Versavo

Versavo

bevacizumab

Manufacturer:

Dr. Reddy's

Distributor:

Zuellig Pharma

Marketer:

Dr. Reddy's
Concise Prescribing Info
Contents
Bevacizumab
Indications/Uses
Metastatic CRC (mCRC): In combination w/ fluoropyrimidine-based chemotherapy as treatment for metastatic carcinoma of colon or rectum. Locally recurrent or metastatic breast cancer (mBC): 1st-line treatment for locally recurrent or metastatic breast cancer in combination w/ standard cytotoxic chemotherapy. In combination w/ taxanes, capecitabine or gemcitabine for treatment of metastatic breast cancer after failure of 1st-line cytotoxic chemotherapy. Advanced, metastatic, or recurrent NSCLC: In combination w/ platinum-based chemotherapy for 1st-line treatment of unresectable metastatic or recurrent non-squamous NSCLC. In combination w/ erlotinib for 1st-line treatment of unresectable advanced metastatic or recurrent non-squamous NSCLC w/ epidermal growth factor receptor (EGFR) activating mutations. Advanced &/or metastatic renal cell cancer (mRCC): In combination w/ interferon α-2a for 1st-line treatment. Malignant glioma (WHO Grade IV)-glioblastoma: In combination w/ RT & temozolomide for adults w/ newly diagnosed glioblastoma. Monotherapy or in combination w/ irinotecan for treatment of glioblastoma after relapse or disease progression. Epithelial ovarian, fallopian tube & primary peritoneal cancer: In combination w/ carboplatin & paclitaxel for front-line treatment of advanced (FIGO stage III B, III C & IV) epithelial ovarian, fallopian tube, or primary peritoneal cancer. In combination w/ carboplatin & gemcitabine, or carboplatin & paclitaxel for treatment of 1st recurrent, platinum-sensitive, epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received chemotherapy in recurrent setting & not received prior Bevacizumab treatment. In combination w/ paclitaxel, topotecan or pegylated lipos doxorubicin for treatment of recurrent, platinum-resistant epithelial ovarian, fallopian tube & primary peritoneal cancer, who received no >2 prior chemotherapy regimens. Cervical cancer: In combination w/ paclitaxel & cisplatin, or paclitaxel & topotecan for treatment of persistent, recurrent, or metastatic carcinoma of cervix.
Dosage/Direction for Use
IV infusion Initial dose should be delivered over 90 min. If well tolerated 2nd infusion may be administered over 60 min. Subsequent infusions may be administered over 30 min if 60-min infusion is well tolerated. Metastatic colon & rectal cancer (rectum or anus) 1st-line treatment: 5 mg/kg once every 2 wk or 7.5 mg/kg once every 3 wk. 2nd-line treatment: 5 mg/kg or 10 mg/kg once every 2 wk or 7.5 mg/kg or 15 mg/kg once every 3 wk. Continue treatment until progression of underlying disease. Patients previously treated w/ Bevacizumab Continue w/ treatment following 1st progression. Locally recurrent or metastatic Breast Cancer (mBC) 10 mg/kg once every 2 wk, or 15 mg/kg once every 3 wk. Continue treatment until progression of underlying disease. Advanced, metastatic, or recurrent NSCLC 1st-line treatment in combination w/ cisplatin-based chemotherapy: 7.5 mg/kg once every 3 wk; w/ carboplatin-based chemotherapy: 15 mg/kg once every 3 wk. 1st-line treatment of NSCLC w/ EGFR activating mutations in combination w/ erlotinib: 15 mg/kg once every 3 wk, continued until disease progression. Advanced &/or metastatic Renal Cell Cancer (mRCC) 10 mg/kg once every 2 wk, continued until progression of underlying disease. Glioblastoma [malignant glioma (WHO grade IV)] Newly diagnosed: 10 mg/kg once every 2 wk in combination w/ temozolomide & RT for 6 wk. Following 4-wk treatment break, re-initiate (10 mg/kg once every 2 wk) in combination w/ temozolomide for up to 6 cycles of 4-wk duration. Continue treatment (15 mg/kg once every 3 wk) as single agent until disease progression after administration of up to 6 cycles of combined bevacizumab & temozolomide. Treatment of recurrent disease: 10 mg/kg once every 2 wk, or 15 mg/kg once every 3 wk. Continue treatment until progression of underlying disease. Epithelial ovarian, fallopian tube & primary peritoneal cancer Front-line treatment: 15 mg/kg once every 3 wk in addition to carboplatin & paclitaxel for up to 6 cycles followed by continued use of bevacizumab as single agent for 15 mth or until disease progression, whichever come earlier. Treatment of recurrent disease: Platinum-sensitive: 15 mg/kg once every 3 wk in combination w/ carboplatin & paclitaxel for 6 cycles & up to 8 cycles; alternately, 15 mg/kg every 3 wk in combination w/ carboplatin & gemcitabine for 6 cycles & up to 10 cycles followed by continued use of Bevacizumab as single agent until disease progression. Platinum resistant: 10 mg/kg once every 2 wk in combination w/ 1 of the following agents: Paclitaxel, topotecan (given wkly) or pegylated lipos doxorubicin. Alternatively, administer 15 mg/kg every 3 wk in combination w/ topotecan on days 1-5, every 3 wk. Continue treatment until disease progression. Cervical cancer In combination w/ one of the following: Paclitaxel & cisplatin or paclitaxel & topotecan: 15 mg/kg once every 3 wk. Continue treatment until progression of underlying disease.
Contraindications
Hypersensitivity to bevacizumab & Chinese hamster ovary cell products or other recombinant human or humanised Abs.
Special Precautions
Not to be initiated for at least 28 days following major surgery or until surgical wound is fully healed. Withhold until wound is fully healed & for elective surgery. Monitor for signs & symptoms of CNS bleeding. Closely monitor thromboembolic events ≤Grade 3. Adequately control pre-existing HTN before starting treatment. Not for intravitreal use. Permanently discontinue treatment in patient who develop GI perforation & arterial thromboembolic events, experience Grade 3 or 4 bleeding; w/ tracheoesophageal fistulae (TE) or any Grade 4 fistulae; if medically significant HTN is inadequately controlled w/ antihypertensive therapy, or patient develops hypertensive crisis or encephalopathy; in the event of nephrotic syndrome. Discontinue treatment in patients w/ life-threatening (Grade 4) venous thromboembolic events, including pulmonary embolism; in cases of intracranial bleeding; who develop necrotizing fasciitis & posterior reversible encephalopathy syndrome (PRES); if hypersensitivity reactions occur. Increased risk of development of GI perforation; fistulae; fistulae between vagina & any parts of GI tract for patients treated for persistent, recurrent, or metastatic cervical cancer; bleeding, developing arterial thromboembolism events during therapy in patients treated w/ chemotherapy w/ history of arterial thromboembolism, diabetes, or >65 yr; venous thromboembolic events in patients treated for persistent, recurrent, or metastatic cervical cancer. Increased incidence of HTN; arterial thromboembolism events. Increased rates of severe neutropenia, febrile neutropenia, or infection w/ severe neutropenia (including some fatalities) in patients treated w/ some myelotoxic chemotherapy regimens. Patients w/ congenital bleeding diathesis acquired coagulopathy or receiving full dose of anticoagulants; recent pulmonary hemorrhage/hemoptysis; clinically significant CV disease eg, pre-existing CAD or CHF. Individual cases & clusters of serious ocular adverse events. May adversely affect the wound healing process. Monitor BP during therapy. May affect ability to drive & use machines. Renal & hepatic impairment. May impair female fertility. Women of childbearing potential should be advised of fertility preservation strategies prior to treatment; use appropriate contraceptive measures during treatment, & contraceptive measures for at least 6 mth following last dose of treatment. Not to be administered during pregnancy. Discontinue nursing during, & not to breastfeed for at least 6 mth after last dose of treatment. Not to be used in childn & adolescents <18 yr.
Adverse Reactions
Paronychia; febrile neutropenia, leucopenia, neutropenia, thrombocytopenia; anorexia, hypomagnesemia, hyponatremia; peripheral sensory neuropathy, dysgeusia, headache, dysarthria; eye disorder, increased lacrimation; HTN; dyspnea, epistaxis, rhinitis, cough; diarrhea, nausea, vomiting, abdominal pain, constipation, stomatitis, rectal hemorrhage; ovarian failure; exfoliative dermatitis, dry skin, skin discoloration; arthralgia; proteinuria; asthenia, fatigue, pyrexia, pain, mucosal inflammation; decreased wt. Sepsis, abscess, cellulitis, infection; anemia, lymphopenia; dehydration; CVA, syncope, somnolence; congestive cardiac failure, supraventricular tachycardia; arterial thromboembolism, DVT, hemorrhage; pulmonary embolism, hypoxia; ileus, intestinal perforation & obstruction, recto-vag fistulae, GI disorders, proctalgia; palmar-plantar erythrodysaesthesia syndrome; muscular weakness, myalgia, back pain; UTI; lethargy; pelvic pain.
Drug Interactions
Microangiopathic hemolytic anemia may occur w/ sunitinib malate.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01FG01 - bevacizumab ; Belongs to the class of VEGF/VEGFR (Vascular Endothelial Growth Factor) inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Versavo conc for soln for infusion 100 mg/4 mL
Packing/Price
1's
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