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| Brand name | AUBAGIO®1 | AVONEX®2 | BETASERON®3 | COPAXONE®4 20 mg | COPAXONE®4 40 mg | GILENYA®5 | GLATECT™6 | KESIMPTA™7 | LEMTRADA®8 | MAVENCLAD®9 | OCREVUS®10 | PLEGRIDY®11 | REBIF®12 | TECFIDERA®13 | TYSABRI®14 | ZEPOSIA®15 |
| Non-proprietary name (Therapeutic classification) | Teriflunomide (Immunomodulator agent) | Interferon beta-1a (Immunomodulator) | Interferon beta-1b (Immunomodulator) | Glatiramer acetate (Immunomodulator) | Glatiramer acetate (Immunomodulator) | Fingolimod hydrochloride (Sphingosine 1-phosphate receptor modulator) |
Glatiramer acetate (Immunomodulator) | Ofatumumab (Selective immunomodulator) | Alemtuzumab (Selective Immunomodulator) | Cladribine (Selective Immunosuppressant) | Ocrelizumab (Selective Immunomodulator) | Peginterferon beta-1a (Immunomodulator) | Interferon beta-1a (Immunomodulator) | Dimethyl fumarate (Other nervous system drug) | Natalizumab (Selective adhesion molecule inhibitor) | Ozanimod hydrochloride (Sphingosine 1-phosphate receptor modulator) |
| Manufacturer | Sanofi Genzyme, a division of sanofi-aventis Canada Inc. | Biogen Canada Inc. | Bayer Inc. | Teva Canada | Teva Canada | Novartis Pharmaceuticals Canada Inc. | Pharmascience Inc. | Novartis Pharmaceuticals Canada Inc. | Sanofi Genzyme Canada, a division of sanofi-aventis Canada Inc. | EMD Serono, a division of EMD Inc., Canada | Hoffman-La Roche Limited | Biogen Canada Inc. | EMD Serono, a division of EMD Inc., Canada | Biogen Canada Inc. | Biogen Canada Inc. | Celgene Inc |
| Available dosage forms/Strengths | Tablet: 14 mg | Pre-filled syringe and auto-injector: 30 μg/0.5 mL |
Vial: 0.3 mg | Pre-filled syringes: 20 mg/1 mL and 40 mg/1 mL | Pre-filled syringes: 20 mg/1 mL and 40 mg/1 mL | Capsule: 0.5 mg | Pre-filled syringe: 20 mg/1 mL | Pre-filled syringe*: 20mg/0.4 mL * Pre-filled syringes are not available in Canada. |
Vial: 12 mg/1.2 mL | Tablet: 10 mg | Vial: 300 mg/10 mL | Starter pack: Pre-filled syringes and pens: 63 µg/0.5 mL and 94 µg/0.5 mL Pre-filled syringe and pen: 125 µg/0.5 mL | Pre-filled syringes: 22 μg/0.5 mL and 44 μg/0.5 mL Pre-filled cartridges: 66 μg/1.5 mL (delivers 3 doses of 22 μg/0.5 mL) and 132 μg/1.5 mL (delivers 3 doses of 44 μg/0.5 mL) |
Capsules: 120 and 240 mg | Vial: 300 mg/15 mL | Capsules: 0.23 mg, 0.46 mg and 0.92 mg |
| Route of administration | Oral tablets | IM injection (into the muscle) |
SC injection (under the skin) |
SC injection (under the skin) |
SC injection (under the skin) |
Oral capsules | SC injection (under the skin) |
SC injection (under the skin) | IV infusion (into the vein) |
Oral tablets | IV infusion (into the vein) |
SC injection (under the skin) |
SC injection (under the skin) |
Delayed-release oral capsules | IV infusion (into the vein) |
Oral capsules |
| Frequency | 1 X every day | 1 X per week | 1 X every other day | 1 X every day | 3 X per week and ≥48 hours apart | 1 X every day | 1 X every day | Initial dosing: 1 X at weeks 0, 1 and 2. Subsequent dosing: 1 X monthly starting at week 4. | Initial treatment course: 5 consecutive days Second treatment course: Administered 12 months after the initial treatment for 3 consecutive days | 1 X every day for 4 or 5 consecutive days at the beginning of each of the first 2 months of years 1 and 2 of treatment | Second dose 2 weeks after the 1st dose, then 1 X every 6 months. A minimum interval of 5 months should be maintained between each dose of OCREVUS. | 1 X every 2 weeks | 3 X per week | 2 X every day | 1 X every 4 weeks | 1 X every day |
| Recommended dose and dosage adjustment | Relapsing-remitting MS: 14 mg/day. | Relapsing MS: 30 μg/week. May be started at a 1/4 dose of ≈7.5 μg and the dose may be increased by ≈7.5 μg per week for the next 3 weeks until the recommended full dose of 30 μg/week is achieved. Relapsing progressive MS or secondary progressive MS with recurrent attacks of neurological dysfunction: Could benefit from an increase of their dose of up to 60 μg/week. Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is also advised to assist in decreasing flu-like symptoms. | Relapsing-remitting and secondary progressive MS: 0.25 mg (8 MIU) every other day.
Dose titration used at the start of treatment in CIS and secondary-progressive MS studies: In the study in patients with a single clinical event suggestive of MS (CIS), dosage was increased: Treatment day 1, 3, 5: 0.0625 mg (2 MIU) Treatment day 7, 9, 11: 0.125 mg (4 MIU) Treatment day 13, 15, 17: 0.1875 mg (6 MIU) Treatment day ≥19: 0.250 mg (8 MIU) In the secondary-progressive MS study, patients initiated treatment with 1/2 dose (4 MIU every other day) for a period of 2 weeks prior to escalating to the recommended dose of 8 MIU every other day. |
Relapsing-remitting MS: 20 mg/mL: Administer 1 X per day. COPAXONE 20 and 40 mg/mL are not interchangeable. | Relapsing-remitting MS: 40 mg/mL: Administer 3 X per week; ≥48 hours apart. COPAXONE 20 and 40 mg/mL are not interchangeable. | Relapsing-remitting MS: 0.5 mg/day. | Relapsing-remitting MS: 20 mg/day. | Relapsing-remitting MS: Initial dosing of 20 mg at weeks 0, 1 and 2, followed by subsequent monthly dosing of 20 mg starting at week 4. The first injection should be performed under the guidance of an experienced health professional. | Relapsing-remitting MS: 12 mg /day. Initial treatment course: 5 consecutive days (60 mg total dose). Second treatment course: Administered 12 months after the initial treatment for 3 consecutive days (36 mg total dose). Patients should be pre-medicated with corticosteroids immediately prior to the initiation of the infusion for the first 3 days of any treatment course to ameliorate the effects of infusion reactions. Pre-treatment with antihistamines and/or antipyretics prior to 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. | Relapsing-remitting MS: 10 or 20 mg depending on body weight. Recommended cumulative dose of 3.5 mg/kg body weight over 2 years (1.75 mg/kg/year). | Relapsing-remitting MS and primary progressive MS: Initial dose, 300 mg IV infusion, followed 2 weeks later by a second 300 mg IV infusion. Subsequent doses: Single 600 mg IV infusion every 6 months. *Patients need to be observed for at least one hour after the completion of the infusion. Pre-medicate with 100 mg IV of methyl-prednisolone (or an equivalent corticosteroid) approximately 30 minutes prior to each infusion and an anti-histamine approximately 30-60 minutes prior to each infusion to reduce the frequency and severity of infusion reactions. The addition of an antipyretic (e.g., acetaminophen) may also be considered. | Relapsing-remitting MS: 63 µg at dose 1 (on day 0) increasing to 94 µg at dose 2 (on day 14) reaching the full dose of 125 µg by dose 3 (on day 28) and continuing with the full dose (125 µg) every 14 days (2 weeks) thereafter. Dose titration at initiation can help ameliorate flu-like symptoms that can occur at treatment initiation with interferons. Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment. | Relapsing-remitting MS: 44 μg 3 X per week. The dose can be reduced to 22 μg 3 X per week if the patient is not able to tolerate the higher dose. Single demyelinating event: 44 μg 3 X per week. When first starting treatment, it is recommended that 20% of the total dose be administered during the initial 2 weeks of therapy, 50% of the total dose be administered in week 3 and 4, and the full dose from the fifth week onwards. Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms. | Relapsing-remitting MS: Initial dose: 120 mg 2 X per day. Usual dose: After 7 days, increase to 240 mg 2 X per day. Temporary dose reduction to 120 mg 2 X per day may reduce the occurrence of flushing and GI side effects. Administration of 325 mg non-enteric coated ASA prior to dosing reduced the occurrence and severity of flushing in a 4-day healthy volunteer study. Longer term use of ASA to manage flushing has not been studied and is not recommended. | Relapsing-remitting MS: 300 mg IV every 4 weeks. | Relapsing-remitting MS: Initial dose: 0.23 mg 1 X daily on days 1-4 and 0.46 mg 1 X daily on days 5-7. Maintenance dose: 0.92 mg 1 X daily on days 8 and thereafter. |
| Routine Monitoring and laboratory testing | ||||||||||||||||
| Prior to initiating | Obtain CBC before initiation. | The following laboratory tests are recommended prior to initiating BETASERON therapy:
A pregnancy test, chest roentgenogram and ECG should also be performed prior to initiating BETASERON therapy. |
Prior to initiating treatment with COPAXONE, serum aminotransferase, alkaline phosphatase and total bilirubin levels should be obtained (within 6 months) for all patients. | Prior to initiating treatment with COPAXONE, serum aminotransferase, alkaline phosphatase and total bilirubin levels should be obtained (within 6 months) for all patients. | The following laboratory tests are recommended prior to initiating GILENYA treatment:
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Prior to initiating treatment with GLATECT, serum aminotransferase, alkaline phosphatase and total bilirubin levels should be obtained (within 6 months) for all patients. | Prior to initiating KESIMPTA, perform Hepatitis B virus (HBV) screening.
Determine immunization status.
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Prior to initiating LEMTRADA, the following laboratory tests are recommended:
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Before initiating treatment with MAVENCLAD:
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Prior to initiating OCREVUS, perform Hepatitis B virus (HBV) screening.
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Monitor CBC and differential white blood cell counts, platelet counts, blood chemistry, including liver function tests. Patients with myelosuppression may require more intensive monitoring of CBC, with differential and platelet counts. | When initiating REBIF therapy, the following tests are recommended:
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Prior to initiating treatment with TECFIDERA:
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Prior to initiating treatment with TYSABRI, a recent magnetic resonance image (MRI) should be available. Monitor serum hepatic enzymes, transaminases and total bilirubin. Testing for serum anti-JCV antibody status: prior to initiating therapy and in patients with unknown antibody status. | Prior to initiating treatment with ZEPOSIA, the following assessments should be done:
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| First-dose monitoring | Obtain an ECG and measure BP prior to and 6 hours after the first dose. Continuous ECG monitoring as clinically indicated. | An ECG should be done and assessed before each treatment course. Active observation in the clinic is recommended during and for at least 2 hours after each infusion or longer, at the discretion of the physician. | Obtain an ECG at the end of the 6-hour observation period. Further ECG, pulse and blood pressure as clinically indicated. Continued monitoring is required as clinically indicated. | |||||||||||||
| General blood tests — complete blood counts (CBC) | Obtain CBC before initiation and periodically during treatment. Further monitoring as clinically indicated. | CBC with white blood cell differential, platelet counts, and blood chemistries: Baseline, months 1, 3, 6 and every 6 months thereafter. More intensive monitoring of CBCs, with differential and platelet counts as clinically indicated. | Hemoglobin, complete and differential white blood cell counts, platelet counts and blood chemistries: Prior to initiation and periodically thereafter. More intensive monitoring of CBCs, with differential and platelet counts as clinically indicated. | Obtain a CBC before initiating treatment if no recent (i.e. within 6 months or after discontinuation of prior therapy) result is available. | Serum creatinine levels should be obtained prior to initiation of treatment and at monthly intervals thereafter until 48 months after the last infusion and at any time afterwards if clinically indicated. CBC with differential should be obtained prior to initiation of treatment and at monthly intervals thereafter until 48 months after the last infusion. CBC should be obtained immediately if clinically indicated. | CBC, including lymphocyte count, before starting therapy if no recent (i.e., within 6 months or after discontinuation of prior therapy) result is available.
Lymphocyte counts must be determined:
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Complete and differential white blood cell counts, platelet counts, and blood chemistry are recommended during therapy. More intensive monitoring of CBCs, with differential and platelet counts as clinically indicated. Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts. | CBC with white blood cell differential, and platelet counts: Baseline, months 1, 3, 6 and every 6 months thereafter. | Obtain CBC, including lymphocytes, if no recent (within 6 months) result is available.
A CBC, including lymphocytes, is recommended after 6 months of treatment, then every 6-12 months, and as clinically indicated. |
Obtain a recent (i.e., within 6 months or after discontinuation of prior MS therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Assessments of CBC are also recommended periodically during treatment. | ||||||
| Thyroid function tests | Baseline and every 6 months thereafter. | Baseline and if abnormal, every 6-12 months following initiation of therapy and as clinically indicated. | Thyroid function tests, such as thyroid stimulating hormone levels, should be obtained prior to initiation of treatment and every 3 months thereafter until 48 months after the last infusion. Testing should be performed as clinically indicated at any time during or after treatment. | Thyroid function tests should be performed according to standard medical practice. | Thyroid function test should be done at baseline, every 6 months and more frequently as clinically indicated. | |||||||||||
| Blood pressure (BP) | Check BP prior to initiation and periodically thereafter. Blood pressure should be appropriately managed during treatment with AUBAGIO. | Measure BP prior to and 6 hours after the first dose and monitor regularly afterwards. | Perform continuous/frequent (at least every hour) monitoring of heart rate, blood pressure and overall clinical status of the patients. | Blood pressure should be monitored regularly during treatment and managed appropriately. | ||||||||||||
| Cardiovascular tests | ECG prior to initiation. | Obtain an ECG prior to and 6 hours after the first dose. Hourly pulse and BP measurement, for at least 6 hours after the first dose. Continuous ECG monitoring as clinically indicated. | An ECG should be done and assessed before each treatment course. | Obtain an ECG at the end of the 6-hour observation period. Further ECG, pulse and blood pressure as clinically indicated. Continued monitoring is required as clinically indicated. | ||||||||||||
| Pulmonary testing/Monitoring | Prior to initiation, screen patients for latent tuberculosis infection. | Chest roentgenogram prior to initiation. | Spirometric evaluation of respiratory function and evaluation of DLCO should be performed during therapy with GILENYA if clinically indicated. | Before initiating therapy, all patients must be evaluated for both active and inactive (“latent”) tuberculosis infection. | All patients must be evaluated for both active and inactive (“latent”) tuberculosis infection. | |||||||||||
| Ophthalmic evaluation | Ophthalmic evaluation should be performed 3-4 months after treatment initiation and more frequently as clinically indicated. | Ophthalmic evaluation should be performed prior to initiating and during treatment. | ||||||||||||||
| IgG antibody testing | VZV screening prior to treatment initiation. | Perform testing for quantitative serum immunoglobulins prior to treatment initiation. | VZV screening prior to treatment initiation. | VZV screening prior to treatment initiation. | VZV screening prior to treatment initiation. | |||||||||||
| Vaccination | Determine HPV immunization status Determine general immunization status for pediatric patients (10 to < 18 years of age) prior to therapy. | Determine immunization status | Confirm routine immunizations completed at least 6 weeks prior to treatment. | Confirm routine immunizations completed at least 6 weeks prior to treatment. | Confirm routine immunizations completed at least 6 weeks prior to treatment. | Vaccination against human papilloma virus (HPV) should be considered before initiating treatment with ZEPOSIA. | ||||||||||
| Testing for anti-JCV antibody | Testing for serum anti-JCV antibody status (using STRATIFY JCV™ assay) prior to initiating therapy or in patients receiving TYSABRI with an unknown antibody status is recommended. In addition, anti-JCV antibody retesting is recommended for patients with anti-JCV antibody negative status and for those anti-JCV antibody positive patients with lower index value, since the antibody status or index value may change. Retesting of patients who are anti-JCV antibody negative, every 6 months, is recommended. Patients with lower index values who have not had prior immunosuppressant (IS) use should be retested periodically (e.g., every 6 months). | |||||||||||||||
| Magnetic resonance imaging (MRI) tests | Before initiating treatment with GILENYA, a recent MRI should be available. Further monitoring with MRI as clinically necessary. | MRI at treatment initiation. Further MRI investigation as clinically indicated | When switching from another MS agent, a baseline MRI is recommended. | MRI as clinically indicated. | Before initiation of treatment a recent MRI scan should be available. More frequent monitoring (e.g., every 3-6 months) should be considered as clinically indicated. | |||||||||||
| IRIS (Immune Reconstitution Inflammatory Syndrome) | Monitoring for development of IRIS and appropriate treatment of the associated inflammatory reaction involving the brain should be undertaken. | |||||||||||||||
| Liver function/Enzyme tests | Obtain transaminase and bilirubin levels within 6 months before initiation. Monitor ALT levels at least monthly for 6 months after starting therapy. | Baseline, every month for the first 6 months, and every 6 months thereafter. If ALT rises >5 X ULN, discontinuation or interruption should be considered. | Baseline, every month for the first 6 months of treatment, and at 6-month intervals thereafter. If ALT levels increase >5 X ULN, consider dose reduction or discontinuation of therapy. |
Liver transaminases should be checked (within 6 months) before initiating treatment. During treatment, evaluation of transaminases is recommended, as clinically relevant. | Liver transaminases should be checked (within 6 months) before initiating treatment. During treatment, evaluation of transaminases is recommended, as clinically relevant. | Obtain transaminase and bilirubin levels:
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Liver transaminases should be checked (within 6 months) before initiating treatment. Evaluation of transaminases is recommended during treatment, as clinically relevant. | Perform HBV screening prior to initiating treatment. | All patients must be evaluated for HBV and HCV. Screening patients at high risk of HBV and/or HCV infection before initiation should be considered and caution should be exercised in prescribing to patients identified as carriers of HBV and/or HCV, as these patients may be at risk of irreversible liver damage relative to a potential virus reactivation as a consequence of their pre-existing status. | Obtain serum aminotransferase, alkaline phosphatase, and total bilirubin levels prior to initiation of therapy in year 1 and year 2. All patients must be evaluated for hepatitis B and C virus (HBV and HCV). | HBV screening should be performed in all patients before initiation of treatment. Patients with HBV should not be treated with OCREVUS. | Liver function tests are recommended during therapy. | Baseline, every month for the first 6 months, and every 6 months thereafter. If ALT levels >5 X ULN, consider dose modification. | Liver transaminases should be checked (within 6 months) before initiating treatment. During treatment, evaluation of transaminases is recommended after 6 months of treatment, then every 6-12 months, and as clinically indicated. | Monitor serum hepatic enzymes, transaminases and total bilirubin prior to initiation of treatment as well as during and after treatment, as clinically indicated. | Obtain recent (i.e., within last 6 months) transaminase and bilirubin levels before initiation of treatment. Liver transaminases and bilirubin levels should be evaluated within the first 3 months after initiating treatment and periodically or as clinically indicated thereafter. For liver transaminase levels >5 X ULN, more frequent monitoring should be instituted, including serum bilirubin and alkaline phosphatase measurement. Monitor for signs and symptoms of liver injury. . |
| Infection | Sexually active female patients should be screened annually for HPV | Monitor for signs and symptoms of infections regularly during treatment. | ||||||||||||||
| Skin | Monitor for suspicious skin lesions before initiating treatment with GILENYA, particularly in patients with risk factors for skin cancer. | Perform baseline and yearly skin exams. | Monitor for suspicious skin lesions regularly during treatment with ZEPOSIA, particularly in patients with risk factors for skin cancer. | |||||||||||||
| Urinalysis | Urinalysis with urine cell counts should be conducted prior to treatment initiation and at monthly intervals thereafter until 48 months after the last infusion, and at any time afterwards, or more frequently as clinically indicated. | Urinalysis should be performed before initiating treatment, after 6 months of treatment, then every 6-12 months, and as clinically indicated. |
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| Pregnancy | Pregnancy must be excluded before start of treatment. | A pregnancy test should be performed prior to initiating BETASERON therapy. | A negative pregnancy must be confirmed prior to starting treatment. | Pregnancy must be excluded before the initiation of MAVENCLAD in year 1 and year 2. | Pregnancy must be excluded before start of treatment and a negative pregnancy test result must be available. | |||||||||||
| Patient support program | MS One to One® 1 855 671-2663 |
Biogen ONE® 1 855 676-6300 |
Betaplus® 1 800 977-2770 |
Shared Solutions® 1 800 283-0034 |
Shared Solutions® 1 800 283-0034 |
Gilenya® Go ProgramTM 1 855 745-5467 |
ALLY Patient Support Program 1 833 255-9100 |
Kesimpta™ Go Program™ 1 866 841-5518 1 (855) 745‑5467 |
MS One to One® 1 855 671-2663 |
AdvevaTM 1 888 677-3243 |
CompassTM 1 888 334-5956 |
Biogen ONE® 1 855 676-6300 |
AdvevaTM 1 888 677-3243 |
Biogen ONE®
1 855 676-6300 |
Biogen ONE®
1 855 676-6300 |
be. Your Patient Support Program for Zeposia 1 833 951-2478 |