Leucovorin Calcium (Page 3 of 5)
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when leucovorin is administered to a nursing mother.
Pediatric Use:
See PRECAUTIONS, Drug Interactions.
Geriatric Use:
Clinical studies of leucovorin calcium did not show differences in safety or effectiveness between subjects over 65 and younger subjects. Other clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older patients cannot be ruled out. This drug is known to be excreted by the kidney and the risk of toxic reactions to the drug may be greater in patients with impaired renal function. Because elder patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.
ADVERSE REACTIONS
Allergic sensitization, including anaphylactoid reactions and urticaria, has been reported following the administration of both oral and parenteral leucovorin. No other adverse reactions have been attributed to the use of leucovorin per se.
The following table summarizes significant adverse events occurring in 316 patients treated with the leucovorin/5-fluorouracil combinations compared against 70 patients treated with 5-fluorouracil alone for advanced colorectal carcinoma. These data are taken from the Mayo/NCCTG large multicenter prospective trial evaluating the efficacy and safety of the combination regimen.
(High LV *) /5-FU |
(Low LV †)/5-FU |
5-FU Alone | ||||
(N=155) |
(N=161) |
(N=70) | ||||
Any ‡ |
Grade 3+ § |
Any ‡ |
Grade 3+ § |
Any ‡ |
Grade 3+ § | |
(%) |
(%) |
(%) |
(%) |
(%) |
(%) | |
Leukopenia |
69 |
14 |
83 |
23 |
93 |
48 |
Thrombocytopenia |
8 |
2 |
8 |
1 |
18 |
3 |
Infection |
8 |
1 |
3 |
1 |
7 |
2 |
Nausea |
74 |
10 |
80 |
9 |
60 |
6 |
Vomiting |
46 |
8 |
44 |
9 |
40 |
7 |
Diarrhea |
66 |
18 |
67 |
14 |
43 |
11 |
Stomatitis |
75 |
27 |
84 |
29 |
59 |
16 |
Constipation |
3 |
0 |
4 |
0 |
1 |
– |
Lethargy/Malaise/Fatigue |
13 |
3 |
12 |
2 |
6 |
3 |
Alopecia |
42 |
5 |
43 |
6 |
37 |
7 |
Dermatitis |
21 |
2 |
25 |
1 |
13 |
– |
Anorexia |
14 |
1 |
22 |
4 |
14 |
– |
Hospitalization for Toxicity |
5% |
15% |
7% |
All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.
https://medlibrary.org/lib/rx/meds/leucovorin-calcium-16/page/3/