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Drug Interactions between cobicistat / darunavir and elagolix

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Major

cobicistat elagolix

Applies to: cobicistat / darunavir and elagolix

GENERALLY AVOID: Coadministration with potent inhibitors of CYP450 3A4 may significantly increase the plasma concentrations of elagolix, which is a substrate of the isoenzyme. In 11 study subjects, administration of a single 150 mg dose of elagolix with 400 mg once daily dosing of ketoconazole, a potent CYP450 3A4 inhibitor, increased elagolix peak plasma concentration (Cmax) and systemic exposure (AUC) by 77% and 120%, respectively, compared to elagolix administered alone. Increased exposure to elagolix may increase the risk of serious adverse effects such as bone loss, suicidal ideation and behavior, exacerbation of mood disorders, and hepatic transaminase elevations.

MANAGEMENT: Concomitant use of elagolix 200 mg twice daily with potent CYP450 3A4 inhibitors for more than 1 month, or elagolix 150 mg once daily with potent CYP450 3A4 inhibitors for more than 6 months, is not recommended.

References

  1. "Product Information. Orilissa (elagolix)." AbbVie US LLC (2018):

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Moderate

darunavir elagolix

Applies to: cobicistat / darunavir and elagolix

MONITOR: Coadministration with drugs that are inducers of CYP450 3A4 may decrease the plasma concentrations of protease inhibitors (PIs), which are primarily metabolized by the isoenzyme.

MANAGEMENT: Given the risk of reduced viral susceptibility and resistance development associated with subtherapeutic antiretroviral drug levels, protease inhibitors should be used cautiously with agents that induce CYP450 3A4, particularly if only one PI is used in the antiretroviral regimen. Coadministration of atazanavir without ritonavir and carbamazepine, phenobarbital, or phenytoin is not recommended. Antiretroviral response should be monitored more closely whenever a CYP450 3A4 inducer is added to or withdrawn from therapy, and the antiretroviral regimen adjusted as necessary.

References

  1. "Product Information. Invirase (saquinavir)." Roche Laboratories PROD (2001):
  2. "Product Information. Crixivan (indinavir)." Merck & Co., Inc PROD (2001):
  3. "Product Information. Viracept (nelfinavir)." Agouron Pharma Inc PROD (2001):
  4. Brooks J, Daily J, Schwamm L "Protease inhibitors and anticonvulsants." AIDS Clin Care 9 (1997): 87,90
  5. Barry M, Gibbons S, Back D, Mulcahy F "Protease inhibitors in patients with HIV disease. Clinically important pharmacokinetic considerations." Clin Pharmacokinet 32 (1997): 194-209
  6. "Product Information. Agenerase (amprenavir)." Glaxo Wellcome PROD (2001):
  7. Acosta EP, Henry K, Baken L, Page LM, Fletcher CV "Indinavir concentrations and antiviral effect." Pharmacotherapy 19 (1999): 708-12
  8. Sommadossi JP "HIV protease inhibitors: pharmacologic and metabolic distinctions." AIDS 13 (1999): s29-40
  9. Hugen PWH, Burger DM, Brinkman K, terHofstede HJM, Schuurman R, Koopmans PP, Hekster YA "Carbamazepine-indinavir interaction causes antiretroviral therapy failure." Ann Pharmacother 34 (2000): 465-70
  10. Durant J, Clevenbergh P, Garraffo R, Halfon P, Icard S, DelGiudice P, Montagne N, Schapiro JM, Dellamonica P "Importance of protease inhibitor plasma levels in HIV-infected patients treated with genotypic-guided therapy: pharmacological data from the Viradapt Study." Aids 14 (2000): 1333-9
  11. "Product Information. Fortovase (saquinavir)." Roche Laboratories PROD (2001):
  12. "Product Information. Reyataz (atazanavir)." Bristol-Myers Squibb (2003):
  13. "Product Information. Lexiva (fosamprenavir)." GlaxoSmithKline (2003):
  14. Liedtke MD, Lockhart SM, Rathbun RC "Anticonvulsant and antiretroviral interactions." Ann Pharmacother 38 (2004): 482-9
  15. "Product Information. Aptivus (tipranavir)." Boehringer-Ingelheim (2005):
  16. "Product Information. Prezista (darunavir)." Ortho Biotech Inc (2006):
  17. Canadian Pharmacists Association "e-CPS. http://www.pharmacists.ca/function/Subscriptions/ecps.cfm?link=eCPS_quikLink" (2006):
View all 17 references

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Drug and food interactions

Moderate

darunavir food

Applies to: cobicistat / darunavir

ADJUST DOSING INTERVAL: Food enhances the absorption and oral bioavailability of darunavir administered in combination with low-dose ritonavir. The mechanism is unknown. When administered with food, the peak plasma concentration (Cmax) and area under the plasma concentration-time curve (AUC) of darunavir were approximately 30% higher than when administered in the fasting state. Darunavir exposure was similar for the range of meals studied. The total caloric content of the various meals evaluated ranged from 240 Kcal (12 grams fat) to 928 Kcal (56 grams fat).

MANAGEMENT: To ensure maximal oral absorption, darunavir coadministered with ritonavir should be taken with food. The type of food is not important.

References

  1. "Product Information. Prezista (darunavir)." Ortho Biotech Inc (2006):

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

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