Lucemyra (lofexidine)

Lucemyra is a brand-name prescription drug. It’s used to help relieve withdrawal symptoms (such as muscle aches, chills, anxiety, and sweating) for adults who’ve stopped taking opioids suddenly. Withdrawal symptoms can occur in people who are physically dependent on an opioid. This means they need to keep taking the drug to feel “normal.”

Lucemyra is not a treatment for opioid use disorder (formerly called opioid dependence). It only helps relieve some withdrawal symptoms. Lucemyra should be used as part of a complete treatment program, which may include counseling, support groups, and other medications.

Lucemyra contains the active drug lofexidine. It belongs to a class of drugs called alpha-2 adrenergic agonists.

Lucemyra comes as a tablet that’s taken by mouth. It’s usually taken four times daily for up to 14 days.

FDA approval

Lucemyra was approved by the Food and Drug Administration (FDA) in May 2018. It’s the first non-opioid drug approved to help relieve opioid withdrawal symptoms.

Effectiveness

Lucemyra has been found to be effective in helping relieve withdrawal symptoms. Lucemyra’s effectiveness was measured in clinical studies in two ways:

• the number of people who successfully completed 5 to 7 days of Lucemyra treatment after suddenly stopping opioids
• the Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop), which is an average symptom severity score based on a 30-point scale (where higher scores indicate worse symptoms)

One clinical study included adults who suddenly stopped taking opioids. In the study, they took either Lucemyra or a placebo (a treatment with no active drug). The percentage of people who successfully remained in treatment after 7 days was:

• 40% to 41% of people who took Lucemyra
• 28% of people who took a placebo

Also in this study, people who took Lucemyra had less severe withdrawal symptoms than people who took a placebo. Over the course of 7 days, people who took Lucemyra had SOWS-Gossop symptom scores that were 2.3 to 2.7 points lower than people who took a placebo.

For more information on Lucemyra’s effectiveness, see the “Lucemyra uses” section.

Lucemyra is available only as a brand-name medication. It’s not currently available in generic form.

Lucemyra contains the active drug lofexidine.

The Lucemyra dosage your doctor prescribes will depend on several factors. These include:

• the severity of the condition you’re using Lucemyra to treat
• how your body responds to the drug
• other medical conditions you may have

Typically, your doctor will start you on a low dosage. Then they’ll adjust it over time to reach the amount that’s right for you. Your doctor will ultimately prescribe the smallest dosage that provides the desired effect.

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs.

Drug forms and strengths

Lucemyra contains the drug lofexidine. It comes as a tablet that you take by mouth.

Each Lucemyra tablet contains 0.18 mg of lofexidine.

Dosage for opioid withdrawal

The usual starting dosage of Lucemyra for opioid withdrawal is three tablets (0.54 mg) taken four times a day. This will likely be your dose for the first 5 to 7 days of treatment (which usually starts after your last opioid dose).

You should not take a dose more often than every 5 to 6 hours.

The maximum single dosage is four tablets (0.72 mg) at one time. The maximum daily dosage is 16 tablets (2.88 mg) in one day.

Your doctor will lower your dosage slowly over the course of 2 to 4 days as your withdrawal symptoms become less severe. This will allow you to safely stop taking Lucemyra after 14 days.

The maximum length of treatment with Lucemyra is 14 days.

What if I miss a dose?

If you miss a dose of Lucemyra, take it as soon as you remember. However, if it’s almost time for your next dose, just wait and take your next dose at the regular time.

Don’t take a dose more often than every 5 to 6 hours. This can raise your risk for serious side effects.

To help make sure you don’t miss a dose, try setting a reminder on your phone. A medication timer may be useful, too.

Will I need to use this drug long term?

Lucemyra is meant to be taken for up to 14 days. It’s not meant to be used as a long-term treatment.

Lucemyra is used to treat withdrawal symptoms during the first 2 weeks after you stop taking opioids.

You may wonder how Lucemyra compares to other medications that are prescribed for similar uses. Here we look at how Lucemyra and clonidine are alike and different.

Ingredients

Lucemyra is a brand-name medication that contains the drug lofexidine. Clonidine is a drug that’s available as a generic medication and as the brand-name Catapres.

Uses

Lucemyra is approved by the Food and Drug Administration (FDA) to help relieve withdrawal symptoms in adults who stop taking opioids suddenly.

Clonidine is FDA-approved to treat high blood pressure. However, it’s used off-label (a nonapproved use) to help relieve opioid withdrawal symptoms.

Drug forms and administration

Lucemyra comes as a tablet. The usual starting dosage is three tablets taken four times a day.

The maximum length of treatment with Lucemyra is 14 days.

Clonidine comes as tablets. It’s typically taken every 6 to 8 hours to treat opioid withdrawal symptoms.

There is no specific maximum length of treatment with clonidine because it’s not FDA-approved for this use.

Side effects and risks

Lucemyra and clonidine have some similar side effects and others that differ. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Lucemyra, with clonidine, or with both drugs (when taken individually).

• Can occur with Lucemyra:
  • orthostatic hypotension
• Can occur with clonidine:
  • constipation
• Can occur with both Lucemyra and clonidine:
  • sleepiness/drowsiness
  • dry mouth
  • dizziness

Serious side effects

This list contains examples of serious side effects that can occur with both Lucemyra and clonidine (when taken individually).

• low blood pressure
• bradycardia (slow heart rate) or long QT syndrome (abnormal heart rate)
• severe allergic reaction

Effectiveness

Lucemyra and clonidine have different FDA-approved uses, but they’re both used to help relieve withdrawal symptoms in people who stopped taking opioids suddenly. (This is off-label use for clonidine.)

A review of five clinical studies found Lucemyra and clonidine to be similarly effective in relieving opioid withdrawal symptoms. However, low blood pressure and feeling unwell were more commonly reported with clonidine than with Lucemyra.

The American Society of Addiction Medicine describes both drugs as safe and effective treatment options for withdrawal symptoms. Lucemyra or clonidine should be used as part of a complete treatment plan for opioid use disorder, but they should not be taken together.

Costs

Lucemyra and clonidine (Catapres) are both available as brand-name drugs. There are currently no generic forms of Lucemyra, but clonidine is available as a generic. Brand-name medications usually cost more than generics.

Lucemyra costs significantly more than either the brand-name or generic form of clonidine. The actual price you’ll pay for either drug depends on your dosage, your insurance plan, your location, and the pharmacy you use.

Lucemyra can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Lucemyra. These lists do not include all possible side effects.

For more information on the possible side effects of Lucemyra, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs they have approved. If you would like to report to the FDA a side effect you’ve had with Lucemyra, you can do so through MedWatch.

More common side effects

The more common side effects of Lucemyra can include:

• dizziness
• sleepiness or drowsiness
• dry mouth (see “Side effect details” below)
• orthostatic hypotension (see “Side effect details” below)

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Lucemyra aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Serious side effects and their symptoms can include:

• Low blood pressure. Symptoms can include:
  • feeling lightheaded
  • weakness
  • feeling faint when resting, sitting, or lying down
  • fainting
• Bradycardia (slow heart rate) and long QT syndrome (slow or abnormal heart rhythm). See “Side effect details” below.

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on several of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Lucemyra. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• flushing (warmth and redness in your skin)

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing

It’s not known how many people have had an allergic reaction to Lucemyra.

Call your doctor right away if you have a severe allergic reaction to Lucemyra. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Orthostatic hypotension

Orthostatic hypotension may occur with Lucemyra use.

Orthostatic hypotension is a sudden drop in blood pressure that happens when you quickly move from lying down to sitting up or standing. This can make you feel dizzy or lightheaded, and may even make you fall or faint.

In clinical studies, 29% to 42% of people who took Lucemyra had orthostatic hypotension. People taking higher doses had a greater risk for this side effect. In comparison, 5% of people who took a placebo (a treatment with no active drug) had orthostatic hypotension.

To prevent injuries or accidents related to orthostatic hypotension, be sure to sit up and stand up slowly. Hold on to furniture as you sit up or stand up. This can help reduce your risk for orthostatic hypotension. It will also help prevent you from falling and hurting yourself. Drinking plenty of fluids can also help keep your blood pressure in a safe range.

Tell your doctor right away if you have orthostatic hypotension while taking Lucemyra. If this side effect is severe, your doctor may recommend a lower dosage of Lucemyra for you. They may also recommend that you skip your next dose.

If you have heart or kidney problems, Lucemyra may cause more severe orthostatic hypotension. See the “Lucemyra precautions” section below for more information.

Bradycardia

Lucemyra can cause bradycardia (slow heart rate). In clinical studies, 24% to 32% of people who took Lucemyra had bradycardia. This is compared to 5% of people who took a placebo.

Slow heart rate can cause symptoms including:

• fatigue (lack of energy)
• dizziness
• chest pain
• shortness of breath
• heart palpitations (feeling like your heart is skipping a beat)
• fainting

Talk with your doctor right away if you have bradycardia or any of these symptoms while taking Lucemyra. They may recommend that you lower or skip your next dose.

Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

If you have heart, liver, or kidney problems, Lucemyra may cause serious worsening of bradycardia. See the “Lucemyra precautions” section below for more details.

Dry mouth

Dry mouth is a common side effect of Lucemyra. In clinical studies, 10% to 11% of people who took Lucemyra had dry mouth. No one who took a placebo reported dry mouth.

Tell your doctor if you have dry mouth during your Lucemyra treatment. They may recommend some ways to manage this side effect, including:

• drinking more water than you usually do
• chewing sugar-free gum
• using alcohol-free mouthwash
• eating water-filled foods, such as celery or carrots
• using a humidifier in your bedroom to add moisture to the air while you sleep

Other drugs are available that can treat opioid withdrawal. Some may be a better fit for you than others. If you’re interested in finding an alternative to Lucemyra, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is used to treat a different condition.

Alternatives for opioid withdrawal symptoms

Other medications may be used to treat opioid withdrawal symptoms on a short-term basis (days or weeks following your last opioid dose). (This is off-label use for clonidine and guanfacine.)

Examples of these drugs include:

• clonidine (Catapres, Kapvay)
• guanfacine (Intuniv)
• methadone (Dolophine, Methadose)

These drugs are typically prescribed in an inpatient setting, such as a hospital or treatment center, to treat symptoms of opioid withdrawal.

There are also many over-the-counter (OTC) drugs that can be used to treat certain symptoms of opioid withdrawal. See the “Lucemyra use with other drugs” section for a list of other OTC drugs used.

Other drugs for opioid use disorder

Examples of medications used on a long-term basis to treat opioid use disorder include:

• buprenorphine (Probuphine, Sublocade, Butrans)
• buprenorphine/naloxone (Bunavail, Suboxone, Zubsolv)
• methadone (Dolophine, Methadose)
• naltrexone (Vivitrol)

These drugs are usually prescribed in an outpatient setting, such as your doctor’s office. They’re used to reduce cravings and help you avoid taking opioids on a long-term basis.

Lucemyra and Suboxone are prescribed for similar uses. Below are details of how these medications are alike and different.

Ingredients

Lucemyra contains the active drug lofexidine. Suboxone contains two active drugs: buprenorphine and naloxone.

Uses

Lucemyra is approved by the Food and Drug Administration (FDA) to help relieve withdrawal symptoms for adults who’ve stopped taking opioids suddenly. It’s used on a short-term basis.

Lucemyra is not a treatment for opioid use disorder. Instead, it’s used immediately after you stop taking opioids. It helps relieve some withdrawal symptoms, but it won’t stop you from craving opioids.

Suboxone is FDA-approved to treat opioid dependence (now called opioid use disorder by healthcare professionals). It can be used on a short-term or long-term basis.

Suboxone helps lessen a person’s withdrawal symptoms, and it also helps reduce opioid cravings. It’s used to help a person avoid using opioids on an ongoing basis.

Both drugs are used as part of a complete treatment program, which may include counseling, support groups, and other medications.

Drug forms and administration

Lucemyra comes as a tablet. The usual starting dosage is three tablets taken four times a day. The maximum length of treatment with Lucemyra is 14 days.

Suboxone comes as a film that you place under your tongue or between your teeth and cheek. Once you put it in your mouth, it dissolves quickly. It’s taken once a day.

There is no maximum length of treatment with Suboxone. You and your doctor will decide how long your Suboxone treatment will last.

Side effects and risks

Lucemyra and Suboxone contain different types of drugs. Therefore, these medications can cause different side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Lucemyra or with Suboxone.

• Can occur with Lucemyra:
  • dizziness
  • sleepiness/drowsiness
  • dry mouth
  • orthostatic hypotension
• Can occur with Suboxone:
  • nausea
  • headache
  • sleepiness
  • irritation in your mouth where the film is placed
  • reduced sense of taste and feeling in your mouth
  • constipation
  • insomnia (trouble sleeping)
  • belly pain
  • anxiety
  • sweating
  • opioid withdrawal symptoms, such as body aches, abdominal (belly) cramps, and fast heart rate

Serious side effects

These lists contain examples of serious side effects that can occur with Lucemyra or with Suboxone.

• Can occur with Lucemyra:
  • low blood pressure
  • bradycardia (slow heart rate) or long QT syndrome (slow or abnormal heart rate)
• Can occur with Suboxone:
  • misuse of and dependence on the drug
  • respiratory depression (slow and weak breathing)
  • adrenal insufficiency (hormone problems)
  • severe opioid withdrawal symptoms
  • liver damage
  • increased blood pressure in your head
  • increased blood pressure in and near your gallbladder

Effectiveness

Lucemyra and Suboxone have different FDA-approved uses. Lucemyra is FDA-approved to help relieve opioid withdrawal symptoms in adults who stop taking opioids suddenly.

Suboxone is FDA-approved to treat opioid dependence (now called opioid use disorder by healthcare professionals).

A review of several clinical studies found that buprenorphine (one of the active drugs in Suboxone) was more effective in relieving withdrawal symptoms than Lucemyra. This is an off-label (nonapproved) use of Suboxone, however.

The American Society of Addiction Medicine states that both Lucemyra and Suboxone are safe and effective components of a complete treatment plan. It’s important to note that neither Lucemyra nor Suboxone is meant to be used on its own.

Costs

Lucemyra and Suboxone are both brand-name drugs. There are currently no generic forms of Lucemyra. There is a generic form of Suboxone called buprenorphine/naloxone. Brand-name medications usually cost more than generics.

Lucemyra may cost significantly more than Suboxone. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Lucemyra is approved to help relieve withdrawal symptoms in adults who’ve stopped taking opioids suddenly.

About opioid withdrawal

Repeated use of opioid drugs decreases the amount of norepinephrine (a chemical messenger) that’s released in your body and brain.

Norepinephrine plays a role in many everyday bodily functions, such as wakefulness and sleep, muscle and heart activity, gastrointestinal activity, and breathing. Norepinephrine is released from nerve cells that have adrenergic receptors (docking stations) on them.

When your body gets used to having opioids, it adjusts by increasing norepinephrine levels. You don’t feel the unpleasant effects of high norepinephrine levels (see list below) while taking opioids because the opioids block many of them.

When you suddenly stop taking opioids, your body can’t immediately decrease your norepinephrine levels. This leads to overactivity of many of your body’s systems, causing withdrawal symptoms that may include:

• muscle aches
• belly pain and cramps
• chills
• anxiety
• sweating
• diarrhea
• depression
• insomnia
• fast heart rate

What Lucemyra does

Lucemyra contains the active drug lofexidine. It belongs to a class of drugs called alpha-2 adrenergic agonists.

Lucemyra helps relieve withdrawal symptoms. It does this by binding to alpha-2 adrenergic receptors. When Lucemyra attaches to these receptors, it tells your nerve cells to release less norepinephrine. Lower norepinephrine levels help make withdrawal symptoms less severe. This makes withdrawal from opioids more tolerable for many people.

It’s important to note, however, that Lucemyra does not completely get rid of withdrawal symptoms. It also doesn’t reduce cravings for opioids. Lucemyra shouldn’t be used on its own, but rather as one part of a complete treatment plan for opioid use disorder.

How long does it take to work?

Lucemyra begins to help relieve withdrawal symptoms within a few hours after you take it.

The Food and Drug Administration (FDA) approves prescription drugs such as Lucemyra to treat certain conditions.

Lucemyra for opioid withdrawal

Lucemyra is FDA-approved to help relieve withdrawal symptoms for adults who’ve stopped taking opioids suddenly. Withdrawal symptoms can occur in people who are physically dependent on the drug. This means they need to keep taking the drug to feel “normal.”

Lucemyra is not a treatment for opioid use disorder. It only helps make some withdrawal symptoms less severe. Lucemyra shouldn’t be used on its own, but rather as one part of a complete treatment plan. Your treatment plan may include counseling, support groups, and other medications.

Effectiveness

Lucemyra has been found to be effective in helping relieve opioid withdrawal symptoms. Lucemyra’s effectiveness was measured in clinical studies in two ways:

• the number of people who successfully completed 5 to 7 days of Lucemyra treatment after suddenly stopping opioids
• the Short Opiate Withdrawal Scale-Gossop (SOWS-Gossop), which is an average symptom severity score based on a 30-point scale (where higher scores indicate worse symptoms)

In these studies, the effectiveness of Lucemyra was compared to a placebo (a treatment with no active drug).

In one clinical study, the percentage of people who successfully completed 7 days of treatment was:

• 40% to 41% of people who took Lucemyra
• 28% of people who took a placebo

Also in this study, people who took Lucemyra had less severe withdrawal symptoms than people who took a placebo. Over the course of 7 days, people who took Lucemyra had SOWS-Gossop symptom scores that were 2.3 to 2.7 points lower (on a 30-point scale) than those who took a placebo.

In another clinical study, the percentage of people who successfully completed 5 days of treatment was:

• 49% of people who took Lucemyra
• 33% of people who took a placebo

Over those 5 days, people who took Lucemyra had an average SOWS-Gossop symptom severity score that was 1.9 points lower than those who took a placebo.

Lucemyra should be used as part of a complete treatment program. This is because Lucemyra is not a treatment for opioid use disorder.

A complete treatment program may include counseling, behavioral therapy, and support groups. It may also include medication to treat opioid use disorder on an ongoing basis.

Lucemyra may also be used with other drugs that treat certain symptoms of opioid withdrawal. This is because Lucemyra may not treat all withdrawal symptoms that you have. Examples of other drugs that may be used with Lucemyra include:

• antacids, such as Tums, for upset stomach
• bismuth subsalicylate (Pepto-Bismol) for upset stomach
• acetaminophen (Tylenol) or ibuprofen (Advil) for headache and body pain
• loperamide (Imodium-AD) for diarrhea
• metoclopramide (Reglan) or ondansetron (Zofran) for nausea and vomiting
• zolpidem (Ambien) for trouble sleeping
• diazepam (Valium) or alprazolam (Xanax) for anxiety

Taking Lucemyra while drinking alcohol can raise your risk for severe drowsiness and loss of coordination (trouble controlling your movements).

If you drink alcohol, talk with your doctor about whether it’s safe for you to drink while taking Lucemyra.

Lucemyra can interact with several other medications. Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase side effects or make them more severe.

Lucemyra and other medications

Below is a list of medications that can interact with Lucemyra. This list does not contain all drugs that may interact with Lucemyra.

Before taking Lucemyra, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter (OTC), and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Lucemyra and methadone or buprenorphine

Taking Lucemyra with methadone (Dolophine, Methadose) or buprenorphine (Buprenex) can raise your risk for serious heart problems. All three of these drugs can cause long QT syndrome (slow or abnormal heart rhythm) when used on their own. Taking Lucemyra with methadone or buprenorphine can increase your risk for this dangerous side effect.

Buprenorphine can also be a part of combination drugs, such as buprenorphine/naloxone (Bunavail, Suboxone, Zubsolv). Be sure to tell your doctor about all medications you take.

If you need to take Lucemyra with methadone or buprenorphine, your doctor will monitor your heart health closely. They will likely do this by recommending an electrocardiogram (EKG), which tests the electrical activity of your heart.

If your EKG results show that you’re at an increased risk for serious heart problems, your doctor may recommend that you stop taking one or both drugs.

Lucemyra and naltrexone taken by mouth

Naltrexone is a drug used to treat alcohol use disorder and opioid use disorder.

Taking Lucemyra and naltrexone together could make naltrexone less effective. This interaction is most likely to occur if Lucemyra and naltrexone are taken within 2 hours of each other. It’s also likely to occur if naltrexone is taken by mouth. (This interaction is not expected to happen with naltrexone taken other ways, such as by injection.)

If you need to take Lucemyra and naltrexone (by mouth) together, your doctor may recommend that you take the two drugs at least 2 or more hours apart.

Lucemyra and anxiety medications

Taking Lucemyra with anxiety medications, such as benzodiazepines, can cause severe drowsiness and loss of coordination (trouble controlling your movements).

Examples of anxiety medications that can cause this interaction with Lucemyra include:

• alprazolam (Xanax, Xanax XR)
• diazepam (Valium)
• lorazepam (Ativan)
• temazepam (Restoril)

If you need to take Lucemyra with these or other anxiety medications, your doctor will monitor you closely for severe drowsiness and loss of coordination. They may also want to lower your dosage of one or both medications.

Lucemyra and paroxetine

Paroxetine (Brisdelle, Paxil, Pexeva) is used to treat depression, anxiety, and other conditions.

Taking Lucemyra and paroxetine together can increase the levels of Lucemyra in your body. This can raise your risk for serious side effects, including low blood pressure and slow heart rate.

If you need to take Lucemyra with paroxetine, your doctor will monitor you closely for these side effects. They may also want to lower your dosage of Lucemyra.

Lucemyra and certain heart or blood pressure medications

Taking Lucemyra with certain heart or blood pressure medications can raise your risk for severe low blood pressure or slow heart rate.

Examples of medications that can cause severely low blood pressure or slow heart rate if taken with Lucemyra include:

• beta-blockers, such as:
  • atenolol (Tenormin)
  • carvedilol (Coreg)
  • metoprolol (Toprol XL)
  • propranolol (Inderal)
  • sotalol (Betapace)
• calcium channel blockers, such as:
  • diltiazem (Cardizem, Cartia XT)
  • verapamil (Calan)
• potassium channel blockers, such as:
  • amiodarone (Pacerone)
  • dronedarone (Multaq)

Taking Lucemyra with these medications should generally be avoided. If you need to take Lucemyra with one of them, your doctor will monitor you closely for serious side effects.

Many blood pressure or heart drugs are also part of combination medications, so be sure to tell your doctor about all medications you take.

Lucemyra and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Lucemyra. However, you should still check with your doctor or pharmacist before using any of these products while taking Lucemyra.

As with all medications, the cost of Lucemyra can vary.

The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance plan may require you to get prior authorization before approving coverage for Lucemyra. This means that your doctor and insurance company will need to communicate about your prescription before the insurance company will cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Lucemyra.

If you’re not sure if you’ll need to get prior authorization for Lucemyra, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Lucemyra, or if you need help understanding your insurance coverage, help is available.

US WorldMeds LLC, the manufacturer of Lucemyra, offers the LUminate Support Program[AK1], which may be able to help lower the cost of your prescription. For more information and to find out if you’re eligible for support, visit the program website.

You should take Lucemyra according to your doctor’s or healthcare provider’s instructions.

Lucemyra is a tablet that’s taken by mouth.

When to take

Lucemyra is generally taken four times a day. It can be taken at any time of the day, but there should be at least 5 or 6 hours between each dose.

To help make sure you don’t miss a dose, try setting a reminder in your phone. A medication timer may be useful, too.

Taking Lucemyra with food

Lucemyra can be taken with or without food.

Can Lucemyra be crushed, split, or chewed?

The maker of Lucemyra hasn’t stated whether the tablets can be crushed, split, or chewed. Ask your pharmacist if you can crush, split, or chew Lucemyra.

If you have trouble swallowing Lucemyra tablets, talk with your doctor. They can recommend ways to make swallowing the tablets easier. They may also recommend a different drug for you.

It’s not known whether Lucemyra is safe to take during pregnancy. In animal studies, there was harm seen to the fetus when the pregnant animal was given Lucemyra. However, animal studies don’t always predict what will happen in humans.

If you are pregnant or considering becoming pregnant, talk with your doctor about whether Lucemyra is safe for you.

It’s not known if Lucemyra is safe to take during pregnancy. If you’re sexually active and you or your partner can become pregnant, talk with your doctor about your birth control needs while you’re using Lucemyra.

It’s not known if Lucemyra passes into breast milk or if it causes negative effects in children who are breastfed.

If you’re taking Lucemyra, talk with your doctor about safe ways to feed your child.

Here are answers to some frequently asked questions about Lucemyra.

Will my opioid withdrawal symptoms come back after I stop taking Lucemyra?

It’s possible. You may have symptoms that feel like withdrawal after you stop taking Lucemyra. These can include diarrhea, sweating, anxiety, and other symptoms. However, each person’s response to stopping Lucemyra may be different.

Your doctor will recommend a slow dosage reduction over at least 2 to 4 days when you’re near the stop date for Lucemyra treatment. This will lower your risk of having symptoms when you stop taking Lucemyra.

Is Lucemyra an opioid?

No. Lucemyra isn’t an opioid, but it’s used to treat withdrawal symptoms from opioids. In fact, Lucemyra is the first non-opioid drug approved for this purpose. Lucemyra is also not addictive, and you won’t need to take it on a long-term basis.

What will happen if I take opioids while I’m using Lucemyra?

Taking opioids while using Lucemyra could raise your risk for an overdose. This is because people who have suddenly stopped taking opioids and are now taking Lucemyra may be more sensitive to the serious side effects of opioids than they used to be. (This is true even with lower doses of opioids.)

Lucemyra will not block or reverse the effects of opioids.

Do not take opioids (including medications used to treat opioid use disorder) with Lucemyra unless your doctor tells you to.

How can I reduce my risk of orthostatic hypotension while I’m taking Lucemyra?

There are several ways you can lower your risk of orthostatic hypotension, which is low blood pressure that occurs when you stand up after sitting or lying down. Orthostatic hypotension can cause dizziness, falling, and fainting.

Drink plenty of fluids while taking Lucemyra. This will help lower your risk of dehydration, which can worsen orthostatic hypotension. Other ways to help prevent this side effect include:

• sleeping with your head slightly elevated
• wearing compression stockings
• avoiding tough exercise in the heat
• avoiding or limiting alcohol intake
• sitting on the edge of your bed for a minute before standing up

Talk with your doctor if you have severe orthostatic hypotension, which can include falling or fainting, while taking Lucemyra. Don’t take your next dose of Lucemyra until you talk with them about what to do. Your doctor may lower your Lucemyra dosage or recommend that you skip a dose. They may also advise you to stop taking the drug.

Before taking Lucemyra, talk with your doctor about your health history. Lucemyra may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

• Low blood pressure. Lucemyra can cause low blood pressure in some people. This can lead to orthostatic hypotension, falling, and fainting. If you have low blood pressure, talk with your doctor to find out if Lucemyra is safe for you.
• Heart problems. Lucemyra can cause bradycardia (slow heart rate) or long QT syndrome (abnormal heart rhythm). If you have a slow or abnormal heart rate or rhythm, talk with your doctor to find out if Lucemyra is safe for you.
• Liver or kidney problems. Your risk for heart problems caused by Lucemyra is greater if you have liver or kidney problems. Talk with your doctor about your liver and kidney health to find out if Lucemyra is safe for you.
• Pregnancy. It’s not known if Lucemyra is safe to take during pregnancy. For more information, see the “Lucemyra and pregnancy” section above.
• Breastfeeding. It’s not known if Lucemyra is safe to take while breastfeeding. For more information, see the “Lucemyra and breastfeeding” section above.

Note: For more information about the potential negative effects of Lucemyra, see the “Lucemyra side effects” section above.

Using more than the recommended dosage of Lucemyra can lead to serious side effects.

Taking opioids with Lucemyra can also raise your risk for an overdose. To learn more, see “What will happen if I take opioids while I’m using Lucemyra?” under “Common questions about Lucemyra” above.

Overdose symptoms

Symptoms of an overdose can include:

• low blood pressure
• slow heart rate
• drowsiness

What to do in case of overdose

If you think you’ve taken too much of this drug, go to the nearest emergency room right away. You can also call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.

When you get Lucemyra from the pharmacy, the pharmacist will add an expiration date to the label on the bottle. This date is typically 1 year from the date they dispensed the medication.

The expiration date helps guarantee that the medication is effective during this time. The current stance of the Food and Drug Administration (FDA) is to avoid using expired medications. If you have unused medication that has gone past the expiration date, talk to your pharmacist about whether you might still be able to use it.

Storage

How long a medication remains good can depend on many factors, including how and where you store the medication.

Lucemyra tablets should be stored at room temperature (68°F to 77°F/20°C to 25°C) in a tightly sealed container away from light or heat. Avoid storing this medication in areas where it could get damp or wet, such as bathrooms.

Disposal

If you no longer need to take Lucemyra and have leftover medication, it’s important to dispose of it safely. This helps prevent others, including children and pets, from taking the drug by accident. It also helps keep the drug from harming the environment.

The FDA website provides several useful tips on medication disposal. You can also ask your pharmacist for information on how to dispose of your medication.