Patient counseling
information¹

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
REPRESENTATIVE

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

LEARN ABOUT THE VIVITROL^®
CO-PAY SAVINGS PROGRAM

Learn how the VIVITROL^® Co-pay Savings Program may assist eligible* patients with out-of-pocket expenses for their VIVITROL prescriptions.

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Important safety information MORE

Important safety information

Contraindications

VIVITROL is contraindicated in patients:

Receiving opioid analgesics
With current physiologic opioid dependence
In acute opioid withdrawal
Who have failed the naloxone challenge test or have a positive urine screen for opioids
Who have exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent

Indications

VIVITROL is indicated for:

Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration.
Prevention of relapse to opioid dependence, following opioid detoxification.
VIVITROL should be part of a comprehensive management program that includes psychosocial support.

Warnings and precautions

Vulnerability to Opioid Overdose:

After opioid detoxification, patients are likely to have a reduced tolerance to opioids. VIVITROL blocks the effects of exogenous opioids for approximately 28 days after administration. As the blockade wanes and eventually dissipates completely, use of previously tolerated doses of opioids could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.).
Cases of opioid overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment. Patients and caregivers should be told of this increased sensitivity to opioids and the risk of overdose. Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver, at the initial VIVITROL injection and with each subsequent injection. Strongly consider prescribing naloxone for the emergency treatment of opioid overdose.

Although VIVITROL is a potent antagonist with a prolonged pharmacological effect, the blockade produced by VIVITROL is surmountable. The plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids.
Any attempt by a patient to overcome the VIVITROL blockade by taking opioids may lead to fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade.

Injection Site Reactions:

VIVITROL must be prepared and administered by a healthcare provider.
VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe.
In the clinical trials, one patient developed an area of induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that required surgical excision.
Injection site reactions not improving may require prompt medical attention, including, in some cases, surgical intervention.
Inadvertent subcutaneous/adipose layer injection of VIVITROL may increase the likelihood of severe injection site reactions.
Select proper needle size for patient body habitus, and use only the needles provided in the carton.
Patients should be informed that any concerning injection site reactions should be brought to the attention of their healthcare provider.

Precipitation of Opioid Withdrawal:

When withdrawal is precipitated abruptly by administration of an opioid antagonist to an opioid-dependent patient, the resulting withdrawal syndrome can be severe. Some cases of withdrawal symptoms have been severe enough to require hospitalization, and in some cases, management in the ICU.
To prevent occurrence of precipitated withdrawal, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting VIVITROL treatment:
- An opioid-free interval of a minimum of 7–10 days is recommended for patients previously dependent on short-acting opioids.
- Patients transitioning from buprenorphine or methadone may be vulnerable to precipitated withdrawal for as long as two weeks.
If a more rapid transition from agonist to antagonist therapy is deemed necessary and appropriate by the healthcare provider, monitor the patient closely in an appropriate medical setting where precipitated withdrawal can be managed.
Patients should be made aware of the risk associated with precipitated withdrawal and be encouraged to give an accurate account of last opioid use.
Precipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where the prescriber had been unaware of the additional use of opioids or co-dependence on opioids.

Hepatotoxicity:

Cases of hepatitis and clinically significant liver dysfunction have been observed in association with VIVITROL. Warn patients of the risk of hepatic injury; advise them to seek help if experiencing symptoms of acute hepatitis. Discontinue use of VIVITROL in patients who exhibit acute hepatitis symptoms.

Depression and Suicidality:

Alcohol- and opioid-dependent patients taking VIVITROL should be monitored for depression or suicidal thoughts. Alert families and caregivers to monitor and report the emergence of symptoms of depression or suicidality.

When Reversal of VIVITROL Blockade Is Required for Pain Management:

For VIVITROL patients in emergency situations, suggestions for pain management include regional analgesia or use of non-opioid analgesics. If opioid therapy is required to reverse the VIVITROL blockade, patients should be closely monitored by trained personnel in a setting staffed and equipped for CPR.

Eosinophilic Pneumonia:

Patients who develop dyspnea and hypoxemia should seek medical attention immediately. Consider the possibility of eosinophilic pneumonia in patients who do not respond to antibiotics.

Hypersensitivity Reactions including Anaphylaxis:

Cases of urticaria, angioedema, and anaphylaxis have been observed with the use of VIVITROL.
Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis.
In the event of a hypersensitivity reaction, patients should be advised to seek immediate medical attention in a healthcare setting prepared to treat anaphylaxis. The patient should not receive any further treatment with VIVITROL.

Intramuscular Injections:

As with any intramuscular injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder.

Alcohol Withdrawal:

Use of VIVITROL does not eliminate nor diminish alcohol withdrawal symptoms.

Interference with Laboratory Tests:

VIVITROL may be cross-reactive with certain immunoassay methods for the detection of drugs of abuse (specifically opioids) in urine.
For further information, reference to the specific immunoassay instructions is recommended.

Adverse reactions

The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence (ie, those occurring in ≥5% and at least twice as frequently with VIVITROL than placebo) include nausea, vomiting, injection site reactions (including induration, pruritus, nodules, and swelling), arthralgia, arthritis, or joint stiffness, muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders.
The adverse events seen most frequently in association with VIVITROL in opioid-dependent patients (ie, those occurring in ≥2% and at least twice as frequently with VIVITROL than placebo) were hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.

You are encouraged to report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Reference: 1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev March 2021.

*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.

Additional Terms of Use: This offer is not conditioned on any past, present, or future purchase, including refills. Alkermes reserves the right to rescind, revoke, or amend this offer, program eligibility, and requirements at any time without notice. This offer is limited to one per patient, may not be used with any other offer, is not transferable and may not be sold, purchased or traded, or offered for sale, purchase or trade. Void where prohibited by law. Program Administrator or its designee will have the right upon reasonable prior written notice, during normal business hours, and subject to applicable law, to audit compliance with this program.

IS VIVITROL RIGHT FOR YOUR PATIENTS?

Patient counseling information1

VIVITROL FOR OPIOID USE DISORDER

VIVITROL FOR ALL INDICATIONS

Frequently asked questions about administering vivitrol

Can I prepare the suspension prior to my patient’s arrival?

How much time do I have between preparing and administering the dose?

Can I use needles other than those provided in the carton?

The suspension is milky white upon mixing with the diluent. Is this normal?

What if a needle clog occurs during administration of the product?

REQUEST AREPRESENTATIVE

LEARN ABOUT THE VIVITROL®CO-PAY SAVINGS PROGRAM

Important safety information

Important safety information

Contraindications

Indications

Warnings and precautions

Adverse reactions

You are encouraged to report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

IS VIVITROL
RIGHT
FOR
YOUR PATIENTS?

Patient counseling
information¹

Frequently asked questions
about administering vivitrol

REQUEST A
REPRESENTATIVE

LEARN ABOUT THE VIVITROL^®
CO-PAY SAVINGS PROGRAM