In short
Calcium levofolinate pentahydrate is a chemically synthesised medicine that belongs to a class of drugs known as folate analogues. It is authorised as a medicine in Italy and is used during chemotherapy to reduce side effects or to make other cancer drugs work better. The clinical trial records show it is being investigated in two cancer-related settings: one trial in advanced gastrooesophageal cancer and one in cancer cachexia.
Key points
- Calcium levofolinate pentahydrate is a folate-based medicine used alongside certain chemotherapy drugs.
- It is authorised as a medicine in Italy under the product name Lederfolin.
- In one trial it is given as an intravenous infusion at a dose of 400 mg/m².
- The trial in cancer cachexia is a Phase 4 study with 982 participants.
- Another trial lists it as part of a treatment combination for advanced gastrooesophageal cancer.
- Its role in these records is as a supporting medicine, not the main drug being tested.
What is calcium levofolinate pentahydrate?
Calcium levofolinate pentahydrate is a chemically synthesised substance classified as a folate analogue (ATC code V03AF04). It is the calcium salt of levofolinic acid, a form of folate that the body can use directly. The substance is authorised as a medicine in Italy, where it is marketed under the name Lederfolin 175 mg powder for solution for infusion by Pfizer Italia S.r.l. It is also known as levofolinic acid or calcium levofolinate, and is listed in NHS formularies under the brand name Isovorin.
How does calcium levofolinate pentahydrate work?
Levofolinic acid is the active form of folic acid. In the body, folate is needed for cells to make DNA and divide. Cancer chemotherapy drugs such as 5-fluorouracil work partly by interfering with folate metabolism. Calcium levofolinate is used as an adjunct to 5-fluorouracil in colorectal cancer, where it helps the chemotherapy work more effectively. The NHS formulary lists it specifically for this purpose.
Which conditions is calcium levofolinate pentahydrate used or studied for?
- Advanced or metastatic gastrooesophageal cancer — one authorised Phase 2 trial includes calcium levofolinate as part of a chemotherapy combination in patients whose tumours are HER2 negative and carry an ARID1A mutation.
- Cancer cachexia — a Phase 4 study lists calcium levofolinate pentahydrate as a medicine given during treatment for cancer cachexia, a condition of severe weight loss and fatigue in people with pancreatic cancer.
- Colorectal cancer — according to the NHS formulary, calcium levofolinate is supported for use as an adjunct to 5-fluorouracil in colorectal cancer.
How is calcium levofolinate pentahydrate given?
Calcium levofolinate pentahydrate is given as an intravenous infusion. The authorised product in Italy is a powder for solution for infusion, which is dissolved before being given into a vein. In the Phase 4 cancer cachexia trial, the dose recorded in the registry is 400 mg per square metre of body surface area. In the Phase 2 gastrooesophageal cancer trial, the product Lederfolin is listed at a dose of 200 mg per square metre as part of the chemotherapy regimen.
What do the clinical trials show?
Two clinical trial records mention calcium levofolinate pentahydrate. In both, it is not the main medicine being tested; it is given as part of the treatment background or as a supporting medicine.
The first trial is a randomised Phase 2 study in 84 patients with advanced or metastatic gastrooesophageal carcinoma that is HER2 negative and ARID1A mutated. The main medicine being tested is simvastatin, given together with nivolumab and oxaliplatin-based chemotherapy. Calcium levofolinate (as Lederfolin) is part of the chemotherapy backbone. The main measure is progression-free survival at one year, defined as the time from randomisation until disease progression, treatment interruption due to side effects, or death.
The second trial is a Phase 4 study in 982 participants with cancer cachexia related to pancreatic cancer that has spread. The main medicine being tested is ponsegromab. Calcium levofolinate pentahydrate is listed as one of the medicines given during the study. The main measures are percent change in body weight at week 12 and change in appetite-related symptoms measured by a questionnaire called FAACT-5IASS.
Both trials are interventional studies. The Phase 2 gastrooesophageal cancer trial is authorised, meaning it is approved to start or is running. The Phase 4 cancer cachexia trial is currently suspended.
What side effects are known?
The supplementary source used for this page, an NHS formulary entry, does not list specific side effects for calcium levofolinate. It states that the Summary of Product Characteristics (SPC) is available via the MHRA website for those who need detailed safety information.