Asenapine

Saphris 

Saphris is an advanced atypical antipsychotic medication tailored for the treatment of schizophrenia and bipolar I disorder, specifically targeting manic or mixed episodes. It comes in sublingual tablet form, available in 5 and 10-mg doses, and is designed to dissolve under the tongue for effective absorption. Saphris works by modulating neurotransmitters like dopamine and serotonin in the brain, helping to alleviate symptoms such as hallucinations, delusions, and mood fluctuations. For adults, the typical starting dose for schizophrenia is 5 mg twice daily, potentially increasing to 10 mg based on efficacy and tolerance. In bipolar disorder, the initial monotherapy dose is 10 mg twice daily. Careful administration is vital due to serious potential side effects, including neuroleptic malignant syndrome, tardive dyskinesia, and significant metabolic changes. Patients with specific health conditions or taking other medications should consult their healthcare providers to ensure safe usage. Saphris is contraindicated for patients with severe hepatic impairment or known hypersensitivity to asenapine.

Product Overview

Saphris (asenapine) is a potent atypical antipsychotic medication designed for the treatment of schizophrenia and bipolar I disorder, particularly effective in managing manic or mixed episodes. Available in sublingual tablet form in 5 mg and 10 mg strengths, Saphris should be placed under the tongue and allowed to dissolve completely for optimal absorption.

This medication operates by balancing neurotransmitters in the brain, notably dopamine and serotonin, which play crucial roles in mood, perception, and behavior. By blocking specific receptors, Saphris alleviates symptoms of psychosis, such as hallucinations and delusions, as well as improves mood and reduces anxiety.

Saphris is recommended at a starting dose of 5 mg twice daily for schizophrenia, potentially increasing to 10 mg based on patient response and tolerance. For bipolar I disorder, the starting dose as monotherapy is 10 mg twice daily, with adjustments made as necessary. It’s also used adjunctively with lithium or valproate starting at 5 mg.

However, it comes with serious warnings, particularly for elderly patients with dementia-related psychosis due to increased risk of death and stroke. Other potential severe effects include neuroleptic malignant syndrome, tardive dyskinesia, significant metabolic changes, cardiovascular effects, low white blood cell count, and seizures.

Patients must discuss their full medical history and current medications with their healthcare provider to mitigate risks of severe interactions and side effects. Regular monitoring and cautious administration are advised to ensure safety and effectiveness. Saphris is contraindicated in patients with severe hepatic impairment or hypersensitivity to asenapine.

What Are the Uses of Saphris?

• Schizophrenia
• Bipolar I disorder

What Are the Forms & Strengths of Saphris?

Saphris comes in the form of Sublingual Tablets. It is available in the following dosage strengths:

• 5 mg
• 10 mg

What Are the Recommended Dosage of Saphris?

For Schizophrenia in Adults

• Starting Dose: 5 mg sublingually twice daily.
• Maintenance Dose: The dosage may be increased to 10 mg twice daily after one week, based on the patient’s response and tolerability.

For Bipolar I Disorder (Acute Treatment of Manic or Mixed Episodes) in Adults

• Monotherapy:

• • • Starting Dose: 10 mg sublingually twice daily.
    • Maintenance Dose: Continue at 10 mg twice daily; dosage adjustments should be based on clinical response and tolerability.

• Adjunctive Therapy with Lithium or Valproate:

• • Starting Dose: 5 mg sublingually twice daily.
  • Maintenance Dose: The dose can be increased to 10 mg twice daily after one week, based on patient response and tolerability.

Special Considerations

• Renal or Hepatic Impairment:
• • Mild to moderate hepatic impairment: Start at a lower dose and adjust as needed.
  • Severe hepatic impairment: Use is not recommended.
• Elderly Patients: Begin at the lower end of the dosing range and monitor closely due to the increased risk of side effects.

[Note: Remember, these recommendations may vary from person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Use Saphris? 

• Dosage: Follow the exact dosage prescribed by your healthcare provider. Do not alter the dose without consulting your doctor.
• Administration: Saphris is available as a sublingual tablet, which means it is placed under the tongue to dissolve. Do not swallow, chew, or crush the tablet.
• Instructions:
  • Place the tablet under your tongue and allow it to dissolve completely. This usually takes about 10 minutes.
  • Do not eat or drink anything for at least 10 minutes after taking the tablet to ensure full absorption.
• Timing: Take Saphris at the same time each day, as directed by your healthcare provider. This helps maintain an even level of the medication in your bloodstream.
• Missed Dose: If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at once to make up for the missed dose.
• Storage: Store Saphris at room temperature, away from moisture and heat. Keep it in its original packaging until it is ready to use.
• Avoid Alcohol: Do not drink alcohol while taking Saphris, as it can increase the risk of side effects such as drowsiness and dizziness.
• Side Effects: Be aware of potential side effects such as drowsiness, dizziness, weight gain, and changes in blood sugar levels. Contact your healthcare provider if you experience any severe or concerning symptoms.
• Regular Monitoring: Attend all scheduled appointments with your healthcare provider to monitor your progress regularly and check for any adverse effects.
• Inform Your Doctor: Let your healthcare provider know about any other medications you are taking, as well as any medical conditions you have, to avoid potential interactions and complications.

[Note: Your doctor will decide the correct dosage strength for you based on your health condition, following guidelines & studies on the drug. They’ll adjust it as needed over time.]

How Does Saphris Work?

Saphris works by affecting the activity of certain natural substances in the brain, particularly neurotransmitters such as dopamine and serotonin. These neurotransmitters are involved in regulating mood, behavior, and perception.

Saphris belongs to a class of medications called atypical antipsychotics. It primarily functions by blocking or antagonizing specific receptors in the brain, including:

• Dopamine Receptors (D2): By blocking these receptors, Saphris helps reduce symptoms of psychosis, such as hallucinations and delusions, which are commonly seen in conditions like schizophrenia and bipolar disorder.
• Serotonin Receptors (5-HT2A): By antagonizing these receptors, Saphris can help improve mood, anxiety, and depressive symptoms.

The combination of these effects helps to balance the levels of dopamine and serotonin in the brain, thereby alleviating symptoms of schizophrenia and bipolar disorder. Saphris’s action on multiple receptor sites contributes to its effectiveness in managing both positive symptoms (such as hallucinations and delusions) and negative symptoms (such as social withdrawal and lack of motivation) of these mental health conditions.

Additionally, Saphris’s rapid onset of action, typically within 1 to 2 weeks, makes it a valuable option for patients needing prompt relief from acute symptoms, although full therapeutic effects may take several weeks to manifest.

Important Safety Information for Using Saphris

What Are the Side Effects of Saphris?

Saphris can lead to some side effects. These are usually temporary, lasting from a few days to weeks. These side effects include:

• Drowsiness or sleepiness
• Dizziness
• Weight gain
• Increased appetite
• Dry mouth
• Constipation
• Numbness or tingling in the mouth (oral hypoesthesia)
• Akathisia (restlessness or need to move)
• Extrapyramidal symptoms (movement disorders)
• Nausea
• Fatigue
• Insomnia
• Headache
• Anxiety
• Increased salivation

Serious Side Effects of Saphris

Saphris can cause several serious side effects. It’s important to stay aware of these potential risks and seek immediate medical attention if you experience any of the following:

• Higher Risk of Death in Older Adults with Dementia

• • • Description: Increased risk of death and stroke in people over 65 with dementia-related psychosis. Saphris is not approved for treating dementia-related psychosis.

• Neuroleptic Malignant Syndrome (NMS)

• • • Symptoms: High fever, rapid heart rate, severe muscle stiffness, and confusion.
    • Action: Seek emergency medical help immediately.

• Difficulty Controlling Movements (Tardive Dyskinesia)

• • • Symptoms: Uncontrollable movements such as lip-smacking, grimacing, and unusual eye blinking.
    • Action: Report symptoms to your healthcare provider promptly. Early detection is crucial.

• High Blood Sugar, High Cholesterol & Weight Gain

• • • Description: Increased risk of developing diabetes, high cholesterol, and significant weight gain.
    • Action: Regular monitoring of blood sugar levels, cholesterol levels, and weight is advised.

• Low Blood Pressure and Changes in Heartbeat

• • • Symptoms: Dizziness, fainting upon standing, and irregular heartbeats.
    • Action: Be cautious when standing up, and contact your provider if you experience fainting or abnormal heartbeats.

• Low White Blood Cell Count

• • • Symptoms: Increased susceptibility to infections, fever, and frequent illnesses.
    • Action: Regular blood tests to monitor white blood cell count and report any signs of infection to your provider.

• Seizures

• • • Description: Increased risk of seizures.
    • Action: Inform your healthcare provider if you have a history of seizures or conditions that predispose you to seizures.

• Phenylketonuria (PKU)

• • Description: Saphris contains phenylalanine, which can be harmful to people with PKU.
  • Action: Notify your provider if you have PKU. Dosage adjustments may be necessary.

[Note: Remember, this list does not cover all possible side effects of Saphris. Always consult with your healthcare expert for medical advice about side effects.]

Are There Any Warnings for Saphris? 

Saphris has several important warnings and potential side effects that should be considered, especially for specific groups at higher risk. If you have concerns, discussing alternative treatments with your healthcare provider is advisable.

• Increased Mortality in Elderly with Dementia-Related Psychosis: There is a heightened risk of death and stroke in adults over 65 with dementia-related psychosis treated with antipsychotics like Saphris, which is not approved for this condition.
• Neuroleptic Malignant Syndrome (NMS): This rare but serious condition is linked to antipsychotic drugs. Symptoms include high fever, stiff muscles, confusion, and rapid heart rate. Immediate medical attention is crucial, and alternative medications may be needed.
• Tardive Dyskinesia (TD): Long-term use can lead to TD, a potentially irreversible condition characterized by uncontrollable movements such as lip smacking or blinking. Contact your healthcare provider immediately if symptoms appear.
• Metabolic Changes: Saphris may cause increases in blood sugar, cholesterol, and body weight, raising the risk of diabetes, heart disease, and stroke. Regular monitoring and preventive strategies should be discussed with your healthcare provider.
• Cardiovascular Effects: Low blood pressure and altered heart rhythms may occur, particularly when rising from a seated or lying position. These effects can increase the risk of falls and fainting. Patients with heart conditions should consider alternatives.
• Low White Blood Cell Count: Asenapine can reduce white blood cell counts, increasing infection risks. Regular blood tests may be necessary to monitor your levels.
• Seizures: There’s an increased risk of seizures with Saphris, especially for those with a history of seizures or conditions that predispose to them. Inform your provider about your medical history before starting the medication.
• Phenylketonuria (PKU): Saphris tablets contain phenylalanine, which can be harmful to those with PKU. Your healthcare provider should adjust your diet or explore other medications if you have this condition.

What Are the FDA Boxed Warning for Saphris?

Saphris carries FDA-boxed warnings to alert healthcare providers and patients about the potentially serious risks associated with its use. These include:

• Higher Risk of Death in Older Adults with Dementia-Related Psychosis

• • • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Saphris is not approved for the treatment of dementia-related psychosis.

• Increased Risk of Suicidal Thoughts and Behaviors

• • Antidepressants, including Saphris, may increase the risk of suicidal thoughts and behaviors in children, adolescents, and young adults. Close monitoring for clinical worsening, suicidality, or unusual changes in behavior is necessary when prescribing Saphris to these populations.

What Are the Saphris Precautions?

When using Saphris, several precautions should be observed to ensure safe and effective use of the medication:

• Allergy Information: Before starting Saphris, inform your healthcare provider about allergies to asenapine or other medications, especially other antipsychotics.
• Medical History: Discuss your complete medical history with your healthcare provider, particularly if you have conditions related to the heart (like arrhythmias or heart disease), liver or kidney disease, a history of stroke or blood clots, diabetes, high cholesterol, seizures, low white blood cell counts, or conditions affecting metabolism.
• Mental Health Effects: Antipsychotic medications can sometimes cause or worsen symptoms of depression or suicidal thoughts, particularly in young adults and teenagers. Regular monitoring by your healthcare provider is crucial, and any new or worsening symptoms should be reported immediately.
• Interactions with Other Medications: Saphris can interact with other medications, which can increase side effects or reduce the effectiveness of Saphris or other drugs. This includes prescription drugs, over-the-counter medications, and herbal supplements. Be sure to discuss all medications and supplements you are taking with your healthcare provider.
• Alcohol and CNS Depressants: Avoid alcohol and other central nervous system (CNS) depressants while on Saphris, as they can enhance side effects such as dizziness and drowsiness.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits of using Saphris with your healthcare provider. Saphris may have potential effects on the fetus or infant.
• Operating Machinery: Saphris can cause drowsiness, dizziness, and affect your ability to make decisions and react. Avoid driving, operating heavy machinery, or performing other tasks that require alertness until you know how the medication affects you.
• Avoid Overheating and Dehydration: Antipsychotic medications can affect the body’s ability to regulate temperature. Avoid becoming overheated or dehydrated, especially during exercise and in hot weather.
• Regular Monitoring: Frequent visits to your healthcare provider may be necessary to monitor the drug’s effectiveness and check for adverse effects. This may include blood tests to monitor blood counts and metabolic changes.
• Discontinuation: Do not stop taking Saphris abruptly without consulting your healthcare provider, as it can cause withdrawal symptoms and worsening of your condition. Your provider may advise a gradual reduction in dose if discontinuation is needed.

What Are the Contraindications of Saphris? 

The contraindications for using Saphris include:

• Severe Hepatic Impairment: Patients with severe liver impairment should not use Saphris.
• Hypersensitivity: Individuals who have a known hypersensitivity to asenapine or any of its components should avoid using this medication due to the risk of severe allergic reactions, including anaphylaxis and angioedema.

What If You Missed a Dose of Saphris?

If you miss a dose of Saphris (asenapine), take it as soon as you remember. However, if it’s almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take two doses at the same time to make up for the missed one. Missing doses regularly can reduce the effectiveness of the treatment, so it’s essential to take Saphris consistently as prescribed. If you have any concerns or frequently miss doses, discuss this with your healthcare provider for further guidance and strategies to help you remember to take your medication.

[Note: If you have missed a dose of Saphris and are unsure regarding the next one, immediately consult your doctor or pharmacist.]

What Happens If You Take Too Much of Saphris?

Taking too much Saphris can lead to serious health consequences. Symptoms of an overdose may include:

• Severe drowsiness or sedation
• Confusion
• Agitation or restlessness
• Aggressive behavior
• Severe dizziness or fainting
• Irregular heartbeats
• Seizures
• Difficulty breathing

In extreme cases, an overdose can be life-threatening. If you suspect an overdose of Saphris, it’s crucial to seek immediate medical attention. Call emergency services or go to the nearest emergency room. It’s helpful to provide healthcare professionals with information about the amount taken and the time of ingestion. Prompt treatment is essential to manage the overdose and mitigate potential complications.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

How to Store a Saphris?

Saphris (asenapine) should be stored properly to maintain its effectiveness and safety. Here are the general guidelines for storing Saphris:

• Keep at Room Temperature: Store Saphris at room temperature, typically between 68°F to 77°F (20°C to 25°C). Avoid extreme temperatures.
• Protect from Light and Moisture: Keep the medication in its original packaging to protect it from light and moisture. Do not store Saphris in the bathroom or other damp areas.
• Keep it Secure: Ensure that the medication is stored in a secure place, out of the reach and sight of children and pets.
• Check Expiry Date: Regularly check the expiration date on the Saphris package and do not use it past the expiration date.
• Proper Disposal: Dispose of expired or unused Saphris according to the instructions provided by your pharmacist or local waste disposal company.

[Note: Discuss with your healthcare expert regarding the proper disposal of an unused Saphris and any questions you may have regarding its storage.]

What Medications Interact with Saphris?

Saphris can interact with various medications, which can affect its efficacy or increase the risk of serious side effects. It is crucial to discuss all medications you are taking with your healthcare provider before starting asenapine (Saphris). Here are some common interactions:

• Central Nervous System (CNS) Depressants: Combining Saphris with other CNS depressants like benzodiazepines, opioids, or alcohol can enhance sedative effects, leading to severe drowsiness, respiratory depression, and impaired motor skills.
• Antihypertensive Medications: Saphris can lower blood pressure, and when taken with antihypertensive drugs, it may increase the risk of hypotension (low blood pressure).
• QT Prolonging Drugs: Saphris can cause QT prolongation (a heart rhythm disorder). Using it with other medications that also prolong the QT interval can raise the risk of severe heart rhythm problems. Examples include certain antibiotics, antiarrhythmics, and other antipsychotics.
• Enzyme Inhibitors: Drugs that inhibit enzymes responsible for metabolizing Saphris, such as CYP1A2 inhibitors (e.g., fluvoxamine) and CYP2D6 inhibitors (e.g., paroxetine), can increase Saphris levels in the blood, potentially increasing side effects.
• Enzyme Inducers: Drugs that induce enzymes that metabolize Saphris, such as CYP3A4 inducers (e.g., carbamazepine, rifampin), can decrease Saphris levels, reducing its effectiveness.
• Anticholinergic Medications: Combining Saphris with other anticholinergic drugs can increase the risk of anticholinergic side effects like dry mouth, constipation, urinary retention, and blurred vision.
• Medications Affecting Blood Sugar: Asenapine can increase blood sugar levels, so adjustments in diabetes medications may be required.
• Dopamine Agonists: Saphris may reduce the effectiveness of dopamine agonists used in Parkinson’s disease due to its dopamine antagonist properties.
• Cimetidine: This medication can increase the blood levels of asenapine, potentially enhancing its effects and side effects.
• St. John’s Wort: This herbal supplement can reduce the effectiveness of Saphris by increasing its metabolism in the liver.

What Are the Other Saphris Interactions?

Saphris can interact with a variety of substances, impacting its effectiveness or leading to adverse effects. Here are some notable interactions:

Supplements:

• St. John’s Wort: It may lower the effectiveness of Saphris by increasing its metabolism in the liver.

Herbs:

• Valerian Root: This can enhance the sedative effects of Saphris, leading to excessive drowsiness or impaired cognitive functions.
• Kava: This may increase the risk of liver toxicity and sedative effects when combined with Saphris.

Foods:

• Grapefruit Juice: This medication can increase asenapine levels by inhibiting certain enzymes needed for its metabolism, potentially leading to increased side effects.

Beverages:

• Alcohol: It should be avoided as it can significantly increase the sedative effects of Saphris, enhancing drowsiness and impairing motor skills and cognitive functions.
• Caffeinated Beverages: Can potentially counteract the sedative effects of Saphris, leading to reduced efficacy.

 

[Note: This is not a complete list of Saphris interactions, and there could be other drugs that interact with Saphris. Make sure to tell your medical expert about any prescription, over-the-counter medicines & herbal products you’re taking.]

What Are the Saphris Alternatives?

Saphris (asenapine) is an atypical antipsychotic medication primarily used to treat schizophrenia and bipolar disorder. There are several alternatives to Saphris, including:

Other atypical antipsychotics:

• Abilify (aripiprazole)
• Zyprexa (olanzapine)
• Seroquel (quetiapine)
• Risperdal (risperidone)
• Geodon (ziprasidone)
• Latuda (lurasidone)
• Invega (paliperidone)
• Rexulti (brexpiprazole)
• Vraylar (cariprazine)

Typical antipsychotics:

• Haldol (haloperidol)
• Chlorpromazine (chlorpromazine)
• Fluphenazine (fluphenazine)

Mood stabilizers (for bipolar disorder):

• Lithium (lithium)
• Depakene (valproic acid)
• Tegretol (carbamazepine)
• Lamictal (lamotrigine)

Antidepressants (may be used in combination for bipolar depression):

• SSRIs (e.g., Prozac (fluoxetine), Zoloft (sertraline))
• SNRIs (e.g., Effexor (venlafaxine), Cymbalta (duloxetine))

Combination therapies:

• Some patients may benefit from a combination of antipsychotics, mood stabilizers, and/or antidepressants.

 

[Note: Your doctor will choose the most suitable dosage for you. Don’t use any of these alternative medications without consulting your medical professional. Taking them in the absence of medical supervision may cause serious side effects.]

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Frequently Asked Questions

What is the timeline for experiencing the effects of Saphris?

Saphris typically begins to take effect within 1 to 2 weeks, with full therapeutic benefits possibly emerging over several weeks. Continued improvement may be observed over the initial 3 to 4 months of treatment.

How quickly does Saphris start to take effect?

Saphris typically begins to show effects within 1 to 2 weeks of starting treatment. However, it might take several weeks to experience the maximum benefits. Continued improvement is often observed over the first 3 to 4 months of treatment with this medication.

Can Saphris lead to weight gain?

Yes, Saphris, like many antipsychotics, may cause weight gain, although it does not affect everyone. If you experience significant weight gain while using asenapine (Saphris), consult your healthcare provider. Switching to a different medication may sometimes mitigate this side effect.

Is it safe to take Saphris while pregnant?

The safety of Saphris during pregnancy has not been well-studied. Antipsychotic medications used in the third trimester are known to potentially cause movement issues and withdrawal symptoms in newborns. To better understand the effects of mental health medications like asenapine during pregnancy, there is a National Pregnancy Registry for Psychiatric Medications. If you’re pregnant and on asenapine, consider enrolling in this registry to contribute to and access information on its safety. For more details, you can contact the registry directly.

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