[12-6-2011] The U.S. Food and Drug Administration (FDA) has approved modifications to the Risk Evaluation and Mitigation Strategies (REMS) for platelet-booster drugs Nplate (romiplostim) injection and Promacta (eltrombopag) tablets.

Therefore, the FDA has modified the VIVITROL Risk Evaluation and Mitigation Strategy (REMS) to highlight the potential risk of severe injection site reactions and to emphasize the importance of healthcare providers counseling their patients about the serious risks associated with VIVITROL.

It is currently the only approved medication for opioid dependence that is not a controlled substance.

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.

Administer the suspension by deep intramuscular injection into the upper, outer quadrant of a gluteal muscle, alternating buttocks per monthly injection. Remember to aspirate for blood before injection. 2. If blood aspirates or the needle clogs, do not inject.

Vivitrol comes with customized needles for injection and should always be used. 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.

Vivitrol blocks endorphins from attaching to brain cells. This may prevent the excessive release of dopamine. It is believed that this is how Vivitrol may block the excessive reward of alcohol.

Vivitrol is not the same as Suboxone, but both drugs are used to treat opioid use disorder. Vivitrol contains the drug naltrexone alone, and is administered monthly through an injection. Suboxone is a combination of naloxone and buprenorphine, and the medicine is taken orally on a daily basis.

A REMS may include one or more of the following: A Medication Guide or patient package insert for patients, a Communication Plan for healthcare providers, and Elements to Assure Safe Use (ETASU), which often involve some form of restricted distribution and/or evidence of safe-use conditions.

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Absolutely! Having Hepatitis C is not contraindicated to be treated with Vivitrol.

• 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. Patients should not be actively drinking at the time of initial VIVITROL administration (1.1).

Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL Prevention of relapse to opioid dependence, following opioid detoxification

FDA announced on April 13, 2017 the elimination of the risk evaluation and mitigation strategy (REMS) for Epogen/Procrit (epoetin alfa).

VIVITROL is an injectable suspension containing 380 mg of naltrexone in a microsphere formulation and 4 mL diluent (3). CONTRAINDICATIONS VIVITROL is contraindicated in: • Patients with acute hepatitis or liver failure (5.1). • Patients receiving opioid analgesics (5.5). • Patients with current physiologic opioid dependence (5.5).