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The most important prescribing information of Bevatas is; Metastatic colorectal cancer Non-squamous non-small cell lung cancer Recurrent Glioblastoma Advanced renal cell cancer Advanced cervical cancer Epithelial ovarian, fallopian tube or primary peritoneal cancer

Bevacizumab link to the VEGF and inhibits the interaction of VEGF to its receptors (Flt-1 and KDR) on the surface of endothelial cells. The combination of VEGF with its receptors causesendothelial cell replication and new blood vessel formation in in vitro models of angiogenesis. Administration of bevacizumab to xenotransplant models of colon cancer in nude (athymic) mice caused reduction of microvascular growth and inhibition of metastatic disease progression.



ADME Properties

Absorption

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.

Distribution

Volume of distribution of Bevacizumab is 2.9L

Metabolism

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

Excretion

The terminal half-life period of Bevacizumab is nearly 20 days.


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Brand : Bevatas
Ingredients : Bevacizumab
Strength : 100mg/4ml
Manufactured : Intas
Package : one vial in a carton

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.

Metastatic colon rectal cancer

The prescribed dose when Bevatas is administered in co administration with intravenous 5-fluorouracil-based chemotherapy is: Patient Administrate 5 mg/kg every 2 weeks intravenously in combination with bolus-IFL. Patient Administrate 10 mg/kg every 2 weeks intravenously in combination with FOLFOX4. Patient Administrate 5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks in combination with fluoropyrimidine-irinotecan- or fluoropyrimidine-oxaliplatin-based chemotherapy in patients who have progressed on a first-line Bevatas -containing regimen.

Non-squamous non-small cell lung cancer

The usual dose of Bevatas is 15mg/kg should be administered via IV for every 2 weeks by interaction with carboplatin & paclitaxel.

Recurrent Glioblastoma

The usual 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 co administration with interferon alfa.

Advanced cervical cancer

The prescribed dose of Bevatas in this condition is 15mg/kg of drug should be given intravenously for every 3 weeks by interaction 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 concomitant 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.

Administration

Bevatas should be givenvia 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.

OVERDOSE

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

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.

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.

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.

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.

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 interaction with paclitaxel & carboplatin causes decrease exposure of paclitaxel after completion of 4 cycles of therapy. When patients getting paclitaxel & carboplatin as alone, causes elevation of paclitaxel exposure at day 63.

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