Kloxxado

• Kloxxado (naloxone hydrochloride) nasal spray is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond.
• Kloxxado nasal spray is to be given right away and does not take the place of emergency medical care.
• Get emergency medical help right away after giving the first dose of Kloxxado nasal spray, even if the person wakes up.
• Kloxxado nasal spray is safe and effective in children for known or suspected opioid overdose.

Kloxxado nasal spray may cause serious side effects, including:

• Sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving Kloxxado nasal spray and may include:
  • body aches
  • diarrhea
  • increased heart rate
  • fever
  • runny nose
  • sneezing
  • goose bumps
  • sweating
  • yawning
  • nausea or vomiting
  • nervousness
  • restlessness or irritability
  • shivering or trembling
  • stomach cramping
  • weakness
  • increased blood pressure

In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.

The most common side effects of Kloxxado in adults include:

• stomach-area (abdomen) pain,
• weakness,
• dizziness,
• headache,
• nose (nasal) discomfort and
•  a feeling like you are going to faint.

These are not all of the possible side effects of Kloxxado nasal spray.

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

Important Dosage and Administration Instructions

• Kloxxado is for intranasal use only.
• The device is ready to use. Do not prime or test prior to administration.
• Do not attempt to reuse Kloxxado. Each Kloxxado contains a single dose of naloxone and cannot be reused.
• Because suspected opioid overdose is usually managed by someone other than the patient, instruct the prescription recipient to inform those around them about the presence of Kloxxado and the Instructions for Use.

Instruct the patient or caregiver to read the Instructions for Use on the product packaging at the time they receive a prescription for Kloxxado. Emphasize the following instructions to the patient or caregiver.

• Administer Kloxxado as quickly as possible because prolonged respiratory depression may result in damage to the central nervous system or death.
• Always seek immediate emergency medical assistance after the first dose of Kloxxado has been administered in the event of a suspected, potentially life-threatening opioid emergency because the duration of action of most opioids exceeds that of naloxone hydrochloride. Keep the patient under continued surveillance and administer repeated doses of Kloxxado, as necessary, until emergency personnel arrive.
• Administer Kloxxado according to the printed instructions on the carton and the Instructions for Use on the product packaging.
  • Place the patient in the supine position. Prior to administration, be sure the device nozzle is inserted in either nostril of the patient and provide support to the back of the neck to allow the head to tilt back. Do not prime or test the device prior to administration.
  • To administer the dose, press firmly on the device plunger and remove the device nozzle from the nostril after use. Place the patient in recovery position by turning him/her onto their side as shown in the Instructions for Use and call for emergency medical assistance immediately after the first dose of Kloxxado.
  • Administer additional doses of Kloxxado, using a new nasal spray, every 2 to 3 minutes as needed if the patient does not respond or responds and then relapses into respiratory depression. Administer Kloxxado in alternate nostrils with each dose. [see the Dosing In Adult And Pediatric Patients section below].

Dosing in Adult and Pediatric Patients

Initial Dosing

The recommended initial dose of Kloxxado in adult and pediatric patients is one spray delivered by intranasal administration into one nostril, which delivers 8 mg of naloxone hydrochloride to adult or pediatric patients.

Repeat Dosing

• Seek emergency medical assistance as soon as possible, after administering the first dose of Kloxxado.
• If the desired response is not obtained after 2 or 3 minutes, administer an additional dose using a new Kloxxado in alternate nostril. If there is still no response and additional doses are available, administer additional doses of Kloxxado every 2 to 3 minutes, alternating nostrils and using a new Kloxxado, until emergency medical assistance arrives. The requirement for repeat doses of Kloxxado depends upon the amount, type, and route of administration of the opioid being antagonized.
• If the patient responds to Kloxxado and subsequently relapses back into respiratory depression before emergency assistance arrives, administer an additional dose using a new Kloxxado, in the opposite nostril, and continue surveillance of the patient.
• Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
• Reversal of respiratory depression by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete and require repeated administration of Kloxxado using a new nasal spray.

• Available data from retrospective cohort studies on naloxone use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• Naloxone may precipitate opioid withdrawal in the pregnant woman and fetus.
• There is no information regarding the presence of naloxone in human milk, the effects of naloxone on the breastfed infant or on milk production.
• Studies in nursing mothers have shown that naloxone does not affect prolactin or oxytocin hormone levels.
• Naloxone is minimally orally available and is unlikely to affect the breastfed infant.