Dear Health Care Provider:

Novartis would like to inform you of recent changes to the prescribing information (PI) for Cafergot (ergotamine tartrate and caffeine) Suppositories, which include a new BOXED WARNING section related to interactions with potent CYP 3A4 inhibitors as follows:

Coadministration of ergotamine with potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, and troleandomycin) has been associated with acute ergot toxicity (ergotism) characterized by vasospasm and ischemia of the extremities, with some cases resulting in amputation. There have been rare reports of cerebral ischemia in patients on protease inhibitor therapy when CAFERGOT® (ergotamine tartrate and caffeine) was coadministered, at least one resulting in death. Because of the increased risk for ergotism and other serious vasospastic adverse events, ergotamine use is contraindicated with these drugs and other potent inhibitors of CYP 3A4 (e.g., ketoconazole, itraconazole).

The sections CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and CLINICAL PHARMCOLOGY: Pharmacokinetics: Interactions of the PI have been updated accordingly, see the enclosed revised PI for complete prescribing information.

At the same time of this revision of the PI, we have also updated the already existing information about fibrotic complications (see WARNINGS section), and have reinforced that CAFERGOT® (ergotamine tartrate and caffeine) should not be used for chronic daily administration (see DOSAGE AND ADMINISTRATION section).

Novartis is committed to providing you with the most current product information available for the management of patients receiving CAFERGOT® (ergotamine tartrate and caffeine). You can further our understanding of adverse events by reporting them.

Health care professionals should report all serious adverse events suspected to be associated with use of CAFERGOT® (ergotamine tartrate and caffeine) to Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, New Jersey 07936, or phone at (800) 448 - 5938 or the internet at http://www.novartis.com.

Alternatively, this information may be reported to the FDA's MedWatch Reporting System by phone at 1-800-FDA-1088, by fax 1-800-FDA-0178, by mail using the Form 3500 at MedWatch, HF-2, 5600 Fishers Lane, Rockville, MD 20857; or the internet at http://www.accessdata.FDA.gov/scrips/medwatch.

Please see the enclosed revised PI for complete prescribing information. Current and future patients being treated with CAFERGOT® (ergotamine tartrate and caffeine) should be fully informed of the above information.

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