Avastin


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bevacizumab

Avastin

Pharmacologic class: Monoclonal antibody

Therapeutic class: Immunologic agent

Pregnancy risk category C

FDA Box Warning

• Drug may cause GI perforation, in some cases leading to death. Include such perforation in differential diagnosis of patients who experience abdominal pain during therapy. Discontinue permanently in patients with GI perforation.

• Drug may lead to potentially fatal wound dehiscence. Discontinue permanently in patients with wound dehiscence requiring medical intervention.

• Serious and, in some cases fatal, hemoptysis has occurred in patients with non-small-cell lung cancer who received chemotherapy and bevacizumab. Don't give to patients with recent hemoptysis.

Action

Binds to vascular endothelial growth factor, preventing or reducing micro-vascular formation and growth and inhibiting metastatic disease progression

Availability

Solution for injection: 25 mg/ml in 4-ml and 16-ml vials

Indications and dosages

First-line treatment of metastatic cancer of colon or rectum (used in combination with 5-fluorouracil [5-FU]-based chemotherapy)

Adults: 5 mg/kg I.V. infusion q 14 days until disease progression occurs when used with 5-FU, irinotecan, and leucovorin or 10 mg/kg I.V. infusion q 14 days until disease progression occurs when used with 5-FU, oxaliplatin, and leucovorin

Unresectable, locally advanced, recurrent or metastatic nonsquamous, non-small-cell lung cancer

Adults: 15 mg/kg I.V. infusion q 3 weeks

Contraindications

None

Precautions

Use cautiously in:

• hypersensitivity to drug

• cardiovascular disease

• development of immunogenicity

• patients sensitive to infusion reactions

• patients recovering from major surgery, nongastrointestinal fistula

• recent history of hemoptysis (Don't administer drug.)

• patients with proteinuria

• elderly patients

• pregnant or breastfeeding patients

• children.

Administration

• Withdraw necessary amount to obtain required dose, and dilute in 100 ml of 0.9% sodium chloride injection.

Don't mix or administer drug with dextrose solutions.

Don't deliver by I.V. push or bolus.

• Initially, infuse drug over 90 minutes. If patient tolerates infusion well, infuse over 60 minutes the second time; if he continues to tolerate it well, infuse each dose over 30 minutes thereafter.

Withhold dose if hypertension occurs.

Stop infusion if patient develops infusion reaction, hypertensive crisis, severe bleeding, abdominal pain (may signal intra-abdominal abscess or GI perforation), wound dehiscence, or urinary problems.

• Be aware that drug shouldn't be given within 28 days after major surgery and that therapy should be suspended several weeks before elective surgery.

Adverse reactions

CNS: asthenia, dizziness, headache, confusion, syncope, abnormal gait, transient ischemia attack, reversible leukoencephalopathy syndrome, cerebral infarction

CV: hypotension, hypertension, angina, hypertensive crisis, heart failure, deep-vein thrombosis, intraabdominal thrombosis, thromboembolism, MI

EENT: excess lacrimation, visual disturbances, rhinitis, severe epistaxis

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, stomatitis, dyspepsia, flatulence, colitis, dry mouth, anorexia, GI perforation, intra-abdominal abscess, rectal hemorrhage

GU: proteinuria, urinary frequency or urgency, nephrotic syndrome

Hematologic: leukopenia, neutropenia, hemorrhage

Hepatic: bilirubinemia

Metabolic: hypokalemia, hyponatremia

Musculoskeletal: myalgia, back pain

Respiratory: upper respiratory tract infection, dyspnea, massive hemoptysis

Skin: wound-healing complications, dry skin, exfoliative dermatitis, wound dehiscence

Other: abnormal taste, altered voice, pain, weight loss, infusion reaction

Interactions

Drug-drug. Irinotecan: increased concentration of irinotecan metabolite

Drug-diagnostic tests. Leukocytes, potassium, sodium: decreased levels Urine protein: increased level

Patient monitoring

Monitor patient closely and discontinue drug if signs and symptoms of thromboembolism and GI perforation (such as abdominal pain, vomiting, and constipation), serious bleeding, nephrotic syndrome, or hypertensive crisis develops.

Stay alert for and discontinue drug if nongastrointestinal fistula formation, delayed wound healing, or wound dehiscence requiring medical intervention occurs.

Stay alert for and discontinue drug if signs and symptoms of leukoencephalopathy occur (such as headache, seizures, lethargy, confusion, or blindness).

• Assess blood pressure frequently.

• Monitor CBC with differential and urine protein and serum electrolyte levels.

Patient teaching

Tell patient to call prescriber immediately if he experiences dizziness, severe bleeding, stomach pain, or urinary problems or if a wound opens.

• Instruct patient to tell prescriber if he has been exposed to chickenpox or if he has gout, heart disease, viral infection, urinary problems, hepatic disease, or another form of cancer.

• Advise patient to tell prescriber if he has surgery planned; drug may delay wound healing.

• Caution patient not to get immunizations unless prescriber approves.

• Inform female patients of childbearing potential risk of ovarian failure before starting drug.

• Instruct female patient to tell prescriber if she is pregnant, plans to become pregnant, or is breast-feeding.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

Avastin

(ā′văs′tn)
n.
A trademark for the drug bevacizumab.

bevacizumab

A humanised monoclonal antibody which inhibits vascular endothelial growth factor (VEGF) which has anti-angiogenic effects, and is used to treat colorectal, lung and kidney cancers, as well as glioblastomas. It is not FDA-approved for managing breast cancer.

Adverse effects
Hypertension, haemorrhage.
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We are delighted that Avastin is now available to women across the country."
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