Label: ALYFTREK- vanzacaftor, tezacaftor, and deutivacaftor tablet, film coated

  • NDC Code(s): 51167-121-01, 51167-135-01
  • Packager: Vertex Pharmaceuticals Incorporated
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated January 31, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use ALYFTREK safely and effectively. See full prescribing information for ALYFTREK. ALYFTREK (vanzacaftor, tezacaftor, and ...
  • Table of Contents
    Table of Contents
  • BOXED WARNING (What is this?)

    WARNING: DRUG-INDUCED LIVER INJURY AND LIVER FAILURE

    Elevated transaminases have been observed in patients treated with ALYFTREK. Cases of serious and potentially fatal drug-induced liver injury and liver failure were reported in patients who were taking a fixed-dose combination drug containing elexacaftor, tezacaftor, and ivacaftor, which contains the same or similar active ingredients as ALYFTREK. Liver injury has been reported within the first month of therapy and up to 15 months following initiation of elexacaftor/tezacaftor/ivacaftor [see Warnings and Precautions (5.1) and Adverse Reactions (6)].

    Assess liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) in all patients prior to initiating ALYFTREK, every month during the first 6 months of treatment, then every 3 months for the next 12 months, then at least annually thereafter. Consider more frequent monitoring for patients with a history of liver disease or elevated liver function tests at baseline [see Dosage and Administration (2.1), Warnings and Precautions (5.1), Adverse Reactions (6), and Use in Specific Populations (8.7)].

    Interrupt ALYFTREK for significant elevations in liver function tests or in the event of signs or symptoms of liver injury. Consider referral to a hepatologist. Follow patients closely with clinical and laboratory monitoring until abnormalities resolve. If abnormalities resolve, resume treatment only if the benefit is expected to outweigh the risk. Closer monitoring is advised after resuming ALYFTREK [see Warnings and Precautions (5.1)].

    ALYFTREK should not be used in patients with severe hepatic impairment (Child-Pugh Class C). ALYFTREK is not recommended in patients with moderate hepatic impairment (Child-Pugh Class B) and should only be considered when there is a clear medical need, and the benefit outweighs the risk. If used, monitor patients closely [see Dosage and Administration (2.4), Warnings and Precautions (5.1), Adverse Reactions (6), Use in Specific Populations (8.7), and Clinical Pharmacology (12.3)].

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  • 1 INDICATIONS AND USAGE
    ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in patients 6 years of age and older who have at least one F508del mutation or another responsive mutation in the cystic fibrosis ...
  • 2 DOSAGE AND ADMINISTRATION
    2.1 Recommended Laboratory Testing Prior to ALYFTREK Initiation and During Treatment - Prior to initiating ALYFTREK, obtain liver function tests (ALT, AST, alkaline phosphatase, and bilirubin ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Tablets: Fixed-dose combination containing vanzacaftor 4 mg (equivalent to 4.24 mg of vanzacaftor calcium dihydrate), tezacaftor 20 mg, and deutivacaftor 50 mg. Each tablet is purple ...
  • 4 CONTRAINDICATIONS
    None.
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Drug-Induced Liver Injury and Liver Failure - Elevated transaminases have been observed in patients treated with ALYFTREK [Adverse Reactions (6.1)]. Cases of serious and potentially fatal ...
  • 6 ADVERSE REACTIONS
    The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Drug-Induced Liver Injury and Liver Failure [see Warnings and Precautions ...
  • 7 DRUG INTERACTIONS
    7.1 Effect of Other Drugs and Grapefruit on ALYFTREK - Strong or Moderate CYP3A Inducers - Concomitant use of ALYFTREK with strong or moderate CYP3A inducers is not recommended. Vanzacaftor ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - There are no available data on ALYFTREK use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse ...
  • 10 OVERDOSAGE
    Treatment of overdosage consists of general supportive measures including monitoring of vital signs and observation of the clinical status.
  • 11 DESCRIPTION
    ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor tablets) are fixed-dose combination tablets for oral use available as: 10 mg of vanzacaftor (equivalent to 10.6 mg of vanzacaftor calcium ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Vanzacaftor and tezacaftor bind to different sites on the CFTR protein and have an additive effect in facilitating the cellular processing and trafficking of select ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - No studies of carcinogenicity, mutagenicity, or impairment of fertility were conducted with the combination of vanzacaftor, tezacaftor ...
  • 14 CLINICAL STUDIES
    The efficacy of ALYFTREK in patients aged 12 years and older with cystic fibrosis (CF) who have at least one F508del mutation or a responsive mutation in the CFTR gene was evaluated in two 52-week ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor) tablets are supplied as follows: Table 10: ALYFTREK Tablets and Package Configuration - StrengthsTablet DescriptionPackage ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide). Drug-Induced Liver Injury and Liver Failure - Inform patients that elevations of transaminases have occurred in ...
  • SPL UNCLASSIFIED SECTION
    Manufactured for - Vertex Pharmaceuticals Incorporated - 50 Northern Avenue - Boston, MA 02210 - ALYFTREK, VERTEX and associated logos are trademarks of Vertex Pharmaceuticals Incorporated. All other ...
  • MEDICATION GUIDE
    This Medication Guide has been approved by the U.S. Food and Drug Administration.Revised: 01/2025           MEDICATION GUIDE - ALYFTREK™ (ah-LIF-trek) (vanzacaftor, tezacaftor, and ...
  • PRINCIPAL DISPLAY PANEL - 4 mg/20 mg/50 mg Tablet Wallet Carton
    Rx Only - NDC 51167-135-01 - 84 tablets - 4-wallets - (each containing - 21 tablets) alyftrek™ (vanzacaftor/tezacaftor/deutivacaftor) tablets - 4 mg/20 mg/50 mg - per tablet - ATTENTION PHARMACIST ...
  • PRINCIPAL DISPLAY PANEL - 10 mg/50 mg/125 mg Tablet Wallet Carton
    Rx Only - NDC 51167-121-01 - 56 tablets - 4-wallets - (each containing - 14 tablets) alyftrek™ (vanzacaftor/tezacaftor/deutivacaftor) tablets - 10 mg/50 mg/125 mg - per tablet - ATTENTION PHARMACIST ...
  • INGREDIENTS AND APPEARANCE
    Product Information