Addyi

The active ingredient in Addyi is flibanserin, which is an agonist and antagonist of the serotonin receptor. Although the precise mechanism of action of the medicine is unknown, it is believed to impact serotonin receptors in the brain. Since serotonin is a naturally occurring hormone in your body that controls both your mood and sex drive, this could help increase your sex drive.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Addyi. However, the following is a synopsis of the general guidelines for the use of Addyi:

• Only take Addyi before bed.
• Drinking alcohol with Addyi may produce dangerously low blood pressure and fainting.
• You should either skip your dose of Addyi or wait at least two hours if you have had one or two standard alcoholic drinks. You should omit your Addyi dose if you have had three or more regular alcoholic beverages in the evening.
• Because flibanserin lowers blood pressure, it may cause vertigo. If you are not already in bed, lie down if taking this medication makes you feel dizzy.

The most common side effects of Addyi seen in clinical trials as compared to placebo include:

• Nausea or vomiting.
• Dizziness.
• Tiredness or sleepiness.
• Trouble sleeping.
• Dry mouth.
• Constipation.
• Stomach pain.
• Skin rash.
• Anxiety.

Some individuals may experience serious side effects while using Addyi. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• An allergic reaction might cause breathing difficulties, itching, hives, and swelling of the mouth, lips, or face.

These are not all of the possible side effects of Addyi. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Addyi, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Liver disease or liver problems.
• Recent alcohol use.
• Depression or mental health issues.
• Low blood pressure.

Boxed Warning

• When taken by individuals with liver illness or in combination with certain medications, or alcohol, flibanserin (Addyi) may result in fainting or severe hypotension. If you take certain moderate or severe CYP3A4 inhibitors, you should avoid using Addyi.

Taking certain drugs that interact with Addyi (flibanserin) increases your risk of fainting (syncope) and low blood pressure.

• Consume grapefruit juice.
• Injury to the liver.
• Postmenopausal women.
• Males.

Your symptoms could not get better for up to eight weeks. If your symptoms don't get better, keep taking the medication as prescribed and let your doctor know.

When Addyi is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Nefazodone.
• An antibiotic - ciprofloxacin, clarithromycin, erythromycin, telithromycin.
• Antifungal medicine - fluconazole, itraconazole, ketoconazole, posaconazole.
• Antiviral medicine to treat hepatitis C - boceprevir, telaprevir.
• Heart or blood pressure medicine - conivaptan, diltiazem, verapamil.
• HIV or AIDS medicine - atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.
• St. John’s Wort.
• Grapefruit juice.

The typical dose is 100 mg by mouth once a day at bedtime.

If a dose is missed, skip the missed dose and take the medication at bedtime the next day. Avoid taking two doses of Addyi at once and avoid taking it in the morning.

Store at room temperature and keep out of reach of children.

Sprout Pharmaceuticals Inc. is the company that manufactures Addyi.

There are no generic versions of Addyi available.

It is not necessary to taper Addyi tablets for patients who wish to discontinue taking them. Withdrawal symptoms are not linked to abruptly stopping Addyi.

It is not known if Addyi is safe to use during pregnancy. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is not known if Addyi is safe to use while breastfeeding. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.