Alimta® (pemetrexed): Excipients and overfill

Excipients

Alimta 100 mg vials contain:¹

• Pemetrexed disodium equivalent to 100 mg pemetrexed
  active ingredient

• 106.4 mg Mannitol
  bulking agent

• Hydrochloric acid and/or sodium hydroxide
  may have been added to adjust pH

• Water for Injection
  Removed during freeze drying/lyophilization process

Alimta 500 mg Vials contain:¹

• Pemetrexed disodium equivalent to 500 mg pemetrexed
  active ingredient

• 500 mg Mannitol
  bulking agent

• Hydrochloric acid and/or sodium hydroxide
  may have been added to adjust pH

• Water for Injection
  Removed during freeze drying/lyophilization process

Overfill

When reconstituted and used as directed, the vial will contain the product’s labeled amount (e. g. 500 mg or 100 mg) of usable/deliverable product.¹ 

All Alimta vials are overfilled to ensure that the container “delivers” the label claim and to allow for any vial and syringe retention. The appropriate volume of diluent has to be used to ensure the usable/deliverable volume.¹ 

The following overages are added for vial and syringe retention:¹ 

• 8.5 % for Alimta 100 mg vials

• 2 % for Alimta 500 mg vials

Reconstitute 100-mg vials with 4.2 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.²

Reconstitute 500-mg vials with 20 ml of sodium chloride 9 mg/ml (0.9 %) solution for injection, without preservative, resulting in a solution containing 25 mg/ml pemetrexed.²

Further dilution is required.²

Pemetrexed solutions are for single use only. Any unused medicinal product or waste material must be disposed of in accordance with local requirements.²

For precautions to be taken before handling or administering Alimta and for instructions on reconstitution and dilution of Alimta before administration, see section summary of product characteristics, section 6.6.² 

References

1. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

2. Alimta [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands