Bevarest-100-mg-Injection

Brand name: Bevarest Active substance: Bevacizumab Strength: 100mg/4ml Mfg: Emcure Pack: one vial in a carton Classified as:  Anti-neoplastic drug read more

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Drug profile of Bevarest

Bevarest is an anti-neoplastic medication which is containing Bevacizumab as an active substance, which is involved in the treatment of various cancers.

Bevacizumab is a monoclonal antibody, which aimed 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.

Bevarest therapy is involved by interceding with development of blood supply, so it is termed as anti-angiogenesis therapy.

Bevarest is classified as;

Targeted therapy

Monoclonal antibody

Anti-angiogenesis

VEGF inhibitor


Prescribing information of Bevarest

The most important prescribing information of Bevarest is;

Metastatic colorectal cancer: In this condition, Bevarest should be used in combination with intravenous 5-FU based chemotherapy. This is considered as first or second line therapy.

Bevarest 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 Bevarest.

Bevarest is not a supporting therapy for colon cancer.

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

Recurrent Glioblastoma: Bevarest is majorly used in this condition

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

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

Epithelial ovarian, fallopian tube or primary peritoneal cancer: Bevarest should be combined with carboplatin & paclitaxel, followed by Bevarest as a single therapy.

In platinum resistance epithelial ovarian, fallopian or peritoneal cancer, Bevarest should be combined with paclitaxel, pegylated liposomal doxorubicin or topotecan.

In platinum sensitive recurrent epithelial ovarian, fallopian tube or peritoneal cancer, Bevarest should be combined with carboplatin & paclitaxel or carboplatin & gemcitabine.

 

Mechanism of Bevarest

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.

 

Absorption

The pharmacokinetic of Bevarest 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 experienced with opsonization for elimination.

This may occurs through reticuloendothelial system at time of binding to endothelial cells.

 

Excretion

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

Creatinine clearance value is 0.23 (33)L/day

 

When to take the Bevarest

Bevarest should be administered as intravenous site.

It should be administered with or without food.

 

Dosage regimens of Bevarest

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

Advanced colon rectal cancer:

Bevarest combined with 5-FU

The dose of Bevarest is;

The dose of 5mg/kg of Bevarest should be taken for every 2 weeks administered through intravenously in combination with bolus IFL.

10mg/kg of Bevarest should be taken for every 2 weeks administered intravenously by combining with FOLFOX4.

The dose of Bevarest 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 Bevarest is 15mg/kg should be administered through IV for every 2 weeks by combining with carboplatin & paclitaxel.

Recurrent Glioblastoma:

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

Advanced renal cell cancer:

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

Advanced cervical cancer:

The advised dose of Bevarest 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 Bevarest is 15mg/kg IV for every 3 weeks by combining with carboplatin & paclitaxel for period of 6 cycles, continued by Bevarest 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 In this condition, Bevarest should be combined with paclitaxel, pegylated liposomal doxorubicin or topotecan for every week. The dose of Bevarest is 10mg/kg IV for 2 weeks

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

Platinum sensitive:

The prescribed dose of Bevarest 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 Bevarest 15mg/kg for every 3 weeks as a single regimen.

The prescribed dose of Bevarest is 15mg/kg IV for every 3 weeks by combining with carboplatin & gemcitabine for period of 6 to 10 cycles, continue with Bevarest 15mg/kg as a single regimen.

Dose alteration:

In GI perforation: Bevarest therapy should be stopped

Wound healing complications: Stop the Bevarest treatment

Hemorrhage: stop the therapy

Thromboembolic events: Discontinue the Bevarest treatment

Hypertension: In crisis hypertension, discontinue the therapy or in severe condition interrupt the treatment

Posterior reversible encephalopathy syndrome: Stop the treatment

Renal toxicity: stop the treatment

Infusion reaction: in severe condition, treatment should be discontinued; if clinically significant the treatment should be interrupted; mild condition, reduce the infusion rate.

Congestive heart failure: Stop the treatment.

Administration:

Bevarest 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 Bevarest containing 4ml solution which is diluted in 100ml of 0.9% sodium chloride solution.

Bevarest should not be diluted in dextrose solution.

 

Bevarest caused side effects

The most common adverse effects in Bevarest 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

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

Post marketing reports:

Polyserositis

Pulmonary hypertension

GI ulcers, intestinal necrosis

Pancytopenia

Osteonecrosis

Nasal septum perforation

Renal thrombotic microangiopathy

 

Drug- drug interaction

Bevarest 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.

 

Food drug interaction

There is no appropriate food drug interaction occur during Bevarest therapy, patients must get advice from medical oncologist about diet.

Generally during cancer therapy some fruits should not be consumed;

Grapefruit or juice

Pomegranate

Seville oranges

Star fruit

 

Possible contraindications

No specific contraindications occur.

Hypersensitivity reactions may present in patients who are contraindicate to component of Bevarest

Bevarest is contraindicated to pregnant & lactating women.

 

Safety measures

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 Bevarest injection.

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

In wound or surgery complications: Bevarest 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 occurs during the Bevarest treatment.

Discontinue the treatment.

Arterial thromboembolic events: Discontinue the therapy with Bevarest 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 Bevarest 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 Bevarest therapy and PRES should be monitored by undergoing MRI.

In severe condition, patients should be discontinuing with Bevarest 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 Bevarest treatment.

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

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

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

 

Pregnancy and lactation

Pregnancy category: C

Bevarest should be contraindicated to pregnancy condition; beast feeding is also not suggested.

Bevarest 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.

 

Storage and handling

Bevarest vial should be stored in 2oC to 8oC.

Protect the container from moisture, heat & light.

Discard the unused portion immediately.

The diluted solution of Bevarest should be stored at 2 to 8oC for up to 8 hours.

There is no compatibilities occurs between Bevarest & polyvinylchloride or polyolefin bags has been detected

 

Missed dose

If patients are fail to take cycles of Bevarest, must consult with medical oncologist and follow the instructions.

Do not miss the cycle of Bevarest.

 

Over dosage

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

Bevarest should be used cautiously.

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