Terms and conditions eligibility for alkermessponsored copay savings. Vivitrol naltrexone is a prescription injectable medicine used to treat alcohol dependence and to prevent relapse to opioid dependence, after opioid detoxification. Color offwhite to light tan powder naltrexone odor no information identified. Other important warnings and safety precautions for this drug are described in this article, including what to tell your doctor before receiving it. Reinforce vivitrol official healthcare professional site. Government statistics indicate that our countrys opioid epidemic continues to worsen see issue 1. Naltrexone hydrochloride tablets usp for oral administration are available as film coated tablets, containing 50 mg of naltrexone hydrochloride. Naltrexone for extendedrelease injectable suspension. Naltrexone is an opioid antagonist with little, if any, opioid agonist activity. Documentation of compliance with comprehensive management program with psychosocial support. It is an antagonist medication that blocks opioid receptors in the brain for one month.
Do not expose the product to temperatures above 25c 77f. Caution should be exercised when naltrexone hydrochloride is administered. It is not entirely known if vivitrol passes through breast milk. Buprenorphine sublingual tablets should be used as part of a complete treatment plan to include counseling and psychosocial support. Talk to your healthcare provider about whether you will breastfeed or take vivitrol. Vivitrol must not be given intravenously, subcutaneously, or into adipose tissue. An introduction to extendedrelease injectable naltrexone for the. Patients should not be actively drinking at the time of initial vivitrol administration. Mark tl, montejano l, kranzler hr, chalk m, gastfriend dr. Your healthcare provider may recommend other types of treatment, such as counseling or support groups. Highlights of prescribing information these highlights do not include all the information needed to use esbriet safely and effectively. Januvia is a dipeptidyl peptidase4 dpp4 inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adultswith type 2 diabetes mellitus.
Vivitrol naltrexone for extendedrelease injectable suspension is supplied as a microsphere formulation of naltrexone for suspension, to be administered by intramuscular injection. Vivitrol is shipped and should be prepared under specific temperaturecontrolled conditions to ensure proper delivery and help secure patient safety. The recommended dose of vivitrol is 380 mg delivered intramuscularly every 4 weeks or once a month. Appearance vivitrol is supplied in singleuse cartons. Vivitrol medication guide food and drug administration. Repeat the procedure at an adjacent site in the same gluteal muscle. It markedly attenuates or completely blocks, reversibly, the subjective effects of intravenously administered. Store vivitrol separately from food, in accordance with occupational safety and health administration guidelines. Naltrexone hydrochloride is a white, crystalline compound. American society of addiction medicine asam national practice guideline for the use of medications in the treatment of addiction involving opioid use.
This emedtv article examines who may have an increased risk for complications while using vivitrol. The entire dose pack should be stored in the refrigerator 2 to 8c, 36 to 46f 2. Treat opioid or alcohol dependence with a nonaddictive. Managing procedural pain in a patient taking naltrexone. Cimzia is a biologic treatment for multiple chronic inflammatory conditions. Attach a needle by twisting in a clockwise direction until the needle fits securely on the syringe. Vivitrol blocks the effects of opioids, such as heroin or opioid pain.
See important information about possible side effects with vivitrol treatment. Claims history documenting compliance with vivitrol. To be effective, treatment with vivitrol must be used with other alcohol or drug. If blood aspirates or the needle clogs, remove the needle and replace with the supplied spare administration needle. Vivitrol should always be refrigerated at 2 to 8c 36 to 46f and not frozen. Vivitrol is given as an injection into a muscle in your buttocks using a special needle that comes with vivitrol. Vivitrol extendedrelease injectable naltrexone iowa. Alkermes has developed a medication guide to replace the patient package insert for vivitrol to communicate this and other important information. Help reinforce your recovery vivitrol naltrexone for extendedrelease injectable suspension is a nonaddictive, oncemonthly treatment for opioid and alcohol dependence.
The hydrochloride salt is soluble in water to the extent of about 100 mgml. Revia is available in scored filmcoated tablets containing 50 mg of naltrexone hydrochloride. The recommended dose of vivitrol is 380 mg delivered intramuscularly every 4. Documentation the member has remained abstinent of substances of abuse. This offer is only available to patients 18 years or older, with a prescription consistent with the prescribing information and the patient is not enrolled in, or covered by, any local, state, federal or other government program.
Learn how vivitrol may help naltrexone for extended. The fda approved vivitrol, a oncemonthly intramuscular naltrexone formulation used to help control cravings for alcohol in april 2006, and then in october 2010, the fda approved vivitrol for the prevention of relapse to opioid dependence after opioid detoxification. The recommended dose of vivitrol is 380 mg, delivered intramuscularly once a month every 4 weeks. Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Highlights of prescribing information these highlights do not include all the information needed to use sublocadesafely and effectively. See the dosing and administration information for vivitrol here. Food and drug administration fda approved extendedrelease injectable naltrexone. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for vivitrol naltrexone skip to. Inadvertent subcutaneous injection of vivitrol may increase the likelihood of severe injection site reactions. Highlights of prescribing information patients of the. Each carton contains one 380mg vial of vivitrol microspheres. Naltrexone longacting formulation in the treatment of. Administer the entire dose as per standard protocol.
Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month. Vivitrol naltrexone for extendedrelease injectable suspension. Highlights of prescribing information these highlights do not include all the information needed to use sublocade safely and effectively. Vivitrol must be prepared and administered by a healthcare professional. Under the drug addiction treatment act data codified at 21 u. Page 1 of 3 vivitrol extendedrelease injectable naltrexone iowa medicaid program. Insert the needle into the gluteal muscle, and aspirate before injection to avoid injection into a blood vessel. Follow these handling instructions for vivitrol before administering to patients. Naltrexone, the active ingredient in vivitrol, is the same active ingredient in tablets taken by mouth that contain naltrexone. Naltrexone is designated chemically as morphinan6one, 17cyclopropylmethyl4,5epoxy3,14dihydroxy5.
Vivitrol is indicated for the prevention of relapse to opioid dependence, following opioid detoxification. Highlights of prescribing information heart failure. Severe injection site reactions that required surgery andor hospitalization have occurred with vivitrol. Vivitrol must be injected by a healthcare provider. Vivitrol naltrexone for extendedrelease injectable. Vivitrol is an injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 ml diluent 3. Revia and its primary metabolite are excreted primarily in the urine, and.
Vivitrol naltrexone dose, indications, adverse effects. Vivitrol fda prescribing information, side effects and uses. Vivitrol naltrexone for extended release injectable suspension, for intramuscular use. Vivitrol 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. Vivitrol naltrexone for extendedrelease injectable suspension, for intramuscular use initial u. See full prescribing information including boxed warning on serious infections. January 21, 2020 physician administered drug prior. Vivitrol is provided as a kit containing a vial each of vivitrol microspheres and diluent, one 5ml syringe. The pi is different from the patient package insert ppi, which contains information intended for patients, notwithstanding that the ppi may be required as part of the fdaapproved labeling for the drug.
Vivitrol in october 2010 to treat people with opioid. Vivitrol is just one part of a comprehensive treatment program for drug or alcohol dependence. The related drug information index provides comprehensive access to all drug information related to a specific drug types of content include full prescribing information, drug summaries, full prescribing information continuing medication education full pi cme, medication guides, risk evaluation and mitigation strategies rems summaries, rems continuing medication education rems cme, and. Vivitrol must be prepared and administered by a healthcare provider. Naltrexone is an opioid antagonist with high affinity for the mu opioid receptor. Product monograph pr reviatm naltrexone hydrochloride tablets, 50 mg therapeutic classification opioid antagonist action and clinical pharmacology pharmacodynamic actions revia naltrexone hydrochloride is a pure opioid antagonist. Vivitrol microspheres consist of a sterile, offwhite to light tan powder that is available in a dosage strength of 380mg naltrexone per vial. Dailymed naltrexone hydrochloride tablet, film coated. Vivitrol is injected by a healthcare provider, about 1 time each month. Vivitrol may react with a few other medications see vivitrol drug interactions.