Nalmefene (Nasal)

Nalmefene (Nasal) spray is used for the emergency treatment of an opioid overdose or a possible overdose. It will temporarily reverse the effects of an opioid medicine. Some signs and symptoms of an opioid emergency include breathing problems (which can range from slow or shallow breathing to no breathing), extreme sleepiness, slow heartbeat, not being able to respond, or very small (pinpoint) pupils in a person who is hard to wake.

This medicine is available with your doctor's prescription.

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

Severe opioid withdrawal symptoms may occur suddenly after receiving this medicine. These can 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.

Some types of opioid medications (for example, buprenorphine, pentazocine) may need larger or repeat doses of nalmefene to reverse the opioid effects.

In deciding to use a medicine, you and your doctor need to weigh the risks against the benefits. For this medicine, consider the following:

Allergies

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

Pediatric

There are no appropriate studies on how nalmefene nasal spray affects children younger than 12 years old. Safety and effectiveness have not been established for this age group.

Geriatric

Current studies have not shown any geriatric-specific issues that would limit the usefulness of nalmefene nasal spray in older adults. However, older patients are more likely to have age-related problems with their kidneys, liver, or heart, which may require caution and a dose adjustment for those using nalmefene nasal spray.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine during breastfeeding. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together with caution. If you are taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the following medicines. The following interactions are significant and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfentanil
• Anileridine
• Benzhydrocodone
• Buprenorphine
• Butorphanol
• Codeine
• Dezocine
• Diacetylmorphine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Ethylmorphine
• Fentanyl
• Hydrocodone
• Hydromorphone
• Ketobemidone
• Levorphanol
• Meperidine
• Meptazinol
• Methadone
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Piritramide
• Remifentanil
• Sufentanil
• Tapentadol
• Tilidine
• Tramadol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating or with certain foods due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect the use of this medicine. Make sure to inform your doctor if you have any other medical problems, especially:

• Heart or blood vessel disease—Use with caution. This may worsen these conditions.

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

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

More common

• Blurred vision
• dizziness
• fast, pounding, or irregular heartbeat or pulse
• headache
• nervousness
• pounding in the ears

Less common

• Agitation
• anxiety
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• increased sweating
• unusual tiredness or weakness

Rare

• Chest pain or discomfort
• decrease in frequency of urination
• decrease in urine volume
• difficulty in passing urine
• discouragement
• feeling sad or empty
• irritability
• lack of appetite
• lack of interest or pleasure
• lightheadedness, dizziness, or fainting
• muscle twitching or jerking
• nervousness
• painful urination
• rhythmic movement of muscles
• shakiness in the legs, arms, hands, or feet
• sleepiness or unusual drowsiness
• slow or irregular heartbeat
• trembling or shaking of the hands or feet
• trouble breathing
• trouble concentrating
• trouble sleeping

Incidence not known

• Blue lips and fingernails
• blurred vision
• body aches
• coughing that sometimes produces a pink frothy sputum
• diarrhea
• excessive crying
• fever
• goosebumps
• headache
• increase in blood pressure
• increased or excessive unconscious or jerking movements
• nausea
• no blood pressure or pulse
• pale skin
• pounding in the ears
• restlessness
• runny nose
• seizures
• shivering
• sneezing
• stomach cramps
• stopping of the heart
• swelling in the legs and ankles
• unconsciousness
• vomiting
• 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

• Feeling of warmth
• redness of the face, neck, arms and occasionally, upper chest

Less common

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in taste
• decreased appetite
• loss of taste
• stuffy nose
• throat and mouth pain
• throat irritation

Rare

• Dry mouth
• dryness or soreness of the throat
• hoarseness
• tender, swollen glands in the neck
• trouble in swallowing
• voice changes

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.

In the U.S.

• Opvee

Available Dosage Forms:

• Spray

Therapeutic Class: Antidote

Pharmacologic Class: Opioid Antagonist

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

This medicine is for use only in the nose. Do not get any of it in the eyes or on the skin. If it does get on these areas, rinse it off right away.

This medicine must be given to you (the patient) by someone else. Talk with people close to you so they know what to do in case of an emergency.

This medicine is not a substitute for emergency medical care. Call for emergency assistance after administering the first dose and keep the patient under continued surveillance.

This medicine comes with a patient information leaflet and patient instructions. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

To use the nasal spray:

• Remove the nasal spray from the box. Peel off the back from the top corner to open it.
• Do not prime or test the nasal spray. It contains a single dose of nalmefene and cannot be reused.
• Hold the nasal spray with your thumb on the white plunger and your fingers on either side of the nozzle.
• Lay the patient on their back. Support the patient's neck by your hand and allow the head to tilt back before giving this medicine.
• Gently insert the tip of the nozzle into one nostril of the patient, until your fingers on either side of the nozzle are against the bottom of the patient's nose.
• Press the plunger firmly to give the dose. Remove the nasal spray from the patient's nostril after giving the dose.
• 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. Use a new nasal spray for each dose and spray the medicine into the other nostril each time.

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 nasal dosage form (spray):For opioid overdose: Adults and children 12 years of age and older—At first, 2.7 milligrams (mg) (1 spray into one nostril). Another spray may be given into the other nostril 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.

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