Warnings & Recalls for Invega Sustenna
Black Box Warning for Invega Sustenna
Invega Sustenna has been issued a box warning due to the increased risk for death in elderly patients who used this medication and suffer from dementia. This medication is not approved for use in elderly patients who suffer from this condition.
FDA and Invega
In September of 2011, the FDA approved safety labeling changes involving a warning about the increased risk of
cardiovascular or
cerebrovascular problems such as high blood pressure, high levels of lipid, and weight gain.
Invega Sustenna and Pregnancy
Invega Sustenna is an FDA
pregnancy Category C medicine. Taking this drug during the
last three months of pregnancy may cause muscle spasms or withdrawal symptoms in the newborn. Invega Sustenna can pass through breast-milk and
should not be used while breastfeeding. Talk to your doctor before using Invega Sustenna if you are pregnant.
General Warnings
Invega Sustenna
should not be used by anyone who is allergic to the ingredients of the treatment or anyone with the following conditions:
- moderate or serious kidney problems or disorders
- heart rhythm disorders
- "Long QT Syndrome" (LQTS)
- anyone who is taking antiarrythmics, phenothiazine drugs, particular quinolone antibiotics, or tetrabenazine
Let your doctor know about your
medical history to be sure that you may safely use Invega Sustenna. Be sure to include information about any of the following you may have had:
- any allergies
- seizures or seizure-causing disorders
- heart disorders or disease, heart attack, or stroke
- problems with your blood vessels, low count of white blood cells, low blood volume, low potassium or magnesium levels
- high cholesterol or triglyceride levels
- high blood pressure or low blood pressure
- kidney or liver disease or disorders
- gastrointestinal issues, bowel or stomach problems or obstructions, trouble swallowing, if you are dehydrated or if you have persistent diarrhea
- diabetes or if you are obese
- any disease affecting the memory such as Alzheimer's disease or dementia
- Parkinson's disease
- any cancers or if you are prone to breast cancer
- if you have ever used a medicine similar to Invega Sustenna
Invega Sustenna may affect your blood sugar levels. Have your blood checked frequently to ensure that Invega Sustenna is working safely. Use extreme caution in patients who are younger than 18, it may not be safe for these patients to use Invega Sustenna. Elderly patients may have an increased sensitivity to the side effects of Invega Sustenna.
What to Avoid While Using Invega Sustenna
Do not drink
alcohol if you are receiving Invega Sustenna. Be aware that Invega Sustenna may cause dizziness and fatigue. Patients should avoid:
- any activity that requires alertness unless they are certain of their reaction to the medicine
- other sleep-inducing medicines
- standing up too quickly
- hot weather or activity that may cause your body temperature to raise to dangerous levels, you may become overheated
- anyone who is sick or has an infection. Invega Sustenna may decrease the ability of your immune system.
Invega Sustenna Interactions
Let your healthcare provider know about
all medicines you are using in order to avoid interactions. The following could affect your use of Invega Sustenna:
- arsenic
- anti-malaria drugs or antibiotics
- pain relievers
- transplant-rejection preventive medicines
- antihistamines
- Tardive Dyskinesia treatments
- medications for heartburn
- chemotherapy medicines
- drugs for preventing nausea
- medicines for controlling heart rhythm disorders, heart disease or
- high-blood pressure treatments
- anticholinergics
- other products containing paliperidone or risperidone
- carbamazepine or treatments for seizure-causing disorders
- dopamine receptor agonists or any antipsychotics
Invega Sustenna Treatment and Use
Invega Sustenna | paliperidone palmitate is an atypical antipsychotic marketed by Janssen Pharmaceutical Company for treating and reducing symptoms of schizophrenia, a mental illness characterized by symptoms of strange or disturbing thoughts, abnormal and strong emotions, and a decreased interest in living. Invega Sustenna may reduce side effects of schizophrenia including:
- hallucinations (seeing or hearing things that are not real)
- paranoia (unexplained fear or suspicion)
- delusional thoughts (not believing the truth or trusting what people say)
- a desire to be alone
Invega Sustenna is only for patients who can tolerate paliperidone and other similar medicines.
Invega Sustenna should not be used by elderly patients with dementia-related mental illnesses.
How Does Invega Sustenna Work?
It is not fully known how Invega Sustenna works. However, the medicine is thought to work by interfering with dopamine activity which is believed to be abnormally high in patients with schizophrenia. By balancing dopamine in the brain and blocking serotonin receptors, Invega Sustenna is believed to aid in decreasing symptoms of this condition.
Invega Sustenna Dosage
Invega Sustenna is given as an injection into a muscle (in the upper arm or buttocks) to be received once each month. Invega Sustenna is administered by a healthcare professional who will help you remember to receive your medicine. Be sure to keep all scheduled appointments and continue taking Invega Sustenna unless your doctor has instructed you to end your use of this treatment.
Dosage and treatment vary according to the patient’s medical condition.