Loading…
METHOFILL SELF-DOSE INJECTOR 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: Methofill Self-Dose Injector (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 in adult patients Severe disabling rheumatoid arthritis (RA) in adult patients…
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. 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 mg increments. 5 to 25 mg per week until adequate response is achieved.
5 mg of methotrexate once weekly. 5 mg per week to achieve optimal clinical response. A weekly dose of 25 mg should not be exceeded. 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 Methofill Self-Dose Injector may permit the return to conventional topical therapy, which should be encouraged. 5 to 25 mg per week until adequate response is achieved. 5 mg of methotrexate once weekly. 5 mg per week to achieve optimal clinical response.
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:
Methofill Self-Dose Injector 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 mild or moderate renal impairment the health professional may need to adjust the dose to prevent accumulation of drug.
Table 1, 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 Impairment Creatinine Clearance (mL/min) % Standard Dose to Administer ≥ 90 Full Dose 60-89 75 30-59 50 < 30 Must not be used; use alternative therapy Methofill Self-Dose Injector – Methotrexate (as methotrexate sodium) Injection Page 7 of 44 Hepatic Impairment: Methofill Self-Dose Injector is contraindicated in patients with alcoholic liver disease or other chronic liver disease (see 2 CONTRAINDICATIONS).
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. The most frequently reported adverse reactions with methotrexate include elevated liver enzymes (15%), nausea/vomiting (10%), ulcerative stomatitis (3% to 10%), thrombocytopenia (3% to 10%), leukopenia (1-3%), rash/pruritus/dermatitis (1-3%), alopecia (1-3%), diarrhea (1- Methofill Self-Dose Injector – Methotrexate (as methotrexate sodium) Injection Page 18 of 44 3%), dizziness (1-3%), pancytopenia (1-3%), and abdominal distress/dyspepsia.
Other frequently reported adverse effects are malaise, undue fatigue, chills and fever, and decreased resistance to infection. Rarely, painful psoriatic plaque erosions may appear. Table 3 provides an overview of additional adverse reactions observed with methotrexate use.
Table 3 – Adverse Drug Reactions by Organ System Blood and lymphatic system disorders Anaemia, 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 Loss of appetite, oral ulcers, pharyngitis, enteritis, gastrointestinal ulcers, haematemesis, haematorrhea and toxic megacolon. General disorders and administration site conditions Allergic reactions, anaphylactic shock, allergic vasculitis, conjunctivitis, sepsis, wound-healing impairment, hypogammaglobulinaemia and local damage (formation of sterile abscess, lipodystrophy) of injection site following intramuscular or subcutaneous administration.
Hepatobiliary disorders 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. Musculoskeletal and connective tissue disorders Arthralgia, myalgia and osteoporosis, osteonecrosis of jaw (secondary to lymphoproliferative disorders).
3 Pharmacokinetics, Special Populations and Conditions). 1 Pregnant Women). 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.
1 Pregnant Women). 2 Breast-feeding). Patients with alcoholism, alcoholic liver disease or other chronic liver disease (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). Patients with overt or laboratory evidence of immunodeficiency syndromes (see 7 WARNINGS AND PRECAUTIONS, Immune).
Patients with pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia (see 7 WARNINGS AND PRECAUTIONS, Hematologic). 4 Drug- Drug Interactions). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Methofill Self-Dose Injector (methotrexate injection) should be prescribed only by health professionals 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 for pregnant patients (see 2 CONTRAINDICATIONS). Methofill Self-Dose Injector must be administered only once a week.
Dosage errors in the use of Methofill Self-Dose Injector (methotrexate injection) can result in serious adverse reactions, including death. 1 Dosing Considerations Parenteral drug products should be inspected visually for particulate matter and discolouration prior to administration, whenever solution and container permit.
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.
Methofill Self-Dose Injector (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 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section.
3 Pharmacokinetics, Special Populations and Conditions). 1 Pregnant Women). 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.
1 Pregnant Women). 2 Breast-feeding). Patients with alcoholism, alcoholic liver disease or other chronic liver disease (see 7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic). Patients with overt or laboratory evidence of immunodeficiency syndromes (see 7 WARNINGS AND PRECAUTIONS, Immune).
Patients with pre-existing blood dyscrasias, such as bone marrow hypoplasia, leukopenia, thrombocytopenia or significant anemia (see 7 WARNINGS AND PRECAUTIONS, Hematologic). 4 Drug- Drug Interactions).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Methotrexate in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Pediatrics (<18 years of age):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥65 years of age):
Due to diminished hepatic and renal function as well as decreased folate stores in elderly population, relatively low doses should be considered (especially in rheumatoid arthritis and psoriasis indications) and these patients should be closely monitored for early signs of toxicity.
See Table 1 for reduced doses in patients with renal impairment. 4 Administration Methofill Self-Dose Injector is injected once weekly. Methofill Self-Dose Injector should only be prescribed by health professionals with expertise in the use of methotrexate and a full understanding of the risks of methotrexate therapy.
The administration should routinely be done by health professionals. The treating health professional can, in selected cases for whom it is appropriate, delegate the subcutaneous administration to the patients themselves or to a caregiver.
In these cases, patients or caregivers must receive proper training on how to prepare and correctly administer Methofill Self-Dose Injector. At minimum, the first injection of Methofill Self-Dose Injector should be performed under direct medical supervision.
ca), which can be used as reminder of the day for each weekly dose, and main symptoms of overdose. Methofill Self-Dose Injector solution should be yellowish in colour and should be clear with no particles in it. Visually inspect Methofill Self-Dose Injector for particulate matter and discolouration prior to administration.
5 Missed Dose If a scheduled dose is missed, the next dose should be given as soon as possible. However, the total weekly dose should not exceed 25 mg.
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.
Nervous system disorders Headache, tiredness, 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. Methofill Self-Dose Injector – Methotrexate (as methotrexate sodium) Injection Page 19 of 44 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, 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. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other 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 4 – Adverse Drug Reactions by System Organ Class Reported Post-Market System Organ Class Adverse Reaction Blood and lymphatic system disorders Anemia megaloblastic; aplastic anemia; eosinophilia; hypogammaglobulinemia; lymphadenopathy; neutropenia; renal vein thrombosis Eye disorders Transient blindness/vision loss Gastrointestinal disorders Abdominal pain; gingivitis; glossitis; intestinal perforation; noninfectious peritonitis; pancreatitis Methofill Self-Dose Injector – Methotrexate (as methotrexate sodium) Injection Page 20 of 44 System Organ Class Adverse Reaction General disorders and administration site conditions Anaphylactic reactions; asthenia; malaise; pyrexia; swelling/edema at sites independent of injection Hepatobiliary disorders Abnormal liver function tests (increased alanine transaminase, aspartate transaminase, alkaline phosphatase, and bilirubin); hepatic failure Infections and infestations Cryptococcosis; cytomegalovirus infection (including cytomegaloviral pneumonia); disseminated H.
simplex; H. simplex hepatitis; herpes zoster; histoplasmosis; infections (including fatal sepsis); nocardiosis; Pneumocystis jirovecii pneumonia; pneumonia; reactivation of hepatitis B infection or other inactive chronic infection; worsening of hepatitis C infection Musculoskeletal and connective tissue […]
5 mg increments. 5 to 25 mg per week until adequate response is achieved. 5 mg of methotrexate once weekly. 5 mg per week to achieve optimal clinical response. A weekly dose of 25 mg should not be exceeded. 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 Methofill Self-Dose Injector may permit the return to conventional topical therapy, which should be encouraged. 5 to 25 mg per week until adequate response is achieved. 5 mg of methotrexate once weekly. 5 mg per week to achieve optimal clinical response.
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:
Methofill Self-Dose Injector 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 mild or moderate renal impairment the health professional may need to adjust the dose to prevent accumulation of drug.
Table 1, 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 Impairment Creatinine Clearance (mL/min) % Standard Dose to Administer ≥ 90 Full Dose 60-89 75 30-59 50 < 30 Must not be used; use alternative therapy Methofill Self-Dose Injector – Methotrexate (as methotrexate sodium) Injection Page 7 of 44 Hepatic Impairment: Methofill Self-Dose Injector is contraindicated in patients with alcoholic liver disease or other chronic liver disease (see 2 CONTRAINDICATIONS).
Pediatrics (<18 years of age):
No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
Geriatrics (≥65 years of age):
Due to diminished hepatic and renal function as well as decreased folate stores in elderly population, relatively low doses […]