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.
Vinblastine – June 2024
Revision in the Dosing: Hepatic Impairment field of the Vinblastine monograph in the Lexi-Drugs and Drug Facts and Comparisons databases, available online and in mobile apps, as well as the following print publications: Pediatric & Neonatal Dosage Handbook 30th edition; Drug Information Handbook for Oncology 17th edition.
The monograph previously read:
Dosing: Hepatic Impairment: Adult and Pediatric (only portion of field impacted is presented):
Toxicity may be increased in patients with hepatic dysfunction. The manufacturer’s labeling recommends the following adjustment:
Serum bilirubin >3 mg/dL: Administer 50% of dose.
The following adjustments have also been recommended (Floyd 2006, Superfin 2007):
Serum bilirubin 1.5 to 3 mg/dL or transaminases 2 to 3 times ULN: Administer 50% of dose.
Serum bilirubin >3 times ULN: Avoid use.
It has been revised to read:
Dosing: Hepatic Impairment: Adult and Pediatric (only portion of field impacted is presented):
Toxicity may be increased in patients with hepatic dysfunction (manufacturer’s labeling).
Serum bilirubin 1.5 to 3 mg/dL: Reduce dose by 50% (Floyd 2006, Superfin 2007).
Serum bilirubin >3 mg/dL: Conflicting information exists; some sources recommend to avoid use (Floyd 2006, Superfin 2007), while other sources suggest reducing the dose by 50% (Krens 2019, manufacturer’s labeling).
Transaminases 2 to 3 times ULN: Administer 50% of dose (Floyd 2006).
Transaminases >3 times ULN: Avoid use (Floyd 2006).
These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.
Alteplase – April 2024
Revision in the Alteplase IV Compatibility with D5W (Dextrose 5% in Water) monograph in the Trissel’s IV Compatibility database, available online and in mobile apps.
The monograph previously read (only portion of table impacted is presented):
| Study | Drug 1 |
| Study 3 | Alteplase 0.05 mg/mL |
It has been revised to read (only portion of table impacted is presented):
| Study | Drug 1 |
| Study 3 | Alteplase 0.5 mg/mL |
These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.
Nadroparin – March 2024
Revision in the Dosing: Adult field of the Nadroparin monograph in the Lexi-Drugs database, available online and in mobile apps.
The monograph previously read:
Dosing: Adult (only portion of field impacted is presented):
Weight-based dosing: SUBQ: Initial:
Fixed dosing: SUBQ: Initial:
It has been revised to read:
Dosing: Adult (only portion of field impacted is presented):
Weight-based dosing: Initial:
Fixed dosing: Initial:
These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.
Leucovorin Calcium – March 2024
Revision in the Dosing: Adult field of the Leucovorin Calcium monograph in the Lexi-Drugs and Drug Facts and Comparisons databases, available online and in mobile apps.
The monograph previously read:
Dosing: Adult (only portion of field impacted is presented):
Colorectal cancer, advanced: IV: 200 mg/m2/day over ≥3 minutes for 5 days every 4 weeks for 2 cycles, then every 4 to 5 weeks (in combination with fluorouracil) or 20 mg/m2/day for 5 days every 4 weeks for 2 cycles, then every 4 to 5 weeks (in combination with fluorouracil). Note: Multiple leucovorin-containing regimens are available for the treatment of colorectal cancer; may be in combination with other agents (eg, monoclonal antibodies). Refer to appropriate literature/guidelines for additional details.
FOLFOXIRI regimens: IV: 200 mg/m2 over 2 hours on day 1 every 14 days (in combination with fluorouracil, oxaliplatin, and irinotecan) until disease progression or unacceptable toxicity up to a maximum of 12 cycles (Falcone 2007). Refer to protocol for further information.
It has been revised to read:
Dosing: Adult (only portion of field impacted is presented):
Colorectal cancer, advanced: IV: 200 mg/m2/day over ≥3 minutes for 5 days every 4 weeks for 2 cycles, then every 4 to 5 weeks (in combination with fluorouracil) or 20 mg/m2/day for 5 days every 4 weeks for 2 cycles, then every 4 to 5 weeks (in combination with fluorouracil). Note: Multiple leucovorin-containing regimens are available for the treatment of colorectal cancer; may be in combination with other agents (eg, monoclonal antibodies). Refer to appropriate literature/guidelines for additional details.
These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.
Ibrutinib – November 2023
Revision in the Dosing: Adjustment for Toxicity: Adult field of the Ibrutinib monograph in the Lexi-Drugs and Drug Facts and Comparisons databases, available online and in mobile apps.
The monograph previously read:
Dosing: Adjustment for Toxicity: Adult (only portion of field impacted is presented):
Restart at 280 mg once daily
It has been revised to read:
Dosing: Adjustment for Toxicity: Adult (only portion of field impacted is presented):
Restart at 140 mg once daily
These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.
Albumin – October 2023
Revision in the Dosing: Adult field of the Albumin monograph in the Lexi-Drugs database, available online and in mobile apps.
The monograph previously read:
Dosing: Adult (only portion of field impacted is presented):
25% albumin: IV: Initial: 1 g/kg daily for 2 days (maximum: 100 g/day), followed by 20 to 50 g daily until norepinephrine, terlipressin, or midodrine plus octreotide until adequate intravascular volume is achieved (ie, central venous pressure goal) (AASLD [Biggins 2021], Angeli 1999, Boyer 2016, Cavallin 2015, Kwong 2021, Runyon 2013, Wong 2021)
It has been revised to read:
Dosing: Adult (only portion of field impacted is presented):
25% albumin: IV: Initial: 1 g/kg daily for 2 days (maximum: 100 g/day), followed by 20 to 50 g daily until clinical outcome is achieved (AASLD [Biggins 2021], Angeli 1999, Boyer 2016, Cavallin 2015, Kwong 2021, Runyon 2013, Wong 2021).
These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.
Esmolol – August 2023
Revision in the following fields of the Esmolol monograph in the Pediatric & Neonatal Lexi-Drugs database, available online and in mobile apps, as well as the following print publications: Pediatric & Neonatal Dosage Handbook 30th edition
The monograph previously read:
Use
(missing content)
Clinical Practice Guidelines: Pediatric
(missing content)
Dosing: Neonatal
(missing content)
Dosing: Pediatric
(missing content)
Dosing: Altered Kidney Function: Pediatric
(missing content)
Dosing: Hepatic Impairment: Pediatric
(missing content)
Monitoring Parameters
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It has been revised to read:
Use:
Treatment of supraventricular tachycardia (primarily to control ventricular rate in patients with atrial fibrillation or flutter) (FDA approved in adults); treatment of noncompensatory sinus tachycardia (FDA approved in adults); treatment of perioperative tachycardia and hypertension (FDA approved in adults).
Clinical Practice Guidelines: Pediatric
Hypertension:
AAP, Screening and Management of High Blood Pressure in Children and Adolescents, September 2017
NHBPEP Working Group, The Fourth Report on the Diagnosis, Evaluation, and Treatment of High Blood Pressure in Children and Adolescents, May 2005
Dosing: Neonatal
Note: Dose must be titrated to individual response and tolerance.
Postoperative hypertension
Postoperative hypertension (congenital heart disease): Limited data available; further studies are needed. An open-label trial used the following dosing guidelines to treat postoperative hypertension following cardiac surgery; dose was titrated until blood pressure was ≤90th percentile for age; final dose required was significantly higher in patients with aortic coarctation repair than in patients with repair of other congenital heart defects (Wiest 1998):
Term neonates:
PNA 0 to 7 days: Continuous IV infusion: Initial: 50 mcg/kg/minute; titrate dose by 25 to 50 mcg/kg/minute every 20 minutes; maximum dose: 1,000 mcg/kg/minute (Wiest 1998).
PNA 8 to 28 days: Continuous IV infusion: Initial: 75 mcg/kg/minute; titrate dose by 50 mcg/kg/minute every 20 minutes; maximum dose: 1,000 mcg/kg/minute (Wiest 1998).
Dosing: Pediatric
Note: Dose must be titrated to individual response and tolerance.
Hypertension, acute severe with significant, life-threatening symptoms
Hypertension, acute severe with significant, life-threatening symptoms (eg, seizures): Limited data available:
Infants, Children, and Adolescents: Continuous IV infusion: 100 to 500 mcg/kg/minute infusion (AAP [Flynn 2017]); another approach is to initiate therapy with a bolus of 100 to 500 mcg/kg over 1 minute, followed by an infusion of 25 to 100 mcg/kg/minute; titrate as needed up to 500 mcg/kg/minute (Park 2021).
Postoperative hypertension
Postoperative hypertension (congenital heart disease): Limited data available; large effective dose range reported:
Infants and Children: Initial IV bolus: 100 to 500 mcg/kg over 1 minute, followed by continuous IV infusion: Initial rate: 100 to 500 mcg/kg/minute; titrate to effect; range of effective doses: 125 to 1,000 mcg/kg/minute; higher doses may be needed in patients after repair of coarctation of the aorta (Park 2021, Tabbutt 2008a, Tabbutt 2008b, Wiest 1998).
Supraventricular tachycardia
Supraventricular tachycardia (SVT): Limited data available:
Children and Adolescents: Initial IV bolus: 100 to 500 mcg/kg over 1 minute followed by a continuous IV infusion: Initial rate: 25 to 100 mcg/kg/minute; titrate by 25 to 50 mcg/kg/minute; usual maintenance dose: 50 to 500 mcg/kg/minute (Park 2021); doses up to 1,000 mcg/kg/minute have been reported (Trippel 1991).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing: Altered Kidney Function: Pediatric
Infants, Children, and Adolescents: No dosage adjustment necessary. Not removed by hemodialysis, peritoneal dialysis, or CRRT; supplemental dose is not necessary (Aronoff 2007).
Dosing: Hepatic Impairment: Pediatric
There are no pediatric-specific recommendations; based on experience in adult patients, no dosage adjustment required.
Monitoring Parameters
Blood pressure, ECG, heart rate, respiratory rate, IV site; serum potassium (especially with renal impairment).
These changes have been automatically posted to online and mobile app databases. Please update your mobile Lexi-Drugs application to get the updated monograph.