WARNING

Abstral, a brand name for the generic drug fentanyl, is a powerful opioid pain medication typically prescribed for managing severe pain in cancer patients who are already tolerant to other opioid treatments. While effective for pain relief, Abstral carries significant risks:

• Addiction and Dependence: Fentanyl is highly addictive, and even prescribed use can lead to physical dependence. Misuse can quickly lead to addiction.
• Respiratory Depression: One of the most dangerous side effects is respiratory depression, where breathing becomes slow or stops entirely. This is particularly risky if the drug is taken in higher doses than prescribed or combined with other depressants like alcohol or sedatives.
• Overdose Risk: Due to its potency, there is a high risk of overdose, which can be fatal. Signs of overdose include extreme drowsiness, slow or stopped breathing, and loss of consciousness.
• Interactions with Other Drugs: Abstral can interact with various other medications, increasing the risk of severe side effects or overdose. This includes other opioids, sedatives, and certain antidepressants.
• Withdrawal Symptoms: If the drug is discontinued abruptly, it can cause severe withdrawal symptoms, including anxiety, sweating, nausea, and muscle pain.
• Side Effects: Common side effects include nausea, vomiting, constipation, drowsiness, and dizziness. Serious side effects include severe allergic reactions, extreme drowsiness, or confusion.

Given these risks, Abstral should only be used under strict medical supervision, and patients should follow their healthcare provider’s instructions carefully.

Why is this medication prescribed?

Abstral (fentanyl) is prescribed primarily for the management of breakthrough pain in cancer patients who are already receiving, and are tolerant to, other opioid therapy for their persistent cancer pain. Breakthrough pain is a sudden, intense flare-up of pain that occurs even though a patient is regularly taking pain medication.

Fentanyl, the active ingredient in Abstral, is a potent synthetic opioid that works quickly to alleviate severe pain. Because of its strength and rapid action, Abstral is particularly effective in controlling the sudden episodes of pain that cannot be managed by long-acting opioids alone.

How should this medicine be used?

Using Abstral requires strict adherence to medical instructions due to its potency and associated risks. Here’s how it should be used:

• Initial Dose: The initial dose is determined by your healthcare provider, based on your current opioid regimen and tolerance. Abstral is only for patients who are already opioid-tolerant.
• Administration: Abstral is taken sublingually, meaning it is placed under the tongue to dissolve completely. Do not chew, suck, or swallow the tablet, as this can affect its absorption and effectiveness. Avoid eating or drinking anything until the tablet has fully dissolved.
• Timing: Use Abstral at the onset of a breakthrough pain episode. Do not use more than two doses per breakthrough pain episode. Wait at least 2 hours before treating another episode with Abstral.
• Dose Adjustments: Your doctor may adjust your dose based on your response to the medication and the frequency of breakthrough pain episodes. Do not change your dose without consulting your healthcare provider.
• Monitoring: Regular follow-up with your healthcare provider is essential to monitor for effectiveness, side effects, and potential signs of misuse or overdose.
• Storage and Handling: Keep Abstral in a safe place, out of reach of children and pets, as accidental ingestion can be fatal. Dispose of unused tablets properly, according to your healthcare provider’s instructions.
• Avoid Combining with Other Depressants: Do not mix Abstral with alcohol, sedatives, or other CNS depressants, as this can increase the risk of severe side effects, including respiratory depression.

Because of its strength and the risks associated with opioid use, Abstral should be used exactly as prescribed and under close supervision by a healthcare provider

Other uses for this medicine

• Severe Chronic Pain: In some cases, for patients with non-cancer-related chronic pain who have become opioid-tolerant, Abstral might be used off-label, though this is less common.
• Post-Surgical Pain: It could be used in specific cases where other pain management strategies are ineffective, but this is rare and typically done in a closely monitored medical setting.

What special precautions should I follow?

When using Abstral, consider the following precautions:

• Inform Your Doctor: Provide a full medical history, especially if you have breathing problems (such as asthma or COPD), brain disorders (like head injury or seizures), heart problems, liver or kidney disease, mental/mood disorders (such as depression or anxiety), or a history of substance use disorder.
• Avoid Certain Activities: Avoid driving, operating heavy machinery, or engaging in any activities that require full alertness until you know how Abstral affects you. It can cause drowsiness and dizziness.
• Do Not Use if Not Opioid-Tolerant: Abstral should only be used by patients who are already taking and are tolerant to regular opioid pain medication. Using it without tolerance significantly increases the risk of fatal respiratory depression.
• Avoid Alcohol and Other CNS Depressants: Alcohol and other central nervous system (CNS) depressants can enhance the sedative effects of Abstral, increasing the risk of severe drowsiness, respiratory depression, coma, or death.
• Proper Use and Dosing: Take Abstral exactly as prescribed. Do not take more frequent doses, or in larger amounts, as this can lead to overdose. Never share Abstral with others, especially with someone who has a history of substance use disorder, as it can be fatal.
• Storage and Disposal: Store Abstral in a secure place out of reach of others, particularly children and pets. Accidental ingestion can be fatal. Dispose of unused tablets properly, following your healthcare provider’s or pharmacist’s instructions to prevent misuse.
• Recognize Overdose Symptoms: Be aware of symptoms of overdose, which include severe drowsiness, slow or difficult breathing, and unresponsiveness. Seek emergency medical help immediately if you or someone else experiences these symptoms.
• Inform Healthcare Providers: If you need surgery or dental work, inform the surgeon or dentist that you are using Abstral.
• Avoid Sudden Discontinuation: Do not stop using Abstral suddenly without consulting your healthcare provider, as this can cause withdrawal symptoms. Your doctor may gradually reduce your dose.

By following these precautions and closely monitoring your response to the medication, the risks associated with Abstral can be managed effectively under the supervision of your healthcare provider.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with taking Abstral. However, you should follow general best practices:

• Avoid Alcohol: Since alcohol can increase the risk of severe side effects, avoid consuming alcoholic beverages while using Abstral.
• Hydration and Fiber: Opioids like Abstral can cause constipation, so it’s helpful to stay well-hydrated and include sufficient fiber in your diet to prevent this side effect.

What should I do if I forget a dose?

• Breakthrough Pain: Abstral is used on an “as-needed” basis for breakthrough pain, so there isn’t a regular dosing schedule.
• Missed Dose: If you miss a dose for a breakthrough pain episode, do not double up or take an extra dose to make up for it. Instead, take your next dose as soon as you experience another episode of breakthrough pain, ensuring at least 2 hours have passed since your last dose.

What side effects can this medication cause?

Abstral (fentanyl) can cause a range of side effects, some of which may be serious. It’s important to be aware of these potential effects and consult your healthcare provider if you experience any unusual symptoms.

Common Side Effects:  These are the more typical side effects that some patients may experience:

• Nausea and Vomiting
• Constipation
• Drowsiness or Sedation
• Dizziness or Lightheadedness
• Headache
• Dry Mouth
• Sweating
• Fatigue or Weakness

Serious Side Effects: While less common, some side effects can be severe and require immediate medical attention:

• Respiratory Depression: Slow, shallow, or difficult breathing. This is one of the most serious risks associated with fentanyl use and can be life-threatening.
• Severe Allergic Reactions: Symptoms may include rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, or trouble breathing.
• Low Blood Pressure: This can cause symptoms like fainting, dizziness, or lightheadedness, particularly when standing up quickly.
• Bradycardia: A slow heart rate, which may cause fatigue, dizziness, or fainting.
• Confusion or Hallucinations: Experiencing unusual thoughts, agitation, or seeing or hearing things that aren’t there.
• Muscle Rigidity: Stiffness or difficulty moving.
• Seizures: Rare but serious, especially if you have a history of seizure disorders.
• Severe Constipation: This can lead to a blockage in the intestines, which might require medical treatment.

Long-Term Side Effects and Risks:

• Dependence and Addiction: Prolonged use of fentanyl can lead to physical dependence and addiction, even when taken as prescribed.
• Hormonal Imbalance: Long-term opioid use can lead to hormonal imbalances, including decreased sex hormones, which might affect libido and fertility.
• Immune System Suppression: Chronic use of opioids like fentanyl can weaken the immune system, making you more susceptible to infections.

Overdose Symptoms: An overdose of Abstral is a medical emergency. Symptoms of overdose include:

• Extreme Drowsiness or Unconsciousness
• Slow or Stopped Breathing
• Cold, Clammy Skin
• Blue-Colored Lips or Fingernails
• Weak or No Pulse

If you suspect an overdose, seek emergency medical help immediately.

If you experience any severe or persistent side effects, contact your healthcare provider right away. It’s essential to use Abstral under close medical supervision to minimize the risk of side effects and ensure safe use.

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

Storage and Disposal of Abstral

Storage:

• Keep Secure: Store Abstral in a secure place, out of reach of children, pets, and anyone who should not have access to it. Given the risk of misuse, it’s essential to keep it in a locked cabinet or drawer.
• Room Temperature: Store Abstral at room temperature, away from excessive heat, moisture, and light. Do not store it in the bathroom.
• Keep in Original Packaging: Store Abstral in its original packaging until you are ready to use it. This helps protect the medication from exposure to air and moisture, and ensures that it is taken correctly.

Disposal:

• Unused Medication: If you have unused or expired Abstral tablets, follow your healthcare provider’s instructions for disposal. Do not keep unused medication “just in case.”
• FDA Guidelines: The FDA recommends flushing fentanyl products like Abstral down the toilet as a disposal method if a drug take-back program is not available. This helps prevent accidental ingestion or misuse.
• Drug Take-Back Programs: If available, use a community drug take-back program for safe disposal. Many pharmacies and local law enforcement agencies offer these services.

In case of emergency/overdose

An Abstral overdose is a medical emergency. Symptoms of overdose include:

• Severe Drowsiness or Unresponsiveness
• Slow, Shallow, or Stopped Breathing
• Cold, Clammy Skin
• Bluish Tint to Lips or Fingernails
• Weak or No Pulse

Immediate Actions:

• Call Emergency Services: Dial 911 or your local emergency number immediately.
• Administer Naloxone: If available, administer naloxone (Narcan), a medication that can temporarily reverse the effects of an opioid overdose. This can be administered by injection or as a nasal spray. Even if naloxone is used, emergency medical care is still essential.
• Stay with the Person: Try to keep the person awake and breathing. If they are unconscious, place them on their side to prevent choking, especially if they vomit.
• Provide CPR if Necessary: If the person is not breathing, begin CPR if you are trained to do so, and continue until emergency medical personnel arrive.

What other information should I know?

• Follow-Up Care: Regularly see your healthcare provider to monitor your response to Abstral and discuss any side effects, potential dose adjustments, or the need for continuing the medication.
• Medication Interactions: Inform your doctor about all other medications, supplements, and over-the-counter drugs you are taking, as Abstral can interact with many substances, potentially causing dangerous effects.
• Allergy and Emergency Identification: Consider wearing a medical alert bracelet or carrying an ID card that states you are taking fentanyl. This can be crucial information for emergency responders.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks with your healthcare provider. Fentanyl can cause withdrawal symptoms in newborns and pass into breast milk, potentially harming a nursing baby.
• Tapering Off: If you need to stop taking Abstral, do not do so suddenly, as this can cause withdrawal symptoms. Your doctor will provide a tapering schedule to gradually reduce the dose safely.
• Support and Education: Educate your family or caregivers about the potential risks and signs of overdose, as well as how to administer naloxone if necessary.
• Stay Informed: Keep up to date with any new information regarding fentanyl use, potential risks, or updated guidelines from your healthcare provider or the FDA.

By carefully managing your use of Abstral, adhering to your healthcare provider’s instructions, and being aware of the risks, you can use this medication safely to manage breakthrough pai