Bipolar I Disorder and Schizophrenia Treatment | GEODON® (ziprasidone HCl) | Safety Info

Time 2020-09-27 13:05:11

Web Name: Bipolar I Disorder and Schizophrenia Treatment | GEODON® (ziprasidone HCl) | Safety Info

WebSite: http://www.geodon.com

ID:61644

Keywords:

Schizophrenia,Treatment,and,

Description:

Geodon Offers Savings To Patients If eligible, patients may pay as little as $4 for each 30-day fill of brand-name GEODON—and could save up to $3,000 a year.* Clinically proven to treat bipolar I disorder and schizophrenia Ongoing commitment to product quality and safety monitoring IMPORTANT SAFETY INFORMATION AND INDICATIONSWARNING: INCREASED DEATH IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSISGEODON is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to sugar pill. GEODON may increase the risk of changes to your heart rhythm. You should not take GEODON if you have certain kinds of heart conditions that change your heart rhythm, a recent heart attack, heart failure, or take certain medicines known to change heart rhythm. It is important to talk to your doctor about this possible side effect. Call your doctor right away if you faint, pass out, or feel a change in your heartbeat. It is important to tell your doctor about any other medicines that you take, including non-prescription medicines, supplements, and herbal medicines.If you experience a high fever, stiff muscles, shaking, confusion, sweating, or increased heart rate or blood pressure, tell your doctor right away. These can be signs of a rare but potentially fatal condition called neuroleptic malignant syndrome (NMS).Delayed-onset drug reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can occur with ziprasidone. Signs of DRESS may include rash, fever, and swollen lymph nodes. Other severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome, can occur with ziprasidone. Signs of Stevens-Johnson syndrome may include rash with blisters which could include ulcers in mouth, skin shedding, fever, and target-like spots in the skin. DRESS and other SCAR are sometimes fatal; therefore, call your health care professional(s) and seek immediate care if you develop any of these signs or symptoms.If you experience abnormal or uncontrollable facial or body movements, notify your doctor. These could be a sign of tardive dyskinesia (TD), a potentially permanent condition whose risk increases with the length of treatment, but which can also occur after brief periods at low doses.If you have diabetes or have risk factors or symptoms of diabetes, your blood sugar should be monitored. Symptoms include excessive thirst, urination, appetite, and weakness. High blood sugar has been reported with GEODON and medicines like it. In some cases, extreme high blood sugar can lead to coma or death. Increases in cholesterol and weight gain have also been reported with medicines like GEODON.Tell your doctor if you are pregnant or intend to become pregnant. Breastfeeding is not recommended.Antipsychotic drugs (like GEODON) may cause drowsiness, dizziness, or lightheadedness upon standing which could lead to falls, fractures, or other injuries. If you experience these symptoms, tell your doctor.If you experience a rash or seizures, tell your doctor. Also tell your doctor if you have thoughts of suicide.Other risks may include decreases in white blood cells (which can be serious), trouble swallowing, high prolactin levels, and impairment in judgment or motor skills. Until you know how GEODON affects you, you should not drive or operate machinery.Do not drink alcohol while taking GEODON. Avoid becoming overheated or dehydrated.Common side effects of GEODON include: Restlessness Abnormal muscle movements, including tremor, shuffling, and uncontrolled involuntary movements Diarrhea Rash Increased cough/runny noseIn short-term bipolar mania clinical studies, 4.9% of GEODON-treated patients gained significant weight (7% or more of body weight) vs 3.3% for placebo.In a long-term bipolar maintenance clinical study, patients who tolerated GEODON plus lithium or valproate (Depakote®) for 10-16 weeks were either continued on GEODON or switched to placebo for up to 6 months. During these six months, 5.6% of patients in both groups gained significant weight. These results do not include patients who did not complete the study.In short-term schizophrenia clinical studies, 10% of GEODON-treated patients gained significant weight vs 4% for placebo.Since there is no experience regarding the safety of administering GEODON for Injection to schizophrenic patients already taking oral GEODON, the practice of co-administration is not recommended.INDICATIONSGEODON is a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. GEODON can be used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. GEODON can also be used as maintenance treatment of bipolar disorder when added to lithium or valproate. GEODON may increase the risk of changes to your heart rhythm. In some cases, these types of changes can be fatal though it is unknown whether this is the case with GEODON. It is important to talk to your doctor about this potential side effect, as your doctor may consider a different medicine first.Please see Full Prescribing Information, including BOXED WARNING and Patient Information. At your doctor's office:Ask your doctor to prescribe brand-name GEODON and to indicate "DAW" (Dispense As Written)—or the language used in your state—on all of your GEODON prescriptions. At your pharmacy's drop-off:Tell the pharmacist that you want brand-name GEODON—and be sure to use the GEODON Savings Card if eligible. At your pharmacy's pick-up:Check your pills to be sure they're brand-name GEODON—not the generic—and also check that you've saved on your prescription if eligible.Download a Tip Sheet here. Look for the distinctive shape and marking of GEODON, so you get the brand-name medication you want—from a company you know—pill to pill and month to month. Geodon Offers Savings To Patients If eligible, patients may pay as little as $4 for each 30-day fill of brand-name GEODON—and could save up to $3,000 a year.*WARNING: INCREASED DEATH IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSISGEODON is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to sugar pill. GEODON may increase the risk of changes to your heart rhythm. You should not take GEODON if you have certain kinds of heart conditions that change your heart rhythm, a recent heart attack, heart failure, or take certain medicines known to change heart rhythm. It is important to talk to your doctor about this possible side effect. Call your doctor right away if you faint, pass out, or feel a change in your heartbeat. It is important to tell your doctor about any other medicines that you take, including non-prescription medicines, supplements, and herbal medicines.If you experience a high fever, stiff muscles, shaking, confusion, sweating, or increased heart rate or blood pressure, tell your doctor right away. These can be signs of a rare but potentially fatal condition called neuroleptic malignant syndrome (NMS).Delayed-onset drug reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can occur with ziprasidone. Signs of DRESS may include rash, fever, and swollen lymph nodes. Other severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome, can occur with ziprasidone. Signs of Stevens-Johnson syndrome may include rash with blisters which could include ulcers in mouth, skin shedding, fever, and target-like spots in the skin. DRESS and other SCAR are sometimes fatal; therefore, call your health care professional(s) and seek immediate care if you develop any of these signs or symptoms.If you experience abnormal or uncontrollable facial or body movements, notify your doctor. These could be a sign of tardive dyskinesia (TD), a potentially permanent condition whose risk increases with the length of treatment, but which can also occur after brief periods at low doses.If you have diabetes or have risk factors or symptoms of diabetes, your blood sugar should be monitored. Symptoms include excessive thirst, urination, appetite, and weakness. High blood sugar has been reported with GEODON and medicines like it. In some cases, extreme high blood sugar can lead to coma or death. Increases in cholesterol and weight gain have also been reported with medicines like GEODON.Tell your doctor if you are pregnant or intend to become pregnant. Breastfeeding is not recommended.Antipsychotic drugs (like GEODON) may cause drowsiness, dizziness, or lightheadedness upon standing which could lead to falls, fractures, or other injuries. If you experience these symptoms, tell your doctor.If you experience a rash or seizures, tell your doctor. Also tell your doctor if you have thoughts of suicide.Other risks may include decreases in white blood cells (which can be serious), trouble swallowing, high prolactin levels, and impairment in judgment or motor skills. Until you know how GEODON affects you, you should not drive or operate machinery.Do not drink alcohol while taking GEODON. Avoid becoming overheated or dehydrated.Common side effects of GEODON include:Feeling unusually tired or sleepy Nausea or upset stomach Constipation Dizziness RestlessnessAbnormal muscle movements, including tremor, shuffling, and uncontrolled involuntary movements Diarrhea Rash Increased cough/runny noseIn short-term bipolar mania clinical studies, 4.9% of GEODON-treated patients gained significant weight (7% or more of body weight) vs 3.3% for placebo.In a long-term bipolar maintenance clinical study, patients who tolerated GEODON plus lithium or valproate (Depakote®) for 10-16 weeks were either continued on GEODON or switched to placebo for up to 6 months. During these six months, 5.6% of patients in both groups gained significant weight. These results do not include patients who did not complete the study.In short-term schizophrenia clinical studies, 10% of GEODON-treated patients gained significant weight vs 4% for placebo.Since there is no experience regarding the safety of administering GEODON for Injection to schizophrenic patients already taking oral GEODON, the practice of co-administration is not recommended.INDICATIONSGEODON is a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. GEODON can be used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. GEODON can also be used as maintenance treatment of bipolar disorder when added to lithium or valproate. GEODON may increase the risk of changes to your heart rhythm. In some cases, these types of changes can be fatal though it is unknown whether this is the case with GEODON. It is important to talk to your doctor about this potential side effect, as your doctor may consider a different medicine first.Please see Full Prescribing Information, including BOXED WARNING and Patient Information. By participating in the GEODON® Savings Offer Program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:This Savings Offer is not valid for prescriptions that are reimbursed, in whole or in part, by Medicaid, Medicare, TRICARE, Veterans Affairs healthcare, or any other federal or state healthcare program (including any state prescription drug assistance program), or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”) The value of this Savings Offer is limited to $250 per use or the amount of your co-pay, whichever is less This Savings Offer is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plans or other health or pharmacy benefit programs You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf Eligible patients may pay a minimum of $4 per monthly prescription fill. By using this Savings Offer, eligible patients may receive a savings of up to $250 per fill off their co-pay or out-of-pocket costs. This Savings Offer is available for a maximum savings of $3,000 per year ($250 per month x 12 months). This Savings Offer may limit your prescription cost to $4, subject to a $250 maximum monthly benefit. Thus, if your co-pay or out-of-pocket cost is more than $254, you will save $250 off of your co-pay or total out-of-pocket costs. [Example: If your co-pay or out-of-pocket costs are $275, you will pay $25 ($275 – $250 = $25).] If your co-pay or out-of-pocket costs are no more than $254, you pay $4. For a mail-order 3-month prescription, your total maximum savings may be $750 ($250 x 3) You must be 18 years of age or older to redeem this Savings Offer Patients who are enrolled in Medicare, Medicaid, or another state or federal healthcare program may use this Savings Offer if paying for the prescription covered by this Savings Offer outside of their government insurance benefit, and no claim is submitted to Medicare, Medicaid, or any federal or state healthcare program. Such patients must not apply any out-of-pocket expenses incurred using this Savings Offer toward any government insurance benefit out-of-pocket spending calculations, such as Medicare Part D true out-of-pocket (TrOOP) costs You are responsible for reporting use of this Savings Offer to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using this Savings Offer, as may be required. You should not use this Savings Offer if your insurer or health plan prohibits use of manufacturer Savings Offers This Savings Offer is not valid (i) for Massachusetts residents or (ii) for California residents whose prescriptions are covered, in whole or in part, by third-party insurance This Savings Offer is not valid where prohibited by law This Savings Offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription This Savings Offer will be accepted only at participating pharmacies This Savings Offer is not health insurance This Savings Offer is good only in the U.S. and Puerto Rico This Savings Offer is limited to 1 per person during this offering period and is not transferable This Savings Offer may not be redeemed more than once per 30 days per patient No other purchase is necessary Data related to your redemption of this Savings Offer may be collected, analyzed, and shared with Pfizer for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Savings Offer redemptions and will not identify you Pfizer reserves the right to rescind, revoke, or amend the program without notice No membership fees. This Savings Offer and Program expire on 12/31/2021 For further information, call 1-888-779-2134, visit GEODON.com, or write: Pfizer Inc., 235 E 42nd Street, New York, NY 10017If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this Savings Offer. Pay for your GEODON prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: GEODON Savings Offer, 2250 Perimeter Park Drive, Suite 300, Morrisville, NC 27560. Be sure to include a copy of the front of your GEODON Savings Card, your name, and mailing address.GEODON is available by prescription only.Patients should always ask their doctors for medical advice about adverse events.You are encouraged to report adverse events related to Pfizer products by calling 1-800-438-1985 (U.S. only). If you prefer, you may contact the U.S. Food and Drug Administrations (FDA) directly. Visit http://www.fda.gov/MedWatch or call 1-800-FDA-1088.This site is intended only for U.S. residents. The products discussed in this site may have different product labeling in different countries. The information provided is for educational purposes only and is not intended to replace discussions with a healthcare provider.WARNING: INCREASED DEATH IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSISGEODON is not approved for the treatment of patients with dementia-related psychosis. Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to sugar pill. GEODON may increase the risk of changes to your heart rhythm. You should not take GEODON if you have certain kinds of heart conditions that change your heart rhythm, a recent heart attack, heart failure, or take certain medicines known to change heart rhythm. It is important to talk to your doctor about this possible side effect. Call your doctor right away if you faint, pass out, or feel a change in your heartbeat. It is important to tell your doctor about any other medicines that you take, including non-prescription medicines, supplements, and herbal medicines.If you experience a high fever, stiff muscles, shaking, confusion, sweating, or increased heart rate or blood pressure, tell your doctor right away. These can be signs of a rare but potentially fatal condition called neuroleptic malignant syndrome (NMS).Delayed-onset drug reaction called Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) can occur with ziprasidone. Signs of DRESS may include rash, fever, and swollen lymph nodes. Other severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome, can occur with ziprasidone. Signs of Stevens-Johnson syndrome may include rash with blisters which could include ulcers in mouth, skin shedding, fever, and target-like spots in the skin. DRESS and other SCAR are sometimes fatal; therefore, call your health care professional(s) and seek immediate care if you develop any of these signs or symptoms.If you experience abnormal or uncontrollable facial or body movements, notify your doctor. These could be a sign of tardive dyskinesia (TD), a potentially permanent condition whose risk increases with the length of treatment, but which can also occur after brief periods at low doses.If you have diabetes or have risk factors or symptoms of diabetes, your blood sugar should be monitored. Symptoms include excessive thirst, urination, appetite, and weakness. High blood sugar has been reported with GEODON and medicines like it. In some cases, extreme high blood sugar can lead to coma or death. Increases in cholesterol and weight gain have also been reported with medicines like GEODON.Tell your doctor if you are pregnant or intend to become pregnant. Breastfeeding is not recommended.Antipsychotic drugs (like GEODON) may cause drowsiness, dizziness, or lightheadedness upon standing which could lead to falls, fractures, or other injuries. If you experience these symptoms, tell your doctor.If you experience a rash or seizures, tell your doctor. Also tell your doctor if you have thoughts of suicide.Other risks may include decreases in white blood cells (which can be serious), trouble swallowing, high prolactin levels, and impairment in judgment or motor skills. Until you know how GEODON affects you, you should not drive or operate machinery.Do not drink alcohol while taking GEODON. Avoid becoming overheated or dehydrated.Common side effects of GEODON include:Feeling unusually tired or sleepy Nausea or upset stomach Constipation Dizziness RestlessnessAbnormal muscle movements, including tremor, shuffling, and uncontrolled involuntary movements Diarrhea Rash Increased cough/runny noseIn short-term bipolar mania clinical studies, 4.9% of GEODON-treated patients gained significant weight (7% or more of body weight) vs 3.3% for placebo.In a long-term bipolar maintenance clinical study, patients who tolerated GEODON plus lithium or valproate (Depakote®) for 10-16 weeks were either continued on GEODON or switched to placebo for up to 6 months. During these six months, 5.6% of patients in both groups gained significant weight. These results do not include patients who did not complete the study.In short-term schizophrenia clinical studies, 10% of GEODON-treated patients gained significant weight vs 4% for placebo.Since there is no experience regarding the safety of administering GEODON for Injection to schizophrenic patients already taking oral GEODON, the practice of co-administration is not recommended.INDICATIONSGEODON is a type of prescription medicine called a psychotropic, also known as an atypical antipsychotic. GEODON can be used to treat symptoms of schizophrenia and acute manic or mixed episodes associated with bipolar disorder. GEODON can also be used as maintenance treatment of bipolar disorder when added to lithium or valproate. GEODON may increase the risk of changes to your heart rhythm. In some cases, these types of changes can be fatal though it is unknown whether this is the case with GEODON. It is important to talk to your doctor about this potential side effect, as your doctor may consider a different medicine first.Please see Full Prescribing Information, including BOXED WARNING and Patient Information.

TAGS:Schizophrenia Treatment and 

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