Advise the patient to read the FDA-approved patient labeling (Medication Guide). Physicians should include the following issues in discussions with patients for whom they prescribe VIVITROL.
VIVITROL FOR OPIOID USE DISORDER
- Advise patients that if they previously used opioids, they may be more sensitive to lower doses of opioids and at risk of accidental overdose should they use opioids when their next dose is due, if they miss a dose, or after VIVITROL treatment is discontinued. It is important that patients inform family members and the people closest to the patient of this increased sensitivity to opioids and the risk of overdose. Educate patients and caregivers on how to recognize the signs and symptoms of an opioid overdose
- Advise patients that because VIVITROL can block the effects of opioids, patients will not perceive any effect if they attempt to self-administer heroin or any other opioid drug in small doses while on VIVITROL. Further, emphasize that administration of large doses of heroin or any other opioid to try to bypass the blockade and get high while on VIVITROL may lead to serious injury, coma, or death
Patient access to naloxone for the emergency treatment of opioid overdose: Because of the vulnerability to opioid overdose described above, discuss with the patient and caregiver the importance of having access to naloxone, and inform them of options for obtaining it, as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) (see Warnings and Precautions in the Prescribing Information [5.1])
Educate patients and caregivers on how to recognize the signs and symptoms of an opioid overdose
Explain to patients and caregivers that naloxone’s effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered
If naloxone is prescribed, also advise patients and caregivers:
- How to treat with naloxone in the event of an opioid overdose
- To tell family and the people closest to the patient about their naloxone and to keep it in a place where family and the people closest to the patient can access it in an emergency
- To read the Patient Information (or other educational material) that will come with their naloxone. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do
VIVITROL FOR ALL INDICATIONS
- Inform patients on VIVITROL that they may not experience the expected effects from opioid-containing analgesic, antidiarrheal, or antitussive medications
- Instruct patients that VIVITROL must be prepared and administered by a healthcare provider
- Advise patients that a reaction at the site of VIVITROL injection may occur. Reactions include pain, tenderness, induration, swelling, erythema, bruising, or pruritus. Serious injection site reactions including necrosis may occur. Some of these injection site reactions have required surgery. Patients should be advised to seek medical attention for worsening skin reactions
- Advise patients that they should be off all opioids, including opioid-containing medicines, for a minimum of 7–10 days before starting VIVITROL in order to avoid precipitation of opioid withdrawal. Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as two weeks. Ensure that patients understand that withdrawal precipitated by administration of an opioid antagonist may be severe enough to require hospitalization if they have not been opioid-free for an adequate period of time, and is different from the experience of spontaneous withdrawal that occurs with discontinuation of opioid in a dependent individual. Advise patients that they should not take VIVITROL if they have any symptoms of opioid withdrawal. Advise all patients, including those with alcohol dependence, that it is imperative to notify healthcare providers of any recent use of opioids or any history of opioid dependence before starting VIVITROL to avoid precipitation of opioid withdrawal
- Advise patients that VIVITROL may cause liver injury. Patients should immediately notify their physician if they develop symptoms and/or signs of liver disease
- Advise patients that they may experience depression while taking VIVITROL. It is important that patients inform family members and the people closest to the patient that they are taking VIVITROL and that they should call a doctor right away should they become depressed or experience symptoms of depression
- Advise patients to carry documentation to alert medical personnel to the fact that they are taking VIVITROL (naltrexone for extended-release injectable suspension). This will help to ensure that patients obtain adequate medical treatment in an emergency
- Advise patients that VIVITROL may cause an allergic pneumonia. Patients should immediately notify their physician if they develop signs and symptoms of pneumonia, including dyspnea, coughing, or wheezing
- Advise patients that they should not take VIVITROL if they are allergic to VIVITROL or any of the microsphere or diluent components
- Advise patients that they may experience nausea following the initial injection of VIVITROL. These episodes of nausea tend to be mild and subside within a few days post-injection. Patients are less likely to experience nausea in subsequent injections. Patients should be advised that they may also experience tiredness, headache, vomiting, decreased appetite, painful joints and muscle cramps
- Advise patients that because VIVITROL is an intramuscular injection and not an implanted device, once VIVITROL is injected, it is not possible to remove it from the body
- Advise patients that VIVITROL has been shown to treat alcohol and opioid dependence only when used as part of a treatment program that includes counseling and support
- Advise patients that dizziness may occur with VIVITROL treatment, and they should avoid driving or operating heavy machinery until they have determined how VIVITROL affects them
Advise patients to notify their physician if they:
- become pregnant or intend to become pregnant during treatment with VIVITROL
- are breast-feeding
- experience respiratory symptoms such as dyspnea, coughing, or wheezing when taking VIVITROL
- experience any allergic reactions when taking VIVITROL
- experience other unusual or significant side effects while on VIVITROL therapy
Frequently asked questions about administering vivitrol
Can I prepare the suspension prior to my patient’s arrival?
No. You may remove the carton from the refrigerator prior to the patient’s arrival, but once the diluent is added to the VIVITROL microspheres, the dose should be mixed and the suspension administered immediately. It is very important to use proper aseptic technique when preparing the suspension (see Dosage and Administration [2.6]).
How much time do I have between preparing and administering the dose?
It is recommended that the suspension be administered immediately once the product has been suspended and transferred into the syringe. If a few minutes’ delay occurs after suspension but before transfer into the syringe (see Dosage and Administration [2.6; Figure D]), the vial can be inverted a few times to resuspend and then transferred into the syringe for immediate use (see Dosage and Administration [2.6]).
Can I use needles other than those provided in the carton?
No. The needles in the carton are specially designed for administration of VIVITROL. Do not make any substitutions for components of the carton (see Dosage and Administration [2.6]).
The suspension is milky white upon mixing with the diluent. Is this normal?
Yes. VIVITROL microspheres will form a milky suspension when mixed with the provided diluent (see Dosage and Administration [2.6]).
What if a needle clog occurs during administration of the product?
If a clog occurs during administration, the needle should be withdrawn from the patient, capped with the attached needle protection device, and replaced with the spare administration needle. Gently push on the plunger until a bead of the suspension appears at the tip of the needle. The remainder of the suspension should then be administered into an adjacent site in the same gluteal region (see Dosage and Administration [2.6]).
VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, injection site reactions, and sudden opioid withdrawal. Strongly consider prescribing naloxone for the emergency treatment of opioid overdose. See Important Safety Information below. See Prescribing Information. Review Medication Guide with your patients.
Request a visit from a VIVITROL representative to learn more about how VIVITROL may help your appropriate patients with opioid dependence or alcohol dependence.REQUEST A REPRESENTATIVE
*Terms and Conditions
Eligibility for Alkermes-Sponsored Co-pay Savings. 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 that pays for any portion of medication costs, including but not limited to Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care and Alternative Benefit Plans under the Affordable Care Act; Medigap; VA; DOD; TRICARE; or a residential correctional program.