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Incassia and Orkambi (Lumacaftor and Ivacaftor Granules)

Determining the interaction of Incassia and Orkambi (Lumacaftor and Ivacaftor Granules) and the possibility of their joint administration.

Check result:
Incassia <> Orkambi (Lumacaftor and Ivacaftor Granules)
Relevance: 09.12.2022 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:

Lumacaftor may reduce the blood levels and effects of norethindrone. If you are using low-dose oral contraceptives, you may have an increased risk of menstrual abnormalities, breakthrough bleeding, or unintended pregnancy. You should discuss the use of alternative or additional methods of birth control with your healthcare provider. If you take hormone replacement for menopause, notify your doctor if your medication is no longer controlling your symptoms or you experience abnormal bleeding. You may need a dose adjustment or more frequent monitoring by your doctor to safely use both medications. 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:

ADDITIONAL CONTRACEPTION RECOMMENDED: Coadministration with lumacaftor may significantly decrease the plasma concentrations of contraceptive hormones. The proposed mechanism is lumacaftor induction of the CYP450 3A4-mediated metabolism of estrogens and progestins. In premarketing clinical trials, the incidence of menstrual related adverse reactions such as amenorrhea, dysmenorrhea, menorrhagia, and menstrual irregularity was more common with lumacaftor/ivacaftor than with placebo (10% vs. 2%). These events occurred more frequently in the subset of female patients treated with lumacaftor/ivacaftor who were using hormonal contraceptives compared to those not using hormonal contraceptives (27% vs. 3%).

MANAGEMENT: Hormonal contraceptives, including oral, injectable, transdermal, and implantable forms, should not be relied upon as an effective method of contraception when coadministered with lumacaftor/ivacaftor. Female patients of childbearing potential should use an alternative or additional method of contraception. Intrauterine systems are unlikely to be significantly affected because of their local action. Input from a gynecologist or similar expert on adequate contraception, including emergency contraception, should be sought as needed.

References
  • Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  • Faculty of Sexual & Reproductive Healthcare "FSRH Clinical Guidance: Drug Interactions with Hormonal Contraception. Available from: URL: file:///C:/Users/df033684/Downloads/ceuguidancedruginteractionshormonal.pdf." ([2012, Jan 1]):
  • "Product Information. Orkambi (ivacaftor-lumacaftor)." Vertex Pharmaceuticals, Cambridge, MA.
Incassia

Generic Name: norethindrone

Brand name: Aygestin, Camila, Errin, Jolivette, Nora-Be, Ortho Micronor, Deblitane, Heather, Jencycla, Nor-QD, Norlyda, Tulana, Incassia

Synonyms: n.a.

Orkambi (Lumacaftor and Ivacaftor Granules)

Generic Name: ivacaftor / lumacaftor

Brand name: Orkambi

Synonyms: Orkambi

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.