WARNING

Fentanyl sublingual spray is a potent opioid medication used for managing severe pain, typically in cancer patients who are already tolerant to opioid therapy. However, like all opioids, it carries several risks:

• Respiratory Depression: Fentanyl can suppress breathing, especially if taken in high doses or with other central nervous system depressants like alcohol or benzodiazepines. This can lead to respiratory distress or even death.
• Addiction and Dependence: Fentanyl is highly addictive, and even when used as prescribed, it can lead to physical dependence and withdrawal symptoms upon cessation.
• Overdose: Due to its potency, it’s easier to overdose on fentanyl compared to other opioids. Accidental overdose can occur if the dose is miscalculated or if it’s taken by someone who is not tolerant to opioids.
• Tolerance and Reduced Effectiveness: With prolonged use, the body can develop tolerance to fentanyl, requiring higher doses to achieve the same pain-relieving effect. This can increase the risk of overdose and other complications.
• Drug Interactions: Fentanyl can interact with other medications, particularly other central nervous system depressants, increasing the risk of respiratory depression and other adverse effects.
• Misuse and Diversion: Fentanyl is sometimes misused recreationally or diverted for illicit purposes. Street versions of fentanyl can be much more potent than pharmaceutical-grade products, leading to a higher risk of overdose and death.
• Side Effects: Common side effects of fentanyl sublingual spray include nausea, vomiting, dizziness, sedation, constipation, and confusion. These side effects can be particularly problematic in older adults.

Due to these risks, fentanyl sublingual spray is typically prescribed cautiously, and patients are closely monitored by healthcare providers. It’s important to use it exactly as prescribed and to be aware of the signs of overdose or other adverse effects.

Why is this medication prescribed?

Fentanyl sublingual spray is prescribed for the management of breakthrough pain in cancer patients who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Breakthrough pain is characterized by sudden, intense episodes of pain that occur despite regular opioid therapy.

How should this medicine be used?

Here’s how fentanyl sublingual spray should be used:

• Dosage: The dosage of fentanyl sublingual spray is individualized based on the patient’s opioid tolerance and the severity of their breakthrough pain. It’s important to start with the lowest effective dose to minimize the risk of overdose.
• Administration: The medication is sprayed under the tongue (sublingually) and absorbed through the mucous membranes. It should not be swallowed. Patients should avoid eating or drinking for at least 5 minutes before and after administering the spray to ensure optimal absorption.
• Frequency: Fentanyl sublingual spray is typically used as needed for breakthrough pain episodes, with a minimum of 4 hours between doses. However, patients should not use more than 4 doses of fentanyl sublingual spray per day.
• Titration: The dose may need to be titrated based on the patient’s response to the medication. Healthcare providers will work closely with patients to find the appropriate dose that provides effective pain relief with manageable side effects.
• Monitoring: Patients using fentanyl sublingual spray should be closely monitored for signs of respiratory depression, sedation, and other opioid-related side effects. Dosage adjustments may be necessary based on these observations.
• Storage: Fentanyl sublingual spray should be stored at room temperature, away from moisture and heat. It should be kept out of reach of children and pets.
• Disposal: Unused or expired fentanyl sublingual spray should be disposed of properly according to local regulations. This usually involves returning the medication to a pharmacy or using a medication take-back program.

It’s crucial for patients to follow their healthcare provider’s instructions carefully when using fentanyl sublingual spray to minimize the risk of adverse effects and ensure safe and effective pain management.

Other uses for this medicine

Fentanyl sublingual spray is specifically approved for managing breakthrough cancer pain in patients who are already receiving and tolerant to opioid therapy for their underlying persistent cancer pain. It is not indicated for other uses, and using it for other conditions or in non-cancer patients can be extremely dangerous and potentially life-threatening due to its potency.

What special precautions should I follow?

Special precautions should be followed when using fentanyl sublingual spray:

• Patient Education: Patients should receive thorough education on the appropriate use of fentanyl sublingual spray, including proper administration techniques, dosing instructions, and potential side effects. They should also be informed about the risks of respiratory depression, addiction, and overdose associated with opioid medications.
• Opioid Tolerance: Fentanyl sublingual spray should only be used in patients who are already receiving and tolerant to opioid therapy for their underlying persistent cancer pain. It is not intended for opioid-naive patients or those with acute or postoperative pain.
• Individualized Dosage: The dosage of fentanyl sublingual spray should be individualized based on the patient’s opioid tolerance and the severity of their breakthrough pain. Starting with the lowest effective dose and titrating slowly can help minimize the risk of overdose and adverse effects.
• Respiratory Monitoring: Patients using fentanyl sublingual spray should be closely monitored for signs of respiratory depression, particularly during initiation of therapy and dose adjustments. Respiratory rate and oxygen saturation should be monitored regularly.
• Avoid Alcohol and CNS Depressants: Patients should be advised to avoid alcohol and other central nervous system depressants (such as benzodiazepines, sedatives, and tranquilizers) while using fentanyl sublingual spray, as concomitant use can increase the risk of respiratory depression and overdose.
• Storage and Disposal: Fentanyl sublingual spray should be stored securely out of reach of children and pets. Unused or expired medication should be disposed of properly according to local regulations to prevent accidental ingestion or misuse.
• Emergency Response: Patients and caregivers should be educated on the signs of opioid overdose and instructed on how to respond in case of an emergency, including the use of naloxone (Narcan) to reverse opioid overdose.

It’s essential for patients to closely follow their healthcare provider’s instructions and to communicate any concerns or changes in symptoms while using fentanyl sublingual spray. Regular follow-up appointments with healthcare providers are also important to assess treatment effectiveness and safety.

What special dietary instructions should I follow?

Regarding special dietary instructions, there aren’t specific dietary restrictions associated with Fentanyl Sublingual Spray. However, it’s essential to follow your healthcare provider’s instructions regarding food and drink consumption around the time of administration to ensure optimal absorption.

What should I do if I forget a dose?

If you forget a dose of Fentanyl Sublingual Spray:

• If it’s close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule.
• Do not double the dose to make up for the missed one.
• If you’re unsure about what to do, contact your healthcare provider or pharmacist for guidance.

What side effects can this medication cause?

Fentanyl Sublingual Spray, like other opioid medications, can cause various side effects. Common side effects may include:

• Nausea and vomiting: These are among the most common side effects of opioid medications, including Fentanyl Sublingual Spray.
• Dizziness and drowsiness: Opioids can cause central nervous system depression, leading to feelings of dizziness and sedation.
• Constipation: Opioids often slow down the digestive system, which can result in constipation. It’s essential to manage this side effect through dietary changes, increased fluid intake, and, if necessary, the use of laxatives.
• Headache: Some individuals may experience headaches while taking Fentanyl Sublingual Spray.
• Dry mouth: Opioids can reduce saliva production, leading to a dry mouth sensation.
• Fatigue: Feeling tired or fatigued is a common side effect of opioid medications.
• Itching or rash: Some people may experience itching or develop a rash while using Fentanyl Sublingual Spray.
• Respiratory depression: This is a severe side effect where breathing becomes dangerously slow or shallow. It’s more likely to occur with higher doses of opioids or when combined with other medications that depress the central nervous system.
• Hypotension: Fentanyl Sublingual Spray can cause low blood pressure in some individuals.
• Confusion and cognitive impairment: Opioids can affect cognitive function, leading to confusion or difficulty concentrating.
• Urinary retention: Difficulty urinating may occur in some individuals.
• Sweating: Excessive sweating is another potential side effect of opioid medications.

It’s important to note that not everyone will experience these side effects, and some side effects may resolve as the body adjusts to the medication. However, if any side effects persist or worsen, it’s essential to contact a healthcare provider for further evaluation and management. Additionally, some side effects, such as respiratory depression, can be serious and require immediate medical attention.

What should I know about storage and disposal of this medication?

Storage and disposal of Fentanyl Sublingual Spray:

• Storage: Store Fentanyl Sublingual Spray at room temperature (approximately 20-25°C or 68-77°F) away from light and moisture. Keep it in a secure location out of reach of children and pets. Avoid storing it in the bathroom or kitchen where it could be exposed to moisture. Do not freeze the medication.
• Disposal: Dispose of unused or expired Fentanyl Sublingual Spray properly according to local regulations. Do not flush it down the toilet or pour it down the drain unless instructed to do so by your healthcare provider or pharmacist. Instead, consult with your pharmacist or local waste disposal facility for guidance on safe disposal methods.

In case of emergency/overdose

In case of emergency/overdose of Fentanyl Sublingual Spray:

• Recognize the Signs: Signs of a Fentanyl Sublingual Spray overdose include extreme drowsiness, difficulty breathing or shallow breathing, slow heart rate, loss of consciousness, and pinpoint pupils.
• Seek Immediate Medical Attention: If you suspect an overdose or encounter someone who may have overdosed on Fentanyl Sublingual Spray, call emergency services (e.g., 911 in the United States) immediately. Prompt medical intervention is crucial in managing opioid overdoses.
• Administer Naloxone: If available, administer naloxone (Narcan) according to the instructions provided with the medication. Naloxone is an opioid antagonist that can quickly reverse the effects of opioid overdose, including respiratory depression.
• Stay with the Person: Stay with the individual until emergency medical help arrives. Monitor their breathing and other vital signs, and be prepared to provide additional information to emergency responders.

What other information should I know?

• Avoid Alcohol and CNS Depressants: Do not consume alcohol or other central nervous system depressants while using Fentanyl Sublingual Spray, as they can increase the risk of respiratory depression and other adverse effects.
• Follow Healthcare Provider’s Instructions: Always follow your healthcare provider’s instructions regarding dosing, administration, and monitoring while using Fentanyl Sublingual Spray. Do not adjust the dosage or frequency of use without consulting your healthcare provider.
• Regular Follow-up: Attend all scheduled follow-up appointments with your healthcare provider to assess treatment effectiveness, monitor for potential side effects, and adjust the treatment plan as needed.
• Inform Healthcare Providers: Inform all healthcare providers involved in your care, including dentists and emergency room personnel, that you are using Fentanyl Sublingual Spray. This is important to prevent potential drug interactions and ensure appropriate treatment in case of emergencies.