LUCEMYRA contains the active ingredient lofexidine, which is a central alpha-2 adrenergic agonist in the form of lofexidine hydrochloride. It is available as peach-colored, round-shaped biconvex film-coated tablets for oral administration, with each tablet containing 0.18 lofexidine, equivalent to 0.2 mg of lofexidine hydrochloride. Key inactive ingredients include calcium stearate, citric acid anhydrous, and lactose anhydrous. The medication is intended to be used in the management of opioid withdrawal symptoms, as inferred from its drug class as a central alpha-2 adrenergic agonist.

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. If it upsets your stomach, take it with food. Take your medication at regular intervals. Do not suddenly stop taking this medication because you may develop a dangerous increase in blood pressure. If your care team wants you to stop the medication, the dose will be slowly lowered over time to avoid any side effects.

Talk to your care team about the use of this medication in children. Special care may be needed.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store between 15 and 30 degrees C (77 and 86 degrees F). Keep this medication in the original container. Keep away from heat and moisture. Throw away any unused medication after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• CNS depression—slow or shallow breathing, shortness of breath, feeling faint, dizziness, confusion, trouble staying awake
• Heart rhythm changes— fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Low blood pressure—dizziness, feeling faint or lightheaded, blurry vision
• Slow heartbeat—dizziness, feeling faint or lightheaded, confusion, trouble breathing, unusual weakness or fatigue

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Drowsiness
• Dry mouth
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Heart disease
• History of irregular or slow heartbeat
• History of lightheadedness, fainting spells
• History of stroke
• If you drink alcohol
• Kidney disease
• Liver disease
• Long QT syndrome
• Low levels of calcium, magnesium, or potassium in the blood
• Low blood pressure
• An unusual or allergic reaction to lofexidine, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dronedarone
• Pimozide
• Thioridazine

This medication may also interact with the following:

• Alcohol
• Antihistamines for allergy, cough and cold
• Certain medications for anxiety or sleep
• Certain medications for blood pressure, heart disease, irregular heartbeat
• Certain medications for depression, such as amitriptyline, fluoxetine, sertraline, paroxetine
• Certain medications for seizures, such as phenobarbital, primidone
• General anesthetics, such as halothane, isoflurane, methoxyflurane, propofol
• Medications that relax muscles for surgery
• Methadone
• Naltrexone
• Opioid medications for pain
• Other medications that cause heart rhythm changes
• Phenothiazines, such as chlorpromazine, mesoridazine, prochlorperazine, thioridazine

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team regularly. For this medication to be most effective, you should attend any counseling or support groups that your care team recommends.

You may become more sensitive to opioids after a period of not using them. This may increase your risk of overdose and death if you start using them again.

Be alert for any symptoms of low blood pressure or slow heart rate, such as dizziness and feeling faint or lightheaded at rest or after standing quickly from a sitting or lying position. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Avoid becoming dehydrated or overheated, which may increase the risk for low blood pressure and fainting. If you experience symptoms of low blood pressure or slow heart rate, do not take your next dose of this medication until you have talked to your care team.

This medication may affect your coordination, reaction time, or judgment. Do not drive or operate machinery until you know how this medication affects you. Sit up or stand slowly to reduce the risk of dizzy or fainting spells. Drinking alcohol with this medication can increase the risk of these side effects.