What you need to know (and do) to prescribe the new drug flibanserin
11 questions and answers highlight indications, risks, adverse reactions, and requirements for prescribers
In this Article
- How is HSDD diagnosed?
- What are clinicians required to do?
- Is the drug safe in pregnancy?
Less common reactions include anxiety, constipation, abdominal pain, rash, sedation, and vertigo.
In studies of the drug, appendicitis was reported among 0.2% of flibanserin-treated patients, compared with no reports of appendicitis among placebo-treated patients. The FDA has requested additional investigation of the association, if any, between flibanserin and appendicitis.
9. What drug interactions are notable?
As stated earlier, the concomitant use of flibanserin with alcohol or a moderate or strong CYP3A4 inhibitor can result in severe hypotension and syncope. Flibanserin also should not be prescribed for patients who use other CNS depressants such as diphenhydramine, opioids, benzodiazepines, and hypnotic agents.
Some examples of strong CYP3A4 inhibitors are ketoconazole, itraconazole, posaconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, boceprevir, telaprevir, telithromycin, and conivaptan.
Moderate CYP3A4 inhibitors include amprenavir, atazanavir, ciprofloxacin, diltiazem, erythromycin, fluconazole, fosamprenavir, verapamil, and grapefruit juice.
In addition, the concomitant use of flibanserin with multiple weak CYP3A4 inhibitors—which include herbal supplements such as ginkgo and resveratrol and nonprescription drugs such as cimetidine—also may increase the risks of hypotension and syncope.
The concomitant use of flibanserin with digoxin increases the digoxin concentration and may lead to toxicity.
10. Is the drug safe in pregnancy
and lactation?
There are currently no data on the use of flibanserin in human pregnancy. In animals, fetal toxicity occurred only in the presence of significant maternal toxicity. Adverse effects included decreased fetal weight, structural anomalies, and increases in fetal loss when exposure exceeded 15 times the recommended human dosage.
As for the advisability of using flibanserin during lactation, it is unknown whether the drug is excreted in human milk, whether it might have adverse effects in the breastfed infant, or whether it affects milk production. Package labeling states: “Because of the potential for serious adverse reactions, including sedation in a breastfed infant, breastfeeding is not recommended during treatment with [flibanserin].”1
11. When should the drug
be discontinued?
If there is no improvement in sexual desire after an 8-week trial of flibanserin, the drug should be
discontinued.
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