Adzenys XR-ODT

What Is Adzenys XR-ODT?

Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablets) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older.

What Are Side Effects of Adzenys XR-ODT?

Common side effects of Adzenys XR-ODT include:

• loss of appetite,
• insomnia,
• abdominal pain,
• mood swings,
• vomiting,
• nervousness,
• nausea,
• fever,
• weight loss,
• dry mouth,
• anxiety,
• agitation,
• dizziness,
• diarrhea,
• fast heart rate,
• weakness,
• and urinary tract infections.

Dosage for Adzenys XR-ODT

The starting dose of Adzenys XR-ODT for pediatric patients (ages 6 to 17 years) is 6.3 mg once daily in the morning. The maximum dose of Adzenys XR-ODT is 18.8 mg once daily for patients 6 to 12 years, and 12.5 mg once daily for patients 13 to 17 years. The adult dose of Adzenys XR-ODT is 12.5 mg once daily in the morning.

What Drugs, Substances, or Supplements Interact with Adzenys XR-ODT?

Adzenys XR-ODT may interact with monoamine oxidase inhibitors (MAOIs), sodium bicarbonate, acetazolamide, thiazide diuretics, guanethidine, reserpine, glutamic acid HCl, ascorbic acid, tricyclic antidepressants, and proton pump inhibitors (PPIs). Tell your doctor all medications and supplements you use.

Adzenys XR-ODT During Pregnancy and Breastfeeding

Adzenys XR-ODT is not recommended for use during pregnancy; it may harm a fetus. Adzenys XR-ODT is not recommended for use while breastfeeding.

Additional Information

Our Adzenys XR-ODT (amphetamine extended-release orally disintegrating tablets) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

Adzenys XR-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 Adzenys XR-ODT (Amphetamine Extended-release Orally Disintegrating Tablets)

 

Adzenys XR-ODT Professional Information

SIDE EFFECTS

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

• Drug Dependence [see BOX WARNING, WARNINGS AND PRECAUTIONS, and Drug Abuse And Dependence]
• Hypersensitivity to amphetamine, or other components of ADZENYS XR-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]
• 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.

The safety of ADZENYS XR-ODT has been established from adequate and well-controlled studies of single-entity amphetamine product extended-release (MAS ER) capsules [see Clinical Studies]. The adverse reactions of MAS ER capsules in these adequate and well-controlled studies are described below.

The premarketing development program for MAS ER included exposures in a total of 1315 participants in clinical trials (635 pediatric patients, 350 adolescent patients, 248 adult patients, and 82 healthy adult subjects). Of these, 635 patients (ages 6 to 12 years) were evaluated in two controlled clinical studies, one open-label clinical study, and two single-dose clinical pharmacology studies (N= 40).

Adverse Reactions Leading To Discontinuation Of Treatment

The most frequent adverse reactions leading to discontinuation of MAS ER in controlled and uncontrolled, multiple-dose clinical trials of pediatric patients ages 6 to 12 years (N=595) were anorexia (loss of appetite) (2.9%), insomnia (1.5%), weight loss (1.2%), emotional lability (1%), and depression (0.7%).

In a separate placebo-controlled 4-week study in pediatric patients ages 13 to 17 years with ADHD, five patients (2.1%) discontinued treatment due to adverse events among MAS ER-treated patients (N=233) compared to 0% who received placebo (N=54). The most frequent adverse event leading to discontinuation and considered to be drug-related (i.e., leading to discontinuation in at least 1% of MAS ER-treated patients and at a rate at least twice that of placebo) was insomnia (1.3%, n=3).

In one placebo-controlled 4-week study among adults with ADHD with doses 20 mg to 60 mg, 23 patients (12.0% ) discontinued treatment due to adverse events among MAS ER-treated patients (N=191) compared to one patient (1.6%) who received placebo (N=64). The most frequent adverse events leading to discontinuation and considered to be drug-related (i.e., leading to discontinuation in at least 1% of MAS ER-treated patients and at a rate at least twice that of placebo) were insomnia (5.2%, n=10), anxiety (2.1%, n=4), nervousness (1.6%, n=3), dry mouth (1.6%, n=3), anorexia (1.6%, n=3), tachycardia (1.6%, n=3), headache (1.6%, n=3), and asthenia (1.0%, n=2).

Adverse Reactions Occurring In Clinical Trials

Adverse reactions reported in a 3-week clinical trial of pediatric patients 6 to 12 years of age and a 4-week clinical trial in pediatric patients 13 to 17 years of age and adults, respectively, treated with MAS ER or placebo are presented in the tables below.

Table2: Adverse Reactions Reported by 2% or More of Pediatric Patients (6-12 years old) Receiving MAS ER with Higher Incidence than on Placebo in a 584Patient Clinical Study

Body System	Adverse Reaction	MAS ER (n=374)	Placebo (n=210)
General	Abdominal Pain (stomachache)	14%	10%
	Fever	5%	2%
	Infection	4%	2%
	Accidental Injury	3%	2%
	Asthenia (fatigue)	2%	0%
Digestive System	Loss of Appetite	22%	2%
	Vomiting	7%	4%
	Nausea	5%	3%
	Dyspepsia	2%	1%
Nervous System	Insomnia	17%	2%
	Emotional Lability	9%	2%
	Nervousness	6%	2%
	Dizziness	2%	0%a
Metabolic/Nutritional	Weight Loss	4%	0%

Table 3: Adverse Reactions Reported by 5% or More of Pediatric Patients (13-17 Years Old) Weighing ≤ 75kg Receiving MAS ER with Higher Incidence than Placebo in a 287 Patient Clinical Forced Weekly-Dose Titration Study*

Body System	Preferred Term	MAS ER (n=233)	Placebo (n=54)
General	Abdominal Pain (stomachache)	11%	2%
Digestive System	Loss of Appetitea	36%	2%
Nervous System	Insomniaa	12%	4%
Metabolic/Nutritional	Weight Lossa	9%	0%
* Included doses up to 40 mg a Dose-related adverse reactions Note: The following reactions did not meet the criterion for inclusion in Table 3 but were reported by 2% to 4% of adolescent patients receiving MAS ER with a higher incidence than patients receiving placebo in this study: accidental injury, asthenia (fatigue), dry mouth, dyspepsia, emotional lability, nausea, somnolence, and vomiting.

Table 4: Adverse Reactions Reported by 5% or More of Adults Receiving MAS ER with Higher Incidence Than Placebo in a 255 Patient Clinical Forced Weekly-Dose Titration Study*

Body System	Preferred Term	MAS ER (n=191)	Placebo (n=64)
General	Headache	26%	13%
	Asthenia	6%	5%
Digestive System	Dry Mouth	35%	5%
	Loss of Appetite	33%	3%
	Nausea	8%	3%
	Diarrhea	6%	0%
Nervous System	Insomnia	27%	13%
	Agitation	8%	5%
	Anxiety	8%	5%
	Dizziness	7%	0%
Cardiovascular System	Tachycardia	6%	3%
Metabolic/Nutritional	Weight Loss	10%	0%
Urogenital System	Urinary Tract Infection	5%	0%
* Included doses up to 60 mg. Note: The following reactions did not meet the criterion for inclusion in Table 4 but were reported by 2% to 4% of adult patients receiving MAS ER with a higher incidence than patients receiving placebo in this study: infection, photosensitivity reaction, constipation, tooth disorder (e.g., teeth clenching, tooth infection), emotional lability, libido decreased, somnolence, speech disorder (e.g., stuttering, excessive speech), palpitation, twitching, dyspnea, sweating, dysmenorrhea, and impotence.

Note: The following reactions did not meet the criterion for inclusion in Table 4 but were reported by 2% to 4% of adult patients receiving MAS ER with a higher incidence than patients receiving placebo in this study: infection, photosensitivity reaction, constipation, tooth disorder (e.g., teeth clenching, tooth infection), emotional lability, libido decreased, somnolence, speech disorder (e.g., stuttering, excessive speech), palpitation, twitching, dyspnea, sweating, dysmenorrhea, and impotence.

Adverse Reactions From Clinical Trials And Spontaneous Postmarketing Reports Of Other Amphetamine Products

The following adverse reactions are from clinical trials and spontaneous postmarketing reports of other amphetamine products in pediatric patients and adults with ADHD. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

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

Central Nervous System: Restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, aggression, anger, logorrhea, and paresthesia (including formication) Eye Disorders: Vision blurred, mydriasis.

Gastrointestinal: Unpleasant taste, constipation, other gastrointestinal disturbances.

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

Endocrine: Impotence, change in libido, frequent or prolonged erections.

Skin: Alopecia.

Musculoskeletal, Connective Tissue, and Bone Disorders: rhabdomyolysis.

Psychiatric Disorders: dermatillomania, bruxism.

Vascular Disorders: Raynaud’s phenomenon.

Read the entire FDA prescribing information for Adzenys XR-ODT (Amphetamine Extended-release Orally Disintegrating Tablets)