Invega Sustenna

For schizophrenia, the starting dose of Invega Sustenna (Paliperidone) injectable suspension is 150 mg, injected intramuscularly (into a muscle) at the doctor's office. The second dose of 100 mg should be given 1 week after the first dose. After this, the recommended adult dose is 75 mg injected into a muscle once a month. Depending on how well the medication is tolerated and how well it works for you, your doctor may increase or decrease the dose.

For schizoaffective disorder, the starting dose of Invega Sustenna (Paliperidone) injectable suspension is 150 mg, injected intramuscularly (into a muscle) at the doctor's office. The second dose of 100 mg should be given 1 week after the first dose. After this, the recommended adult dose is 50 mg to 150 mg injected into a muscle once a month. Depending on how well the medication is tolerated and how well it works for you, your doctor may adjust the dose.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Invega Sustenna (Paliperidone) exactly as prescribed by your doctor. If you miss an appointment to receive a Invega Sustenna (Paliperidone) injection, contact your doctor as soon as possible to reschedule your appointment. Store Invega Sustenna (Paliperidone) at room temperature, protect it from moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause indigestion; it may cause drowsiness or dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause nausea or, rarely, vomiting; it may cause weight gain, mostly with prolonged use. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

50 mg/0.5 mL
Each prefilled syringe containing a white-to-off-white, sterile, aqueous, prolonged-release suspension contains 50 mg of Invega Sustenna (Paliperidone) (as 78 mg of Invega Sustenna (Paliperidone) palmitate). Nonmedicinal ingredients: citric acid monohydrate, disodium hydrogen phosphate anhydrous, polyethylene glycol 4000, polysorbate 20, sodium dihydrogen phosphate monohydrate, sodium hydroxide, and water for injection.

75 mg/0.75 mL
Each prefilled syringe containing a white-to-off-white, sterile, aqueous, prolonged-release suspension contains 75 mg of Invega Sustenna (Paliperidone) (as 117 mg of Invega Sustenna (Paliperidone) palmitate). Nonmedicinal ingredients: citric acid monohydrate, disodium hydrogen phosphate anhydrous, polyethylene glycol 4000, polysorbate 20, sodium dihydrogen phosphate monohydrate, sodium hydroxide, and water for injection.

100 mg/1 mL
Each prefilled syringe containing a white-to-off-white, sterile, aqueous, prolonged-release suspension contains 100 mg of Invega Sustenna (Paliperidone) (as 156 mg of Invega Sustenna (Paliperidone) palmitate). Nonmedicinal ingredients: citric acid monohydrate, disodium hydrogen phosphate anhydrous, polyethylene glycol 4000, polysorbate 20, sodium dihydrogen phosphate monohydrate, sodium hydroxide, and water for injection.

150 mg/1.5 mL
Each prefilled syringe containing a white-to-off-white, sterile, aqueous, prolonged-release suspension contains 150 mg of Invega Sustenna (Paliperidone) (as 234 mg of Invega Sustenna (Paliperidone) palmitate). Nonmedicinal ingredients: citric acid monohydrate, disodium hydrogen phosphate anhydrous, polyethylene glycol 4000, polysorbate 20, sodium dihydrogen phosphate monohydrate, sodium hydroxide, and water for injection.

Do not take Invega Sustenna (Paliperidone) if you:

• are allergic to Invega Sustenna (Paliperidone) or any ingredients of the medication
• are allergic to Risperidone

There may be an interaction between Invega Sustenna (Paliperidone) and any of the following:

• alcohol
• Aldesleukin
• Aliskiren
• alpha-agonists (e.g., Clonidine, methyldopa)
• alpha-blockers (e.g., Alfuzosin, Doxazosin, Silodosin, Tamsulosin)
• amantadine
• amiodarone
• amphetamines (e.g., Dextroamphetamine, Lisdexamfetamine)
• angiotensin converting enzyme inhibitors (ACEIs; Captopril, Ramipril)
• angiotensin receptor blockers (ARBs; e.g., Candesartan, Irbesartan, Losartan)
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• Apalutamide
• azelastine
• "azole" antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• barbiturates (e.g., butalbital, Phenobarbital)
• benzodiazepines (e.g., Alprazolam, Diazepam, Lorazepam)
• beta-adrenergic blockers (e.g., Atenolol, Propranolol, sotalol)
• brimonidine
• Buprenorphine
• Bupropion
• Buspirone
• calcium channel blockers (e.g., Amlodipine, Diltiazem, Nifedipine, Verapamil)
• cannabis
• chloral hydrate
• Cyclosporine
• diabetes medications (e.g., chlorpropamide, Glyburide, insulin, Metformin, Rosiglitazone)
• Disopyramide
• diuretics (water pills; e.g., Furosemide, Hydrochlorothiazide, Indapamide, triamterene)
• dofetilide
• Donepezil
• dopamine agonists (Parkinson's disease medications; e.g., Apomorphine, Bromocriptine, levodopa, Pramipexole, Ropinirole, Rotigotine)
• Dronedarone
• efavirenz
• Eliglustat
• Galantamine
• general anaesthetics (medications to put you to sleep for surgery)
• grapefruit juice
• Hepatitis C antivirals (e.g., glecaprevir, ledipasvir, ombitasvir, paritaprevir, velpatasvir)
• Hydralazine
• hydroxychloroquine
• kava kava
• Lapatinib
• lithium
• Loperamide
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
• Methadone
• Methylphenidate
• Metoclopramide
• monoamine oxidase inhibitors (M.O.S. e.g., Moclobemide, Phenelzine, Rasagiline, Selegiline, Tranylcypromine)
• muscle relaxants (e.g., Baclofen, Cyclobenzaprine, methocarbamol, orphenadrine)
• Nabilone
• narcotic pain relievers (e.g., Codeine, Fentanyl, Morphine, Oxycodone)
• Obinutuzumab
• other antipsychotics (e.g., chlorpromazine, Clozapine, Haloperidol, Olanzapine, Pimozide, Quetiapine, risperidone)
• procainamide
• Propafenone
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, moxifloxacin)
• rifampin
• ritonavir
• Rivastigmine
• St. John's wort
• seizure medications (e.g., Carbamazepine, Gabapentin, Levetiracetam, Perampanel, Phenytoin, Topiramate)
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin-norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• sodium oxybate
• suvorexant
• Tapentadol
• Tetrabenazine
• thalidomide
• tolcapone
• Tramadol
• Trazodone
• tricyclic antidepressants (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• Tryptophan
• Zolpidem
• Zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Invega Sustenna (Paliperidone). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Invega Sustenna (Paliperidone).

Abnormal heart rhythms: Invega Sustenna (Paliperidone) can cause abnormal heart rhythms. Certain medications (e.g., quinidine, procainamide, Amiodarone, Sotalol, Chlorpromazine, thioridazine, moxifloxacin) can increase the risk of a type of abnormal heart rhythm called QT prolongation and should not be used in combination with Invega Sustenna (Paliperidone). People who have a slow heart rate, low potassium or magnesium levels, or have congenital prolongation of the QT interval are more at risk for this type of abnormal heart rhythm and its complications. Talk to your doctor about the risks and benefits of using Invega Sustenna (Paliperidone).

Blood Clots: Rarely, Invega Sustenna (Paliperidone) increases the chance of blood clot formation, causing reduction of blood flow to organs or the extremities.

If you have a history of clotting, you may be at increased risk of experiencing blood clot-related problems such as Heart Attack, stroke, or clots in the deep veins of your leg. Discuss with your doctor how Invega Sustenna (Paliperidone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Invega Sustenna (Paliperidone), and whether any special monitoring is needed.

Blood counts: Invega Sustenna (Paliperidone) can decrease the number of neutrophils (a type of white blood cell that helps fight infection), red blood cells (which carry oxygen), and platelets (which help your blood to clot). Your doctor will do blood tests to monitor this. If you notice any signs of infection (e.g., fever, chills, or sore throat) or unusual bleeding or bruising, contact your doctor immediately.

Body temperature: Invega Sustenna (Paliperidone), like other antipsychotic medications, can disrupt the body's ability to control body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., Benztropine, Oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool down while taking Invega Sustenna (Paliperidone).

Cataract surgery: During eye surgery for Cataracts, people who take or have taken Invega Sustenna (Paliperidone) are at risk for developing a condition called Intraoperative Floppy Iris Syndrome (IFIS). This condition can lead to eye damage. If you are planning to have an operation on your eye, inform your doctor if you are taking or have taken Invega Sustenna (Paliperidone).

Cholesterol: Invega Sustenna (Paliperidone) can cause increased blood cholesterol levels. If you are at risk of developing High Cholesterol or you have high cholesterol levels before starting Invega Sustenna (Paliperidone), discuss with your doctor how Invega Sustenna (Paliperidone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Invega Sustenna (Paliperidone), and whether any special monitoring is needed.

Diabetes and blood sugar: Invega Sustenna (Paliperidone) may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Invega Sustenna (Paliperidone).

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Invega Sustenna (Paliperidone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Invega Sustenna (Paliperidone), and whether any special monitoring is needed.

If you experience weakness, increased thirst, increased urination, and increased appetite while taking Invega Sustenna (Paliperidone), contact your doctor.

Drowsiness/reduced alertness: Invega Sustenna (Paliperidone) may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how Invega Sustenna (Paliperidone) affects you.

Gastrointestinal problems: Invega Sustenna (Paliperidone) should not be taken by people with conditions associated with narrowing of the gastrointestinal tract (e.g., esophagus disorders, inflammatory bowel disease, "short gut" syndrome, Cystic Fibrosis), or by people who have difficulty swallowing.

Heart conditions: If you have a heart condition, such as Angina, heart failure, irregular heartbeat, or you have had a heart attack, discuss with your doctor how Invega Sustenna (Paliperidone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Invega Sustenna (Paliperidone), and whether any special monitoring is needed.

Hypersensitivity syndrome: A severe allergic reaction called hypersensitivity syndrome has occurred for some people taking medications similar to Invega Sustenna (Paliperidone). Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, severe rash, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash or blistering.

Lactose intolerance: Certain strengths (3 mg tablets) of Invega Sustenna (Paliperidone) tablets are prepared with lactose. If you have hereditary lactose or galactose intolerance problems you should not take this strength of the medication.

Kidney function: Kidney Disease or reduced kidney function may cause Invega Sustenna (Paliperidone) to build up in the body, causing side effects. If you have reduced kidney function or kidney disease, discuss with your doctor how Invega Sustenna (Paliperidone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Invega Sustenna (Paliperidone), and whether any special monitoring is needed.
Low Blood Pressure: Invega Sustenna (Paliperidone) may cause low blood pressure when rising from a sitting or lying down position. If you feel dizzy, lightheaded, or feel your pulse racing, call your doctor. While you are taking Invega Sustenna (Paliperidone), get up slowly after you have been sitting or lying down for a prolonged period.

Neuroleptic malignant syndrome (NMS): Invega Sustenna (Paliperidone), like other antipsychotic medications, can cause a potentially fatal syndrome known as NMS. If you experience the symptoms of NMS, such as high fever, muscle stiffness, confusion or loss of consciousness, sweating, racing or irregular heartbeat, and fainting, get immediate medical attention.

Parkinson's Disease: People with Parkinson's disease or Dementia with Lewy bodies (DLB) may be at an increased risk of NMS (see warning about NMS), as well as other side effects associated with Invega Sustenna (Paliperidone). Talk to your doctor about the risks and benefits of using Invega Sustenna (Paliperidone).

Risperidone: People who are taking risperidone should not take Invega Sustenna (Paliperidone) at the same time. These medications are related, and taking them together may cause an increased risk of side effects.

Seizures: Invega Sustenna (Paliperidone) may increase the risk of seizures, especially in people who have had seizures in the past. People who are at risk of seizures who take Invega Sustenna (Paliperidone) should be closely monitored by their doctor. If you have had seizures, discuss with your doctor how Invega Sustenna (Paliperidone) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Invega Sustenna (Paliperidone), and whether any special monitoring is needed.

Suicidal or agitated behaviour: People taking Invega Sustenna (Paliperidone) may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting Invega Sustenna (Paliperidone). If you experience these side effects or notice them in a family member who is taking Invega Sustenna (Paliperidone), contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking Invega Sustenna (Paliperidone).

Tardive dyskinesia (TD): TD, a syndrome consisting of potentially irreversible, involuntary, repetitive movements of the face and tongue muscles, may develop in people who take certain antipsychotic medications including Invega Sustenna (Paliperidone). Although TD appears most commonly in seniors, especially women, it is impossible to predict who will develop TD. The risk of developing TD increases with higher doses and long-term treatment. If you experience muscle twitching or abnormal movements of the face or tongue, contact your doctor as soon as possible.

Pregnancy: Invega Sustenna (Paliperidone) should not be used during pregnancy unless the benefits outweigh the risks. Using Invega Sustenna (Paliperidone) during the last three months of pregnancy can harm the developing baby and cause withdrawal symptoms after birth. If you become pregnant while taking Invega Sustenna (Paliperidone), contact your doctor immediately.

Breast-feeding: Invega Sustenna (Paliperidone) passes into breast milk. If you are a breast-feeding mother and are taking Invega Sustenna (Paliperidone), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Invega Sustenna (Paliperidone) have not been established for children under 18 years of age. Clinical studies using Invega Sustenna (Paliperidone) to treat adolescents with schizophrenia have shown an increased likelihood of movement disorders occurring in this group.

Seniors: Medications similar to Invega Sustenna (Paliperidone) can increase the risk of death as a result of a stroke, mini-stroke, and severe infection, when used to treat seniors with dementia. Invega Sustenna (Paliperidone) should not be used to treat seniors with dementia.

This product is usually injected into a muscle (intramuscularly) by a health professional. The injection may be sore for a few days. This medication is typically used only once a month. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Use it regularly and continuously to maintain its beneficial effects. It is not advisable to stop using this product suddenly, particularly if you have been on it for several weeks. If you are considering stopping the medication, talk to your pharmacist first. This product may intensify the effect of alcohol. Limit alcohol consumption to an occasional intake.