Alimta ® (pemetrexed for injection)

This information is intended for UK registered healthcare professionals only as a scientific exchange in response to your search for information. Please refer to the link for full prescribing information: 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.

Diluent

Pemetrexed 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]).


Storage and Stability After Reconstitution or Dilution

Label Recommendations

When 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).

PVC Bags

Although 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).

Polypropylene Syringes

Although 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 SPC).

Physical Instability of Frozen Solutions

Although 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).

References

Alimta EU Summary of Product Characteristics. Utrecht, The Netherlands: Eli Lilly and Company Limited.

Zhang Y, Trissel LA. Physical and chemical stability of pemetrexed solutions in plastic syringes. Ann Pharmacother. 2005;39(12):2026-2028.

Zhang Y, Trissel LA. Physical and chemical stability of pemetrexed in infusion solutions. Ann Pharmacother. 2006a;40(6):1082-1085.

Zhang 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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