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METHOTREXATE 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 Injection USP 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 Injection USP until pregnancy is excluded.
Neoplastic Diseases: • Methotrexate Injection USP without preservative may be given by the intramuscular, intravenous (as a bolus), intra-arterial, intrathecal or intracerebroventricular (via Ommaya reservoir into the CNS) routes. • Methotrexate Injection USP formulations which contain benzyl alcohol as preservative are contraindicated in neonates and for intrathecal, intracerebroventricular, or high-dose therapy (see 2 CONTRAINDICATIONS).
• Methotrexate Injection USP 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. PrMETHOTREXATE INJECTION USP (methotrexate sodium) – Product Monograph Page 7 of 54 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.
). 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. PrMETHOTREXATE INJECTION USP (methotrexate sodium) – Product Monograph Page 7 of 54 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 <50 mL/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 03/2024 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES TABLE OF CONTENTS ..............................................................................................................
2 PART I: HEALTH PROFESSIONAL INFORMATION ...................................................................... 4 1 INDICATIONS ...............................................................................................................
5 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ............................................................ 5 4 DOSAGE AND ADMINISTRATION .................................................................................
16 5 OVERDOSAGE............................................................................................................ 16 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING ............................... 16 7 WARNINGS AND PRECAUTIONS ................................................................................
1 Special Populations ................................................................................................... 26 8 ADVERSE REACTIONS ................................................................................................
28 9 DRUG INTERACTIONS ................................................................................................ 34 10 CLINICAL PHARMACOLOGY .......................................................................................
35 11 STORAGE, STABILITY AND DISPOSAL ......................................................................... 38 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 38 PART II: SCIENTIFIC INFORMATION .......................................................................................
Methotrexate Injection USP 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). Methotrexate Injection USP formulations containing benzyl alcohol are also contraindicated: • To use for intrathecal, intracerebroventricular, or high-dose therapy.
• To use in neonates (children less than one month age).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Methotrexate in Canada.
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**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 <50 mL/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 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 PrMETHOTREXATE INJECTION USP (methotrexate sodium) – Product Monograph Page 8 of 54 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.
Lymphomas:
In Burkitt's tumour, Stages I-II, methotrexate has produced prolonged remissions in some […]
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 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 PrMETHOTREXATE INJECTION USP (methotrexate sodium) – Product Monograph Page 8 of 54 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.
Lymphomas:
In Burkitt's tumour, Stages I-II, methotrexate has produced prolonged remissions in some cases. In Stage III, methotrexate is commonly given concomitantly with other antitumour agents. Treatment in all stages usually consists of several courses of the drug interposed with 7 to 10 day rest periods.
5 mg/kg daily. The treatment of choice for localized histologically aggressive lymphoma is primary combination chemotherapy with or without involved-field radiation therapy. Frequently used regimens for intermediate, or high grade NHL that include methotrexate include groups: the ProMACE/MOPP, ProMACE-CytaBOM, Magrath Protocols.
Represented in the table below for example, is the ProMACE- CytaBOM Regimen. V. V. V. V. V. V. V. x with leucovorin rescue Prednisone 60 mg/m2 PO x---------------------------------------------- x Co-trimoxazole 2 PO bid throughout 6 cycles of therapy In early stage childhood non-Hodgkin's lymphoma, methotrexate is used effectively in combination chemotherapy regimens.
Mycosis […]
40 13 PHARMACEUTICAL INFORMATION ............................................................................ 40 14 CLINICAL TRIALS ........................................................................................................
40 15 MICROBIOLOGY ........................................................................................................ 40 16 NON-CLINICAL TOXICOLOGY .....................................................................................
40 PATIENT MEDICATION INFORMATION .................................................................................. 42 PrMETHOTREXATE INJECTION USP (methotrexate sodium) – Product Monograph Page 4 of 54 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Methotrexate Injection USP is indicated for Neoplastic diseases: • Choriocarcinoma: Methotrexate - as single chemotherapy or […]