WARNING

Zulresso (brexanolone) carries certain risks, and its use should be carefully considered by healthcare providers based on the individual patient’s condition. Here are some potential risks associated with taking Zulresso:

• Loss of Consciousness: Some individuals may experience loss of consciousness during the Zulresso infusion. This risk underscores the importance of receiving the treatment in a supervised healthcare setting.
• Sedation: Zulresso commonly causes somnolence, which is a state of drowsiness or sleepiness. Patients should be cautious about engaging in activities that require alertness, such as driving, until they know how the medication affects them.
• Dizziness: Dizziness is a reported side effect of Zulresso, and patients should be cautious when changing positions to avoid falls or accidents.
• Hypersensitivity Reactions: Rarely, hypersensitivity reactions, including rash, pruritus (itching), and urticaria (hives), may occur. Monitoring for these reactions is essential during treatment.
• Cognitive Effects: Changes in attention or memory may be experienced during and after the infusion.
• Interaction with Other Medications: Zulresso may interact with other medications, and patients should inform their healthcare providers about all the medications, supplements, or herbal products they are taking.
• Pregnancy and Breastfeeding: Zulresso is not approved for use during pregnancy, and breastfeeding is not recommended during treatment. The potential risks and benefits should be carefully considered in consultation with healthcare providers.
• Administration Site Adverse Reactions: Adverse reactions related to the administration site, such as redness and swelling, may occur.

It’s crucial for patients to discuss their medical history, including any pre-existing conditions or medications, with their healthcare providers before starting Zulresso. Additionally, patients should be monitored closely during the infusion period for any signs of adverse reactions.

This information is a brief overview, and the decision to use Zulresso is a complex one made by healthcare professionals based on a thorough evaluation of the patient’s needs and potential risks and benefits. Patients should consult their healthcare providers for personalized information and guidance.

Why is this medication prescribed?

Zulresso (brexanolone) is a medication prescribed for the treatment of postpartum depression (PPD) in adult women. Postpartum depression is a type of depression that occurs after childbirth and can affect a woman’s mood, thoughts, and ability to function. Zulresso is specifically indicated for PPD in patients who require intravenous (IV) pharmacological treatment.

The active ingredient in Zulresso, brexanolone, is a synthetic form of a hormone called allopregnanolone, which is thought to have a positive effect on mood regulation.

How should this medicine be used?

Zulresso (brexanolone) is administered as an intravenous (IV) infusion and is typically given in a healthcare setting, such as a hospital or a specialized treatment center. Here are the general steps and considerations for the use of Zulresso:

• Healthcare Setting: Zulresso is administered under the supervision of healthcare professionals in a facility equipped to monitor patients during the infusion.
• Duration of Infusion: The infusion of Zulresso is given over a total of 60 hours, which is equivalent to 2.5 days. This extended infusion period allows for a gradual delivery of the medication.
• Dosage: The dosage is determined by the healthcare provider based on the patient’s specific needs and medical condition. The prescribed dose is diluted and administered intravenously.
• Monitoring: During the infusion, the patient’s vital signs, such as blood pressure, heart rate, and oxygen levels, are closely monitored to ensure safety and detect any potential adverse reactions.
• Side Effects and Adverse Reactions: Zulresso may be associated with certain side effects and risks, and healthcare providers will monitor for any signs of adverse reactions. Common side effects may include dizziness, somnolence (sleepiness), and headache.
• Patient Information: Patients receiving Zulresso should be informed about the nature of the treatment, potential side effects, and the importance of adhering to the prescribed infusion schedule.
• Post-Infusion Monitoring: After the infusion is complete, healthcare providers may continue to monitor the patient to ensure a smooth transition and assess the overall response to the treatment.

It’s important to note that Zulresso is specifically indicated for the treatment of postpartum depression in adult women who require pharmacological intervention. The decision to use Zulresso is made by healthcare professionals based on a thorough evaluation of the patient’s condition and the potential benefits and risks associated with the medication.

Patients and their healthcare providers should engage in open communication to address any questions or concerns regarding the treatment plan, and the patient’s progress should be regularly assessed throughout and after the infusion period.

Other uses for this medicine

Zulresso is primarily indicated for the treatment of postpartum depression and is not approved for other uses. It’s important to note that medication indications can change over time, and new uses may be identified. Always consult with a healthcare professional or refer to the most recent prescribing information for the latest updates.

What special precautions should I follow?

As for special precautions for using Zulresso, it’s crucial to follow the guidance provided by healthcare professionals. Here are some general considerations and precautions associated with Zulresso use:

• Patient Evaluation: Zulresso is typically prescribed after a thorough evaluation of the patient’s medical history, current health status, and the severity of postpartum depression. The decision to use Zulresso is made by healthcare providers based on the individual patient’s needs.
• Monitoring: Patients receiving Zulresso are closely monitored during the infusion for any signs of adverse reactions or side effects. Vital signs, such as blood pressure, heart rate, and oxygen levels, are regularly checked.
• Side Effects: Zulresso may cause side effects, including dizziness, somnolence (sleepiness), and headache. Patients should be made aware of these potential side effects, and healthcare providers will assess whether the benefits of treatment outweigh the risks.
• Contraindications: Zulresso may not be suitable for everyone. Certain medical conditions or medications may contraindicate the use of Zulresso. It’s important for healthcare providers to be aware of a patient’s complete medical history before prescribing the medication.
• Drug Interactions: Zulresso may interact with other medications. It’s essential for patients to inform their healthcare providers about all the medications, supplements, or herbal products they are taking.
• Pregnancy and Breastfeeding: Zulresso is not approved for use during pregnancy. The potential risks and benefits should be carefully considered, and alternative treatments may be explored. Additionally, it is not known whether Zulresso is excreted in human breast milk, so breastfeeding is not recommended during treatment.
• Hepatic Impairment: Zulresso is metabolized in the liver, and caution is advised in patients with hepatic impairment. Dose adjustments or alternative treatments may be considered in such cases.

It’s essential for patients to communicate openly with their healthcare providers about their medical history, current medications, and any concerns or questions they may have about Zulresso. This ensures that the treatment plan is tailored to the individual patient’s needs and circumstances. As information may change, it’s advisable to consult with a healthcare professional or refer to the most recent prescribing information for Zulresso for the latest guidance.

What special dietary instructions should I follow?

As of last update, there are no specific dietary instructions associated with Zulresso. However, always follow any guidance provided by your healthcare provider. If there have been updates or changes since my last update, your healthcare provider will have the most current information.

What should I do if I forget a dose?

Since Zulresso is administered as a continuous intravenous infusion over a total of 60 hours, it is less likely that you will forget a dose compared to medications taken orally or by injection. The infusion is typically administered in a healthcare setting under the supervision of medical professionals.

If, for any reason, the infusion is interrupted or delayed, inform your healthcare provider immediately. They will determine the appropriate course of action, which may involve adjusting the infusion rate or taking other measures to ensure the effectiveness of the treatment.

What side effects can this medication cause?

Zulresso (brexanolone) may cause side effects, and it’s important to be aware of these potential reactions. Keep in mind that not everyone will experience these side effects, and their severity can vary from person to person. Common side effects of Zulresso may include:

• Sedation (Sleepiness): One of the most commonly reported side effects is somnolence, which is a state of drowsiness or sleepiness.
• Dry Mouth: Some individuals may experience a dry mouth as a side effect of Zulresso.
• Loss of Consciousness: There have been reports of patients losing consciousness during the Zulresso infusion. This underscores the importance of receiving the treatment in a supervised healthcare setting.
• Flushing (Redness of the Skin): Flushing or redness of the skin can occur as a side effect.
• Cognitive Effects: Some patients may experience changes in attention or memory during and after the infusion.
• Dizziness: Dizziness has been reported as a side effect.
• Hypersensitivity Reactions: In rare cases, hypersensitivity reactions, including rash, pruritus (itching), and urticaria (hives), have been reported.

It’s crucial to note that Zulresso is administered in a healthcare setting under the supervision of trained professionals who can monitor for any adverse reactions. If you experience any concerning side effects or have questions about your treatment, it’s important to communicate with your healthcare provider promptly. Always refer to the most recent prescribing information for Zulresso or consult with a healthcare professional for the latest guidance.

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

Storage and Disposal of Zulresso:

• Storage: Zulresso, being administered in a healthcare setting, is typically stored and handled by healthcare professionals. If there are any specific storage requirements for the medication, these will be managed by the healthcare facility. Patients are not responsible for storing Zulresso at home.
• Disposal: Proper disposal of any unused or expired medication is essential. Healthcare providers or facilities will have protocols in place for the safe disposal of medical waste, including unused Zulresso. Patients should not attempt to dispose of the medication themselves but should follow the guidance of healthcare professionals.

In case of emergency/overdose

In the case of an emergency or suspected overdose, it is crucial to seek immediate medical attention. Overdose symptoms or adverse reactions may include severe sedation, loss of consciousness, or other serious effects. Contact emergency services or go to the nearest emergency room.

What other information should I know?

• Follow-up Care: After receiving Zulresso, patients may need follow-up care to assess their response to treatment and monitor for any lingering side effects. Attend all scheduled follow-up appointments as recommended by your healthcare provider.
• Inform Healthcare Providers: Keep your healthcare provider informed about your overall health, any changes in medications, and any new or persistent symptoms.
• Pregnancy and Breastfeeding: Zulresso is not approved for use during pregnancy, and breastfeeding is not recommended during treatment. Discuss family planning and contraception with your healthcare provider.
• Driving and Operating Machinery: Zulresso may cause sedation and dizziness. Patients should avoid activities that require alertness, such as driving or operating heavy machinery, until they know how Zulresso affects them.
• Allergies: Inform your healthcare provider of any known allergies or sensitivities, as Zulresso may cause hypersensitivity reactions in some individuals.
• Medication Interactions: Provide a complete list of all medications, supplements, and herbal products you are taking to your healthcare provider, as Zulresso may interact with other substances.

Always consult with your healthcare provider or the prescribing physician for specific and up-to-date information regarding the use, storage, and disposal of Zulresso. This information is based on general guidelines, and specific details may vary depending on individual circumstances and any updates in medical guidelines.