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Ivacaftor Granules and Kaletra

Determining the interaction of Ivacaftor Granules and Kaletra and the possibility of their joint administration.

Check result:
Ivacaftor Granules <> Kaletra
Relevance: 01.07.2022 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Ritonavir may significantly increase the blood levels of ivacaftor. This may increase the risk and/or severity of serious side effects such as liver damage. A dosage adjustment is normally recommended for ivacaftor. Talk to your doctor if you have any questions or concerns, or if you do not know whether your dosage has already been adjusted. Call your doctor immediately if you have fever, chills, joint pain or swelling, unusual bleeding or bruising, skin rash, itching, loss of appetite, fatigue, nausea, vomiting, abdominal pain, dark urine, pale stools, and/or yellowing of the skin or eyes, as these may be signs and symptoms of liver damage. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

Professional:

ADJUST DOSE: Coadministration with potent inhibitors of CYP450 3A4 may significantly increase the plasma concentrations of ivacaftor, which is primarily metabolized by the isoenzyme. In study subjects, ivacaftor systemic exposure (AUC) increased by 8.5-fold when it was administered concomitantly with ketoconazole, a potent CYP450 3A4 inhibitor. When lumacaftor/ivacaftor was coadministered with itraconazole, another potent CYP450 3A4 inhibitor, lumacaftor pharmacokinetics were not affected, but ivacaftor peak plasma concentration (Cmax) and AUC increased by an average of 3.7- and 4.3-fold, respectively. Due to the induction effect of lumacaftor on CYP450 3A4, at steady state the net AUC of ivacaftor is not expected to exceed that when given in the absence of lumacaftor at a dosage of 150 mg every 12 hours (the approved dosage of ivacaftor monotherapy). For this reason, no dosage adjustment is recommended when CYP450 3A4 inhibitors are initiated in patients already receiving lumacaftor/ivacaftor, whereas a dosage reduction for lumacaftor/ivacaftor is recommended when initiating treatment in patients receiving potent CYP450 3A4 inhibitors. When tezacaftor/ivacaftor was coadministered with itraconazole, tezacaftor and ivacaftor AUC increased by 4-fold and 15.6-fold, respectively. Likewise, elexacaftor AUC has also been reported to increase 2.8-fold by itraconazole.

MANAGEMENT: Please consult manufacturer's product labeling for complete dosing information.
For ivacaftor - The dosage for patients 6 years or older should be reduced to 150 mg twice a week during coadministration with potent CYP450 3A4 inhibitors (2 to

References
  • Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  • Cerner Multum, Inc. "Australian Product Information." O 0
  • "Product Information. Symdeko 4-Week (ivacaftor-tezacaftor)." Vertex Pharmaceuticals, Cambridge, MA.
  • "Product Information. Orkambi (ivacaftor-lumacaftor)." Vertex Pharmaceuticals, Cambridge, MA.
  • "Product Information. Kalydeco (ivacaftor)." Vertex Pharmaceuticals, Cambridge, MA.
  • "Product Information. Trikafta (elexacaftor/ivacaftor/tezacaftor)." Vertex Pharmaceuticals, Cambridge, MA.
Ivacaftor Granules

Generic Name: ivacaftor

Brand name: Kalydeco

Synonyms: Ivacaftor

Kaletra

Generic Name: lopinavir / ritonavir

Brand name: Kaletra

Synonyms: n.a.

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

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