Instructions for Use and Handling: Use appropriate aseptic technique during the reconstitution and further dilution of Pemetrexed for intravenous infusion administration.
Calculate the dose and number of Pemetrexed vials needed. The vial contains and excess of Pemetrexed to facilitate delivery of the label amount.
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. 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. Gently swirl each vial until the powder is completely dissolved. The resulting solution is clear and ranges in color from colorless to yellow or green-yellow without adversely affecting product quality. The pH of the reconstituted solution is between 6.6 to 7.8. Further dilution is required.
The appropriate volume of reconstituted Pemetrexed solution should be further diluted to 100 mL with sodium chloride 9 mg/mL (0.9%) solution for injection, without preservatives and administered as an intravenous infusion over 10 minutes.
Pemetrexed infusion solutions prepared as previously directed are compatible with polyvinyl chloride and polyolefin-lined administration sets and infusion bags.
Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration. If particulate matter is observed, do not administer.
Pemetrexed solutions are for single use only. Any unused product or waste material should be disposed of in accordance with local requirements.
Chemical and physical stability at refrigerated or ambient room temperature and lighting. When prepared as directed, reconstitution and infusion solutions of Pemetrexed for injection contain no antimicrobial preservative. Discard any unused portion. Reconstitution and further dilution prior to intravenous infusion is only recommended with 0.9% Sodium Chloride Injection.
Preparation and Administration Precautions: As with other potentially toxic anticancer agents, care should be exercised in the handling and preparation of Pemetrexed infusion solutions. The use of gloves is recommended. If a Pemetrexed solution contacts the skin, wash the skin immediately and thoroughly with soap and water. If Pemetrexed solutions contact the mucous membranes, flush thoroughly with water. Pemetrexed is not a vesicant. There is not a specific antidote for extravasation of Pemetrexed. There have been few reported cases of Pemetrexed extravasation, which were not assessed as serious by the investigator. Extravasation should be managed by local standard practice as with other non-vesicants.
Incompatibilities: Pemetrexed is physically incompatible with diluents containing calcium, including lactated Ringer's Injection and Ringer's Injection. In the absence of compatibility studies (with other drugs and diluents), this medicinal product must not be mixed with other medicinal products.