Saphris (Asenapine)

Also Known as Sycrest

Prescription medicineOnly Available By Prescription
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What is a Generic Drug?

A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.

The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.

Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.

Description

Saphris is classified as an atypical antipsychotic. The generic for Saphris is asenapine. 

Saphris (asenapine) is indicated for the treatment of schizophrenia in adults and bipolar I disorder in adults and pediatric patients ages 10 to 17 years old.


Fact Table

Formula

C17H16ClNO

License

EU EMA, US DailyMed, US FDA

Bioavailability

35%

Legal status

Rx-Only

Chemical Name

Asenapine

Elimination half-life

24 hours

Dosage (Strength)

5mg Sublingual, 10mg Sublingual, 10mg (Tablets)

Pregnancy

Consult Doctor

Brands

Saphris

Protein binding

95%

PubChem CID

163091

MedlinePlus

a610015

ChEBI

71253

ATC code

N05AH05

DrugBank

DB06216

KEGG

D11769

Routes of administration

Sublingual, by mouth

Directions

Saphris (asenapine) is a sublingual tablet. It should not be swallowed. Once you are prescribed and buy Saphris, then it should be placed under the tongue to dissolve. Food and drink should be avoided for 10 minutes after taking Saphris.

Saphris (asenapine) sublingual tablets are supplied in strengths of 2.5 mg, 5 mg, and 10 mg. 

Schizophrenia: The dosage ranges from 5 mg sublingually twice a day to 10 mg sublingually twice a day. 

Bipolar I disorder in adults: The dosage ranges from 5 mg sublingually twice a day to 10 mg sublingually twice a day. 

Bipolar I disorder in pediatrics ages 10-17 years: The dosage ranges from 2.5 mg sublingually twice a day to 10 mg sublingually twice a day. 

Ingredients

The active ingredient contained in Saphris is Asenapine.

Contraindications

You should not take Saphris if you have severe liver problems.

Discuss your allergies with your doctor. You should not take Saphris if you have an allergy to any of the ingredients contained in Saphris.

Cautions

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

See full prescribing information for complete boxed warnings.

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 patients with dementia-related psychosis.

  • Elderly patients with dementia-related psychosis are at an increased risk of cerebrovascular events such as a heart attack or stroke.
  • Stop Saphris immediately and closely monitor if you suspect neuroleptic malignant syndrome.Symptoms may include altered mental status, fever, rigid muscles, fast heart rate, sweating, or blood pressure problems.
  • If you experience tardive dyskinesia, which is characterized by uncontrollable movements of the face, neck, or tongue, then Saphris should be stopped if clinically appropriate.
  • Taking Saphris increases your risk for metabolic changes. Tell your doctor if you have diabetes or dyslipidemia. Monitor your blood sugar and weight.
  • Watch for signs of orthostatic hypotension by monitoring your blood pressure and heart rate. Orthostatic hypotension is when your blood pressure suddenly drops when you stand up from sitting or lying down. 
  • Get a complete blood count (CBC) if you have a low white blood cell count (WBC) or have had leukopenia or neutropenia. Your doctor may choose to discontinue Saphris if your WBC count significantly drops and there are no other reasons for the drop.
  • Monitor for signs of QT prolongation. Avoid taking Saphris with other drugs that can cause QT prolongation. If you have risk factors for QT prolongation, you should avoid taking Saphris.
  • Use with caution if you have or had seizures. Caution should also be used if you have a condition(s) that increases your risk for seizures.
  • Sleepiness or drowsiness may occur. Caution should be used when driving or operating machinery.
  • Let your doctor know if you are pregnant or plan to become pregnant. Women should be advised that taking Saphris while pregnant may cause extrapyramidal symptoms and/or withdrawal symptoms in infants. There is a pregnancy exposure registry that monitors the health of the baby and the mother while taking Saphris during pregnancy.
  • Let your doctor know if you are breastfeeding or plan to breastfeed. The effects and risks of taking Saphris (asenapine) while breastfeeding are unknown. The benefits and risks must be taken into account.

Side Effects

Be sure you talk to your doctor if you experience any adverse effects while taking Saphris (asenapine). Common Saphris (asenapine) side effects include:

  • Altered taste
  • Appetite increase
  • Dizziness
  • Extrapyramidal symptoms (movement problems)
  • Fatigue
  • Loss of sensation in your mouth
  • Nausea
  • Restlessness, can't sit still
  • Sleepiness, drowsiness
  • Weight gain

References:

  1. SAPHRIS Prescribing Information. Madison, NJ: Allergan USA, 2021.
  2. Tardive Dyskinesia. National Alliance of Mental Illness. Last updated January Accessed November 1, 2021.



IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

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