Patient Medication Information: uses, side effects, how to take - Muse (Knight Therapeutics)

What is MUSE used for?

MUSE is used in adult males (18 years and older) to treat erectile dysfunction. Erectile dysfunction, also called impotence, is the inability to get or maintain an erection sufficient for sexual activity.

How does MUSE work?

MUSE belongs to a group of medicines called prostaglandins. It is inserted and absorbed in the urethra (tube that allows urine from the bladder out of the body during urination). MUSE works to relax and dilate the blood vessels of the penis. This increases blood flow, leading to an erection.

What are the ingredients in MUSE?

Medicinal ingredient: alprostadil.

Non-medicinal ingredient: polyethylene glycol 1450.

MUSE comes in the following dosage forms:

Suppositories: 250 mcg, 500 mcg, or 1000 mcg of alprostadil.

Do not use MUSE if:

you are allergic to alprostadil or to any of the other ingredients in MUSE.
you have an abnormally formed penis.
you have an infection or inflammation at the head of the penis or the urethra.
you have been advised not to undertake sexual activity.
you have conditions that might result in long-lasting erections, blood clots, or blood being thicker than normal, such as:
- sickle cell anemia (a disorder that affects the shape of red blood cells) or sickle cell trait (if you carry one copy of the sickle cell gene but do not have the sickle cell anemia),
- leukemia (a type of blood cancer), or
- multiple myeloma (a tumour of the bone marrow).
you have sexual intercourse with a pregnant woman without a condom barrier.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MUSE. Talk about any health conditions or problems you may have, including if you:

have or may have an erectile dysfunction related to a reversible cause.
have heart problems.
have a history of fainting.
have a bleeding disorder or are at a higher risk of bleeding.
have rigid erections lasting at least 4 hours.
have lung problems.

Other warnings you should know about:

Driving and using machines: MUSE can cause dizziness or fainting, especially at the start of your treatment and within one hour after taking MUSE. You should avoid driving or doing tasks that require special attention after taking MUSE.

Pregnancy: MUSE does not have birth control properties. If the partner is a female that is able to get pregnant, it is recommended you use adequate birth control. MUSE must not be used for sexual intercourse with a pregnant woman unless a condom barrier is used.

Sexually transmitted diseases (STDs): MUSE will not protect you or your partner from sexually transmitted diseases. This includes chlamydia, gonorrhea, herpes simplex virus, viral hepatitis, human immunodeficiency virus (HIV - the virus that causes AIDS), human papilloma virus (genital warts), and syphilis. Latex condoms can protect against these sexually transmitted diseases.

Testing and check-ups: Your healthcare professional will assess your health before and during your treatment with MUSE, especially at the start of your treatment. This may include checking your heart, measuring your blood pressure, looking at your medical history, and doing a physical check-up.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with MUSE:

antihypertensives, medicines used to lower high blood pressure.
anticoagulants, medicines used to prevent blood clotting.
medicines that can impact the erectile function.
decongestants, medicines used to relieve stuffy nose (e.g., over-the-counter cold remedies, and allergy and sinus medications).
appetite suppressants, medicines used to decrease the feeling of being hungry and increase the feeling of being full.

How to take MUSE:

Use MUSE exactly as directed by your healthcare professional. They will instruct you on the proper technique for administering MUSE. • MUSE consists of a single-use applicator with a cap, containing a medicated urethral suppository (pellet) inside of the applicator (Figure 1). The applicator is provided in a sealed foil pouch. Please review the components of the applicator below:

A = Button

B = Body

C = Collar

D = Stem

E = Urethral stick

F = Cap

Follow these steps for MUSE administration:

1. Right before you use MUSE, urinate and gently shake the penis several times to remove excess urine. This will reduce the chance of discomfort or abrasions and is important for dissolving the medicated pellet.
2. Open the pouch by tearing fully across from the notched edge (Figure 2). Let the MUSE applicator slide out of the pouch. Save this pouch for discarding the used MUSE applicator later.
3. Remove the protective cap from the applicator stem (Figure 3) by holding the body of the applicator with your thumb and forefinger, twisting the body, and pulling out the applicator from the cap. Be careful not to push the applicator button. Avoid touching the applicator stem and tip. Save the cap to place on the used applicator for discarding the MUSE applicator later.
4. Visually inspect the MUSE applicator (Figure 4). The MUSE applicator is see-through, and you will be able to see the medicated pellet at the end of the stem. Make sure that the pellet is there before insertion.

G = medicated pellet

5. Hold the applicator in a way which is the most comfortable for you (Figure 5, positions a or b).
6. Please review Figure 6a for the anatomy of the penis.

H = Urethra
I = Bladder
J = Glans
K = Scrotum

While sitting or standing, whichever is more comfortable for you, take several seconds to gently and slowly stretch the penis upward to its full length, with gentle compression from top to bottom of the glans (Figure 6b). This straightens and opens the urethra. Slowly insert the MUSE stem into the urethra up to the collar (Figure 6c). If you feel any discomfort or a pulling sensation, remove the applicator slightly and then gently reinsert.

At first, you may feel some minor discomfort. Be sure to straighten your penis to its full length when inserting the MUSE applicator. With repeated use, administration will become easier.

7. Gently push down the button completely at the top of the applicator (Figure 7) until it stops. It is important to do this to ensure that the medicated pellet is completely released. Hold the applicator in this position for 5 seconds.

8. Gently rock the applicator from side to side. This will separate the medicated pellet from the applicator tip (Figure 8). If you apply too much pressure, you may scratch the lining of the urethra causing it to bleed.
9. Remove the applicator while keeping the penis upright.
10. Visually inspect the applicator tip to see that the medication is no longer in the applicator. Do not touch the stem. If you notice some residual medication in the end of the applicator, gently reinsert into the urethra and repeat steps 7, 8, and 9.
11. Holding the penis upright and stretched to its full length, roll the penis firmly between your hands (Figure 9) for at least 10 seconds. This will ensure that the medication is adequately distributed along the walls of the urethra. If you feel a burning sensation, it may help to continue to roll the penis for an additional 30 to 60 seconds or until the burning subsides.
12. Each MUSE applicator is good for a single administration only. Replace the cap on the MUSE applicator, place in the pouch, fold, and discard as normal household waste.

After you have administered MUSE, it is important to sit, stand or walk about for 10 minutes while the erection is developing. This helps to increase blood flow to the penis and will enhance your erection. Avoid lying down, especially on your back shortly after administration.

After this initial period, you can assume different positions.

An erection should begin within 5 to 10 minutes after administering MUSE. The duration of effect depends from patient to patient but is approximately 30 to 60 minutes.

Usual dose:

Your healthcare professional will decide the right dose for you. This may depend on your health, age, and how you respond to MUSE. The lowest dose that produces the desired results for you will be used. The usual initial dose is 250 mcg per day.

Do NOT use more than two suppositories (pellets) within a 24-hour period.

Your healthcare professional may adjust your dose if you cannot keep an erection for the time needed for sexual activities or if your erection lasts longer than desired. Talk to your healthcare professional if you think you may need a change to your dose.

Overdose:

You should report any erections persisting for more than 4 hours to a healthcare professional.

If you think you, or a person you are caring for, have taken too much MUSE, contact a healthcare professional, hospital emergency department, regional poison control centre or

Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.

What are possible side effects from using MUSE?

These are not all the possible side effects you may have when taking MUSE. If you experience any side effects not listed here, tell your healthcare professional.

Side effects of MUSE may include:

headache
pain of the penis, urethra, testicles, back, pelvic, and leg
flu-like symptoms (including runny nose and stuffiness)
fast heartbeat
swelling of the veins in the legs

Your penis may feel full, warm, and somewhat sensitive to the touch after the erection. These effects are normal and may last a few hours.

An application of ice packs to the inner thigh may shorten the duration of the erection, since the cold will restrict blood flow to the penis. If used, ice packs should be applied alternately to each inner thigh for a period not exceeding 10 minutes.

Patient’s female partner: After using MUSE, intercourse with a female partner may cause vaginal itching and burning.

Serious side effects and what to do about them

Symptom / effect	Talk to your healthcare professional	Stop taking drug and get immediate medical help
Only if severe	In all cases
VERY COMMON
Urethral burning: burning feeling when urinating.	✓
COMMON
Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, or fatigue (may occur when you go from lying or sitting to standing up).		✓
Infection: fever, chills, nausea, vomiting, diarrhea, or generally feeling unwell.		✓
Urethral abrasion: urethral bleeding or spotting.	✓
VERY RARE
Erection lasting more than 4 hours.			✓

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

You can report any suspected side effects associated with the use of health products to Health Canada by:

Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
Calling toll-free at 1-866-234-2345.

NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage:

Store MUSE in the unopened foil pouches inside a refrigerator between 2°C and 8°C. It may also be kept at room temperature (below 30°C) for up to 14 days before use.
If you are travelling, MUSE should be stored with a portable ice pack or in a cooler.
Avoid exposing MUSE to high temperatures above 30°C (e.g., trunk of car or checked baggage).

Keep out of reach and sight of children.

If you want more information about MUSE:

Talk to your healthcare professional
Find the full Product Monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (https://knighttx.com), by emailing medinfo@knighttx.com, or by calling at 1-844-483-5636.

Muse (Knight Therapeutics): Uses, Side Effects and Dosage