| Cystic Fibrosis

Kalydeco vs Orkambi

Side-by-side clinical, coverage, and cost comparison for cystic fibrosis.

Deep comparison between: Kalydeco vs Orkambi with Prescriber.AI

AI compares prescribing info and payer-specific access barriers across 1,200+ formularies. Here's a preview of what prescribers are already asking.

Safety signalsOrkambi has a higher rate of injection site reactions vs Kalydeco based on FDA-approved prescribing information

Coverage gaps3 major payers require step therapy for Orkambi but not Kalydeco, including UnitedHealthcare

Category

Kalydeco

Orkambi

At A Glance

RouteOral

FrequencyEvery 12 hours

ClassCFTR potentiator

RouteOral

FrequencyEvery 12 hours

ClassCFTR corrector/potentiator

Indications

Cystic Fibrosis

Cystic Fibrosis

Dosing

Cystic Fibrosis Weight-based dosing every 12 hours with fat-containing food: oral granules from 5.8 mg (1 to <2 months, >=3 kg) up to 75 mg (6 months to <6 years, >=14 kg); 150 mg tablet for patients >=6 years; dose reduced to once daily for moderate hepatic impairment or concomitant moderate CYP3A inhibitors (>=6 months), and to twice weekly for strong CYP3A inhibitors (>=6 months).

Cystic Fibrosis Weight- and age-based dosing orally every 12 hours with fat-containing food: ages 1-2 years receive lumacaftor 75-150 mg/ivacaftor 94-188 mg granules depending on weight; ages 2-5 years receive lumacaftor 100-150 mg/ivacaftor 125-188 mg granules; ages 6-11 years receive lumacaftor 200 mg/ivacaftor 250 mg (2 tablets); ages >=12 years receive lumacaftor 400 mg/ivacaftor 250 mg (2 tablets). Reduce dosage in moderate or severe hepatic impairment. Reduce dosage for the first week when initiating in patients taking strong CYP3A inhibitors.

Contraindications

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Drug Interactions

1128View drug interactions

1832View drug interactions

Adverse Reactions

Most common (>=8%) Headache, oropharyngeal pain, upper respiratory tract infection, nasal congestion, abdominal pain, nasopharyngitis, diarrhea, rash, nausea, dizziness

Serious Abdominal pain, increased hepatic enzymes, hypoglycemia, transaminase elevations

Postmarketing Anaphylaxis, intracranial hypertension, anxiety, depression, suicidal ideation and behavior, insomnia

Most common (>=5%) Dyspnea, nasopharyngitis, nausea, diarrhea, upper respiratory tract infection, fatigue, respiration abnormal, blood creatine phosphokinase increased, rash, flatulence, rhinorrhea, influenza

Serious Pneumonia, hemoptysis, cough, increased blood creatine phosphokinase, transaminase elevations, liver-related serious adverse reactions including hepatic encephalopathy

Postmarketing Liver function decompensation including liver failure leading to death (patients with pre-existing cirrhosis with portal hypertension), anaphylaxis, angioedema, intracranial hypertension, anxiety, depression, suicidal ideation and behavior, insomnia

Pharmacology

Ivacaftor is a CFTR potentiator that facilitates increased chloride transport by potentiating the channel open probability (gating) of CFTR protein located at the epithelial cell surface; clinical benefit requires at least one ivacaftor-responsive CFTR mutation identified by clinical and/or in vitro assay data.

Lumacaftor is a CFTR corrector that improves the conformational stability of F508del-CFTR, resulting in increased processing and trafficking of mature protein to the cell surface; ivacaftor is a CFTR potentiator that facilitates increased chloride transport by potentiating the channel-open probability of CFTR at the cell surface. Together, the combination increases the quantity, stability, and function of F508del-CFTR in patients homozygous for the F508del mutation.

View Full FDA Information

View full FDA information

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Most Common Insurance

Anthem BCBS

Kalydeco