Evekeo ODT

Last updated on RxList: 7/19/2021
Evekeo ODT Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Evekeo ODT?

Evekeo ODT (amphetamine sulfate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

What Are Side Effects of Evekeo ODT?

Common side effects of Evekeo ODT include:

Dosage for Evekeo ODT

The starting dose of Evekeo ODT is 5 mg once or twice daily. If necessary, administer an additional dose of Evekeo ODT after 4 to 6 hours.

What Drugs, Substances, or Supplements Interact with Evekeo ODT?

Evekeo ODT may interact with monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort, sodium bicarbonate, proton pump inhibitors, acetazolamide, some thiazides, guanethidine, reserpine, glutamic acid HCl, ascorbic acid, ammonium chloride, sodium acid phosphate, methenamine salts, quinidine, and ritonavir. Tell your doctor all medications and supplements you use.

Evekeo ODT During Pregnancy or Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Evekeo ODT; it may harm a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Evekeo ODT during pregnancy. Because of the potential for serious adverse reactions in nursing infants, breastfeeding is not recommended while using Evekeo ODT. Withdrawal symptoms may occur if you suddenly stop taking Evekeo ODT.

Additional Information

Our Evekeo ODT (amphetamine sulfate) Orally Disintegrating Tablets, CII Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

The abbreviated term ADHD denotes the condition commonly known as: See Answer
Evekeo ODT Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • signs of heart problems--chest pain, trouble breathing, feeling like you might pass out;
  • signs of psychosis--hallucinations (seeing or hearing things that are not real), new behavior problems, aggression, hostility, paranoia;
  • signs of circulation problems--numbness, pain, cold feeling, unexplained wounds, or skin color changes (pale, red, or blue appearance) in your fingers or toes;
  • a seizure (convulsions);
  • muscle twitches (tics);
  • pain or burning when you urinate; or
  • changes in your vision.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Amphetamine can affect growth. Tell your doctor if your child is not growing at a normal rate.

Common side effects may include:

  • increased heart rate;
  • mood changes, anxiety, feeling restless or nervous;
  • trouble sleeping;
  • dry mouth, stomach pain, nausea, vomiting, diarrhea, constipation;
  • loss of appetite, weight loss;
  • painful urination;
  • sexual problems, impotence;
  • headache, dizziness;
  • fever, weakness; or
  • itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Evekeo ODT (Aphetamine Sulfate Orally Disintegrating Tablets)

SLIDESHOW

ADHD Symptoms in Children See Slideshow
Evekeo ODT Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

  • Abuse and Dependence [see BOX WARNING, WARNINGS AND PRECAUTIONS, and Drug Abuse And Dependence]
  • Hypersensitivity to amphetamine, or other components of EVEKEO ODT [see CONTRAINDICATIONS]
  • Hypertensive Crisis When Used Concomitantly with Monoamine Oxidase Inhibitors [see CONTRAINDICATIONS and DRUG INTERACTIONS]
  • Serious Cardiovascular Reactions [see WARNINGS AND PRECAUTIONS]
  • Blood Pressure and Heart Rate Increases [see WARNINGS AND PRECAUTIONS]
  • Psychiatric Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Seizures [see WARNINGS AND PRECAUTIONS]
  • Long-Term Suppression of Growth [see WARNINGS AND PRECAUTIONS]
  • Peripheral Vasculopathy, including Raynaud's Phenomenon [see WARNINGS AND PRECAUTIONS]
  • Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Study 1 was conducted with EVEKEO tablets (i.e., not the ODT formulation) in children ages 6 to 12 years who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria for ADHD. This study began with an 8-week, open-label, dose-optimization phase followed by a 2-week double-blind, placebo-controlled, randomized, crossover phase. Adverse reactions reported in > 5% of patients (N=105; doses of 10 to 40 mg/day) during the open-label phase included: decreased appetite (28%), infections (22%), abdominal pain (15%), irritability (14%), headache (13%), nausea (6%), vomiting (6%), affect lability (includes mood swings; 9%), tachycardia (9%), insomnia (10%), fatigue (10%),and dry mouth (6%). During the open-label phase, six patients discontinued due to adverse reactions: irritability (n=3), affect lability (n=1), initial insomnia (n=1), and rash (n=1). Table 1 lists the adverse reactions reported during the double-blind, cross-over phase. No patient discontinued the study for an adverse reaction during the double-blind crossover phase. Because of the trial design (an initial 8-week, open-label, active treatment phase), the adverse reaction rates described in the double-blind phase are lower than expected in clinical practice.

Table 1: Adverse Reactions Reported in ≥ 2%, and > Placebo, of EVEKEO-Treated Pediatric Patients (6 to 12 Years) During the Double-Blind Cross-Over Weeks. a

System Organ Class
  Preferred Term
EVEKEO (n= 97) Placebo (n= 97)
Subjects with at least one adverse event 22% 14%
Metabolism and Nutrition Disorders
  Decreased appetite 4% 0%
Gastrointestinal Disorders
  Abdominal pain 3% 0%
Psychiatric Disorders
  Affect Labilityb 3% 0%
  Insomnia 4% 0%
Injury, poisoning and procedural complications
  Injury 3% 2%
a Drug exposures and placebo exposures from cross-over were combined for analysis.
b Includes mood swings.

Postmarketing Experience

The following adverse reactions have been associated during post approval use of amphetamines. Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System: Psychotic episodes at recommended doses, overstimulation, irritability, restlessness, dizziness, insomnia, euphoria, mood swings, aggression, anger, logorrhea, dermatillomania, dyskinesia, dysphoria, tremor, fatigue, headache, exacerbation of motor and phonic tics and Tourette’s syndrome

Gastrointestinal: Dry mouth, unpleasant taste, constipation, nausea, other gastrointestinal disturbances, anorexia, and weight loss.

Allergic: Urticaria, rash, hypersensitivity reactions, including angioedema and anaphylaxis. Serious skin rashes, including StevensJohnson Syndrome and toxic epidermal necrolysis have been reported.

Endocrine: Impotence, changes in libido, and frequent or prolonged erections.

Skin: Alopecia.

Vascular Disorders: Raynaud’s phenomenon.

Musculoskeletal: Rhabdomyolysis.

DRUG INTERACTIONS

Drugs Having Clinically Important Interactions With Amphetamines

Table 2: Drugs Having Clinically Important Interactions with Amphetamines

MAO Inhibitors (MAOI)
Clinical Impact MAOI antidepressants slow amphetamine metabolism, increasing amphetamines effect on the release of norepinephrine and other monoamines from adrenergic nerve endings causing headaches and other signs of hypertensive crisis. Toxic neurological effects and malignant hyperpyrexia can occur, sometimes with fatal results.
Intervention Do not administer EVEKEO ODT during or within 14 days following the administration of MAOI [see CONTRAINDICATIONS].
Examples selegiline, isocarboxazid, phenelzine, tranylcypromine, linezolid, methylene blue
Serotonergic Drugs
Clinical Impact The concomitant use of EVEKEO ODT and serotonergic drugs increases the risk of serotonin syndrome.
Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during EVEKEO ODT initiation or dosage increase. If serotonin syndrome occurs, discontinue EVEKEO ODT and concomitant serotonergic drug(s) [see WARNINGS AND PRECAUTIONS]
Examples Selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort
Alkalinizing Agents
Clinical Impact May increase exposure to amphetamine and exacerbate the action of amphetamine.
Intervention Caution should be taken when co-administering EVEKEO ODT and gastrointestinal and urinary alkalinizing agents.
Examples Gastrointestinal alkalinizing agents (e.g., sodium bicarbonate; proton pump inhibitors [e.g. omeprazole]) Urinary alkalinizing agents (e.g. acetazolamide, some thiazides)
Acidifying Agents
Clinical Impact Lower blood levels and efficacy of amphetamines.
Intervention Increase dose of EVEKEO ODT based on clinical response.
Examples Gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid HCl, ascorbic acid) Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts)
Tricyclic Antidepressants
Clinical Impact May enhance the activity of tricyclic or sympathomimetic agents causing sustained increases in the concentration of d- amphetamine in the brain; cardiovascular effects can be potentiated.
Intervention Monitor frequently and adjust EVEKEO ODT dose or use alternative therapy based on clinical response.
Examples desipramine, protriptyline
CYP2D6 Inhibitors
Clinical Impact The concomitant use of EVEKEO ODT and CYP2D6 inhibitors may increase the exposure of EVEKEO ODT compared to the use of the drug alone and increase the risk of serotonin syndrome.
Intervention Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during EVEKEO ODT initiation and after a dosage increase. If serotonin syndrome occurs, discontinue EVEKEO ODT and the CYP2D6 inhibitor. Alternatively, consider using a drug that does not inhibit CYP2D6 [see WARNINGS AND PRECAUTIONS and OVERDOSE].
Examples paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir.

Drug-Laboratory Test Interactions

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

Read the entire FDA prescribing information for Evekeo ODT (Aphetamine Sulfate Orally Disintegrating Tablets)

© Evekeo ODT Patient Information is supplied by Cerner Multum, Inc. and Evekeo ODT Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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