VIVITROL

2 DOSAGE AND ADMINISTRATION VIVITROL must be prepared and administered by a healthcare provider ( 2.1 , 2.6 ). Prior to initiating VIVITROL, an opioid-free duration of a minimum of 7–10 days is recommended for patients, to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization ( 2.1 ). The recommended dose of VIVITROL is 380 mg delivered intramuscularly (deep) as a gluteal injection, every 4 weeks or once a month, alternating buttocks for each subsequent injection, using the carton components provided ( 2.1 ). VIVITROL must ONLY be administered as a deep intramuscular gluteal injection ( 2.1 ). See Full Prescribing Information for complete Directions for Use ( 2.6 ). 2.1 Important Dosage and Administration Information VIVITROL must be prepared and administered by a healthcare provider. VIVITROL must ONLY be administered as a deep intramuscular gluteal injection. Parenteral products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. A properly mixed suspension will be milky white, will not contain clumps, and will move freely down the wall of the vial [see Dosage and Administration ( 2.6 )] . Prior to initiating VIVITROL, an opioid-free duration of a minimum of 7–10 days is recommended for patients, to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization [see Warnings and Precautions ( 5.3 )]. The recommended dose of VIVITROL is 380 mg delivered intramuscularly (deep) as a gluteal injection every 4 weeks or once a month, alternating buttocks for each subsequent injection, using the carton components provided [see How Supplied/Storage and Handling ( 16 )] . The needles provided in the carton are customized needles. VIVITROL must not be injected using any other needle. The needle lengths (either 1 1/2 or 2 inches) may not be adequate in every patient because of body habitus. Body habitus should be assessed prior to each injection for each patient to assure that needle length is adequate for intramuscular administration. For patients with a larger amount of subcutaneous tissue overlying the gluteal muscle, the administering healthcare provider may utilize the supplied 2-inch needle with needle protection device to help ensure that the injectate reaches the intramuscular mass. For very lean patients, the 1 1/2-inch needle may be appropriate to prevent the needle contacting the periosteum. Either needle may be used for patients with average body habitus. Healthcare providers should ensure that the VIVITROL injection is given correctly, and should consider alternate treatment for those patients whose body habitus precludes an intramuscular gluteal injection with one of the provided needles. If a patient misses a dose, he/she should be instructed to receive the next dose as soon as possible. Pretreatment with oral naltrexone is not required before using VIVITROL. 2.2 Patient Access to an Opioid Reversal Agent for the Emergency Treatment of Opioid Overdose At the initial VIVITROL injection and with each subsequent injection, inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene) and discuss the importance of having access to an opioid overdose reversal agent. Because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose after VIVITROL treatment is discontinued, at the end of the VIVITROL dosing interval (i.e., near the end of the month that VIVITROL was administered), or after a dose of VIVITROL is missed, strongly consider recommending or prescribing an overdose reversal agent for the emergency treatment of opioid overdose [see Warnings and Precautions ( 5.1 )] . Discuss the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program [see Warning and Precautions ( 5.1 )] . There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics. Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent. 2.3 Reinitiation of Treatment in Patients Previously Discontinued There are no data to specifically address reinitiation of treatment. Patients reinitiating treatment with VIVITROL should be opioid-free at the time of dose administration [see Indications and Usage ( 1 ), Contraindications ( 4 ), and Warnings and Precautions ( 5.3 )] . 2.4 Switching From Oral Naltrexone There are no systematically collected data that specifically address the switch from oral naltrexone to VIVITROL. 2.5 Switching from Buprenorphine, Buprenorphine/Naloxone, or Methadone There are no systematically collected data that specifically address the switch from buprenorphine or methadone to VIVITROL; however, review of postmarketing case reports have indicated that some patients may experience severe manifestations of precipitated withdrawal when being switched from opioid agonist therapy to opioid antagonist therapy [see Warnings and Precautions ( 5.3 )] . Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as 2 weeks. Healthcare providers should be prepared to manage withdrawal symptomatically with non-opioid medications. 2.6 Directions for Use VIVITROL must be prepared and administered by a healthcare provider. VIVITROL must ONLY be administered as a deep intramuscular gluteal injection. To ensure proper dosing, it is important that you follow the preparation and administration instructions outlined in this document. VIVITROL must be suspended only in the diluent supplied in the carton and must be administered only with one of the administration needles supplied in the carton. The microspheres, diluent, preparation needle, and an administration needle with needle protection device are required for preparation and administration. Two thin-walled 1 1/2-inch needles with needle protection device and two 2-inch thin-walled needles with needle protection device have been provided to accommodate varying patient body habitus. For patients with a larger amount of subcutaneous tissue overlying the gluteal muscle, the administering healthcare provider may utilize the supplied 2-inch needle with needle protection device to help ensure that the injectate reaches the intramuscular mass. For very lean patients, the 1 1/2-inch needle may be appropriate to prevent the needle contacting the periosteum. Either needle may be used for patients with average body habitus. A spare administration needle of each size is provided in case of clogging [see How Supplied/Storage and Handling ( 16 )] . Do not substitute any other components for the components of the carton. Prior to preparation, allow drug to reach room temperature (approximately 45 minutes). Parenteral products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. A properly mixed suspension will be milky white, will not contain clumps, and will move freely down the wall of the vial [see Directions for Use, illustration below ] . Keep out of reach of children. Prepare and administer the VIVITROL suspension using aseptic technique. WARNING: To reduce the risk of a needlestick: Do not intentionally disengage the needle protection device. Discard bent or damaged needle into a sharps container and use the spare needle provided. Do not attempt to straighten the needle or engage needle protection device if the needle is bent or damaged. Do not mishandle the needle protection device in a way that could lead to protrusion of the needle. Do not use free hand to press sheath over needle. THE CARTON SHOULD NOT BE EXPOSED TO TEMPERATURES EXCEEDING 25 °C (77 °F). The entire carton should be stored in the refrigerator (2 °C to 8 °C, 36 °F to 46 °F). Unrefrigerated, VIVITROL microspheres can be stored at temperatures not exceeding 25 °C (77 °F) for no more than 7 days prior to administration. Do not expose unrefrigerated product to temperatures above 25 °C (77 °F). VIVITROL should not be frozen. Parenteral products should be visually inspected for particulate matter and discoloration prior to administration. Remove the carton from refrigeration. Prior to preparation, allow drug to reach room temperature (approximately 45 minutes). To ease mixing, firmly tap the VIVITROL microspheres vial on a hard surface, ensuring the powder moves freely. (see Figure B ) Remove flip-off caps from both vials. DO NOT USE IF FLIP-OFF CAPS ARE BROKEN OR MISSING. Wipe the vial tops with an alcohol swab. Place the 1-inch preparation needle on the syringe and withdraw 3.4 mL of the diluent from the diluent vial. Some diluent will remain in the diluent vial. (see Figure B ) Inject the 3.4 mL of diluent into the VIVITROL microsphere vial. (see Figure C ) Mix the powder and diluent by vigorously shaking the vial for approximately 1 minute. (see Figure D ) Ensure that the dose is thoroughly suspended prior to proceeding to Step E. A PROPERLY MIXED SUSPENSION WILL BE MILKY WHITE, WILL NOT CONTAIN CLUMPS, AND WILL MOVE FREELY DOWN THE WALLS OF THE VIAL. Immediately after suspension, withdraw 4.2 mL of the suspension into the syringe using the same preparation needle. (see Figure E ) Select the appropriate needle for a deep intramuscular injection based on patient's body habitus: 1 1/2-inch TERUMO ® Needle 2-inch TERUMO ® Needle Remove the preparation needle and replace with appropriately selected administration needle for immediate use. Peel the blister pouch of the selected administration needle open halfway. Grip the base of the needle , not the safety sheath. Attach the luer connection to the syringe with an easy clockwise twisting motion. (see Figure F ) Seat the needle firmly on the needle protection device with a push and clockwise twist. Move the safety sheath away from the needle and toward the syringe barrel. Pull the sheath away from the needle -do not twist the sheath because it could result in loosening the needle. Prior to injecting, tap the syringe to release any air bubbles, then push gently on the plunger until 4 mL of the suspension remains in the syringe. (see Figure G ) THE SUSPENSION IS NOW READY FOR IMMEDIATE ADMINISTRATION Using a circular motion, clean the injection site with the alcohol swab. Let the site dry before injecting. Do not touch the site again before giving injections. Administer the suspension by deep intramuscular (IM) injection into a gluteal muscle, alternating buttocks per monthly injection. Remember to aspirate for blood before injection . (see Figure H ) If blood aspirates or the needle clogs, do not inject. Change to the spare needle provided in the carton and administer into an adjacent site in the same gluteal region, again aspirating for blood before injection. Inject the suspension in a smooth and continuous motion. VIVITROL must ONLY be administered as a deep intramuscular gluteal injection. After the injection is administered, cover the needle by pressing the needle protection device against a flat surface using a one-handed technique to activate the safety mechanism away from self and others. (see Figure I ) Visually confirm needle is fully engaged into the needle protection device. (see Figure J ) DISPOSE OF USED AND UNUSED ITEMS IN PROPER WASTE CONTAINERS. Figure A Figure B Figure C Figure D Figure E Figure F Figure G Figure H Figure I Figure J

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1 INDICATIONS AND USAGE Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.