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Selected Important Safety Information
Do not share your Saxenda® pen with others even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
What is the most important information I should know about Saxenda®?
Serious side effects may happen in people who take Saxenda®, including:
Possible thyroid tumors, including cancer. Tell your health care professional if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Saxenda® and medicines that work like Saxenda® caused thyroid tumors, including thyroid cancer. It is not known if Saxenda® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use Saxenda® if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
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Generic Name:naltrexone (injection) (nal TREX own)
Brand Name:Vivitrol
Medically reviewed by Judith Stewart, BPharm. Last updated on April 2, 2020.
What is Vivitrol?
Vivitrol (naltrexone) blocks the effects of opioid medication, including pain relief or feelings of well-being that can lead to opioid abuse. An opioid is sometimes called a narcotic. Vivitrol is used as part of a treatment program for drug or alcohol dependence.
Vivitrol injection is used to prevent relapse in people who became dependent on opioid medicine and then stopped using it. Naltrexone can help keep you from feeling a 'need' to use the opioid.
Vivitrol injection is also used to treat alcoholism by reducing your urge to drink alcohol. This may help you drink less or stop drinking altogether. Naltrexone will not decrease the effects of alcohol you recently consumed. You should not be drinking at the time you receive your first Vivitrol injection.
Naltrexone is not a cure for drug addiction or alcoholism.
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Important information
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You should not receive Vivitrol if you are having drug or alcohol withdrawal symptoms, if you have taken any opioid medicine within the past 2 weeks, or if you are still actively drinking alcohol.
Call your doctor at once if you have signs of liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).
Vivitrol can cause liver damage, especially at high doses. You should not receive Vivitrol injection if you have hepatitis or symptoms of liver failure.
Before receiving Vivitrol
You should not receive a Vivitrol injection if you still use opioid medicine, or you could have sudden and severe withdrawal symptoms.
You should not receive Vivitrol if you are allergic to naltrexone, or if:
you are having withdrawal symptoms from drug or alcohol addiction;
you have used any opioid medicine within the past 10 days (including fentanyl, Vicodin, OxyContin, and many others); or
you have used methadone or buprenorphine (Subutex, Butrans, Suboxone, Zubsolv) in the past 14 days.
To make sure Vivitrol is safe for you, tell your doctor if you have:
liver disease;
kidney disease; or
a bleeding or blood-clotting disorder such as hemophilia.
It is not known whether Vivitrol will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Naltrexone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.
How is Vivitrol used?
Vivitrol is injected into a muscle. This injection is usually given once a month (every 4 weeks) and can be given only by a doctor or nurse in a clinic.
It is important to receive your Vivitrol regularly to get the most benefit.
You may notice pain, redness, bruising, swelling, or a hard lump where the medicine was injected. Call your doctor if you have this type of reaction to the shot, especially if it does not clear up or gets worse within 2 weeks.
Vivitrol injections are only part of a complete treatment program that may also include additional forms of counseling and/or monitoring. Follow your doctor's instructions very closely.
Wear a medical alert tag or carry an ID card stating that you use Vivitrol. Any medical care provider who treats you should know that you are receiving this medication. If you need surgery, tell the surgeon ahead of time that you are receiving Vivitrol injections.
After receiving Vivitrol, your body will be more sensitive to opioids. If you use an opioid medicine in the future, you will need to use less than before Vivitrol treatment. Using the same amount you used before could lead to overdose or death.
Vivitrol dosing information
Usual Adult Dose for Alcohol Dependence:
Oral Tablets:
50 mg orally once a day
Extended-release injectable suspension:
380 mg every 4 weeks (or once a month) via intramuscular gluteal injection, alternating buttocks
Usual Adult Dose for Opiate Dependence:
Treatment should not be attempted unless the patient has remained free of opioids for at least 7 to 10 days. Opioid abstinence should be verified by analysis of urine for absence of opioids. The patient should not be manifesting withdrawal signs or reporting withdrawal symptoms. If there is any question of occult opioid dependence, perform a naloxone challenge test and do not initiate naltrexone therapy until the naloxone challenge is negative. The naloxone challenge test should not be performed in a patient showing clinical signs or symptoms of opioid withdrawal, or whose urine contains opioids. The naloxone challenge can be repeated in 24 hours.
Initial dose: 25 mg orally one time.
Maintenance dose: If no withdrawal signs occur, 50 mg orally once a day may be started.
Alternative dose schedules: (to improve compliance) 50 mg orally on week days and 100 mg orally on Saturday; or 100 mg orally every other day; or 150 mg orally every third day.
Extended-release injectable suspension: 380 mg every 4 weeks (or once a month) via intramuscular gluteal injection, alternating buttocks
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment to receive your Vivitrol injection.
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What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Vivitrol?
Do not use narcotic medication, heroin, or other street drugs while you are receiving Vivitrol. Never try to overcome the effects of Vivitrol by taking large doses of opioids. Doing so could result in dangerous effects, including coma and death.
Do not drink alcohol during treatment with Vivitrol.
Ask your doctor before using any medicine to treat a cold, cough, diarrhea, or pain. These medicines may contain narcotics or alcohol.
Vivitrol may impair your thinking or reactions. Avoid driving or operating machinery until you know how this medicine will affect you.
Vivitrol side effects
Get emergency medical help if you have signs of an allergic reaction to Vivitrol: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Using opioid medicine while you are receiving Vivitrol injections could stimulate opioid withdrawal symptoms. Common withdrawal symptoms are yawning, irritability, sweating, fever, chills, shaking, vomiting, diarrhea, watery eyes, runny nose, goose bumps, body aches, trouble sleeping, and feeling restless.
Call your doctor at once if you have:
weak or shallow breathing;
confusion, severe dizziness, feeling like you might pass out;
depression, thoughts about suicide or hurting yourself;
severe pain, swelling, blistering, skin changes, a dark scab, or a hard lump where the medicine was injected;
new or worsening cough, wheezing, trouble breathing; or
liver problems - nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Vivitrol ivitrol side effects may include:
nausea, vomiting, changes in appetite;
muscle cramps;
dizziness, drowsiness;
abnormal liver function tests;
sleep problems (insomnia);
stuffy nose, tooth pain; or
pain, swelling, or itching where the injection was given.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Vivitrol?
Vivitrol will block the effects of any narcotic medicines you take (such as prescription medicine for pain, cough, or diarrhea). Harmful side effects could also occur.
Other drugs may interact with naltrexone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.
Popular FAQ
What happens if you drink alcohol while taking naltrexone?Naltrexone blocks the feelings of intoxication (the “buzz”) from alcohol when you drink it. This allows people with alcohol use disorder to lessen their drinking behaviors enough to stay in treatment, avoid relapses, and take their medication. Over time, cravings for alcohol will decrease. However, naltrexone will not prevent you from becoming impaired while drinking alcohol. Do not use naltrexone so that you can drive or perform other activities under the influence of alcohol. Continue reading
Should I take naltrexone in the morning or at night?The manufacturer does not specify if you should take naltrexone tablets in the morning or at night. Take naltrexone exactly as your doctor orders it. Many patients take their medication in the morning to help affirm their continued treatment success for either opioid use disorder or alcohol use disorder. Taking naltrexone tablets after a meal (for example: breakfast) may help to lessen any stomach side effects such as nausea or pain. Continue reading
What to avoid when taking naltrexone?Do NOT take opiates, including heroin or other prescription or illegal opiates while using naltrexone. Taking opiates with naltrexone increases your risk for an overdose, coma and death. Do not use naltrexone if you are dependent on opioids or if you are experiencing opioid withdrawal symptoms. Naltrexone should not be used before you complete a medically-supervised opioid withdrawal lasting at least 7 to 14 days. Continue reading
How long does naltrexone take to work?Oral naltrexone is well absorbed and will usually begin working within one hour after a dose. Intramuscular naltrexone is an extended-release formulation and has two peaks, first at 2 hours then again 2 to 3 days later, although its therapeutic effect lasts for one month Continue reading
Does naltrexone make you sleepy?Herbal Clean Qtabs
Dizziness, drowsiness, sedation and fainting have all been reported as possible side effects with naltrexone treatment. Avoid driving, operating heavy machinery, or performing other hazardous activities until you know how naltrexone may affect you. Continue reading
Is naltrexone a controlled substance?Naltrexone is not classified as a controlled substance. It's a full opioid antagonist that blocks euphoric actions at the opioid receptor (meaning it can't lead to a 'high' or addiction).
It is used as one part of the treatment plan of patients with alcohol dependence or opioid use disorder, along with counseling. Continue reading
More FAQ
Further information
- Your doctor can provide more information about Vivitrol.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Vivitrol only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Copyright 1996-2021 Cerner Multum, Inc. Version: 4.03.
More about Vivitrol (naltrexone)
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