Saphris (asenapine)

What is Saphris Used For?

Saphris is used in the treatment of schizophrenia for adults; and bipolar 1 disorder for adults and children who are at least 10 years old.

Saphris is not recommended:

• If you are allergic to Saphris or any of its ingredients.
• Children younger than 10 years old.
• Anyone with severe liver impairment.

How is Saphris Used?

Storage

Saphris should be stored between 68°F to 77°F (20°C to 25°C)

How to Take

Saphris is a sublingual tablet that comes in a blister pack. It should not be removed from the blister pack until it is ready to be administered. The tablet should be placed under the tongue and allowed to dissolve completely so the medication can be fully absorbed. The tablet should take no longer than a few seconds to dissolve. You should not eat or drink for 10 minutes after the tablet has dissolved.

Dosage

Saphris comes in 2.5mg, 5mg, and 10mg, black-cherry flavored sublingual tablets.

Dosing for Adults

Schizophrenia

The recommended starting dose of Saphris for patients with schizophrenia is 5mg twice daily. If tolerated after one week, the dose can be increased to 10mg twice daily.

Bipolar 1 Disorder

The recommended starting dose of Saphris for adult patients with bipolar 1 disorder is 5mg-10mg twice daily.

The maximum daily dose of Saphris is 20mg/day. It is important to note that the safety of 20mg/day has not been evaluated in clinical studies.

Dosing for Children

The recommended starting dose of Saphris in children aged 10-17 with bipolar 1 disorder is 2.5mg twice a day. The dose can be increased after 3 days to 5mg daily, and from 5-10mg twice daily after another 3 days.

Missed Dose

If you miss a dose of Saphris, take it as soon as you remember. If it’s almost time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses at the same time.

Overdose

If you overdose on Saphris, serious side effects can develop. Symptoms of an overdose include agitation, confusion, and restless muscle movements. Call 911 or seek emergency medical care if you suspect an overdose.

Side Effects

If you experience signs of an allergic reaction such as hives, fast heart rate, wheezing, difficulty breathing, or swelling of your face, mouth, or throat, call 911 or seek emergency medical care.

The most common side effects of Saphris include:

• Dizziness
• Drowsiness or tiredness;
• Feeling restless or agitated
• Numbness or tingling in or around your mouth;
• Muscle stiffness or jerky muscle movements
• Nausea
• Altered sense of taste
• Increased appetite or weight gain.

Long-term use or high doses of Saphris can cause serious movement disorders that may not be reversible. Call your doctor if you notice:

• Uncontrolled muscle movements in your face include chewing, lip-smacking, frowning, tongue movement, blinking, or irregular eye movements.
• Ulcers, blisters, swelling, or peeling of the mouth
• Lightheadedness
• Breast pain or swelling or nipple discharge
• Fever, chills, mouth sores, skin sores, sore throat, cough, or trouble breathing.
• Rigid muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Warnings & Precautions

Saphris is contraindicated in those who have a known allergy or sensitivity to asenapine or any of its ingredients.

Children

Saphris is not indicated in children younger than the age of 10.

Pregnancy

Use of Saphris during pregnancy is not recommended unless the benefits outweigh the risks. Neonates exposed to antipsychotics during the third trimester have exhibited agitation, muscle rigidity, tremors respiratory distress, and feeding difficulties.

Lactation

It is not recommended to breastfeed while taking antipsychotic medications such as Saphris.

Severe Liver Impairment

Saphris is a high clearance drug and is contraindicated in patients with severe liver impairment. Absorption is 7 times higher in patients with severe liver impairment.

Dementia-Related Psychosis

Saphris is not indicated in elderly patients with dementia-related psychosis. These patients exhibited a higher incidence of cerebrovascular events such as CVA and TIA.

Neuroleptic Malignant Syndrome

Some patients who have taken Saphris have developed Neuroleptic Malignant Syndrome (NMS). NMS is associated with hyperreflexia, muscle rigidity, altered mental status, autonomic instability (irregular or fast heart rate and blood pressure, sweating, and cardiac arrhythmias), elevated creatine phosphokinase, rhabdomyolysis, and acute renal failure. If you exhibit any of these symptoms, the use of Saphris should be discontinued.

Tardive Dyskinesia

Some patients who have taken Saphris have developed potentially irreversible, involuntary, dyskinetic movements. The likelihood of developing tardive dyskinesia in patients who take Saphris is unknown, patients should be monitored for signs and symptoms such as facing grimacing, fish-like mouth movements, and involuntary tongue movements.

Metabolic Changes

Atypical antipsychotic drugs have been associated with an increase in hyperglycemia, dyslipidemia, and weight gain. Patients taking Saphris should be monitored for these conditions.

Hypersensitivity Reactions

Hypersensitivity reactions have been observed in patients after taking the first dose of Saphris. Symptoms of a reaction include anaphylaxis, angioedema, hypotension, tachycardia, swollen tongue, dyspnea, wheezing, and rash.

Orthostatic Hypotension/Syncope

Saphris can cause orthostatic hypotension and syncope in some patients. Patients should be instructed about non-pharmacologic interventions to reduce the occurrence such as sitting on the edge of the bed for several minutes before attempting to stand.

Leukopenia, Neutropenia, and Agranulocytosis

Blood dyscrasias have been reported in some patients taking Saphris. Patients with preexisting low white blood cell counts, low neutrophil counts, or a history of drug-induced leukopenia/neutropenia should be monitored routinely while taking Saphris. Saphris should be discontinued if severe neutropenia occurs.

QT Interval Prolongation

Saphris has been associated with QT prolongation. Saphris should be avoided in combination with other drugs known to cause prolonged QT intervals. Patients with a history of cardiac arrhythmias should also avoid Saphris due to the increased risk of torsade de pointes and sudden death.

Hyperprolactinemia

Saphris can cause elevated prolactin levels. Hyperprolactinemia can suppress hypothalamic GnRH which can result in impaired reproductive function in both males and females.

Seizures

Caution should be used in patients with a history of seizures. Saphris can lower the seizure threshold. Seizures may be more prevalent in patients aged 65 and older taking Saphris.

Potential for Cognitive or Motor Impairment

Cognitive or motor impairment may occur due to central nervous system depression. Patients taking Saphris should use caution when operating heavy machinery until certain that they do not experience adverse effects.

Body Temperature Regulation

Saphris has been associated with body temperature dysregulation. Caution should be used in patients who have a history of temperature disorders.

Dysphagia

Dysphagia and aspiration have been reported in patients taking Saphris. Caution should be used in patients with a history of aspiration.

Weight Gain

Saphris may cause weight gain. Weight should be monitored at baseline and throughout treatment. Pediatric patients should be monitored and assessed for expected normal growth.

Drug Interactions

This is not a complete list of potential drug interactions. Before taking Saphris, tell your doctor if you take any medications, herbal supplements, or vitamins.

Medications that Cause Sedation

Many medications can increase the risk of side effects associated with Saphris. Medications such as opioids, alcohol, marijuana, sleep or anxiety medications, muscle relaxants, and antihistamines should be discussed with your doctor before taking with Saphris due to the increased risk of drowsiness.

Medications that Cause QT Interval Prolongation

Medications with the potential to increase the QT interval should be avoided or closely monitored while taking Saphris.

Alternative Medications

There are other drugs available to treat Schizophrenia. Speak to your doctor to discuss other medications.

First-Generation Typical Antipsychotic Medications

Typical Antipsychotics are an older class of drugs used in the treatment of schizophrenia. They work by blocking dopamine receptors in the brain and improving motor control, focus, mood, and emotions.

• Chlorpromazine(Thorazine), Fluphenazine (Prolixin), Haloperidol (Haldol), Perphenazine (Trilafon), Thioridazine (Mellaril), Thiothixene (Navane), Trifluoperazine (Stelazine)

Second Generation Atypical Antipsychotic Medications

Atypical antipsychotics are a newer class of antipsychotic medications used in the treatment of schizophrenia and bipolar disorder. They work by blocking the excitatory activity of dopamine and serotonin. Dopamine and serotonin regulate pleasure sensation, mood, behavior, and memory.

• Aripiprazole(Abilify), Aripiprazole lauroxil (Aristada), Brexpiprazole (Rexulti), Cariprazine (Vraylar), Clozapine (Clozaril), Iloperidone (Fanapt), Lumateperonee (Caplyta), Lurasidone (Latuda), Olanzapine (Zyprexa) , Olanzapine/samidorphan (Lybalvi), Paliperidone (Invega Sustenna), Paliperidone palmitate (Invega Trinza), Quetiapine (Seroquel), Risperidone (Risperdal), Ziprasidone (Geodon).

Add on Medications

Along with antipsychotic drugs, your doctor may prescribe another type of medication to help manage your symptoms. Some other drug classes that you may be prescribed include mood stabilizers and antidepressants.

Frequently Asked Questions