Introduction of aripiprazole lauroxil (Aristada®)
On October 5, 2015, the United States Food and Drug Administration approved aripiprazole lauroxil (Aristada®) for the treatment of schizophrenia in adults. But, wait a minute! Don’t we already have long-acting aripiprazole – Abilify Maintena®? Yes, we do. Abilify Maintena® is marketed by Otsuka America Pharmaceutical, Inc in partnership with Lundbeck. Now the product has a competitor: Aristada®, long-acting aripiprazole made by another company, Alkermes. Otsuka’s petition to the FDA to block approval of Aristada® was denied. Alkermes, by the way, is well-known for its expertise in drug delivery technology, including long-acting injections.
Dosing
Step 1:
Make sure the person has taken aripiprazole orally and is tolerating it
Step 2:
Choose the dose of aripiprazole lauroxil. It comes in four strengths: 441 mg, 662 mg, 882 mg and 1064 mg. These doses are equivalent to oral aripiprazole 300 mg, 450 mg, 600 mg, and 724 mg respectively.
Since the aripiprazole lauroxil will be given once a month, patients on oral aripiprazole 10 mg/day will need 300 mg of aripiprazole in a month (10 X 30 days). If you want to keep the person on the same dose, you would give 441 mg of aripiprazole intramuscularly once a month.
For patients on 15 mg/day of oral aripiprazole, give 662 mg of aripiprazole lauroxil once a month or 882 mg every 6 weeks or 1064 mg every 2 months.
For patients on 20 mg/day or more of oral aripiprazole, give 882 mg of aripiprazole lauroxil once a month.
Step 3:
Choose the interval between doses. For the 441 mg and 662 mg doses, give the injection once a month. If you decide to give 882 mg of aripiprazole lauroxil, you can give it every 6 weeks. For 1064 mg dose, you can give it every 2 months.
Step 4:
For the first 21 days, give BOTH oral aripiprazole and aripiprazole lauroxil.
Step 5:
Adjust the dose and the interval between doses based on response and side effects.
Step 6:
If the patient needs an increase in the dose, you can either increase the dose when the next injection is due OR give the aripiprazole lauroxil earlier than scheduled. However, the earliest a second injection can be given is 14 days after the first one.
Step 7:
If the person later starts on a strong inhibitor or inducer of either cytochrome P450 2D6 or 3A4 to be taken for more than two weeks, you will have to adjust the dose of the aripiprazole lauroxil.
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References
Prescribing information for aripiprazole lauroxil (Aristada®)
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