Secuado

Secuado is a prescription medicine used to treat adults with schizophrenia.

This medication belongs to a group of drugs called atypical antipsychotics. The exact way Secuado works is unknown, but it may help improve schizophrenia by affecting dopamine and serotonin levels to improve mood, thinking, and behavior.

Secuado comes as a transdermal system (patch) you apply to your skin once daily. 

Common side effects include restlessness, difficulty moving, muscle stiffness, tremor, skin irritation and weight gain. Secuado can cause drowsiness. Do not drive or operate heavy machinery until you know how Secuado affects you.

Secuado is a prescription medicine used to treat adults with schizophrenia. Secuado is a transdermal system (patch) you apply to your skin. It is not known if Secuado is safe and effective in children less than 18 years of age with schizophrenia.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Secuado. See the “Secuado Precautions” section.

Common side effects include:

• Restlessness, difficulty moving, muscle stiffness, tremor
• Skin irritation where the patch is placed
• Weight gain

This is not a complete list of Secuado side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Diuretics, ACE Inhibitors, Angiotensin Receptor Blockers, and Beta-Blockers, and Alpha-blockers (Secuado may enhance the effects of certain medications used to lower blood pressure)
• Fluvoxamine
• ciprofloxacin
• enoxacin
• Paroxetine

This is not a complete list of Secuado drug interactions. Ask your doctor or pharmacist for more information.

Secuado may cause serious side effects, including:

• Increased risk of death in elderly people with dementia-related psychosis. Medicines like Secuado can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Secuado is not approved for the treatment of people with dementia-related psychosis.
• Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.
• Neuroleptic Malignant Syndrome (NMS): a serious condition that can lead to death. Immediately remove the patch. Call your healthcare provider or go to the nearest hospital emergency room right away if you have some or all of the following: high fever, confusion, stiff muscles, increased sweating and changes in your breathing, heart rate and blood pressure.
• Uncontrolled body movements (tardive dyskinesia). Secuado may cause movements that you cannot control in your face, tongue, or other body parts. Tardive dyskinesia may not go away, even if you stop taking Secuado. Tardive dyskinesia may also start after you stop taking Secuado.
• Problems with your metabolism such as:
  • High blood sugar (hyperglycemia) and diabetes. Increases in blood sugar can happen in some people who take Secuado.
    
    Call your healthcare provider if you have any of these symptoms of high blood sugar during treatment with Secuado:
    • Feel very thirsty or very hungry
    • Feel sick to your stomach
    • Feel weak or tired
    • Need to urinate more than usual
    • Feel confused, or your breath smells fruity
  • Increased fat levels (cholesterol and triglycerides) in your blood
  • Weight gain. You and your healthcare provider should check your weight regularly during treatment with Secuado.
• Allergic reactions. You may observe rash, decreased blood pressure or a fast heart rate.
• Decreased blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.
• Falls. Secuado may make you sleepy or dizzy, may cause a decrease in your blood pressure when changing position, and can slow your thinking which may lead to falls.
• Low white blood cell count. Your healthcare provider may do blood tests during the first few months of treatment with Secuado.
• Irregular heartbeat or a heartbeat that does not feel normal (QT prolongation)
• Increased prolactin levels in your blood (hyperprolactinemia). Your healthcare provider may do blood tests to check your prolactin levels during treatment with Secuado.
• Seizures (convulsions)
• Impaired thinking and motor skills. Use caution when operating heavy machinery when using Secuado.
• Problems controlling your body temperature so that you feel too warm
• Difficulty swallowing
• External heat. Avoid exposing Secuado to direct external heat sources such as hair dryers, heating pads, electric blankets, heated water beds, etc.
• Application site reactions. Increased skin irritation may occur if Secuado is applied for a longer period than instructed or if the same application site is used repeatedly. Use a different application site each day to decrease skin reactions. If skin reactions continue or spread beyond the application site, tell your healthcare provider. Symptoms of application site reactions may include:
  • Redness
  • Itching
  • Irritation
  • Pimple-like raised skin
  • Pain of the skin
  • Swelling

Do not use Secuado if you:

• Are allergic to asenapine or any other ingredients in Secuado
• Have severe liver impairment

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Secuado, there are no specific foods that you must exclude from your diet when receiving this medication.

Before you use Secuado, tell your healthcare provider about all of your medical conditions, including if you have or have had:

• Heart problems or stroke
• Low or high blood pressure
• Diabetes or high blood sugar, or have a family history of diabetes or high blood sugar
• High levels of total cholesterol or triglycerides
• High prolactin levels
• Low white blood cell count
• Seizures
• Liver problems

Tell your healthcare provider if you become pregnant or think you are pregnant during treatment with Secuado. It is not known if Secuado will harm your unborn baby.

• If you become pregnant during treatment with Secuado, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to https://womensmentalhealth.org/research/pregnancyregistry/.

Talk to your healthcare provider about the best way to feed your baby during treatment with Secuado. It is not known if Secuado passes into your breast milk.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Secuado and other medicines may affect each other causing possible serious side effects. Secuado may affect the way other medicines work, and other medicines may affect how Secuado works.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Secuado will harm your unborn baby.

Studies have not been conducted with Secuado in pregnant women. Movement disorders known as extrapyramidal symptoms, agitation, tremor and other effects have been reported in newborn infants who were exposed to antipsychotic drugs during the third trimester of pregnancy.

This medication should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

If you become pregnant during treatment with Secuado, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics. You can register by calling 1-866-961-2388 or go to https://womensmentalhealth.org/research/pregnancyregistry/.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Secuado crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Secuado. It is recommended that women receiving Secuado should not breast feed.

Apply the Secuado patch as instructed by your healthcare provider in order to receive your medicine. 

• The Secuado transdermal system (patch) is for use on the skin only (transdermal).
• Do not cut the pouch open until you are ready to apply the patch.
• You should apply only 1 Secuado patch to 1 application site every 24 hours. The patch should only be worn for 24 hours. Do not wear the patch longer than 24 hours.
• Avoid bathing or swimming while wearing the patch. Swimming or bathing may cause the patch to fall off. You may shower.
• Avoid exposing the patch application site to direct heat sources such as hair dryers, heating pads, electric blankets, or heated water beds.
• If your skin feels irritated or feels like it is burning after you apply the patch, remove the patch and apply a new patch to a new application site.

Applying your Secuado patch:

• Change (rotate) your patch application site every time you apply a new patch. Changing your application site every time you apply a patch will help to lessen your chances of developing skin irritation at the application site. Do not use the same application site 2 times in a row.
• The application site you choose should be clean, dry, and intact. Do not apply the patch on skin that has cuts, scrapes, burns, rashes, redness, or other skin problems. 
• The application site you choose should be hairless or nearly hairless. If there is a lot of hair, use scissors to clip the hair as close to the skin as possible. Do not shave the application site.
• Do not apply the patch on skin that has oils, lotions, or powders on it. 
• Do not apply the patch to areas of your skin where you wear tight clothing, such as waistbands, bras, or tank top straps.

Read the leaflet that comes with your medication before you start using the Secuado transdermal system (patch) and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

Your doctor may begin your Secuado treatment at a dosage of 3.8 mg/24 hours. The dosage may be increased to 5.7 mg/24 hours or 7.6 mg/24 hours, as needed, after one week.

If you take too much Secuado, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Secuado patches at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Secuado patches and all medicines out of the reach of children.

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

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