Bridion

1. Bridion

Serious side effects have been reported with Bridion. See the "Drug Precautions" section.

Common side effects of Bridion include the following:

• low blood pressure (hypotension)
• vomiting
• pain
• headache
• nausea

This is not a complete list of Bridion side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• toremifene (Fareston)
• hormonal contraceptives (birth control) containing an estrogen or progestogen. Bridion will make hormonal contraceptives less effective. If a hormonal contraceptive is taken on the same day that you receive Bridion, you will need to use an effective back-up method of birth control (such as condoms or spermicides) for the next 7 days.

This is not a complete list of Bridion drug interactions. Ask your doctor or pharmacist for more information.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Bridion, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

There have been no studies that have been done in pregnant women with Bridion. In animal studies, pregnant animals were given this medication and some babies were harmed. If you receive Bridion, talk to your doctor about the potential risks associated with pregnancy.

Sugammadex reverses the effects of certain medications that are given during surgical procedures to relax your muscles.

Sugammadex is used at the end of surgery, to help restore muscle function that has been blocked during surgery by the other medicines.

Sugammadex may also be used for purposes not listed in this medication guide.

Before you receive sugammadex, tell your doctor about all your medical conditions or allergies, and all the medicines you are using. Also make sure your doctor knows if you are pregnant or breast-feeding.

Sugammadex is injected into a vein through an IV. A healthcare provider will give you this medicine in a single injection.

Your breathing, blood pressure, oxygen levels, kidney function, and other vital signs will be watched closely while you are receiving sugammadex.

Since sugammadex is used as a single dose, it does not have a daily dosing schedule.

Contraindications

• Known hypersensitivity to sugammadex or any ingredient in the formulation.1

Warnings/Precautions

Anaphylaxis and Hypersensitivity

Serious, potentially fatal, hypersensitivity reactions reported.1 12 13 20 Manifestations have ranged from isolated skin reactions (e.g., flushing, urticaria, erythematous rash) to more severe systemic reactions (e.g., anaphylaxis) requiring use of vasopressors, prolonged hospitalization, and/or additional respiratory support.1 12

Monitor for hypersensitivity reactions and ensure ability to manage such reactions.1

Bradycardia

Marked bradycardia may occur minutes after sugammadex administration; cardiac arrest precipitated by bradycardia also reported.1 Closely monitor for hemodynamic changes and administer anticholinergic agents (e.g., atropine) if clinically important bradycardia occurs.1

Respiratory Function Monitoring

Delayed or minimal reversal of neuromuscular blockade following sugammadex administration has occurred in some patients.1 Neuromuscular blockade also may recur following extubation.1 Respiratory depression may persist after complete recovery of neuromuscular function.1

Monitor respiratory function and provide ventilatory support until adequate spontaneous respiration is restored and the ability to maintain a patent airway is assured.1 If neuromuscular blockade persists or recurs, take appropriate steps to provide adequate ventilation.1

Readministration of Neuromuscular Blocking Agents

If readministration of a steroidal neuromuscular blocking agent is necessary (e.g., for intubation) after reversal with sugammadex, observe a minimum wait time based on dose of sugammadex and renal function.1

Following administration of sugammadex (2 or 4 mg/kg), a minimum wait time of 5 minutes is recommended before readministration of rocuronium bromide 1.2 mg/kg, and a minimum wait time of 4 hours is recommended before readministration of rocuronium bromide 0.6 mg/kg or vecuronium bromide 0.1 mg/kg.1 If rocuronium bromide 1.2 mg/kg is administered ≤30 minutes after sugammadex, the onset of neuromuscular blockade may be delayed up to approximately 4 minutes and the duration of blockade shortened by approximately 15 minutes.1

Following administration of sugammadex 16 mg/kg, a minimum wait time of 24 hours is recommended before rocuronium or vecuronium is readministered.1

In patients with mild or moderate renal impairment, a minimum wait time of 24 hours is recommended after administration of sugammadex (2 or 4 mg/kg) before rocuronium bromide 0.6 mg/kg or vecuronium bromide 0.1 mg/kg is readministered.1 If a shorter wait time is necessary, the rocuronium bromide dose for a new blockade should be 1.2 mg/kg.1

If neuromuscular blockade is required before the recommended wait times have elapsed, consider use of a nonsteroidal neuromuscular blocking agent (e.g., succinylcholine).1 However, onset of neuromuscular blockade with depolarizing neuromuscular blocking agents may be delayed in this setting.1

Recurrence of Neuromuscular Blockade

Risk of recurrence of neuromuscular blockade may be increased with concurrent use of certain drugs (i.e., drugs that displace rocuronium or vecuronium from sugammadex binding sites) or use of lower than recommended doses of sugammadex.1 Mechanical ventilation may be required.1

Risk also may be increased with use of drugs that potentiate neuromuscular blockade during postoperative period; consult prescribing information for rocuronium or vecuronium for specific drugs that may potentiate neuromuscular blockade.1 (See Interactions.)

Coagulopathy and Bleeding

Increased coagulation parameters (e.g., aPTT, PT, INR) observed.1 However, does not appear to correlate with an increased risk of bleeding.1

Risk of bleeding not evaluated with sugammadex 16 mg/kg in patients receiving thromboprophylaxis drugs.1 Risk of bleeding also not evaluated in patients with known coagulopathies or receiving therapeutic anticoagulation or thromboprophylaxis with drugs other than heparin and low molecular weight heparin.1 Carefully monitor coagulation parameters in such patients.1

Light Anesthesia

Signs of light anesthesia (e.g., movement, coughing, grimacing, suckling of the tracheal tube) may be noted if neuromuscular blockade is reversed during anesthesia.1

Specific Populations

No data regarding use of sugammadex in pregnant women.1 Teratogenicity not observed in animal studies; however, incomplete ossification and reduced fetal body weight observed at dose exposures greater than the maximum recommended human dose.1

Distributed into milk in rats; not known whether distributed into human milk.1 Consider benefits of breast-feeding and importance of the drug to the woman; also consider potential adverse effects on the breast-fed infant from the drug or underlying maternal condition.1

Safety and efficacy not established in pediatric patients.1

Has been used in some pediatric patients for reversal of moderate rocuronium-induced neuromuscular blockade.7 Some evidence suggests similar efficacy and safety in pediatric patients 2–17 years of age and adults.9

Animal toxicity studies indicate possible adverse effects on developing bone; increased bone deposition, decreased bone length, and tooth enamel abnormalities observed in juvenile animals receiving daily IV doses of sugammadex.1

Median time to recovery following administration of sugammadex 2 mg/kg at reappearance of T2 after rocuronium-induced blockade was 2.5 and 3.6 minutes in geriatric patients 65–74 and ≥75 years of age, respectively, compared with 2.2 minutes in patients 18–64 years of age.1 Median time to recovery following sugammadex 4 mg/kg at 1–2 PTC was 2.5 minutes in geriatric patients ≥65 years of age compared with 2 minutes in younger adults.1

Pharmacokinetics not studied in patients with hepatic impairment; not metabolized or excreted by the liver.1 Use with caution in patients with hepatic impairment accompanied by coagulopathy or severe edema.1

Not recommended in patients with severe renal impairment, including those requiring dialysis, because of prolonged and increased overall drug exposure and insufficient experience in such patients.1 8 (See Renal Impairment under Dosage and Administration.)

If patients with mild or moderate renal impairment require readministration of a neuromuscular blocking agent, a minimum wait time may be required.1 (See Readministration of Neuromuscular Blocking Agents under Cautions.)

Common Adverse Effects

Vomiting,1 pain,1 nausea,1 hypotension,1 headache.1

Storage

Parenteral

25°C (may be exposed to 15–30°C).1 Protect from light; use within 5 days if not protected from light.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of bleeding like throwing up blood or throw up that looks like coffee grounds; coughing up blood; blood in the urine; black, red, or tarry stools; bleeding from the gums; vaginal bleeding that is not normal; bruises without a reason or that get bigger; or any bleeding that is very bad or that you cannot stop.
• Flushing.
• Skin irritation.
• Fast or slow heartbeat.
• A heartbeat that does not feel normal.
• Chest pain.
• Very bad dizziness or passing out.
• Very bad headache.
• Fever or chills.