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Vanzacaftor / tezacaftor / deutivacaftor

Class
Targeted therapy
Subclass
CFTR correceptors and potentiators
Generic name
Vanzacaftor / tezacaftor / deutivacaftor
Brand names
Alyftrek®
Common formulations
Tablet
Indications for use
Labeled indications
Adults
•
Treatment of cystic fibrosis (F508del or another responsive CFTR gene mutation)
Safety risks
Boxed warnings
Drug-induced liver injury, ALF
•
Maintain a high level of suspicion, as vanzacaftor/tezacaftor/deutivacaftor has been associated with an increased risk of elevated serum transaminase levels, drug-induced liver injury, and liver failure. Assess LFTs at baseline and every month during the first 6 months of treatment, every 3 months for the next 12 months, and at least annually thereafter. Consider obtaining more frequent monitoring in patients with a history of liver disease, elevated LFTs at baseline, or a history of elevated LFTs with drugs containing elexacaftor, tezacaftor, and/or ivacaftor. Interrupt vanzacaftor/tezacaftor/deutivacaftor for significant elevations in LFTs or when signs or symptoms of liver injury develop.
•
Do not use vanzacaftor/tezacaftor/deutivacaftor in patients with severe hepatic impairment (Child-Pugh C). Vanzacaftor/tezacaftor/deutivacaftor is not recommended in patients with moderate hepatic impairment (Child-Pugh B) and should only be used when there is a clear medical need, and the benefit outweighs the risk.
Contraindications
Concomitant use of strong or moderate CYP3A inducers
Warnings and precautions
Cataracts
•
Maintain a high level of suspicion, as cases of non-congenital lens opacities have been reported in pediatric patients treated with drugs containing ivacaftor. Obtain baseline and follow-up ophthalmological examinations in pediatric patients treated with vanzacaftor/tezacaftor/deutivacaftor.
Drug hypersensitivity reaction
•
Maintain a high level of suspicion, as vanzacaftor/tezacaftor/deutivacaftor has been associated with an increased risk of hypersensitivity reactions, including anaphylaxis.
Increased serum vanzacaftor/tezacaftor/deutivacaftor levels
•
Use caution in patients taking strong or moderate CYP3A inhibitors. Reuce the vanzacaftor/tezacaftor/deutivacaftor dosage.
Specific populations
Renal impairment
eGFR ≥ 30 mL/min/1.73 m²
•
Use acceptable. No dose adjustment required.
eGFR < 30 mL/min/1.73 m²
•
Use only if benefits outweigh potential risks.
Renal replacement therapy
Any modality
•
Use only if benefits outweigh potential risks.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required. Monitor liver function tests.
Child-Pugh B (moderate)
•
Use only if benefits outweigh potential risks. Monitor liver function tests.
Child-Pugh C (severe)
•
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Insufficient evidence. Evidence of fetal harm in animals.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Influenza virus infection, nasopharyngitis, cough, headache, throat pain, upper respiratory tract infections
Common 1-10%
•
Hypertension, ↑ serum ALT, skin rash, ↑ serum AST, normal serum CK, fatigue, sinusitis
Unknown frequency
•
Drug-induced liver injury, anaphylaxis, cataracts
Interactions
Drug(s)
Check Interactions
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