Selling or giving away AZSTARYS may harm others and is against the law. To learn more about ADHD and how Azstarys is used, see the Is Azstarys used for ADHD? section below. Subscribe to learn and pronounce a new word each day! Stimulant ADHD medications, such as Azstarys, are Schedule II drugs. Place the mixture in a container such as a sealed plastic bag and throw away (discard) Azstarys in the household trash. Administer AZSTARYS orally once daily in the morning with or without food [see Clinical Pharmacology (12.3)]. if you or your child are breastfeeding or plan to breastfeed. Patients 6 to 12 years: The recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. To learn more about this boxed warning, see the Can Azstarys be misused or cause dependence? section below. 3 dosage strengths to fit Azstarys capsules are taken once daily with or without food. Congrats! Youll take Azstarys once daily in the morning. ADHD is a mental health disorder that can cause inattentiveness, hyperactivity, and impulsive behavior. Sudden death has been reported in association with stimulants at recommended doses in pediatric patients with structural cardiac abnormalities or other serious heart problems. Pharmacokinetic data from two clinical studies of AZSTARYS demonstrated its rapid onset of action and long duration of effect CELEBRATION, Fla., Oct. 27, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc . Azstarys and some medicines may interact with each other and cause serious side effects. The effect of Azstarys is strongest in the hours after you swallow it, which is usually in the morning. Dependence on a drug means your body gets used to a drug and needs it to function as usual. Doctors who prescribe Schedule II drugs such as Azstarys must check people for signs of misuse and dependence before and during treatment with the drugs. AZSTARYSTM is an FDA-approved, once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years or older. Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. For more information, call 866-961-2388 or visit the National Pregnancy Registry for ADHD Medications website. It also helps the medication to work effectively when you need it during the daytime. A boxed warning is a serious warning from the Food and Drug Administration (FDA). Bring someone with you to your appointment if doing so will help you feel more comfortable. Seems like your pronunciation of AZSTARYS is not correct. It is not known if this medicine is safe and effective in children younger than 6 years of age. The FDA approval of the AZSTARYS NDA is a transformational event for KemPharm and, we believe, an important advancement in the treatment of ADHD, said Travis C. Mickle, Ph.D., President and CEO of KemPharm. Store Azstarys in a safe place and in a tightly closed container at room temperature between 68F to 77F (20C to 25C). There is a pregnancy registry for females who are exposed to ADHD medications, including Azstarys, during pregnancy. The most common side effects of Azstarys include: If you or your child has heart problems, heart defects, high blood pressure, or a family history of these problems, your doctor should check you or your child before and during taking Azstarys; increases in blood pressure and heart rate may occur. It will persist until the afternoon, about 13 hours after taking your dose. Do not take more Azstarys than your doctor prescribes. How Do Adderall and Meth (Methamphetamine) Differ? In case of poisoning, call your poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away. Increase the dosage after one week to a dosage of 52.3 mg serdexmethylphenidate/10.4 mg dexmethylphenidate per day. Itll take about 55 hours for your body to clear Azstarys. But if you think youre having a medical emergency, call 911 or your local emergency number. Those taking antihypertensive drugs in additional to Azstarys should have their blood pressure monitored. Azstarys was approved in March 2021 and the cash price for 30 capsules is about $410. Otherwise, the drug may cause you to have trouble sleeping. Its part of a group of drugs called central nervous system stimulants. In addition to these three drugs, other treatments for ADHD are available. Azstarys is used to treat attention deficit hyperactivity disorder (ADHD) in adults and in children ages 6 years and older. These stimulants can also be more effective for ADHD by providing a slow-rising and constant steady-state level of stimulant. Misuse of a drug means using it in a different way than how it was prescribed. Its not certain whether its safe to take Azstarys while breastfeeding. AZSTARYS for ADHD Intro: Stimulant mnemonics from Cafer's Psychopharmacology: Visualize to Memorize 270 Medication Mascots Dexmethylphenidate and Ser dexmethylphenidate (AZSTARYS) Phonetic pronunciation: DEX meth uhl FEN i deyt / az STAR is FDA-approved for: ADHD (age 6+) Azstarys mascot If no take-back program or authorized collector is available, mix Azstarys with an undesirable, nontoxic substance such as dirt, cat litter, or used coffee grounds to make it less appealing to children and pets. For example, symptoms may occur at school or work and at home. In the evening, Azstarys gradually wears off. Do not store the applesauce or water mixture. Swallow all the applesauce or water mixture right away or within 10 minutes of mixing. Corium does not endorse and makes no claim or warranty of, and is not responsible for, any information found in the linked website. are breastfeeding or plans to breastfeed. Medicare covers mental healthcare. Symptoms of a mild allergic reaction can include: A more severe allergic reaction is rare but possible. Does Azstarys cause long-term side effects? Although adults with ADHD may be impaired by inattentive symptoms, ADHD is often not the focus of pharmacotherapy because of comorbid conditions. Other factors may also affect whether Azstarys is a good treatment option for you. Tell your doctor if you have bipolar disorder before you start taking Azstarys. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. Azstarys is a central nervous system stimulant prescription medicine used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Call your healthcare provider right away if there are any new or worsening mental symptoms or problems during treatment. It is not known if AZSTARYS may harm your unborn baby. Theyll check you for heart problems before prescribing Azstarys. But some experts suggest that people living with ADHD have fewer dopamine receptors. Azstarys comes as capsules that you swallow. People sometimes misuse CNS stimulants to stay alert or increase their focus. Azstarys, like other stimulants, can increase blood pressure and heart rate. Do not substitute AZSTARYS for other methylphenidate products on a milligram-per-milligram basis because these products have different pharmacokinetic profiles from AZSTARYS and may have different methylphenidate base composition [see Description (11), Clinical Pharmacology (12.3)]. Call your healthcare provider or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with Azstarys. Keep AZSTARYS in a safe place to prevent misuse and abuse. Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression. Azstarys passes into breast milk talk to your healthcare provider about the best way to feed your baby if you take Azstarys. Stimulants decrease appetite by increasing adrenergic and dopaminergic activity in the hypothalamus. Below are some common questions about the dosing of Azstarys. To help prevent dependence, your doctor will routinely evaluate your need for treatment with Azstarys. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. If youve ever misused alcohol, Azstarys may not be the right drug for you. If you or your child becomes pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Psychostimulants at. It works by. AZSTARYS may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. CELEBRATION, Fla., March 02, 2021 (GLOBE NEWSWIRE) -- KemPharm, Inc. (NASDAQ: KMPH), a specialty pharmaceutical company engaged in the discovery and development of proprietary prodrugs, today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for (NDA) AZSTARYS (formerly referred to as KP415), a once-daily product for the treatment of attention deficit hyperactivity disorder (ADHD) in patients age six years and older. Although less addictive than amphetamine, modafinil is not necessarily safer or better tolerated. Selling or giving away . Its a place where people with certain conditions can find support and connect with others. After a week of treatment, raters used the SKAMP-Combined rating scale to evaluate the children's attention and behavior in a classroom setting. Drug class: CNS stimulants. of behavior disturbance and thought. ADHD also affects many adults. Azstarys belongs to a class of drugs called ADHD Agents; Stimulants. Your healthcare provider should check you or your childs blood pressure and heart rate regularly during treatment. certain anesthetics used before surgery,* such as sevoflurane (Sojourn) and desflurane (Suprane), euphoria (a state of extreme happiness or excitement). If youve had an allergic reaction to Azstarys or any of its ingredients, your doctor will likely not prescribe Azstarys. Dosage form: capsule It is a type of medicine that is given top treat ADHD. Keep AZSTARYS in a safe place to prevent misuse and abuse. Or go to the nearest emergency room. blood pressure medicines (anti-hypertensive). Keep AZSTARYS and all medicines out of the reach of children. 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If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued. from Cafer's Psychopharmacology: Visualize to Memorize 270 Medication Mascots, Phonetic pronunciation: DEX meth uhl FEN i deyt / az STAR is. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. Risk of misuse and risk of dependence. QL: Quantity Limits Drugs that have quantity limits associated with each prescription. Sudden death has, if you or your child have mental (psychiatric) problems, or a family history of suicide, bipolar illness, or depression. Under the License Agreement, KemPharm may be eligible for up to $468 million in regulatory and sales milestone payments, as well as tiered royalty payments, on a product-by-product basis for net sales, with potential percentages up to the mid-twenties for U.S. net sales, and up to the mid-single digits of net sales in each country outside of the U.S. AZSTARYS capsules may be taken whole, or opened and the entire contents sprinkled into 50 mL of water or over 2 tablespoons of applesauce. Dosage form: Capsules This combination provides a fast onset and a longer duration of action without the spikes in dexmethylphenidate concentrations. Last updated on Sep 1, 2021. KemPharm is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise. individual needs, Each dosage strength is a different color, The AZSTARYS capsule is slightly smaller Disorder (ADHD) in people 6 years of age and older. If you experience chest pain, fainting, or problems with your heart rate while taking Azstarys, contact your doctor right away. Unfortunately, ADHD medications across the board have been found to be less efficacious and less well tolerated in adults than in children/adolescents (Cortese et al, 2018). While withdrawal from opioids is highly distressing, withdrawal from stimulants is less severe and mostly consists of fatigue, hypersomnia, irritability, and increased appetite. Paradoxically, some patients with ADHD complain stimulants make them overly slowed or even zombified. Suitable methylphenidate products include Concerta, Aptensio XR and Adhansia XR. These and other considerations to discuss with your doctor are described below. Predominantly inattentive ADHD usually does not tend to improve throughout adulthood. (An active ingredient is what makes a drug work.) It is unique because it is the first medication to combine dexmethylphenidate and serdexmethylphenidate. Prior to initiating treatment with AZSTARYS, assess for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see Warnings and Precautions (5.2)]. Adults and Patients 13 to 17 years: The recommended starting dosage is 39.2 mg/7.8 mg orally once daily in the morning. If your heart rate is too high, your doctor may also prescribe medication to slow your heart rate. Azstarys is a prescription medicine used to treat symptoms of Attention Deficit Hyperactivity Disorder. If paradoxical aggravation of symptoms or other adverse reactions occur; the dosage should be reduced, or, if necessary, the drug should be discontinued. For Neurodivergent Black Adults, Whats in a Diagnosis? KemPharms product portfolio is highlighted by AZSTARYS, an FDA-approved, once-daily treatment for attention deficit hyperactivity disorder (ADHD) which is based on serdexmethylphenidate, (SDX), KemPharms prodrug of d-methylphenidate (d-MPH). However, risk of addiction with prescription stimulants taken as prescribed is very low. *|ux$C2+oVc. Place the mixture in a container such as a sealed plastic bag and throw away (discard) AZSTARYS in the household trash. Your doctor will explain how you should take Azstarys. Some medications interact with alcohol, but Azstarys isnt one of them. Psychosis. Maximum recommended dosage is 52.3 mg serdexmethylphendiate/10.4 mg dexmethyphenidate once daily. Tell your doctor about all your current medicines and any medicine you start or stop using. Can Azstarys be misused or cause dependence? Allergic reaction. You have earned {{app.voicePoint}} points. But be sure to consume the applesauce or water mixture right away. What Types of Mental Health Services Does Medicare Cover? This will help keep the amount of medication your body absorbs consistent, which, in turn, helps Azstarys work effectively. individual needs, AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. But there. Jason Rando/Maureen McEnroe, CFATiberend Strategic Advisors, Inc.(212) 375-2665 / 2664jrando@tiberend.commmcenroe@tiberend.com, ________________________1 American Psychiatric Association (https://www.psychiatry.org/patients-families/adhd/what-is-adhd) 2 Danielson, ML, et al. Keep AZSTARYS in a safe place to prevent misuse and abuse. WARNING: AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. His or her height and weight should be checked often while taking Azstarys. Azstarys dexmethylphenidate 5.2 mg / serdexmethylphenidate 26.1 mg (KP415 286). The complete approved prescribing information for AZSTARYS may be downloaded in PDF format here:http://ml.globenewswire.com/Resource/Download/4f63af91-9427-40da-b881-82a5e22a0315. Taking more than this can lead to serious side effects. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. The dose could be titrated weekly to 26.1 mg/5.2 mg, 39.2 mg/7.8 mg, or 52.3 mg/10.4 mg (maximum dose) based on tolerability and best individual response in the . Azstarys comes as a capsule that you swallow. Azstarys is a central nervous system stimulant approved by the FDA in March 2021 to treat ADHD. The dual-action of Azstarys addresses an unmet need for a medication that has early onset of action and long duration of therapy, with steady ADHD symptom control in one capsule, stated Corium Inc . Serious side effects from Azstarys can occur, but they arent common. Unfortunately, this device does not support voice recording, Click the record button again to finish recording. Interested participants and investors may access the conference call by dialing either: An audio webcast with slide presentation will be accessible via the Investor Relations section of the Companys website,http://investors.kempharm.com/. Azstarys is a central nervous system stimulant prescription medicine used for the treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. Call your healthcare provider right away if any signs of unexplained wounds appear on fingers or toes while taking Azstarys. Even at therapeutic doses, stimulants increase blood pressure (averaging 2 to 4 mmHg) and heart rate (averaging 36 bpm); some individuals have larger increases. Dosage may be increased after one week to 52.3 mg/10.4 mg once daily. If its hard for you to read the label on your prescription, tell your doctor or pharmacist. AZSTARYS should be periodically discontinued to assess the pediatric patient's condition. Theyll also explain how much to take and how often. ADHD, attention deficit hyperactivity disorder. Disorder (ADHD) in people 6 years of age and older. During the open-label dose-optimization phase (3 weeks), 155 patients were started. Maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically re-evaluate the need for AZSTARYS use [see Boxed Warning, Warnings and Precautions (5.1), and Drug Abuse and Dependence (9)]. Do not start any new medicine during treatment with Azstarys without talking to your healthcare provider first. AZSTARYS may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. on AZSTARYS 39.2 mg/7.8 mg once daily in the morning. Oops! Azstarys consists of SDX, KemPharm's prodrug of d-methylphenidate (d-MPH), co-formulated with immediate-release d-MPH. AZSTARYS passes into breast milk. New or worse, if you or your child develop painful and prolonged erections (priapism), seek medical help right away. Azstarys was approved in 2021 for treatment of ADHD in patients over age 6. The complete label for AZSTARYS, including prescribing information and important safety information, may be found at www.kempharm.com/pipeline-products/#kp415. Your doctor will recommend the dosage of Azstarys thats right for you. Azstarys may help increase attention and decrease impulsiveness and hyperactivity in people 6 years of age and older with ADHD. Azstarys can be taken with or without food. KemPharm is also advancing several clinical development candidates, including KP484 for the treatment of ADHD and KP879 for the treatment of Stimulant Use Disorder (SUD). Children treated with Azstarys had an average SKAMP-C score reduction of -5.4 points, compared with those receiving placebo. No, you cannot chew, crush, or split capsules of Azstarys. Many psychiatrists believe prescription amphetamines are overly regulated, especially in the case of lisdexamfetamine (Vyvanse) which has gradual onset of action, even if snorted or injected. After both drugs in Azstarys take effect, your body will clear them. AZSTARYS consists of SDX, KemPharms prodrug of d-methylphenidate (d-MPH), co-formulated with immediate release d-MPH. Channel providing free audio/video pronunciation tutorials in English and many other languages. The principal target symptoms for treatment of attention deficit hyperactivity disorder (ADHD) are inattention and impulsivity. AZSTARYS is a central nervous system (CNS) stimulant prescription medicine for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in people 6 years of age and older. 1 (26/5.2 mg and 39/7.8 mg), FD&C Red No. Generic name: SERDEXMETHYLPHENIDATE CHLORIDE 26.1mg, DEXMETHYLPHENIDATE HYDROCHLORIDE 5.2mg Central nervous system stimulants such as Azstarys have high potential for misuse and dependence. Symptoms, Diagnosis, and Treatments. Having investigated AZSTARYS and directly observed its clinical impact on patients, I believe this product will be an important new tool for physicians to use in providing effective care for patients with ADHD.. PO opioids are much more addictive than PO amphetamines. Before starting Azstarys, ask your doctor or pharmacist whether its safe for you to drink alcohol during treatment. Several large studies have found no evidence that stimulants increase the risk of serious cardiovascular events for individuals without known heart problems. The first-line treatment of ADHD is a stimulant of the amphetamine or methylphenidate class. You may have questions about Azstarys and your treatment plan. Bronchospasm, rash, and pruritus have been reported in patients who received Azstarys. Please enable JavaScript and refresh the page in order to complete this form. The contents can be sprinkled onto 2 tablespoons of applesauce. Since 1998, millions of parents and adults have trusted ADDitude's expert guidance and support for living better with ADHD and its related mental health conditions. Keep AZSTARYS in a safe place to prevent misuse and abuse. WARNING: AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. Because of this, Azstarys may offer all-day symptom relief with a single pill. Both Asperger's and ADHD are conditions which may be diagnosed early in life, and they may share certain symptoms which may appear similar. In people who have high blood pressure or a fast heart rate, taking this drug may worsen their condition. endstream endobj startxref Do not store applesauce or water and medicine mixture. taking or have stopped taking within the past 14 days a medicine used to treat depression called a monoamine oxidase, if you or your child have heart problems, heart defects, high blood pressure, or a family history of these problems. Below are commonly used dosages, but always take the dosage your doctor prescribes. So dont be afraid to ask questions or offer feedback on your treatment. This link will take you to a third-party website. Azstarys dexmethylphenidate 5.2 mg / serdexmethylphenidate 26.1 mg (KP415 286). ADHD is a mental health disorder that can cause inattentiveness, hyperactivity, and impulsive behavior. Br J Psychiatry194(3):204211,2009, www.kempharm.com/pipeline-products/#kp415, http://ml.globenewswire.com/Resource/Download/4f63af91-9427-40da-b881-82a5e22a0315. The norepinephrine reuptake inhibitor atomoxetine (Strattera) is noncontrolled and approved for ADHD but is substantially less effective than stimulants. If you have trouble swallowing pills, see this article for a few tips that may help. Symptoms of a severe allergic reaction can include swelling under your skin, usually in your eyelids, lips, hands, or feet. Azstarys increases the amount of dopamine present between cells in the brain. The recommended starting dosage of AZSTARYS is 39.2 mg serdexmethylphenidate/7.8 mg dexmethylphenidate once daily in the morning. AZSTARYS is a federally controlled substance (CII) because it can be abused or lead to dependence. Azstarys passes into breast milk Talk to your healthcare provider about the best way to feed the baby during treatment. AZSTARYS, KP484, and KP879 are all based on SDX. Azstarys (serdexmethylphenidate and dexmethylphenidate) is a prescription medication used to treat Attention-Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, and adults. Before taking Azstarys, be sure to tell your doctor about all medications you take, including prescription and over-the-counter drugs. Milligram per milligram, Adderall (amphetamine) is about twice as potent as Ritalin (methylphenidate). ADHD is a mental health disorder that can cause inattentiveness . Call your doctor for medical advice about side effects. Find answers to some commonly asked questions about Azstarys. Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Costs of prescription drugs can vary depending on many factors. Before you start taking Azstarys, tell your doctor if you have a history of psychosis.