Brand Name
Alyftrek
Generic Name
Tezacaftor
View Brand Information FDA approval date: December 20, 2024
Classification: Cystic Fibrosis Transmembrane Conductance Regulator Potentiator
Form: Tablet
What is Alyftrek (Tezacaftor)?
ALYFTREK is indicated for the treatment of cystic fibrosis in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein [see Clinical Pharmacology (1.
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Brand Information
ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor)
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
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
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
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
1INDICATIONS AND USAGE
ALYFTREK is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients 6 years of age and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator (
If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the
2CONTRAINDICATIONS
None.
3ADVERSE 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
- Hypersensitivity Reactions, Including Anaphylaxis
- Patients Who Discontinued or Interrupted Elexacaftor-, Tezacaftor-, or Ivacaftor-Containing Drugs Due to Adverse Reactions
- Intracranial Hypertension
- Neuropsychiatric Events, Including Suicidal Thoughts and Behaviors
- Cataracts
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The adverse reactions data below are from clinical trials of ALYFTREK in patients 6 years of age and older with CF with at least one responsive
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of ALYFTREK or drugs containing the same or similar active ingredients as ALYFTREK. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Nervous System Disorders: intracranial hypertension
Psychiatric Disorders: anxiety, depression, suicidal ideation and behavior, insomnia
4OVERDOSAGE
Treatment of overdosage consists of general supportive measures including monitoring of vital signs and observation of the clinical status.
5DESCRIPTION
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 dihydrate), 50 mg of tezacaftor, 125 mg of deutivacaftor or
- 4 mg of vanzacaftor (equivalent to 4.24 mg of vanzacaftor calcium dihydrate), 20 mg of tezacaftor, 50 mg of deutivacaftor.
The tablets contain the following inactive ingredients: croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet film coating contains Brilliant Blue FCF aluminum lake/FD&C Blue #1, carmine, hydroxypropyl cellulose, hypromellose, iron oxide red, talc, and titanium dioxide.
The active ingredients of ALYFTREK are described below:
6CLINICAL STUDIES
The efficacy of ALYFTREK in patients aged 12 years and older with cystic fibrosis (CF) who have at least one
- Trial 1 enrolled patients with CF heterozygous for
- Trial 2 enrolled patients with CF who had one of the following genotypes: homozygous for the
7HOW SUPPLIED/STORAGE AND HANDLING
ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor) tablets are supplied as follows:
8PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
9PRINCIPAL DISPLAY PANEL - 4 mg/20 mg/50 mg Tablet Wallet Carton
Rx Only
84 tablets
alyftrek™
4 mg/20 mg/50 mg
ATTENTION PHARMACIST: Dispense enclosed Medication Guide to each patient.
Lift to open
10PRINCIPAL DISPLAY PANEL - 10 mg/50 mg/125 mg Tablet Wallet Carton
Rx Only
56 tablets
alyftrek™
10 mg/50 mg/125 mg
ATTENTION PHARMACIST: Dispense enclosed Medication Guide to each patient.
Lift to open
