Provided by You Health for patients

Naltrexone + Vitamin B12 Tablets

Following consultation, a You Health provider determined that Naltrexone + Vitamin B12 is medically appropriate and necessary for your treatment.

Naltrexone + Vitamin B12 is compounded by licensed pharmacists using active pharmaceutical ingredients, naltrexone and vitamin B12. Unless otherwise indicated, the safety information below is based on the known safety profiles of these active ingredients as used in the compounded medication. Like all compounded medications, Naltrexone + Vitamin B12 is not FDA approved. This means that the safety, effectiveness, and quality of this medication has not been verified by the FDA, as the FDA does not verify the safety, effectiveness, and quality of any compounded drugs.

The following provides a medication overview of Naltrexone + Vitamin B12, how the active ingredients work, and how to effectively and safely use it to support weight loss. It does not contain all possible information. You will also receive a physical document called a medication guide or patient drug information in the package with your medication when it arrives from the pharmacy which contains full information about Naltrexone + Vitamin B12. Please read all of the information, specific to the medication(s) you were prescribed, before taking your medication and at each refill. It’s important to take your medication as directed by your provider and to always read your prescription label and follow your healthcare provider's instructions. If you’re not sure which medication you were prescribed, please reference the label on your prescription bottle or contact a member of your Care Team.

What is Naltrexone + Vitamin B12?

Naltrexone promotes weight loss by curbing cravings and reducing appetite. While naltrexone is FDA approved to treat alcohol and opioid dependence, it’s commonly prescribed off-label by leading obesity specialists and weight clinics to help patients lose weight.

Vitamin B12 is a dietary supplement utilized in many areas of the body principally for the proper function of your red blood cells, nerve cells, energy levels and mood. Additionally it is used to supplement B12 when other drugs may possibly decrease its level.

When prescribed off-label Naltrexone + Vitamin B12 may help some adults with overweight and obesity lose weight and keep the weight off.

In this medication overview

1
Usage
How to get the most out of your treatment
2
Side Effects
What to look out for when using your treatment
3
Warnings
Important safety information

Usage

1
To get started, follow your provider's dosing instructions
You will begin treatment by slowly titrating up the dose of Naltrexone + Vitamin B12 over a 4 or 5 week period, depending on the instructions given by your provider. Both schedules are shown in the tables below. Once you reach a dose of 1 tablet in the morning and 1 tablet in the evening you will remain at this dose unless instructed otherwise.
2
Missed a dose?
Take a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses.
3
Undergoing a planned medical/surgical procedure, or have an injury that requires the use of opioid/narcotic pain medications?
If at any time during treatment with Naltrexone + Vitamin B12, you are planning to undergo an elective surgical procedure that may require opioid/narcotic pain medication use, examples include, but are not limited to (morphine (MS Contin®), hydrocodone (Vicodin®), oxycodone (Oxycontin®), hydromorphone (Percocet®), codeine, tramadol) please discontinue use of Naltrexone + Vitamin B12 a minimum of 3 full days (72 hours) prior to the procedure. If anything unplanned, such as an accident or injury, requires the use of a pain medication you should use a non-opioid type, such as ibuprofen or another NSAID type medication if tolerated. It is important to inform all healthcare providers who are involved in your care for any procedures or injury that may require pain medication that you take Naltrexone + Vitamin B12, and when you last took a dose.

4 Week Starter Plan (if instructed by your provider):

Week	Morning	Evening
Week 1	Take ½ tablet in the morning once every other day	_
Week 2	Take ½ tablet in the morning every day	_
Week 3	Take ½ tablet in the morning	Take ½ tablet in the evening
Week 4	Take ½ tablet in the morning	Take 1 tablet in the evening
Week 4	Take 1 tablet in the morning	Take 1 tablet in the evening

5 Week Starter Plan (if instructed by your provider)

Week	Morning	Evening
Week 1	Take ½ tablet in the morning	_
Week 2	Take ½ tablet in the morning	Take ½ tablet in the evening
Week 3	Take ½ tablet in the morning	Take 1 tablet in the evening
Week 4	Take 1 tablet in the morning	Take 1 tablet in the evening

Continue taking this medication as you have been instructed by your provider.

Side effects

Common side effects of Naltrexone and Vitamin B12 may include:

nausea
sleepiness
headache
dizziness
vomiting
decreased appetite
painful joints
muscle cramps
cold symptoms
trouble sleeping
toothache
feeling faint or passing out
low energy
abdominal pain
nervousness/anxiety

Naltrexone and Vitamin B12 can cause serious side effects, including:

Depressed mood. Sometimes this leads to suicide, or suicidal thoughts, and suicidal behavior. Tell your family members and people closest to you that you are taking Naltrexone + Vitamin B12.
Pneumonia. Some people receiving Naltrexone + Vitamin B12 treatment have had a type of pneumonia that is caused by an allergic reaction. If this happens to you, you may need to be treated in the hospital.
Serious allergic reactions. Serious allergic reactions can happen during or soon after an injection of Naltrexone + Vitamin B12. Message your healthcare provider or get medical help right away if you have any of these symptoms:
- skin rash
- swelling of your face, eyes, mouth, or tongue
- trouble breathing or wheezing
- chest pain
- feeling dizzy or faint

These are not all the side effects of Naltrexone and Vitamin B12. Message your healthcare provider if you have any side effect that bothers you or that does not go away. You can message a provider through your Hims & Hers account if you have any questions about your treatment, including any side effects you may be experiencing.

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

Warnings

IMPORTANT SAFETY INFORMATION

Naltrexone and Vitamin B12 can cause serious side effects, including:

Risk of opioid overdose. You can accidentally overdose in two ways.
- Naltrexone + Vitamin B12 blocks the effects of opioids, such as heroin or opioid pain medicines, such as but not limited to; morphine (MS Contin®), hydrocodone (Vicodin®), oxycodone (Oxycontin®), hydromorphone (Percocet®), codeine, or tramadol. Do not try to overcome this blocking effect by taking large amounts of opioids—this can lead to serious injury, coma, or death.
- After you receive a dose of Naltrexone + Vitamin B12, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with Naltrexone + Vitamin B12 can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:
  - after you have gone through detoxification
  - when your next Naltrexone + Vitamin B12 dose is due
  - if you miss a dose of Naltrexone + Vitamin B12
  - after you stop Naltrexone + Vitamin B12 treatment
Tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

Your compounded medication contains Vitamin B12. Please use caution when taking additional over-the-counter vitamins or supplements and ensure that your total daily intake does not exceed recommended limits.

Talk to your healthcare provider about naloxone, a medicine that is available to patients for the emergency treatment of an opioid overdose.

Call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered.

Sudden opioid withdrawal. To avoid sudden opioid withdrawal, you must stop taking any type of opioid, including street drugs; prescription pain medicines; cough, cold, or diarrhea medicines that contain opioids; or opioid-dependence treatments, including buprenorphine or methadone, for at least 7 to 14 days before starting Naltrexone + Vitamin B12. Sudden opioid withdrawal can be severe and may require hospitalization.

Liver damage or hepatitis. Naltrexone + Vitamin B12 can cause liver damage or hepatitis. Message your healthcare provider if you have any of these symptoms during treatment with Naltrexone + Vitamin B12:

stomach area pain lasting more than a few days
dark urine
yellowing of the whites of your eyes
tiredness

Your healthcare provider may need to stop treating you with Naltrexone + Vitamin B12 if you get signs or symptoms of a serious liver problem.

You must stop taking opioids before you start taking Naltrexone + Vitamin B12. It is not known if Naltrexone + Vitamin B12 is safe and effective in children.

Who should not take Naltrexone + Vitamin B12?

Do not take Naltrexone + Vitamin B12 if you:

are using or have a physical dependence on opioid-containing medicines, such as but not limited to, morphine (MS Contin®), hydrocodone (Vicodin®), oxycodone (Oxycontin®), hydromorphone (Percocet®), codeine, or tramadol, or opioid street drugs, such as heroin.
are having opioid withdrawal symptoms. Opioid withdrawal symptoms may happen when you have been taking opioid containing medicines or opioid street drugs regularly and then stop. Symptoms of opioid withdrawal may include: anxiety, sleeplessness, yawning, fever, sweating, teary eyes, runny nose, goosebumps, shakiness, hot or cold flushes, muscle aches, muscle twitches, restlessness, nausea and vomiting, diarrhea, or stomach cramps.
are allergic to Naltrexone + Vitamin B12 or any of the inactive ingredients in Naltrexone + Vitamin B12. Inactive ingredients include: magnesium stearate, maltodextrin, dextrose, sucralose, FD&C Yellow #5/Tartrazine, green color, silicon dioxide, microcrystalline cellulose, silica.

What should I tell my healthcare provider before taking Naltrexone + Vitamin B12?

Before you take Naltrexone + Vitamin B12, tell your healthcare provider if you:

have liver problems, use or abuse street (illegal) drugs, have hemophilia or other bleeding problems, have kidney problems, or have any other medical conditions.
are pregnant or plan to become pregnant. It is not known if Naltrexone + Vitamin B12 will harm your unborn baby.
are breastfeeding. Naltrexone + Vitamin B12 passes into breast milk. Talk to your healthcare provider about whether you will breastfeed or take Naltrexone + Vitamin B12. You should not do both.

Message your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any opioid-containing medicines for pain, cough or colds, or diarrhea.

Medication disposal

If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.

If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can visit FDA- Disposal of Unused Medicines for more information or follow these simple steps to dispose of most medicines in your trash at home:

Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;
Place the mixture in a container such as a sealed plastic bag;
Throw away the container in your trash at home; and
Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.

This is only a summary of the most important information about Naltrexone + Vitamin B12.

Need more information?

Ask your healthcare provider or pharmacist.

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