Pemetrexed 25mg/ml Concentrate for solution for Infusion - particulates in small number of vials

Caduceus Pharma Ltd., Pemetrexed 25mg/ml Concentrate for solution for Infusion: caution in use after particulates identified in a small number of vials (EL (16)A/09)

16 June 2016

Class 4 medicines information - Caution in use for all strengths and all batches

Hospital pharmacy level

MDR 81-05/16

Product information

EL number

EL (16)A/09

Company name

Actavis UK Ltd on behalf of the Marketing Authorisation holder, Caduceus Pharma Ltd.

Product description

Pemetrexed 25mg/ml Concentrate for solution for Infusion. 100mg in 4ml; 500mg in 20ml; 1000mg in 40ml PL 24668/0187

Brief description of the problem

Actavis UK Ltd on behalf of the Marketing Authorisation holder, Caduceus Pharma Ltd, has informed us that particulates have been identified in a small number of vials of Pemetrexed 100mg and 500mg vials following an investigation of some product complaints.

The particulates have been identified as Cystine, the oxidation product of one of the excipients in the product, Cysteine. Further investigation of affected vials has shown that all other parameters of the Finished Product Specification, including assay, complied with the required specification.

In order to avoid shortages of the product, affected batches are not being recalled. Since the root cause has not as yet been identified, Actavis is advising that the following precautions should be taken when administering any batch and any strength of the product:

  • The product should be inspected visually prior to use for particulates and discolouration. Any affected vials should be discarded. This reiterates the advice already given in the SPC.

  • Diluted product should be administered via an in-line filter with a microporous membrane of ≤ 0.22 µm.

Further information

For medical information enquiries, please contact Actavis Medical Information Department on 01271 385257

For information on product availability, please contact Actavis Customer Service Team on 0800 373573

Recipients of this Drug Alert should bring it to the attention of relevant contacts by copy of this letter.

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Actavis UK Ltd - Pemetrexed 25mg/ml Concentrate for solution for Infusion (EL(16)A/09)

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