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METHOTREXATE SODIUM is a brand name for Methotrexate, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Methotrexate Sodium Injection is indicated for Neoplastic diseases: • Choriocarcinoma: Methotrexate - as single chemotherapy or in combination with other drugs. • Intermediate, or high-grade Non-Hodgkin's Lymphoma as part of ProMACE-CytaBOM, ProMACE-MOPP, and Magrath protocols. • Breast Cancer - as part of CMF…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit. • Women of childbearing potential should not be started on Methotrexate Sodium Injection until pregnancy is excluded.
Neoplastic Diseases: • Methotrexate Sodium Injection may be given by the intramuscular, intravenous (as a bolus), intra-arterial, intrathecal or intracerebroventricular (via Ommaya reservoir into the CNS) routes. • Methotrexate may only be administered by physicians experienced in the treatment of neoplasia.
Typical dosages reported in the literature for the following malignancies are listed in the following section. Psoriasis and Rheumatoid Arthritis: • The patient should be fully informed of the risks involved and should be under constant supervision of the physician (see 7 WARNINGS AND PRECAUTIONS).
• All dosage schedules should be continually tailored to the individual patient. An initial test dose may be given prior to the regular dosing schedule to detect any extreme sensitivity to adverse effects (see 8 ADVERSE REACTIONS). Maximal myelosuppression usually occurs in seven to ten days.
• Both the physician and pharmacist should emphasize to the patient that the recommended dose is taken weekly in rheumatoid arthritis and psoriasis, and that mistaken daily use of the recommended dose has led to fatal toxicity. o. days 1 through 14, methotrexate 40 mg/m2 IV day 1, 8, and 5 - Fluorouracil 600 mg/m2 IV day 1, 8.
Cycle length will be 28 days ("2 weeks-on, 2 weeks-off"). In patients over 60 years of age, the dosage of methotrexate will be 30 mg/m2 IV day 1, 8. 5 mg/dL, decrease the dose of methotrexate only by 50%.
Bladder Cancer:
Typical dosage regimens for bladder cancer are the CMV Regimen and the "M-VAC Regimen" which are represented in the following tables.
Table 1:
CMV Regimen* Drugs** Days 1 2 8¶ Cisplatin‡ - 100 - Vinblastine 4 - 4 Methotrexate*** 30 - 30 * All doses in mg/m2 with cycles repeated on day 22. ** Patients > 70 years old receive 80% of all doses; if vomiting persists to day 8, no drug is given.
). Maximal myelosuppression usually occurs in seven to ten days. • Both the physician and pharmacist should emphasize to the patient that the recommended dose is taken weekly in rheumatoid arthritis and psoriasis, and that mistaken daily use of the recommended dose has led to fatal toxicity.
o. days 1 through 14, methotrexate 40 mg/m2 IV day 1, 8, and 5 - Fluorouracil 600 mg/m2 IV day 1, 8. Cycle length will be 28 days ("2 weeks-on, 2 weeks-off"). In patients over 60 years of age, the dosage of methotrexate will be 30 mg/m2 IV day 1, 8.
5 mg/dL, decrease the dose of methotrexate only by 50%.
Bladder Cancer:
Typical dosage regimens for bladder cancer are the CMV Regimen and the "M-VAC Regimen" which are represented in the following tables.
Table 1:
CMV Regimen* Drugs** Days 1 2 8¶ Cisplatin‡ - 100 - Vinblastine 4 - 4 Methotrexate*** 30 - 30 * All doses in mg/m2 with cycles repeated on day 22. ** Patients > 70 years old receive 80% of all doses; if vomiting persists to day 8, no drug is given.
‡ For each cycle, adjust cisplatin to 100% for Ccr >60 mL/min; 50% of dose for Ccr 50-60 mL/min; none for Ccr <50mL/min. 8 mg/dL. ¶ Major dose modifications for both drugs depending on myelosuppression.
Table 2:
M-VAC Regimen* Drugs Days 1 2 15 22*** Methotrexate 30 - 30 30 Vinblastine - 3 3 3 Doxorubicin - 30** - - Cisplatin - 70 - - * All doses in mg/m2 with cycles repeated every 28-32 days. ** Patients having prior pelvic irradiation equivalent to >2500 rad in 5 days, reduce the dose of doxorubicin 15 mg/m2.
*** No doses given when the WBC <2500 cells/mm3, platelets >100,000 cells/mm3, or mucositis present.
, Neurologic 01/2025 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION ........................................................................
4 1 INDICATIONS ......................................................................................................................... 1 Pediatrics .....................................................................................................................
2 Geriatrics ..................................................................................................................... 4 2 CONTRAINDICATIONS............................................................................................................
5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................................... 6 4 DOSAGE AND ADMINISTRATION ...........................................................................................
1 Dosing Considerations .................................................................................................. 2 Recommended Dose and Dosage Adjustments.............................................................. 3 Reconstitution............................................................................................................
4 Administration ........................................................................................................... 5 Missed Dose...............................................................................................................
17 5 OVERDOSAGE ...................................................................................................................... 17 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING..........................................
Methotrexate Sodium Injection is contraindicated: • In patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
2 Recommended dose and dosage adjustment: Special populations). • In pregnant patients with psoriasis or rheumatoid arthritis and should be used in the treatment of neoplastic diseases only when the potential benefit outweighs the risk to the fetus.
• In women of childbearing potential until pregnancy is excluded. • In nursing mothers. • In patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease or other chronic liver disease. • In patients with psoriasis or rheumatoid arthritis who have overt or laboratory evidence of immunodeficiency syndromes.
• In patients with psoriasis or rheumatoid arthritis who have pre -existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or significant anemia. 4 Drug- Drug Interactions). Page 6 Protected B / Protégé B
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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‡ For each cycle, adjust cisplatin to 100% for Ccr >60 mL/min; 50% of dose for Ccr 50-60 mL/min; none for Ccr <50mL/min. 8 mg/dL. ¶ Major dose modifications for both drugs depending on myelosuppression.
Table 2:
M-VAC Regimen* Drugs Days 1 2 15 22*** Methotrexate 30 - 30 30 Vinblastine - 3 3 3 Doxorubicin - 30** - - Cisplatin - 70 - - * All doses in mg/m2 with cycles repeated every 28-32 days. ** Patients having prior pelvic irradiation equivalent to >2500 rad in 5 days, reduce the dose of doxorubicin 15 mg/m2.
*** No doses given when the WBC <2500 cells/mm3, platelets >100,000 cells/mm3, or mucositis present.
Head and Neck Cancer:
Methotrexate remains the standard of therapy for patients with recurrent or metastatic disease. It has been given in a wide variety of doses and schedules (a Page 8 Protected B / Protégé B few of which are represented in the table below).
8 mg/kg every 4 days IV 25 - 50 mg every 4 to 7 days 60 mg/m2 weekly IV or 40 mg/m2 biweekly IV 40 - 60 mg/m2 weekly IV 80 mg/m2 for 30 h every 2 wk with escalation to toxicity 40 mg/m2 weekly IV 40-200 mg/m2 IV on days 1, 4 weekly; leucovorin on days 2,5 60 mg/m2 IV weekly **excerpt from Devita, et al: CANCER 3rd Ed, p.
496 For palliation of patients with advanced, incurable disease and acceptable renal function, it is appropriate to begin intravenous methotrexate with weekly doses of 40-50 mg/m2 or biweekly doses of 15 to 20 mg/m2 and escalate the dose in weekly increments until either mild toxicity or therapeutic response is achieved.
5 g/m2 IV) + Leucovorin (15 mg/m2 orally or IV every 6 hours for 72 hours) + Adriamycin (30 mg/m2 IV, day 15). The schedule is repeated on day 29 for 6 cycles.
Choriocarcinoma and similar trophoblastic diseases:
Methotrexate is administered intramuscularly in doses of 15 to 30 mg daily for a 5-day course. Such courses are usually repeated for 3 to 5 times as required, with rest periods of one or more weeks interposed between courses, until any manifesting toxic symptoms subside.
The effectiveness of therapy is ordinarily evaluated by 24-hour quantitative analysis of urinary chorionic gonadotropin hormone (beta-HCG), which should return to normal or less than 50 IU/24 hr usually after the third or fourth course and usually be followed by a complete resolution of measurable lesions in 4 to 6 weeks.
One to two courses of methotrexate after normalization of beta-HCG are usually recommended. Before each course of the drug, careful clinical assessment is essential. Cyclic combination therapy of methotrexate with other antitumour drugs has been reported as being useful.
Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with methotrexate has been recommended. Chorioadenoma destruens is considered to be an invasive form of hydatidiform mole. Methotrexate is administered in these disease states in doses similar to those recommended for choriocarcinoma.
Page 9 Protected B / Protégé B Leukemia:
Acute lymphoblastic leukemia (ALL) in children and young adolescents is the most responsive to present day chemotherapy. In young adults and older patients, clinical remission is more difficult to obtain and early relapse is more common.
Methotrexate alone or in combination with steroids was used initially for induction of remission in ALL. More recently corticosteroid therapy, in combination with other […]
Head and Neck Cancer:
Methotrexate remains the standard of therapy for patients with recurrent or metastatic disease. It has been given in a wide variety of doses and schedules (a Page 8 Protected B / Protégé B few of which are represented in the table below).
8 mg/kg every 4 days IV 25 - 50 mg every 4 to 7 days 60 mg/m2 weekly IV or 40 mg/m2 biweekly IV 40 - 60 mg/m2 weekly IV 80 mg/m2 for 30 h every 2 wk with escalation to toxicity 40 mg/m2 weekly IV 40-200 mg/m2 IV on days 1, 4 weekly; leucovorin on days 2,5 60 mg/m2 IV weekly **excerpt from Devita, et al: CANCER 3rd Ed, p.
496 For palliation of patients with advanced, incurable disease and acceptable renal function, it is appropriate to begin intravenous methotrexate with weekly doses of 40-50 mg/m2 or biweekly doses of 15 to 20 mg/m2 and escalate the dose in weekly increments until either mild toxicity or therapeutic response is achieved.
5 g/m2 IV) + Leucovorin (15 mg/m2 orally or IV every 6 hours for 72 hours) + Adriamycin (30 mg/m2 IV, day 15). The schedule is repeated on day 29 for 6 cycles.
Choriocarcinoma and similar trophoblastic diseases:
Methotrexate is administered intramuscularly in doses of 15 to 30 mg daily for a 5-day course. Such courses are usually repeated for 3 to 5 times as required, with rest periods of one or more weeks interposed between courses, until any manifesting toxic symptoms subside.
The effectiveness of therapy is ordinarily evaluated by 24-hour quantitative analysis of urinary chorionic gonadotropin hormone (beta-HCG), which should return to normal or less than 50 IU/24 hr usually after the third or fourth course and usually be followed by a complete resolution of measurable lesions in 4 to 6 weeks.
One to two courses of methotrexate after normalization of beta-HCG are usually recommended. Before each course of the drug, careful clinical assessment is essential. Cyclic combination therapy of methotrexate with other antitumour drugs has been reported as being useful.
Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with methotrexate has been recommended. Chorioadenoma destruens is considered to be an invasive form of hydatidiform mole. Methotrexate is administered in these disease states in doses similar to those recommended for choriocarcinoma.
Page 9 Protected B / Protégé B Leukemia:
Acute lymphoblastic leukemia (ALL) in children and young adolescents is the most responsive to present day chemotherapy. In young adults and older patients, clinical remission is more difficult to obtain and early relapse is more common.
Methotrexate alone or in combination with steroids was used initially for induction of remission in ALL. More recently corticosteroid therapy, in combination with other antileukemic drugs or in cyclic combinations with methotrexate included, has appeared to produce rapid and effective remissions.
3 mg/m2 in combination with 60 mg/m2 of prednisone, given daily, produced remissions in 50% of patients treated, usually within a period of 4 to 6 weeks. Methotrexate in combination with other agents appears to be the drug of choice for securing maintenance of drug-induced remissions.
When remission is achieved and supportive care has produced general clinical improvement, maintenance therapy is initiated, as follows: methotrexate is administered twice weekly intramuscularly in total weekly doses of 30 mg/m2. 5 mg/kg intravenously every 14 days.
If and when relapse does occur, re -induction of remission can again usually be obtained by repeating the initial induction regimen. A variety of combination chemotherapy regimens have been used for both induction and maintenance therapy in ALL.
Meningeal Leukemia:
In the treatment or prophylaxis of meningeal leukemia, methotrexate must be administered intrathecally. For […]
18 7 WARNINGS AND PRECAUTIONS........................................................................................... 1 Special Populations ..........................................................................................................
1 Pregnant Women .................................................................................................... 2. Breast-feeding ........................................................................................................
3 Pediatrics ................................................................................................................ 4 Geriatrics.................................................................................................................
27 8 ADVERSE REACTIONS........................................................................................................... 1 Adverse Reaction Overview ........................................................................................
5 Post-Market Adverse Reactions .................................................................................. 30 9 DRUG INTERACTIONS ..........................................................................................................
1 Serious Drug Interactions.......................................................................................... 2 Drug Interactions Overview ......................................................................................
3 Drug-Behaviour Interactions ..................................................................................... 4 Drug-Drug Interactions .............................................................................................
5 Drug-Food Interactions ............................................................................................. 6 Drug-Herb Interactions .............................................................................................
7 Drug-Laboratory Test Interactions ............................................................................ 38 10 CLINICAL PHARMACOLOGY................................................................................................
1 Mechanism of Action .............................................................................................. 2 Pharmacodynamics ................................................................................................
3 Pharmacokinetics ................................................................................................... 39 11 STORAGE, STABILITY AND DISPOSAL.................................................................................
42 12 SPECIAL HANDLING INSTRUCTIONS ................................................................................... 42 PART II: SCIENTIFIC INFORMATION ........................................................................................
44 13 PHARMACEUTICAL INFORMATION .................................................................................... 44 14 CLINICAL TRIALS ................................................................................................................
44 15 MICROBIOLOGY................................................................................................................. 44 16 NON-CLINICAL TOXICOLOGY ..............................................................................................
47 17 SUPPORTING PRODUCT MONOGRAPH .............................................................................. 46 PATIENT MEDICATION INFORMATION.................................................................................... 47 Page 4 Protected B / Protégé B PART I: […]