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Alimta Summary of Product Characteristics (SmPC)
Alimta (pemetrexed): Stability of Reconstituted Vials
Reconstituted vials and diluted infusion solutions of pemetrexed are stable for up to 24 hours when stored under refrigeration 2°C to 8°C.
is physically incompatible with diluents containing calcium,
including lactated Ringer’s injection and Ringer’s
injection. In the absence of other compatibility studies this
medicinal product must not be mixed with other medicinal products
(Alimta Summary of Product Characteristics [SPC]).
and Stability After Reconstitution or Dilution
prepared as directed, reconstituted and infusion solutions of Alimta
contain no antimicrobial preservatives. Chemical and physical in-use
stability of reconstituted and infusion solutions of pemetrexed were
demonstrated for 24 hours at refrigerated temperature. From a
microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and
conditions prior to use are the responsibility of the user and would
not be longer than 24 hours at 2°C to 8°C (Alimta SPC).
chemical stability is unaffected, a substantial amount of
microparticulates may form if pemetrexed diluted in infusion
solutions is stored under refrigeration in polyvinyl chloride (PVC)
bags for longer than 24 hours (Zhang, 2006a). Therefore, storage
should be limited to the manufacturer-recommended 24 hours under
refrigeration (Alimta SPC).
a stability study demonstrated that mixed solutions of pemetrexed
were physically and chemically stable when stored in polypropylene
syringes for 2 days at room temperature and for 31 days
under refrigeration, this study did not address bacteriologic
concerns (Zhang, 2005). Therefore, storage should be limited to the
manufacturer-recommended 24 hours under refrigeration (Alimta
Instability of Frozen Solutions
chemically stable, freezing of pemetrexed admixtures in PVC bags
should be avoided due to the large number of microparticulates
formed. Therefore, previously frozen pemetrexed solutions should not
be used (Zhang, 2006b).
EU Summary of Product Characteristics. Utrecht, The Netherlands: Eli
Lilly and Company Limited.
Y, Trissel LA. Physical and chemical stability of pemetrexed
solutions in plastic syringes. Ann Pharmacother.
Y, Trissel LA. Physical and chemical stability of pemetrexed in
infusion solutions. Ann Pharmacother. 2006a;40(6):1082-1085.
Y, Trissel LA. Physical instability of frozen pemetrexed solutions in
PVC bags. Ann Pharmacother. 2006b;40(7-8):1289-1292.
Date of Last Review:December 11, 2017
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