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F. Hoffmann-La Roche Ltd. ընկերությունը  նախատեսում է  վերանայել   Xeloda® (capecitabine) հակաուռուցքային դեղի  անվտանգության վերաբերյալ տեղեկատվությունը:

Date 16.01.2014

Subject:        Draft Direct Healthcare Professional Communication on the introduction of
warnings and precautions for severe skin reactions with Xeloda® (capecitabine)

 

Dear Healthcare Provider,

Hoffmann-La Roche Ltd. would like to inform you of the following safety information regarding the use of Xeloda® (capecitabine):

 

Summary

·           Very rare cases of severe skin reactions such as Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), in some cases with fatal outcome, have been reported during treatment with Xeloda.

·           Xeloda should be permanently discontinued in patients who experience a severe skin reaction possibly attributable to Xeloda treatment

The information in this letter has been agreed with the European Medicines Agency (EMA) and NCA

Roche is working closely with health authorities to update the product information. Once approved by the health authorities, the revised  Xeloda product information is available on….

Further information on the safety concern and recommendations

Severe skin reactions such as SJS and TEN, in some cases with a fatal outcome, have been reported during treatment with Xeloda.

 The frequency of severe skin reactions such as SJS and TENs is estimated as very rare taking into account the exposure to Xeloda as per April 2013.

 TEN and SJS are considered to represent variants within a continuous spectrum of skin disorders characterized by generalized tender erythematous maculae progressing to blisters and denudation and often preceded by photophobia, symptoms of upper respiratory tract infection and fever. There is significant morbidity and mortality associated with severe skin reactions, especially for SJS and TEN. Morbidity and mortality may be reduced in patients where the suspect drug is stopped early compared to those where the suspect drug is carried on after the development of the blisters. 

 ·           Health care providers should be aware of the potential causality of severe skin reactions and Xeloda treatment and be vigilant regarding such reactions to ensure prompt action and treatment. This includes discontinuation of Xeloda.

 ·           Patients should be informed of the association and be made aware to seek medical advice should any symptoms of severe skin reactions occur

 Other skin reactions seen with Xeloda include

 (Xeloda monotherapy): Palmar-plantar erythrodysaesthesia (hand-foot syndrome) and dermatitis occurs very commonly (> 10%) with capecitabine. Rash, alopecia, erythema and dry skin are common reactions with Xeloda. Pruritus, localized exfoliation, skin hyperpigmentation, photosensitivity reactions and radiation recall syndromes have also been seen with Xeloda treatment.

Therapeutic indications

Xeloda® is indicated for

• The treatment of locally advanced or metastatic breast cancer in combination with docetaxel after failure of cytotoxic therapy of which one must have included an anthracycline.
• The treatment of locally advanced or metastatic breast cancer as monotherapy after failure of a taxane and an anthracycline-containing chemotherapy regimen or for whom further anthracycline therapy is not indicated.
• The adjuvant treatment of patients with colon cancer
• The treatment of patients with metastatic colorectal cancer
• First-line treatment of patients with advanced gastric cancer

 Xeloda® is contraindicated in patients who have:

 Hypersensitivity to capecitabine or to any of its components

• Patents with a history of severe and unexpected reactions to fluoropyrimidine therapy or with a known hypersensitivity to fluorouracil
• Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency
• Concomitant administration with sorivudine or its chemically related analogues; such as brivudine

 

Call for reporting

 Health care professionals should report any serious adverse events suspected to be associated with the use of Xeloda according to national reporting requirements:

 Scientific Center of Drug and Medical Technology Expertise (web site:  www.pharm.am )

 Company contact point

 Should you have any questions or require additional information regarding the use of Xeloda (capecitabine) please feel free to contact 

 Roche product specialist on Xeloda: Beglaryan Diana

 

4.4     Special warnings and precautions for use

…

Severe skin reactions: Xeloda can induce severe skin reactions such as Stevens-Johnson syndrome and Toxic Epidermal Necrolysis. Xeloda should be permanently discontinued in patients who experience a severe skin reaction possibly attributable to Xeloda treatment.

…

4.8     Undesirable effects

 Post-Marketing Experience:

 The following additional serious adverse reactions have been identified during post-marketing exposure:

 …

 Severe Skin Reactions (see section 4.4)

 Very rare: Severe skin reactions such as Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis.