This extended-release injectable suspension aims to prevent relapse in opioid-dependent patients after detox and treat alcoholism.
As a retail pharmacist in the expanding field of specialty pharmacy, I am seeing prescriptions come in for new agents that were previously only available to be billed under patients' medical plans.
Vivitrol is naltrexone made in an extended-release injectable suspension to prevent relapse for opioid-dependent patients after detoxification and for the treatment of alcohol dependence. Vivitrol is injected monthly via deep intramuscular injection in the gluteal muscle of the buttocks. Vivitrol must be injected by a health care professional, which means that patients must attend monthly appointments.1
Vivitrol works by acting as an antagonist on the opioid receptors. Vivitrol is non-addictive, preventing dependence because it prevents the release of dopamine that is known for its role in reward-motivating behaviors.
The patient must be opioid-free, including of buprenorphine, methadone, and various cough, cold, and diarrhea medications, for at least 7 to 14 days before receiving an injection of Vivitrol. This is to prevent them from having sudden opioid withdrawal.
The recommended dose of Vivitrol is 380 mg delivered intramuscularly every 4 weeks or once a month. Vivitrol comes with customized needles for injection and should always be used.2
For all pharmacists who may be a part of the administration process, it is important to know what each preparation contains and how to draw the medication up for administration. Store Vivitrol in the refrigerator and take it out about 45 minutes before the injection is to be given to reach room temperature. After opening and cleaning both vials, with the 1-inch preparation needle on the syringe, draw up 3.4 mL from the diluent vial and inject it into the microsphere vial. Remove and set the preparation syringe, and shake the vial vigorously for about 1 minute to make sure that it is thoroughly suspended. Immediately after, draw up 4.2 mL of the suspension using the syringe and the preparation needle that was previously set aside. Once drawn up, remove the preparation needle, and attach the administration needle that correlates with the patient’s size. At this time, all air bubbles should be pushed out of the syringe up to the dose of 4 mL. Clean the area on the gluteus with an alcohol wipe, allowing the area to air dry to prep the patient. Then inject the contents of the syringe into the patient via deep intramuscular injection into the gluteal muscle. After administration, press the needle protection device against a surface using 1 hand technique to prevent needle sticks to the provider.
The most common adverse reactions (AEs) are at the injection site, including bruising, inflammation, pain, rash, swelling, and tenderness. If the reaction is severe, emergency medical treatment with surgical intervention may be necessary because of possible tissue death. Signs of severe injection site reactions include blisters, a dark scab, excess swelling, hardening in the area, intense pain, lumps, or open wounds.
Other common AEs seen mostly in patients with alcoholism include nausea, vomiting, muscle cramps, dizziness, sedation, decreased appetite and other appetite disorders. Common AEs associated with opioid-dependent patients include colds or influenza, hepatic enzyme abnormalities, insomnia, and toothaches.
Retail pharmacists can assist patients by informing them that they can enroll in a copay savings program to help cover any out-of-pocket costs that they may have with their insurance or elect to pay cash price for the medication. Patients can apply for the Vivitrol copay savings program, which covers up to $500 per month toward their cost of the medication. Patients who are not eligible to enroll in the program include those who benefit from federal or state health care programs, such as Medicaid, Medicare, Medicaid, Medigap, Veterans Administration, Department of Defense, TriCare, or state-funded programs. All Vivitrol prescriptions are shipped directly to the provider office, whether they are being filled by a specialty pharmacy or via the buy-and-bill system, where it is sent from a distributor.
Important counseling information for patients would include not taking any medications that are classified as opioid receptor agonists. Patients may immediately think that medications such as codeine, hycrodone, and oxycodone, need to be avoided. However, there are many other medications that act on the opioid receptors, including common OTC medications. OTC medications to avoid include those with dextromethorphan, loperamide, and alcohol content. Patients seeking cough and cold remedies may realizing that some of OTC medications contain these ingredients. For inpatient care, the risk of giving a drug that interacts with Vivitrol is even greater and must be assessed before providing treatment.
Finally, all patients who take Vivitrol should wear an identification tag indicating that they take the drug for emergency purposes where they cannot advocate for themselves. The Vivitrol provider should give them the ID tags. All health care providers must understand Vivitrol and the potential interactions that can occur when treating a patient in an emergency medical situation.
1. Alkermes, Inc. What is Vivitrol? vivitrol.com/opioid-dependence/what-is-vivitrol. Accessed December 12, 2017.
2. Vivitrol [prescribing information]. Waltham, MA: Alkermes, Inc; 2015. vivitrol.com/content/pdfs/prescribing-information.pdf. Accessed December 12, 2017.
3. Alkermes, Inc. Filling a Vivitrol prescription. vivitrolhcp.com/filling-a-prescription. Accessed December 12, 2017.