Brexanolone Injection : Uses, Side Effects, Interactions & More

IMPORTANT WARNING:

Brexanolone injection can make you very sleepy or suddenly lose consciousness during treatment. You will receive your Brexanolone injection at a medical facility. Your doctor will examine you for signs of drowsiness every 2 hours while you are awake. Tell your doctor right away if you are extremely tired, feel like you cannot stay awake during the time you are normally awake, or if you feel like you are going to faint.

You should have a caregiver or family member to help you with your child (ren) during and after receiving the Brexanolone injection.

Do not drive a car or operate machinery until you are no longer sleepy or sleepy after your brexanolone infusion.

Due to the risks of this drug, Brexanolone is only available through a special restricted distribution program. A program called the Zulresso Risk Assessment and Mitigation Strategy Program (REMS). You, your doctor, and your pharmacy must be enrolled in the Zulresso REMS program before you can receive it. You will receive Brexanolone at a medical facility under the observation of a doctor or other healthcare professional.

Keep all your appointments with your doctor.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you start treatment with brexanolone and each time you get a refill. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website or the manufacturer’s website to obtain the Medication Guide.

How should this medicine be used?

Brexanolone comes as a solution to be injected intravenously (into a vein). It is usually given as a single infusion over 60 hours (2.5 days) at a medical facility.

Your doctor may temporarily or permanently stop your treatment or adjust your dose of brexanolone depending on your response to treatment and the side effects you experience.

Brexanolone can be habit-forming. While receiving brexanolone, discuss your treatment goals with your healthcare provider.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before receiving brexanolone,

  • Tell your doctor and pharmacist if you are allergic to any other medications or to any of the ingredients in brexanolone injection. Ask your pharmacist or see the Medication Guide for a list of ingredients.
  • Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants, benzodiazepines including alprazolam (Xanax), diazepam (Diastat, Valium), midazolam, or triazolam (Halcion); medications for mental illness, pain medications such as opioids, seizure medications, sedatives, sleeping pills, and tranquilizers. Your doctor may need to change the doses of your medications or monitor you closely for side effects.
  • Tell your doctor if you have or have ever had kidney disease.
  • Tell your doctor if you are pregnant or think you may be or are breastfeeding.
  • You should know that alcohol can make the side effects of brexanolone worse. Do not drink alcohol while receiving brexanolone.
  • You should know that your mental health can change unexpectedly when you receive brexanolone or other antidepressants, even if you are an adult over 24 years of age. You may be suicidal, especially at the beginning of your treatment and any time your dose changes. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening depression; thinking about, or planning or attempting to, hurt or commit suicide; extreme worry; agitation; panic attacks; Difficulty falling asleep or staying asleep; aggressive behavior; irritability; act without thinking; severe restlessness; and a frenzy of abnormal excitement. Make sure your family or caregiver knows what symptoms can be serious so they can call your doctor if you are unable to seek treatment on your own.
Also Read:  Kemstro : Uses, Side Effects, Interactions & More

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What side effects can this medication cause?

Brexanolone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • dry mouth
  • heartburn
  • mouth or throat pain
  • flushing
  • hot flashes
  • dizziness or a spinning sensation
  • fatigue

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately or get emergency medical treatment:

  • racing heartbeat

Brexanolone can cause other side effects. Call your doctor if you have any unusual problems while receiving this medicine.

If you experience a serious side effect, you or your doctor can submit a report online to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim collapsed, had a seizure, is having trouble breathing, or is unable to wake up, immediately call 911 for emergency services.

Symptoms of overdose may include:

  • sedation
  • loss of consciousness

What other information should I know?

Brand Names

  • Zulresso®

Disclaimer: DrLinex has made every effort to ensure that all information is factually accurate, comprehensive and up-to-date. However, this article should not be used as a licensed health care professional’s choice of knowledge and expertise. You should always consult your doctor or other health care professional before taking any medication. The information given here is subject to change and it has not been used to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions or adverse effects. The lack of warning or other information for any drug does not indicate that the combination of medicine or medication is safe, effective or appropriate for all patients or all specific uses.

 

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