"The U.S. Food and Drug Administration today approved Vivitrol to treat and prevent relapse after patients with opioid dependence have undergone detoxification treatment.
Vivitrol is an extended-release formulation of naltrexone administ"...
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Treatment with VIVITROL (naltrexone xr inj) should be part of a comprehensive management program that includes psychosocial support. Opioid-dependent patients, including those being treated for alcohol dependence, must be opioid-free at the time of initial VIVITROL (naltrexone xr inj) administration.
VIVITROL (naltrexone xr inj) is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL (naltrexone xr inj) . Patients should not be actively drinking at the time of initial VIVITROL (naltrexone xr inj) administration.
VIVITROL (naltrexone xr inj) is indicated for the prevention of relapse to opioid dependence, following opioid detoxification.
DOSAGE AND ADMINISTRATION
VIVITROL (naltrexone xr inj) must be prepared and administered by a healthcare professional.
The recommended dose of VIVITROL (naltrexone xr inj) is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare professional as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection, using the carton components provided [see HOW SUPPLIED/Storage and Handling]. The needles provided in the carton are customized needles. VIVITROL (naltrexone xr inj) must not be injected using any other needle. The needle lengths (either 1.5 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. Healthcare professionals should ensure that the VIVITROL (naltrexone xr inj) 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.
VIVITROL (naltrexone xr inj) must not be administered intravenously or subcutaneously.
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 (naltrexone xr inj) .
Reinitiation of Treatment in Patients Previously Discontinued
There are no data to specifically address reinitiation of treatment. Patients reinitiating treatment with VIVITROL (naltrexone xr inj) need to be opioid-free at the time of dose administration [see INDICATIONS, CONTRAINDICATIONS, and WARNINGS AND PRECAUTIONS].
Switching From Oral Naltrexone
There are no systematically collected data that specifically address the switch from oral naltrexone to VIVITROL (naltrexone xr inj) .
Directions for Use
To ensure proper dosing, it is important that you follow the preparation and administration instructions outlined in this document.
VIVITROL (naltrexone xr inj) 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 1.5 inch needles with needle protection device are provided in the clinical drug cartons for intramuscular administration. In addition, longer 2 inch thin-walled needles with needle protection device have been provided as ancillary supplies. For patients with a larger amount of subcutaneous tissue overlying the gluteal muscle, the administering health care professional may utilize the supplied 2 inch needle with needle protection device to ensure that the injectate reaches the intramuscular mass. Both 1.5 and 2 inch administration needles are provided to accommodate varying patient body habitus. A spare administration needle of each size is provided in case of clogging [see HOW SUPPLIED/Storage and Handling]. 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].
Product to be prepared and administered by a healthcare professional.
Keep out of reach of children.
Prepare and administer the VIVITROL (naltrexone xr inj) 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 (2-8 °C, 36-46 °F). Unrefrigerated, VIVITROL (naltrexone xr inj) 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 (naltrexone xr inj) should not be frozen.
NEEDLE-PRO® and the color orange applied to the needle protection device are trademarks of the Smiths Medical family of companies.
Parenteral products should be visually inspected for particulate matter and discoloration prior to administration.
1. Remove the carton from refrigeration. Prior to preparation, allow drug to reach room temperature (approximately 45 minutes).
2. To ease mixing, firmly tap the VIVITROL (naltrexone xr inj) Microspheres vial on a hard surface, ensuring the powder moves freely. (see Figure B)
3. Remove flip-off caps from both vials. DO NOT USE IF FLIP-OFF CAPS ARE BROKEN OR MISSING.
4. Wipe the vial tops with an alcohol swab.
5. 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 (naltrexone xr inj) 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 an intramuscular injection based on patient's body habitus:
- 1.5 inch TERUMO® Needle
- 2 inch NEEDLE-PRO® 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. Grasp sheath using the plastic pouch. 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.
- 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.
- 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 (naltrexone xr inj) must NOT be given intravenously or subcutaneously.
After the injection is administered, cover the needle by pressing the needle protection device against a flat surface using a one-handed motion 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.
Dosage Forms And Strengths
VIVITROL (naltrexone xr inj) is an injectable suspension for single use. VIVITROL contains 380 mg of naltrexone in a microsphere formulation per vial (337 mg of naltrexone per gram of microspheres) and 4 mL diluent.
VIVITROL (naltrexone for extended-release injectable suspension) is supplied in single use cartons. Each carton contains one 380 mg vial of VIVITROL (naltrexone xr inj) microspheres, one vial containing 4 mL (to deliver 3.4 mL) diluent for the suspension of VIVITROL (naltrexone xr inj) , one 5-mL prepackaged syringe, one 1-inch 20-gauge needle, two 1.5-inch 20-gauge needles and two 2-inch 20-gauge needles with needle protection devices: NDC 65757-300-01.
Storage and Handling
The entire dose pack should be stored in the refrigerator (2 - 8°C, 36 - 46°F). Unrefrigerated, VIVITROL (naltrexone xr inj) can be stored at temperatures not exceeding 25°C (77°F) for no more than 7 days prior to administration. Do not expose the product to temperatures above 25°C (77°F). VIVITROL (naltrexone xr inj) should not be frozen.
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].
Keep out of Reach of Children.
For additional information, visit www.vivitrol (naltrexone xr inj) .com or call 1-800-848-4876
Manufactured and marketed by: Alkermes, Inc. 852 Winter Street Waltham, MA 02451-1420. Revised: October 2010
Last reviewed on RxList: 11/8/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Vivitrol Information
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