Sustiva (Efavirenz) Drug Information: Overdosage and Contraindications

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May 27, 2012

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HIV and AIDS: Antiretroviral Drugs, Treatments and Medications »

Entry Inhibitors (including Fusion Inhibitors) and CCR5 Co-receptor Antagonist

Entry Inhibitors
Entry inhibitors block HIV entry into CD4+ cells.

Fusion inhibitors
The only drug in this class is T-20, which is administered as a twice daily subcutaneous injection. The most common side effect is redness and pain at the site of injection. Rarely, infection can occur at the injection site. There also are reports of generalized allergic reactions.

CCR5 antagonist
Although there were some early concerns of liver inflammation for drugs in this class, MVC appeared to be well tolerated in clinical trials without any specific toxicities attributable to the drug. However, it is a new drug in a new class and the first to actually target the cell. For these reasons, longer follow-up from clinical trials and those followed in the clinic will be very important for assessing the overall safety of the...

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OVERDOSE

Some patients accidentally taking 600 mg twice daily have reported increased nervous system symptoms. One patient experienced involuntary muscle contractions.

Treatment of overdose with SUSTIVA should consist of general supportive measures, including monitoring of vital signs and observation of the patient's clinical status. Administration of activated charcoal may be used to aid removal of unabsorbed drug. There is no specific antidote for overdose with SUSTIVA. Since efavirenz is highly protein bound, dialysis is unlikely to significantly remove the drug from blood.

CONTRAINDICATIONS

Hypersensitivity

SUSTIVA is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (eg, Stevens-Johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of this product.

Contraindicated Drugs

For some drugs, competition for CYP3A by efavirenz could result in inhibition of their metabolism and create the potential for serious and/or life-threatening adverse reactions (eg, cardiac arrhythmias, prolonged sedation, or respiratory depression). Drugs that are contraindicated with SUSTIVA are listed in Table 2.

Table 2: Drugs That Are Contraindicated or Not Recommended for Use With SUSTIVA

Drug Class: Drug Name	Clinical Comment
Antimigraine: ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine)	Potential for serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
Benzodiazepines: midazolam, triazolam	Potential for serious and/or life-threatening reactions such as prolonged or increased sedation or respiratory depression.
Calcium channel blocker: bepridil	Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
GI motility agent: cisapride	Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Neuroleptic: pimozide	Potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
St. John's wort (Hypericum perforation)	May lead to loss of virologic response and possible resistance to efavirenz or to the class of non-nucleoside reverse transcriptase inhibitors (NNRTI).