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Alimta ® (pemetrexed for injection)
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Alimta® (pemetrexed): Association between spikes and particles
The use of a spike (large bore needles) to prepare the dose may produce stopper fragments. Lilly does NOT recommend the use of spikes with Alimta. If particulate matter is observed, do not administer.
Reasons for particles in the solution
The primary contributor of particulate matter in vial presentations originates from the rubber closure (stopper). Therefore, particles observed after reconstitution might originate from puncturing the stopper with the needle.1
Many elements can influence the production of stopper fragments during reconstitution including:1
- Needle type: Blunt needle tips have a much greater tendency to produce fragments than sharp tips.
- Needle gauge: Needles larger than 21-gauge tend to promote fragmentation.
- Force of puncture: Lower needle insertion forces reduce the tendency to produce fragments.
- Angle of puncture: Needle insertion at a 45° angle to the plane of the stopper reduces the likelihood of fragments.
- Incorrect use: Using a spike on a stopper design that was not intended to receive a spike will produce fragments.
Although particles may arise during the manufacturing process Alimta is produced using the stringent manufacturing controls and undergoing inspection and sorting procedures to reduce the potential presence of any atypical vials as low as possible. Other sources of particles can also include the diluent, needle, tubing or administration sets used during the infusion.1
If particles are observed
Parenteral medicinal products must be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.2
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Alimta [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands
Date of Last Review: 20 May 2021