Alimta® (Pemetrexed)

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Pemetrexed: Vitamin B12 Injection Formulation Equivalence

Cyanocobalamin and hydroxocobalamin are both acceptable forms of injectable vitamin B12 for use as vitamin supplementation with pemetrexed treatment.


Detailed Information

In Lilly-sponsored pemetrexed clinical trials, patients received a 1000 mcg IM injection of vitamin B12 approximately 1 to 2 weeks before the first dose of pemetrexed. The first dose of pemetrexed was not to be given until the first vitamin B12 injection had been administered. The vitamin B12 injection was repeated approximately once every 9 weeks (or every 3 cycles) thereafter. Subsequent vitamin B12 injections can be given the same day as treatment with pemetrexed. The final vitamin B12 injection was given 3 weeks after the last dose of pemetrexed during the post treatment period.1 The vitamin B12 dose schedule is presented in Vitamin B12 Dose Schedule Used in Pemetrexed Clinical Trials.

Vitamin B12 Dose Schedule Used in Pemetrexed Clinical Trials1

1-2 Weeks Prior to Treatment

During Treatment

Post Treatmenta

Cycle 1

Cycle 2

Cycle 3b

Vitamin B12 injection




aA period of 3 weeks after the last dose of pemetrexed.

bGiven on day 1 of cycle 3. Repeat every 9 weeks (or every 3 cycles) for additional cycles of treatment.

Study protocols did not specify which of the 2 clinically equivalent forms of vitamin B12 that were available (United States Pharmacopeia) should be administered, cyanocobalamin or hydroxocobalamin. Therefore, depending on which form of vitamin B12 was available locally, clinical trial patients could have received either cyanocobalamin or hydroxocobalamin and satisfied the protocol requirements.1

The pemetrexed labeling and protocols are written in such a way as to allow for the use of either form of injectable vitamin B12. Either cyanocobalamin or hydroxocobalamin may be administered as part of the pemetrexed premedication regimen.1

Injectable vitamin B12 for IM administration is the only dosage form studied in the pivotal trials and referred to in the pemetrexed labeling. Alternate administration routes of vitamin B12 (eg, intranasal, oral, sublingual, or subcutaneous) have not been studied by Lilly and are not recommended for use.1


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


IM = intramuscular

Lilly = Eli Lilly and Company

Fecha de la última revisión: 2020 M01 06

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