Zulresso
Brexanolone injection is used to treat postpartum depression (unusual physical, emotional, and behavioral changes in women after giving birth). This medicine is available only under a restricted distribution program called Zulresso® REMS (Risk Evaluation and Mitigation Strategy) Program. This product is available in the following dosage forms:
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Appropriate studies have not been performed on the relationship of age to the effects of brexanolone injection in children younger than 15 years of age. Safety and efficacy have not been established. No information is available on the relationship of age to the effects of brexanolone injection in geriatric patients. There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the needle will have to stay in place for a total of 60 hours (2 1/2 days). Your doctor will check you for excessive drowsiness or symptoms of sleepiness during infusion and for every 2 hours while you are awake. It is very important that you understand the requirements of the Zulresso® REMS program, and become familiar with the Zulresso® medication guide. Read and follow these instructions carefully. Ask your doctor if you have any questions. Ask your pharmacist for the medication guide if you do not have one.
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