Invega Sustenna

Approved Uses

Invega Sustenna is primarily used for the following conditions in adults:

• Schizophrenia: It is used to manage the symptoms of schizophrenia, a chronic mental health condition that can cause hallucinations, delusions, and disorganized thinking.
• Schizoaffective disorder: It is used to treat schizoaffective disorder, a condition characterized by symptoms of schizophrenia along with mood disorder symptoms, such as depression or mania. For this condition, it may be used as a standalone treatment or in combination with other medications, such as mood stabilizers or antidepressants.

Treatment Goals

As a long-acting injection administered by a healthcare professional, Invega Sustenna is designed to release medication slowly into the bloodstream over several weeks. This delivery method is often used to help maintain a consistent level of medicine in the body, which can help prevent the return of symptoms and reduce the risk of relapse or hospitalization. It is typically prescribed for long-term maintenance therapy rather than immediate relief of acute symptoms.

Mechanism of Action

Invega Sustenna contains the active ingredient paliperidone. It belongs to a class of drugs known as atypical antipsychotics. While the exact way it works is not fully understood, it is believed to help manage symptoms of schizophrenia and schizoaffective disorder by changing the activity of natural substances in the brain called neurotransmitters.

Specifically, paliperidone is thought to work by blocking receptors for two key chemicals:

• Dopamine: This chemical is involved in how the brain processes information and perceives reality. Overactivity of dopamine in certain brain pathways is linked to symptoms like hallucinations and delusions.
• Serotonin: This chemical helps regulate mood, behavior, and sleep.

By modulating the activity of these chemicals, the medication helps to stabilize mood and reduce the intensity of psychotic symptoms.

Extended-Release Delivery

Invega Sustenna is a long-acting injectable formulation. After it is injected into the muscle, the medication dissolves slowly into the bloodstream. This delivery method allows for a steady level of the drug to remain in the body for several weeks, providing continuous symptom control.

Common Side Effects

Common side effects of Invega Sustenna may include:

• Pain, swelling, or redness at the injection site
• Drowsiness or fatigue
• Dizziness
• Headache
• Weight gain
• Restlessness or an inability to sit still
• Muscle stiffness or tremors
• Dry mouth
• Nausea or stomach pain

Serious Side Effects

Some side effects can be serious and require immediate medical attention. Contact a healthcare provider right away if you experience:

• Uncontrolled movements: Twitching or repetitive movements of the face, tongue, or limbs (tardive dyskinesia).
• Neuroleptic Malignant Syndrome: High fever, stiff muscles, confusion, sweating, and irregular heartbeat.
• High blood sugar: Increased thirst, frequent urination, or extreme hunger.
• Hormonal changes: Breast enlargement, menstrual changes, or sexual dysfunction.
• Orthostatic hypotension: Dizziness or fainting when standing up quickly.
• Difficulty swallowing: Trouble moving food or liquid through the throat.
• Priapism: A painful erection lasting four hours or longer.
• Low white blood cell count: Signs of infection like fever or sore throat.
• Seizures: Sudden, uncontrolled electrical disturbances in the brain.

Boxed Warning: Increased Mortality in Elderly Patients with Dementia-Related Psychosis

Elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Invega Sustenna is not approved for the treatment of patients with dementia-related psychosis.

Cerebrovascular Adverse Reactions

In clinical trials, elderly patients with dementia experienced an increased risk of stroke and transient ischemic attacks, which can be fatal. This medication is not intended for use in this patient population.

Neuroleptic Malignant Syndrome (NMS)

NMS is a rare but potentially fatal condition associated with antipsychotic medications. Symptoms may include:

• High fever
• Muscle stiffness or rigidity
• Changes in mental status
• Irregular pulse or blood pressure
• Excessive sweating

Tardive Dyskinesia

The use of antipsychotics may lead to tardive dyskinesia, a condition involving involuntary, repetitive body movements, particularly of the face, tongue, or jaw. This condition may become permanent even after the medication is stopped. The risk is generally higher with long-term treatment and in elderly patients.

Metabolic Changes

Antipsychotic medications can cause significant metabolic changes, including:

• Hyperglycemia and Diabetes Mellitus: Severe cases of high blood sugar, sometimes leading to ketoacidosis or coma, have been reported. Regular monitoring of blood glucose is recommended.
• Dyslipidemia: Changes in cholesterol and triglyceride levels may occur during treatment.
• Weight Gain: Significant weight gain has been observed in patients receiving this treatment, and clinical monitoring of weight is advised.

Other Serious Precautions

• QT Prolongation: This medication may affect the heart's electrical rhythm. It should be avoided in combination with other drugs known to prolong the QT interval or in patients with certain heart rhythm disorders.
• Orthostatic Hypotension: Patients may experience a sudden drop in blood pressure when standing up, leading to dizziness or fainting, especially during the initial dose or dose increases.
• Blood Disorders: Leukopenia, neutropenia, and agranulocytosis (low white blood cell counts) have been reported. Patients with a history of low white blood cell counts should have their blood monitored frequently.
• Hyperprolactinemia: Elevated levels of prolactin may occur, potentially leading to menstrual irregularities, breast enlargement, or sexual dysfunction.
• Seizures: Caution is necessary for patients with a history of seizures or conditions that lower the seizure threshold.
• Priapism: Rare cases of painful, long-lasting erections have been reported and require immediate medical attention to prevent permanent tissue damage.
• Body Temperature Regulation: Antipsychotics may disrupt the body's ability to reduce core temperature. Caution is advised for patients experiencing strenuous exercise, extreme heat, or dehydration.

Pregnancy

The use of antipsychotic medications like Invega Sustenna during the third trimester of pregnancy may lead to complications in the newborn. These issues can include withdrawal symptoms or extrapyramidal symptoms, such as:

• Muscle stiffness or shakiness
• Drowsiness
• Breathing problems
• Difficulty feeding

If you become pregnant while using this medication, do not stop treatment without consulting your healthcare provider, as untreated mental health conditions can also pose risks. There is a pregnancy exposure registry that monitors the health of individuals and their babies who are exposed to antipsychotics during pregnancy.

Breastfeeding

Paliperidone, the active ingredient in Invega Sustenna, can pass into breast milk and may affect a nursing infant. Because of the potential for side effects in the baby, it is important to discuss the risks and benefits of breastfeeding while using this medication with a doctor. They can help determine the best course of action for both the parent and the child.

Dosage Forms

Invega Sustenna is supplied as an extended-release injectable suspension. It is provided in prefilled syringes for intramuscular use. This medication is administered by a healthcare professional as an injection into the muscle of the upper arm or the buttocks.

FDA Approval and Indications

The U.S. Food and Drug Administration (FDA) approved Invega Sustenna for the treatment of schizophrenia in adults in 2009. Its approved indications were later expanded to include the treatment of schizoaffective disorder in adults, either as a standalone treatment or as an add-on therapy to mood stabilizers or antidepressants.

Boxed Warning

Invega Sustenna carries a Boxed Warning, which is the FDA's most serious warning for medications. This warning states that elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk of death. Invega Sustenna is not approved for the treatment of patients with dementia-related psychosis.

Administration and Oversight

As a long-acting injectable medication, Invega Sustenna must be administered by a healthcare professional. It is not available for self-administration. While it is not classified as a controlled substance, the FDA requires specific labeling to monitor for serious side effects, including:

• Cerebrovascular adverse reactions, such as stroke, in elderly patients.
• Neuroleptic Malignant Syndrome (NMS), a rare but potentially fatal reaction.
• Tardive dyskinesia, a movement disorder that may become irreversible.
• Metabolic changes, including high blood sugar, increased cholesterol, and weight gain.

Factors Affecting Cost

The price of Invega Sustenna can vary significantly based on several factors. Because it is a long-acting injectable medication, the total cost often includes both the drug itself and the professional services required to administer it.

• Insurance Coverage: Your out-of-pocket expenses will depend on whether the medication is on your insurance plan's formulary and what tier it occupies. Medicare and Medicaid typically cover this medication, though specific costs vary by plan.
• Pharmacy and Location: Prices may differ between pharmacies. Some specialty pharmacies may be required to handle this type of medication.
• Administration Fees: Invega Sustenna must be injected by a healthcare professional. You may incur separate charges for the office visit or the administration of the shot.

Generic Availability

Invega Sustenna is currently available only as a brand-name medication. There is no generic version of this specific long-acting injectable formulation available at this time, which can contribute to a higher cost compared to older antipsychotic medications.

Financial Support Options

If you are concerned about the cost, there are often resources available to help:

• Manufacturer Programs: The drug manufacturer may offer savings cards or patient assistance programs for those who qualify based on insurance status or income.
• Government Assistance: Programs like Extra Help through Medicare can assist with prescription drug costs for eligible individuals.