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Generic Name: flibanserin (flib AN ser in)
Brand Names: Addyi

What is Addyi?

Addyi (flibanserin) is available only from a certified pharmacy under a special program.

Addyi is used to treat decreased sexual desire in women who have not gone through menopause and who have never had low sexual desire in the past. Addyi is for use only when low sexual desire is NOT caused by a medical condition, a mental disorder, relationship problems, or by using drugs or other medicines.

Addyi is not for women who have already gone through menopause. This medicine is also not for use by men.

Important information

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

You must not drink alcohol while taking Addyi. It may cause you to have dangerously low blood pressure.

You should not use Addyi if you are allergic to flibanserin, or if you have:

  • low blood pressure;

  • a history of alcoholism or drug addiction;

  • liver disease;

  • a history of depression or mental illness; or

  • if you currently drink alcohol.

Some medicines can cause unwanted or dangerous effects when used with Addyi. Your doctor may need to change your treatment plan if you use any of the following drugs:

  • 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; or

  • HIV or AIDS medicine - atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

To make sure Addyi is safe for you, tell your doctor if you have:

  • history of alcoholism or drug addiction.

It is not known whether flibanserin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether flibanserin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Addyi is not approved for use by anyone younger than 18 years old.

How should I take Addyi?

Take Addyi exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Take Addyi only at bedtime.

Addyi can lower your blood pressure, which can make you dizzy. If you feel light-headed after taking this medicine, lie down if you are not already in bed.

It may take up to 8 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

Store at room temperature away from moisture and heat.

Addyi dosing information

Usual Adult Dose for Hypoactive Sexual Desire Disorder:

100 mg orally once per day at bedtime

Duration of therapy: This drug should be discontinued after 8 weeks if the patient does not report an improvement in symptoms.

Comments: This drug is not indicated to enhance sexual performance, and is not indicated for treatment in postmenopausal women or in men.

Use: Treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD) as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Skip the missed dose and take the medicine the following day at bedtime. Do not take Addyi in the morning, and do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Addyi?

Do not drink alcohol while taking Addyi. Drinking alcohol with this medicine can cause dangerous or unwanted side effects.

Grapefruit and grapefruit juice may interact with flibanserin nd lead to unwanted side effects. Avoid the use of grapefruit products while taking Addyi.

Avoid taking an herbal supplement containing: ginkgo, resveratrol, or St. John's wort.

Addyi may impair your thinking or reactions. Avoid driving or operating machinery for at least 6 hours after you take this medicine, and until you know how this medicine will affect you. Dizziness or low blood pressure can cause falls or other accidents.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Addyi side effects

Get emergency medical help if you have signs of an allergic reaction to Addyi: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • severe drowsiness; or

  • a light-headed feeling, like you might pass out.

Common Addyi side effects may include:

  • dizziness, drowsiness;

  • tiredness;

  • nausea;

  • dry mouth; or

  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Addyi?

Taking this medicine with other drugs that make you sleepy or lower your blood pressure can worsen this effect. Ask your doctor before taking Addyi with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • cimetidine;

  • gingko biloba;

  • resveratrol; or

  • St. John's wort.

This list is not complete. Other drugs may interact with flibanserin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

  • Your pharmacist can provide more information about Addyi.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Addyi only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 1.01. Revision Date: 2015-10-06, 2:39:45 PM.