ElamipretideNursing considerations

Side effects by what to assess

Sources: [1][2][3]

eGFR (glomerular filtration rate)

Why

Dose selection in renal impairment

When

Before starting and when kidney function changes

Act on

Below 30 mL/min and not on dialysis: reduce to 20 mg daily

Normal

90 to 120 mL/min/1.73 m². Below 60 for 3 or more months points to chronic kidney disease.

Sources: [1][2]

Eosinophil count

Why

Drug-related eosinophilia

Act on

Rises peak near 90 days and resolve within 6 to 12 months; no action needed if asymptomatic

Sources: [1]

High-alert status

Elamipretide is not on the ISMP acute care high-alert list.

Sources: [1]

Narrow therapeutic index

The label does not describe a narrow therapeutic index or direct dosing by measured blood levels of the drug.

Sources: [1]

Boxed warning

None. The Forzinity label carries no boxed warning.

Sources: [1]

Antidote or reversal

No specific antidote. No overdoses occurred in trials; symptoms would likely be histamine-related, such as low blood pressure or near-fainting. Interrupt treatment and give standard supportive care.

Sources: [1]

Patient teaching

• Inject at the same time every day and rotate between the abdomen and outer thighs
• Redness, itching, pain, or bruising at the injection site can be treated with antihistamines or a steroid cream
• Stop and get emergency care for rash, widespread itching, cough with trouble breathing, or swelling
• Throw away a vial 8 days after opening it
• If you miss a dose, skip it; do not take two doses
• Tell your clinician about any kidney disease, since the dose may need to be lower

Sources: [1][2][3][4]

Sound-alike and look-alike names

None listed in the ISMP list of confused drug names.

Sources: [1]

Adult dose

Barth syndrome, weight 30 kg or more

40 mg subcutaneously once daily.

Adults with eGFR below 30 mL/min, not on dialysis

20 mg subcutaneously once daily. No recommendation for adults on dialysis or for pediatric patients with renal impairment.

Sources: [1][2]

Renal adjustment

Adults with eGFR below 30 mL/min who are not on dialysis: 20 mg daily. Exposure rose 39%, 75%, and 125% across mild, moderate, and severe impairment, and the inactive metabolites rose far more. No recommendation for dialysis or for children with renal impairment.

Sources: [1][2][3]

Hepatic adjustment

None expected. Elamipretide has no hepatic metabolism in vitro, so hepatic impairment should not change its pharmacokinetics.

Sources: [1]

Mechanism

A mitochondrial cardiolipin binder. It settles on the inner mitochondrial membrane and improves the shape and function of mitochondria. Subcutaneous bioavailability is about 92%, protein binding about 39%, and the drug and its two inactive metabolites are excreted in urine.

Sources: [1][2]