Erzofri
Erzofri (paliperidone) is an atypical antipsychotic. It's a long-acting injection used to treat schizophrenia and schizoaffective disorder in adults. It's injected into your muscle by a healthcare professional. You’ll get a starting dose injected into the shoulder muscle. Then, your maintenance injections are once a month in the shoulder or buttock muscle. Common side effects include headache, injection site reactions, and sleepiness.
What is Erzofri (paliperidone)?
What is Erzofri (paliperidone) used for?
- Schizophrenia in adults
- Schizoaffective disorder in adults
How Erzofri (paliperidone) works
Erzofri (paliperidone) is an atypical antipsychotic. It works by helping balance dopamine and serotonin in the brain to regulate how you think, feel, and act. This can help reduce symptoms like hallucinations, delusions, and mood changes.
Drug facts
| Common Brands | Erzofri |
|---|---|
| Drug Class | Atypical antipsychotic |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
Side effects of Erzofri (paliperidone)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Headache (up to 15%)
- Injection site reactions (up to 10%)
- Agitation (up to 10%)
- Anxiety (up to 8%)
- Drowsiness (up to 7%)
- Dizziness (up to 6%)
- Restlessness (up to 6%)
- Vomiting (up to 5%)
- Nausea (up to 4%)
- Common cold symptoms (up to 4%)
- Weight gain (up to 4%)
Less Common Side Effects
- Stomach pain
- Diarrhea
- Dry mouth
- Tiredness
- Back pain
- Pain in the arm or leg
- Muscle stiffness
- Upper respiratory tract infection
Note: Side effects were reported by adults with schizophrenia.
Erzofri (paliperidone) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Abnormal heart rhythm: dizziness, pounding heart, feeling like your heart skipped a beat, chest pain, trouble breathing
- Neuroleptic malignant syndrome: high fever, sweating, stiff muscles, confusion, changes in pulse or heart rate, changes in blood pressure
- Tardive dyskinesia (movements you can't control): grimacing, face twitching, lip-smacking, sticking out your tongue, rocking back and forth, swinging your arms
- Serious infection: fever, chills, body aches, tiredness, cough
- Seizure
- Trouble swallowing
- Priapism: painful erection that lasts longer than 4 hours
- Problems with body temperature control
The following Erzofri (paliperidone) side effects have also been reported
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
bladder pain
bloody or cloudy urine
body aches or pain
chills
deep or fast breathing with dizziness
difficult, burning, or painful urination
difficulty with breathing
difficulty with swallowing
ear congestion
frequent urge to urinate
headache
inability to sit still
irregular heartbeat
irritability
loss of balance control
loss of voice
lower back or side pain
mask-like face
need to keep moving
nervousness
numbness of the feet, hands, and around the mouth
restlessness
runny or stuffy nose
shaking
shuffling walk
slowed movements
slurred speech
stiffness of the arms and legs
tic-like (jerky) movements of the head, face, mouth, and neck
trembling and shaking of the fingers and hands
trouble with sleeping
twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
unusual tiredness or weakness
Less common
Blurred vision
difficulty with speaking
dizziness
inability to move the eyes
increase in body movements
increased blinking or spasms of the eyelid
loss of balance control
muscle trembling, jerking, or stiffness
pounding in the ears
slow or fast heartbeat
sticking out of the tongue
uncontrolled movements, especially of the face, neck, and back
uncontrolled twisting movements of the neck, trunk, arms, or legs
unusual facial expressions
Incidence not known
Change in mental status
decrease in the amount and frequency of urination
difficulty speaking
large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
loss of bladder control
pale color of the skin
pinpoint red spots on the skin
puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
seizures
severe constipation
severe vomiting
stomach pain
swollen tongue
tightness in the chest
yellow eyes or skin
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
Less common
Back pain
difficulty with moving
increased weight
lack or loss of strength
muscle pains, cramps, or stiffness
nightmares
pain and swelling in the joints
pain in the arms or legs
tearing of the skin
toothache
upper abdominal or stomach pain
vomiting
Incidence not known
Sleepwalking
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Pros and cons of Erzofri (paliperidone)
Pros
- Treats both schizophrenia and schizoaffective disorder
- Only needs to be given once a month
- Just one starting dose (no second injection needed 1 week later)
- Good option if it's hard for you to remember to take your daily paliperidone or risperidone pills
Cons
- Must be given as an injection into the muscle by a healthcare professional
- Not recommended if you have moderate or severe kidney problems
- Can cause weight gain in some people
- Risk of movement-related side effects, like stiffness or restlessness
Pharmacist tips for Erzofri (paliperidone)
- Before starting Erzofri (paliperidone), your prescriber will ask if you've taken paliperidone (Invega) or risperidone (Risperdal) before. If you haven't, you'll need to take one of these medications as a pill first as a "test run." This helps make sure your body can handle the medication before you get Erzofri (paliperidone), which stays in your body for a long time.
- Plan your monthly visits for your Erzofri (paliperidone) injection. There's a small 7‑day window (before or after the monthly date) to get your injection. So as long as your appointment is within this window, it's okay.
- If you miss a dose of Erzofri (paliperidone), call the medical office to reschedule as soon as possible. Depending on how long it's been since your last injection, you might need a different dose or follow a different dosing schedule at first. This helps get you back on track with treatment safely.
- Tell your care team about all the medications and supplements you take or plan to take. Some can interact with Erzofri (paliperidone). Examples include carbamazepine (Tegretol), phenytoin, rifampin, and St. John’s wort. These can lower paliperidone levels in your body and make Erzofri (paliperidone) work less well. Your care team can make sure your medications are safe for you.
- Be sure to get up slowly after sitting or lying down, especially after your first Erzofri (paliperidone) injection or dose changes. This medication can cause a drop in blood pressure when you stand, which can make you dizzy or lead to fainting and falls. Staying hydrated can also help. Tell your prescriber if you feel too dizzy.
- Be aware of unusual movement problems called tardive dyskinesia while taking Erzofri (paliperidone). This can include lip smacking, tongue movements, or jerky motions you can’t control. If you notice this, call your care team. Catching these issues early can prevent them from getting worse.
- Avoid overheating while taking Erzofri (paliperidone). This medication can make it harder for you to cool down. In hot weather, rest in the shade, wear light clothing, and drink water. Be sure to skip saunas and very hard workouts on hot days.
- If you're pregnant or thinking about getting pregnant: Talk to your prescriber. They can explain the risks and benefits of taking Erzofri (paliperidone). If you take antipsychotic medications near the end of pregnancy, your baby might have movement problems or withdrawal symptoms after birth. At the same time, it's important to keep your mental health well controlled during pregnancy. Your prescriber can help you decide what's best for you.
- If you take Erzofri (paliperidone) while pregnant: Ask your prescriber about the National Pregnancy Registry for Atypical Antipsychotics. This program helps researchers learn more about how antipsychotic medications affect pregnancy.
Risks and warnings for Erzofri (paliperidone)
Erzofri (paliperidone) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Higher risk of death in older adults with dementia-related psychosis
- Risk factors: Older adults with dementia-related psychosis
Older adults with dementia can sometimes have some symptoms of schizophrenia. They might see, hear, or believe things that aren't real. This is called dementia-related psychosis. Studies show that older adults with this problem taking antipsychotic medications like Erzofri (paliperidone) have a higher risk of stroke or death. The cause of death was typically from heart problems or infections.
Because of this risk, Erzofri (paliperidone) is not approved for treating older adults with dementia-related psychosis. Tell your prescriber if you have dementia before starting this medication. Caregivers should let the prescriber know if the person they care for has dementia.
Neuroleptic malignant syndrome (NMS)
Antipsychotic medications like Erzofri (paliperidone) have been linked to a rare but serious problem called neuroleptic malignant syndrome (NMS). Stop taking this medication and get medical help as soon as you can if you have signs of NMS. Watch for signs like a very high fever, sweating a lot, fast heartbeat, stiff muscles, or problems thinking clearly.
Heart rhythm problem (QT prolongation)
- Risk factors: History of heart problems or abnormal heart rhythms (arrhythmias) | Slow heart rate | Born with QT prolongation | Low potassium or magnesium levels | Taking other medications that can cause QT prolongation
Although rare, Erzofri (paliperidone) can affect your heart rhythm. It can make the heart take longer to relax after each beat. This is called QT prolongation and it can be life-threatening.
Tell your prescriber about all your medical conditions. Also let your prescriber and pharmacist know about all the medications you take or plan to take. Certain medical conditions and medications can raise your risk of QT prolongation. Your care team can check that Erzofri (paliperidone) is safe for you. For example, people born with QT prolongation or those who have arrhythmia shouldn't take this medication.
If you feel your chest pounding, have trouble breathing, have chest pain, or feel like you might faint while taking Erzofri (paliperidone), call 911 right away. These can be signs of a problem with your heart rhythm.
Trouble controlling muscle movements (tardive dyskinesia)
- Risk factors: Older adults | Female 65 years and older
Antipsychotics like Erzofri (paliperidone) can cause movements you can't control. This is called tardive dyskinesia. It can look like face twitching or grimacing, mouth movements, and sticking out your tongue. Other examples include rocking back and forth or swinging your arms.
The risk for these movement problems, and that they'll become permanent, goes up if you take the medication for a long time or at a high dose. But it can also sometimes happen even at low doses or after you stop treatment. To help lower the risk, you'll be given the lowest dose for the shortest time needed to treat your symptoms.
Get medical help right away if you notice any unusual movements you can't control while taking Erzofri (paliperidone).
Higher blood sugar, higher cholesterol, and weight gain
- Risk factors: Diabetes | High cholesterol
Some people taking atypical antipsychotics like Erzofri (paliperidone) might have higher blood sugar. In rare cases, blood sugar levels can get dangerously high. Tell your prescriber if you or a family member has diabetes. You might need to check your blood sugar more often. Tell them if it stays higher than usual. Watch for signs like feeling very thirsty, hungry, or weak; urinating more often; or having fruity-smelling breath. These could be signs of very high blood sugar.
Antipsychotics like Erzofri (paliperidone) might also make your cholesterol and triglycerides high. Get blood tests done when your prescriber tells you. This helps keep track of your cholesterol and makes sure it doesn't get too high.
In addition, some people might gain weight while taking Erzofri (paliperidone). Try to eat balanced, nutritious meals and get regular exercise to help stay healthy. If you're worried about your weight, talk to your prescriber or primary care provider.
Low blood pressure and risk of falls
- Risk factors: Older adults | Low blood pressure | Dehydration | Heart problems | Taking blood pressure medications | Starting Erzofri (paliperidone) for the first time
Erzofri (paliperidone) can make your blood pressure drop when you stand up. This can make you feel dizzy and lightheaded, which can make you lose your balance. Although rare, some people have also fainted. These effects can lead to falls or accidental injuries.
The risk of these effects is higher for older adults. It also might be higher for people who are dehydrated or have certain heart problems.
Be sure to sit or stand up slowly, especially during the first few days after starting Erzofri (paliperidone). If you feel dizzy, sit back down until you feel better. Talk to your care team if you still feel dizzy while taking Erzofri (paliperidone). Call for medical help if you accidentally fall and get hurt.
Lower white blood cell count (leading to risk of infection)
- Risk factors: History of low white blood cell counts | Taking other medications that lower white blood cell counts
Some people who took antipsychotic medications like Erzofri (paliperidone) had lower white blood cell counts. These blood cells are important for fighting off germs. So when you have a low white blood cell count, it can put you at risk of getting infections.
People who already have a low white blood cell count might need blood tests often during the first few months of treatment. This helps the care team check that your blood cell count is okay. If it drops too much, you might need to stop taking Erzofri (paliperidone).
Call your care team right away if you have any signs of infection while taking Erzofri (paliperidone). Watch for signs like fever, chills, weakness, cough, trouble breathing, and sore throat.
High prolactin levels
Erzofri (paliperidone) can raise your prolactin levels. When your prolactin levels are high, it can cause milky discharge from the nipple and larger breasts. You might also have irregular menstrual periods, sexual dysfunction, and problems with fertility. Your bones might also become weak if your prolactin levels stay high for a long time. Talk to your prescriber if you notice these symptoms while taking Erzofri (paliperidone).
Trouble concentrating and extreme sleepiness
- Risk factors: Age 65 years and older | Drinking alcohol | Taking other medications that can make you sleepy and have trouble thinking
Erzofri (paliperidone) can make you very sleepy, which can raise your risk of falls. It can also make it hard to think, pay attention, and react quickly.
Your risk of these side effects is higher if you also take other medications that make you sleepy. Examples include benzodiazepines, muscle relaxants, and sleep medications.
These side effects can make driving or doing other things dangerous. Be sure you know how Erzofri (paliperidone) affects you before doing anything that needs your full attention. Tell your prescriber if you get too sleepy and it's hard to go about your daily life.
Seizures
- Risk factors: History of seizures | Health conditions or medications that make it easier to have a seizure
Once-monthly paliperidone injections like Erzofri (paliperidone) might raise the risk of seizures in certain people. Tell your prescriber if you've had a seizure before. Also tell them if you have a medical condition makes seizures more likely to happen. They can help you decide if Erzofri (paliperidone) is right for you. Call for medical help if you have a seizure.
Trouble swallowing and possible complications
Some people taking antipsychotic medications like Erzofri (paliperidone) might have trouble swallowing. If food or liquid accidentally gets into your lungs, it can be dangerous. This can sometimes lead to breathing problems or pneumonia (a lung infection).
Be sure to chew your food well and swallow slowly, especially if your throat or neck area feels tight. Talk to your prescriber if you have any trouble swallowing.
Erzofri (paliperidone) dosage
Typical dosage for Erzofri (paliperidone)
Erzofri (paliperidone) is given as an injection into the muscle by a trained healthcare professional. The typical dosing schedule is outlined below.
-
Schizophrenia
- Starting dose (day 1): The first dose is 351 mg injected once into the shoulder muscle.
- Maintenance dose: Starting 4 weeks after the first injection, the recommended maintenance dose is 117 mg once a month. But it can range between 39 mg and 234 mg per month, depending on your response to the medication. The injection is given into either the shoulder or buttock muscle.
-
Schizoaffective disorder
- Starting dose (day 1): The first dose is 351 mg injected once into the shoulder muscle.
- Maintenance dose: Starting 4 weeks after the first injection, the recommended maintenance dose is 117 mg injected once a month. But it can range from 78 mg to 234 mg per month, depending on your response to the medication. The injection is given into either the shoulder or buttock muscle.
Your dose might be different if you have kidney problems.
Interactions between Erzofri (paliperidone) and other drugs
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Bepridil
- Bromopride
- Cisapride
- Dronedarone
- Mesoridazine
- Metoclopramide
- Pimozide
- Piperaquine
- Saquinavir
- Sparfloxacin
- Terfenadine
- Thioridazine
- Ziprasidone
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Acecainide
- Ajmaline
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Amoxapine
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Artemether
- Asenapine
- Azimilide
- Azithromycin
- Bedaquiline
- Bretylium
- Buprenorphine
- Buserelin
- Carbamazepine
- Ceritinib
- Chloroquine
- Chlorpromazine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
- Dasatinib
- Degarelix
- Delamanid
- Desipramine
- Deslorelin
- Deutetrabenazine
- Disopyramide
- Dofetilide
- Dolasetron
- Domperidone
- Donepezil
- Droperidol
- Efavirenz
- Encorafenib
- Entrectinib
- Enzalutamide
- Erythromycin
- Escitalopram
- Fingolimod
- Flecainide
- Fluconazole
- Fluoxetine
- Formoterol
- Foscarnet
- Fosphenytoin
- Fostemsavir
- Gatifloxacin
- Gemifloxacin
- Glasdegib
- Gonadorelin
- Goserelin
- Granisetron
- Halofantrine
- Haloperidol
- Histrelin
- Hydroquinidine
- Hydroxychloroquine
- Hydroxyzine
- Ibutilide
- Iloperidone
- Imipramine
- Inotuzumab Ozogamicin
- Ivabradine
- Ivosidenib
- Ketoconazole
- Lapatinib
- Lefamulin
- Lenvatinib
- Levofloxacin
- Lofexidine
- Lopinavir
- Lumacaftor
- Lumefantrine
- Macimorelin
- Mefloquine
- Methadone
- Metronidazole
- Mifepristone
- Mirtazapine
- Mitotane
- Moxifloxacin
- Nafarelin
- Nilotinib
- Norfloxacin
- Nortriptyline
- Octreotide
- Ofloxacin
- Ondansetron
- Osilodrostat
- Osimertinib
- Oxaliplatin
- Oxymorphone
- Ozanimod
- Panobinostat
- Pasireotide
- Pazopanib
- Phenytoin
- Pimavanserin
- Pitolisant
- Ponesimod
- Posaconazole
- Procainamide
- Prochlorperazine
- Promethazine
- Propafenone
- Protriptyline
- Quetiapine
- Quinidine
- Quinine
- Ranolazine
- Remifentanil
- Ribociclib
- Rifampin
- Selpercatinib
- Sematilide
- Sertraline
- Sevoflurane
- Simeprevir
- Siponimod
- Sodium Phosphate
- Sodium Phosphate, Dibasic
- Sodium Phosphate, Monobasic
- Solifenacin
- Sorafenib
- Sotalol
- St John's Wort
- Sulpiride
- Sunitinib
- Tacrolimus
- Tedisamil
- Telavancin
- Telithromycin
- Tetrabenazine
- Tipranavir
- Toremifene
- Trazodone
- Triclabendazole
- Trifluoperazine
- Trimipramine
- Triptorelin
- Vandetanib
- Vardenafil
- Vemurafenib
- Vinflunine
- Voclosporin
- Voriconazole
- Zuclopenthixol
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Erzofri (paliperidone) contraindications
Contraindications are specific health conditions or situations in which a person should not take a medication due to safety concerns. If you have any of the following conditions or if any of the following apply to you, let your healthcare provider know because Erzofri (paliperidone) will not be safe for you to take.
- Allergy to paliperidone (Invega) or risperidone (Risperdal)
What are alternatives to Erzofri (paliperidone)?
Erzofri (paliperidone) images
