Lisdexamfetamine

Lisdexamfetamine comes as a capsule to be taken by mouth. It is usually taken once a day in the morning with or without food. Take lisdexamfetamine at around the same time every day. Do not take lisdexamfetamine in the late afternoon or evening because it may cause difficulty falling asleep or staying asleep. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take lisdexamfetamine exactly as directed.

You may swallow the capsule whole, or you may open the capsule, sprinkle the entire contents into yogurt, a glass of water, or orange juice. Stir to dissolve and swallow the mixture right away. Do not store the mixture for future use, and do not divide the contents of one capsule into more than one dose.

Your doctor will probably start you on a low dose of lisdexamfetamine and increase your dose gradually, not more often than once every week.Your doctor may decrease your dose if you experience unpleasant side effects.

Your doctor may tell you to stop taking lisdexamfetamine from time to time to see if the medication is still needed. Follow these directions carefully.

Lisdexamfetamine should not be used for weight loss in people who are obese or who are overweight.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

• Monoamine oxidase inhibitor (MAOIs) antidepressants such as isocarboxazid (Marplan), phenelzine (Nardil), tranylcypromine (Parnate), selegiline (Eldepryl) and procarbazine (Matulane), slow the elimination of amphetamines in the body. This increases the concentration of amphetamines and their effect. This can cause serious elevations in blood pressure (hypertensive crisis) with headaches, other signs of hypertensive crisis, and even fatal reactions. Vyvanse should not be administered until 14 days after MAOIs have been discontinued in order to allow the effects of the MAOIs to dissipate.
• Amphetamines increase the effect of norepinephrine. Combining both drugs may lead to serious cardiovascular toxicity.

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Tell your doctor and pharmacist about any drugs you're taking.

This includes prescription and over-the-counter (OTC) medications, vitamins and other dietary supplements (nutritional shakes, protein powders, etc.), herbal remedies, and any illegal and recreational drugs.

Don't take Vyvanse if you are taking monoamine oxidase inhibitors (MAOIs) or have taken them within 14 days.

MAOIs include Nardil (phenelzine), Parnate (tranylcypromine), and Marplan (isocarboxazid).

Ask your doctor if it's safe to take Vyvanse if you are also taking:

• Diet drugs, such as benzphetamine (Didrex), phendimetrazine (Brontril, Brontril PDM), and phentermine (Adipex-P)
• Selegeline (Eldepryl, Emsam, Zelapar)
• Procarbazine (Matulane)

There are many drugs that interact with Vyvanse.

These include drugs that make the urine more acidic than normal, such as vitamin C, or alkaline, such as sodium bicarbonate.

Vyvanse and Alcohol

Both alcohol and Vyvanse can cause dizziness, changes in mood, and dry mouth.

Drinking while taking Vyvanse could make all of these side effects worse, so don't drink while taking it.

Vyvanse and Grapefruit Juice

The liver breaks down Vyvanse and grapefruit juice differently, so grapefruit and the juice don't appear to affect Vyvanse.

>10%

Anorexia (27%)

Insomnia (27%)

Xerostomia (26%)

Headache (12%)

Upper abdominal pain (12%)

1-10%

Irritability (10%)

Problem of growth and development, weight decreased (pediatric patients, 9% )

Nausea (7%)

Diarrhea (7%)

Seizure (4% )

Rash (pediatric patients, 3%)

Hyperhidrosis (3%)

Increased blood pressure (3%)

Increased heart rate (2%)

Dizziness (5%)

Emotional lability (3%)

Tremor (2%)

Tics (2%)

Vomiting (9%)

Frequency Not Defined

Serious

• Chest pain, sudden death (rare), myocardial infarction, palpitations, ventricular hypertrophy
• Cerebrovascular accident, Gilles de la Tourette syndrome
• Stevens-Johnson syndrome, toxic epidermal necrolysis due to drug

Postmarketing Reports

Ophthalmic disorders: Blurred vision, mydriasis, diplopia, difficulties with visual accommodation

Cardiovascular: Palpitations, cardiomyopathy

General disorders and administration site conditions: Fatigue

Hepatobiliary disorders: Eosinophilic hepatitis

Immune and allergy system disorders: Anaphylactic reaction, hypersensitivity, Stevens-Johnson syndrome, angioedema, urticaria

Nervous system disorders: Somnolence, seizure, dyskinesia, tics, bruxism

Psychiatric disorders: Psychotic episodes, mania, hallucination, depression, aggression, dysphoria, euphoria, logorrhea, dermatillomania

Genitourinary: Libido changes, frequent/prolonged erections

Gastrointestinal: Constipation, dysgeusia

Musculoskeletal: Rhabdomyolysis

Serotonin syndrome (when coadministered with serotonergic drugs)

Dermatologic: Alopecia

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of lisdexamfetamine there are no specific foods that you must exclude from your diet when receiving lisdexamfetamine.

You should not use lisdexamfetamine if you are allergic to it.

Do not use lisdexamfetamine if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Stimulants have caused stroke, heart attack, and sudden death in certain people. Tell your doctor if you have:

• heart problems or a congenital heart defect;

• high blood pressure; or

• a family history of heart disease or sudden death.

To make sure this medicine is safe for you, tell your doctor if you or anyone in your family has ever had:

• depression, mental illness, bipolar disorder, psychosis, or suicidal thoughts or actions;

• kidney disease;

• coronary artery disease (clogged arteries);

• blood circulation problems in the hands or feet; or

• drug or alcohol addiction.

Some medicines can interact with lisdexamfetamine and cause a serious condition called serotonin syndrome. Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. Ask your doctor before making any changes in how or when you take your medications.

It is not known whether this medicine will harm an unborn baby. However, taking the medicine during pregnancy can cause premature birth, low birth weight, or withdrawal symptoms in the newborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Lisdexamfetamine can pass into breast milk and may cause side effects in the nursing baby. You should not breast-feed while using this medicine.

Lisdexamfetamine is not approved to treat ADHD in a child younger than 6 years old. Lisdexamfetamine is not approved to treat binge eating disorder in anyone younger than 18 years old.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of lisdexamfetamine can be fatal.

Overdose symptoms may include restlessness, tremor, muscle twitches, rapid breathing, hostility, violence, panic, muscle pain or weakness, and dark colored urine. These symptoms may be followed by depression and tiredness. Overdose may also cause seizure or coma.

(lis dex am FET a meen)

GFR ≥30 mL/minute/1.73 m2: There are no dosage adjustments provided in the manufacturer’s labeling.

GFR 15 to <30 mL/minute/1.73 m2: Maximum dose: 50 mg/day.

GFR <15 mL/minute/1.73 m2: Maximum dose: 30 mg/day.

ESRD requiring hemodialysis: Maximum dose: 30 mg/day; lisdexamfetamine and dextroamphetamine are not dialyzable.

Store at 20°C to 25°C (68°F to 77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from light.

Concerns related to adverse effects:

• Cardiovascular events: Stimulant use has been associated with serious cardiovascular events including sudden death in patients with preexisting structural cardiac abnormalities or other serious heart problems (sudden death in children and adolescents; sudden death, stroke and MI in adults). These products should be avoided in patients with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that could increase the risk of sudden death. Patients should be carefully evaluated for these cardiac disorders prior to initiation of therapy. Patients who develop exertional chest pain, unexplained syncope, or arrhythmias during therapy should be evaluated promptly. CNS stimulants may increase heart rate (mean increase: 3 to 6 bpm) and blood pressure (mean increase: 2 to 4 mm Hg); monitor all patients for tachycardia and hypertension.

• CNS effects: Amphetamines may impair the ability to engage in potentially hazardous activities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).

• Hypersensitivity: Hypersensitivity reactions, including anaphylaxis, Stevens-Johnson syndrome, angioedema, and urticaria have been observed.

• Peripheral vasculopathy: Stimulants are associated with peripheral vasculopathy, including Raynaud phenomenon; signs/symptoms are usually mild and intermittent, and generally improve with dose reduction or discontinuation. Digital ulceration and/or soft tissue breakdown have been observed rarely; monitor for digital changes during therapy and seek further evaluation (eg, rheumatology) if necessary.

• Visual disturbance: Difficulty in accommodation and blurred vision has been reported with the use of stimulants.

Disease-related concerns:

• Psychiatric disorders: Use with caution in patients with preexisting psychosis or bipolar disorder (may induce mixed/manic episode). May exacerbate symptoms of behavior and thought disorder in psychotic patients; new onset psychosis or mania may occur in children or adolescents with stimulant use. Patients should be screened for bipolar disorder and risk factors for developing mania prior to treatment; consider discontinuation if such symptoms (eg, delusional thinking, hallucinations, or mania) occur. May be associated with aggressive behavior or hostility (causal relationship not established); monitor for development or worsening of these behaviors.

• Tourette syndrome/tics: Use with caution in patients with Tourette syndrome or other tic disorders. Stimulants may exacerbate tics (motor and phonic) and Tourette syndrome; however, evidence demonstrating increased tics is limited. Evaluate for tics and Tourette syndrome prior to therapy initiation (AACAP [Murphy 2013]; Pliszka 2007).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Serotonin syndrome: Potentially life-threatening serotonin syndrome (SS) may occur when lisdexamfetamine is used in combination with other serotonergic agents (eg, selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, St. John's wort, tryptophan), agents that impair metabolism of serotonin (eg, monoamine oxidase inhibitors) or CYP2D6 inhibitors that impair metabolism of lisdexamfetamine. Concomitant use with monoamine oxidase inhibitors is contraindicated. If concomitant use of lisdexamfetamine with serotonergic drugs or CYP2D6 inhibitors is indicated, initiate lisdexamfetamine at a low dose and monitor patient closely for signs and symptoms of SS. Discontinue treatment (and any concomitant serotonergic agent) immediately if signs/symptoms arise.

Special populations:

• Elderly: Use caution in this age group due to CNS stimulant adverse effects.

• Pediatric: Appetite suppression may occur; particularly in children. Use of stimulants has been associated with weight loss and slowing of growth rate; monitor growth rate and weight during treatment. Treatment interruption may be necessary in patients who are not increasing in height or gaining weight as expected.

Other warnings/precautions:

• Abuse/misuse/diversion: [US Boxed Warning]: Has high potential for abuse and dependence; assess for abuse potential prior to use and monitor for signs of abuse and dependence while on therapy. Use with caution in patients with a history of ethanol or drug abuse. Prescriptions should be written for the smallest quantity consistent with good patient care to minimize possibility of overdose.

• ADHD treatment: Appropriate use: Recommended to be used as part of a comprehensive treatment program for attention deficit disorders.

• Weight loss: Appropriate use: Not indicated or recommended for weight loss; safety and efficacy not established for treatment of obesity.

• Discontinuation of therapy: Abrupt discontinuation following high doses or for prolonged periods may result in symptoms for withdrawal (eg, depression, extreme fatigue).

Cardiac evaluation should be completed on any patient who develops exertional chest pain, unexplained syncope, and any symptom of cardiac disease during treatment with stimulants. Thoroughly evaluate for cardiovascular risk and the presence of (and family history of) cardiac disease, cardiac arrhythmias, or Marfan syndrome prior to initiating treatment. Monitor heart rate, blood pressure, and consider obtaining ECG prior to initiation (Vetter 2008). Monitor growth (height and weight) in children; CNS activity in all patients; signs of peripheral vasculopathy (eg, digital changes); behavioral changes. Assess for risk of abuse prior to prescribing and signs of misuse, abuse, or addiction throughout treatment.

Commonly reported side effects of lisdexamfetamine include: insomnia and irritability. Other side effects include: dizziness, weight loss, and xerostomia. See below for a comprehensive list of adverse effects.

• Peak effects reached in approximately four hours.
• Differences in behavior have been observed two to four hours after taking a dose of lisdexamfetamine to treat symptoms of ADHD.
• When lisdexamfetamine is used in the treatment of binge eating disorder, a reduction in symptoms (specifically the number of binge days per week) may not happen for several weeks (in some people symptom reduction may take up to 12 weeks).

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LactMed Record Number

834

Last Revision Date

20150107

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