Uses of Alprostadil Injection:

• It is used to treat erectile dysfunction (ED).
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Alprostadil Injection?

• If you have an allergy to alprostadil or any other part of alprostadil injection.
• If you are allergic to alprostadil injection; any part of alprostadil injection; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have been told that you are not healthy enough to have sex.
• If you have a deformed penis, penile implant, or other penile problems.
• If you have any of these health problems: Polycythemia or thrombocythemia.
• If you have any of these health problems: Leukemia, multiple myeloma, sickle cell anemia, or other health problems that may raise the chance of painful erection (hard penis) or an erection that lasts for longer than 4 hours. Ask your doctor if you are not sure.
• If you are a woman. This medicine is not approved for use in women.

This is not a list of all drugs or health problems that interact with alprostadil injection.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take alprostadil injection with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Alprostadil Injection?

• Tell all of your health care providers that you take alprostadil injection. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how alprostadil injection affects you.
• To lower the chance of feeling dizzy or passing out, rise slowly if you have been sitting or lying down. Be careful going up and down stairs.
• Talk with your doctor before you drink alcohol.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors.
• There is a chance of the needle breaking when using the injection. Needles have broken with part of the needle still in the penis. If the needle breaks and you can grab the broken end, take it out and call your doctor. If you cannot grab the broken end, call your doctor right away.
• This medicine has benzyl alcohol in it. Benzyl alcohol may cause very bad and sometimes deadly side effects in newborns or infants. This medicine is not approved for use in children. Talk with the doctor.

How is this medicine (Alprostadil Injection) best taken?

Use alprostadil injection as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Your doctor will teach you how to take alprostadil injection.
• Wash your hands before and after use.
• Do not shake.
• Attach new needle before each dose.
• Do not use a bent needle. Do not try to straighten a bent needle. It may be more likely to break.
• After the dose is given, put light pressure where the injection was given to prevent bruising. Do this for 5 minutes and until bleeding stops.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Switch sides of the penis and where alprostadil injection is given with each dose of alprostadil injection.

What do I do if I miss a dose?

• This medicine is used on an as needed basis. Do not use more often than told by the doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Redness, lumps, swelling, tenderness, or curving of the erection (hard penis).
• Irritation where alprostadil injection is given.
• Chest pain or pressure or a fast heartbeat.
• Dizziness or passing out.
• Very bad headache.
• Shortness of breath.
• Any unexplained bruising or bleeding.
• Swelling of the leg veins.
• Call your doctor right away if you have a painful erection (hard penis) or an erection that lasts for longer than 4 hours. This may happen even when you are not having sex. If this is not treated right away, it may lead to lasting sex problems and you may not be able to have sex.

What are some other side effects of Alprostadil Injection?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Penile pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Alprostadil Injection?

• Store as you have been told by the doctor.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about alprostadil injection, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.