WARNING
Onsolis is a prescription medication that contains the active ingredient fentanyl, which belongs to a class of drugs known as opioid analgesics. While it can effectively manage severe pain, it also carries several risks and potential side effects that need to be considered. Here are some of the risks associated with taking Onsolis:
- Respiratory depression: Onsolis, like other opioids, can slow down your breathing. This effect can be particularly dangerous, leading to a decreased oxygen supply to the brain and other vital organs. In extreme cases, it can even cause respiratory arrest, which is life-threatening.
- Addiction and dependence: Opioids have a high potential for abuse, and using Onsolis can lead to addiction or dependence. Prolonged use of opioids may result in tolerance, meaning higher doses are needed to achieve the same level of pain relief. Suddenly stopping the medication can cause withdrawal symptoms.
- Sedation and drowsiness: Onsolis can cause drowsiness, sedation, and impaired cognitive function. It may affect your ability to drive or operate machinery safely. It is important to avoid activities that require alertness until you know how Onsolis affects you.
- Hypotension: Onsolis can cause low blood pressure, which may lead to dizziness, lightheadedness, or fainting. This risk is higher when you first start taking the medication or if the dose is increased.
- Constipation: Opioids commonly cause constipation, which can be managed with appropriate measures and medications. However, it is important to address this side effect to prevent complications.
- Interactions with other substances: Onsolis should not be taken with certain medications, especially other central nervous system depressants such as benzodiazepines, alcohol, or certain antidepressants. Combining these substances can increase the risk of sedation, respiratory depression, and even overdose.
- Accidental exposure: Onsolis should be stored securely, as accidental exposure to the medication can be fatal, especially for children or pets.
It is essential to use Onsolis exactly as prescribed by your healthcare provider and to follow all safety precautions. Discuss any concerns or potential risks with your doctor before starting this medication.
Why is this medication prescribed?
Onsolis is prescribed for the management of breakthrough pain in opioid-tolerant adult cancer patients. Breakthrough pain refers to episodes of severe pain that “break through” the regular pain management regimen. It is intended for use in patients who are already taking, and tolerant to, around-the-clock opioid therapy for their underlying persistent cancer pain.
The primary active ingredient in Onsolis is fentanyl, a potent opioid analgesic. Fentanyl works by binding to opioid receptors in the brain and other parts of the body, reducing the perception of pain.
How should this medicine be used?
Here are the general guidelines for using Onsolis:
- Prescription and dosing: Onsolis should be prescribed by a healthcare professional experienced in the use of potent opioids. The starting dose is determined based on the patient’s current opioid regimen and their breakthrough pain intensity. The dose should be individualized and titrated carefully for optimal pain relief.
- Administration: Onsolis comes in the form of a buccal soluble film, which is placed on the inner lining of the cheek, where it dissolves and releases the medication. It should not be swallowed or chewed. The film should be applied to a clean, dry buccal area and allowed to dissolve completely. The film should not be cut or torn.
- Timing of administration: Onsolis is used only when needed for episodes of breakthrough pain. It should be used as soon as the pain begins, but at least 15 minutes before or after consuming any food or beverage. Multiple episodes of breakthrough pain can be treated, but only one film should be used per episode.
- Follow-up and dose adjustment: The effectiveness and safety of Onsolis should be regularly assessed by the prescribing healthcare professional. The dose may need adjustment based on the patient’s response to treatment.
It is crucial to carefully read and follow the instructions provided with Onsolis, as well as consult with your healthcare provider for personalized guidance. Additionally, it is important to note that Onsolis is intended for use in cancer patients who are already on around-the-clock opioid therapy and should not be used in opioid-naïve individuals or for acute or postoperative pain.
Other uses for this medicine
Onsolis is specifically indicated for the management of breakthrough pain in opioid-tolerant adult cancer patients. Its use in other situations or for other types of pain is not recommended. The medication is designed to be used as part of a comprehensive pain management plan in individuals who are already receiving and tolerant to around-the-clock opioid therapy for their underlying persistent cancer pain.
What special precautions should I follow?
Regarding special precautions with Onsolis, here are some important considerations:
- Opioid tolerance: Onsolis is only suitable for patients who are already receiving and tolerant to opioids on a regular basis. It should not be used in individuals who have not been previously exposed to opioids, as they may be at an increased risk of severe respiratory depression.
- Respiratory depression: Onsolis, like other opioids, can cause respiratory depression, which can be life-threatening. It should be used with caution in patients with compromised respiratory function, such as those with respiratory insufficiency, asthma, or chronic obstructive pulmonary disease (COPD).
- Abuse potential and addiction: Onsolis is a Schedule II controlled substance due to its high potential for abuse and addiction. It should be used exactly as prescribed by a healthcare professional, and the patient’s history of substance abuse or addiction should be carefully evaluated before starting treatment.
- Drug interactions: Onsolis can interact with other medications, particularly central nervous system depressants such as benzodiazepines, sedatives, tranquilizers, or alcohol. Combining these substances can increase the risk of sedation, respiratory depression, and even overdose. It is important to inform your healthcare provider about all medications you are taking.
- Accidental exposure: Onsolis should be stored securely and out of reach of children and pets. Accidental exposure to even a single dose of the medication can be fatal, especially in individuals who are not tolerant to opioids.
- Withdrawal and dependence: Prolonged use of Onsolis can lead to physical dependence and withdrawal symptoms when the medication is discontinued. The dose should be gradually tapered under medical supervision when discontinuing the treatment.
These are some of the key precautions associated with Onsolis. It is essential to discuss your medical history, current medications, and any concerns with your healthcare provider before starting or adjusting the use of Onsolis.
What special dietary instructions should I follow?
There are no specific dietary instructions associated with Onsolis. However, it is generally recommended to follow a balanced and healthy diet while taking any medication. Maintaining good nutrition can support overall health and well-being, which may contribute to better pain management.
What should I do if I forget a dose?
If you forget a dose of Onsolis, follow these general guidelines:
- Timing: Take the missed dose as soon as you remember, unless it is almost time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule.
- Do not double dose: Do not take a double dose to make up for the missed one. Taking more than the prescribed amount of Onsolis can increase the risk of side effects and complications.
- Consult your healthcare provider: If you are unsure about what to do or have any concerns, it is best to contact your healthcare provider for guidance. They can provide specific instructions based on your individual situation.
What side effects can this medication cause?
Onsolis (fentanyl) can cause several side effects, ranging from common and relatively mild to potentially serious adverse reactions. It is important to note that not all individuals will experience these side effects, and their severity and frequency can vary. Here are some of the possible side effects associated with Onsolis:
- Common side effects:
- Nausea
- Vomiting
- Constipation
- Dizziness
- Sleepiness or drowsiness
- Headache
- Fatigue
- Weakness
- Sweating
- Less common side effects:
- Dry mouth
- Diarrhea
- Abdominal pain
- Loss of appetite
- Anxiety
- Confusion
- Depression
- Hallucinations
- Itching or rash
- Difficulty urinating
- Serious side effects (Rare, but can be potentially life-threatening):
- Respiratory depression (slow or shallow breathing)
- Respiratory arrest (breathing stops)
- Hypotension (low blood pressure)
- Allergic reactions (e.g., hives, swelling, difficulty breathing)
- Adrenal insufficiency (symptoms can include weakness, fatigue, weight loss, low blood pressure)
It is important to seek immediate medical attention if you experience severe or concerning side effects, especially those related to respiratory depression or allergic reactions.
This is not an exhaustive list of side effects, and other rare or unexpected reactions may occur. It is recommended to consult your healthcare provider for a comprehensive understanding of potential side effects and to discuss any concerns you may have while taking Onsolis.
What should I know about storage and disposal of this medication?
- Storage: Onsolis should be stored securely in a safe place, out of the reach of children and pets. It should be stored at room temperature, away from excessive heat, moisture, and direct sunlight.
- Disposal: Unused or expired Onsolis should be disposed of properly to prevent accidental ingestion or misuse. The U.S. Food and Drug Administration (FDA) provides guidelines for safe medication disposal, including using drug take-back programs, if available. If specific instructions are not available, the medication can be mixed with an undesirable substance (e.g., coffee grounds or kitty litter) in a sealed bag and disposed of in the household trash. It is important to follow local regulations and guidelines for medication disposal.
In case of emergency/overdose
- Emergency assistance: In the event of an emergency or suspected overdose, immediately call emergency services (e.g., 911 in the United States) for assistance.
- Overdose symptoms: Signs of an overdose may include severe respiratory depression (slow or shallow breathing), extreme sedation, confusion, pinpoint pupils, muscle weakness, or loss of consciousness.
- Inform healthcare professionals: It is important to inform the medical professionals responding to the emergency about the suspected Onsolis overdose, providing them with all relevant information about the medication and the situation.
What other information should I know?
- Regular follow-ups: Onsolis should be used under the supervision of a healthcare provider experienced in opioid therapy. Regular follow-up appointments should be scheduled to monitor the effectiveness of the medication, adjust the dose if necessary, and assess for any potential side effects or concerns.
- Avoid alcohol and certain medications: It is important to avoid alcohol consumption while taking Onsolis, as it can increase the risk of sedation and respiratory depression. Additionally, inform your healthcare provider about all medications (including over-the-counter drugs, herbal supplements, and other prescription medications) you are taking, as certain medications can interact with Onsolis and increase the risk of side effects or reduce its effectiveness.
- Driving and operating machinery: Onsolis can cause drowsiness, sedation, and impaired cognitive function. It is important to avoid driving, operating machinery, or engaging in activities that require alertness until you know how Onsolis affects you.
- Pregnancy and breastfeeding: Onsolis is not recommended for use during pregnancy as it can cause harm to the unborn baby. It is also advised to avoid Onsolis while breastfeeding, as fentanyl can pass into breast milk and may cause harm to the nursing infant. Consult with your healthcare provider for guidance if you are pregnant, planning to become pregnant, or breastfeeding.
It is crucial to carefully follow the instructions provided by your healthcare provider and the medication’s packaging, as well as seek professional medical advice for specific concerns or questions related to Onsolis.
