Protocol for desensitization to rosuvastatin

Statins decrease cholesterol levels by inhibiting 3-hydroxy-3-methyl-glutaryl–coenzyme A reductase levels. Statins reduce morbidity and mortality in patients with a previous myocardial infarction (MI).

Use of statins has been associated with myositis and skin reactions, such as toxic epidermal necrolysis, urticarial vasculitis, drug reaction with eosinophilia and systemic symptoms syndrome, and chronic urticaria. However, anaphylaxis to statins and desensitization have been rarely reported.

A letter to the editor published in JACI, reported successful rapid oral desensitization to rosuvastatin in a 37-year-old man. He had a reported anaphylaxis to multiple statin agents.

He had a life-threatening reaction to 2 different statins that was consistent with an IgE-mediated immediate hypersensitivity mechanis. He was not challenged with a full-dose statin agent because of the significant risks.

Rosuvastatin was chosen as the agent for rapid oral desensitization because he had not previously received this statin. Rosuvastatin contains a sulfonamide group, but the patient had no prior history of adverse reactions to sulfonamides.

The patient was admitted to the cardiac intensive care unit (ICU) and an arterial line was placed. In preparation for the desensitization, beta-blocker was held for 72 hours before the procedure should epinephrine need to be administered. He was pretreated with montelukast and zileuton for 48 hours before the procedure, and on the morning of the desensitization, he received aspirin, ranitidine, and odansetron. H1 blockers were held before desensitization over concerns that this might mask an early IgE-mediated reaction.

He was started on a dose of 0.01 mg of rosuvastatin, which was increased as outlined in Table 1.

Table 1. Oral rosuvastatin desensitization protocol.

Time -- Dose (mg) -- Concentration (mg/mL) -- mL
0:00 0.01 0.01 1
0:30 0.02 0.01 2
1:00 0.04 0.01 4
1:30 0.08 0.01 8
2:00 0.1 0.1 1
2:30 0.2 0.1 2
3:00 0.4 0.1 4
3:30 0.8 0.1 8
4:00 1 1 1
4:30 2 1 2
5:00 4 1 4
5:30 8 1 8
6:00 10 10-mg tablet 10-mg tablet

Solutions were made by dissolving a 10-mg tablet of rosuvastatin in 10 mL of saline, then diluting to the 0.1 and 0.01 mg/mL concentrations. Doses were given every 30 minutes; if any reaction occurs, the dose can be repeated or decreased based on severity.

After receiving the 0.1-mg dose, the patient reported pruritus but had no urticaria. Blood pressure was stable. He was treated with 50 mg of diphenhydramine and 100 mg of hydrocortisone, the 0.1-mg dose was repeated, and the protocol was continued and successfully completed with a final oral dose of 10 mg. The patient stayed overnight in ICU and was discharged the next day.

The authors claim that this is the first published desensitization protocol to statin agents in a patient with a history of anaphylaxis to these agents. The protocol enabled a high-risk cardiac patient to undergo successful desensitization in a carefully monitored intensive care setting.


Successful desensitization to rosuvastatin in a patient with a history of anaphylaxis to multiple statins. The Journal of Allergy and Clinical Immunology, Volume 131, Issue 1 , Pages 234-236, January 2013.

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