Important Safety Information About NAYZILAM® (midazolam) Nasal Spray, CIV
NAYZILAM® is a prescription medication used for the short-term treatment of seizure clusters in patients 12 years and older. It’s crucial to understand the safety information associated with NAYZILAM, as it is a benzodiazepine and a controlled substance. This medication carries risks, but support is available through programs like the Ucb Cares Patient Assistance Program to help patients access necessary treatments.
Critical Safety Warnings: Risks of NAYZILAM
NAYZILAM, containing midazolam, a benzodiazepine, can cause serious side effects. It is vital to be aware of these risks before using this medication.
Combining NAYZILAM with Other Substances:
Taking benzodiazepines like NAYZILAM with opioid medicines, alcohol, or other central nervous system (CNS) depressants can lead to very dangerous conditions. These combinations can cause:
- Severe drowsiness
- Breathing problems (respiratory depression)
- Coma
- Death
Immediate Medical Help is Necessary: If you experience any of the following, seek emergency medical attention right away:
- Shallow or slowed breathing
- Breathing that stops
- Excessive sleepiness (sedation)
It is essential to understand how NAYZILAM affects you before driving or operating heavy machinery, especially if you are also taking opioids.
Risk of Abuse, Misuse, and Addiction:
Like all benzodiazepines, NAYZILAM has a risk of abuse, misuse, and addiction. This can lead to serious health consequences, including overdose, coma, and even death.
- Severe Side Effects from Misuse: Abusing or misusing benzodiazepines, including midazolam, has resulted in serious side effects such as coma and death. Other severe side effects include delirium, paranoia, suicidal thoughts or actions, seizures, and breathing difficulties. Seek immediate medical help if you experience any of these symptoms.
- Addiction Risk: You can become addicted to NAYZILAM even when using it as prescribed by your healthcare provider.
- Prescription Adherence: Always use NAYZILAM exactly as prescribed by your healthcare provider.
- Do Not Share: Never share NAYZILAM with anyone else.
- Safe Storage: Keep NAYZILAM in a secure place, out of reach of children.
Physical Dependence and Withdrawal Reactions:
Using NAYZILAM, especially daily use which is not recommended, can lead to physical dependence and withdrawal reactions. NAYZILAM is intended for short-term, intermittent use for seizure clusters, not daily prevention.
- Avoid Sudden Discontinuation: Do not stop using NAYZILAM suddenly without consulting your healthcare provider. Abruptly stopping NAYZILAM can cause severe and life-threatening side effects, including unusual movements, seizures, sudden mental changes, depression, hallucinations, increased activity, loss of reality, and suicidal thoughts. Seek immediate medical help if you experience these symptoms upon stopping NAYZILAM.
- Prolonged Withdrawal Symptoms: Some individuals who stop benzodiazepines suddenly may experience symptoms lasting weeks or even over a year. These can include anxiety, memory and concentration problems, depression, sleep issues, skin sensations, weakness, tremors, muscle twitching, burning sensations, and tinnitus.
- Understanding Dependence vs. Addiction: Physical dependence is different from addiction. Your healthcare provider can explain the distinction.
- Dosage Limits: Do not use more NAYZILAM than prescribed or more frequently than prescribed.
Effects on Alertness and Motor Skills:
NAYZILAM can cause drowsiness, dizziness, slowed thinking, and reduced motor skills.
- Avoid Hazardous Activities: Do not drive, operate machinery, or engage in dangerous activities until you know how NAYZILAM affects you.
- Alcohol and Other Depressants: Avoid alcohol and other drugs that cause sleepiness or dizziness while using NAYZILAM without consulting your healthcare provider, as they can worsen these effects.
Suicidal Thoughts or Actions:
Like other antiepileptic drugs, NAYZILAM may increase the risk of suicidal thoughts or actions in a small number of people (about 1 in 500).
Seek Immediate Medical Advice if you experience any of the following symptoms, especially if they are new, worsening, or concerning:
- Thoughts about suicide or dying
- Agitation or restlessness
- Aggressive, angry, or violent behavior
- Suicide attempts
- Panic attacks
- Acting on dangerous impulses
- New or worsening depression
- Trouble sleeping (insomnia)
- Extreme increase in activity and talking (mania)
- New or worsening anxiety
- New or worsening irritability
- Unusual changes in behavior or mood
Monitoring for Suicidal Thoughts and Actions:
- Be Vigilant for Changes: Pay close attention to any changes in mood, behavior, thoughts, or feelings, especially sudden changes.
- Keep Appointments: Attend all scheduled follow-up appointments with your healthcare provider.
- Communicate with Your Doctor: Contact your healthcare provider between visits if needed, especially if you have concerns about symptoms. Suicidal thoughts can have causes other than medication, and your healthcare provider can investigate other potential factors.
What is NAYZILAM Used For?
NAYZILAM is a prescription medicine used for the short-term treatment of seizure clusters (acute repetitive seizures) in patients 12 years of age and older. It is classified as a federally controlled substance (CIV) due to its midazolam content, which has the potential for abuse or dependence. It is crucial to store NAYZILAM securely to prevent misuse and abuse. Selling or giving away NAYZILAM is illegal and can be harmful. Inform your healthcare provider if you have a history of alcohol, prescription drug, or street drug abuse or dependence. The safety and effectiveness of NAYZILAM in children under 12 years have not been established.
When Should You Not Use NAYZILAM?
Do not use NAYZILAM if you:
- Are allergic to midazolam.
- Have acute narrow-angle glaucoma.
Before Using NAYZILAM, Inform Your Healthcare Provider About Your Medical History, Especially If You Have:
- History of depression, mood problems, or suicidal thoughts or behavior.
- Asthma, emphysema, bronchitis, COPD, or other breathing problems.
- Kidney or liver problems.
- Congestive heart failure.
- History of drug or alcohol abuse.
- Pregnancy or plans to become pregnant. NAYZILAM taken late in pregnancy may cause sedation or withdrawal symptoms in the newborn.
- Breastfeeding or plans to breastfeed. NAYZILAM can pass into breast milk and affect the baby.
Medication Interactions:
Inform your healthcare provider about all medications you are taking, including prescriptions, over-the-counter drugs, vitamins, and herbal supplements.
How to Use NAYZILAM:
- Nasal Use Only: NAYZILAM is administered in the nose only.
- Follow Instructions: Use NAYZILAM exactly as your healthcare provider instructs and follow the detailed “Instructions for Use.”
- Seizure Cluster Treatment: NAYZILAM is prescribed specifically to treat seizure clusters.
- Second Dose: If a seizure cluster continues 10 minutes after the first dose, a second dose may be administered in the other nostril if instructed by your healthcare provider.
- Dosage Limits: Do not administer more than two doses of NAYZILAM to treat a single seizure cluster.
- Emergency Medical Help: If seizures do not stop after NAYZILAM use, seek emergency medical help immediately.
- Frequency Limits: Do not use NAYZILAM for more than one seizure cluster episode every 3 days or for more than 5 episodes per month.
- Not for Daily Use: NAYZILAM is not intended for daily use.
- Overdose: In case of overdose, seek immediate medical attention.
What to Avoid While Using NAYZILAM:
Refer back to the section “What is the most important information I should know about NAYZILAM?”
Possible Side Effects of NAYZILAM:
NAYZILAM can cause serious side effects. Refer to “What is the most important information I should know about NAYZILAM?” for critical warnings.
- Increased Eye Pressure: NAYZILAM can increase eye pressure in people with acute narrow-angle glaucoma. See “Do not use NAYZILAM if you:”.
Common Side Effects: The most common side effects of NAYZILAM include:
- Sleepiness
- Headache
- Runny nose
- Nasal discomfort
- Throat irritation
This is not an exhaustive list of all possible side effects. Consult your doctor for medical advice about side effects. You are encouraged to report negative side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088. You can also contact UCBCares® at 1-844-599-CARE (1-844-599-2273).
Accessing Support: The UCB Cares Patient Assistance Program
Understanding the cost of medication can be a concern. UCB Cares® is a patient assistance program designed to help eligible patients access UCB medications, including NAYZILAM. If you are concerned about the affordability of NAYZILAM, the UCB Cares Patient Assistance Program may be able to provide support.
How UCB Cares Can Help:
The UCB Cares Patient Assistance Program aims to ensure that patients who need UCB medications can access them, regardless of their financial situation. The program may offer:
- Financial Assistance: Help with out-of-pocket costs for NAYZILAM.
- Co-pay Assistance: Support to lower your co-pays.
- Uninsured Patient Assistance: Medication at no cost for eligible uninsured patients.
Eligibility and Application:
Eligibility criteria for the UCB Cares program typically involve factors such as income level, insurance status, and medical need. To learn more about the specific eligibility requirements for NAYZILAM and to apply for assistance, you should:
- Visit the UCBCares Website: Look for the patient assistance program section on the official UCB website.
- Call UCBCares Directly: Contact UCBCares at 1-844-599-CARE (1-844-599-2273) to speak with a program representative who can guide you through the application process and answer your questions.
Taking Control of Your Treatment:
It’s important to have open conversations with your healthcare provider about both your treatment with NAYZILAM and any financial concerns you may have. Exploring resources like the UCB Cares Patient Assistance Program is a proactive step in managing your health and ensuring access to the medications you need.
Further Information:
For more detailed patient information, please refer to the Medication Guide available at Medication Guide. This information is not a substitute for talking with your healthcare provider about your condition or treatment. For more information about NAYZILAM, visit www.NAYZILAM.com or call 1-844-599-2273.
Please discuss any questions or concerns about NAYZILAM with your healthcare provider.
