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.

Interferon Alfa-2a – June 2020

Revision in the Dosing: Adult field of the Interferon Alfa-2a 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):

Adjunct to chemotherapy: Usual dose: 6 million units given concomitantly with chemotherapy on days 22 to 26 of each 28-day cycle.

It has been revised to read:

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

Adjunct to chemotherapy: Usual dose: 6 million units/m2 once daily on days 22 to 26 of each 28-day cycle (in combination with chemotherapy).

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

Pralatrexate Injection – June 2020

Revision in the Dosage: Adult field of the Pralatrexate Injection monograph in the Drug Facts & Comparisons database, available online.

The monograph previously read:

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

Pralatrexate Dose Modifications for Hematologic Toxicities(1)

Blood cell count on day of treatment

Duration of toxicity

Action

Dose upon restart

Dose upon restart in patients with severe renal impairment

Platelet < 50,000/mm3

1 wk

Omit dose

Continue prior dose

Continue prior dose

2 wks

Omit dose

10 mg/m2

20 mg/m2

3 wks

Stop therapy

It has been revised to read:

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

Pralatrexate Dose Modifications for Hematologic Toxicities(1)

Blood cell count on day of treatment

Duration of toxicity

Action

Dose upon restart

Dose upon restart in patients with severe renal impairment

Platelet < 50,000/mm3

1 wk

Omit dose

Continue prior dose

Continue prior dose

2 wks

Omit dose

20 mg/m2

10 mg/m2

3 wks

Stop therapy

These changes have been automatically posted online.

Amoxicillin and Clavulanate – June 2020

Revision in the Dosing: Adult field of the Amoxicillin and Clavulanate monograph in the Lexi-Drugs, Pediatric & Neonatal Lexi-Drugs, and Drug Facts & Comparisons databases, available online and in mobile apps.

The monograph previously read:

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

Neutropenic fever, low-risk cancer patients (empiric therapy) (off-label use): Oral: Immediate release: 500 mg every 8 hours (Freifeld 1999; Kern 1999) or 1000 mg every 12 hours (Kern 2013). Combine either dosing regimen with oral ciprofloxacin; continue until resolution of fever and neutropenia.

It has been revised to read:

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

Neutropenic fever, low-risk cancer patients (empiric therapy) (off-label use): Oral: Immediate release: 500 mg every 8 hours (Freifeld 1999; Kern 1999) or 875 mg every 12 hours (Kern 2013). Combine either dosing regimen with oral ciprofloxacin; continue until resolution of fever and neutropenia.

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

Butalbital, Acetaminophen, and Caffeine – May 2020

Revision in the Dosing: Pediatric field of the Butalbital, Acetaminophen, and Caffeine monograph in the Lexi-Drugs and Pediatric & Neonatal Lexi-Drugs databases, available online and in mobile apps.

The monograph previously read:

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

Headache, tension or muscle contraction: Note: Dosing based on products containing: Butalbital 50 mg, acetaminophen 325 mg, and caffeine 40 mg per tablet/capsule or per 15 mL (Vtol LQ).

Children ≥12 years and Adolescents:

Capsules, tablets: Oral: 1 to 2 tablets or capsules every 4 hours as needed; maximum daily dose: 6 tablets or capsules/day.

Solution (Vtol LQ): Oral: 15 to 30 mL every 4 hours as needed; maximum daily dose: 180 mL/day.

It has been revised to read:

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

Headache, tension or muscle contraction: Note: Dosing based on products containing: Butalbital 50 mg, acetaminophen 325 mg, and caffeine 40 mg per tablet/capsule or per 15 mL (Vtol LQ).

Children ≥12 years and Adolescents:

Capsules, tablets: Oral: 1 to 2 tablets or capsules every 4 hours as needed; maximum daily dose: 6 tablets or capsules/day.

Solution (Vtol LQ): Oral: 15 to 30 mL every 4 hours as needed; maximum daily dose: 90 mL/day.

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

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.