Cypsedo

Cypsedo is a general anesthetic used to induce (start) general anesthesia in adults undergoing surgery. It is given as an injection into a vein by an anesthesia provider immediately before your surgery begins.

Cypsedo contains the active ingredient cipepofol, which is thought to work by enhancing the activity of GABA, the main inhibitory neurotransmitter in the brain. This produces sedation and a loss of consciousness so that you are asleep during your surgery.

Cypsedo was approved by the U.S. Food and Drug Administration (FDA) on May 29, 2026. It is made by HaiscoUSA Pharmaceuticals, Inc.

• Cypsedo is given as an injection into a vein (intravenously) by an anesthesia provider right before your surgery starts
• Your dose is based on your body weight, and the recommended dose also depends on your age, body mass index (BMI), and your American Society of Anesthesiologists Physical Status (ASA-PS) classification, which is a measure of your overall health before surgery
• If the first dose does not fully induce anesthesia, an additional dose may be given intravenously over 10 seconds, about one minute after the end of the first dose
• Lower doses are recommended for patients with a BMI greater than 40 kg/m2 and for patients with an ASA-PS III classification

Because Cypsedo is given by a healthcare professional in a hospital or surgical setting, you will not need to handle, prepare, or store this medicine yourself.

You should not receive Cypsedo if you have had a serious allergic reaction (anaphylaxis) to eggs, egg products, soybeans, or soy products, or if you are allergic to cipepofol or any of the inactive ingredients in Cypsedo. Life-threatening allergic reactions, including anaphylaxis, have been reported after Cypsedo administration.

Cypsedo can cause a slow heart rate, low blood pressure, slowed breathing, and reduced oxygen levels. Your anesthesia provider will continuously monitor your heart, blood pressure, breathing, and oxygen levels while you are receiving Cypsedo and will treat any problems promptly if they occur.

Cypsedo is not approved for use in children. It is not recommended in younger children because of the risk of harmful effects on the developing brain (neurotoxicity) seen in animal studies.

Tell your healthcare provider about all of your medical conditions before your surgery, including if you:

• have ever had an allergic reaction to eggs, egg products, soybeans, or soy products
• have ever had a reaction to an anesthetic medicine
• have heart, blood pressure, or breathing problems
• are pregnant or plan to become pregnant. Cypsedo should only be used during pregnancy if the potential benefit to the mother and fetus outweighs the risks
• are breastfeeding or plan to breastfeed.

Serious side effects of Cypsedo may include:

• Serious allergic reactions, including anaphylaxis. People with a history of anaphylaxis to eggs, egg products, soybeans, or soy products may be at higher risk
• Slow heart rate (bradycardia), low blood pressure, slowed breathing (respiratory depression), and reduced oxygen levels. Your anesthesia provider will monitor you continuously and treat these problems if they occur.

The most common side effects of Cypsedo (occurring in 2% or more of patients) are:

• low blood pressure (hypotension)
• nausea
• injection site pain
• procedural pain
• high blood pressure (hypertension)
• low blood pressure during the procedure (procedural hypotension)
• weakness (asthenia)
• vomiting
• dizziness
• low oxygen levels (hypoxia)
• slow heart rate (bradycardia)
• fast heart rate (tachycardia)
• constipation
• headache.

These are not all the possible side effects of Cypsedo. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or to HaiscoUSA Pharmaceuticals, Inc. at 1-866-358-7181.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using Cypsedo together with opioids or other sedatives may cause more pronounced decreases in blood pressure and the amount of blood pumped by the heart (cardiac output). Your anesthesia provider will take this into account when planning your anesthesia.

Cypsedo is stored, prepared, and administered by your healthcare team in a hospital or surgical setting. You will not need to store it at home.

Healthcare providers should maintain strict aseptic technique when handling Cypsedo, disinfect the rubber stopper of the vial with 70% isopropyl alcohol before use, use each vial in one person only, and discard opened, pierced, or used vials within 12 hours.

Active ingredient: cipepofol

Inactive ingredients: edetate disodium anhydrous 0.05 mg (equivalent to edetate disodium 0.055 mg), egg phospholipids 12 mg, glycerin 22.5 mg, medium-chain triglycerides 50 mg, sodium oleate 0.3 mg, soybean oil 50 mg, and water for injection, with sodium hydroxide to adjust pH.

Cypsedo is isotonic and has a pH of 6.0 to 9.0. Egg phospholipids are derived from eggs, and soybean oil is derived from soybeans.

Cypsedo is made in Italy for HaiscoUSA Pharmaceuticals, Inc., 1200 US Highway 22E, Suite 2000, Bridgewater, New Jersey 08807.