistaxis & vaginal bleeding are occurring during the Bevatas treatment. Discontinue the treatment.

Arterial thromboembolic events:
Discontinue the therapy with Bevatas in patients who are suffered with severe ATE.

Venous thromboembolic events:
Incidence of toxicity should be detected; in case of severe condition therapy should be stopped.

Hypertension:
Increased blood pressure in patients who are receiving Bevatas therapy, should be monitor frequently with blood pressure and provided with alternative medication for correct the pressure. In hypertension crisis or encephalopathy should be discontinue the treatment.

Posterior reversible encephalopathy syndrome:
Symptoms should be cleared with providing supportive measures after discontinuing the Bevatas therapy and PRES should be monitored by undergoing MRI. In severe condition, patients should be discontinuing with Bevatas treatment.

In renal injury & Proteinuria:
Toxicity grade should be resolved by monitoring the renal function and Proteinuria.

Infusion reactions:
In severe infusion reactions, patients should not take Bevatas treatment.

Embryo fetal damage:
Bevatas is contraindicated to pregnancy condition, produce fetal harm.

Ovarian failure:
Bevatas receiving patients may have a chance of getting ovarian failure.

Congestive heart failure:
In anthracycline based chemotherapy, Bevatas treatment should not be used. Bevatas treatment should be discontinuing while CHF occurs.

Drug- drug interaction

Bevatas combined with paclitaxel & carboplatin causes reducing exposure of paclitaxel after completion of 4 cycles of therapy. When patients receiving paclitaxel & carboplatin as alone, causes elevation of paclitaxel exposure at day 63.



No specific contraindications occur. Hypersensitivity reactions may present in patients who are contraindicate to component of Bevatas. Bevatas is contraindicated to pregnant & lactating women.

Pregnancy category: C Bevatas should be contraindicated to pregnancy condition; breast feeding is also not suggested. Bevatas produces some embryo fetal damage which may leads to cause fetal harm. The potency of Bevacizumab should not be evaluated in pediatric patients. There is an increased chance of getting arterial thromboembolic events in > or equal to 65 years of age.

Bevatas vial should be stored in 2°C to 8°C. Protect the container from moisture, heat & light. Discard the unused portion immediately. The diluted solution of Bevatas should be stored at 2 to 8°C for up to 8 hours. There are no compatibilities occurs between Bevatas& polyvinylchloride or polyolefin bags has been detected

If patients are missed to take cycles of Bevatas , must consult with medical oncologist and follow the instructions. Do not miss the cycle of Bevatas.

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