Invega Sustenna injection

Invega Sustenna is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Invega Sustenna is used to treat schizophrenia in adults. This medicine is also used alone or with other medicines to treat schizoaffective disorder in adults.

Invega Sustenna may also be used for purposes not listed in this medication guide.

You should not use Invega Sustenna if you are allergic to Invega Sustenna or to risperidone (Risperdal).

Invega Sustenna is not approved for use in psychotic conditions related to dementia. This medicine may increase the risk of death in older adults with dementia-related conditions.

Invega Sustenna can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you use this medicine, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in women and older adults.

To make sure Invega Sustenna is safe for you, tell your doctor if you have ever had:

• heart disease, heart attack, heart rhythm disorder, long QT syndrome;

• high or low blood pressure, or fainting spells;

• low white blood cell (WBC) counts;

• uncontrolled muscle movements in your face;

• liver or kidney disease;

• seizures or epilepsy;

• breast cancer;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• diabetes (Invega Sustenna may raise your blood sugar); or

• a serious neurologic disorder caused by taking an antipsychotic medicine.

Before you receive your first injection, tell your doctor if you have never taken oral (by mouth) Invega Sustenna or risperidone.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Using antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop using your medicine during pregnancy. If you become pregnant while using Invega Sustenna, do not stop using it without your doctor's advice.

Paliperidone can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Invega Sustenna is not approved for use by anyone younger than 18 years old.

Invega Sustenna is injected into a muscle. A healthcare provider will give you this injection.

Invega Sustenna is usually given only once per month, but the first two doses are given 1 week apart. Invega Trinza is usually given once every 3 months, after you have used Invega Sustenna for at least 4 months in a row.

Follow your doctor's dosing instructions very carefully. Get your Invega Sustennas regularly to get the most benefit.

Your doctor will need to check your progress while you are using Invega Sustenna.

Call your doctor for instructions if you miss an appointment for your Invega Sustenna.

While you are using Invega Sustenna, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are using this medicine.

Avoid drinking alcohol. Dangerous side effects could occur.

Invega Sustenna may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Applies to paliperidone: intramuscular suspension extended release, oral tablet extended release

General

EXTENDED RELEASE TABLETS: The most commonly reported side effects included sedation, extrapyramidal disorder, akathisia, and hyperkinesia.

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION: The most commonly reported side effects included akathisia, parkinsonism, insomnia, and headache.

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION: The most commonly reported side effects included increased weight, insomnia, and use of anticholinergic medications (for extrapyramidal symptoms).[Ref]

Nervous system

EXTENDED RELEASE TABLETS:

Very common (10% or more): Sedation/somnolence (up to 26%), extrapyramidal symptoms/disorder (up to 23%), akathisia (up to 17%), hyperkinesia (up to 17%), parkinsonism (up to 15%), headache (up to 14%), dystonia/acute dystonia (up to 14%), tremor (up to 12%)

Common (1% to 10%): Abnormal gait, dizziness, drooling, dysarthria, dyskinesia, hypertonia, lethargy

Uncommon (0.1% to 1%): Convulsion, disturbance in attention, dysgeusia, hypoesthesia, paresthesia, postural dizziness, syncope, tardive dyskinesia

Rare (0.01% to 0.1%): Abnormal coordination, balance disorder, cerebral ischemia, depressed level of consciousness, diabetic coma, head titubation, loss of consciousness, neuroleptic malignant syndrome, unresponsive to stimuli

Frequency not reported: Abnormal glabellar reflex, akinesia, athetosis, bradykinesia, cerebrovascular accident/disorder, cervical spasm, chorea, choreoathetosis, cogwheel rigidity, emprosthotonus, facial spasm, grand mal convulsion, hypersomnia, hypokinesia, masked facies, movement disorder, myoclonus, myotonia, opisthotonos, parkinsonian gait, parkinsonian rest tremor, pleurothotonus, restless legs syndrome, risus sardonicus, tongue paralysis, vertigo

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Very common (10% or more): Akathisia (up to 18%), parkinsonism (up to 18%), headache (up to 15%), extrapyramidal disorder (up to 12%)

Common (1% to 10%): Dizziness, dyskinesia, dystonia, hyperkinesia, sedation/somnolence, tremor

Uncommon (0.1% to 1%): Abnormal gait, bradykinesia, convulsion, disturbance in attention, drooling, dysarthria, dysgeusia, hypoesthesia, lethargy, oromandibular dystonia, paresthesia, postural dizziness, syncope, tardive dyskinesia, vertigo

Rare (0.01% to 0.1%): Abnormal coordination, balance disorder, cerebral ischemia, cerebrovascular accident/disorder, depressed level of consciousness, diabetic coma, head titubation, loss of consciousness, neuroleptic malignant syndrome, unresponsive to stimuli

Frequency not reported: Abnormal glabellar reflex, akinesia, athetosis, choreoathetosis, cogwheel rigidity, emprosthotonus, facial spasm, grand mal convulsion, hypertonia, hypokinesia, masked facies, myoclonus, myotonia, opisthotonos, oropharyngeal spasm, parkinsonian gait, parkinsonian rest tremor, pleurothotonus, restless legs syndrome, risus sardonicus, tongue paralysis, tongue spasm, transient ischemic attack

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Akathisia, dizziness, dyskinesia, dystonia, extrapyramidal disorder/symptoms, headache, hyperkinesia, parkinsonism, sedation/somnolence, tremor

Uncommon (0.1% to 1%): Abnormal gait, disturbance in attention, dysarthria, dysgeusia, hypoesthesia, paresthesia, postural dizziness, syncope, tardive dyskinesia, vertigo

Rare (0.01% to 0.1%): Balance disorder, cerebral ischemia, convulsion, depressed level of consciousness, loss of consciousness, neuroleptic malignant syndrome, unresponsive to stimuli

Frequency not reported: Abnormal coordination, abnormal glabellar reflex, akinesia, athetosis, bradykinesia, cerebrovascular accident, chorea, choreoathetosis, cogwheel rigidity, diabetic coma, drooling, emprosthotonus, facial spasm, grand mal convulsion, head titubation, hypertonia, hypokinesia, involuntary muscle contractions, lethargy, masked facies, movement disorder, myoclonus, myotonia, on and off phenomenon, opisthotonos, oromandibular dystonia, oropharyngeal spasm, parkinsonian crisis, parkinsonian gait, parkinsonian rest tremor, Parkinson's disease, pleurothotonus, restless leg syndrome, risus sardonicus, tongue paralysis, tongue spasm, transient ischemic attack[Ref]

Extrapyramidal symptoms included oculogyric crisis, muscle rigidity, musculoskeletal stiffness, nuchal rigidity, torticollis, trismus, bradykinesia, cogwheel rigidity, dyskinesia, dystonia, extrapyramidal disorder, hypertonia, hypokinesia, involuntary muscle contractions, parkinsonism gait, parkinsonism, tremor, and restlessness. Somnolence includes the terms somnolence, sedation, and hypersomnia.

Based on pooled data from 6-week fixed dose studies, the following nervous system adverse events appear to be dose-related: akathisia, dystonia, extrapyramidal disorder, hypertonia, and parkinsonism. The increased incidence occurred primarily at the 12 mg dose, although in some cases, also the 9 mg dose.[Ref]

Metabolic

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Decreased appetite, decreased weight, increased appetite, increased weight

Uncommon (0.1% to 1%): Anorexia, diabetes mellitus, hyperglycemia, increased blood triglycerides, increased waist circumference, thirst

Rare (0.01% to 0.1%): Diabetic ketoacidosis, hypoglycemia, increased blood cholesterol, polydipsia, water intoxication

Frequency not reported: Hyperinsulinemia, increased c-peptide, increased fasting glucose, increased HDL, increased LDL, tetany

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Decreased appetite, decreased weight, hyperglycemia, increased blood cholesterol/low density lipoproteins/triglycerides, increased blood glucose, increased weight

Uncommon (0.1% to 1%): Anorexia, diabetes mellitus, hyperinsulinemia, increased appetite, thirst

Rare (0.01% to 0.1%): Diabetic ketoacidosis, hypoglycemia, polydipsia

Frequency not reported: Tetany, water intoxication

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Very common (10% or more): Increased weight (up to 21.3%)

Common (1% to 10%): Decreased weight, hyperglycemia, increased blood glucose

Uncommon (0.1% to 1%): Anorexia, decreased appetite, diabetes mellitus, hyperinsulinemia, increased appetite, increased blood cholesterol/triglycerides

Rare (0.01% to 0.1%)K Diabetic ketoacidosis, hypoglycemia, polydipsia, thirst

Frequency not reported: Increased waist circumference, tetany, water intoxication[Ref]

Psychiatric

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Agitation, anxiety, depression, insomnia, mania, sleep disorder

Uncommon (0.1% to 1%): Anorgasmia, confusional state, decreased libido, nervousness, nightmare, psychomotor hyperactivity

Rare (0.01% to 0.1%): Blunted affect, drug withdrawal syndrome, neonatal drug withdrawal syndrome

Frequency not reported: Initial insomnia, middle insomnia, restlessness

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Very common (10% or more): Insomnia (up to 15%), agitation (up to 10%)

Common (1% to 10%): Anxiety, auditory hallucinations, depression, nightmare, suicidal ideation

Uncommon (0.1% to 1%): Confusional state, decreased libido, mania, nervousness, psychomotor hyperactivity, restlessness, sleep disorder

Rare (0.01% to 0.1%): Anorgasmia, blunted affect, drug withdrawal syndrome

Frequency not reported: Initial insomnia, middle insomnia, neonatal drug withdrawal syndrome, psychotic disorder, schizophrenia

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Agitation, anxiety, depression, insomnia, schizophrenia

Uncommon (0.1% to 1%): Blunted affect, decreased libido, irritability, nervousness, nightmare, psychomotor hyperactivity, sleep disorder

Rare (0.01% to 0.1%): Anorgasmia, confusional state, drug withdrawal syndrome, mania

Frequency not reported: Initial insomnia, middle insomnia, neonatal drug withdrawal syndrome, restlessness, suicidal ideation[Ref]

Cardiovascular

In a QT study evaluating the effect of immediate-release oral paliperidone (the active ingredient contained in Invega Sustenna) 8 mg (n=50), a mean placebo-subtracted increase from baseline on day 8 at 1.5 hours postdose was 12.3 milliseconds (ms). The mean steady-state peak plasma concentration achieved with immediate-release paliperidone was determined to be more than twice the exposure expected with the recommended 12 mg dose. None of the subjects had a QTc interval exceeding 60 ms. According to the phase 3 safety database which included double-blind and open-label extension studies (n=2054), 2 patients experienced QTc interval prolongation greater than 500 ms.

In placebo controlled trials with oral paliperidone, orthostatic hypotension increased with increasing doses, primarily at the 12 mg per day dose.[Ref]

EXTENDED RELEASE TABLETS:

Very common (10% or more): Tachycardia (up to 14%)

Common (1% to 10%): Bradycardia, bundle branch block, first-degree atrioventricular block/atrioventricular block, conduction disorder, electrocardiogram QT prolonged, hypertension, orthostatic hypotension, sinus arrhythmia, sinus tachycardia

Uncommon (0.1% to 1%): Abnormal electrocardiogram, chest discomfort/pain, edema, hypotension, palpitations

Rare (0.01% to 0.1%): Atrial fibrillation, flushing, ischemia, postural orthostatic tachycardia syndrome, venous thrombosis/thromboembolism

Frequency not reported: Cardiac arrest, generalized edema, increased blood pressure, increased heart rate, peripheral edema, pitting edema, Torsade de pointes, ventricular arrhythmia, ventricular tachycardia

Postmarketing reports: Deep vein thrombosis

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Bradycardia, electrocardiogram QT prolonged, hypertension, tachycardia/sinus tachycardia/increased heart rate

Uncommon (0.1% to 1%): Abnormal electrocardiogram, atrioventricular block, chest discomfort/pain, conduction disorder, edema, hypotension, orthostatic hypotension, palpitations, postural orthostatic tachycardia syndrome

Rare (0.01% to 0.1%): Atrial fibrillation, flushing, sinus arrhythmia, venous thrombosis/thromboembolism

Frequency not reported: Bundle branch block, cardiac arrest, deep vein thrombosis, first-degree atrioventricular block/atrioventricular block, generalized edema, ischemia, left bundle branch block, peripheral edema, pitting edema, Torsade de pointes, ventricular arrhythmia, ventricular fibrillation, ventricular tachycardia

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Bradycardia, hypertension, tachycardia/sinus tachycardia

Uncommon (0.1% to 1%): Abnormal electrocardiogram, atrioventricular block, chest discomfort/pain, conduction disorder, edema, electrogram QT prolonged, hypotension, orthostatic hypotension, palpitations, postural orthostatic tachycardia syndrome

Rare (0.01% to 0.1%): Atrial fibrillation, flushing, sinus arrhythmia, venous thrombosis/thromboembolism

Frequency not reported: Bundle branch block, cardiac arrest, deep vein thrombosis, first-degree atrioventricular block, generalized edema, ischemia, left bundle branch block, peripheral edema, pitting edema, Torsade de pointes, ventricular arrhythmias, ventricular fibrillation, ventricular tachycardia[Ref]

Other

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Asthenia, fatigue, pyrexia

Uncommon (0.1% to 1%): Chills, ear infection, ear pain, falls, increased body temperature, malaise, tinnitus

Rare (0.01% to 0.1%): Decreased body temperature, hypothermia

Frequency not reported: Sudden unexplained death

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Asthenia, fatigue, pain, pyrexia

Uncommon (0.1% to 1%): Ear infection, ear pain, increased body temperature, malaise, tinnitus

Rare (0.01% to 0.1%): Chills, decreased body temperature, hypothermia

Frequency not reported: Fall, sudden unexplained death

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Very common (10% or more): Use of anticholinergic medications (up to 11%)

Common (1% to 10%): Asthenia, fatigue, pyrexia

Uncommon (0.1% to 1%): Ear infection, ear pain, fall, increased body temperature, malaise, tinnitus

Rare (0.01% to 0.1%): Chills, hypothermia

Frequency not reported: Decreased body temperature, sudden unexplained death[Ref]

Gastrointestinal

EXTENDED RELEASE TABLETS:

Very common (10% or more): Vomiting (up to 11%)

Common (1% to 10%): Abdominal discomfort/pain, constipation, diarrhea, dry mouth, dyspepsia, nausea, salivary hypersecretion, stomach discomfort, toothache, upper abdominal pain

Uncommon (0.1% to 1%): Dysphagia, flatulence, gastroenteritis, swollen tongue

Rare (0.01% to 0.1%): Cheilitis, fecal incontinence, fecaloma, ileus, intestinal obstruction, pancreatitis

Frequency not reported: Difficulty swallowing, tongue protrusion, tongue spasm, upper abdominal pain/discomfort/stomach discomfort

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Abdominal discomfort/pain, constipation, diarrhea, dry mouth, dyspepsia, gastroesophageal reflux disease, nausea, swallowing difficulty, toothache, vomiting

Uncommon (0.1% to 1%): Dysphagia, flatulence, gastroenteritis, salivary hypersecretion

Rare (0.01% to 0.1%): Cheilitis, fecaloma, fecal incontinence, pancreatitis, swollen tongue

Frequency not reported: Ileus, intestinal obstruction, small intestinal obstruction

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Abdominal pain, constipation, diarrhea, dyspepsia, nausea, toothache, vomiting

Uncommon (0.1% to 1%): Abdominal discomfort, dry mouth, dysphagia, flatulence, gastroenteritis

Rare (0.01% to 0.1%): Cheilitis, difficulty swallowing, fecaloma, fecal incontinence, pancreatitis, swollen tongue

Frequency not reported: Ileus, intestinal obstruction, salivary hypersecretion, small intestinal obstruction, tongue protrusion, upper abdominal pain[Ref]

Local

Redness and swelling were observed in 2% or less of patients receiving the 3-month IM extended-release suspension. Residual injection pain peaked 1 or 6 hours after injection and trended downward 3 days after the injection. Deltoid injections were numerically more painful than gluteal injections.[Ref]

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Very common (10% or more): Injection site reactions (up to 10%)

Common (1% to 10%):

Rare (0.01% to 0.1%): Injection site abscess, injection site cellulitis, injection site cyst, injection site hematoma/bruising

Frequency not reported: Injection site extravasation, injection site induration, injection site irritation/pruritus/erythema/discomfort, injection site joint pain, injection site mass, injection site necrosis, injection site nodule, injection site pain, injection site swelling/edema/inflammation, injection site ulcer

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Injection site induration, injection site pain, injection site reaction

Rare (0.01% to 0.1%): Injection site abscess, injection site cellulitis, injection site cyst, injection site hematoma

Frequency not reported: Injection site erythema, injection site extravasation, injection site inflammation, injection site necrosis, injection site nodule/mass, injection site ulcer[Ref]

Musculoskeletal

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Arthralgia, back pain, extremity pain, musculoskeletal pain, musculoskeletal stiffness, myalgia

Uncommon (0.1% to 1%): Increased blood creatine phosphokinase, joint stiffness/swelling, muscle spasms, muscular weakness, neck pain

Rare (0.01% to 0.1%): Abnormal posture, rhabdomyolysis

Frequency not reported: Involuntary muscle contractions, muscle contracture, muscle rigidity/tightness/twitching, neck muscle spasm, nuchal rigidity, torticollis, trismus

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Arthralgia, back pain, musculoskeletal pain

Uncommon (0.1% to 1%): Increased blood creatine phosphokinase, joint stiffness, muscle rigidity/tightness, muscle spasms/twitching, muscular weakness, neck pain

Rare (0.01% to 0.1%): Abnormal posture, joint swelling, nuchal rigidity, rhabdomyolysis

Frequency not reported: Involuntary muscle contractions, muscle contracture, musculoskeletal stiffness, neck muscle spasm, torticollis, trismus

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Arthralgia, back pain, musculoskeletal pain

Uncommon (0.1% to 1%): Increased blood creatine phosphokinase, joint stiffness, muscle spasms/twitching, muscular weakness, neck pain

Rare (0.01% to 0.1%): Joint swelling

Frequency not reported: Abnormal posture, cervical spasm, extremity pain, muscle contracture, muscle rigidity, muscle tightness, musculoskeletal stiffness, myalgia, neck muscle spasm, nuchal rigidity, rhabdomyolysis, torticollis, trismus[Ref]

Respiratory

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Bronchitis, cough, epistaxis, nasal congestion, nasopharyngitis, pharyngolaryngeal pain, rhinitis, sinusitis, upper respiratory tract infection

Uncommon (0.1% to 1%): Dyspnea, pneumonia, respiratory tract infection, tonsillitis, wheezing

Rare (0.01% to 0.1%): Aspiration pneumonia, dysphonia, hyperventilation, pulmonary embolism, respiratory tract congestion, sleep apnea syndrome

Frequency not reported: Difficulty breathing, laryngospasm, nasal congestion, oropharyngeal spasm, pulmonary congestion, rales, throat tightness

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Cough, dyspnea, nasal congestion, nasopharyngitis, oropharyngeal pain, upper respiratory tract infection

Uncommon (0.1% to 1%): Bronchitis, epistaxis, pharyngolaryngeal pain, pneumonia, respiratory tract congestion, respiratory tract infection, sinusitis, tonsillitis, wheezing

Rare (0.01% to 0.1%): Pulmonary congestion syndrome, rales, sleep apnea syndrome

Frequency not reported: Aspiration pneumonia, difficulty breathing, dysphonia, hyperventilation, laryngospasm, pulmonary embolism, rhinitis, rhinorrhea, throat tightness, tongue protrusion

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Cough, nasal congestion, nasopharyngitis, upper respiratory tract infection

Uncommon (0.1% to 1%): Bronchitis, dyspnea, epistaxis, pharyngolaryngeal pain, pneumonia, respiratory tract infection, sinusitis, tonsillitis

Rare (0.01% to 0.1%): Pulmonary congestion, respiratory tract congestion, sleep apnea syndrome, wheezing

Frequency not reported: Aspiration pneumonia, difficulty breathing, dysphonia, hyperventilation, laryngospasm, pharyngitis, pulmonary embolism, rales, rhinitis, throat tightness[Ref]

Genitourinary

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Amenorrhea, galactorrhea, urinary tract infection

Uncommon (0.1% to 1%): Breast discomfort/pain/tenderness, dysuria, ejaculation disorder, erectile dysfunction, menstrual disorder, pollakiuria, sexual dysfunction, urinary incontinence, urinary retention

Rare (0.01% to 0.1%): Breast discharge/engorgement/enlargement, delayed menstruation, priapism, vaginal discharge

Frequency not reported: Breast swelling, irregular menstruation, menstrual disturbances, oligomenorrhea, retrograde ejaculation

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Amenorrhea, galactorrhea, urinary tract infection

Uncommon (0.1% to 1%): Breast pain, delayed menstruation, dysuria, ejaculation disorder, erectile dysfunction, irregular menstruation, menstrual disorder, pollakiuria, sexual dysfunction, urinary incontinence, vaginal discharge

Rare (0.01% to 0.1%): Breast discharge, breast discomfort/engorgement/enlargement, urinary retention

Frequency not reported: Oligomenorrhea, priapism, retrograde ejaculation

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Amenorrhea, menstrual disorder, urinary tract infection

Uncommon (0.1% to 1%): Breast discomfort/pain, delayed menstruation, dysuria, ejaculation disorder, erectile dysfunction, galactorrhea, pollakiuria, sexual dysfunction, urinary incontinence

Rare (0.01% to 0.1%): Breast engorgement/enlargement, urinary retention, vaginal discharge

Frequency not reported: Breast discharge, delayed menstruation, irregular menstruation, oligomenorrhea, priapism, retrograde ejaculation[Ref]

Galactorrhea, amenorrhea, and impotence have been reported in patients receiving prolactin-elevating compounds.[Ref]

Dermatologic

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Pruritus, rash

Uncommon (0.1% to 1%): Acne, alopecia, eczema, face edema, urticaria

Rare (0.01% to 0.1%): Acrodermatitis, cellulitis, dandruff, drug eruption, dry skin, erythema, hyperkeratosis, induration, onychomycosis, seborrheic dermatitis, skin discoloration

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Skin laceration

Uncommon (0.1% to 1%): Acrodermatitis, acne, alopecia, cellulitis, dry skin, eczema, erythema, face edema, generalized pruritus, induration, onychomycosis, pruritus, rash, subcutaneous abscess, urticaria

Rare (0.01% to 0.1%): Dandruff, drug eruption, hyperkeratosis, seborrheic dermatitis, skin discoloration

Frequency not reported: Papular rash

Postmarketing reports: Hyperhidrosis, thrombotic thrombocytopenic purpura

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Rash

Uncommon (0.1% to 1%): Acrodermatitis, acne, alopecia, cellulitis, dry skin, eczema, erythema, face edema, induration, onychomycosis, pruritus, urticaria

Rare (0.01% to 0.1%): Dandruff, drug eruption, hyperkeratosis, subcutaneous abscess

Frequency not reported: Generalized pruritus, induration, papular rash, seborrheic dermatitis, skin discoloration

Postmarketing reports: Thrombotic thrombocytopenic purpura[Ref]

Hepatic

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Increased transaminases (ALT, AST)

Uncommon (0.1% to 1%): Gamma-glutamyltransferase increased, increased hepatic enzymes

Rare (0.01% to 0.1%): Jaundice

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Increased transaminases (AST, ALT)

Uncommon (0.1% to 1%): Gamma-glutamyltransferase increased, increased hepatic enzymes

Frequency not reported: Jaundice

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Increased transaminases

Uncommon (0.1% to 1%): Gamma-glutamyltransferase increased, increased hepatic enzymes

Frequency not reported: Jaundice[Ref]

Immunologic

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Influenza

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Influenza

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Influenza[Ref]

Ocular

EXTENDED RELEASE TABLETS:

Common (1% to 10%): Blurred vision, oculogyric crisis

Uncommon (0.1% to 1%): Conjunctivitis, dry eye, photophobia

Rare (0.01% to 0.1%): Eye infection, eye movement disorder, eye rolling, glaucoma, increased lacrimation, ocular hyperemia

Frequency not reported: Blepharospasm, intraoperative floppy iris syndrome, oculogyration

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Eye swelling

Uncommon (0.1% to 1%): Blurred vision, conjunctivitis, dry eye, eye infection

Rare (0.01% to 0.1%): Eye movement disorder, eye rolling, glaucoma, increased lacrimation, ocular hyperemia, photophobia

Frequency not reported: Blepharospasm, intraoperative floppy iris syndrome, oculogyration, oculogyric crisis

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Blurred vision, conjunctivitis, dry eye, increased lacrimation

Rare (0.01% to 0.1%): Eye infection, eye movement disorder, eye rolling, glaucoma, ocular hyperemia, photophobia

Frequency not reported: Blepharospasm, intraoperative floppy iris syndrome, oculogyration, oculogyric crisis[Ref]

Endocrine

Paliperidone (the active ingredient contained in Invega Sustenna) has a prolactin-elevating effect similar to that seen with risperidone. Risperidone is associated with higher levels of prolactin elevation than other antipsychotic drugs.

Hyperprolactinemia may suppress hypothalamic gonadotropin-releasing hormone (GnRH), resulting in reduced pituitary gonadotropin secretion and in turn inhibit reproductive function by impairing gonadal steroidogenesis. Gynecomastia has been reported in patients receiving prolactin-elevating compounds.[Ref]

EXTENDED RELEASE TABLETS:

Uncommon (0.1% to 1%): Hyperprolactinemia

Rare (0.01% to 0.1%): Gynecomastia, inappropriate antidiuretic hormone secretion

Frequency not reported: Increased serum prolactin

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Common (1% to 10%): Hyperprolactinemia

Uncommon (0.1% to 1%): Gynecomastia

Rare (0.01% to 0.1%): Inappropriate antidiuretic hormone secretion

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Gynecomastia, hyperprolactinemia

Rare (0.01% to 0.1%): Inappropriate antidiuretic hormone secretion[Ref]

Hematologic

EXTENDED RELEASE TABLETS:

Uncommon (0.1% to 1%): Anemia, decreased hematocrit, decreased white blood cell count, thrombocytopenia

Rare (0.01% to 0.1%): Agranulocytosis, increased eosinophil count, neutropenia

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Anemia, decreased hematocrit, decreased white blood cell count, increased eosinophil count, thrombocytopenia

Rare (0.01% to 0.1%): Neutropenia

Frequency not reported: Agranulocytosis

Postmarketing reports: Granulocytopenia, leukopenia

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Anemia, decreased white blood cell count, neutropenia, thrombocytopenia

Rare (0.01% to 0.1%): Increased eosinophil count

Frequency not reported: Agranulocytosis[Ref]

Hypersensitivity

There have been postmarketing reports of anaphylactic reaction in patients receiving long-acting injection who had previously tolerated oral risperidone or oral paliperidone (the active ingredient contained in Invega Sustenna) [Ref]

EXTENDED RELEASE TABLETS:

Rare (0.01% to 0.1%): Anaphylactic reaction, angioedema, hypersensitivity

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Hypersensitivity

Frequency not reported: Anaphylactic reaction, angioedema

Postmarketing reports: Anaphylactic shock, anaphylaxis

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Hypersensitivity

Frequency not reported: Anaphylactic reaction, angioedema[Ref]

Renal

EXTENDED RELEASE TABLETS:

Uncommon (0.1% to 1%): Cystitis

Rare (0.01% to 0.1%): Presence of glucose in urine

1-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Cystitis

Rare (0.01% to 0.1%): Presence of glucose in urine

3-MONTH EXTENDED-RELEASE INJECTABLE SUSPENSION:

Uncommon (0.1% to 1%): Cystitis, presence of glucose in urine[Ref]