1 Answers
Bevastim IV Infusion contains Bevacizumab
Bevastim IV Infusion side effects
Most common adverse reactions incidence (> 10% and at least twice the control arm rate) are epistaxis, headache, hypertension, rhinitis, proteinuria, taste alteration, dry skin, rectal hemorrhage, lacrimation disorder, back pain and exfoliative dermatitis. Some of the adverse reactions are commonly seen with chemotherapy; however, Bevacizumab may exacerbate these reactions when combined with chemotherapeutic agents. Examples include palmar-plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine peripheral sensory neuropathy with paclitaxel or oxaliplatin, and nail disorders or alopecia with paclitaxel.
Perforation or Fistula: Bevacizumab should be discontinued if perforation or fistula occurs.
Arterial Thromboembolic Events (e.g., myocardial infarction, cerebral infarction): Bevacizumab should be discontinued for severe ATE.
Venous Thromboembolic Events: Bevacizumab should be discontinued for life-threatening VTEHypertension: Monitor blood pressure and treat hypertension. Temporarily suspend Avastin if not medically controlled. Bevacizumab should be discontinued for hypertensive crisis or hypertensive encephalopathy
Posterior Reversible Encephalopathy Syndrome (PRES): Bevacizumab should be discontinuedProteinuria: Urine protein should be monitored. Bevacizumab should be discontinued for nephrotic syndrome. Bevacizumab should be temporarily discontinued for moderate proteinuria.
Infusion Reactions: Bevacizumab should be stopped in case of severe infusion reactions.
Embryo-fetal Toxicity: Females should be advised of the potential risk to a fetus and the need for use of effective contraception
Ovarian Failure: Females should be advised of the potential risk
A drug interaction study was performed in which irinotecan was administered as part of the FOLFIRI regimen with or without Bevacizumab. The results demonstrated no significant effect of Bevacizumab on the pharmacokinetics of irinotecan or its active metabolite SN38.
In a randomized study in 99 patients with NSCLC, based on limited data, there did not appear to be a difference in the mean exposure of either carboplatin or paclitaxel when each was administered alone or in combination with Bevacizumab. However, 3 of the 8 patients receiving Bevacizumab plus paclitaxel/carboplatin had substantially lower paclitaxel exposure after four cycles of treatment (at Day 63) than those at Day 0, while patients receiving paclitaxel/carboplatin without Bevacizumab had a greater paclitaxel exposure at Day 63 than at Day 0.
Bevacizumab may cause fetal harm based on findings from animal studies and the drug’s mechanism of action. Pregnant women should be advised of the potential risk to a fetus.
No data are available regarding the presence of Bevacizumab in human milk, the effects on the breast fed infant, or the effects on milk production. Because of the potential for serious adverse reactions in breastfed infants from Bevacizumab, nursing woman should be advised that breastfeeding is not recommended during treatment with Bevacizumab.
Pediatric UseSafety and effectiveness of Bevacizumab have not been established in pediatric patients.
There are no contraindications listed in the manufacturer’s labeling.
The safety, effectiveness and pharmacokinetic profile of Bevacizumab in pediatric patients have not been established. In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years who have received Bevacizumab. Bevacizumab is not approved for use in patients under the age of 18 years.
Antitumor activity was not observed among eight children with relapsed glioblastoma treated with Bevacizumab and irinotecan. There is insufficient information to determine the safety and efficacy of Bevacizumab in children with glioblastoma.
A drug interaction study was performed in which Irinotecan was administered as part of the FOLFIRI regimen with or without Bevacizumab. The results demonstrated no significant effect of Bevacizumab on the pharmacokinetics of Irinotecan or its active metabolite SN38.
Read more here Bevastim