ERBITUX PI PDF

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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Enrollment to this study, however, could not be completed due to the fast adoption of bevacizumab as a component of first-line therapy. Therefore, the improvement in overall activity seen with cetuximab in erbktux studies was accompanied by better maintenance of quality of life. Accordingly, cetuximab — frbitux with 5-FU, irinotecan, oxaliplatin, and bevacizumab — has emerged as one of the basic agents needed in overall mCRC management.

Olaratumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Olaratumab. Interstitial pneumonitis with non-cardiogenic pulmonary edema resulting in death was reported in one case.

The risk or severity of adverse pl can be increased when Cetuximab is combined with Naptumomab Estafenatox. As additional clinical results become available, the role of cetuximab in management of mCRC as well as in earlier stages of disease should be more clearly understood.

The risk or severity of adverse effects can be increased when Cetuximab is combined with Idarucizumab. Polatuzumab Vedotin The risk or severity of adverse effects can be increased when Cetuximab is combined with Polatuzumab Vedotin. Emibetuzumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Emibetuzumab.

From the bench to the bedside: Finally, in these studies, the degree of EGFR expression — whether defined by the percentage of EGFR-expressing cells or by the maximal staining intensity per cell — did not correlate with the clinical activity of cetuximab Cunningham et al ; Lenz et al Monitor serum electrolytes, including serum magnesium, potassium, and calcium, during and after Erbitux [see Warnings and Precautions 5.

Cetuximab has clinically emerged as a core agent, along with 5-fluorouracil, irinotecan, oxaliplatin, and bevacizumab, for overall mCRC management to optimize survival. Ustekinumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Ustekinumab. Monitor patients receiving Erbitux for dermatologic toxicities and infectious sequelae.

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

The risk or severity of adverse effects can be increased when Cetuximab is combined with Evolocumab. Magnesium homeostasis and clinical disorders of magnesium deficiency. Fanolesomab The risk or severity of adverse effects can be increased when Cetuximab is combined with Fanolesomab.

Epimestrol Epimestrol may increase the thrombogenic activities of Cetuximab. Results of the planned PFS and ORR analysis in all randomized patients and post-hoc PFS and ORR analysis in subgroups of patients defined by K-Ras mutation status, and post-hoc analysis of updated OS based on additional follow-up events in all randomized patients and in subgroups of patients defined by K-Ras mutation status are presented in Table 8 and Figure 2.

Acneiform rash usually developed within the first 2 weeks of therapy; the rash lasted more than 28 days after stopping ERBITUX in most patients.

Building upon the effectiveness of cetuximab in refractory mCRC, several studies have also been conducted to explore whether adding cetuximab to first-line therapy would improve patient outcome Table 2. For these reasons, comparison of the incidence of antibodies to cetuximab in the studies below with the incidence of antibodies to cetuximab in other studies or to other products may be misleading.

Amatuximab The risk or severity of adverse effects can be increased when Cetuximab is combined with Amatuximab. Concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in advanced non-small cell lung cancer NSCLC: The risk or severity of adverse effects can be increased when Cetuximab is combined with Inotuzumab ozogamicin.

Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. Acquired resistance to erbifux antitumor effect of epidermal growth factor receptor-blocking antibodies in vivo: Advise patients to notify their healthcare provider of any sign pj acne-like rash, which can include itchy, dry, scaly, or cracking skin and inflammation, infection or swelling at the base of the nails or loss of the nailsconjunctivitis, blepharitis, or decreased vision [see Warnings and Erbigux 5.

Leucovorin and fluorouracil with or without oxaliplatin as first-line treatment in advanced colorectal cancer.

Cetuximab in the management of colorectal cancer

The risk or severity of adverse effects can be increased when Cetuximab is combined with Fulranumab. Replete electrolytes as necessary. 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.

Because cetuximab enhances the efficacy of chemotherapy, it may be possible to justify a break in chemotherapy for those who respond to treatment while continuing maintenance therapy with cetuximab or another biologic, an approach currently under investigation. Monitor patients for at least 1 hour following each ERBITUX infusion in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis.

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Additional studies are needed to better define the clinical significance of ADCC to the efficacy of cetuximab. Ficlatuzumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Ficlatuzumab. Fontolizumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Fontolizumab.

However, because of its long elimination half-life — 4—5 days at steady-state ERBITUX PI — it is possible to administer cetuximab every 2 weeks and thereby improve patient convenience. If you become pregnant during your treatment or within 2 months after your last dose, discuss this with your doctor.

Overall survival of patients with advanced colorectal cancer correlates with availability of fluorouracil, irinotecan, and oxaliplatin regardless of whether doublet or single-agent therapy is used first line [letter] J Clin Oncol.

In the Erbitux with irinotecan arm, irinotecan was added to Erbitux using the same dosage for irinotecan as the patient had previously failed. Irinotecan combined with fluorouracil compared with fluorouracil alone as first-line treatment for metastatic colorectal cancer: The risk or severity of adverse effects can be increased when Cetuximab is combined with Visilizumab. The risk or severity of adverse effects can be increased when Cetuximab is combined with Tanezumab.

Sibrotuzumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Sibrotuzumab. The observed toxicities were consistent with those of the individual agents, with no evidence that adding bevacizumab enhanced toxicity. Print this page Add to My Med List.

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U Low affinity immunoglobulin gamma Fc region receptor II-a. Gantenerumab The risk or severity of adverse effects can be increased when Cetuximab is combined with Gantenerumab.

Promotes phagocytosis of opsonized The risk or severity of adverse effects can be increased when Cetuximab is combined with Reslizumab.

Severe infusion reactions occurred in 7 patients 1. Bavituximab The risk or severity of adverse effects can be increased when Erbituz is combined with Bavituximab.