bupivacaine implant (Rx)

Brand and Other Names:XaraColl
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

surgical implant

  • 100mg/implant
  • Each single-dose package (pouch) contains 3 implants totaling 300 mg

Postsurgical Analgesia

Indicated for management of postsurgical pain after open inguinal hernia surgery

Single dose of 300 mg (3 x 100-mg implants)

Doses >300 mg not studied in clinical trials

Dosage Modifications

Renal impairment

  • Bupivacaine is substantially excreted by the kidneys
  • Consider increased monitoring for local anesthetic systemic toxicity

Hepatic impairment

  • Amide-type local anesthetics (eg, bupivacaine) are metabolized by the liver
  • Moderate-to-severe: Consider increased monitoring for local anesthetic systemic toxicity

Dosing Considerations

Safety and efficacy not established in other surgical procedures (eg, orthopedic and boney procedures)

Safety and efficacy not established

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Interactions

Interaction Checker

and bupivacaine implant

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    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            >10%

            Incision site swelling (14.6%)

            1-10%

            Dysgeusia (7.5%)

            Postprocedural discharge (4.9%)

            Headache (4.1%)

            Tremor (3.6%)

            Blurred vision (3.6%)

            Seroma (2.9%)

            Scrotal swelling (2.9%)

            Pyrexia (2.4%)

            Oral hypoesthesia (2.2%)

            Postmarketing Reports

            Nervous system disorders: Restlessness, anxiety, dizziness, tinnitus, blurred vision, tremors, convulsions, drowsiness, unconsciousness, respiratory arrest, nausea, vomiting, chills, pupillary constriction

            Neurological effects following routes of administration other than epidural or caudal have included persistent anesthesia, paresthesia, weakness, and paralysis, all with slow, incomplete, or no recovery

            Cardiovascular (high doses): Myocardial depression, decreased cardiac output, heart block, hypotension, bradycardia, ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation, and cardiac arrest

            Immune system disorders: Urticaria, pruritus, erythema, angioneurotic edema (including laryngeal edema), tachycardia, sneezing, nausea, vomiting, dizziness, syncope, excessive sweating, elevated temperature, and severe hypotension; cross-sensitivity among members of amide-type local anesthetic group reported

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            Warnings

            Contraindications

            Hypersensitivity to any amide-type local anesthetic or any component of the implant

            Obstetrical paracervical block anesthesia; use of bupivacaine in this technique has resulted in fetal bradycardia and death

            Cautions

            Caution with hepatic impairment; amide local anesthetics are metabolized by the liver; monitor for systemic toxicity with moderate-to-severe liver impairment

            Patients with impaired cardiovascular function (eg, hypotension, heart block) may be less able to compensate for functional changes associated with prolonged atrioventricular conduction produced by bupivacaine; monitor blood pressure, heart rate, and ECG

            Safety and efficacy in surgical procedures other than open inguinal hernia repair are not established; not approved for other surgical procedures (eg, orthopedic procedures); a study evaluating osteotomy in rats demonstrated inhibition of bone healing

            Methemoglobinemia

            • Local anesthetics may cause methemoglobinemia; signs may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and/or abnormal coloration of the blood; immediate treatment is required to avert more serious CNS and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death
            • Patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are at higher risk; if local anesthetics must be used in these patients, monitor closely for signs and symptoms
            • Methemoglobin levels may continue to rise; initiate treatment immediately
            • Depending on severity of signs and symptoms, patients may respond to supportive care, including oxygen therapy, hydration; a severe clinical presentation may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen

            Dose-related toxicity

            • Avoid additional local anesthetics within 96 hr after bupivacaine implant placement
            • Monitor for neurological, cardiovascular, and respiratory symptoms related to local anesthetic systemic toxicity
            • Early warning signs of CNS toxicity may include restlessness, anxiety, incoherent speech, lightheadedness, numbness and tingling of the mouth and lips, metallic taste, tinnitus, dizziness, blurred vision, tremors, twitching, CNS depression, or drowsiness
            • Delay in proper management of dose-related toxicity, underventilation from any cause, and/or altered sensitivity may lead to acidosis, cardiac arrest, and, possibly, death
            • Consider surgically removing implant depending on clinical situation

            Drug interaction overview

            • Local anesthetics
              • Avoid additional local anesthetic administration within 96 hr after bupivacaine implant placement
              • Toxic effects of local anesthetics are additive
              • If additional local anesthetic administration cannot be avoided, monitor for neurologic and cardiovascular effects related to local anesthetic systemic toxicity
            • Drugs associated with methemoglobinemia
              • Additive risk of methemoglobinemia if coadministered with other drugs that increase risk
              • Local anesthetics may increase risk of methemoglobinemia
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            Pregnancy & Lactation

            Pregnancy

            Data are not available

            Based on animal data, advise pregnant females of potential risks to fetus

            Animal studies

            • Embryofetal lethality was noted when bupivacaine was administered SC to pregnant rabbits during organogenesis at clinically relevant doses
            • Decreased pup survival observed in a rat prenatal and postnatal developmental study (dosing from implantation through weaning) at dose level comparable to the daily maximum recommended human dose

            Labor or delivery

            • Local anesthetics rapidly cross the placenta
            • Incidence and degree of toxicity depend on procedure performed, type and amount of drug used, and technique of drug administration
            • Adverse reactions in parturient, fetus, and neonate can involve alterations of the CNS, peripheral vascular tone, and cardiac function

            Lactation

            Excreted in human milk

            Data are not available on effects in breastfed infants or on milk production

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Collagen-matrix implant that delivers bupivacaine to the surgical site

            Local anesthetic; blocks generation and conduction of nerve impulses presumably by increasing the electrical excitation threshold in the nerve, slowing nerve impulse propagation, and reducing the rate of action potential rise

            Absorption

            Peak plasma time: 3 hr

            Peak plasma concentration: 663 ng/mL

            AUC: 19,493-20,368 hr⋅ngmL

            Distribution

            Protein bound: 95%

            Crosses placenta by passive diffusion

            Metabolism

            Primarily in liver via conjugation with glucuronic acid

            Metabolite: Pipecoloxylidine

            Elimination

            Half-life: 19 hr

            Excretion: Primarily via kidneys (6% unchanged)

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            Administration

            Compatibility

            Administration of additional local anesthetics, including bupivacaine, into surgical site with implant has not been studied

            Studies conducted demonstrated that commonly used surgical materials (nonabsorbable surgical suture, delayed absorbable surgical suture, and surgical mesh) are not affected by bupivacaine implant

            Allow surgical site to dry before placing bupivacaine implants if topical antiseptic (eg, povidone iodine) applied

            Implant Preparation

            Administered by or under supervision of experienced clinicians versed in the diagnosis and management of dose-related toxicity and other acute emergencies arising from bupivacaine exposure

            Local anesthetic effects are additive; avoid additional local anesthetic administration within 96 hr after implantation; if additional local anesthetic administration cannot be avoided based on clinical need, monitor patients for neurologic and cardiovascular effects related to local anesthetic systemic toxicity

            Immediate availability of oxygen, other resuscitative drugs, CPR equipment, and personnel needed for proper management of toxic reactions and related emergencies

            Inspect outer pouch and inner blister before use; do not use if packaging compromised

            Aseptically peel open package to remove the 3 inner blister packages containing the implant; to avoid cutting implants before placement, do not open the blister packaging using scissors or a scalpel

            Carefully remove from inner blister packages and inspect each implant before use

            Implant is white to off-white in color, has uniform thickness, and is ~5-cm x 5-cm x 0.5-cm in size

            Do not use if implant appears discolored, contains foreign particulates, or is collapsed, compressed, or misshapen

            Avoid excessive handling and compression

            Using aseptic technique, cut each implant in half before placement into the surgical site

            Implant Administration

            Place halved implants into the surgical site dry; avoid contact of implant with liquids before placement; premoistening may result in premature release of bupivacaine from implant

            Place 3 halves below site of mesh placement and 3 halves just below the skin closure

            Implant may become difficult to move once placed in surgical site and moistened; use care when moving implant after placement

            Storage

            Store at 20-25ºC (68-77ºF), excursions permitted to 15-30ºC (59-86ºF)

            Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
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            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.