Vyvanse (Lisdexamfetamine) and the Kidneys: Renal Protection or Renal Risk?

Does lisdexamfetamine protect the kidneys?

The label describes no kidney-protective effect and lists no kidney indication. Vyvanse is approved for ADHD in adults and children 6 and older, and for moderate to severe binge eating disorder in adults [1]. The label's kidney-specific content is a pair of dose limits for reduced kidney function and a urinary pH interaction [1].

How lisdexamfetamine is cleared

Lisdexamfetamine is a prodrug of dextroamphetamine. It is converted to dextroamphetamine and l-lysine mainly in blood by red blood cells, not by cytochrome P450 enzymes; the parent drug is inactive and does not bind norepinephrine or dopamine reuptake sites in vitro [1]. Amphetamines block reuptake of norepinephrine and dopamine into the presynaptic neuron and increase release of these monoamines; the exact mode of therapeutic action in ADHD and binge eating disorder is not known [1].

About 96% of an oral dose is recovered in urine: 42% as amphetamine, 25% as hippuric acid, and 2% as intact lisdexamfetamine [1]. Dextroamphetamine half-life is about 10 to 11.3 hours in healthy adults and 8.6 to 9.5 hours in children 6 to 12 [1].

What the label says about kidney impairment

The label sets two renal dose caps. For severe renal impairment (GFR 15 to <30 mL/min/1.73 m2), the maximum is 50 mg once daily. For end-stage renal disease (GFR <15), the maximum is 30 mg once daily [1]. The usual maximum for ADHD and binge eating disorder is 70 mg once daily [1].

Kidney disease is not one of the label's contraindications. The listed contraindications are known hypersensitivity to amphetamine products or other ingredients, and use of monoamine oxidase inhibitors or within 14 days of stopping one [1].

Does Vyvanse cause kidney damage?

The label's Warnings and Precautions cover abuse, misuse and addiction; serious cardiac disease; blood pressure and heart rate; psychiatric reactions; growth suppression in children; peripheral vasculopathy including Raynaud's phenomenon; serotonin syndrome; and tics and Tourette's syndrome. Kidney damage is not among them [1].

Blood pressure and heart rate

The label says CNS stimulants raise blood pressure by a mean of about 2 to 4 mm Hg and heart rate by about 3 to 6 bpm, with larger increases in some patients. It says to monitor all Vyvanse-treated patients for tachycardia and hypertension [1]. It also says to avoid Vyvanse in people with known structural cardiac abnormalities, cardiomyopathy, serious arrhythmia, coronary artery disease, or other serious cardiac disease; sudden death has been reported in patients with serious cardiac disease treated with CNS stimulants at ADHD doses [1]. Before treatment, the label says to assess for cardiac disease with a careful history, family history of sudden death or ventricular arrhythmia, and physical exam [1].

Urinary pH and sodium bicarbonate

The label says drugs that alter urinary pH change amphetamine blood levels. Acidifying agents such as ascorbic acid decrease levels, while alkalinizing agents such as sodium bicarbonate increase levels and potentiate the effects of amphetamine [1]. The label says coadministration with urinary alkalinizing agents should be avoided, and with acidifying agents it says to increase the dose based on clinical response [1].

Bottom line

Vyvanse's label handles reduced kidney function with two dose caps: 50 mg once daily for severe renal impairment and 30 mg once daily for end-stage renal disease. It also says to monitor blood pressure and pulse, because stimulants raise both [1].