Pronunciation:

NAL-me-feen

Brand Names:

• Zurnai

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Antidote

Pharmacologic—

Opioid Antagonist

Uses of This Medicine:

Nalmefene injection is used for emergency treatment of an opioid overdose or a possible overdose. Some signs and symptoms of an opioid emergency are breathing problems (which can range from slow or shallow breathing to no breathing), extreme sleepiness, or not being able to respond.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of nalmefene injection in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of nalmefene injection in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease—Use with caution. May make these conditions worse.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

This medicine should be given immediately when a suspected or known opioid overdose has occurred. This will help prevent serious breathing problems and severe sleepiness that can lead to death.

Call for emergency help right away after the first dose of this medicine. The reversal effects of nalmefene are temporary. Patients who receive this medicine should be closely monitored.

A home health caregiver or a family member will give you or your child this medicine. It may be given as a shot under your skin or into a muscle of the outer thigh, through clothing if needed. Do not inject into any other area of the body.

This medicine comes with patient information leaflet and patient instructions. Let your home health caregiver or family member read and follow the directions carefully. Ask your doctor if you have any questions.

To use the autoinjector:

• Do not test or prime the autoinjector before use. This medicine can only be used one time.
• Check the liquid in the autoinjector. It should be clear, colorless to light-yellow. Do not use this medicine if it is cloudy, discolored, or has particles in it. Do not use it if it is broken or the blue cap is missing.
• Twist the blue cap counterclockwise to break the safety seal and pull straight off to remove the cap. Do not replace the cap after it has been removed. Do not touch the needle.
• Place the needle guard against the outer thigh. Push the autoinjector firmly down against the outer thigh until you hear a "click". Hold in place for 3 seconds. The viewing window should turn completely orange (fully blocked). Remove the autoinjector.
• Move the patient on their side (recovery position) after giving the medicine and get emergency medical help right away.
• Watch the patient closely. You may also give additional doses to the patient every 2 to 5 minutes until the patient responds or emergency medical assistance becomes available. Give a new nalmefene injection for each dose.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form (autoinjector):
  • For opioid overdose:
    • Adults and children 12 years of age and older—At first, 1.5 milligrams (mg) injected under the skin or into a muscle. Another injection may be given every 2 to 5 minutes until the patient responds or until emergency medical assistance becomes available.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

The effects of the opioid medicine may last longer than the effects of the nalmefene. This means the breathing problems and sleepiness could come back. Always call for emergency help after the first dose of nalmefene.

Severe opioid withdrawal symptoms may happen suddenly after receiving this medicine. These include body aches, a fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramps, fast heartbeat, and increased blood pressure.

Nalmefene injection may not be able to completely reverse the opioid effects (eg, respiratory depression) of buprenorphine and pentazocine. Repeated doses of nalmefene may be needed to reverse the opioid effects.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Fast, irregular, pounding, or racing heartbeat or pulse

Less common

Blurred vision

confusion

dizziness

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

feeling of warmth

flushing or redness or the skin, especially on the face and neck

headache

nervousness

pounding in the ears

sweating

unusual tiredness or weakness

Rare

Anxiety

body aches or pain

chest pain or discomfort

cough

decrease in frequency of urination

decrease in urine volume

difficulty in passing urine [dribbling]

discouragement

dryness or soreness of the throat

dry mouth

feeling sad or empty

fever

hoarseness

hyperventilation

irritability

lack of appetite

loss of interest or pleasure

muscle twitching or jerking

painful urination

rhythmic movement of the muscles

shakiness in the legs, arms, hands, or feet

shaking

sleepiness or unusual drowsiness

slow or irregular heartbeat

stuffy or runny nose

tender, swollen glands in the neck

trembling or shaking of the hands or feet

trouble breathing

trouble concentrating

trouble in swallowing

trouble sleeping

voice changes

Incidence not known

Blue lips and fingernails

coughing that sometimes produces a pink frothy sputum

diarrhea

goosebumps

loss of bladder control

muscle spasm

no blood pressure or pulse

pale skin

shiver

stomach cramps

stopping of the heart

sudden loss of consciousness

swelling in the legs and ankles

yawning

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Burning sensation

continuing ringing or buzzing or other unexplained noise in the ears

hearing loss

redness of the face, neck, arms and occasionally, upper chest

Rare

Itching skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.