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Bevacirel (Bevacizumab 100mg / 4ml)

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BEVACIREL 100mg

Description

Bevacizumab is a generic form of brand name Bevacirel necessary for the anti-cancer medication, which belongs to a group of drugs knowns as monoclonal antibodies. An antibody is a molecule produced by the body in response to a foreign antigen. A monoclonal antibody is made in the laboratory to target and prevents certain proteins. These agents are very essential for the molecules which they are formed against and are therefore called targeted therapies.

Bevacirel indication

Bevacirel is indicated for the treatment of following conditions;

  • Metastatic colon or rectal cancer
  • Non-squamous, non-small cell lung cancer
  • Glioblastoma
  • Metastatic renal cell cancer
  • Metastatic cervical cancer:
  • Epithelial ovarian, fallopian tube or peritoneal cancer:

Bevacirel pharmacology

Mechanism of action

Bevacizumab consist on targets a cancer cell protein called vascular endothelial growth factor (VEGF). This protein helps cancers to develop blood vessels, so they can have food and oxygen from the blood. All cancers require a blood supply to be able to survive and develop.

Bevacizumab stops this protein and inhibits the cancer from growing blood vessels, so it is macerated and can't grow. Treatments that prohibits the development of a blood supply are called anti-angiogenesis treatments.

 Pharmacokinetic

The pharmacokinetic form of Bevacirel is assayed by measuring total serum Bevacizumab concentration.

Distribution

The volume of distribution is 2.9 (22%) L

Elimination

The terminal half-life period of Bevacizumab is 20days (11 to 50days)

Bevacirel dosage and administration

Key point: Bevacirel do not administered before at least 28 days following surgery and the wound is completely cured

Non-small cell lung cancer

The usual dosage of Bevacirel is 15mg/kg IV for every 3 weeks by co administration with carboplatin and paclitaxel

Metastatic colorectal carcinoma

The usual dosage of Bevacirel by combination with 5-fluorouracil based chemotherapy

  • 5mg/kg of Bevacirel for every 2 weeks IV in concomitant with bolus IFL
  • 10mg/kg of Bevacirel for every 2 weeks IV in combination with FOLFOX4
  • 5mg/kg IV Bevacirel for every 2 weeks or 7.5 mg/kg Bevacirel as IV every 3 weeks by concurrently used with fluoropyrimidine Irinotecan or fluoropyrimidine oxaliplatin based therapy

Glioblastoma

The usual dose is 10mg/kg of Bevacirel administered IV for every 2 weeks

Epithelial ovarian, fallopian tube or peritoneal cancer

Platinum opposing:

The usual dosage of Bevacirel; 10mg/kg of Bevacirel for every 2 weeks by combination with paclitaxel, pegylated liposomal doxorubicin or topotecan

Or

The usual dosage of Bevacirel; 15mg/kg of Bevacirel given through IV for every 3 weeks by combining with topotecan

Platinum responsive

The recommended dosage of Bevacirel; 15mg/kg given IV for 3 weeks in concomitant with carboplatin and paclitaxel for 6 to 8 cycles

The recommended dosage of Bevacirel; 15mg/kg of Bevacirel given IV for 3 weeks by combining with gemcitabine & carboplatin for 6 to 10 cycles

Metastatic renal cell cancer

The recommended dosage of Bevacirel is 10mg/kg IV for every 2 weeks by concomitant use with interferon alfa

Metastatic cervical cancer

The usual dosage of Bevacirel; 15mg/kg of Bevacirel given intravenously for every 3 weeks by concomitant with paclitaxel and cisplatin or with paclitaxel and topotecan

Preparation & administration

Bevacirel used as  intravenous solution

At initial infusion: given IV infusion over 90 minutes

Following infusions: give second infusion over 60 minutes, if tolerated

Administer all following infusion over 30minutes

Bevacirel IV infusion is prepared in aseptic condition

Bevacirel 400mg containing 16ml solution whereas 100mg containing 4ml

Bevacirel dilute into 100ml of 0.9% NS

Do not dilute with dextrose solution

Discard the remaining portion which is left in a vial

Side effects

  • Venous thromboembolic events
  • Hypertension
  • Posterior reversible encephalopathy syndrome
  • Gastrointestinal perforation and fistulae
  • Surgery and wound healing complication
  • Hemorrhage
  • Arterial thromboembolic events
  • Renal injury & Proteinuria
  • Infusion reactions
  • Ovarian failure
  • Congestive heart failure
  • Neutropenia,
  • Mucosal inflammation,
  • Infection,
  • Neuropathy,
  • Epistaxis,
  • Erythrodysesthesia

Drug interaction

While concomitant use of Bevacirel with paclitaxel & carboplatin, causes reduces in exposure of paclitaxel after four cycles of therapy

While getting patients with paclitaxel & carboplatin leads to raises the paclitaxel exposure at day 6

Contraindication

No contraindication occurred

Precautions

Caution with use in the conditions like

Surgery and wound healing complications observes while Administration may result in the development of fatal wound dehiscence. Discontinue treatment in patients with wound dehiscence requiring medical intervention.

Serious or lethal hemorrhage, haemoptysis, gastrointestinal bleeding, hematemesis, CNS hemorrhage, and vaginal bleeding are increased in bevacizumab-treated patients. Do not administer the drug along with severe hemorrhage.

Severe, sometimes lethal, arterial thromboembolic events (ATE) involving cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and a variety of other ATE; discontinue bevacizumab for severe ATE

Due Bevacirel may have high relative risk for heart failure has been along with therapy

Advise females of reproductive possible to use active contraception during treatment with and for 6 months after the final dose

Pregnancy

Pregnancy category: D

Bevacirel may cause fetal harm to infants based on findings from animal studies and mechanism of action. The drug produces malformation while using during pregnancy.

Lactation

Excretion into human breast milk is unknown. Breast feeding is also not recommended

Storage

Bevacirel vial should be stored at 2 to 8oC (36 to 46oF)

Single use vial and protect from light

Do not freeze or shake the vial

Missed dose

If patient missed to have the dose or forget the cycle means must consult with oncologist and follow the regular dosing schedule

Do not take overdose. Consult the doctor immediately

  • Trade name Bevacirel
  • Substance Bevacizumab 100mg / 4ml
  • Manufacturer Reliance Life Sciences
  • Packaging 4ml of Bevacizumab containing vial
  • Country of origin India
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