Muse (Alprostadil) - Indications and Dosage

INDICATIONS AND USAGE

MUSE is indicated for the treatment of erectile dysfunction. Studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with similarly administered placebo.

DOSAGE AND ADMINISTRATION

MUSE is a transurethral delivery system available in 4 dosage strengths: 125 mcg, 250 mcg, 500 mcg, and 1000 mcg. MUSE should be administered as needed to achieve an erection. The onset of effect is within 5-10 minutes after administration. The duration of effect is approximately 30-60 minutes. However, the actual duration will vary from patient to patient. Each patient should be instructed by a medical professional on proper technique for administering MUSE prior to self-administration. The maximum frequency of use is no more than 2 systems per 24-hour period.

Initiation of Therapy: Dose titration should be administered under the supervision of a physician to test a patient's responsiveness to MUSE, to demonstrate proper administration technique (see detailed instructions for MUSE administration in patient package insert), and to monitor for evidence of hypotension (see WARNINGS). Patients should be individually titrated to the lowest dose that is sufficient for sexual intercourse. The lower doses of MUSE (125 mcg or 250 mcg) are recommended for initial dosing. If necessary, the dose should be increased (or decreased) on separate occasions in a stepwise manner until the patient achieves an erection that is sufficient for sexual intercouse.

Home Treatment Regimen: MUSE should be used as needed to achieve an erection. The maximum frequency of use is 2 administrations per 24-hour period. Each MUSE is for single use only and should be properly discarded after use.

CHANGING YOUR DOSAGE

It is assumed that you and your doctor have determined the proper dose of MUSE. If you suspect that your dose needs to be increased or decreased to achieve the response that works best for you, please call your doctor to determine if your dose needs to be reevaluated. Do not use MUSE more than twice in a 24-hour period.

HOW SUPPLIED

MUSE is supplied in individual foil pouches containing one (1) system per pouch. MUSE is available in unit cartons containing six (6) systems. MUSE is available in the following 4 dosage strengths:

STORAGE AND HANDLING

Store unopened foil pouches in a refrigerator at 2°-8°C (36°-46°F). Do not expose MUSE to temperatures above 30°C (86°F). MUSE may be kept by the patient at room temperature (below 30°C or 86°F) for up to 14 days prior to use.

Caution: Federal law prohibits dispensing without prescription.

Medical information line at VIVUS 1-888-345-MUSE (1-888-345-6873).

MUSE® IS A REGISTERED TRADEMARK OF VIVUS, INC. IN THE U.S. AND OTHER COUNTRIES.

Revised February 1998

PATIENT INFORMATION

Please read this pamphlet before using MUSE® (alprostadil). This pamphlet is a quick reference source on important information about MUSE for you and your partner. Before administering MUSE, please review the patient video and education booklet. These materials provide visual instruction and more detailed information as well as practical tips on how to use MUSE.

WHAT IS MUSE?

MUSE represents a unique approach for the treatment of erectile dysfunction, commonly called impotence. It is based on the discovery that the urethra (the normal pathway for urine) can absorb certain medications into the surrounding erectile tissues thereby creating an erection. There are 4 dose strengths available: 125, 250, 500, and 1000 micrograms. The MUSE applicator (Fig. 1) contained in each foil pouch is intended for 1 administration only. Your dose of MUSE will be determined by you and your physician. After administration, the erection process will begin within 5-10 minutes, and may last 30-60 minutes. However, the actual duration will vary from patient to patient.

WHAT IS MUSE USED FOR?

MUSE is indicated for the treatment of erectile dsyfunction. Erectile dysfunction is the inability to attain or maintain an erection sufficient for sexual intercourse.

WHO SHOULD NOT USE MUSE?

You should not use MUSE if you have any of the following:

• Known hypersensitivity to alprostadil (the active medication in MUSE)
• An abnormally formed penis
• Have been advised not to undertake sexual activity
• Conditions that might result in long-lasting erections, such as sickle cell anemia or trait, leukemia, or tumor of the bone marrow (multiple myeloma)
• MUSE should not be used for sexual intercourse with a pregnant woman unless the couple uses a condom barrier.