Quillivant XR

Primary Use

Quillivant XR is a prescription medication used to treat Attention Deficit Hyperactivity Disorder (ADHD). It is a stimulant that helps increase attention and decrease impulsiveness and hyperactivity in people with this condition.

Target Population

This medication is approved for use in adults and children 6 years of age and older. Because it is an extended-release liquid, it is often prescribed for patients who have difficulty swallowing tablets or capsules.

Role in Therapy

Quillivant XR is intended to be part of a comprehensive treatment plan for ADHD. This plan may also include:

• Counseling or other psychological therapies.
• Educational interventions.
• Social behavioral therapy.

The medication is designed to release the active ingredient slowly throughout the day, providing consistent symptom management after a single morning dose.

Mechanism of Action

Quillivant XR belongs to a class of medications called central nervous system stimulants. While the exact way it works to treat Attention Deficit Hyperactivity Disorder (ADHD) is not fully understood, it is believed to change the balance of certain natural substances in the brain.

The medication primarily affects two chemicals called neurotransmitters:

• Dopamine: This chemical is involved in motivation, reward, and movement.
• Norepinephrine: This chemical helps the brain focus and respond to stimuli.

Quillivant XR works by blocking these chemicals from being reabsorbed by the nerve cells in the brain. By keeping more dopamine and norepinephrine available in the spaces between nerve cells, the medication helps improve focus and concentration while reducing impulsive behavior and hyperactivity.

Because this is an extended-release liquid formulation, the medication is designed to release the active ingredient slowly into the body. This allows for a steady effect over a longer period of time compared to immediate-release versions of the medication.

Common Side Effects

The most frequently reported side effects of Quillivant XR include:

• Loss of appetite and weight loss
• Difficulty falling asleep or staying asleep
• Nausea, vomiting, or stomach pain
• Dry mouth
• Dizziness
• Irritability, nervousness, or anxiety
• Increased heart rate and blood pressure

Serious Side Effects

Seek medical attention immediately if any of the following serious side effects occur:

• Heart problems: Chest pain, difficulty breathing, or fainting.
• Psychiatric issues: New or worsening aggressive behavior, hallucinations (seeing or hearing things that are not real), or paranoia.
• Circulatory problems: Numbness, pain, or skin color changes in the fingers or toes, often triggered by cold temperatures.
• Priapism: Painful or prolonged erections lasting more than four hours.
• Allergic reactions: Severe skin rash, itching, or swelling of the face and throat.

Long-term use in children may be associated with slowed growth (height and weight). Healthcare providers usually monitor growth progress regularly during treatment.

Boxed Warning: Abuse and Dependence

Quillivant XR is a federally controlled substance because it can be abused or lead to dependence. Healthcare providers typically assess the risk of abuse before prescribing and monitor for signs of misuse or addiction during treatment. Long-term use may lead to a substance use disorder.

Contraindications

This medication should not be used by individuals who are currently taking or have taken a monoamine oxidase inhibitor (MAOI) within the last 14 days. It is also contraindicated for those with a known hypersensitivity to methylphenidate or any other ingredients in the formulation.

Cardiovascular Risks

Serious heart-related problems have been reported with the use of stimulant medications, including:

• Sudden Death: This has occurred in children and adolescents with structural heart defects or other serious heart problems.
• Stroke and Heart Attack: These events have been reported in adults taking stimulant medications.
• Blood Pressure and Heart Rate: Quillivant XR can cause increases in blood pressure and heart rate. Healthcare providers usually monitor these vitals regularly during treatment.

Psychiatric Adverse Reactions

Stimulants may cause new or worsening psychiatric symptoms, even in patients without a prior history of these issues. These symptoms may include:

• Psychotic or manic symptoms, such as hallucinations, delusional thinking, or mania.
• Increased aggression, hostility, or anxiety.
• Worsening of pre-existing psychosis or bipolar disorder.

Circulatory Problems

Patients may experience circulation problems in their fingers and toes, a condition known as peripheral vasculopathy or Raynaud's phenomenon. Symptoms can include numbness, feeling cold, or skin color changes from pale to blue or red.

Additional Precautions

• Priapism: Painful and prolonged erections (priapism) have been reported with methylphenidate products. This is a medical emergency that requires immediate treatment to prevent permanent damage.
• Growth Suppression: Long-term use of stimulants in children may lead to a temporary slowing of growth. Healthcare providers typically monitor height and weight during treatment.
• Seizures: There is some evidence that stimulants may lower the seizure threshold in patients with a history of seizures.
• Visual Disturbance: Some patients may experience blurred vision or difficulties with eye focus.

Pregnancy

There is limited information regarding the safety of Quillivant XR in pregnant women. Healthcare providers generally recommend using this medication during pregnancy only if the potential benefit to the mother outweighs the potential risk to the developing fetus. Some studies have investigated whether methylphenidate increases the risk of heart-related birth defects, but the evidence remains limited and inconclusive.

Individuals who are pregnant or planning to become pregnant should consult their healthcare provider to discuss the risks and benefits of continuing treatment. There is a pregnancy registry that monitors outcomes for people who take ADHD medications during pregnancy to help researchers better understand any potential risks.

Breastfeeding

Methylphenidate, the active ingredient in Quillivant XR, is known to pass into breast milk. It is important to discuss the risks and benefits of breastfeeding while taking this medication with a healthcare professional. If a mother chooses to breastfeed while taking Quillivant XR, the infant should be closely monitored for potential side effects, such as:

• Agitation or irritability
• Difficulty sleeping
• Poor weight gain or feeding problems

A healthcare provider can help determine whether to continue breastfeeding or adjust the medication based on the needs of both the mother and the infant.

Available Forms

Quillivant XR is provided in the following form:

• Extended-release oral suspension: This medication is supplied as a powder. A pharmacist adds water to the powder to create a liquid suspension before it is dispensed to the patient.

The extended-release liquid is designed to release the medication over a prolonged period after ingestion.

FDA Approval and Indication

Quillivant XR was approved by the U.S. Food and Drug Administration (FDA) in September 2012. It is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. It was the first liquid extended-release methylphenidate formulation to receive FDA approval for this condition.

Boxed Warning

The FDA requires a Boxed Warning for Quillivant XR because methylphenidate has a high potential for abuse and dependence. Healthcare providers are instructed to assess the risk of abuse before prescribing the medication and to monitor patients for signs of misuse and dependence during treatment.

Controlled Substance Status

Quillivant XR is classified as a Schedule II (CII) controlled substance by the Drug Enforcement Administration (DEA). This classification is due to the medication's high potential for abuse, which may lead to severe psychological or physical dependence. Because of this status, there are strict regulatory requirements for prescribing and dispensing the drug, including limitations on refills.

Pediatric Safety Monitoring

The FDA conducts ongoing safety reviews of methylphenidate products, including pediatric safety reviews presented to advisory committees. These reviews monitor for potential adverse events such as cardiovascular issues and psychiatric symptoms to ensure the continued safety of the medication in children and adolescents.

Appetite and Weight Changes

Weight loss is a frequently reported side effect for individuals taking Quillivant XR. This occurs primarily because the medication can significantly decrease appetite, leading to lower caloric intake.

Impact on Children and Adolescents

In pediatric patients, the use of stimulants like Quillivant XR may be associated with a temporary slowing in growth rate, including both weight gain and height. Because of this, doctors usually perform the following checks during treatment:

• Regularly monitoring weight and height.
• Assessing growth patterns against standard charts.
• Adjusting the treatment plan if growth or weight gain is not as expected.

Managing Weight Loss

If weight loss becomes a concern, a healthcare provider may suggest strategies to ensure adequate nutrition. These might include:

• Eating larger meals at times when the medication effects are lower, such as breakfast before the morning dose or a late evening snack.
• Choosing nutrient-dense foods.
• Discussing the possibility of a treatment break under medical supervision if growth is significantly impacted.

It is important to contact a healthcare provider if weight loss is significant or if a child does not seem to be growing or gaining weight at a normal rate while taking this medication.