Dyanavel Xr

(Amphetamine)

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Dosage & Administration

* Recommended starting dosage is 2.5 mg or 5 mg once daily in the morning (

2.2 Recommended Dosage

The recommended starting dosage is 2.5 mg or 5 mg once daily in the morning. The dosage may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days based on clinical response. The maximum recommended dosage is 20 mg once daily.

)
* Dosage may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days up to a maximum daily dose of 20 mg (

2.2 Recommended Dosage

)
* May be taken with or without food (

2.3 Administration Information

Administer DYANAVEL XR orally once daily in the morning with or without food.

DYANAVEL XR Extended-Release Oral Suspension

Instruct patients to read the “Instructions for Use” for complete administration instructions.

* Ensure that the bottle adapter is firmly inserted into the bottle and do not remove once inserted.
* Shake the bottle of DYANAVEL XR extended-release oral suspension well before every administration.
* Use with the oral dosing dispenser provided by the pharmacist.

DYANAVEL XR Extended-Release Tablets

* May be chewed or swallowed whole

[see Clinical Pharmacology (12.3)].

The 5 mg extended-release tablet is functionally scored and may be divided into equal halves (2.5 mg) at the score line.

)
* Extended-release oral suspension: Shake bottle before administering (

2.3 Administration Information

Administer DYANAVEL XR orally once daily in the morning with or without food.

DYANAVEL XR Extended-Release Oral Suspension

Instruct patients to read the “Instructions for Use” for complete administration instructions.

DYANAVEL XR Extended-Release Tablets

* May be chewed or swallowed whole

[see Clinical Pharmacology (12.3)].

The 5 mg extended-release tablet is functionally scored and may be divided into equal halves (2.5 mg) at the score line.

)
* Extended-release tablets: May be chewed or swallowed whole (

2.3 Administration Information

Administer DYANAVEL XR orally once daily in the morning with or without food.

DYANAVEL XR Extended-Release Oral Suspension

Instruct patients to read the “Instructions for Use” for complete administration instructions.

DYANAVEL XR Extended-Release Tablets

* May be chewed or swallowed whole

[see Clinical Pharmacology (12.3)].

The 5 mg extended-release tablet is functionally scored and may be divided into equal halves (2.5 mg) at the score line.

)
* DYANAVEL XR oral suspension can be substituted with DYANAVEL XR tablets on a milligram per milligram basis (

2.4 Switching from Other Amphetamine Products

DYANAVEL XR extended-release oral suspension can be substituted with DYANAVEL XR extended-release tablets on a milligram-per-milligram basis

[

see

Clinical Pharmacology (12.3)

]

If switching from other amphetamine products, discontinue that treatment, and titrate with DYANAVEL XR using the above titration schedule. Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine salt compositions and differing pharmacokinetic profiles

[

see

Description (11) ,

Clinical Pharmacology (12.3)

]

)
* Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine salt compositions and differing pharmacokinetic profiles (

2.4 Switching from Other Amphetamine Products

DYANAVEL XR extended-release oral suspension can be substituted with DYANAVEL XR extended-release tablets on a milligram-per-milligram basis

[

see

Clinical Pharmacology (12.3)

]

[

see

Description (11) ,

Clinical Pharmacology (12.3)

]

)

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Dyanavel XR Prescribing Information

DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death

[see

10
OVERDOSAGE

Clinical Effects of Overdose

Overdose of CNS stimulants is characterized by the following sympathomimetic effects:

Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop.
CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur.
Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop.

Overdose Management

Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of DYANAVEL XR should be considered when treating patients with overdose. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

]

, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout DYANAVEL XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction

[see

5.1 Abuse, Misuse, and Addiction

DYANAVEL XR has a high potential for abuse and misuse. The use of DYANAVEL XR exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. DYANAVEL XR can be diverted for non-medical use into illicit channels or distribution

[see Drug Abuse and Dependence (9.2)].

Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death

[see Overdosage (10)]

, and this risk is increased with higher doses and or unapproved methods of administration, such as snorting or injection.

Before prescribing DYANAVEL XR, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug. Advise patients to store DYANAVEL XR in a safe place, preferably locked, and instruct patients to not give DYANAVEL XR to anyone else. Throughout DYANAVEL XR treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction.

9.2 Abuse

DYANAVEL XR has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction

[see Warnings and Precautions (5.1)]

. DYANAVEL XR can be diverted for non-medical use into illicit channels or distribution.

Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.

Misuse and abuse of amphetamine may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including DYANAVEL XR, can result in overdose and death

[see Overdosage (10)],

and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.

]

Indications and Usage (

1
INDICATIONS AND USAGE

DYANAVEL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older

[see Clinical Studies (14)].

Limitations of Use

The use of DYANAVEL XR is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage

[see Warnings and Precautions (5.5), Use in Specific Populations (8.4)].

DYANAVEL XR is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older

Limitations of Use

)

09/2025

Warnings and Precautions (

5.5 Long-Term Suppression of Growth in Pediatric Patients

DYANAVEL XR is not approved for use and is not recommended in pediatric patients below 6 years of age

[see Use in Specific Populations (8.4)].

CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in DYANAVEL XR treated pediatric patients treated with CNS stimulants.

Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

)

09/2025

DYANAVEL XR is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years and older

[see

14
CLINICAL STUDIES

The efficacy of DYANAVEL XR extended-release oral suspension was evaluated in a laboratory classroom study conducted in 108 pediatric patients (aged 6 to 12 years) with ADHD. The study began with an open-label dose optimization period (5 weeks) with an initial DYANAVEL XR dose of 2.5 or 5 mg once daily in the morning. The dose could be titrated weekly in increments of 2.5 to 10 mg until an optimal dose or the maximum dose of 20 mg/day was reached. Subjects then entered a 1-week randomized, double-blind treatment with the individually optimized dose of DYANAVEL XR or placebo. At the end of the week, school teachers and raters evaluated the attention and behavior of the subjects in a laboratory classroom using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) rating scale. SKAMP is a 13-item teacher-rated scale that assesses manifestations of ADHD in a classroom setting. Each item is rated on a 7-point impairment scale.

The primary efficacy endpoint was change from pre-dose in the SKAMP-Combined score at 4 hours post-dosing. The key secondary efficacy parameters were onset and duration of clinical effect. The change scores from pre-dose SKAMP-Combined scores at post-dose time points (1, 2, 4, 6, 8, 10, 12 and 13 hours) were used to evaluate the key secondary efficacy parameters. Results from the double-blind, placebo-controlled week of the study are summarized in Table 3 and Figure 3.

SKAMP-Combined change scores from pre-dose demonstrated a statistically significant improvement at all time points (1, 2, 4, 6, 8, 10, 12, 13 hours) post-dosing with DYANAVEL XR compared to placebo.

Table 3. Summary of Primary Efficacy Results in Pediatric Patients (6 to 12 years) with ADHD


Study Number	Treatment Group	Primary Efficacy Measure: SKAMP-Combined Score
		Mean Pre - dose Score (SD)	LS Mean Change from Pre-Dose at 4 Hours Post-Dosing (SE)	Placebo-subtracted Difference ^a ( 95% CI )
Study 1	DYANAVEL XR Extended-Release Oral Suspension	17.3 (8.88)	-8.8 (1.14)	-14.8 (-17.9, -11.6)
	Placebo	15.5 (7.35)	6.0 (1.19)	--
SD: standard deviation; SE: standard error; LS Mean: least-squares mean; CI: confidence interval. ^aDifference (drug minus placebo) in least-squares mean change from pre-dose.

Figure 3.

LS Mean Change from Pre-dose in SKAMP-Combined Score after Treatment with

DYANAVEL XR Extended-Release Oral Suspension

or Placebo in Pediatric Patients (6 to 12 years) with ADHD

Figure3

Limitations of Use

[see

5.5 Long-Term Suppression of Growth in Pediatric Patients

DYANAVEL XR is not approved for use and is not recommended in pediatric patients below 6 years of age

[see Use in Specific Populations (8.4)].

Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.

8.4 Pediatric Use

The safety and effectiveness of DYANAVEL XR have not been established in pediatric patients below the age of 6 years.

In studies evaluating extended-release amphetamine products, patients 4 to <6 years of age had higher systemic amphetamine exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss.

The safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years

[

see

Adverse Reactions (6.1)

Clinical Pharmacology (12)

, and

Clinical Studies (14)

Long-Term Growth Suppression

Growth should be monitored during treatment with stimulants, including DYANAVEL XR, and pediatric patients who are not growing or gaining weight as expected may need to have their treatment interrupted

[

see

Warnings and Precautions (5.5)

]

Recommended starting dosage is 2.5 mg or 5 mg once daily in the morning (
2.2 Recommended Dosage
The recommended starting dosage is 2.5 mg or 5 mg once daily in the morning. The dosage may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days based on clinical response. The maximum recommended dosage is 20 mg once daily.
)
Dosage may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days up to a maximum daily dose of 20 mg (
2.2 Recommended Dosage
The recommended starting dosage is 2.5 mg or 5 mg once daily in the morning. The dosage may be increased in increments of 2.5 mg to 10 mg per day every 4 to 7 days based on clinical response. The maximum recommended dosage is 20 mg once daily.
)
May be taken with or without food (
2.3 Administration Information
Administer DYANAVEL XR orally once daily in the morning with or without food.

DYANAVEL XR Extended-Release Oral Suspension
Instruct patients to read the “Instructions for Use” for complete administration instructions.
- Ensure that the bottle adapter is firmly inserted into the bottle and do not remove once inserted.
- Shake the bottle of DYANAVEL XR extended-release oral suspension well before every administration.
- Use with the oral dosing dispenser provided by the pharmacist.
DYANAVEL XR Extended-Release Tablets
- May be chewed or swallowed whole
  [see Clinical Pharmacology (12.3)].
- The 5 mg extended-release tablet is functionally scored and may be divided into equal halves (2.5 mg) at the score line.
)
Extended-release oral suspension: Shake bottle before administering (
2.3 Administration Information
Administer DYANAVEL XR orally once daily in the morning with or without food.

DYANAVEL XR Extended-Release Oral Suspension
Instruct patients to read the “Instructions for Use” for complete administration instructions.
- Ensure that the bottle adapter is firmly inserted into the bottle and do not remove once inserted.
- Shake the bottle of DYANAVEL XR extended-release oral suspension well before every administration.
- Use with the oral dosing dispenser provided by the pharmacist.
DYANAVEL XR Extended-Release Tablets
- May be chewed or swallowed whole
  [see Clinical Pharmacology (12.3)].
- The 5 mg extended-release tablet is functionally scored and may be divided into equal halves (2.5 mg) at the score line.
)
Extended-release tablets: May be chewed or swallowed whole (
2.3 Administration Information
Administer DYANAVEL XR orally once daily in the morning with or without food.

DYANAVEL XR Extended-Release Oral Suspension
Instruct patients to read the “Instructions for Use” for complete administration instructions.
- Ensure that the bottle adapter is firmly inserted into the bottle and do not remove once inserted.
- Shake the bottle of DYANAVEL XR extended-release oral suspension well before every administration.
- Use with the oral dosing dispenser provided by the pharmacist.
DYANAVEL XR Extended-Release Tablets
- May be chewed or swallowed whole
  [see Clinical Pharmacology (12.3)].
- The 5 mg extended-release tablet is functionally scored and may be divided into equal halves (2.5 mg) at the score line.
)
DYANAVEL XR oral suspension can be substituted with DYANAVEL XR tablets on a milligram per milligram basis (
2.4 Switching from Other Amphetamine Products
DYANAVEL XR extended-release oral suspension can be substituted with DYANAVEL XR extended-release tablets on a milligram-per-milligram basis
[
see
Clinical Pharmacology (12.3)
]
.
If switching from other amphetamine products, discontinue that treatment, and titrate with DYANAVEL XR using the above titration schedule. Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine salt compositions and differing pharmacokinetic profiles
[
see
Description (11) ,
Clinical Pharmacology (12.3)
]
.
)
Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine salt compositions and differing pharmacokinetic profiles (
2.4 Switching from Other Amphetamine Products
DYANAVEL XR extended-release oral suspension can be substituted with DYANAVEL XR extended-release tablets on a milligram-per-milligram basis
[
see
Clinical Pharmacology (12.3)
]
.
If switching from other amphetamine products, discontinue that treatment, and titrate with DYANAVEL XR using the above titration schedule. Do not substitute for other amphetamine products on a milligram-per-milligram basis, because of different amphetamine salt compositions and differing pharmacokinetic profiles
[
see
Description (11) ,
Clinical Pharmacology (12.3)
]
.
)

DYANAVEL XR (amphetamine) extended-release oral suspension:

Extended-release oral suspension contains 2.5 mg amphetamine base equivalents per mL.

DYANAVEL XR (amphetamine) extended-release tablets:

5 mg: Off-white, speckled, caplet shaped tablet with ‘5’ debossed on one side and functionally scored on the other side
10 mg: Off-white, speckled, diamond shaped tablet with ‘10’ debossed on one side and plain on the other side
15 mg: Off-white, speckled, triangle shaped tablet with ‘15’ debossed on one side and plain on the other side
20 mg: Off-white, speckled, oval shaped tablet with ‘20’ debossed on one side and plain on the other side

All strengths are expressed in terms of amphetamine base equivalents.

Pregnancy:
May cause fetal harm (
8.1 Pregnancy
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to DYANAVEL XR during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/.
Risk Summary
There are limited published data on the use of amphetamines in pregnant women. These data are insufficient to determine a drug-associated risk of major congenital malformations or miscarriage. Adverse pregnancy outcomes, including premature delivery and low birth weight, have been seen in infants born to mothers dependent on amphetamines. No effects on morphological development were observed in embryo-fetal development studies with oral administration of amphetamine to rats and rabbits during organogenesis at doses that are approximately 3 and 16 times, respectively, the maximum recommended human dose (MRHD) of 20 mg/day (as base equivalents) on a mg/m²basis, given to adults. However, long-term neurochemical and behavioral effects have been reported in published animal developmental studies using clinically relevant doses of amphetamine
[see
Data
].
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Fetal/Neonatal adverse reactions
Amphetamines, such as DYANAVEL XR, may cause vasoconstriction, including vasoconstriction of placental blood vessels, and may increase the risk for intrauterine growth restriction. In addition, amphetamines can stimulate uterine contractions increasing the risk of premature delivery. Premature delivery and low birth weight infants have been reported in amphetamine-dependent mothers.
Monitor infants born to mothers taking amphetamines for symptoms of withdrawal, such as feeding difficulties, irritability, agitation, and excessive drowsiness.
Data
Animal Data
Amphetamine (
d
- to
l
- enantiomer ratio of 3:1) had no apparent effects on embryofetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 3 and 16 times, respectively, the MRHD of 20 mg/day (as base equivalents) on a mg/m²basis, given to adults. Fetal malformations and death have been reported in mice following parenteral administration of
d
-amphetamine doses of 50 mg/kg/day (approximately 12 times the MRHD) given to adults on a mg/m²basis or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity.
A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine
(
d
- or
d
,
l
-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.
)
Lactation:
Breastfeeding not recommended (
8.2 Lactation
Risk Summary
Based on limited case reports in published literature, amphetamine (
d
- or
d
,
l
-) is present in human milk, at relative infant doses of 2% to 13.8% of the maternal weight-adjusted dosage and a milk/plasma ratio ranging between 1.9 and 7.5. There are no reports of adverse effects on the breastfed infant and no effects on milk production. However, long term neurodevelopmental effects on infants from stimulant exposure are unknown. Because of the potential for serious adverse reactions in a breastfed infant, advise patients that breastfeeding is not recommended during treatment with DYANAVEL XR.
)

Dyanavel Xr

Dosage & Administration

Dyanavel XR Prescribing Information

Dyanavel XR Prior Authorization Resources

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