WARNING

Risks of Taking Addyi (Generic Flibanserin):

• Severe Low Blood Pressure and Fainting: Addyi can cause significant drops in blood pressure, especially when taken with alcohol or certain medications. This can lead to fainting, dizziness, and potential injury from falls.
• Interaction with Alcohol: Combining Addyi with alcohol greatly increases the risk of severe low blood pressure and fainting. It’s essential to completely avoid alcohol while taking this medication.
• Medication Interactions: Addyi interacts with many medications, including certain antifungals, antibiotics, and antidepressants, which can amplify its side effects or reduce its effectiveness. Always inform your healthcare provider of all medications you’re taking.
• Central Nervous System Effects: Addyi can cause sleepiness, dizziness, and fatigue. These effects can impair your ability to drive, operate machinery, or perform tasks that require full alertness.
• Not Suitable for All Women: Addyi is not recommended for postmenopausal women, men, or those with liver impairment due to an increased risk of serious side effects.
• Potential for Ineffectiveness: Some women may not experience an improvement in sexual desire even after 8 weeks of use, and the medication should be discontinued if it proves ineffective.

Understanding these risks is important for safe use and making informed decisions about your treatment.

Why is this medication prescribed?

Addyi (generic name: Flibanserin) is a medication prescribed primarily for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. HSDD is characterized by a persistent or recurrent lack of sexual desire that causes marked distress or interpersonal difficulty and is not attributable to other medical, psychological, or relationship issues.

• Treats Low Sexual Desire: Addyi is used to help increase sexual desire in women who have not gone through menopause and are experiencing low sexual desire that is not due to other factors.
• Improves Quality of Life: For women experiencing distress related to low sexual desire, Addyi can improve their quality of life by restoring sexual desire.

How should this medicine be used?

Addyi should be used according to your healthcare provider’s instructions. Here are some general guidelines:

• Dosage: The standard dose is one 100 mg tablet taken once daily at bedtime. Taking the medication at bedtime helps reduce the risk of side effects such as low blood pressure, dizziness, and fainting.
• Alcohol Warning: Addyi should not be taken with alcohol. Drinking alcohol while on Addyi can significantly increase the risk of severe low blood pressure and fainting.
• Consistency: It is important to take Addyi consistently every day. It may take several weeks (up to 8 weeks) of use to see an improvement in sexual desire.
• Discontinuation: If there is no improvement in sexual desire after 8 weeks of use, the medication should be discontinued.
• Avoid Certain Medications: Certain medications and substances can interact with Addyi, increasing the risk of side effects. Consult with a healthcare provider before combining Addyi with other treatments.
• Side Effects: Common side effects include dizziness, sleepiness, nausea, fatigue, insomnia, and dry mouth. If these effects are severe or persist, contact your healthcare provider.

If you have any concerns about missed doses or how to manage your medication, consult your healthcare provider for advice tailored to your situation.

Other uses for this medicine

• Primary Use: Addyi is FDA-approved specifically for the treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women.
• Off-Label Uses: There are no well-established off-label uses for Addyi. It is specifically formulated and approved for HSDD, so its use outside of this indication is not common.

What special precautions should I follow?

When taking Addyi, it’s important to follow specific precautions to minimize the risk of side effects and interactions:

• Avoid Alcohol: Do not drink alcohol while taking Addyi. The combination can cause severe hypotension (low blood pressure) and syncope (fainting), which can be dangerous.
• Medication Interactions: Certain medications can interact with Addyi, increasing the risk of side effects. These include:
  • Strong or moderate CYP3A4 inhibitors (e.g., certain antifungals, antibiotics, and antiviral medications)
  • Certain antidepressants
  • Blood pressure medications
  • Benzodiazepines and other sedatives

  Always inform your healthcare provider of all medications and supplements you are taking before starting Addyi.

• Blood Pressure: Be cautious if you have low blood pressure (hypotension) or are taking medications that lower blood pressure, as Addyi can cause a further drop in blood pressure, leading to fainting or dizziness.
• Pregnancy and Breastfeeding: The safety of Addyi during pregnancy and breastfeeding is not established. If you are pregnant, planning to become pregnant, or breastfeeding, consult your healthcare provider before using Addyi.
• Driving and Operating Machinery: Addyi can cause dizziness, sleepiness, and sedation. Do not drive, operate heavy machinery, or engage in activities requiring full alertness until you know how Addyi affects you.
• Liver Function: Addyi is contraindicated in patients with hepatic impairment (liver problems). Liver issues can affect how the body metabolizes Addyi, increasing the risk of severe side effects.
• Age Considerations: Addyi is specifically approved for premenopausal women. Its safety and efficacy in postmenopausal women or men have not been established.
• Regular Monitoring: Your healthcare provider may want to monitor your response to Addyi, especially during the first few weeks of treatment. Report any severe or unusual side effects to your doctor immediately.

Following these precautions can help reduce the risk of serious side effects and improve the effectiveness of the treatment. Always follow your healthcare provider’s instructions carefully when taking Addyi.

What special dietary instructions should I follow?

• Avoid Grapefruit and Grapefruit Juice: Grapefruit and grapefruit juice can increase the levels of Addyi in your blood, leading to an increased risk of side effects such as dizziness, low blood pressure, and fainting. It is recommended to avoid consuming grapefruit products while taking Addyi.
• General Diet: Aside from avoiding alcohol and grapefruit, there are no specific dietary restrictions while taking Addyi. However, maintaining a balanced diet and staying hydrated is always beneficial.

What should I do if I forget a dose?

• Skip the Missed Dose: If you miss a dose of Addyi, do not take it in the morning or double up on your next dose. Simply skip the missed dose and take your next dose at the regular time (at bedtime). Taking Addyi at a different time of day or taking extra doses can increase the risk of side effects such as dizziness and low blood pressure.
• Resume Regular Schedule: Continue taking Addyi as prescribed, at your regular bedtime dose.

What side effects can this medication cause?

Addyi (Flibanserin) can cause a range of side effects, some of which may be more common or mild, while others can be more serious. It’s important to be aware of these potential side effects and consult your healthcare provider if you experience any concerning symptoms.

Common Side Effects:

• Dizziness: One of the most common side effects, especially if you stand up quickly after sitting or lying down.
• Sleepiness (Somnolence): Addyi can cause drowsiness, particularly in the hours following a dose. This is why it’s recommended to take it at bedtime.
• Nausea: Some people may experience nausea, which can vary in intensity.
• Fatigue: Feeling unusually tired or fatigued can occur, especially during the initial weeks of treatment.
• Insomnia: Difficulty sleeping may be experienced by some women.
• Dry Mouth: A dry mouth is another common side effect, which might be uncomfortable but is generally manageable.

Less Common but More Serious Side Effects:

• Low Blood Pressure (Hypotension): Addyi can cause a significant drop in blood pressure, which may lead to symptoms such as dizziness, lightheadedness, or fainting. This risk is heightened when combined with alcohol or certain medications.
• Fainting (Syncope): Some individuals may faint, particularly if they experience a significant drop in blood pressure. This is a serious side effect that requires medical attention.
• Severe Allergic Reactions: Although rare, some people may experience a severe allergic reaction to Addyi. Symptoms might include rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing. Seek emergency medical attention if you experience these symptoms.
• Depression or Suicidal Thoughts: While not common, some individuals may experience mood changes, including feelings of depression or thoughts of self-harm. It’s crucial to contact a healthcare provider immediately if these symptoms occur.
• Liver Function Abnormalities: Addyi is contraindicated in women with liver impairment because of the increased risk of severe side effects. Monitoring liver function may be necessary in some cases.
• Interaction with Alcohol: The combination of Addyi and alcohol significantly increases the risk of severe hypotension and fainting. This is a major concern and is why alcohol should be avoided entirely while taking this medication.

If you experience any severe or persistent side effects, or if you have any concerns about the effects of Addyi, it is important to consult your healthcare provider. They may need to adjust your treatment or provide guidance on how to manage the side effects.

What should I know about storage and disposal of this medication?

Storage and Disposal of Aceon:

• Storage:
  • Store Addyi at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Store the medication in a dry place, away from moisture and direct sunlight. Do not store it in the bathroom.
  • Ensure that Addyi is stored in a secure location where children or pets cannot access it.
• Disposal:
  • Do not flush Addyi down the toilet or pour it into a drain unless instructed to do so by a pharmacist or local waste disposal authority.
  • The best way to dispose of Addyi is through a medication take-back program. Check with your pharmacist or local waste disposal company for take-back programs in your area.

In case of emergency/overdose

• Symptoms of an overdose may include severe dizziness, fainting, extreme sleepiness, or signs of very low blood pressure.
• If you suspect an overdose, call your local poison control center or seek emergency medical attention immediately. In the U.S., you can contact the Poison Help line at 1-800-222-1222.
• Be prepared to provide the healthcare professionals with details about how much Addyi was taken and when, as well as any other medications or substances that may have been consumed.

What other information should I know?

• Regular Check-Ups: Follow up with your healthcare provider regularly to monitor the effectiveness of Addyi and to check for any side effects or issues.
• Effectiveness Timeline: Addyi may take several weeks (up to 8 weeks) to show improvements in sexual desire. If there is no improvement after 8 weeks, your healthcare provider may advise discontinuing the medication.
• Not for Use in Men: Addyi is not approved for use in men. Its safety and efficacy in men have not been established.
• Interaction with Other Medications: Always inform your healthcare provider of all the medications, supplements, or herbal products you are taking before starting Addyi to avoid harmful interactions.
• Avoid Driving or Operating Heavy Machinery: Due to the potential for dizziness and drowsiness, avoid activities that require full alertness until you know how Addyi affects you.
• Consult Before Surgery: If you are planning to have surgery, including dental surgery, inform your doctor that you are taking Addyi.

By following these guidelines, you can ensure that Addyi is used safely and effectively while minimizing potential risks.