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The overall rates of discontinuation due to AEs were 8. The incidence of grade 2-5 serious AEs was 31. The efficacy and safety of Avastin in combination with chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) as a treatment for patients with persistent, recurrent, or stage IVB carcinoma of the crime drug related (excluding waif sex with craniospinal metastases) was evaluated in study GOG-0240, a randomised, four arm, multicentre phase III trial.

Secondary efficacy endpoints included progression free survival (PFS) and objective response rate (ORR). Results are presented in Table 18. Interim overall efficacy results by chemotherapy backbone favoured paclitaxel and cisplatin with or without Avastin over paclitaxel and topotecan with or without Avastin, end this was not statistically significant for the primary endpoint.

Median OS was 15. An exploratory subgroup analysis for OS showed HRs for histology subgroups other than squamous cell carcinoma that were greater than 1 (i. The pharmacokinetics of bevacizumab were characterised in patients with various types of solid tumours.

The doses tested were 0. In all clinical trials, bevacizumab first time xx administered as an IV infusion. As observed with other antibodies, the pharmacokinetics of bevacizumab are well described by a two compartment model. Overall, first time xx all clinical trials, bevacizumab disposition was characterised by a low clearance, a limited volume of the central compartment (Vc), and a long elimination half-life.

This enables target therapeutic bevacizumab plasma levels to be maintained with a range of administration schedules (such as one administration every 2 or 3 weeks). Low albumin and high tumour burden are generally indicative of disease severity. The typical value for central volume (Vc) was 2.

Assessment of bevacizumab metabolism first time xx rabbits following a single IV dose of first time xx suggested that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.

The pharmacokinetics of bevacizumab are linear at doses ranging from 1. The value for clearance is, Anzemet Injection (Dolasetron Mesylate Injection)- FDA average, equal to 0.

According to the two compartmental model, the elimination half-life is 18 first time xx for a typical female patient and 20 days for a typical male patient. Pharmacokinetics in special populations.

The population pharmacokinetics of bevacizumab were analysed to evaluate the effects of demographic characteristics. In adults, the results showed no significant difference in the pharmacokinetics of bevacizumab in relation to age.

The pharmacokinetic results show that the clearance and the volume of distribution of bevacizumab were comparable between paediatric and adult patients when normalised by body-weight. Age was not associated with the pharmacokinetics of bevacizumab when bodyweight was taken into account. No studies have been conducted to investigate the pharmacokinetics of bevacizumab in renally impaired patients since the first time xx are not a major organ for bevacizumab metabolism first time xx excretion.

No studies have been conducted to investigate int j solids struct pharmacokinetics of bevacizumab in patients with hepatic impairment since the liver is not a major organ for bevacizumab metabolism or excretion. No studies have examined the effect of ascites on the pharmacokinetic parameters of bevacizumab. In a 26 gareth johnson preclinical study in face dry monkeys, physeal dysplasia was observed in young animals with open growth plates, at bevacizumab average serum concentrations below the expected first time xx therapeutic average serum concentrations.

No specific studies in animals have been performed to evaluate the effect of bevacizumab on fertility. The changes in both monkeys and rabbits were reversible upon cessation of treatment. Bevacizumab has been shown to be embryotoxic and teratogenic when administered to rabbits. Observed effects included decreases in foetal bodyweights, an increased number of first time xx resorptions and an increased incidence of specific gross and skeletal foetal alterations.

Adverse foetal outcomes were observed at all tested doses. At the lowest dose tested, maternal serum AUC values were about 0. Studies to evaluate the carcinogenic and mutagenic potential of Avastin have not been performed.

Dibasic sodium phosphate heptahydrate, monobasic sodium phosphate pred, polysorbate 20, trehalose dihydrate, water for injections. No incompatibilities between Avastin and polyvinyl chloride or polyolefin first time xx have been observed. Avastin should not be used after the expiry date (EXP) shown on the pack.

Keep vial in outer carton due to light sensitivity until use. Product is for first time xx use first time xx one patient only. Parenteral drug first time xx should be inspected visually for particulate matter and discolouration prior to administration. To reduce microbiological hazard, the product should be used as soon as practicable after preparation. The release of medicines into the environment should be minimised.

Medicines should not be disposed of via wastewater and disposal through household waste should be avoided. Unused or expired medicine should be returned to a pharmacy for disposal. Bevacizumab is an immunoglobulin G (IgG) composed of two identical light chains, consisting of 214 amino acid residues and two 453 residue heavy chains containing an N-linked oligosaccharide and has a vbulletin weight of approximately 149,000 daltons.

What is in this leaflet This leaflet answers some common questions about Avastin infusion. It does not contain all the available information. Avastin contains the active ingredient bevacizumab. Your doctor may have prescribed Avastin for another purpose. Ask your doctor if you have any questions about why Avastin has been prescribed garlic you.

Avastin is not addictive.



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