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MABCAMPATH 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: MabCampath (alemtuzumab) is indicated for: • the treatment of patients with previously untreated progressive B-CLL. • the treatment of B-CLL patients who have been treated with alkylating agents and who have failed fludarabine therapy. The effectiveness of MabCampath as a single agent for the treatment of patients…
Verbatim from this product's HC label. Tap a section to expand.
). • Infections, Opportunistic Infections: Serious, sometimes fatal, bacterial, viral, fungal, and protozoan infections have been reported in patients receiving MabCampath therapy. Patients should be monitored for signs or symptoms of any infection.
Prophylaxis directed against Pneumocystis jiroveci pneumonia (PCP) and herpes virus infections has been shown to decrease, but not eliminate, the occurrence of these infections. Anti-viral prophylaxis is strongly recommended. ) • Progressive Multifocal Leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has been reported in patients with B-CLL with or without treatment with MabCampath.
The frequency of PML in B-CLL patients treated with MabCampath is no greater than the background frequency. Patients should be monitored for any new sign or symptom that may be suggestive of PML. MabCampath dosing should be withheld immediately at the first sign or symptom suggestive of PML (see 7 WARNINGS AND PRECAUTIONS: Progressive Multifocal Leukoencephalopathy).
Warnings and Precautions, including the serious Warnings and Precautions, apply to all patients (previously untreated and previously treated) who receive MabCampath.
Product Monograph Master Template Template Date:
September 2020 MabCampath (alemtuzumab) Page 6 of 59 4 DOSAGE AND ADMINISTRATION All Dosage and Administration recommendations apply to previously untreated and previously treated B-CLL patients. 1 Dosing Considerations MabCampath (alemtuzumab) should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.
2 Recommended Dose and Dosage Adjustment MabCampath therapy should be initiated at a dose of 3 mg administered as a two hour IV infusion daily (see 8 ADVERSE REACTIONS). , infusion- related toxicities are Grade 2), the daily dose should be escalated to 10 mg and continued until tolerated.
When the 10 mg dose is tolerated, the maintenance dose of MabCampath 30 mg may be initiated. , Monday, Wednesday, and Friday) for up to 12 weeks. In most patients, escalation to 30 mg can be accomplished in three to seven days. Dose escalation to the recommended maintenance dose of 30 mg administered three times per week is required.
Single doses of MabCampath greater than 30 mg or cumulative weekly doses of greater than 90 mg should not be administered since higher doses are associated with an increased incidence of pancytopenia. (see 3 SERIOUS WARNINGS AND PRECATUONS BOX).
). , infusion- related toxicities are Grade 2), the daily dose should be escalated to 10 mg and continued until tolerated. When the 10 mg dose is tolerated, the maintenance dose of MabCampath 30 mg may be initiated. , Monday, Wednesday, and Friday) for up to 12 weeks.
In most patients, escalation to 30 mg can be accomplished in three to seven days. Dose escalation to the recommended maintenance dose of 30 mg administered three times per week is required. Single doses of MabCampath greater than 30 mg or cumulative weekly doses of greater than 90 mg should not be administered since higher doses are associated with an increased incidence of pancytopenia.
(see 3 SERIOUS WARNINGS AND PRECATUONS BOX). MabCampath should be administered intravenously only. The infusion should be administered over a two hour period. DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS.
Recommended Concomitant Medications:
Premedication should be given prior to the first dose, at dose escalations, and as clinically indicated. The premedication used in clinical studies was diphenhydramine 50 mg and acetaminophen 500-1000 mg administered 30 minutes prior to MabCampath infusion.
, glucocorticoids, epinephrine, meperidine) for infusion reactions as needed. For patients who experience an infusion reaction physicians may consider glucocorticoids and/or meperidine as additional premedication for subsequent doses, as clinically indicated.
In the clinical study in previously untreated patients, if grade 3 or 4 infusion-related adverse events were not prevented or ameliorated sufficiently with the protocol-recommended premedications, meperidine 25 mg or hydrocortisone 200 mg IV (or equivalent) given 1 hour prior to MabCampath administration may have been of benefit.
) • Progressive Multifocal Leukoencephalopathy: Progressive multifocal leukoencephalopathy (PML) has been reported in patients with B-CLL with or without treatment with MabCampath. The frequency of PML in B-CLL patients treated with MabCampath is no greater than the background frequency.
Patients should be monitored for any new sign or symptom that may be suggestive of PML. MabCampath dosing should be withheld immediately at the first sign or symptom suggestive of PML (see 7 WARNINGS AND PRECAUTIONS: Progressive Multifocal Leukoencephalopathy).
Warnings and Precautions, including the serious Warnings and Precautions, apply to all patients (previously untreated and previously treated) who receive MabCampath.
Product Monograph Master Template Template Date:
September 2020 MabCampath (alemtuzumab) Page 6 of 59 4 DOSAGE AND ADMINISTRATION All Dosage and Administration recommendations apply to previously untreated and previously treated B-CLL patients. 1 Dosing Considerations MabCampath (alemtuzumab) should be administered under the supervision of a physician experienced in the use of antineoplastic therapy.
2 Recommended Dose and Dosage Adjustment MabCampath therapy should be initiated at a dose of 3 mg administered as a two hour IV infusion daily (see
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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MabCampath should be administered intravenously only. The infusion should be administered over a two hour period. DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS.
Recommended Concomitant Medications:
Premedication should be given prior to the first dose, at dose escalations, and as clinically indicated. The premedication used in clinical studies was diphenhydramine 50 mg and acetaminophen 500-1000 mg administered 30 minutes prior to MabCampath infusion.
, glucocorticoids, epinephrine, meperidine) for infusion reactions as needed. For patients who experience an infusion reaction physicians may consider glucocorticoids and/or meperidine as additional premedication for subsequent doses, as clinically indicated.
In the clinical study in previously untreated patients, if grade 3 or 4 infusion-related adverse events were not prevented or ameliorated sufficiently with the protocol-recommended premedications, meperidine 25 mg or hydrocortisone 200 mg IV (or equivalent) given 1 hour prior to MabCampath administration may have been of benefit.
Thirty six percent of previously untreated patients treated with MabCampath and 14% of patients treated with chlorambucil received concomitant glucocorticoid therapy (see 8 ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).
It is strongly recommended that patients should receive anti-infective prophylaxis to minimize the risks of serious opportunistic infections (see 3 SERIOUS WARNINGS AND PRECATUONS BOX). Administer trimethoprim/sulfamethoxazole DS twice daily (BID) three times per week (or equivalent) as PCP prophylaxis and famciclovir 250 mg twice a day (BID) or equivalent as herpetic prophylaxis upon Product Monograph Master Template Template Date: September 2020 MabCampath (alemtuzumab) Page 7 of 59 initiation of MabCampath therapy.
Prophylaxis should be continued for a minimum of two months after completion of MabCampath therapy or until the CD4+ count is 200 cells/L, whichever occurs later. See 7 WARNINGS AND PRECAUTIONS, Immunosuppression/Opportunistic Infections for information on cytomegalovirus (CMV) management.
The use of allopurinol and hydration to reduce the risk of tumor lysis syndrome is recommended. In the clinical study in previously untreated patients, allopurinol was administered orally at a dose of 300 mg per day beginning 1 day before MabCampath treatment began and for the next 14 days for the first month.
Allopurinol could be administered thereafter as clinically indicated.
Dose Modification and Reinitiation of Therapy:
MabCampath therapy should be withheld during serious infection or other serious adverse reactions until the event resolves (see 7 WARNINGS AND PRECAUTIONS). MabCampath therapy should be discontinued if evidence of autoimmune anemia or autoimmune thrombocytopenia appears.
Table1 includes recommendations for dose modification for neutropenia or thrombocytopenia.
Table 1:
Dose Modification for Neutropenia and Thrombocytopenia Hematologic Values Dose Modification* Absolute Neutrophil Count (ANC) < 250/L and/or platelet count 25,000/L For first occurrence Withhold MabCampath therapy. Resume MabCampath therapy at 30 mg when ANC 500/L and platelet count 50,000/L.
For second occurrence Withhold […]
Thirty six percent of previously untreated patients treated with MabCampath and 14% of patients treated with chlorambucil received concomitant glucocorticoid therapy (see 8 ADVERSE REACTIONS, Clinical Trial Adverse Drug Reactions).
It is strongly recommended that patients should receive anti-infective prophylaxis to minimize the risks of serious opportunistic infections (see 3 SERIOUS WARNINGS AND PRECATUONS BOX). Administer trimethoprim/sulfamethoxazole DS twice daily (BID) three times per week (or equivalent) as PCP prophylaxis and famciclovir 250 mg twice a day (BID) or equivalent as herpetic prophylaxis upon Product Monograph Master Template Template Date: September 2020 MabCampath (alemtuzumab) Page 7 of 59 initiation of MabCampath therapy.
Prophylaxis should be continued for a minimum of two months after completion of MabCampath therapy or until the CD4+ count is 200 cells/L, whichever occurs later. See 7 WARNINGS AND PRECAUTIONS, Immunosuppression/Opportunistic Infections for information on cytomegalovirus (CMV) management.
The use of allopurinol and hydration to reduce the risk of tumor lysis syndrome is recommended. In the clinical study in previously untreated patients, allopurinol was administered orally at a dose of 300 mg per day beginning 1 day before MabCampath treatment began and for the next 14 days for the first month.
Allopurinol could be administered thereafter as clinically indicated.
Dose Modification and Reinitiation of Therapy:
MabCampath therapy should be withheld during serious infection or other serious adverse reactions until the event resolves (see 7 WARNINGS AND PRECAUTIONS). MabCampath therapy should be discontinued if evidence of autoimmune anemia or autoimmune thrombocytopenia appears.
Table1 includes recommendations for dose modification for neutropenia or thrombocytopenia.
Table 1:
Dose Modification for Neutropenia and Thrombocytopenia Hematologic Values Dose Modification* Absolute Neutrophil Count (ANC) < 250/L and/or platelet count 25,000/L For first occurrence Withhold MabCampath therapy. Resume MabCampath therapy at 30 mg when ANC 500/L and platelet count 50,000/L.
For second occurrence Withhold MabCampath therapy. Resume MabCampath therapy at 10 mg when ANC 500/L and platelet count 50, 000/L. For third occurrence Discontinue MabCampath therapy. ≥ 50% decrease from baseline value in patients initiating therapy with a baseline ANC 250/L and/or a baseline platelet count 25,000/L Product Monograph Master Template Template Date: September 2020 MabCampath (alemtuzumab) Page 8 of 59 For first occurrence Withhold MabCampath therapy.
Resume MabCampath at 30 mg upon return to baseline value(s). For second occurrence Withhold MabCampath therapy. Resume MabCampath at 10 mg upon return to baseline value(s). For third occurrence Discontinue MabCampath therapy. *If the delay between dosing is ≥ 7 days, initiate therapy at MabCampath 3 mg and escalate to 10 mg and then to 30 mg as tolerated (see 4 DOSAGE AND ADMINISTRATION) There are no dose modifications recommended for lymphopenia.
3 Reconstitution Parenteral drug products should be inspected for visible particulate matter and discoloration prior to administration. If particulate matter is present or the solution is discolored, the 30 mg/mL vial should not be used.
DO NOT SHAKE VIAL PRIOR TO USE. As with all parenteral drug products, aseptic technique should be used during the preparation and administration of MabCampath. 1 mL for the 30 mg dose (as shown below). 9% Sodium Chloride USP or 5% Dextrose in Water USP.
Gently invert the bag to mix the solution. Discard syringe. 10 mg […]