Xtampza ER

Severe Chronic Pain Management

Xtampza ER is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment. It is used for chronic conditions where pain is persistent and requires a continuous level of medication in the bloodstream to remain controlled.

Criteria for Use

Because of the risks of addiction, abuse, and misuse, healthcare providers reserve Xtampza ER for patients for whom alternative treatment options are inadequate. These alternatives may include:

• Non-opioid pain relief medications.
• Immediate-release opioid medications.
• Non-pharmacological therapies.

Limitations of Use

Xtampza ER is an extended-release formulation and is not intended for all types of pain. Specific limitations include:

• It is not for use as an "as-needed" (PRN) pain reliever.
• It is not intended for acute pain, such as short-term pain from a minor injury or medical procedure, unless the patient is already receiving long-term opioid therapy.
• It is only used when around-the-clock treatment is necessary for an extended period of time.

Mechanism of Action

Xtampza ER contains oxycodone, a type of medicine known as an opioid agonist. It works by attaching to specific proteins called opioid receptors located in the brain, spinal cord, and other parts of the body. When the medicine binds to these receptors, it blocks pain signals and changes the way the body perceives and reacts to pain.

Extended-Release Delivery

This medication is designed for around-the-clock treatment of severe pain that cannot be managed by other treatments. Unlike immediate-release medications that work quickly and then wear off, Xtampza ER is formulated to release oxycodone gradually over approximately 12 hours. This slow release helps maintain a steady level of the drug in the bloodstream.

Formulation Design

The active ingredient in Xtampza ER is contained within many tiny microspheres. This specific formulation is intended to ensure that the medication continues to release slowly even if the capsule is opened and the contents are sprinkled onto soft food. This design helps prevent the sudden release of a large amount of medication at once.

Common Side Effects

The most frequently reported side effects of Xtampza ER include:

• Nausea and vomiting
• Constipation
• Drowsiness or sleepiness
• Dizziness
• Headache
• Itching
• Dry mouth
• Increased sweating

Serious Side Effects

Seek emergency medical help if you experience any of the following:

• Slowed, shallow, or difficult breathing
• Severe drowsiness or inability to wake up
• Fainting or extreme dizziness
• Chest pain or a fast, pounding heartbeat
• Seizures
• Signs of an allergic reaction, such as a rash, hives, or swelling of the face, lips, or throat

Adrenal Insufficiency: Long-term use of this medication may affect your adrenal glands. Symptoms can include persistent nausea, vomiting, loss of appetite, and unusual tiredness or weakness.

Serotonin Syndrome: This is a potentially life-threatening condition that may occur if Xtampza ER is used with certain other medications. Symptoms include agitation, hallucinations, fever, sweating, shivering, fast heart rate, and muscle twitching or stiffness.

Boxed Warnings

Xtampza ER has several boxed warnings, which are the most serious warnings issued by the FDA:

• Addiction, Abuse, and Misuse: Use of this medication can lead to opioid use disorder, which can result in overdose and death.
• Life-Threatening Respiratory Depression: Serious, life-threatening, or fatal breathing problems may occur. Risk is highest when starting the medication or following a dose increase.
• Accidental Ingestion: Accidental ingestion of even one dose, especially by children, can result in a fatal overdose of oxycodone.
• Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can cause life-threatening withdrawal symptoms in the newborn.
• Interactions with Other Drugs: Using Xtampza ER with benzodiazepines or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, or death.

Contraindications

Xtampza ER should not be used in patients with:

• Significant respiratory depression or acute or severe bronchial asthma in an unmonitored setting.
• Known or suspected gastrointestinal obstruction, including paralytic ileus.
• Hypersensitivity to oxycodone or any of the ingredients in the formulation.

Additional Precautions

Adrenal Insufficiency

Cases of adrenal insufficiency have been reported with opioid use, often after more than one month of use. Symptoms may include nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, and low blood pressure.

Severe Hypotension

Xtampza ER may cause a serious drop in blood pressure (hypotension), including orthostatic hypotension and fainting. This is more likely in patients whose ability to maintain blood pressure is already compromised.

Increased Intracranial Pressure

In patients who may be susceptible to the intracranial effects of CO2 retention, such as those with evidence of increased intracranial pressure or brain tumors, Xtampza ER may reduce respiratory drive and further increase pressure in the brain.

Gastrointestinal Conditions

The medication may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis. It may also increase the risk of seizures in patients with seizure disorders.

Withdrawal

Abruptly stopping the medication in a patient who is physically dependent may lead to serious withdrawal symptoms. Doses should be tapered gradually under medical supervision.

Pregnancy

Prolonged use of opioid medications like Xtampza ER during pregnancy can result in neonatal opioid withdrawal syndrome (NOWS). This condition occurs because the fetus can become physically dependent on the drug. After birth, the infant may require specialized medical treatment for withdrawal symptoms, which can be life-threatening if not managed correctly.

Symptoms of neonatal withdrawal may include:

• Irritability and excessive or high-pitched crying
• Tremors or seizures
• Difficulty feeding or vomiting
• Diarrhea and failure to gain weight

Using this medication near the time of delivery may also cause respiratory depression in the newborn, leading to slowed or shallow breathing. Medical professionals should be prepared to provide resuscitation or use reversal agents if needed.

Breastfeeding

The active ingredient in Xtampza ER, oxycodone, is excreted in human breast milk. This can lead to serious side effects in a nursing infant, such as extreme sleepiness, limpness, or breathing difficulties. If a person suddenly stops taking the medication while breastfeeding, the infant may also experience withdrawal symptoms.

Due to these risks, it is important to monitor breastfed infants for any unusual signs of sedation. Patients should discuss their options with a healthcare provider to determine the safest approach for both the parent and the child.

Dosage Forms

Xtampza ER is supplied as an oral extended-release capsule. The medication is formulated within microspheres inside the capsule to allow for a steady release over time.

Administration Methods

• Swallowing whole: The capsules are typically swallowed whole with enough water to ensure complete swallowing.
• Sprinkling on food: For patients who have difficulty swallowing, the capsules can be opened and the contents sprinkled onto soft foods such as applesauce, pudding, or yogurt.
• Feeding tubes: The contents of the opened capsules may also be administered through gastric or nasogastric feeding tubes.

FDA Approval and Indication

Xtampza ER was approved by the U.S. Food and Drug Administration (FDA) in 2016. It is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate. It is not intended for use as an as-needed analgesic.

Controlled Substance Status

The FDA classifies Xtampza ER as a Schedule II controlled substance. This classification indicates that the medication has a high potential for abuse, which may lead to severe psychological or physical dependence.

Boxed Warning and Safety Requirements

Xtampza ER carries a boxed warning, the FDA’s most serious warning, highlighting several critical risks:

• Addiction, Abuse, and Misuse: Use of this medication exposes users to the risks of opioid addiction and misuse, which can lead to overdose and death.
• Respiratory Depression: Serious, life-threatening, or fatal breathing problems may occur.
• Accidental Ingestion: Accidental ingestion of even one dose, especially by children, can result in a fatal overdose.
• Neonatal Opioid Withdrawal Syndrome: Prolonged use during pregnancy can result in life-threatening withdrawal symptoms in the newborn.
• Interactions with Other Depressants: Using opioids with benzodiazepines or other central nervous system depressants can cause profound sedation, respiratory depression, coma, and death.

REMS Program

To ensure the benefits of the medication outweigh the risks of misuse and abuse, Xtampza ER is part of the Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This program requires that healthcare providers are made aware of the risks and that patients receive education on the safe use of these products.

Abuse-Deterrent Labeling

The FDA has approved labeling for Xtampza ER that describes its abuse-deterrent properties. The medication is formulated to maintain its extended-release profile even if the capsules are crushed or chewed, which is intended to discourage common methods of manipulation for abuse, such as snorting or injection.

Withdrawal Risks

Physical dependence is a common occurrence with long-term use of Xtampza ER. If the medication is stopped suddenly or the dose is lowered too quickly, withdrawal symptoms may develop.

Common Withdrawal Symptoms

Symptoms of opioid withdrawal can include:

• Restlessness, anxiety, and irritability
• Muscle aches, backache, or joint pain
• Stomach cramps, nausea, vomiting, or diarrhea
• Insomnia or difficulty sleeping
• Increased heart rate, blood pressure, or respiratory rate
• Sweating, chills, or goose bumps
• Runny nose, watery eyes, or frequent yawning
• Dilated pupils and loss of appetite

Safe Tapering

To minimize the risk of withdrawal, healthcare providers typically recommend a gradual reduction in dosage rather than stopping the medication all at once. This process, known as tapering, allows the body to adjust slowly. The specific schedule for tapering depends on the individual's medical history and the duration of treatment.