WARNING

Brexanolone injection, also known as Zulresso, is primarily used to treat postpartum depression (PPD). While it can be effective, like any medication, it comes with potential risks and side effects. Here’s a brief overview:

• Excessive Sedation: Brexanolone can cause significant sedation, which may impair your ability to perform tasks that require alertness, such as driving.
• Sudden Loss of Consciousness: Some individuals may experience sudden loss of consciousness or loss of awareness shortly after receiving the injection.
• Altered Mental Status: Brexanolone may cause changes in mental status, such as confusion or disorientation.
• Serious Side Effects: In some cases, Brexanolone can lead to serious side effects like fainting, excessive sleepiness, or loss of consciousness.
• Hypoxia: There is a risk of hypoxia (low oxygen levels) during administration, especially if not monitored properly.
• Interaction with Other Medications: Brexanolone may interact with other medications or substances, potentially leading to adverse effects.
• Monitoring Requirements: Due to these risks, Brexanolone administration typically requires close monitoring in a healthcare setting for at least 60 hours after the infusion.

It’s essential to discuss these risks with your healthcare provider before starting Brexanolone treatment, and closely follow their recommendations for monitoring and management.

Why is this medication prescribed?

Brexanolone injection, sold under the brand name Zulresso, is prescribed primarily for the treatment of postpartum depression (PPD) in adults. PPD is a form of depression that occurs after childbirth and can significantly impact a new mother’s ability to care for herself and her baby. Brexanolone is specifically indicated for women experiencing moderate to severe symptoms of PPD.

How should this medicine be used?

As for its usage:

• Administration: Brexanolone is administered intravenously (through a vein) over a continuous 60-hour infusion period. This is typically done in a healthcare facility under close supervision due to the risk of side effects, particularly excessive sedation.
• Dosage: The dosage and infusion rate of Brexanolone are determined by a healthcare professional based on the individual’s weight and other factors. The medication is supplied as a concentrated solution and must be diluted before administration.
• Monitoring: During the infusion period, patients are closely monitored for any adverse reactions or changes in vital signs. This monitoring is essential for ensuring safety and managing any potential side effects promptly.
• Post-Infusion: After the 60-hour infusion period, patients may still require monitoring to assess their response to treatment and ensure the resolution of any side effects. Additional treatment or support may be recommended based on individual needs.

It’s crucial for patients to follow their healthcare provider’s instructions precisely when using Brexanolone and to communicate any concerns or side effects promptly. Additionally, Brexanolone treatment is typically part of a comprehensive treatment plan for PPD, which may include therapy, support groups, and other interventions.

Other uses for this medicine

Brexanolone injection, marketed as Zulresso, is primarily indicated for the treatment of postpartum depression (PPD) and is not approved for other uses. However, ongoing research may explore its potential applications in other mood disorders or conditions.

What special precautions should I follow?

Regarding special precautions for Brexanolone injection:

• Medical History: Before receiving Brexanolone, it’s crucial to inform your healthcare provider about your medical history, including any past or present medical conditions, allergies, and medications you are taking. This information helps ensure the safe use of the medication.
• Pregnancy and Breastfeeding: Brexanolone should not be used during pregnancy unless the potential benefits outweigh the risks. It is also not recommended while breastfeeding due to the potential for harm to the infant. Discuss the risks and benefits with your healthcare provider if you are pregnant or breastfeeding.
• Monitoring: Brexanolone infusion requires close monitoring in a healthcare facility for the entire 60-hour duration due to the risk of side effects, including excessive sedation and loss of consciousness. Vital signs and mental status should be regularly assessed during the infusion.
• Driving and Operating Machinery: Brexanolone can cause significant sedation, which may impair your ability to drive or operate machinery. Avoid these activities until you know how Brexanolone affects you.
• Alcohol and Sedativesv Avoid consuming alcohol or taking other sedative medications while receiving Brexanolone, as this can increase the risk of excessive sedation and other adverse effects.
• Allergic Reactions: If you have a known allergy to Brexanolone or any of its components, inform your healthcare provider before receiving the medication.
• Medical Assistance: Be aware of the signs of serious side effects, such as fainting, excessive sleepiness, or altered mental status, and seek medical assistance if you experience any concerning symptoms during or after the infusion.

Always follow your healthcare provider’s instructions and recommendations when using Brexanolone injection to ensure safe and effective treatment.

What special dietary instructions should I follow?

There are typically no specific dietary restrictions associated with brexanolone injection. However, maintaining a healthy, balanced diet can support overall well-being, which is important when managing depression. Eating regular meals and snacks that include a variety of nutrient-rich foods like fruits, vegetables, whole grains, lean proteins, and healthy fats can help support your mental health.

What should I do if I forget a dose?

If you miss a dose of brexanolone injection, contact your healthcare provider for guidance. They may recommend rescheduling the missed dose or adjusting your dosing schedule accordingly. It’s essential not to double the dose to make up for a missed one unless specifically instructed by your healthcare provider. Follow their advice closely to ensure the effectiveness and safety of your treatment.

What side effects can this medication cause?

Brexanolone injection, also known by the brand name Zulresso, is a medication used for the treatment of postpartum depression (PPD) in adult women. Like any medication, it can potentially cause side effects. Some common side effects of brexanolone injection may include:

• Dizziness
• Sedation
• Dry mouth
• Fatigue
• Headache
• Loss of consciousness (syncope)
• Vertigo
• Flushing

It’s important to note that these are not all possible side effects and some people may experience different reactions. Additionally, some side effects can be serious and may require medical attention. Always consult your healthcare provider if you have any concerns about the side effects of brexanolone injection.

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

Storage and disposal of Brexafemme Injection:

Storage:

• Store brexanolone injection vials in the refrigerator at a temperature between 36°F to 46°F (2°C to 8°C).
• Do not freeze the medication.
• Protect the vials from light by keeping them in the original carton until ready for use.
• Keep brexanolone injection out of reach of children and pets.

Disposal:

• Dispose of any unused brexanolone injection vials properly according to local regulations or guidelines.
• Do not flush medications down the toilet or pour them into a drain unless instructed to do so.
• Consult your healthcare provider or pharmacist for information on how to properly dispose of brexanolone injection.

In case of emergency/overdose

In case of emergency/overdose of brexanolone injection, you should seek immediate medical attention. Emergency symptoms of overdose may include severe dizziness, loss of consciousness, difficulty breathing, or seizures. Be sure to inform medical professionals about the medication involved and provide them with as much information as possible.

What other information should I know?

• Brexanolone injection is administered as a continuous intravenous infusion over a period of 60 hours under the supervision of a healthcare provider in a certified healthcare facility.
• Prior to treatment, inform your healthcare provider about all medications, supplements, and medical conditions you have.
• Be aware of potential drug interactions with brexanolone injection, including central nervous system depressants.
• It may take some time for brexanolone injection to take effect in treating postpartum depression, and improvement may not be seen immediately.
• Follow all instructions provided by your healthcare provider regarding the administration of brexanolone injection and follow-up care after treatment.

Always consult your healthcare provider or pharmacist if you have any questions or concerns about brexanolone injection or its use.