INVEGA SUSTENNA(paliperidone palmitate) - America[美国药品]

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INVEGA SUSTENNA(paliperidone palmitate)

2016-09-10 09:09:42 来源: 作者: 【大中小】浏览:396次评论:0条

IMPORTANT SAFETY INFORMATION FOR INVEGA SUSTENNA
INVEGA SUSTENNA(paliperidone palmitate) is used for the treatment of schizophrenia.
INVEGA SUSTENNAis not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who
were given oral antipsychotics like INVEGA SUSTENNA in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.
Neuroleptic Malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEGA
SUSTENNA and similar medicines. Call the doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.
Tardive Dyskinesia (TD) is a rare, but serious and sometimes permanent side effect reported with INVEGA SUSTENNA and similar medicines.
Call your doctor right away if you start to develop twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the total dose received.
This condition can also develop after a short period of treatment at low doses but
this is less common. There is no known treatment for TD but it may go away partially or completely if the medicine is stopped.One risk of INVEGA SUSTENNA is that it may change your heart rhythm. This effect is potentially serious. You should talk to your
doctor about any current or past heart problems. Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).
High blood sugar and diabetes have been reported with INVEGA
SUSTENNA and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment.
The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or "pass urine" more often than usual, or feeling
weak or hungry.
Weight gain has been observed with INVEGA® SUSTENNA™ and other atypical antipsychotic medications. If you notice that you are gaining weight, please notify your doctor.
Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly.
It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the medicine.
INVEGA SUSTENNA and similar medicines have been associated with decreases in the counts of white cells in circulating blood.
If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.
INVEGA SUSTENNA and similar medicines can raise the blood levels of a hormone called prolactin and blood levels of prolactin remain high with continued use. This may result in some side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.
If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.
Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.
INVEGA SUSTENNA can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA SUSTENNA, be careful driving a car, operating machines, or doing things that require you to be alert.
This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.
Some medications interact with INVEGA® SUSTENNA™ Please inform your healthcare professional of any medications or supplements that you are taking.
INVEGA SUSTENNA should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.
Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with INVEGA SUSTENNA.
Do not drink alcohol while you are taking INVEGA SUSTENNA.In a study of people taking INVEGA® SUSTENNA, common side effects in the treatment of schizophrenia were reactions at the injection site, sleepiness, dizziness, feeling of inner restlessness, and abnormal muscle movements, including tremor (shaking), shuffling,
uncontrolled involuntary movements, and abnormal movements of the eyes.
This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.
If you have any questions about INVEGA SUSTENNA or your therapy, talk with your doctor.
INVEGA SUSTENNA Rx
Generic Name and Formulations:
Paliperidone (as palmitate) 39mg, 78mg, 117mg, 156mg, 234mg; ext-rel susp for IM inj.
Company:
Janssen Pharmaceuticals, Inc.

Select therapeutic use: Psychosis
Indications for INVEGA SUSTENNA:
Treatment of schizophrenia. Treatment of schizoaffective disorder as monotherapy or as an adjunct to mood stabilizers or antidepressants.

Adult:
Establish tolerability with oral paliperidone or oral risperidone prior to initiating. Give by deep deltoid IM inj, initially 234mg on Day 1, then 156mg one week later. Maintenance: Give by deep deltoid or gluteal IM inj once monthly. Schizophrenia: 117mg; may increase or decrease in the range of 39–234mg. Schizoaffective: usual range of 78–234mg. Both max: 234mg/month. Renal impairment: CrCl ≥50–<80mL/min: initially 156mg on Day 1, then 117mg one week later, then 78mg monthly; CrCl<50mL/min: not recommended. Missed doses or switching from other antipsychotics: see full labeling.

Children:
<18yrs: not established.

Contraindications:
Risperidone hypersensitivity.

Warnings/Precautions:
Elderly (not for dementia-related psychosis): increased risk of death. Avoid in congenital long QT syndrome, cardiac arrhythmias. Discontinue if neuroleptic malignant syndrome (NMS) occurs; consider discontinuing if tardive dyskinesia occurs. Diabetes risk factors (obtain baseline fasting blood sugar). Cardio- or cerebrovascular disease; risks may be increased due to metabolic changes (eg, hyperglycemia, dyslipidemia, weight gain); monitor. Pre-existing low WBCs or history of leukopenia/neutropenia; monitor CBCs during 1st few months of treatment; discontinue if WBCs decline. Monitor for signs/symptoms of infection; discontinue if severe neutropenia (ANC <1000mm3) occurs. Orthostatic hypotension. Parkinson's disease. Dementia with Lewy bodies. History of seizures. Patients at risk for aspiration pneumonia. Renal insufficiency. Severe hepatic impairment. Exposure to extreme temperatures. May have antiemetic effect. Suicidal patients. Reeva luate periodically. Neonates: risk of extrapyramidal and/or withdrawal symptoms post delivery (due to exposure during 3rd-trimester pregnancy). Pregnancy. Nursing mothers: not recommended.

Interactions:
Avoid drugs that prolong QT interval (eg, Class 1A and Class III antiarrhythmics, chlorpromazine, thioridazine, gatifloxacin, moxifloxacin). Caution with other CNS drugs, alcohol, drugs that may cause orthostatic hypotension. May antagonize levodopa, other dopamine agonists. Additive effects with concomitant risperidone or oral paliperidone for long-term use; caution. Concomitant strong CYP3A4 and/or P-gp inducers (eg, carbamazepine, rifampin, St. John's Wort): may need to increase Sustenna dose and decrease when inducers discontinued; avoid inducers with Trinza; if coadmin necessary, consider oral paliperidone ext-rel tabs.