Vivitrol FDA Approval
If you’re wondering, when was Vivitrol approved by the FDA for public use, the answer is rather recent in history. The prescription drug received full Vivitrol FDA approval in October of 2010, following extensive research, testing, and assessments spanning from late March 2005. The drug was approved for use by the FDA for extended-release use in patients recovering from alcohol and opioid addiction. The only stipulations revolving this were that patients had to be able to abstain from use, in an outpatient setting, themselves for at least 7 to 10 days following a full detox. This was done in an effort to assure that patients would not undergo sudden withdrawal symptoms that could be brought on by Vivitrol if used with the offending substance.
Treating Opioid Dependence with Vivitrol
Vivitrol, or naltrexone, is used for its ability to help prevent opioids from working within the body. Thus reversing the effects opioids have on chemicals within the brain, and eliminating cravings. The Vivitrol injection for opiates works in three specific ways:
- By blocking the effects of opiates in the body
- Decreasing the patient’s desire for opiates
- Consistent medically aided use, for continuous battling of cravings
Vivitrol doctors began prescribing the treatment in cases of opioid dependence when they realized the Vivitrol shot for opiates helped patients abstain from use on their own longer. Thus encouraging them to enter into counseling and recovery programs to further their treatment, and aiding them in sticking with their programs. The doctors who prescribe Vivitrol, and other substances approved by the FDA for opioid use disorder treatment, undergo specific training before being able to administer this drug to any patient.
The Vivitrol injection works as a relapse prevention method. It is prescribed to be taken, only after a successful opioid detox has been completed.
Who Benefits Most?
The opiate blocker shot Vivitrol, benefits those who have already completed a medically assisted detox, and are in an established recovery program, most. Of course, every individual is different, and therefore their treatment plans for recovery should be tailored to their own needs. Vivitrol may not work for everyone, but there are certain parameters for which the medication describes its “ideal candidates.”
These ideal candidates would use the Vivitrol shot for opiate addiction primarily in relapse prevention. These are patients who have already completed a medically assisted detox and are either open to participating, or are already participating in an addiction treatment and recovery program. Ideal Vivitrol candidates have typically had a shorter or less severe abuse history. Injectable Naltrexone is optimal for candidates that meet several of the following criteria according to the NCBI:
- They are medically approved for naltrexone treatment by a healthcare provider.
- They are not using opioids currently and have not used for several days.
- They do not suffer from chronic pain and do not anticipate surgery or any condition or procedure in which opioid analgesic medication may be required.
- They do not suffer from liver or kidney disease.
- They do not suffer from obesity or a bleeding disorder that might prevent them from being able to receive a deep intramuscular injection.
- They have motivation to stay sober and avoid alcohol or opioids.
- They are actively participating in psychological treatment for SUD including individual therapy and support as well as group counseling sessions.
Vivitrol is not a “one size fits all” kind of treatment. No such kind of treatment, that can help everyone fully 100% of the time, exists. But, Vivitrol has had a great amount of success in helping people to continue their fight and to remain in recovery both while at SJRP and upon their return home from our Florida drug and alcohol rehab center. Vivitrol, when used in conjunction with therapy programs, has given clients the best overall outcomes through three months of recovery from powerful substances including opioids and alcohol.
If you think that you, or someone you love, might benefit from Vivitrol treatment, call our admissions team at 833-397-3422 to speak with us about Vivitrol treatment and the various other treatment programs available at St. John’s Recovery Place.
Who Should Avoid Vivitrol?
Using opiates while on Vivitrol is not recommended. Patients who are still using opioids (or any other illicit drug or alcohol), or are going through opioid detox, should not use Vivitrol. Vivitrol is only to be used after detox has been completed successfully. Taking Vivitrol with opiates in the system could cause precipitated or unwelcomed withdrawal symptoms. Vivitrol may also worsen existing withdrawal symptoms if it is taken too soon. Patients who are allergic to Vivitrol, or have pre-existing conditions including liver problems, PAWS, or acute hepatitis should also avoid Vivitrol in order to prevent potentially life-threatening reactions from occurring.
How Does Vivitrol Work?
For most people who use Vivitrol, the drug works to block, or reverse, the effects of opioids on the brain, reducing cravings. This allows patients to retain their full mental functioning. Helping them to focus on recovery, instead of focusing on their want or “need” for opioid use.
How does Vivitrol work? Physically, Vivitrol works by chemically blocking opioids from binding to the opioid receptors in the brain and preventing the release of neurotransmitters responsible for signaling cravings. Vivitrol may also dampen or minimize the effects of opioid use if relapse were to occur, further helping to minimize cravings for opioid use.
Vivitrol is injected once a month to block opiates and prevent cravings for alcohol or opioids for a period of about 30 days in most patients. The medication is injected deep into the gluteal muscle and may cause tenderness or swelling at the injection site. For this reason, Vivitrol injection is often alternated from side-to-side of the buttocks with each month to reduce tenderness and swelling.
Vivitrol vs Suboxone
Both suboxone and vivitrol are prescribed medications, used to treat or aid patients by reducing the risk of opioid relapse. There are benefits and drawbacks to both of these medications. While both pros and cons continue to be researched to this day, most Vivitrol vs suboxone studies have shown that Vivitrol is harder to start than suboxone is. Some scientists find concern directly related to the Vivitrol shot vs Suboxone. Suboxone is a combination of medications that features both Naltrexone and Buprenorphine. Buprenorphine is an opioid that has a small potential for abuse and misuse. Whereas Vivitrol features only the active ingredient naltrexone and has a substantially lower potential for abuse or misuse. Overall, there remains room for improvement for both Suboxone treatment and for Vivitrol treatment. In the end, the Vivitrol vs suboxone argument may run down to a matter of preference and desire. Whereas one can reduce cravings only, the other (when used correctly) has the power to minimize withdrawal and cravings at the same time.
Vivitrol Pros Include:
- Patients only need one shot, once a month instead of everyday alternatives
- Dampens opioid cravings
- Not addictive
- Is an opioid antagonist, largely meaning it cannot be taken with any type of drug or alcohol (this can be viewed as either a pro or con, based upon perspective)
Vivitrol Cons Include:
- Injection site side effects
- Hard to get patients started on due to length of time needed between detox and first injection
Suboxone Pros Include:
- Early start, can be used to prevent relapse both short and long term
- Likely to help reduce the likelihood of death in opioid overdose cases
Suboxone Cons Include:
- Needs to be taken on a daily basis, which recovering patient may struggle with the motivation to do so
- Is an opioid agonist and central nervous system depressant. Meaning it can be taken (although not advised) with other depressants like alcohol without much initial discomfort
There are other factors that include the success rates of Vivitrol vs suboxone, that seem to differ highly in the initial stages, with Vivitrol having a relapse rate of 65% and suboxone a 57% relapse rate. But these percentages commonly relate to the early stages of recovery and the fact that Vivitrol is harder to get started on. Otherwise, both Suboxone and Vivitrol have similar holding success rates.
Those who can administer Vivitrol, are generally medical professionals such as doctors or the clinical team at some drug and alcohol rehab centers. Administering Vivitrol requires injection into the gluteal muscle with special care taken to alternate the buttock side used with each monthly injection. Typically, an intramuscular Vivitrol dose is 380 mg, per injection.
Precipitated Withdrawal Risk
Candidates for receiving Vivitrol injections must have completed opioid detox, and should wait up to 10 days following opioid use before starting this medication. If this rule is not strictly adhered to, or individuals who are currently taking Vivitrol relapse and use opioids again, they are at risk for precipitated withdrawal.
Precipitated withdrawal occurs when Vivitrol is taken before opioids have been completely eliminated from the system. Since the drug is an opioid antagonist, it does not interact well when there are opioids still present in the body. The result is a dampening of the effects which can reverse the effects of opioids all together, sending a patient into withdrawal symptoms rather quickly. This sudden onset of opioid withdrawal symptoms may be severe and could potentially require hospitalization for the patient. A complete list of the potential opioid withdrawal symptoms that may occur in precipitated withdrawal will vary. Some of the more severe possible occurring symptoms may include:
- Opioid Cravings
- Panic Attacks
- Loss of Appetite
- Memory Problems
- Mood Swings
With the risk for onsetting opioid withdrawal symptoms, if taken too soon after, or while still using opioids, Vivitrol does still come with its own set of potential risks. There have been patients who ask if Vivitrol itself can cause seizures. Seizures are not a commonly occurring side effect of Vivitrol. However, it has been noted that naltrexone (which Vivitrol is a brand name of), can – but rarely will – causes seizures in individuals who experience moderate to severe alcohol disorders. The risk potential for seizures in opioid-related Vivitrol treatment cases has not been documented.
Can you overdose on Vivitrol? Fortunately, there really is no risk of overdose on Vivitrol (the prescription drug) itself. But, there is a very real risk of opioid overdose while on Vivitrol. This is considered to be a serious risk when using Vivitrol, as people who used to use opioids may try to surpass the receptor blocking system of the prescription medication, by taking more and more opiates. Accidental overdose may occur with low or small doses of opioids. Opioid overdose can lead to severe adverse effects like coma or other potentially life-threatening circumstances. Vivitrol treatment clients should be actively involved in individual and group-based treatment programs to ensure they remain abstinent and to most effectively minimize their relapse risk.
Vivitrol Side Effects
When deciding whether Vivitrol is right for you or someone you love, it is important to educate yourself on the various opioid addiction treatment programs that are available as well as the potential side effects of each. Like other medications, Vivitrol can have a wide variety of uncomfortable side effects, some more severe than others. In some situations, these side effects may even be life-altering, or life-threatening. Vivitrol side effects may include:
- Pain or cramping in the stomach
- Appetite changes (predominantly loss of appetite)
- Mood swings
- Changes in physical energy (increased or decreased)
- Sleep disturbances
- Delayed ejaculation
- Muscle or joint pain
- Watery or teary eyes
- Discomfort at the injection site (Vivitrol shot side effects) – which can include:
- The intense pain (where injected)
- Dark scab
- Open wound
- Hard feeling (of injection site skin)
Other more severe side effects can include the onset of severe opioid withdrawal symptoms, or overdose on opioids if taken in conjunction with them.
Vivitrol and Pregnancy
The effects of taking Vivitrol during pregnancy are still being researched. Not much data is available on the baby-naltrexone relationship as of yet. Although some studies have shown Vivitrol in pregnancy tendencies, are to include increased birth weight, length, or later occurring development and behavioral problems with Vivitrol in pregnancy.
As such, it is recommended that Vivitrol (naltrexone) and pregnancy are considered very carefully before use. Select opioid-dependent women should be considered candidates for the use of Vivitrol in pregnancy. Even though special care can be taken to observe prenatal care, addiction recovery and treatment processes, and in-hospital deliveries, taking vivitrol (naltrexone) during pregnancy is generally still not recommended.
Typically, Vivitrol shot cost without insurance is around $1,000 dollars per injection. With the Vivitrol cost coverage with insurance, being around $25 – $50, to cover the copay. This has hindered the use of this prescription drug for some time. But, since 2013, the company that produces the drug, Alkermes, was also investigating ways in which they could make Vivitrol more affordable/accessible.
- Does Medicaid Cover Vivitrol?
- As of 2013, 41 states had Medicaid programs that covered for the administration of Vivitrol.
- What is the Vivitrol Free Trial Program?
- Also referred to as a patient assistance program, the Vivitrol free trial program (free Vivitrol shot) was established by Alkermes (and other companies like it), to offer low cost or free drugs to individuals who are unable to pay for their medications. How to get Vivitrol for free is to contact the company, in an attempt to join the patient assistance program.
- Does Insurance Cover Vivitrol?
Vivitrol Effectiveness in Treating Opiate Addiction
Vivitrol is most effective when used as an aid to a counseling treatment plan. The drug works to prevent opioid cravings and thus helps opioid-dependent individuals to avoid relapsing. Still, people wonder, does Vivitrol work for opiate addiction? Yes. Vivitrol reviews for opiate addiction shows that, in combination with psychological support, this 380 mg injection resulted in a significant increase of opioid abstinence in previous opioid-dependent individuals. Patients treated with Vivitrol had a documented 55% decrease in opioid cravings and an estimated 90% increase in opioid-free weeks.
SJRP Provides On-Site Vivitrol Injection Treatment to Help You Recover
Clients that engage in Vivitrol treatment in addition to their psychotherapy and individual and group counseling have a greater chance at maintaining abstinence in recovery. At SJRP we provide clients with access to Vivitrol injection treatment on-site and case management works hard to coordinate continued Vivitrol treatment for clients who discharge from our Florida drug and alcohol rehab center. If you or someone you love is addicted to harmful opioids, consider St. John’s Recovery Place and the various opiate addiction treatment options including our once monthly Vivitrol injection treatments to help you get well. Call our admissions team at 833-397-3422 to learn more about our treatment programs and how they can help you.
Understanding Vivitrol Treatment & Your Recovery
Vivitrol is an opioid antagonist drug created to aid opioid-dependent individuals who are undergoing counseling, to remain abstinent from opioid use. The Vivitrol injection is given once a month, generally for a period of three months, in the gluteal muscle. While this injection may bring about uncomfortable or severe side effects and should never be used in conjunction with opioids of any form or dose, Vivitrol can be a powerful accompaniment to traditional therapy and counseling for OUD. Vivitrol is not suitable for everyone, but its effectiveness in helping aid those who are seeking recovery from alcoholism or OUD is nothing to turn a blind eye at. Vivitrol has helped many clients achieve lasting recovery success and it may be able to help you achieve your recovery goals too!
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