Does Addyi (flibanserin) cause impaired renal function?

From the Guidelines

Addyi (flibanserin) is not known to cause impaired renal function, and its use is not specifically contraindicated in patients with kidney disease. The medication primarily works on brain neurotransmitters like serotonin and dopamine, and its most common side effects include dizziness, sleepiness, nausea, fatigue, dry mouth, and insomnia, but kidney problems are not among the reported adverse effects 1. The standard dosage is 100 mg taken once daily at bedtime. It's essential to note that Addyi should not be taken with alcohol or certain medications that affect its metabolism, as this can increase the risk of severe low blood pressure and fainting. Patients with liver problems should avoid Addyi, but no specific restrictions exist for those with kidney disease. However, as with any medication, if you have pre-existing kidney issues, it's advisable to discuss this with your healthcare provider before starting Addyi to ensure appropriate monitoring, considering the potential for age-related changes in pharmacokinetic parameters, such as decreased renal mass and renal blood flow, which can affect the excretion of certain drugs 1. Some key points to consider when prescribing Addyi or any other medication to patients with kidney disease include:

• Accurate determination of estimated glomerular filtration rate (eGFR) to adjust dose requirements of renally cleared drugs
• Using equations based on serum creatinine measurement, such as the CKD-EPI equation, to estimate eGFR
• Considering the potential for misclassification of kidney disease by one stage in older people due to reduced muscle mass, exercise, and meat intake
• Monitoring renal function regularly to minimize the risk of adverse effects and drug-drug interactions.

From the FDA Drug Label

Renal Impairment Single 50 mg oral doses of flibanserin were administered to 7 patients with mild to moderate renal impairment (GFR 30 to 80 mL/min), 9 patients with severe renal impairment (GFR <30 mL/min, not on dialysis), and 16 healthy subjects matched by age, weight, and gender. Flibanserin exposure (AUC0-inf) increased 1.1-fold in patients with mild to moderate renal impairment and 1. 2-fold in patients with severe renal impairment, compared to the healthy control subjects.

Flibanserin does not cause impaired renal function, but rather, renal impairment can affect flibanserin exposure. In patients with mild to moderate renal impairment, flibanserin exposure increased by 1.1-fold, and in patients with severe renal impairment, it increased by 1.2-fold compared to healthy control subjects 2.

From the Research

Impaired Renal Function and Addyi (Flibanserin)

• There is no direct evidence in the provided studies to suggest that Addyi (flibanserin) causes impaired renal function 3, 4, 5, 6, 7.
• The studies primarily focus on the efficacy and safety of flibanserin in treating hypoactive sexual desire disorder (HSDD) in premenopausal women, with common adverse events including dizziness, somnolence, nausea, and insomnia 3, 4, 5, 6, 7.
• None of the studies mention impaired renal function as a potential side effect or adverse event associated with flibanserin use 3, 4, 5, 6, 7.

Adverse Events Associated with Flibanserin

• Common adverse events reported in the studies include:
  • Dizziness 3, 4, 5, 6, 7
  • Somnolence 3, 4, 5, 6, 7
  • Nausea 3, 4, 5, 6, 7
  • Insomnia 4
  • Dry mouth 4
  • Back pain 4
• Serious adverse events were rare, with no instances of suicidal ideation or behavior reported in one study 4.