Lucemyra works by blocking the release of norepinephrine, a hormone similar to adrenaline that contributes to opioid withdrawal symptoms.

Lucemyra is used to reduce opioid withdrawal symptoms after you stop taking an opioid suddenly.

Lucemyra will not treat opioid addiction.

Other Medicines related to opioid withdrawal:

For opioid overdose in an emergency situation:

Naloxone

• Nasal spray (Narcan, Kloxxado), Naloxone injection

Medicines used to treat opioid use disorder:

Buprenorphine and naloxone

• Sublingual (Bunavail, Suboxone, Zubsolv)

Methadone

• Tablets (Dolophine)

Naltrexone

• IM injection (Vivitrol), Naltrexone tablets

Buprenorphine

• IM injection (Sublocade), Implant (Probuphine), Sublingual (Subutex)

Other brands of buprenorphine used for severe pain:

• IM injection (Buprenex), Sublingual (Belbuca), Transdermal patch (Butrans)

Lucemyra can cause serious side effects on your heart or blood vessels. Call your doctor at once if you have slow heartbeats, severe dizziness, or if you feel faint. Do not take another dose of lofexidine until you have talked to your doctor.

Avoid becoming overheated or dehydrated, or you could have very low blood pressure. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

You should not stop using this medicine suddenly. Follow your doctor's instructions about tapering your dose.

Take Lucemyra exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

You may take Lucemyra with or without food.

You may need to take this medicine for up to 14 days. Your doctor will change your dose or stop this treatment based on your opioid withdrawal symptoms. Follow all dosing instructions very carefully.

Lucemyra may not completely prevent all symptoms of opioid withdrawal, which may include yawning, pounding heartbeats, watery eyes, feeling cold, stomach pain, feeling sick, body aches, muscle tightness, or trouble sleeping.

You may need additional forms of counseling, support, and/or monitoring as you go through opioid withdrawal.

Lucemyra can cause serious side effects on your heart or blood vessels. Call your doctor at once if you have slow heartbeats, severe dizziness, or a light-headed feeling (like you might pass out). If you have these side effects, do not take your next dose until you talk with your doctor.

You should not stop using Lucemyra suddenly, or you could have a rapid increase in blood pressure and unpleasant symptoms. Follow your doctor's instructions about tapering your dose.

Store at room temperature away from moisture and heat. Keep the tablets in their original container, along with the packet or canister of moisture- absorbing preservative.

If you start using opioid medication after a long period of not using it, you will be more sensitive to opioid effects. This could increase your risk of overdose and death.

Usual Adult Dose for Opiate Withdrawal:

Initial dose: 0.54 mg orally 4 times a day during period of peak withdrawal
-Dosing should be guided by symptoms and side effects
Frequency of dosing: Every 5 to 6 hours
Maximum single dose: 0.72 mg
Maximum daily dose: 2.88 mg/day
Maximum duration of therapy: 14 days

Comments:
-The period of peak withdrawal symptoms is generally the first 5 to 7 days following last use of opioid.
-Treatment may be continued for up to 14 days with dosing guided by symptoms; lower doses may be appropriate as opioid withdrawal symptoms wane.
-Discontinuation should occur over a 2 to 4-day period to mitigate withdrawal effects of lofexidine (e.g. reducing by 1 tablet per dose every 1 to 2 days).

Use: For the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation.

You should not use Lucemyra if you are allergic to lofexidine.

Tell your doctor if you have ever had:

• slow heartbeats;

• low blood pressure;

• heart problems;

• a heart attack or stroke;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• long QT syndrome (in you or a family member);

• kidney disease; or

• liver disease.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Lucemyra is not approved for use by anyone younger than 18 years old.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid becoming overheated or dehydrated, or you could have very low blood pressure.

Avoid drinking alcohol.

Get emergency medical help if you have signs of an allergic reaction to Lucemyra: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• slow heartbeats;

• severe dizziness or drowsiness; or

• a light-headed feeling, like you might pass out.

Common Lucemyra side effects may include:

• low blood pressure;

• dizziness (especially when standing up);

• drowsiness; or

• dry mouth.

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.

Lucemyra can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using Lucemyra with other drugs that make you drowsy can worsen this effect. Ask your doctor before using a sedative (such as Valium or Xanax), a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with lofexidine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.