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METHOTREXATE SUBCUTANEOUS 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 SUBCUTANEOUS (methotrexate injection) is indicated as a Disease Modifying Antirheumatic Drug (DMARD) in the following diseases where standard therapeutic interventions fail: • Severe disabling psoriasis/psoriatic arthritis • Severe disabling rheumatoid arthritis (RA) In the treatment of psoriasis,…
Verbatim from this product's HC label. Tap a section to expand.
). • Pregnancy: Methotrexate can cause fetal death, embryotoxicity, abortion or teratogenic effects when administered to a pregnant woman. • Women of childbearing potential should not be started on methotrexate until pregnancy is excluded and should be fully counselled on the serious risk to the fetus should they become pregnant while undergoing treatment.
Pregnancy should be avoided if either partner is receiving methotrexate (see 7 WARNINGS AND PRECAUTIONS). • Breast-feeding mothers: Due to the potential for serious adverse reactions in breast fed infants. • Patients with alcoholism, alcoholic liver disease or other chronic liver disease.
• Patients with overt or laboratory evidence of immunodeficiency syndromes. • Patients with pre-existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or significant anemia. 4 Drug-Drug Interactions).
1 Dosing Considerations METHOTREXATE SUBCUTANEOUS should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. METHOTREXATE SUBCUTANEOUS is contraindicated in patients with severe renal impairment (see 2 CONTRAINDICATIONS).
Methotrexate is excreted to a significant extent by the kidneys, thus in patients with renal impairment, doses may need to be adjusted to prevent accumulation of drug (see Recommended Dose and Dosage Adjustments for recommended starting doses in renally impaired patients).
Methotrexate elimination is reduced in patients with a third distribution space (ascites, pleural effusions). Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of methotrexate administration.
5 to 25 mg per week until adequate response is achieved. 5 mg of methotrexate once weekly. Dosages in each schedule may be gradually adjusted to achieve optimal clinical response; 25 mg/week should not be exceeded. Serious Warnings and Precautions • METHOTREXATE SUBCUTANEOUS (methotrexate injection) should be prescribed only by physicians whose knowledge and experience includes the use of immunosuppressant therapy because of the possibility of serious toxic reactions (see 7 WARNINGS AND PRECAUTIONS- General).
1 Pregnant Women). Therefore, use is contraindicated for women of childbearing potential until pregnancy is excluded and pregnant patients (see 2 CONTRAINDICATIONS). • METHOTREXATE SUBCUTANEOUS must be administered only once a week. Dosage errors in the use of METHOTREXATE SUBCUTANEOUS (methotrexate injection) can result in serious adverse reactions, including death.
1 Adverse Reaction Overview In general, the incidence and severity of acute side effects are related to dose, frequency of administration, and the duration of the exposure to significant blood levels of methotrexate to the target organs.
The most serious reactions are discussed in 7 WARNINGS AND PRECAUTIONS. That section should also be consulted when looking for information about adverse reactions with methotrexate. The most frequently reported adverse reactions include ulcerative stomatitis, leucopenia, nausea, and abdominal distress.
Other frequently reported adverse effects are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection. Adverse Drug Reactions by Organ System Blood and lymphatic system disorders Leukopenia, anaemia, thrombocytopenia, pancytopenia, agranulocytosis and severe courses of bone marrow depression, lymphoproliferative disorders.
Cardiac disorders Pericarditis, pericardial effusion and pericardial tamponade. Eye disorders Visual disturbances and retinopathy. Gastrointestinal disorders Stomatitis, dyspepsia, nausea, loss of appetite, oral ulcers, diarrhoea, pharyngitis, enteritis, vomiting, gastrointestinal ulcers, haematemesis, haematorrhea and toxic megacolon.
General disorders and administration site conditions Allergic reactions, anaphylactic shock, allergic vasculitis, fever, conjunctivitis, infection, sepsis, wound-healing impairment, hypogammaglobulinaemia and local damage (formation of sterile abscess, lipodystrophy) of injection site following intramuscular or subcutaneous administration.
Hepatobiliary disorders Elevated transaminases, cirrhosis, fibrosis and fatty degeneration of the liver, decrease in serum albumin, acute hepatitis and hepatic failure. Metabolism and nutrition disorders Precipitation of diabetes mellitus.
1 Special Populations, and 4 DOSAGE AND ADMINISTRATION). • Pregnancy: Methotrexate can cause fetal death, embryotoxicity, abortion or teratogenic effects when administered to a pregnant woman. • Women of childbearing potential should not be started on methotrexate until pregnancy is excluded and should be fully counselled on the serious risk to the fetus should they become pregnant while undergoing treatment.
Pregnancy should be avoided if either partner is receiving methotrexate (see 7 WARNINGS AND PRECAUTIONS). • Breast-feeding mothers: Due to the potential for serious adverse reactions in breast fed infants. • Patients with alcoholism, alcoholic liver disease or other chronic liver disease.
• Patients with overt or laboratory evidence of immunodeficiency syndromes. • Patients with pre-existing blood dyscrasias, such as bone marrow hypoplasia, leucopenia, thrombocytopenia or significant anemia. 4 Drug-Drug Interactions).
1 Dosing Considerations METHOTREXATE SUBCUTANEOUS should only be prescribed by physicians with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy. METHOTREXATE SUBCUTANEOUS is contraindicated in patients with severe renal impairment (see 2 CONTRAINDICATIONS).
Methotrexate is excreted to a significant extent by the kidneys, thus in patients with renal impairment, doses may need to be adjusted to prevent accumulation of drug (see Recommended Dose and Dosage Adjustments for recommended starting doses in renally impaired patients).
Methotrexate elimination is reduced in patients with a third distribution space (ascites, pleural effusions). Such patients require especially careful monitoring for toxicity, and require dose reduction or, in some cases, discontinuation of methotrexate administration.
5 to 25 mg per week until adequate response is achieved. 5 mg of methotrexate once weekly. Dosages in each schedule may be gradually adjusted to achieve optimal clinical response; 25 mg/week should not be exceeded. Serious Warnings and Precautions • METHOTREXATE SUBCUTANEOUS (methotrexate injection) should be prescribed only by physicians whose knowledge and experience includes the use of immunosuppressant therapy because of the possibility of serious toxic reactions (see 7 WARNINGS AND PRECAUTIONS- General).
METHOTREXATE SUBCUTANEOUS (methotrexate 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 the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section.
1 Special Populations, and
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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METHOTREXATE SUBCUTANEOUS (Methotrexate Injection BP) Page 6 of 45 Protected B / Protégé B Once optimal clinical response has been achieved, the dosage schedule should be reduced to the lowest possible amount of drug and to the longest possible rest period.
The use of METHOTREXATE SUBCUTANEOUS may permit the return to conventional topical therapy, which should be encouraged. 5 to 25 mg per week until adequate response is achieved. Dosages in each schedule may be gradually adjusted to achieve optimal clinical response.
5 mg of methotrexate once weekly. 5 mg per week. A weekly dose of 25 mg should not be exceeded. Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more. Upon achieving the therapeutically desired result, the dose should be reduced gradually to the lowest possible effective maintenance dose.
Special Populations Renal Impairment:
METHOTREXATE SUBCUTANEOUS is contraindicated in patients with severe renal impairment (see 2 CONTRAINDICATIONS). Methotrexate is excreted to a significant extent by the kidneys, thus in patients with renal impairment, the health care provider may need to adjust the dose to prevent accumulation of drug.
The table below provides recommended starting doses in renally impaired patients; dosing may need further adjustment due to wide intersubject pK variability. Table 1 - Dose Adjustments in Patients with Renal Insufficiency Creatinine Clearance % Standard Dose to Administer (mL/min) >80 Full Dose 80 75 60 63 50 56 <50 Use alternative therapy Hepatic Impairment: METHOTREXATE SUBCUTANEOUS is contraindicated in patients with alcoholic liver disease or other chronic liver disease.
Patients with obesity, diabetes, hepatic fibrosis or steatohepatitis are at increased risk for hepatic injury and fibrosis secondary to methotrexate, and should be monitored closely. 3 Pediatrics). METHOTREXATE SUBCUTANEOUS (Methotrexate Injection BP) Page 7 of 45 Protected B / Protégé B Geriatrics (≥65 years of age): Due to diminished hepatic and renal function as well as decreased folate stores in elderly population, relatively low doses (especially in rheumatoid arthritis and psoriasis indications) should be considered and these patients should be closely monitored for early signs of toxicity.
See the table above for reduced doses in patients with renal impairment. 3 Reconstitution […]
Musculoskeletal and connective tissue disorders Arthralgia, myalgia and osteoporosis, osteonecrosis of jaw (secondary to lymphoproliferative disorders). Neoplasms benign, malignant and unspecified (including cysts and polyps) Lymphoma/Lymphoproliferative disorders: there have been reports of individual cases of lymphoma and other lymphoproliferative disorders which subsided in a number of cases once treatment with methotrexate had been discontinued.
METHOTREXATE SUBCUTANEOUS (Methotrexate Injection BP) Page 17 of 45 Protected B / Protégé B Nervous system disorders Headache, tiredness, drowsiness, dizziness, confusion, depression, impaired vision, pain, muscular asthenia or paraesthesia/hypoaesthesia, changes in sense of taste (metallic taste), convulsions, meningism, paralysis and leukoencephalopathy.
Renal and urinary disorders Renal failure, severe nephropathy or renal failure, azotemia, dysuria, cystitis, hematuria, urogenital dysfunction. Proteinuria has also been observed. Reproductive system and breast disorders Inflammation and ulceration of the vagina, loss of libido, impotence, gynaecomastia, oligospermia, impaired menstruation and vaginal discharge.
Respiratory, thoracic and mediastinal disorders Pneumonia, interstitial alveolitis/pneumonitis often associated with eosinophilia, symptoms indicating potentially severe lung injury (interstitial pneumonitis) are: dry, not productive cough, short of breath and fever, pulmonary fibrosis, Pneumocystis jirovecii pneumonia, shortness of breath and bronchial asthma, pleural effusion, epistaxis, and pulmonary alveolar haemorrhage.
Skin and subcutaneous tissue disorders Exanthema, erythema, pruritus, photosensitisation, loss of hair, increase in rheumatic nodules, herpes zoster, vasculitis, herpetiform eruptions of the skin, urticarial, increased pigmentation, acne, ecchymosis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell’s syndrome), increased pigmentary changes of the nails, acute paronychia, furunculosis and telangiectasia.
Vascular disorders Hypotension and thromboembolic events. Other Adverse Drug Reactions Adverse Reactions Reported in Rheumatoid Arthritis Incidence greater than 10%: elevated liver enzymes 15%, nausea/vomiting 10%. Incidence 3% to 10%: stomatitis, thrombocytopenia.
Incidence 1% to 3%: rash/pruritus/dermatitis, alopecia, diarrhea, dizziness, leucopenia and pancytopenia. Adverse Reactions in Psoriasis The adverse reaction rates reported are very similar to those in the rheumatoid arthritis studies.
Rarely, painful psoriatic plaque erosions may appear. 2 Clinical Trial Adverse Reactions Not applicable. 3 Less Common Clinical Trial Adverse Reactions Not applicable. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other METHOTREXATE SUBCUTANEOUS (Methotrexate Injection BP) Page 18 of 45 Protected B / Protégé B Quantitative Data Abnormal hematologic and clinical chemistry findings are discussed in 7 WARNINGS AND PRECAUTIONS – Monitoring and Laboratory Tests.
5 Post-Market Adverse Reactions Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The following adverse events have also been reported during post-marketing experience with methotrexate: Table 3 Post-Market Adverse Reactions System Organ Class Adverse Reaction Infections and Infestations Infections (including fatal sepsis); Pneumonia; Pneumocystis jirovecii pneumonia; Nocardiosis; Histoplasmosis; Cryptococcosis; Herpes zoster; H.
simplex hepatitis; Disseminated H. simplex; Cytomegalovirus infection (including cytomegaloviral pneumonia); Reactivation of hepatitis B infection or other inactive chronic infection; Worsening of hepatitis C infection Blood and Lymphatic System Disorders Agranulocytosis; Pancytopenia; Leukopenia; Neutropenia; Lymphadenopathy and lymphoproliferative disorders (including reversible); Eosinophilia; Anemia megaloblastic; Renal vein thrombosis; Lymphoma; Aplastic anemia; Hypogammaglobulinemia Nervous System Disorders CSF pressure increased; Neurotoxicity; […]
1 Pregnant Women). Therefore, use is contraindicated for women of childbearing potential until pregnancy is excluded and pregnant patients (see 2 CONTRAINDICATIONS). • METHOTREXATE SUBCUTANEOUS must be administered only once a week. Dosage errors in the use of METHOTREXATE SUBCUTANEOUS (methotrexate injection) can result in serious adverse reactions, including death.
METHOTREXATE SUBCUTANEOUS (Methotrexate Injection BP) Page 6 of 45 Protected B / Protégé B Once optimal clinical response has been achieved, the dosage schedule should be reduced to the lowest possible amount of drug and to the longest possible rest period.
The use of METHOTREXATE SUBCUTANEOUS may permit the return to conventional topical therapy, which should be encouraged. 5 to 25 mg per week until adequate response is achieved. Dosages in each schedule may be gradually adjusted to achieve optimal clinical response.
5 mg of methotrexate once weekly. 5 mg per week. A weekly dose of 25 mg should not be exceeded. Therapeutic response usually begins within 3 to 6 weeks and the patient may continue to improve for another 12 weeks or more. Upon achieving the therapeutically desired result, the dose should be reduced gradually to the lowest possible effective maintenance dose.
Special Populations Renal Impairment:
METHOTREXATE SUBCUTANEOUS is contraindicated in patients with severe renal impairment (see 2 CONTRAINDICATIONS). Methotrexate is excreted to a significant extent by the kidneys, thus in patients with renal impairment, the health care provider may need to adjust the dose to prevent accumulation of drug.
The table below provides recommended starting doses in renally impaired patients; dosing may need further adjustment due to wide intersubject pK variability. Table 1 - Dose Adjustments in Patients with Renal Insufficiency Creatinine Clearance % Standard Dose to Administer (mL/min) >80 Full Dose 80 75 60 63 50 56 <50 Use alternative therapy Hepatic Impairment: METHOTREXATE SUBCUTANEOUS is contraindicated in patients with alcoholic liver disease or other chronic liver disease.
Patients with obesity, diabetes, hepatic fibrosis or steatohepatitis are at increased risk for hepatic injury and fibrosis secondary to methotrexate, and should be monitored closely. 3 Pediatrics). METHOTREXATE SUBCUTANEOUS (Methotrexate Injection BP) Page 7 of 45 Protected B / Protégé B Geriatrics (≥65 years of age): Due to diminished hepatic and renal function as well as decreased folate stores in elderly population, relatively low doses (especially in rheumatoid arthritis and psoriasis indications) should be considered and these patients should be closely monitored for early signs of toxicity.
See the table above for reduced […]