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LEMTRADA is a brand name for Alemtuzumab, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: LEMTRADA (alemtuzumab for injection) is indicated for the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with highly active disease defined by clinical and imaging features, despite an adequate course of treatment with at least two other disease modifying treatments (DMTs), or where…
Verbatim from this product's HC label. Tap a section to expand.
). Specific pre-medication should be administered before injecting LEMTRADA (see 4 DOSAGE AND ADMINISTRATION). Administer LEMTRADA in a setting in which equipment and personnel are available to appropriately manage anaphylaxis, serious infusion reactions, myocardial ischemia, myocardial infarction, and cerebrovascular adverse reactions.
Patients treated with LEMTRADA must be given the ‘Patient Alert Card’, ‘Patient Guide’ and package leaflet, and be informed about the risks of LEMTRADA. Safety and efficacy in patients with chronic progressive multiple sclerosis, and in geriatric or pediatric patients, have not been established.
The efficacy of LEMTRADA for treatment duration beyond 2 years has not been determined. 1 Special Populations). 1 Special Populations). 2 CONTRAINDICATIONS LEMTRADA is contraindicated in: • Patients who are hypersensitive to alemtuzumab or to any ingredient in the formulation or component of the container.
For a complete listing, see
). PML has been reported in patients with B-CLL with or without treatment with alemtuzumab, and in patients with multiple sclerosis treated with certain immunosuppressants. The frequency of PML in B-CLL patients treated with MabCampath is no greater than the background frequency.
Therefore, healthcare professionals should monitor patients on LEMTRADA for any new sign or symptom suggestive of PML. LEMTRADA dosing should be withheld immediately at the first sign or symptom suggestive of PML. 1 Dosing Considerations LEMTRADA treatment should be initiated and supervised by a neurologist experienced in the treatment of patients with MS.
Specialists and equipment required for the timely diagnosis and treatment of the LEMTRADA® (alemtuzumab for injection) Page 7 of 54 most frequent adverse reactions (especially autoimmune conditions including infusion reactions and infections) should be available.
Resources for the treatment of hypersensitivity and anaphylactic reactions should be immediately available. Patients treated with LEMTRADA must be given the Patient Alert Card and Patient Guide and be informed about the risks of LEMTRADA (see also package leaflet).
Specific pre-medication should be provided prior LEMTRADA administration (see Recommended Concomitant Medication). LEMTRADA should be administered under the supervision of a physician experienced in the use of immunomodulating therapies.
2 Recommended Dose and Dosage Adjustment The recommended dose of LEMTRADA is 12 mg/day administered by intravenous (IV) infusion for 2 treatment courses: • Initial/ First Treatment Course: 12 mg/day for 5 consecutive days (60 mg total dose) • Second Treatment Course: 12 mg/day for 3 consecutive days (36 mg total dose) administered 12 months after the first initial treatment course.
LEMTRADA should be administered as an IV infusion over a period of approximately 4 hours. Do not administer as IV push or bolus. No dosage adjustment required in hepatic or renal impairment. Health Canada has not authorized an indication for pediatric use (see 1 INDICATIONS).
and 4 DOSAGE AND ADMINISTRATION). Specific pre-medication should be administered before injecting LEMTRADA (see 4 DOSAGE AND ADMINISTRATION). Administer LEMTRADA in a setting in which equipment and personnel are available to appropriately manage anaphylaxis, serious infusion reactions, myocardial ischemia, myocardial infarction, and cerebrovascular adverse reactions.
Patients treated with LEMTRADA must be given the ‘Patient Alert Card’, ‘Patient Guide’ and package leaflet, and be informed about the risks of LEMTRADA. Safety and efficacy in patients with chronic progressive multiple sclerosis, and in geriatric or pediatric patients, have not been established.
The efficacy of LEMTRADA for treatment duration beyond 2 years has not been determined. 1 Special Populations). 1 Special Populations). 2 CONTRAINDICATIONS LEMTRADA is contraindicated in: • Patients who are hypersensitive to alemtuzumab or to any ingredient in the formulation or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Patients who are infected with Human Immunodeficiency Virus (HIV) • Patients who have active or latent tuberculosis (see 7 WARNINGS AND PRECAUTIONS, Infections) • Patients who have severe active infections (see 7 WARNINGS AND PRECAUTIONS, Infections).
• Patients with active malignancies. LEMTRADA® (alemtuzumab for injection) Page 5 of 54 • Patients on antineoplastic or immunosuppressive therapies. • Patients with a history of progressive multifocal leukoencephalopathy (PML) • Patients with a history of stroke and arterial dissection of cervicocephalic arteries (see 7 WARNINGS AND PRECAUTIONS, Stroke, Cervicocephalic Arterial Dissection, Myocardial ischemia and Myocardial Infarction).
• Patients with uncontrolled hypertension • Patients with a history of angina pectoris or myocardial infarction • Patients with known coagulopathy or on concomitant anti-platelet or anti-coagulant therapy LEMTRADA® (alemtuzumab for injection) Page 6 of 54 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • LEMTRADA causes serious and life-threatening infusion reactions.
LEMTRADA is contraindicated in: • Patients who are hypersensitive to alemtuzumab or to any ingredient in the formulation or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Patients who are infected with Human Immunodeficiency Virus (HIV) • Patients who have active or latent tuberculosis (see 7 WARNINGS AND PRECAUTIONS, Infections) • Patients who have severe active infections (see 7 WARNINGS AND PRECAUTIONS, Infections).
• Patients with active malignancies. LEMTRADA® (alemtuzumab for injection) Page 5 of 54 • Patients on antineoplastic or immunosuppressive therapies. • Patients with a history of progressive multifocal leukoencephalopathy (PML) • Patients with a history of stroke and arterial dissection of cervicocephalic arteries (see 7 WARNINGS AND PRECAUTIONS, Stroke, Cervicocephalic Arterial Dissection, Myocardial ischemia and Myocardial Infarction).
• Patients with uncontrolled hypertension • Patients with a history of angina pectoris or myocardial infarction • Patients with known coagulopathy or on concomitant anti-platelet or anti-coagulant therapy LEMTRADA® (alemtuzumab for injection) Page 6 of 54
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Alemtuzumab in Canada.
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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.
Recommended Concomitant Medications:
Patients should be premedicated with corticosteroids immediately prior to LEMTRADA administration for the first 3 days of any treatment course (see 7 WARNINGS AND PRECAUTIONS, General, Infusion Associated Reactions). In clinical trials, patients were pretreated with 1,000 mg methylprednisolone for the first 3 days of each LEMTRADA treatment course.
Pretreatment with antihistamines and/or antipyretics prior to LEMTRADA administration may also be considered. Oral prophylaxis for herpes infection should be administered to all patients starting on the first day of each treatment course and continuing for a minimum of 1 month following treatment with LEMTRADA (see 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance, Infections).
In clinical trials, patients were administered acyclovir 200 mg BID or equivalent. 4 Administration Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use if particulate matter is present or the solution is discolored.
Do not freeze or shake vials prior to use. Protect from light. 2 Ml of LEMTRADA from the vial into a syringe using aseptic technique. 9% Sodium Chloride USP or 5% Dextrose in Water USP. Gently LEMTRADA® (alemtuzumab for injection) Page 8 of 54 invert the bag to mix the solution.
Care should be taken to ensure the sterility of the prepared solution, particularly as it contains no antimicrobial preservatives. Each vial is intended for single use only. LEMTRADA diluted product may be stored at room temperature (15° to 25°C) or refrigerated conditions (2° to 8°C).
The LEMTRADA diluted product should be used within 8 hours after dilution. Protect from light. Partially used, unused, or damaged drug vials should be disposed according to institutional policies. There are no known incompatibilities between LEMTRADA and polyvinyl chloride (PVC) infusion bags, PVC or polyethylene-lined PVC administration sets, or low protein binding filters.
In the absence of compatibility studies, LEMTRADA should not be mixed with other medicinal products. Do not add or simultaneously infuse other drug substances through the same intravenous line. 5 Missed Dose Missed doses should not be given on the same day as a scheduled dose.
, total dose for initial treatment) in a single infusion and experienced serious reactions (headache, rash, and either hypotension or sinus tachycardia). Doses of LEMTRADA greater than those tested in clinical studies may increase the intensity and/or duration of infusion-associated adverse reactions or its immune effects.
There is no known antidote for LEMTRADA overdosage. Treatment consists of drug discontinuation and supportive therapy. For management of a suspected drug overdose, contact your regional poison control centre. LEMTRADA® (alemtuzumab for injection) Page 9 of 54 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING To help ensure the traceability of biologic products, including biosimilars, health professionals should recognise the importance of recording both the brand name and the non-proprietary (active ingredient) name as well as other product-specific identifiers such as the Drug Identification Number (DIN) and the batch/lot number of the product supplied.
Table 1:
Dosage Forms, Strengths, Composition and Packaging LEMTRADA is provided as a sterile, clear, colorless to slightly yellow, preservative-free, concentrate solution that must be diluted prior to IV infusion. It is filled in a clear, single use, 2 Ml glass vial, with a latex-free stopper.
2 Ml of 10 mg/Ml solution (12 mg LEMTRADA). Each carton contains a single LEMTRADA vial. 0 mL of […]
LEMTRADA must be administered in a setting with appropriate equipment and personnel to manage anaphylaxis or serious infusion reactions. Monitor patients for two hours after each infusion. Make patients aware that serious infusion reactions can also occur after the 2-hour monitoring period.
g. vertebral, carotid) arterial dissection, pulmonary alveolar hemorrhage, myocardial ischemia and myocardial infarction have been reported within 1-3 days of LEMTRADA administration. Instruct patients to seek immediate medical attention if symptoms of these conditions occur.
• LEMTRADA may cause increased risk of malignancies, including thyroid cancer, melanoma, and lymphoproliferative disorders. Perform baseline and yearly skin exams. • Serious, including fatal, autoimmune and immune mediated conditions such as immune thrombocytopenic purpura, autoimmune hepatitis and hepatic injury, Hemophagocytic lymphohistiocytosis (HLH) and anti-glomerular basement membrane disease can occur in patients receiving LEMTRADA.
Complete blood counts with differential, serum creatinine levels, and urinalysis with urine cell counts should be monitored at monthly intervals in patients who have received LEMTRADA. Serum transaminases (ALT and AST) and total bilirubin levels should be evaluated prior to starting treatment and periodically thereafter as per clinical judgment.
• Infections, including Opportunistic Infections: Serious and sometimes fatal viral, bacterial, protozoan, and fungal infections, including those due to reactivation of latent infections, have been reported in non-MS patients treated with alemtuzumab at higher and more frequent doses than used in MS.
Physicians should consider delaying initiation of LEMTRADA administration in patients with active infection until the infection is fully controlled. Anti-viral prophylaxis is strongly recommended. (See 7 WARNINGS AND PRECAUTIONS: Infections) o Progressive multifocal leukoencephalopathy (PML) is an opportunistic infection caused by the JC virus which causes serious disability or death (see 7 WARNINGS AND PRECAUTIONS, Infections; 2 CONTRAINDICATIONS;