Tezacaftor and Ivacaftor (Monograph)

Brand name: Symdeko
Drug class: Cystic Fibrosis Transmembrane Conductance Regulator Correctors

Medically reviewed by Drugs.com on Mar 10, 2024. Written by ASHP.

Introduction

Combination containing tezacaftor (cystic fibrosis transmembrane conductance regulator [CFTR] corrector) and ivacaftor (CFTR potentiator).

Uses for Tezacaftor and Ivacaftor

Cystic Fibrosis

Treatment of cystic fibrosis in patients ≥6 years of age who are homozygous for F508del mutation in the CFTR gene or have at least 1 mutation in the CFTR gene that is responsive to the combination drug regimen.

Designated an orphan drug by FDA for treatment of cystic fibrosis.

If the genotype of the patient is not known, use an FDA-approved cystic fibrosis mutation test to detect presence of CFTR mutations followed by verification with bidirectional sequencing when recommended by the mutation test instructions.

The 2018 Cystic Fibrosis Foundation pulmonary guideline specifically addresses the use of CFTR modulators in patients with cystic fibrosis. Tezacaftor/ivacaftor was approved after publication of the guideline, and therefore is not addressed.

Tezacaftor and Ivacaftor Dosage and Administration

General

Pretreatment Screening

Select patients for treatment with tezacaftor/ivacaftor based on whether they have 2 copies of the F508del mutation or at least one mutation in the CFTR gene that is responsive to tezacaftor/ivacaftor based on clinical and/or in vitro assay data. If the patient's genotype is unknown, use an FDA-approved cystic fibrosis mutation test to detect presence of a CFTR mutation followed by verification with bidirectional sequencing when recommended by the mutation test instructions.
Obtain baseline serum ALT and AST concentrations.
Baseline ophthalmologic examinations recommended in pediatric patients.

Patient Monitoring

Assess serum ALT and AST concentrations every 3 months during the first year of therapy and annually thereafter. In patients with a history of ALT or AST elevations, consider more frequent monitoring. Closely monitor patients who develop increased ALT, AST, or bilirubin concentrations until abnormalities resolve.
Follow-up ophthalmologic examinations recommended in pediatric patients.

Administration

Oral Administration

Administer orally with fat-containing food (e.g., eggs, cheese, nuts, whole milk, meats, food prepared with butter or oils) to increase systemic absorption of the drug.

Swallow tablets whole.

Dosage

Available as a kit containing 4 weekly blister cards of 7 tablets containing 100 mg of tezacaftor in fixed combination with 150 mg of ivacaftor copackaged with 7 tablets containing 150 mg of single-entity ivacaftor.

Also available as a kit containing 4 weekly blister cards of 7 tablets containing 50 mg of tezacaftor in fixed combination with 75 mg of ivacaftor copackaged with 7 tablets containing 75 mg of single-entity ivacaftor.

Pediatric Patients

Cystic Fibrosis

Oral

Children 6 to <12 years of age weighing <30 kg: Tezacaftor 50 mg/ivacaftor 75 mg once daily in the morning and single-entity ivacaftor 75 mg once daily in the evening (taken approximately 12 hours apart).

Children 6 to <12 years of age weighing ≥30 kg: Tezacaftor 100 mg/ivacaftor 150 mg once daily in the morning and single-entity ivacaftor 150 mg once daily in the evening (taken approximately 12 hours apart).

Children ≥12 years of age: Tezacaftor 100 mg/ivacaftor 150 mg once daily in the morning and single-entity ivacaftor 150 mg once daily in the evening (taken approximately 12 hours apart).

Dosage adjustment necessary when used concomitantly with moderate or strong inhibitors of CYP3A.

Dosage Modification for Concomitant Use of Moderate or Strong CYP3A Inhibitors

Oral

Pediatric patients 6 to <12 years of age weighing <30 kg receiving a moderate CYP3A inhibitor (e.g., erythromycin, fluconazole): administer tezacaftor 50 mg/ivacaftor 75 mg fixed-combination tablets once every other day and single-entity ivacaftor 75 mg once every other day, on alternate days in the morning. Do not administer the evening dose of single-entity ivacaftor 75 mg in such patients.

Pediatric patients 6 to <12 years of age weighing ≥30 kg receiving a moderate CYP3A inhibitor (e.g., erythromycin, fluconazole): administer 100 mg/ivacaftor 150 mg fixed-combination tablets once every other day and single-entity ivacaftor 150 mg once every other day, on alternate days in the morning. Do not administer the evening dose of single-entity ivacaftor 150 mg in such patients.

Pediatric patients ≥12 years of age receiving a moderate CYP3A inhibitor (e.g., erythromycin, fluconazole): administer tezacaftor 100 mg/ivacaftor 150 mg fixed-combination tablets once every other day and single-entity ivacaftor 150 mg once every other day, on alternate days in the morning. Do not administer the evening dose of single-entity ivacaftor 150 mg in such patients.

Pediatric patients 6 to <12 years of age weighing <30 kg receiving a strong CYP3A inhibitor (e.g., clarithromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole): administer tezacaftor 50 mg/ivacaftor 75 mg fixed-combination tablets twice weekly, approximately 3–4 days apart. Do not administer the evening dose of single-entity ivacaftor 75 mg in such patients.

Pediatric patients 6 to <12 years of age weighing ≥30 kg receiving a strong CYP3A inhibitor(e.g., clarithromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole): administer tezacaftor 100 mg/ivacaftor 150 mg fixed-combination tablets twice weekly, approximately 3–4 days apart. Do not administer the evening dose of single-entity ivacaftor 150 mg in such patients.

Pediatric patients ≥12 years of age receiving a strong CYP3A inhibitor (e.g., clarithromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole): administer tezacaftor 100 mg/ivacaftor 150 mg fixed-combination tablets twice weekly, approximately 3–4 days apart. Do not administer the evening dose of single-entity ivacaftor 150 mg in such patients.

Adults

Cystic Fibrosis

Oral

Tezacaftor 100 mg/ivacaftor 150 mg once daily in the morning and single-entity ivacaftor 150 mg once daily in the evening (taken approximately 12 hours apart).

Dosage adjustment necessary when used concomitantly with moderate or strong inhibitors of CYP3A.

Dosage Modification for Concomitant Use of Moderate or Strong CYP3A Inhibitors

Oral

Concomitant use of a moderate CYP3A inhibitor (e.g., erythromycin, fluconazole): administer tezacaftor 100 mg/ivacaftor 150 mg fixed-combination tablets once every other day and single-entity ivacaftor 150 mg once every other day, given on alternate days in the morning. Do not administer the evening dose of single-entity ivacaftor 150 mg.

Concomitant use of a strong CYP3A inhibitor (e.g., clarithromycin, itraconazole, ketoconazole, posaconazole, telithromycin, voriconazole): administer tezacaftor 100 mg/ivacaftor 150 mg fixed-combination tablets twice weekly, approximately 3–4 days apart. Do not administer the evening dose of single-entity ivacaftor 150 mg.

Special Populations

Hepatic Impairment

Mild hepatic impairment (Child-Pugh class A): Dosage adjustment not necessary.

Patients 6 to <12 years of age weighing <30 kg with moderate hepatic impairment (Child-Pugh class B): tezacaftor 50 mg/ivacaftor 75 mg once daily in the morning. Do not administer the evening dose of single-entity ivacaftor 75 mg in such patients.

Patients 6 to <12 years of age weighing ≥30 kg with moderate hepatic impairment (Child-Pugh class B): tezacaftor 100 mg/ivacaftor 150 mg once daily in the morning. Do not administer the evening dose of single-entity ivacaftor 150 mg in such patients.

Patients ≥12 years of age with moderate hepatic impairment (Child-Pugh class B): tezacaftor 100 mg/ivacaftor 150 mg once daily in the morning. Do not administer the evening dose of single-entity ivacaftor 150 mg in such patients.

Patients 6 to <12 years of age weighing <30 kg with severe hepatic impairment (Child-Pugh class C): tezacaftor 50 mg/ivacaftor 75 mg once daily in the morning or less frequently. Do not administer the evening dose of single-entity ivacaftor 75 mg in such patients.

Patients 6 to <12 years of age weighing ≥30 kg with severe hepatic impairment (Child-Pugh class C): tezacaftor 100 mg/ivacaftor 150 mg once daily in the morning or less frequently. Do not administer the evening dose of single-entity ivacaftor 150 mg in such patients.

Patients ≥12 years of age with severe hepatic impairment (Child-Pugh class C): tezacaftor 100 mg/ivacaftor 150 mg once daily in the morning or less frequently. Do not administer the evening dose of single-entity ivacaftor 150 mg in such patients.

Renal Impairment

Mild to moderate renal impairment: Dosage adjustment not necessary.

Severe renal impairment or end-stage renal disease (ESRD): Caution advised.

Geriatric Patients

No specific dosage recommendations at this time.

Cautions for Tezacaftor and Ivacaftor

Contraindications

None.

Warnings/Precautions

Hepatic Effects

Elevated ALT or AST concentrations reported.

Assess serum ALT and AST concentrations prior to initiation of therapy, every 3 months during the first year, and annually thereafter. In patients with a history of ALT or AST elevations, consider more frequent monitoring. Closely monitor patients who develop increased ALT, AST, or bilirubin concentrations until abnormalities resolve.

Interrupt therapy in patients with ALT or AST elevations >5 times the ULN or in those with ALT or AST elevations >3 times the ULN when associated with elevated bilirubin concentrations >2 times the ULN. Following resolution of ALT or AST elevations, consider benefits and risks of resuming therapy.

Hypersensitivity Reactions

Hypersensitivity reactions, including anaphylaxis, reported. Discontinue therapy if signs or symptoms of serious hypersensitivity reactions occur and institute appropriate therapy. Consider benefits and risks for the patient when determining whether to resume treatment.

Interactions with CYP3A Inducers

Concomitant use with strong CYP3A inducers substantially decreases systemic exposure of ivacaftor and may decrease exposure of tezacaftor; decreased exposures may reduce therapeutic efficacy. Concomitant use with strong CYP3A inducers not recommended.

Ocular Effects

Ocular lens opacities (not congenital in nature) reported in pediatric patients receiving tezacaftor/ivacaftor combination therapy or ivacaftor monotherapy. Baseline and follow-up ophthalmologic examinations recommended in pediatric patients.

Specific Populations

Pregnancy

Limited data available regarding use of tezacaftor/ivacaftor combination therapy or its individual components in pregnant women. Evidence of teratogenicity or adverse effects on fetal development not observed in animals receiving tezacaftor or ivacaftor. No animal data available with concomitant use of tezacaftor and ivacaftor. Placental transfer of tezacaftor observed in pregnant rats; placental transfer of ivacaftor observed in pregnant rats and rabbits.

Lactation

Distributed into milk in rats; not known whether distributed into human milk. Consider developmental and health benefits of breast-feeding and clinical importance of therapy to the woman when deciding whether to use caution or discontinue nursing. Effects of tezacaftor/ivacaftor in fixed combination on nursing infants or milk production unknown.

Pediatric Use

Safety and efficacy not established in pediatric patients <6 years of age.

Efficacy in patients 6 to <12 years of age extrapolated from efficacy results in patients ≥12 years of age with support from population pharmacokinetic analyses demonstrating similar drug exposures in patients 6 to <12 years of age and those ≥12 years of age. Safety profile in patients 6 to <12 years of age similar to that observed in patients ≥12 years of age.

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.

Hepatic Impairment

Mild hepatic impairment (Child-Pugh class A): Effect on pharmacokinetics not studied; dosage adjustment not necessary.

Moderate hepatic impairment (Child-Pugh class B): Increased exposure; dosage reduction recommended.

Severe hepatic impairment (Child-Pugh class C): Effect on pharmacokinetics not studied, but increased exposure expected. Use with caution and at reduced dosage after weighing risks and benefits of therapy.

Renal Impairment

Not studied in patients with moderate or severe renal impairment or in those with ESRD.

Mild or moderate renal impairment: Dosage adjustment not necessary.

Severe renal impairment (Cl_cr ≤30 mL/minute) or ESRD: Use with caution.

Common Adverse Effects

Adverse effects (≥3% of patients): headache, nausea, sinus congestion, dizziness.

Drug Interactions

Tezacaftor is a substrate of CYP3A isoenzymes (e.g., CYP3A4, CYP3A5), P-glycoprotein (P-gp) transport, breast cancer resistance protein (BCRP), and organic anion transporting polypeptide (OATP) 1B1.

Ivacaftor is a sensitive substrate of CYP3A. In vitro, ivacaftor has potential to inhibit CYP3A and P-gp, and also may inhibit CYP2C9.

Drugs Affecting or Metabolized by Hepatic Microsomal Enzymes

CYP3A substrates: No dosage adjustment needed.

Strong CYP3A inhibitors: Pharmacokinetic interaction (possible increased tezacaftor and ivacaftor exposures). Reduce dosage to tezacaftor 100 mg/ivacaftor 150 mg in fixed combination twice weekly, approximately 3–4 days apart. Do not administer single-entity ivacaftor 150 mg.

Moderate CYP3A inhibitors: Pharmacokinetic interaction (possible increased tezacaftor and ivacaftor exposures). In adults, children ≥12 years of age, and children 6 to <12 years of age weighing ≥30 kg, reduce dosage to tezacaftor 100 mg/ivacaftor 150 mg in fixed combination once every other day in combination with single-entity ivacaftor 150 mg once every other day, given on alternate days. Do not administer the evening dose of single-entity ivacaftor 150 mg in such patients. In children 6 to <12 years of age weighing <30 kg, reduce dosage to tezacaftor 50 mg/ivacaftor 75 mg in fixed combination once every other day in combination with single-entity ivacaftor 75 mg once every other day, given on alternate days. Do not administer the evening dose of single-entity ivacaftor 75 mg in such patients.

Strong CYP3A inducers: Pharmacokinetic interaction (decreased ivacaftor exposure; decreased tezacaftor exposure expected). Concomitant use not recommended.

Drugs Affected by P-glycoprotein Transport

P-gp substrates: Pharmacokinetic interaction (possible increased exposure, prolonged therapeutic effect, or increased risk of adverse effects of the substrate drug). Use P-gp substrates with narrow therapeutic index concomitantly with caution; monitor patients appropriately.

Specific Drugs

Drug or Food	Interaction	Comments
Anticonvulsants (carbamazepine, phenobarbital, phenytoin)	Possible decreased tezacaftor and ivacaftor exposures and reduced efficacy of tezacaftor/ivacaftor	Concomitant use not recommended
Antifungals, azoles (fluconazole, itraconazole, ketoconazole, posaconazole, voriconazole)	Itraconazole: Concomitant use with tezacaftor/ivacaftor results in 4- and 15.6-fold increased tezacaftor and ivacaftor AUCs, respectively Fluconazole: Concomitant use with ivacaftor results in threefold increased ivacaftor AUC; concomitant use with tezacaftor may increase tezacaftor exposures approximately twofold	Itraconazole, ketoconazole, posaconazole, voriconazole: In adults, children ≥12 years of age, and children 6 to <12 years of age weighing ≥30 kg, reduce dosage to tezacaftor 100 mg/ivacaftor 150 mg twice weekly, approximately 3–4 days apart (do not administer the evening dose of single-entity ivacaftor 150 mg); in children 6 to <12 years of age weighing <30 kg, reduce dosage to tezacaftor 50 mg/ivacaftor 75 mg twice weekly, approximately 3–4 days apart (do not administer the evening dose of single-entity ivacaftor 75 mg) Fluconazole: In adults, children ≥12 years of age, and children 6 to <12 years of age weighing ≥30 kg, reduce dosage to tezacaftor 100 mg/ivacaftor 150 mg once every other day and single-entity ivacaftor 150 mg once every other day, given on alternate days (do not administer the evening dose of single-entity ivacaftor 150 mg); in children 6 to <12 years of age weighing <30 kg, reduce dosage to tezacaftor 50 mg/ivacaftor 75 mg in fixed combination once every other day in combination with single-entity ivacaftor 75 mg once every other day, given on alternate days (do not administer the evening dose of single-entity ivacaftor 75 mg)
Antimycobacterials (rifabutin, rifampin)	Rifabutin: Possible decreased tezacaftor and ivacaftor exposures and reduced efficacy of tezacaftor/ivacaftor Rifampin: Decreased ivacaftor exposure by 89%; decreased tezacaftor exposure also expected; possible reduced efficacy of tezacaftor/ivacaftor	Concomitant use not recommended
Ciprofloxacin	No clinically important effect on tezacaftor or ivacaftor exposures	Dosage adjustment not needed
Digoxin	Increased digoxin exposure; possible prolonged therapeutic effect of digoxin or increased risk of digoxin-associated adverse effects	Use concomitantly with caution and appropriately monitor
Erythromycin	Possible increased tezacaftor and ivacaftor exposures	In adults, children ≥12 years of age, and children 6 to <12 years of age weighing ≥30 kg, reduce dosage to tezacaftor 100 mg/ivacaftor 150 mg once every other day and single-entity ivacaftor 150 mg once every other day, given on alternate days (do not administer the evening dose of single-entity ivacaftor 150 mg); in children 6 to <12 years of age weighing <30 kg, reduce dosage to tezacaftor 50 mg/ivacaftor 75 mg in fixed combination once every other day in combination with single-entity ivacaftor 75 mg once every other day, given on alternate days (do not administer the evening dose of single-entity ivacaftor 75 mg)
Estrogens and progestins	Ethinyl estradiol and norethindrone: No substantial effect on exposures of ethinyl estradiol, norethindrone, tezacaftor, or ivacaftor Hormonal contraceptives: Concomitant use not expected to affect efficacy of hormonal contraceptives
Grapefruit or grapefruit juice	Possible increased tezacaftor and ivacaftor exposures	Avoid concomitant use
Immunosuppressants (cyclosporine, everolimus, sirolimus, tacrolimus)	Possible increased immunosuppressant exposures, prolonged therapeutic effect, or increased risk of immunosuppressant-associated adverse effects	Use concomitantly with caution; monitor patients appropriately
Pitavastatin	No substantial effect on pitavastatin exposure
St. John’s wort (Hypericum perforatum)	Possible decreased tezacaftor and ivacaftor exposures and reduced efficacy of tezacaftor/ivacaftor	Concomitant use not recommended
Sulfonylureas	Glimepiride, glipizide: Possible increased exposure of glimepiride or glipizide (CYP2C9 substrates)	Use concomitantly with caution
Warfarin	Possible increased exposure of warfarin (CYP2C9 substrate)	Monitor INR

Tezacaftor and Ivacaftor Pharmacokinetics

Absorption

Bioavailability

Peak plasma concentrations of tezacaftor and ivacaftor achieved approximately 4 and 6 hours, respectively, after oral administration in the fed state.

Systemic exposure increases with accumulation ratio of approximately 1.5 (for tezacaftor) and approximately 2.2 (for ivacaftor).

Steady-state concentrations of tezacaftor (once daily) and ivacaftor (twice daily) achieved within 8 and 3–5 days, respectively.

Food

Administration of single dose of fixed combination of tezacaftor/ivacaftor with fat-containing food resulted in systemic exposures of ivacaftor approximately threefold higher when compared with administration in fasting state; systemic exposures of tezacaftor similar to those observed with administration in fasting state.

Special Populations

Mild hepatic impairment (Child-Pugh class A): Effect on pharmacokinetics not studied.

Moderate hepatic impairment (Child-Pugh class B): AUCs and peak plasma concentrations of tezacaftor and ivacaftor increased by 36 and 50%, respectively, when compared with healthy individuals. In a separate study, a twofold increased AUC observed when compared with healthy individuals, but peak plasma concentrations similar between the 2 groups.

Severe hepatic impairment (Child-Pugh class C): Effect on pharmacokinetics not studied. Systemic exposures expected to be higher than that observed in patients with moderate hepatic impairment.

Renal impairment: Not studied in patients with moderate or severe renal impairment or in those with ESRD. Population pharmacokinetic data indicate that mild or moderate renal impairment does not substantially affect clearance of tezacaftor.

Pediatric patients 6 to <18 years of age: Based on population pharmacokinetic analyses, exposures of tezacaftor and ivacaftor similar to those observed in adults.

Distribution

Extent

Distributed into milk in rats; not known whether distributed into human milk.

Plasma Protein Binding

Tezacaftor: Approximately 99% (mainly albumin).

Ivacaftor: Approximately 99% (mainly α₁-acid glycoprotein, albumin).

Elimination

Metabolism

Tezacaftor: Extensively metabolized principally by CYP3A4 and 3A5 to 3 major circulating metabolites (M1, M2, M5). M1 has similar potency to the parent drug and is pharmacologically active; M2 has less pharmacologic activity than M1; M5 is inactive. M3 is a minor metabolite resulting from direct glucuronidation.

Ivacaftor: Extensively metabolized principally by CYP3A4 and 3A5 to 2 major metabolites (M1, M6). M1 has approximately one-sixth the potency of ivacaftor; M6 is inactive.

Elimination Route

Tezacaftor: Mainly excreted unchanged in feces (72% as unchanged drug or M2 metabolite); 14% excreted in urine (mainly as M2 metabolite).

Ivacaftor: Mainly excreted in feces (87.8%) after metabolic conversion. Ivacaftor and metabolites minimally excreted in urine (6.6%).

Half-life

Tezacaftor: 15 hours in patients with cystic fibrosis.

Ivacaftor: 13.7 hours in patients with cystic fibrosis.

Stability

Storage

Oral

Tablets

20–25°C (excursions permitted between 15–30°C).

Actions

Tezacaftor/ivacaftor combination therapy contains 2 drugs acting directly on CFTR protein, a chloride channel present at epithelial cell surface in multiple organs involved in salt and fluid transport. Tezacaftor is a CFTR corrector; ivacaftor is a CFTR potentiator.
Mutations in the gene encoding CFTR affect quantity or function of this protein at the cell surface resulting in cystic fibrosis.
Tezacaftor facilitates processing and trafficking of select mutant forms of CFTR protein to cell surface.
Ivacaftor facilitates increased chloride transport by potentiating probability of channel opening (or gating) of the CFTR protein at cell surface.
Combined effect of tezacaftor and ivacaftor increases quantity and function of CFTR at cell surface, resulting in increased chloride transport.
In vitro, tezacaftor/ivacaftor increased chloride transport by at least 10% compared with baseline in Fischer rat thyroid (FRT) cells expressing certain CFTR mutations. In clinical studies, tezacaftor/ivacaftor improved lung function and decreased sweat chloride concentrations in patients homozygous or heterozygous for F508del mutation.
Patients expected to be responsive to tezacaftor/ivacaftor if they possess homozygous CFTR genotype with F508del mutation or if they have at least 1 copy of a responsive CFTR mutation.
With the exception of homozygous F508del genotype, CFTR gene mutations not responsive to ivacaftor monotherapy not expected to respond to tezacaftor/ivacaftor.

Advice to Patients

Advise patients to read the manufacturer's patient information.
Advise patients to take tezacaftor/ivacaftor with fat-containing food (e.g., eggs, butter, peanut butter, cheese pizza, whole milk dairy products) to increase systemic absorption of the drug.
If a dose of tezacaftor/ivacaftor is missed by ≤6 hours, take the dose with fat-containing food as soon as it is remembered. If a dose is missed by >6 hours, omit the dose and take the next dose at the regularly scheduled time. Do not take a double dose to make up for a missed dose.
Importance of dosage reduction in patients with moderate hepatic impairment (Child-Pugh class B). Consider risks and benefits of tezacaftor/ivacaftor in patients with severe hepatic impairment (Child-Pugh class C) prior to initiating therapy; importance of dosage reduction in such patients.
Risk of elevated liver function test results. Monitor liver function tests prior to initiation of tezacaftor/ivacaftor, every 3 months during the first year of therapy, and annually thereafter.
Inform patients of the early signs of hypersensitivity reactions including rash, hives, itching, facial swelling, tightness of the chest, and wheezing. Advise patients to discontinue therapy immediately and contact their clinican or go to the emergency department if these symptoms occur.
Ocular lens opacities (cataracts) observed in some pediatric patients. Importance of baseline and follow-up ophthalmologic examinations in pediatric patients receiving tezacaftor/ivacaftor.
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, vitamins, and herbal supplements, as well as any concomitant illnesses (e.g., hepatic impairment). Concomitant use of tezacaftor/ivacaftor with sensitive CYP3A inhibitors and inducers requires particular attention.
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
Inform patients of other important precautionary information.

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer’s labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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