Invega Sustenna

The active ingredient in Invega Sustenna is paliperidone palmitate. It belongs to a class of medications known as atypical antipsychotics or second-generation antipsychotics (SGAs). It works to rebalance dopamine and serotonin to improve thinking, mood, and behavior.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Invega Sustenna. However, the following is a synopsis of the general guidelines for the use of Invega Sustenna:

• Take this medication exactly as directed by your physician.
• Invega Sustenna is a long-acting injection that is given into the muscle (IM) by your healthcare provider. They will determine your dose based on how you respond to the medication.
• Avoid the use of alcohol while being treated with Invega Sustenna.

The most common side effects of Invega Sustenna seen in clinical trials include:

• Fast heart rate (tachycardia).
• Restlessness (akathisia).
• Sleepiness or drowsiness.
• Parkinsonism.
• Weight gain.
• Upset stomach.
• Anxiety.
• Constipation.
• Injection site reactions.
• Extrapyramidal symptoms.
• Muscle stiffness.
• Stuffy nose.
• Dry mouth.

Some individuals may experience serious side effects while using Invega Sustenna. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reaction - hives, itching, swelling, rash.
• Tardive dyskinesia - uncontrolled muscle movements.
• Neuroleptic malignant syndrome (NMS) - high fever, muscle stiffness, confusion, sweating, changes in heart rate and blood pressure.
• QT prolongation.
• Metabolic changes - hyperglycemia (high blood sugar), dyslipidemia, weight gain.
• Hyperprolactinemia (increased prolactin levels).
• Orthostatic hypotension and syncope.
• Leukopenia.
• Priapism.
• Seizures.
• Body temperature regulation.
• Cerebrovascular adverse reactions.
• Low white blood cell count - fever, chills, sore throat, cough, trouble breathing.

These are not all of the possible side effects of Invega Sustenna. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Invega Sustenna, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Heart rhythm problems (arrhythmia, long QT syndrome).
• Cholesterol or triglyceride problems.
• Lewy body dementia.
• Neuroleptic malignant syndrome (NMS).
• High or low blood pressure.
• Low white blood cell (WBC) count.
• Uncontrolled muscle movements in your face.
• Stomach or intestinal disorder.
• Liver or kidney disease.
• Seizures.
• Electrolyte imbalance.
• Diabetes.
• Breast cancer.

Boxed Warning

• Increased risk of death in elderly patients with dementia related psychosis.

• Previous hypersensitivity/allergic reaction to paliperidone or risperidone (Risperdal).

It will probably take several weeks to see big enough changes in your symptoms to decide if paliperidone is the right medication for you.

When Invega Sustenna is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Alcohol consumption.
• Use of illegal drugs.
• Carbamazepine.
• Parkinson’s disease medications (levodopa).
• Rifampin.
• St. John’s Wort.
• Medications that cause QT prolongation.
• Medication for high blood pressure.
• Anticholinergic medications.
• Medications that cause dizziness and sleepiness (prescription pain medicines, sleep medicines, medicines for anxiety).

Invega comes in a variety of dosage forms and formulations, including:

• Invega - extended-release oral tablet: 1.5 mg, 3 mg, 6 mg, 9 mg.
• Invega Sustenna - extended-release intramuscular suspension: 39 mg, 78 mg, 117 mg, 156 mg, 234 mg.
• Invega Trinza - extended-release intramuscular suspension: 273mg, 410mg, 546mg, 819mg.
• Invega Hafyera - extended-release intramuscular suspension: 1,092 mg, 1,560 mg.

Store this medication at room temperature and keep it out of reach of children.

Janssen Pharmaceuticals is the pharmaceutical company that manufactures Invega Sustenna.

There are no lower-cost generics available for the brand-name Invega Sustenna.

Do not stop or adjust your use of this medication without first consulting with your healthcare provider. Stopping this medication suddenly may cause new or worsening symptoms of schizophrenia or schizoaffective disorder.

Antipsychotic use during the third trimester of pregnancy has a risk for abnormal muscle movements (extrapyramidal symptoms) and/or withdrawal symptoms in newborns. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

This medication is known to pass into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.