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Methotrexate Dosage

Applies to the following strength(s): 2.5 mg ; 25 mg/mL ; 25 mg/mL preservative-free ; 1 g ; 20 mg ; 50 mg ; 5 mg ; 7.5 mg ; 10 mg ; 15 mg ; 10 mg/0.4 mL ; 12.5 mg/0.4 mL ; 15 mg/0.4 mL ; 17.5 mg/0.4 mL ; 20 mg/0.4 mL ; 22.5 mg/0.4 mL ; 25 mg/0.4 mL ; 7.5 mg/0.4 mL ; 7.5 mg/0.15 mL ; 10 mg/0.2 mL ; 12.5 mg/0.25 mL ; 15 mg/0.3 mL ; 17.5 mg/0.35 mL ; 22.5 mg/0.45 mL ; 25 mg/0.5 mL ; 27.5 mg/0.55 mL ; 30 mg/0.6 mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for Acute Lymphoblastic Leukemia

Induction: 3.3 mg/m2/day orally or IM (in combination with prednisone 60 mg/m2) daily

Comments:
-Remissions were usually achieved within a period of 4 to 6 weeks in 50% of patients.
-Acute lymphoblastic leukemia in pediatric patients 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.

Maintenance (during remission): 15 mg/m2 IM or orally 2 times a week: Alternate remission dosing: 2.5 mg/kg IV every 14 days

Use: Acute lymphoblastic leukemia (ALL)

Usual Adult Dose for Choriocarcinoma

CHORIOCARCINOMA AND SIMILAR TROPHOBLASTIC DISEASES:
Orally or IM: 15 to 30 mg daily for a 5 day course; courses are usually repeated for 3 to 5 times, with rest periods of one or more weeks between courses, until any manifesting toxic symptoms subside

Comments:
-The effectiveness of therapy is evaluated by 24 hour quantitative analysis of urinary chorionic gonadotropin (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 therapy after normalization of hCG is usually recommended.
-Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with this drug has been recommended.
-Chorioadenoma destruens is considered to be an invasive form of hydatidiform mole. This drug is administered in these disease states in doses similar to those recommended for choriocarcinoma.

Use: Gestational trophoblastic disease (GTD) including gestational choriocarcinoma, chorioadenoma destruens, and hydatidiform mole

Usual Adult Dose for Trophoblastic Disease

CHORIOCARCINOMA AND SIMILAR TROPHOBLASTIC DISEASES:
Orally or IM: 15 to 30 mg daily for a 5 day course; courses are usually repeated for 3 to 5 times, with rest periods of one or more weeks between courses, until any manifesting toxic symptoms subside

Comments:
-The effectiveness of therapy is evaluated by 24 hour quantitative analysis of urinary chorionic gonadotropin (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 therapy after normalization of hCG is usually recommended.
-Since hydatidiform mole may precede choriocarcinoma, prophylactic chemotherapy with this drug has been recommended.
-Chorioadenoma destruens is considered to be an invasive form of hydatidiform mole. This drug is administered in these disease states in doses similar to those recommended for choriocarcinoma.

Use: Gestational trophoblastic disease (GTD) including gestational choriocarcinoma, chorioadenoma destruens, and hydatidiform mole

Usual Adult Dose for Lymphoma

For Burkitt's tumor in Stages I to II: 10 to 25 mg orally once a day for 4 to 8 days

Malignant lymphoma in Stage III: 0.625 to 2.5 mg/kg orally daily as a part of combination chemotherapy

Treatment in all stages usually consists of several courses of the drug interposed with 7 to 10 day rest periods.

Use: Lymphomas

Usual Adult Dose for Meningeal Leukemia

12 mg/m2 (maximum 15 mg) intrathecally every 2 to 5 days until the cell count of the CSF returns to normal; at this point, one additional dose is advisable.

Comments:
-Administration at intervals of less than 1 week may result in increased subacute toxicity.
-The preserved formulations of this drug contain benzyl alcohol and must not be used for intrathecal or high dose therapy.

Use: Treatment and prophylaxis of meningeal leukemia

Usual Adult Dose for Mycosis Fungoides

Early stage dosing: 5 to 50 mg once a week; alternatively, 15 to 37.5 mg 2 times a week may be used in patients who have responded poorly to weekly therapy

Comments:
-Therapy with this drug as a single agent appears to produce clinical responses in up to 50% of patients treated.
-Dose reduction or cessation is guided by patient response and hematologic monitoring.
Combination chemotherapy regimens that include IV MTX at higher doses with leucovorin rescue have been utilized in advanced stages of disease.

Use: Mycosis fungoides (cutaneous T cell lymphoma)

Usual Adult Dose for Osteosarcoma

Initial Dose: 12 g/m2 IV as a 4 hour infusion (in combination with other chemotherapeutic agents); if this dose is not adequate to achieve a peak serum concentration of 1000 micromolar at the end of the infusion, the dose may be increased to 15 g/m2 IV.

Treatments may occur at 4, 5, 6, 7, 11, 12, 15, 16, 29, 30, 44, and 45 weeks after surgery.

Comments:
-If the patient is vomiting or unable to tolerate oral medication, leucovorin given IV or IM should be added to this regimen at the same dose and schedule as the methotrexate.
-Consult product labeling or local protocol for dosage of concomitant medications in the chemotherapy regimen.

Use: Osteosarcoma

Usual Adult Dose for Psoriasis

Single Dose: 7.5 mg/week orally, IM, or IV until adequate response is achieved
Divided Dose: 2.5 mg orally, IM, or IV every 12 hours for 3 doses once a week
Maximum weekly dose: 20 mg

Comments:
-Once optimal clinical response has been achieved, each dosage schedule should be reduced to the lowest possible amount of drug and to the longest possible rest period.
-The use of MTX may permit the return to conventional topical therapy, which should be encouraged.

Use: For the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis "flare" is not due to an undiagnosed concomitant disease affecting immune responses.

Usual Adult Dose for Rheumatoid Arthritis

Single dose: 7.5 mg orally once a week
Divided dose: 2.5 mg orally every 12 hours for 3 doses once a week
Maximum weekly dose: 20 mg
Duration of therapy: Unknown

Comments:
-Dosages may be adjusted gradually to achieve optimal response.
-Limited experience shows a significant increase in the incidence and severity of serious toxic reactions, especially bone marrow suppression, at doses greater than 20 mg per week in adults.
-Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.

Use: For the management of selected adults with severe, active rheumatoid arthritis (ACR criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose nonsteroidal anti-inflammatory agents (NSAIDs).

Usual Adult Dose for Breast Cancer - Adjuvant

40 mg/m2 IV once on days 1 and 8 of each cycle

Use: As adjuvant treatment to radical mastectomy in primary breast cancer with positive axillary lymph nodes

Usual Adult Dose for Neoplastic Diseases

-Oral administration in tablet form is often preferred since absorption is rapid and effective serum levels are obtained.
-TEST DOSE (PARENTERAL): 5 to 10 mg IM or IV once given 1 week prior to initiation of therapy.
-Doses are usually based on the patient's body surface area (BSA): For conversion of mg/kg bodyweight to mg/m2 of body surface area or the reverse, a ratio of 1:30 is given as a guideline. The conversion factor varies between 1:20 and 1:40 depending on age and body build.
-Doses greater than 100 mg should be given parenterally and should be administered with leukovorin rescue.

Usual Pediatric Dose for Acute Lymphoblastic Leukemia

Induction: 3.3 mg/m2/day orally or IM (in combination with prednisone 60 mg/m2) daily

Comments:
-Remissions were usually achieved within a period of 4 to 6 weeks in 50% of patients.
-Acute lymphoblastic leukemia in pediatric patients 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.

Maintenance (during remission): 15 mg/m2 IM or orally 2 times a week: Alternate remission dosing: 2.5 mg/kg IV every 14 days

Use: Acute lymphoblastic leukemia (ALL)

Usual Pediatric Dose for Meningeal Leukemia

Less than 1 year: 6 mg/dose intrathecally
1 year of age: 8 mg/dose intrathecally
2 years of age: 10 mg/dose intrathecally
3 years of age or older: 12 mg/dose intrathecally

Comments:
-The dose may be administered every 2 to 5 days until CSF counts return to normal followed by one additional dose.
-For prophylaxis against meningeal leukemia, the dosage is the same as for treatment except for the intervals of administration. The physician should consult the medical literature.

Usual Pediatric Dose for Rheumatoid Arthritis

-Initial dose: 10 mg/m2 orally once a week; adjust doses gradually to achieve optimal response
Maximum dose: 20 mg/m2 once a week (limited experience exists with doses of 30 mg/m2 per week)

Comments:
-Experience suggests that children receiving 20 to 30 mg/m2/week (0.65 to 1.0 mg/kg/week) may have better absorption and fewer gastrointestinal side effects if the drug is administered either IM or subcutaneously.
-Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more.

Use: Polyarticular-Course Juvenile Rheumatoid Arthritis

Renal Dose Adjustments

CrCl should be greater than 60 mL/min before initiation of therapy.

Liver Dose Adjustments

Patients with psoriasis or rheumatoid arthritis with alcoholism, alcoholic liver disease, or other chronic liver disease should not receive this drug.

Precautions

US BOXED WARNINGS:
-For intrathecal and high dose therapy, the preservative-free formulation of this drug should be used because it does not contain benzyl alcohol.
-This drug should be used only in life threatening neoplastic diseases, or in patients with psoriasis or rheumatoid arthritis with severe, recalcitrant, disabling disease which is not adequately responsive to other forms of therapy.
-Deaths have been reported with the use of this drug in the treatment of malignancy, psoriasis, and rheumatoid arthritis.
-Patients should be closely monitored for bone marrow, liver, lung and kidney toxicities.
-Patients should be informed by their physician of the risks involved and be under physician care throughout therapy.
-The use of high-dose regimens recommended for osteosarcoma requires meticulous care. High-dose regimens for other neoplastic diseases are investigational and a therapeutic advantage has not been established.
-This drug has been reported to cause fetal death and/or congenital anomalies; therefore, it is not recommended for women of childbearing potential unless there is clear medical evidence that the benefits can be expected to outweigh the risks.
-Pregnant women with psoriasis or rheumatoid arthritis should not receive this drug.
-Methotrexate elimination is reduced in patients with impaired renal functions, ascites, or pleural effusions. Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of methotrexate administration.
-Unexpectedly severe (sometimes fatal) bone marrow suppression, aplastic anemia, and GI toxicity have been reported with concomitant administration of this drug (usually in high dosage) along with some nonsteroidal anti-inflammatory drugs (NSAIDs).
-This drug causes hepatotoxicity, fibrosis, and cirrhosis, but generally only after prolonged use. Acute liver enzyme elevations are frequently seen; these are usually transient and asymptomatic, and also do not appear predictive of subsequent hepatic disease. Liver biopsy after sustained use often shows histologic changes, and fibrosis and cirrhosis have been reported; these latter lesions may not be preceded by symptoms or abnormal liver function tests in the psoriasis population. For this reason, periodic liver biopsies are usually recommended for psoriatic patients who are under long term treatment. Persistent abnormalities in liver function tests may precede the appearance of fibrosis or cirrhosis in the rheumatoid arthritis population.
-MTX-induced lung disease, including acute or chronic interstitial pneumonitis, is a potentially dangerous lesion, which may occur acutely at any time during therapy and has been reported at low doses. It is not always fully reversible and fatalities have been reported. Pulmonary symptoms (especially a dry, nonproductive cough) may require interruption of treatment and careful investigation.
-Diarrhea and ulcerative stomatitis require interruption of therapy; otherwise, hemorrhagic enteritis and death from intestinal perforation may occur.
-Malignant lymphomas, which may regress following withdrawal of therapy, may occur in patients receiving low-dose MTX and, thus, may not require cytotoxic treatment. Discontinue MTX first and, if the lymphoma does not regress, appropriate treatment should be instituted.
-Like other cytotoxic drugs, this drug may induce "tumor lysis syndrome" in patients with rapidly growing tumors. Appropriate supportive and pharmacologic measures may prevent or alleviate this complication.
-Severe, occasionally fatal, skin reactions have been reported following single or multiple doses of this drug. Reactions have occurred within days of oral, IM, IV, or intrathecal administration. Recovery has been reported with discontinuation of therapy.
-Potentially fatal opportunistic infections, especially Pneumocystis carinii pneumonia, may occur with MTX therapy.
-This drug is given concomitantly with radiotherapy may increase the risk of soft tissue necrosis and osteonecrosis.

Safety and effectiveness in pediatric patients have been established only in cancer chemotherapy and in polyarticular-course juvenile rheumatoid arthritis.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Storage requirements:
Consult manufacturer product information.

Reconstitution/preparation techniques:
Consult manufacturer product information.

IV compatibility:
Consult manufacturer product information.

General:
-Oral administration in tablet form is often preferred when low doses are being administered since absorption is rapid and effective serum levels are obtained.
-The injectable formulation may be given by the IM, IV, intra-arterial or intrathecal route.
-For intrathecal and high-dose MTX therapy, use the preservative-free formulation. Do not use the preserved formulation for intrathecal or high-dose therapy because it contains benzyl alcohol.

Monitoring:
-Patients undergoing therapy with this drug should be closely monitored for toxic effects.
-Baseline assessment should include a complete blood count with differential and platelet counts, hepatic enzymes, renal function tests, and a chest X-ray.
-During therapy of rheumatoid arthritis and psoriasis, monitoring of these parameters is recommended: hematology at least monthly, renal function and liver function every 1 to 2 months. More frequent monitoring is usually indicated during antineoplastic therapy.
-During initial or changing doses, or during periods of increased risk of elevated MTX blood levels (e.g., dehydration), more frequent monitoring may be indicated.
-Transient liver function test abnormalities are observed frequently after MTX administration and are usually not cause for modification of therapy. Persistent liver function test abnormalities, and/or depression of serum albumin may be indicators of serious liver toxicity and require evaluation.
-A relationship between abnormal liver function tests and fibrosis or cirrhosis of the liver has not been established for patients with psoriasis. Persistent abnormalities in liver function tests may precede appearance of fibrosis or cirrhosis in the rheumatoid arthritis population.
-Pulmonary function tests may be useful if MTX-induced lung disease is suspected, especially if baseline measurements are available.

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