Consumer medicine information

1. Why am I using VYVANSE?

VYVANSE contains the active ingredient lisdexamfetamine dimesilate. VYVANSE is used to treat 1) Attention Deficit Hyperactivity Disorder (ADHD) AND 2) Binge Eating Disorder (BED).
For more information, see Section 1. Why am I using VYVANSE? in the full CMI.

2. What should I know before I use VYVANSE?

Do not use if you: have ever had an allergic reaction to VYVANSE or any of the ingredients listed at the end of the CMI; taking a medicine called a ‘monoamine oxidase inhibitor’ (MAOI) or have taken an MAOI in the last 14 days; have a thyroid problem; feel unusually excited, over-active, or un-inhibited; have ever had heart problems.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use VYVANSE? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with VYVANSE and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use VYVANSE?

• Take VYVANSE capsule once a day in the morning with or without food. The usual starting dose is 30 mg once a day, your doctor may change the dose until it is right for you. If you have trouble swallowing capsules, you may open your VYVANSE capsule and pour all of the powder into a soft food such as yogurt, water or orange juice; mix completely and consume mixed contents right away.

• Follow all directions given to you by your doctor or pharmacist carefully.

5. What should I know while using VYVANSE?

6. Are there any side effects?

Common side effects include decreased appetite, insomnia, dry mouth, headache, upper abdominal pain, weight decreased, feeling tired. Serious side effects include allergic reaction, chest pain, shortness of breath, mood changes, confusion, seizures.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

Boxed Warnings

Vyvanse has a potential for abuse, misuse, dependence, or diversion for non-therapeutic uses. Physicians should assess the risk of abuse prior to prescribing and monitor for signs of abuse and dependence while on therapy. Vyvanse should be prescribed cautiously to patients with a history of substance abuse or dependence. Careful supervision is required during withdrawal from abusive use since severe depression may occur. Withdrawal following chronic therapeutic use may unmask symptoms of the underlying disorder that may require follow-up.

1 Name of Medicine

Lisdexamfetamine dimesilate.

2 Qualitative and Quantitative Composition

Vyvanse capsules contain 20 mg, 30 mg, 40 mg, 50 mg, 60 mg or 70 mg of lisdexamfetamine dimesilate as the active ingredient.
Vyvanse (lisdexamfetamine dimesilate) was developed as a capsule for once a day oral administration. The chemical designation for lisdexamfetamine dimesilate is (2S)-2,6-diamino-N-[(1S)-1-methyl-2-phenylethyl] hexanamide dimethanesulfonate.
Lisdexamfetamine dimesilate is a white to off white powder that is highly soluble in water. Lisdexamfetamine dimesilate has a 2-octanol/water partition coefficient (logP) of -1.76; pKa₁ of 10.5/ pKa₂ of 7.7; and pH of 4.1 when dissolved in water.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Capsules.
Appearance. Vyvanse 20 mg capsule. Ivory opaque body and ivory opaque cap, printed 'S489' and '20 mg' in black ink.
Vyvanse 30 mg capsule. White opaque body and pink opaque cap, printed 'S489' and '30 mg' in black ink.
Vyvanse 40 mg capsule. White opaque body and blue/green opaque cap, printed 'S489' and '40 mg' in black ink.
Vyvanse 50 mg capsule. White opaque body and blue opaque cap, printed 'S489' and '50 mg' in black ink.
Vyvanse 60 mg capsule. Aqua blue opaque body and aqua blue opaque cap, printed 'S489' and '60 mg' in black ink.
Vyvanse 70 mg capsule. Blue opaque body and pink opaque cap, printed 'S489' and '70 mg' in black ink.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre telephone: 131126 (Australia).
Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rapid respiration, confusion, aggression, hallucinations, panic states, hyperpyrexia, rhabdomyolysis and other features of serotonin syndrome. Fatigue and depression usually follow the central nervous system stimulation. Cardiovascular effects include arrhythmias, hypertension or hypotension, and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhoea, and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma.
Management of acute amphetamine intoxication is largely symptomatic and includes administration of activated charcoal and sedation. If acute severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved.
Lisdexamfetamine and dexamphetamine are not dialysable. Acidification of the urine increases amphetamine excretion but is believed to increase risk of acute renal failure if myoglobinuria is present.
The prolonged release of Vyvanse in the body should be considered when treating patients with overdose.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Lisdexamfetamine dimesilate was negative (not clastogenic) in the mouse micronucleus test in vivo and was negative in the bacterial reverse mutation test and the L5178Y/TK+/- mouse lymphoma assay in vitro.
Carcinogenicity. Carcinogenicity studies of lisdexamfetamine dimesilate have not been performed.
No evidence of carcinogenicity was found in studies in which d-, l-amphetamine sulphate (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Formula: C₁₇H₃₃N₃O₇S₂.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSLISDIM.gif CAS numbers. Lisdexamfetamine: 608137-32-2.
Lisdexamfetamine dimesilate: 608137-33-3.
Molecular weight: 455.59.

7 Medicine Schedule (Poisons Standard)

Controlled Drug (S8).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/VYVANSST.gif