ERBITUX PI PDF

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treated with Erbitux and radiation therapy and in 3% of patients Limitation of Use: Erbitux is not indicated for treatment of K-Ras mutation- positive colorectal. Each mL of solution for infusion contains 5 mg cetuximab. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck. Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck All sections. PI reformatted.

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There are no available data for Erbitux exposure in pregnant women. Estrone sulfate Estrone sulfate may increase the thrombogenic activities of Cetuximab. The risk or severity of adverse effects can be increased when Cetuximab is combined with Natalizumab. Patients received a median of 24 infusions range 1 to [see Clinical Studies The addition of cetuximab to radiation therapy or irinotecan in human tumor xenograft models in mice resulted in an increase in anti-tumor effects compared to radiation therapy or chemotherapy alone.

The pharmacokinetics of cetuximab, in combination with irinotecan, were evaluated in pediatric patients with refractory solid tumors in an open-label, single-arm, dose-finding study. Capromab pendetide The risk or severity of adverse effects can be increased when Cetuximab is combined with Capromab pendetide. Although these studies were not comparative, they provided an important framework for the clinical development of this agent, and warranted its ppi approval both in North America and the EU.

Necitumumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Necitumumab. Cetuximab also enhances radiosensitivity Huang et al Mavrilimumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Mavrilimumab. Erbitux can cause interstitial lung disease ILD. The primary study endpoint was overall survival.

Naptumomab Estafenatox The risk or severity of adverse effects can be increased when Cetuximab is combined with Naptumomab Estafenatox. Cetuximab Targets 12 Biointeractions 1. No overall differences in safety or efficacy were observed between these patients and po patients. Advise patients that the risk of serious infusion reactions may be increased in patients who have had a tick bite or red meat allergy. The risk or severity of adverse effects can be increased when Cetuximab is combined with Amatuximab.

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Erbotux risk or severity of adverse effects can be increased when Cetuximab is combined with Farletuzumab. If you are breastfeeding or plan to breastfeed. Furthermore, several smaller trials in which cetuximab was added to first-line FOLFOX have produced promising results.

Cetuximab in the management of colorectal cancer

The risk or severity of adverse effects pl be increased when Cetuximab is combined with Siplizumab. The risk or severity of adverse effects can be increased when Cetuximab is combined with Bimagrumab.

The risk or severity of adverse effects can be increased when Cetuximab is combined with Conatumumab. Drug Interaction Abciximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Abciximab. Antithymocyte immunoglobulin rabbit The erbktux or severity of adverse effects can be increased when Cetuximab is combined with Antithymocyte immunoglobulin rabbit. U High affinity immunoglobulin gamma Fc receptor I. As an IgG1 antibody, cetuximab may exert its antitumor efficacy through both EGFR antagonism and antibody-dependent cell-mediated cytotoxicity.

In an animal reproduction study, intravenous administration of cetuximab once weekly to pregnant cynomolgus monkeys during the period of organogenesis resulted in an increased incidence of embryolethality and abortion.

The risk or severity of adverse effects can be increased when Cetuximab is combined with Sarilumab. Secukinumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Secukinumab.

Cetuximab in the management of colorectal cancer

Verify pregnancy status in females of reproductive potential prior to initiating Erbitux [see Use in Specific Population 8. Pregnant cynomolgus monkeys were administered cetuximab intravenously once weekly during the period of organogenesis gestation day [GD] at dose levels 0.

Estradiol benzoate Estradiol benzoate may increase the thrombogenic activities of Cetuximab. The value of adding bevacizumab to irinotecan following FOLFOX failure, or continuing bevacizumab therapy after failure of a bevacizumab-containing regimen is not fully established. Monitor patients weekly during treatment for hypomagnesemia, hypocalcemia, and hypokalemia, and for at least 8 weeks following the completion of ERBITUX.

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The risk or severity of adverse effects can be increased when Cetuximab is combined with Human cytomegalovirus immune globulin.

Volociximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Volociximab.

Of particular interest is the benefit derived by patients with liver disease only, whose rates of R0 resectability increased by 3 fold with the addition of cetuximab. U Complement C1s subcomponent. Mirvetuximab Soravtansine The risk or severity of adverse effects can be increased when Cetuximab is combined with Mirvetuximab Soravtansine. Another important aspect in the practical application of cetuximab therapy in mCRC, where the therapeutic goals are palliative, is the assessment of its effect on quality of life.

The risk or severity of adverse effects can be increased when Cetuximab is combined with Edrecolomab. Another outcome measure was overall survival OS. Ongoing studies are also exploring whether the benefits of cetuximab extend earlier in the course of colorectal cancer into the adjuvant and neoadjuvant settings. The risk or severity of adverse effects can be increased when Cetuximab is combined with Ozanezumab.

This regimen has remained the standard whether cetuximab is given in monotherapy or in combination with other agents.

Rash intensity is associated with clinical efficacy, and in the future, may be used as a marker for optimal drug exposure. If chemotherapy was discontinued for adverse reactions, weekly cetuximab as monotherapy could be continued until disease progression or unacceptable toxicity.

Technetium Tcm arcitumomab The risk or severity of adverse effects can be increased when Cetuximab is combined with Technetium Tcm arcitumomab. Daclizumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Daclizumab.

The risk or severity of adverse effects can be increased when Cetuximab is combined with Rilotumumab. Premedicate with a histamine-1 H 1 receptor antagonist as recommended [see Dosage and Administration 2.