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Testtailortreat.com.au

Erbitux®(cetuximab) PSP
for metastatic colorectal cancer (mCRC)
HEALTHCARE PROFESSIONAL INFORMATION
Background
Erbitux® (cetuximab) is approved in Australia for the treatment of epidermal growth receptor (EGFR)-expressing,
K-RAS wild-type metastatic colorectal cancer (mCRC):
• in combination with infusional 5-fluorouracil/folinic acid plus irinotecan
• in combination with irinotecan in patients who are refractory to first-line chemotherapy
• first-line in combination with FOLFOX
• as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and
Erbitux is currently not available via the Pharmaceutical Benefits Scheme (PBS) for the first-line treatment of metastatic colorectal cancer.
In order to facilitate access to Erbitux for first-line treatment of mCRC, Merck Serono Australia has agreed to provide more affordable access to patients who meet the approved indication, but are unable to access Erbitux via the PBS. Please refer to the Erbitux Product Information before prescribing. Merck Serono does not support the use of Erbitux for non-approved indications. Important aspects of the Erbitux Patient Support Program are summarised below: Program details
For approved registrations, Merck Serono Australia will supply the first of every two treatments of Erbitux free of charge.
The cost of the additional treatments of Erbitux will be borne by the patient, hospital or third party provider. The total out-of-pocket cost of Erbitux will be no more than $16,000, after which Merck Serono Australia will provide Erbitux free of charge, until progression of disease or the oncologist or patient deems it is necessary to withdraw. This will be at the discretion of the treating physician. Erbitux supply
In order to facilitate this program, Erbitux will be ordered through, and shipped directly to, your nominated pharmacy for
dispensing. The pharmacy will be charged at the price of $400 per 100 mg/20 mL vial and Merck Serono agrees to supply
the first of every two treatments free of charge. Erbitux must be ordered and purchased directly from Merck Serono
Australia Customer Service.
Please note that there may be additional charges including the preparation of Erbitux by the pharmacy. Merck Serono Australia will not be responsible for any additional fees and charges that may apply to a treatment. Program dates
The supply of Erbitux through the Erbitux Patient Support Program will be available from 1 June 2013 until 31 December
2014. New patient registrations will not be accepted after the program closes, however, Merck Serono Australia reserves
the right to review this at any time.
Should the program be suspended, Merck Serono Australia will honour the agreement to continue supply to all existing patients until progression of disease or when the patient withdraws from treatment. Confidential - To be used for determination of eligible patients for the Erbitux Patient Support Program. For Healthcare Professional only. Not be to distributed to patients Registration
In order to participate, as the treating physician you are required to:
a. Discuss the treatment option and the details of the program with the patient. We have provided you with a patient
b. Provide the patient with a copy of the Erbitux Consumer Medicine Information (CMI) sheet either prior to enrolling the patient or following their enrolment in this program c. Register the patient once the patient has agreed to treatment using the Erbitux Patient Support Program registration form, and acknowledge that you accept the terms and conditions d. Forward a completed and signed copy of the registration form to Merck Serono Australia. Merck Serono Australia will notify you and the nominated pharmacy of the outcome in writing, along with other expected requirements including the management of adverse events. Privacy
Merck Serono acknowledges and agrees that any of the patient’s personal information (as defined in the Privacy Act
1988 (Cth)), disclosed to or collected by Merck Serono, for the purposes of or in connection with the provision, or
otherwise acting pursuant to the Erbitux Patient Support Program, is treated as confidential and will only be collected,
used or disclosed by Merck Serono:
a. in accordance with the Physician agreement of the Erbitux Patient Support Program;
b. in accordance with any applicable Merck Serono privacy policy; and
c. otherwise in compliance with the requirements of the Privacy Act 1988 (Cth).
Merck Serono reserves the right to revise or cease the Erbitux Patient Support Program at their discretion.
For further assistance please contact Merck Serono: Program Information: (02) 8977 4189 PBS Information: Authority required. Refer to PBS Schedule for full authority information.
Please review approved Product Information before prescribing.
Product Information is available from Merck Serono, Ph 1800 633 463.
Erbitux® Minimum PI: Indications: For the treatment of patients with epidermal growth factor receptor (EGFR)-expressing, K-RAS wild-type metastatic colorectal
cancer (mCRC): 1) in combination with: infusional 5-fluorouracil/folinic acid plus irinotecan*, irinotecan in patients who are refractory to first-line chemotherapy* or in first-line with FOLFOX*, 2) as a single agent in patients who have failed or are intolerant to oxaliplatin-based therapy and irinotecan-based therapy. Also for the treatment of patients with squamous cell cancer of the head and neck (SCCHN): 1) in combination with radiation therapy for locally advanced disease, 2) in combination with platinum-based chemotherapy for recurrent and/or metastatic disease. Contraindications: Known severe (grade 3 or 4) hypersensitivity reaction
to cetuximab, mutant or unknown K-RAS mCRC status*. Contraindications for concomitant therapy must be considered. Precautions: Infusion-related reactions;
respiratory disorders; skin reactions; electrolyte disturbances; cardiovascular disorders; eye disorders; mCRC patients with K-RAS mutations or for whom K-RAS status is unknown; combination with capecitabine + irinotecan*; pregnancy Category D; no breast-feeding. Interactions: Increased incidence of specific adverse reactions
in combination with chemo- or radiotherapy (see below). Adverse effects: Very Common: skin reactions, hypomagnesaemia, mild to moderate infusion-related
reactions, mucositis, increased liver enzyme levels. Common: headache, conjunctivitis, diarrhoea, nausea, vomiting, dehydration, hypocalcaemia, anorexia, severe infusion-related reactions, fatigue. The risk of adverse events due to chemotherapy or radiotherapy may be higher when combined with Erbitux: severe leukopenia/ neutropenia, infections and infectious complications (with platinum-based agents); cardiac ischaemia, hand-foot syndrome (with fluoropyrimidines); severe diarrhoea (with capecitabine and oxaliplatin); hypokalaemia (with irinotecan or platinum/fluorouracil); radiation-related effects (with radiotherapy). Dosage: Initial dose 400
mg/m2; subsequent weekly doses 250 mg/m2. Administer intravenously over 120 min for initial dose; 60 min for subsequent doses. Premedicate with antihistamine and corticosteroid for first infusion; recommended for subsequent infusions. Monitor closely during and for at least 1 hour after the end of the infusion. Do not administer chemotherapy agents until at least 1 hour after cetuximab infusion. For mCRC: K-RAS status must be determined prior to first infusion; in combination with chemotherapy or as monotherapy, continue until disease progression. For locally advanced SCCHN: start one week prior to and then use concomitantly with radiation therapy. For recurrent/metastatic SCCHN: in combination with platinum-based chemotherapy agent then as monotherapy until disease progression.
Based on PI dated 14 May 2013* Please note change in Product Information ® Erbitux is a registered Trademark of ImClone LLC used under licence by Merck KGaA, Germany. Sponsor: Merck Serono Australia Pty Ltd, Units 3–4, 25 Frenchs Forest Road East, Frenchs Forest NSW 2086 Australia. PA ONC 07/13 AUS 117. Date of preparation: July 2013. ZEST/MSESY036/0713

Source: https://testtailortreat.com.au/pdfs/ErbituxFirst/mCRC_HCP_InfoSheet.pdf

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PROSPECTO: INFORMACIÓN PARA EL USUARIO Baycip 500 mg comprimidos recubiertos con película Lea todo el prospecto detenidamente antes de empezar a usar el medicamento. • Conserve este prospecto, ya que puede tener que volver a leerlo. • Si tiene alguna duda, consulte a su médico o farmacéutico. • Este medicamento se le ha recetado a usted y no debe dárselo a otras person

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