Bevacizumab

Trade Names:
Avastin
- Injection 25 mg/mL

Pharmacology

User Reviews & Ratings As a treatment for... Avg User Ratings [?] Macular Degeneration 0 reviews Rate it! 9.0 Pancreatic Cancer 1 reviews Rate it! 9.0 Breast Cancer, Metastatic 1 reviews Rate it! 9.0 Showing 3 of 9 conditions - Show All... Compare with other drugs.

Binds to vascular endothelial growth factor, interfering with endothelial cell proliferation.

Pharmacokinetics

Absorption

Time to reach steady state is predicted to be 100 days.

Elimination

Estimated t _½ is approximately 20 days.

Special Populations

No pharmacokinetic studies have been conducted in patients with renal function impairment.

No pharmacokinetic studies have been conducted in patients with hepatic function impairment.

Demographic data suggest that no dosage adjustments are needed for age.

Demographic data suggest that no dosage adjustments are needed for gender.

Indications and Usage

In combination with IV 5-fluorouracil (5-FU)–based chemotherapy as first- or second-line treatment of metastatic carcinoma of the colon or rectum. In combination with carboplatin and paclitaxel as first-line treatment of unresectable, locally advanced, recurrent or metastatic nonsquamous non–small cell lung cancer. In combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic human epidermal growth factor receptor 2 (HER2)–negative breast cancer.

Unlabeled Uses

In combination with erlotinib to treat metastatic renal cell carcinoma.

Contraindications

Standard considerations.

Dosage and Administration

IV 10 mg/kg every 14 days.

IV 5 or 10 mg/kg every 14 days in combination with IV 5-FU–based chemotherapy. The recommended dosage is 5 mg/kg every 14 days when administered with irinotecan/5-FU/leucovorin, and 10 mg/kg every 14 days when administered with 5-FU/leucovorin/oxaliplatin.

IV The recommended dosage is 15 mg/kg every 21 days.

General Advice

• For IV infusion only. Not for intradermal, subcutaneous, IM, or IV push or bolus administration.
• Administer diluted solution immediately after reconstitution; if necessary, store for up to 8 h under refrigeration (36° to 46°F).
• Do not administer or mix bevacizumab with dextrose solutions.
• Administer first dose via IV infusion over 90 min following chemotherapy. If first infusion is well tolerated, second infusion may be administered over 60 min. If the 60-min infusion is well tolerated, subsequent infusions may be administered over 30 min.
• Discard any unused solution. Do not save for future administration.

Storage/Stability

Store vials in refrigerator (36° to 46°F) in original carton until time of use. Protect from light and freezing. Do not shake vials.

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

The following adverse reactions were reported with combined use of bevacizumab and 5-FU/irinotecan/leucovorin, 5-FU/leucovorin/oxaliplatin, or carboplatin/paclitaxel based regimens.

Cardiovascular

Hypertension (60%); hypotension (15%); deep vein thrombosis (9%); venous thrombus/embolism (5%); cerebrovascular ischemia, intra-abdominal thrombosis, syncope (3%); fatal MI.

CNS

Dizziness, headache (26%); sensory neuropathy (24%); fatigue (19%); neurologic disorders (5%).

Dermatologic

Alopecia (32%); skin ulcer (6%); rash/desquamation (3%).

EENT

Nasal septum perforation.

GI

Abdominal pain (61%); vomiting (52%); anorexia (43%); constipation (40%); diarrhea (34%); stomatitis (32%); dyspepsia, GI hemorrhage (24%); taste disorder (21%); nausea (12%); dry mouth (7%); colitis (6%); ileus (4%); anastomotic ulceration, death due to GI perforation, intestinal necrosis, mesenteric venous occlusion.

Genitourinary

Proteinuria (36%).

Hematologic-Lymphatic

Leukopenia (37%); neutropenia (27%); neutrophils (6%); febrile neutropenia, hemorrhage, thrombocytopenia (5%); infection with neutropenia (4%); microangiopathic hemolytic anemia; pancytopenia.

Metabolic-Nutritional

Weight loss (16%); dehydration (10%); hyponatremia (4%).

Musculoskeletal

Bone pain (4%).

Respiratory

Upper respiratory tract infection (47%); epistaxis (35%); dyspnea (26%); voice alteration (9%); pneumonitis/pulmonary infiltrates (5%); pulmonary hypertension.

Miscellaneous

Pain (62%); asthenia (10%); infection without neutropenia (9%); infection with unknown absolute neutrophil count (3%); death associated with combined constipation, diarrhea, hypotension, pain, and weakness; polyserositis.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Several studies indicate that patients 65 yr of age and older may have a greater relative risk for adverse reactions (eg, ileus, nausea, proteinuria) compared with younger patients.

Hypersensitivity

Use with caution in patients with known hypersensitivity to any component of the product.

Arterial thrombotic events

Arterial thrombotic events, including cerebral infarction, transient ischemic attacks, MI, and angina, have occurred. Permanently discontinue therapy in patients who experience a severe arterial thromboembolic event during therapy.

CHF

Risk of developing CHF may be increased compared with administration of other chemotherapy alone. The safety of continuation or resumption of bevacizumab in patients with cardiac dysfunction has not been studied.

CV disease

Incidence of CV thromboembolic events and fatal arterial thromboembolic events were greater in patients receiving bevacizumab plus chemotherapy compared with chemotherapy alone.

Hypertension

Temporarily suspend therapy in patients who develop severe hypertension (greater than 200/110 mm Hg) that is not controlled with medical management. Permanently discontinue therapy in patients who develop hypertensive crisis.

Immunogenicity

As with other proteins, immunogenicity may occur.

Infusion reactions

Interrupt therapy in cases of severe infusion reactions (eg, chest pain, hypertensive crisis).

Nephrotic syndrome

May occur. Discontinue bevacizumab in patients with nephrotic syndrome.

Neutropenia and infection

Severe neutropenia, febrile neutropenia, and infection with severe neutropenia can occur with concurrent myelosuppressive chemotherapy.

Non-GI fistula formation

Biliary, bladder, bronchopleural, tracheoesophageal, and vaginal fistula formation have been reported.

Proteinuria

Risk of developing proteinuria may be increased compared with administration of 5-FU alone. Temporarily suspend therapy in patient who develops moderate to severe proteinuria pending further evaluation.

Reversible posterior leukoencephalopathy syndrome

Has been reported and can present as blindness (and other visual disturbances), confusion, headache, lethargy, neurologic disturbances, and seizures.

Surgery

Do not initiate therapy for at least 28 days following major surgery and until complete healing of the surgical incision has occurred. Because of potential for impaired wound healing, suspend bevacizumab therapy several weeks prior to elective surgery.

Overdosage

Symptoms

Severe headache.

Patient Information

• Advise patient or caregiver that medication will be prepared and administered by a health care provider in a health care setting.
• Advise patient or caregiver that medication will be administered in combination with other chemotherapy medications.
• Advise family or caregiver to report any of the following to health care provider: coughing up blood; injection-site reaction; rash, itching, or hives; stomach pain in association with constipation and/or vomiting; swelling of the face, lips, eyes, or tongue; wheezing, shortness of breath, or difficulty breathing; any other unusual or unexplained feelings or symptoms.
• Advise women of childbearing potential to use effective contraception during and for at least 3 mo following treatment.

Link to Page

Print Page

Email Page

Add to List