Revisions

To ensure that we are providing our clients with the industry's best and most current clinical information, we complete a "post-publication" process and receive feedback regarding opportunities to add additional information or, in rare cases, make revisions.

Below is information on revisions, corrections, or modifications to existing monographs that have been identified in the past 12 months.

Mometasone Furoate Oral Inhalation – January 2020

Revision in the Maximum Dose field of the Mometasone Furoate Oral Inhalation monograph in the Drug Facts & Comparisons database, available online.

The monograph previously read:

Maximum Dose (only portion of field impacted is presented):

Asmanex HFA (metered-dose inhaler)

Adults and pediatric patients ≥5 years of age

800 mcg/day.

It has been revised to read:

Maximum Dose (only portion of field impacted is presented):

Asmanex HFA (metered-dose inhaler)

Adults and pediatric patients ≥12 years of age

800 mcg/day.

Pediatric patients 5 to <12 years of age

200 mcg/day.

These changes have been automatically posted online.

Obinutuzumab – January 2020

Revision in the Dosing: Adult field of the Obinutuzumab monograph in the Drug Facts & Comparisons database, available online.

The monograph previously read:

Dosing: Adult (only portion of field impacted is presented):

Off label

Chronic lymphocytic leukemia, previously untreated

In combination with ibrutinib

Concomitant therapy

Ibrutinib is continued until disease progression or unacceptable toxicity.

Cycle 1

100 mg IV on day 1, followed by 900 mg IV on day 2, followed by 1,000 mg IV weekly for 2 doses (days 8 and 15); treatment cycle is 28 days.

Cycles 2 to 8

1,000 mg IV on day 1 every 28 days for 5 doses.

It has been revised to read:

Dosing: Adult (only portion of field impacted is presented):

Off label

Chronic lymphocytic leukemia, previously untreated

In combination with ibrutinib

Concomitant therapy

Ibrutinib is continued until disease progression or unacceptable toxicity.

Cycle 1

100 mg IV on day 1, followed by 900 mg IV on day 2, followed by 1,000 mg IV weekly for 2 doses (days 8 and 15); treatment cycle is 28 days.

Cycles 2 to 6

1,000 mg IV on day 1 every 28 days for 5 doses.

These changes have been automatically posted online.

Ribociclib – September 2019

Revision in the Dosing: Adjustment for Toxicity: Adult field of the Ribociclib monograph in the Lexi-Drugs database, available online and in mobile apps, as well as the following publications: Drug Information Handbook 28th edition, Drug Information Handbook with International Trade Names Index 27th edition, and Drug Information Handbook for Oncology 16th edition.

The monograph previously read:

Dosing: Adjustment for Toxicity: Adult (only portion of field impacted is presented):

Nonhematologic toxicity:

Cardiovascular: QT prolongation:

QTcF >480 msec: Interrupt treatment; when QTcF resolves to <481 msec, may resume ribociclib at the same dose level. If QTcF ≥481 msec recurs, interrupt treatment until QTcF resolves to <481 msec and resume ribociclib at the next lower dose level.

It has been revised to read:

Dosing: Adjustment for Toxicity: Adult (only portion of field impacted is presented):

Nonhematologic toxicity:

Cardiovascular: QT prolongation:

QTcF >480 msec: Interrupt treatment; when QTcF resolves to <481 msec, may resume ribociclib at the next lower dose level. If QTcF ≥481 msec recurs, interrupt treatment until QTcF resolves to <481 msec and resume ribociclib at the next lower dose level.

These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.

Ribociclib Oral – September 2019

Revision in the Dosing: Adult field of the Ribociclib Oral monograph in the Drug Facts & Comparisons database.

The monograph previously read:

Dosage: Adult (only portion of field impacted is presented):

Ribociclib Dose Modification and Management for QT Prolongation(1)

ECGs with QTcF >480 msec

Interrupt ribociclib treatment

If QTcF prolongation resolves to <481 msec, resume ribociclib treatment at the same dose level;

If QTcF ≥481 msec recurs, interrupt dose until QTcF resolves to <481 msec; then resume ribociclib at next lower dose level.

ECGs with QTcF >500 msec

Interrupt ribociclib treatment if QTcF >500 msec.

If QTcF prolongation resolves to <481 msec, resume ribociclib treatment at the next lower dose level.

Permanently discontinue ribociclib if QTcF interval prolongation is either >500 msec or >60 msec change from baseline AND associated with any of the following: torsades de pointes, polymorphic ventricular tachycardia, unexplained syncope, or signs/symptoms of serious arrhythmia.

It has been revised to read:

Dosage: Adult (only portion of field impacted is presented):

Ribociclib Dose Modification and Management for QT Prolongation(1)

ECGs with QTcF >480 msec

Interrupt ribociclib treatment

If QTcF prolongation resolves to <481 msec, resume ribociclib treatment at the next lower dose level;

If QTcF ≥481 msec recurs, interrupt dose until QTcF resolves to <481 msec; then resume ribociclib at next lower dose level.

ECGs with QTcF >500 msec

Interrupt ribociclib treatment if QTcF >500 msec.

If QTcF prolongation resolves to <481 msec, resume ribociclib treatment at the next lower dose level.

Permanently discontinue ribociclib if QTcF interval prolongation is either >500 msec or >60 msec change from baseline AND associated with any of the following: torsades de pointes, polymorphic ventricular tachycardia, unexplained syncope, or signs/symptoms of serious arrhythmia.

These changes have been automatically posted online.

Lenograstim – June 2019

Revision in the Dosing: Adult field of the Lenograstim monograph in the Lexi-Drugs Multinational database, available online and in mobile apps.

The monograph previously read:

Dosing: Adult (only portion of field impacted is presented):

Peripheral blood progenitor cell (PBPC) transplantation, mobilization: Adults ≤60 years:

Following chemotherapy: SubQ: 150 mcg/m2 or 5 mcg/kg once or twice daily, initiate within 1 to 5 days after chemotherapy. Maximum daily dose: 10 mcg/kg daily. May adjust dose based on clinical response. Discontinue treatment after the expected nadir and the neutrophil count normalizes, after the last leukopheresis, or if during treatment the WBC count exceeds 75,000/mm3.

Lenograstim monotherapy without chemotherapy or PBPC mobilization in healthy donors: SubQ: 10 mcg/kg daily for 4 to 6 days; some manufacturers also recommend up to 10 mcg/kg twice daily. May adjust dose based on clinical response. Discontinue if during treatment the WBC count exceeds 75,000/mm3.

It has been revised to read:

Dosing: Adult (only portion of field impacted is presented):

Peripheral blood progenitor cell (PBPC) transplantation, mobilization: Adults ≤60 years:

Following chemotherapy: SubQ: 150 mcg/m2 or 5 mcg/kg daily, initiate within 1 to 5 days after chemotherapy. Maximum daily dose: 10 mcg/kg daily. May adjust dose based on clinical response. Discontinue treatment after the expected nadir and the neutrophil count normalizes, after the last leukopheresis, or if during treatment the WBC count exceeds 75,000/mm3.

Lenograstim monotherapy without chemotherapy or PBPC mobilization in healthy donors: SubQ: 10 mcg/kg daily for 4 to 6 days. May adjust dose based on clinical response. Discontinue if during treatment the WBC count exceeds 75,000/mm3.

These changes have been automatically posted to online and mobile app databases. Please update your mobile application to get the updated monograph.

Ampicillin and Sulbactam – April 2019

Revision in the Dosing: Adult field of the Ampicillin and Sulbactam monograph in the Lexi-Drugs database, available online and in mobile apps.

The monograph previously read:

Field Name (only portion of field impacted is presented):

Peritonitis associated with CAPD:

Intraperitoneal:

Intermittent: 3 g added to one exchange every 12 hours; allow to dwell for at least 6 hours (Blackwell 1990; Li 2010)

Continuous: Loading dose: 1.5 g per liter of dialysate; maintenance dose: 150 mg per liter of dialysate (Li 2010)

It has been revised to read:

Field Name (only portion of field impacted is presented):

Peritonitis associated with CAPD:

Intraperitoneal:

Intermittent: 3 g added to one exchange every 12 hours; allow to dwell for at least 6 hours (Blackwell 1990; ISPD [Li 2016])

Continuous: Loading dose: 750 mg to 1 g per liter of dialysate; maintenance dose: 100 mg per liter of dialysate (ISPD [Li 2016]; Lam 2008)

These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.