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45TH EDITION

2025-2026 DRUG HANDBOOK ®

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1/19/24 11:59 PM

Chief Nurse: Anne Dabrow Woods, dnp , rn , crnp , anp - bc , agacnp - bc , faan Acquisitions Editor: Susan M. Hartman Editor-in-Chief: Collette Bishop, rn , ms , ma , cic Clinical Project Manager: Janet Rader, rn , bsn Clinical Editors: John Bodnar, bsn , bs , rn ; Emily Hudson, bsn , rn ; Meghan Lynch, bsn , rn ; Lisa Merenda, msn , rn ; Linda Lee Phelps, dnp , rn Managing Editors: Carla A. Rudoy Vitale, p h d ; Diane Labus; Ellen Sellers Editors: Jaime L. Buss, Mary T. Durkin Editorial Assistant: Linda K. Ruhf

Graphic Arts & Design Manager: Stephen Druding Senior Production Associate: Bridgett Dougherty Manufacturing Coordinator: Bernard Tomboc Production Services: Aptara, Inc.

© 2025 by Wolters Kluwer. All rights reserved. This book is protected by copyright. No part of this book may be reproduced or transmitted in any form or by any means, including as photocopies or scanned-in or other electronic copies, or utilized by any information storage and retrieval system without written permission from the copyright owner, except for brief quotations embodied in critical articles and reviews. Materials appearing in this book prepared by individuals as part of their official duties as U.S. government employees are not covered by the above-mentioned copyright. To request permission, please contact Wolters Kluwer at Two Commerce Square, 2001 Market Street, Philadelphia, PA 19103; via email at permissions@lww.com; or via website at shop.lww.com (products and services).

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NDH45-010524 ISSN: 0273-320X ISBN-13: 978-1-9752-1711-2 ISBN-10: 1-9752-1711-X

This work is provided “as is,” and the publisher disclaims any and all warranties, express or implied, including any warranties as to accuracy, comprehensiveness, or currency of the content of this work.

This work is no substitute for individual patient assessment based upon health care professionals’ examination of each patient and consideration of, among other things, age, weight, gender, current or prior medical conditions, medication history, laboratory data, and other factors unique to the patient. The publisher does not provide medical advice or guidance, and this work is merely a reference tool. Health care professionals, and not the publisher, are solely responsible for the use of this work, including all medical judgments and any resulting diagnoses and treatments. Given continuous, rapid advances in medical science and health information, independent professional verification of medical diagnoses, indications, appropriate pharmaceutical selections and dosages, and treatment options should be made and health care professionals should consult a variety of sources. When prescribing medication, health care professionals are advised to consult the product information sheet (the manufacturer’s package insert) accompanying each drug to verify, among other things, conditions of use, warnings, and side effects and identify any changes in dosage schedule or contraindications, particularly if the medication to be administered is new, infrequently used, or has a narrow therapeutic range. To the maximum extent permitted under applicable law, no responsibility is assumed by the publisher for any injury and/or damage to persons or property, as a matter of products liability, negligence law or otherwise, or from any reference to or use by any person of this work.

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Contents

Anatomy of a monograph..............................................inside front cover Contributors and consultants................................................................iv How to use Nursing2025–2026 Drug Handbook ® ................................. v Quick guide to special symbols, logos, and highlighted terms.............viii Guide to abbreviations..........................................................................ix General information 1. Drug actions, interactions, and reactions............................................ 1 2. Drug therapy across the lifespan......................................................... 6 3. Safe drug administration...................................................................13 Alphabetical listing of drugs by generic name.............................. 23 Appendices..................................................................................... 1498 A. Antacids: Indications and dosages.................................................1498 B. Antidiarrheals: Indications and dosages........................................1499 C. Laxatives: Indications and dosages................................................1501 D. Vitamins and minerals: Indications and dosages............................1505 E. Additional OTC drugs: Indications and dosages...........................1513 F. Common combination drugs: Indications and dosages .................1517 G. Antidotes: Indications and dosages ...............................................1531 H. Selected ophthalmic drugs: Indications and dosages .....................1538 I. Selected biologicals and blood derivatives: Indications and dosages ................................................................1546 J. Less commonly used drugs: Indications and dosages.....................1552 Index................................................................................................ 1633 New drugs...................................................................................... 1467

iii

Contributors and consultants

Janine Barnaby, RPh, BCOP Manager, Outpatient Hospital Pharmacy Lehigh Valley Hospital Allentown, PA David Bruch, BS, PharmD Associate Lecturer University of Wyoming—School of Pharmacy Laramie, WY Lawrence Carey, PharmD Assistant Dean for Assessment, Accreditation, and Quality Temple University School of Pharmacy Philadelphia, PA Jeffrey J. Cies, PharmD, MPH, BCPS, AG-ID, BCPPS, FCCP, FCCM, FPPA Pediatric Critical Care and Infectious Diseases Clinical Pharmacist St. Christopher’s Hospital for Children Philadelphia, PA Jason C. Cooper, PharmD Clinical Specialist, MUSC Drug Information Center Medical University of South Carolina Health Charleston, SC Kelsey D. Frederick, PharmD Assistant Professor, Clinical Pharmacy & Translational Science The University of Tennessee Health Science Center, College of Pharmacy Nashville, TN Toshal Hallowell, PharmD Pharmacist Edward M. Kennedy Community Health Center Worcester, MA AnhThu Hoang, PharmD Pharmacist North York Cardiovascular Centre North York, Ontario Jill Krabak, PharmD, MAc, BSPharm Clinical Pharmacist Justice Grown Dickson City, PA Chung-Shien Lee, PharmD, BCPS, BCOP

Hannah McCaffery, PharmD Manager, Pharmacy Regulations and Implementations Health Partners Plans Philadelphia, PA Jamie L. McConaha, PharmD, NCTTP, BCACP, CDCES

Associate Professor of Pharmacy Practice Duquesne University School of Pharmacy Pittsburgh, PA Kimberly E. Ng, PharmD, BCPS Associate Professor St. John’s University Queens, NY Christine K. O’Neil, BS, PharmD, BCPS, BCGP, FASCP, FCCP, TTS Professor, Division of Pharmacy Practice Duquesne University Pittsburgh, PA Christine Price, PharmD Clinical Coordinator, PGY1 Pharmacy Residency Director Morton Plant Hospital Clearwater, FL Melissa Rinaldi, PharmD Clinical Pharmacist Independence Blue Cross Philadelphia, PA Kerry Rinato, PharmD, BCPS Clinical Pharmacist Sunrise Hospital Las Vegas, NV Maha Saad, PharmD, BCGP, BCPS Associate Clinical Professor/Co-Director Drug Information Center St. John’s University College of Pharmacy and Health Sciences Long Island Jewish Medical Center-Northwell Health Queens, NY Michele F. Shepherd, PharmD, MS, BCPS, FASHP Clinical Consultant Jordan, MN James S. Wheeler, PharmD, BCPS Associate Professor/Associate Dean University of Tennessee Health Science Center, College of Pharmacy Knoxville, TN Maggie White-Jones, PharmD Pharmacist Walgreens Pharmacy Berlin, MD

Associate Professor St. John’s University Queens, NY

How to use Nursing2025–2026 Drug Handbook ® The best-selling nursing drug guide for 45 years, Nursing Drug Handbook is meticulously re

groupings of drugs—antacids, antidiarrheals, laxatives, vitamins and minerals, additional OTC drugs, common combination drugs, anti dotes, ophthalmic drugs, biologicals and blood derivatives, and less commonly used drugs. Introductory chapters Chapter 1, “Drug actions, interactions, and reactions,” explains how drugs work in the body. It provides a general overview of drug properties (absorption, distribution, metabo lism, and excretion) and other significant fac tors that affect drug action (including protein binding, patient age, underlying disease, dosage form, and route and timing of administration). Also discussed are drug interactions, adverse reactions, and toxic reactions. Chapter 2, “Drug therapy across the lifespan,” covers the unique challenges of giving drugs to children and older adults and offers practical suggestions on how to minimize problems with these special popu lations. This chapter also discusses the danger associated with indiscriminate use of drugs during pregnancy and breastfeeding and the special precautions women should take when medications are necessary. Chapter 3, “Safe drug administration,” explores the ongoing involvement of governmental and nongovern mental organizations in drug safety issues and the necessary measures nurses must take to prevent medication errors from occurring. Drug monographs Each generic drug monograph in the Nursing2025–2026 Drug Handbook includes the most pertinent clinical information nurses must know to administer medications safely, monitor for potential interactions and adverse effects, implement necessary care measures, and provide appropriate patient teaching. Entries are arranged alphabetically, with the generic drug name prominently displayed—along with its ISMP “tall man” lettering (if applicable), pronunciation, corresponding brand (or trade) names, therapeutic class, and pharmacologic class—on a shaded background for quick and easy identification. This highlighted area also includes banners or symbols to identify drugs that warrant a special safety alert or to desig nate biosimilar drugs. Specific information for each drug is then systematically organized under the headings below. Special icons and logos are used

viewed and updated by pharmacists and nurses to include the most current, relevant informa tion that practicing nurses and students need to know to administer medications safely in any health care setting. As in previous editions, Nursing2025–2026 Drug Handbook emphasizes nursing and safety aspects of drug administra tion without attempting to replace detailed pharmacology texts. Only the most essential information is included, and helpful graphic symbols, logos, and highlighting draw special attention to critical details that nurses shouldn’t overlook. Outstanding features The 45th edition provides a wealth of the latest drug information right at your fingertips: ⦁ Tabbed “New drugs” section that ensures quick access to 24 completely new drug mono graphs introduced in this edition ⦁ The latest information on thousands of ge neric, brand, and combination drugs included in 670 comprehensive drug monographs and 10 appendices ⦁ Drug safety always at the forefront, including prominently displayed safety alerts, drug warn ings, and Institute for Safe Medication Practices (ISMP) “tall man” lettering to help differentiate similarly spelled drug names—plus a special chapter on safe drug administration with up dated guidelines on administration of opioid analgesics, prevention and treatment of IV extravasation injury, safe handling of hazardous drugs, and best practices to ensure patient safety and reduce drug errors ⦁ Special logos and symbols throughout to emphasize FDA boxed warnings, clinical alerts, new indications, necessary dosage adjustments, overdose signs and symptoms, off-label uses, drugs that shouldn’t be crushed or chewed, over-the-counter drugs, biosimilar drugs, Canadian drugs, look alike–sound alike drugs, and the dialyzability status of each drug ⦁ Genetic symbols pinpointing monographs and specific genetic-related information to help select and guide drug therapy ⦁ “Pregnancy-lactation-reproduction” section in each monograph that captures all relevant information in one convenient place ⦁ Thoroughly updated appendices containing indications and dosages of various classes and

vi How to use Nursing2025–2026 Drug Handbook ®

mix, and store IV medications) and the major potential IV incompatibilities. Action This section succinctly describes each drug’s mechanism of action—that is, how the drug provides its therapeutic effect. For example, although all antihypertensives lower BP, they don’t all do so by the same process. Also in cluded, in table form, are the onset, peak (described in terms of effect or peak blood level), and duration of drug action for each route of administration, if data are available or applicable. Values listed are for patients with normal kidney function, unless otherwise speci fied. The drug’s half-life is also provided when known. Adverse reactions In this section, adverse reactions that are known to occur at a frequency of 1% or greater are listed according to body system. Life-threatening reactions appear in bold italic type. Interactions Within this section, readers can find each drug’s confirmed, clinically significant interac tions (additive effects, potentiated effects, and antagonistic effects) with other drugs, herbs, foods, beverages, and lifestyle behaviors (such as alcohol use, sun exposure, and smoking). Drug interactions are listed under the drug that’s adversely affected. For example, because celecoxib, a nonsteroidal anti-inflammatory drug, interacts with candesartan to decrease the antihypertensive effect of candesartan, this in teraction is listed under candesartan. To check on the possible effects of using two or more drugs simultaneously, refer to the interaction section for each drug. Effects on lab test results This section lists increased and decreased levels, counts, and other values in lab test results that may be caused by the drug’s systemic effects. It also indicates false-positive, false-negative, and otherwise altered lab test results a drug may cause. Contraindications & cautions The “Contraindications & cautions” section outlines any conditions or special circumstances, such as diseases or conditions, in which use of the drug is undesirable or for which the drug

throughout, as warranted, to point out the drug’s safety concerns. For example, a clinical alert logo ( t ) provides important advice about life-threatening effects associated with the drug or its administration; a boxed warning ( Boxed Warning ) represents a specific warning issued by the FDA; and a special icon ( ) indi cates oral drug forms that shouldn’t be crushed or chewed. (See “Anatomy of a monograph” on the inside book cover for a visual guide to the various symbols that may appear within a drug entry.) Available forms This section lists the preparations available for each drug (for example, tablets, capsules, and solutions for injection) and specifies available dosage forms and strengths. Dosage strengths specifically available in Canada are designated with a maple leaf ( • ). Preparations that may be obtained over the counter, without a pre scription, are marked with an open diamond ( ◊ ). Liquid formulations that contain alcohol are indicated with an asterisk (*). Capsules or tablets that shouldn’t be crushed are marked with a “Do Not Crush” symbol ( ). Indications & dosages The “Indications & dosages” section contains general dosage information for adults and children. The dosage instructions reflect current trends in therapeutics and can’t be considered absolute or universal. For each individual pa tient, dosage instructions must be considered in light of the patient’s condition. Indications and dosages that aren’t approved by the FDA are followed by a closed diamond ( ♦ ). Only highly evidence-based off-label uses are included in this edition. Adjust-a-dose content within this section indicates the need for a special dosage adjustment for certain patient populations, such as older adults or those with kidney or liver impairment. In some cases, a dosage adjust ment may apply to all patient populations for all the indications listed; such cases are marked accordingly. Administration Here, readers will find guidelines for safely administering drugs by all applicable routes, including PO, IV, IM, subcut, ophthalmic, in halational, topical, rectal, vaginal, transdermal, and buccal. A special screened background highlights IV administration guidelines (includ ing specific instructions on how to reconstitute,

How to use Nursing2025–2026 Drug Handbook ®

vii

Lippincott NursingCenter ® Readers also have online access to monthly drug updates, including postings of newly FDA-approved drugs, new indications & dosages, new formulations, drug warnings, and drug news abstracts by visiting NursingCenter.com . Also included are drug quizzes, best-practice medication safety guide lines, administration tips, real-life medication stories, CE tests, and so much more.

should be given with caution. This section also contains information about whether the drug is dialyzable. When applicable, specific signs and symptoms of drug overdose are listed as the last bulleted item under this heading and high lighted by a special logo ( H Overdose S&S: ) for easy identification. Pregnancy-lactation-reproduction This section provides nurses with targeted, easy to-understand safety information about each drug’s use during pregnancy and breastfeeding. It also provides information about fertility effects, contraception recommendations, and enrollment information for registries that monitor drug safety during pregnancy. Nursing considerations Within this section, readers can find practical information on patient-monitoring techniques and suggestions for the prevention and treat ment of adverse reactions as well as helpful tips on promoting patient comfort. Patient teaching Concise guidelines for explaining the drug’s purpose, encouraging compliance, ensuring proper use and storage, and preventing or minimizing adverse reactions are included in this section. Appendices and other helpful aids Nursing2025–2026 Drug Handbook includes 10 handy appendices featuring the latest indications and dosages for some of the most commonly prescribed antacids, antidiarrhe als, laxatives, vitamins and minerals, combi nation drugs, antidotes, ophthalmic drugs, and biologicals and blood derivatives and as well as commonly used OTC generic and brand-name drugs and less commonly used drugs. The book also includes a concise visual “Quick guide to special symbols, logos, and highlighted terms” and “Guide to abbrevia tions” immediately following this “How to use” piece.

Quick guide to special symbols, logos, and highlighted terms

The following symbols or highlighted features appear throughout drug monographs and select appendices in this edition.

Special symbols, logos, and highlighting

Usage or meaning

Drug that presents a heightened risk of avoidable danger

SAFETY ALERT!

FDA-approved biosimilar drug

BIOSIMILAR DRUG

“Tall man” lettering for FDA-designated generic drug names prone to mix-ups

bu PROP ion

Indication for drug

➤

New indication for drug

✷ NEW INDICATION:

Dosage adjustment needed for certain populations

Adjust-a-dose:

Dosage adjustment needed for all indications

Adjust-a-dose (for all indications):

Genetic considerations used to select and guide drug therapy

t Alert:

Clinical alert

• ♢

Available in Canada

Over-the-counter (OTC)

Off-label use

♦

Liquid contains alcohol

Drugs that shouldn’t be crushed or chewed

Look alike–sound alike:

Drugs with easily confused names

FDA boxed warning

Boxed Warning

H Overdose S&S:

Overdose signs & symptoms

life-threatening

Life-threatening reaction

viii

Guide to abbreviations

ACE

angiotensin-converting enzyme acute coronary syndrome antidiuretic hormone attention deficit hyperactivity disorder activities of daily living adenosine 5 ′ diphosphate acute kidney disease acute kidney injury alkaline phosphatase alanine transaminase antinuclear antibody amyotrophic lateral sclerosis absolute neutrophil count angiotensin receptor blocker acute respiratory distress syndrome antiepileptic drugs acquired immunodeficiency syndrome

COPD

chronic obstructive pulmonary disease

ACS ADH

COVID-19 coronavirus disease 2019 COX cyclooxygenase CrCl creatinine clearance CSF cerebrospinal fluid CT computed tomography CTCAE Common Terminology Criteria for Adverse Events CV cardiovascular CVAD central venous access device D 5 W dextrose 5% in water DEHP di(2-ethylhexyl) phthalate DIC disseminated intravascular coagulation dL deciliter DMARD disease-modifying antirheumatic drug DNA deoxyribonucleic acid DPP-4 dipeptidyl peptidase-4 DRESS drug reaction with eosinophilia and systemic symptoms DVT deep vein thrombosis ECG electrocardiogram EEG electroencephalogram EENT eyes, ears, nose, and throat eGFR estimated glomerular filtration rate ET endotracheal FDA U.S. Food and Drug Administration FSH follicle-stimulating hormone 5-FU fluorouracil g gram G gauge G-CSF granulocyte colony-stimulating factor G6PD glucose-6-phosphate dehydrogenase GABA gamma-aminobutyric acid GERD gastroesophageal reflux disease GFR glomerular filtration rate GGT gamma-glutamyltransferase GI gastrointestinal GnRH gonadotropin-releasing hormone GU genitourinary

ADHD

ADLs ADP AEDs AIDS AKI ALP ALS ALT ANA ANC ARB ARDS AKD

AST AUC

aspartate transaminase area under the curve

atrioventricular

BCRP

breast cancer resistance protein

b.i.d. BMI

twice daily

body mass index blood pressure

BPH

benign prostatic hypertrophy breast cancer gene body surface area blood urea nitrogen coronary artery bypass graft coronary artery disease cyclic 3 ′ , 5 ′ adenosine monophosphate complete blood count Clostridioides difficile – associated diarrhea Centers for Disease Control and Prevention

BRCA

BSA BUN

CABG

CAD cAMP

CBC

CDAD

CDC

creatine kinase

CKD

chronic kidney disease continuous kidney replacement therapy

CKRT

CNS

central nervous system

x Guide to abbreviations GVHD

graft-versus-host disease

M m 2

molar

histamine 1 histamine 2 hemoglobin

square meter

H 1 H 2 Hb

MAC MAO

Mycobacterium avium complex

monoamine oxidase

glycosylated hemoglobin hepatitis B virus surface antigen

HbA 1c HBsAg

mcg MD

microgram

muscular dystrophy

MDD

major depressive disorder

HBV HCV

hepatitis B virus hepatitis C virus

mEq mg MI min mL mm 3

milliequivalent

milligram

HDL-C

high-density lipoprotein cholesterol human epidermal growth factor receptor 2

myocardial infarction

minute

HER2

milliliter

cubic millimeter

heart failure

month

HIV

human immunodeficiency virus

MRI

magnetic resonance imaging

MRSA

methicillin-resistant Staphylococcus aureus

HLA human leucocyte antigen HMG-CoA 3-hydroxy-3-methyl-glutaryl coenzyme A HPA hypothalamic-pituitary adrenal HPV human papilloma virus hr hour HR heart rate HTN hypertension IBS irritable bowel syndrome ICP intracranial pressure ICU intensive care unit ID intradermal Ig immunoglobulin ILD interstitial lung disease IM intramuscular INR International Normalized Ratio IOP intraocular pressure IPPB intermittent positive-pressure breathing ITP immune thrombocytopenia IV intravenous KF kidney failure KFRT kidney failure with replacement therapy

multiple sclerosis

msec

millisecond

mTOR

mechanistic target of rapamycin multigated acquisition neuroleptic malignant syndrome non-nucleoside reverse transcriptase inhibitor nucleoside reverse transcriptase inhibitor nonsteroidal anti inflammatory drug non-small-cell lung cancer normal (0.9%) saline solution New York Heart Association obsessive-compulsive disorder orally disintegrating tablet nasogastric normal sinus rhythm

MUGA

NMS

NNRTI

NRTI

NSAID

NSCLC

NSR NSS

NYHA

OCD ODT OTC

over-the-counter

ounce

P-gp

P-glycoprotein

PABA

para-aminobenzoic acid premature atrial contraction

PAC PAH

kilogram

pulmonary arterial hypertension

liter

LABA

long-acting beta-agonist

PCA

patient-controlled analgesia percutaneous coronary intervention phosphodiesterase type 5

pound

PCI

LDH

lactate dehydrogenase low-density lipoprotein cholesterol

LDL-C

PDE5

pulmonary embolus

luteinizing hormone

PML

progressive multifocal leukoencephalopathy

LVEF

left ventricular ejection fraction

Guide to abbreviations xi

PO PPI PR

by mouth

sublingual

proton pump inhibitor

SLE

systemic lupus erythematosus serotonin-norepinephrine reuptake inhibitor selective serotonin reuptake inhibitor

by rectum

SNRI

PRES

posterior reversible encephalopathy

SSRI

PRN PSA

as needed

SSS STI

sick sinus syndrome

prostate-specific antigen

sexually transmitted infection

prothrombin time

subcut

subcutaneous triiodothyronine

PTCA

percutaneous transluminal coronary angioplasty posttraumatic stress disorder partial thromboplastin time

T 3 T 4

thyroxine

PTSD

tuberculosis

PTT PVC PVD q.i.d.

TCA TEN TIA t.i.d. TLS TNF TPN TSH ULN URI USP tsp

tricyclic antidepressant toxic epidermal necrolysis transient ischemic attack tumor lysis syndrome tumor necrosis factor total parenteral nutrition thyroid-stimulating hormone three times daily

premature ventricular contraction

peripheral vascular disease

four times daily

rheumatoid arthritis

RAAS

renin-angiotensin-aldosterone system

RBC RDA REM

red blood cell

recommended daily allowance

teaspoon

rapid eye movement

upper limit of normal

REMS

risk evaluation and mitigation strategy

upper respiratory infection United States Pharmacopeia

RNA RSV

ribonucleic acid

UTI UV

urinary tract infection

respiratory syncytial virus

ultraviolet VLDL-C very-low-density lipoprotein cholesterol VTE venous thromboembolism WBC white blood cell WHO World Health Organization wk week

sinoatrial

SARS-

severe acute respiratory syndrome coronavirus 2 severe cutaneous adverse reaction small cell lung cancer syndrome of inappropriate antidiuretic hormone Stevens-Johnson syndrome second

CoV-2

SCAR

SCLC

sec

SIADH

SJS

cabotegravir 203

• When tapering opioids, watch closely for signs and symptoms of opioid withdrawal. Such symptoms may indicate a need to taper more slowly. Monitor patient for suicidality, use of other substances, and mood changes. Alert: Monitor patient for signs and symp toms of adrenal insufficiency. Perform diag nostic testing if adrenal insufficiency is sus pected. If adrenal insufficiency is confirmed, treat with corticosteroids and wean patient off opioids, if appropriate. Discontinue corticos teroids when clinically appropriate. Alert: Monitor patient for signs and symp toms of decreased sex hormone levels. If signs and symptoms occur, evaluate patient and obtain specimens for lab testing. • Drug may cause constipation. Assess bowel function and need for stool softener and stim ulant laxatives. • Periodically monitor postoperative vital signs and bladder function. Because drug de creases both rate and depth of respirations, monitor arterial oxygen saturation to help as sess respiratory depression. Alert: Drug may cause opioid-induced hyperalgesia (OIH). Symptoms include in creased pain level with opioid dose increase, decreased pain level with opioid dose reduc tion, pain from ordinarily nonpainful stimuli without underlying disease progression, opi oid tolerance or withdrawal, and addictive be havior. For suspected OIH, decrease opioid dose or switch patient to alternative opioid. PATIENT TEACHING Boxed Warning Counsel patient and care giver on serious risks, safe use, and impor tance of reading the medication guide with each prescription. • Advise patient to take drug exactly as pre scribed and to use lowest dose possible for shortest time needed. • Inform patient that, for acute pain, drug may only be needed for a few days. Teach pa tient about safe disposal of unused drug. • Instruct patient to contact health care provider if prescribed dosage isn’t controlling pain. Alert: Encourage patient to report all med ications being taken, including prescription and OTC drugs and supplements. • Advise patient to avoid alcohol during ther apy. Alert: Counsel patient who has been regu larly taking drug not to discontinue without

first discussing the need for gradual tapering with prescriber. Alert: Caution patient to immediately re port signs and symptoms of serotonin syn drome, adrenal insufficiency, and decreased sex hormone levels. Alert: Warn patient to withhold drug and inform prescriber if pain level worsens, pain sensitivity increases, or new pain occurs after taking drug. • Teach patient who is ambulatory to use care when getting out of bed or walking due to possible dizziness or light-headedness. • Warn outpatient to avoid driving and other hazardous activities that require mental alert ness until drug’s effects on the CNS are clear. Boxed Warning Accidental ingestion of even one dose of an opioid, especially by chil dren, can result in a fatal overdose. • Tell patient how to take nasal spray and how to store it in child-resistant container. • Teach patient that naloxone may be pre scribed with the opioid when beginning and renewing therapy to reduce risk of opioid overdose and death. • Caution patient to report to prescriber preg nancy or plan to become pregnant. cabotegravir ka-boe-TEG-ra-vir Apretude, Vocabria Therapeutic class: Antiretrovirals Pharmacologic class: HIV-1 integrase strand transfer inhibitors AVAILABLE FORMS Injection (extended-release): 600mg/3mL single-dose vial Tablets: 30mg INDICATIONS & DOSAGES ➤ Short-term treatment of HIV-1 infection in combination with rilpivirine in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) while on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine Adults and adolescents ages 12 and older weighing at least 35 kg (lead-in therapy): 30 mg PO daily in combination with oral rilpivirine for at least 28 days as lead-in

Canada

OTC

Off-label use

Do not crush

*Liquid contains alcohol

Genetic

204 cabotegravir

IM • Drug is provided in a kit with vial adapter, needle, and syringe. • Allow vial to reach room temperature if stored in refrigerator. • Inspect for particulate matter and discol oration. Discard if present. • Shake vial vigorously until suspension ap pears uniform. Small air bubbles are expected and acceptable. • Give as soon as possible. Suspension may remain in syringe for up to 2 hours. After 2 hours, discard drug and syringe. Don’t refrigerate filled syringe. • Inject into ventrogluteal area (preferred) or dorsogluteal area (upper outer quadrant). • May need longer needle lengths sufficient to reach gluteus muscle for patients with BMI greater than 30 kg/m 2 . • May give injection up to 7 days before or after the date patient is to receive the injection. • If patient plans to miss a scheduled every 2-month injection by more than 7 days, give oral cabotegravir bridge doses. • If injection is missed or delayed more than 7 days and oral therapy hasn’t been given, re assess patient to determine if resumption of injection dosing remains appropriate. Refer to manufacturer’s instructions for recommenda tions on repeated missed injections and time since prior injection. • Store suspension at 36 ◦ to77 ◦ F(2 ◦ to 25 ◦ C). Don’t freeze. ACTION Inhibits HIV integrase by binding to the inte grase active site and blocking the strand trans fer step of retroviral DNA integration. Route Onset Peak Duration PO Unknown 3 hr Unknown IM Unknown 7 days Unknown Half-life: PO, 41 hours; IM, 5.6 to 11.5 weeks. ADVERSE REACTIONS CNS: abnormal dreams, asthenia, depressive disorders, dizziness, fatigue, fever, headache, mood swings, sleep disorder, somnolence. GI: abdominal pain, decreased appetite, diarrhea, flatulence, nausea, vomiting. GU: increased creatinine level. Hepatic: increased AST andALT. Metabolic: increased CK level, in creased lipase level. Musculoskeletal: back pain, myalgia. Respiratory: URI. Skin: rash. Other: injection-site reactions.

therapy to assess cabotegravir tolerability before starting cabotegravir and rilpivirine extended-release injections. Give final oral dose the same day as starting cabotegravir and rilpivirine injections. Adults (bridging therapy): 30 mg PO daily in combination with oral rilpivirine for up to 2 months as bridging therapy for patients who plan to miss a scheduled injection by more than 7 days. Start first dose of bridging therapy 1 month after final cabotegravir and rilpivirine injection for patients on a monthly schedule and about 2 months after last injec tion for patients on an every-2-month sched ule. Continue oral dosing until injections are restarted. ➤ Short-term preexposure prophylaxis (PrEP) to reduce risk of sexually acquired HIV-1 infection in patients at risk Adults and adolescents weighing at least 35 kg (lead-in therapy): 1 tablet PO daily for at least 28 days as lead-in therapy before start ing cabotegravir extended-release injections. Give final oral dose on same day of or within 3 days after initiating cabotegravir injections. Adults and adolescents ages 12 and older weighing at least 35 kg (bridging therapy): 1 tablet PO daily to replace one every-2-month injection as bridging therapy for patients who plan to miss cabotegravir injection by more than 7 days. Start first dose of bridging ther apy 2 months after final cabotegravir injection dose and continue until or within 3 days af ter injections are restarted. An alternative oral PrEP regimen is recommended when duration exceeds 2 months. ➤ PrEP to reduce risk of sexually acquired HIV-1 infection in patients at risk, with or without an oral lead-in with oral cabote gravir Adults and adolescents weighing at least 35 kg: Initially, 600 mg IM on the last day of or within 3 days after oral lead-in therapy (if used), followed by a second injection 1 month later. Continue with injections every 2 months thereafter. ADMINISTRATION • Boxed Warning Don’t initiate drug for PrEP unless negative infection status is confirmed. PO • Give at same time each day with food. • Give missed dose as soon as possible. • Store tablets below 86 ◦ F(30 ◦ C).

Reactions in bold italics are life-threatening .

cabotegravir 205

INTERACTIONS Drug-drug. Antacids containing aluminum, calcium carbonate, or magnesium: Mayde crease oral cabotegravir level. Administer antacids at least 2 hours before or 4 hours after cabotegravir. Methadone: May decrease methadone level. Monitor patient and adjust methadone dosage asneeded. Other antiretrovirals: Avoid use of other an tiretrovirals with cabotegravir when used as monotherapy for PrEP or in combination with rilpivirine for treatment of HIV-1. Rifabutin: May decrease cabotegravir level when given with extended-release injection. If used together, give second injection of extended-release cabotegravir 2 weeks af ter initial dose, and give maintenance doses monthly while patient is receiving rifabutin. Strong inducers of UGT1A1 or UGT1A9 (carbamazepine, oxcarbazepine, phenobar bital, phenytoin, rifampin, rifapentine): May significantly decrease cabotegravir level and cause loss of virologic response. Avoid use together. EFFECTS ON LAB TEST RESULTS • May increase AST, ALT, lipase, creatinine, CONTRAINDICATIONS & CAUTIONS • Contraindicated in patients hypersensitive to drug or its components. • Contraindicated for PrEP in patients with unknown or positive HIV-1 status. Monother apy with drug isn’t a complete regimen for HIV-1 treatment. • Time from initiation of HIV-1 PrEP to max imal protection is unknown. Boxed Warning Risk of drug resistance may occur with use for HIV PrEP in patients with undiagnosed HIV-1 infection. Drug-resistant variants have been identified in patients with undiagnosed HIV-1 infections with use of cabotegravir injections. • Serious or severe hypersensitivity reactions may occur with cabotegravir. Discontinue drug if hypersensitivity reactions occur. • Drug may cause liver toxicity in patients with or without known preexisting liver dis ease or other risk factors. Use cautiously in patients with underlying liver disease or marked transaminase elevations before drug initiation. fasting lipid, and CK levels. • May decrease HDL level.

• Residual extended-release formulation of drug may remain in circulation for 12 months or longer. • Use cautiously in older adults and patients with severe or end-stage kidney disease. Use in patients with Child-Pugh class C liver impairment hasn’t been studied. • Safety and efficacy in children younger than age 12 or weighing less than 35 kg haven’t been established. • Dialyzable drug: Unlikely. PREGNANCY-LACTATION-REPRODUCTION • There are no studies during pregnancy. Cabotegravir injections aren’t recommended for use in patients planning to become preg nant. Consider risks and benefits of therapy in patients of childbearing potential or who are pregnant. • Enroll patients exposed to drug during pregnancy in the Antiretroviral Pregnancy Registry (1-800-258-4263). • It isn’t known if drug appears in human milk or how drug affects milk production or infants who are breastfed. • Breastfeeding isn’t recommended in pa tients who are HIV positive. For uninfected patients taking drug for PrEP, assess risks and benefits of therapy during breastfeeding. Extended-release formulation may appear in human milk 12 months or more after discon tinuing drug. NURSING CONSIDERATIONS Boxed Warning Before starting drug (oral or IM) for PrEP and before each subse quent injection, test for HIV-1 infection us ing an FDA-approved or FDA-cleared test for diagnosis of acute primary HIV-1 in fection. Patients who become infected with HIV-1 while receiving injections for PrEP must transition to a complete HIV-1 therapy regimen. • Evaluate patient for potential exposure events and signs and symptoms of acute HIV-1 infection. Test patient for HIV-1 infec tion if diagnosed with other STIs. • Monitor for signs and symptoms of hyper sensitivity reactions (severe rash; rash with fever; general malaise; fatigue; muscle or joint aches; blisters, including oral blisters or lesions; conjunctivitis; facial edema; hep atitis; eosinophilia; angioedema; difficulty breathing); immediately discontinue drug if any occur and treat patient as appropriate.

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206 cabotegravir–rilpivirine

• Monitor LFT values during therapy and as clinically indicated. Discontinue cabotegravir if liver toxicity is suspected. • Monitor patient for depressive symptoms, and promptly evaluate for relation to cabotegravir. • Refer to rilpivirine’s prescribing informa tion if rilpivirine is used with cabotegravir. PATIENT TEACHING • Inform patient taking cabotegravir for PrEP that it’s part of an overall HIV-1 infection pre vention strategy that includes adherence to dosing schedule and safer sex practices, in cluding condoms, to reduce risk of STIs. • Tell patient taking cabotegravir for PrEP that testing for HIV-1 is needed before ther apy, before each injection, and if patient is diagnosed with other STIs. • Inform patient that drug isn’t always effec tive in preventing HIV-1 infection. • Advise patient to immediately contact prescriber if signs and symptoms of hyper sensitivity reaction (severe rash, rash with fever, tiredness, muscle or joint aches, blis ters, facial swelling, difficulty breathing, liver problems [jaundice, dark urine, pale-colored stools, nausea, vomiting, right upper abdomi nal pain]) occur. • Inform patient that LFT values and HIV-1 infection testing will be monitored during therapy. • Tell patient to promptly report depressive symptoms to prescriber. • Advise patient to follow testing schedule, take drug as prescribed, and avoid missed doses as doing so increases the risk of acquir ing HIV-1 infection and developing drug re sistance. • Counsel patient of childbearing potential to report pregnancy or plans to become pregnant or breastfeed. cabotegravir–rilpivirine ka-boe-TEG-ra-vir/ril-pi-VIR-een Cabenuva Therapeutic class: Antiretrovirals Pharmacologic class: HIV-1 integrase strand transfer inhibitors/HIV-1 NNRTIs AVAILABLE FORMS Injection (extended-release suspension): 400 mg cabotegravir and 600 mg rilpivirine

single-dose vials (kit); 600 mg cabotegravir and 900 mg rilpivirine single-dose vials (kit) INDICATIONS & DOSAGES ➤ HIV-1 infection to replace current anti retroviral regimen in patients who are virologically suppressed on a stable antire troviral regimen with no history of treat ment failure and no known or suspected resistance to cabotegravir or rilpivirine Adults and adolescents ages 12 and older weighing at least 35 kg: Initially, cabote gravir 30 mg PO daily and rilpivirine 25 mg PO daily for at least 28 days to assess toler ability. On the last day of oral dosing, initi ate injections with cabotegravir 600 mg IM and rilpivirine 900 mg IM as separate gluteal injections. Starting 1 month after initial in jections, give cabotegravir 400 mg IM and rilpivirine 600 mg IM as separate gluteal in jections once monthly. Alternatively, on last day of current an tiretroviral therapy, initiate injections with cabotegravir 600 mg IM and rilpivirine 900 mg IM as separate gluteal injections and repeat monthly. Adjust-a-dose: If switching from monthly to every-2-month regimen, give cabotegravir 600 mg IM and rilpivirine 900 mg IM 1 month after last monthly injection, then every 2 months thereafter. If switching from every-2-month to monthly regimen, give cabotegravir 400 mg IM and rilpivirine 600 mg IM 2 months after last every-2-month injection, then every month thereafter. ADMINISTRATION IM • Complete dose requires an injection of cabotegravir and an injection of rilpivirine during the same visit. Order of injections isn’t important. • Don’t further dilute or reconstitute vials. Don’t mix with other products or diluents. • Before use, remove vials from refrigera tor; allow products to reach room temperature (not to exceed 77 ◦ F[25 ◦ C]) for 15 minutes. • Inspect vials for particulate matter and dis coloration. Don’t use if present. Note cabote gravir vial has a brown tint, which may limit inspection. • Shake vials vigorously until suspension looks uniform before withdrawing into syringes. Small air bubbles are expected and acceptable.

Reactions in bold italics are life-threatening .

cabotegravir–rilpivirine 207

injection-site reaction. Other: hypersensi tivity reaction. INTERACTIONS Drug-drug. Anticonvulsants (carba mazepine, oxcarbazepine, phenobarbital, phenytoin): May decrease cabotegravir and rilpivirine levels and decrease antiviral effect. Use together is contraindicated. Antimycobacterials (rifabutin, rifampin, ri fapentine): May decrease cabotegravir and rilpivirine levels and decrease antiviral effect. Use together is contraindicated. Drugs that prolong the QT interval and in crease risk of torsades de pointes (amio darone, ciprofloxacin, haloperidol, SSRIs): May increase risk of prolonged QTc interval. Use together cautiously. Macrolide or ketolide antibiotics (azithromycin, clarithromycin, erythromycin): May increase rilpivirine level and risk of tor sades de pointes. Consider alternatives or use other macrolides with less effect on rilpivirine level (azithromycin). Methadone: May decrease methadone level. Monitor patient closely and adjust methadone maintenance dosage as needed. Other antiretrovirals: May increase risk of adverse effects. Avoid use together. Systemic glucocorticoids (dexamethasone): May decrease rilpivirine level and decrease antiviral effect if more than one dose is given. Use together is contraindicated. Drug-herb. St. John’s wort: May decrease rilpivirine level and decrease antiviral effect. Use together is contraindicated. EFFECTS ON LAB TEST RESULTS • May increase ALT, AST, CK, and lipase levels. CONTRAINDICATIONS & CAUTIONS • Contraindicated in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine. • Hypersensitivity reactions to rilpivirine, including DRESS syndrome, have been re ported. Skin reactions may be accompanied by constitutional symptoms (fever, organ dys function). • Drug may increase risk of liver toxicity in patients with preexisting liver disease or iden tifiable risk factors. • Use in patients with CrCl of less than 30 mL/minute or Child-Pugh class C liver

• Give as soon as possible; suspension may remain in syringe for up to 2 hours. After 2 hours, discard drug and syringe. • Give each injection at separate gluteal sites on opposite sides or at least 2 cm apart us ing the Z-track technique. Ventrogluteal site is preferred. Don’t give by other routes or in other anatomic sites. May need longer needle lengths to reach the gluteus muscle in patients with high BMI. • May give dose up to 7 days before or after the date patient is scheduled to receive main tenance injections. • If patient plans to miss a scheduled injec tion by more than 7 days, give oral therapy to replace up to two consecutive months of injections. Recommended dose is cabote gravir 30 mg PO daily and rilpivirine 25 mg PO daily, with the first dose starting when the next injection is due and continued until the day injection dosing is restarted. If oral ther apy lasts for more than 2 months, an alterna tive regimen is recommended. • Refer to manufacturer’s instructions for un planned missed injections. • Store vials at 36 ◦ to46 ◦ F(2 ◦ to8 ◦ C) in original carton. Don’t freeze. Vials may remain in original carton at room temper ature for up to 6 hours; discard vials after 6hours. ACTION Cabotegravir inhibits the integrase strand transfer step of retroviral DNA integration essential for HIV-1 replication. Rilpivirine in hibits HIV-1 replication by noncompetitive inhibition of HIV-1 reverse transcriptase. Route Onset Peak Duration IM (caboteg ravir) Unknown 7 days Unknown IM (rilpivirine) Unknown 3–4 days Unknown Half-life: Cabotegravir, 5.6 to 11.5 weeks; rilpivirine, 13 to 28 weeks. ADVERSE REACTIONS CNS: abnormal dreams, anxiety, depressive disorders, dizziness, fatigue, fever, headache, sleep disorder. GI: abdominal pain, diarrhea, dyspepsia, flatulence, gastritis, nausea, vom iting. Hepatic: increased transaminases, hepatotoxicity. Metabolic: weight gain, in creased CK and lipase levels. Musculoskele tal: bone and muscle pain. Skin: rash,

Canada

OTC

Off-label use

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Genetic

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