Caverject Impulse

Package insert / prescribing information
Generic name: alprostadil
Dosage form: injection, powder, lyophilized, for solution
Drug classes: Impotence agents, Vasodilators

Medically reviewed by  A Ras MD.

What is Caverject Impulse?

Caverject Impulse is a prescription medicine used to treat erectile dysfunction (ED), with other medical tests to diagnose ED.

Caverject Impulse is not meant for use in women or children under 18 years of age.

What are the causes of and treatments for ED?

There are several causes of ED. These include medications that you may be taking for other conditions, poor blood circulation in the penis, nerve damage, emotional problems, too much smoking or alcohol use, use of street drugs, and hormonal problems. Often, ED is due to more than one cause.

Treatments for ED include switching medications if you are taking a medication that causes erectile dysfunction, prescription medications, medical devices that produce an erection, surgical procedures to correct blood flow in the penis, penile implants, and psychological counseling.

You should not stop taking any prescription medications, unless told to do so by your doctor.

The use of other medical treatments for ED in combination with Caverject is not recommended. Discuss any concerns you may have about combination treatment with your doctor.

Description

CAVERJECT IMPULSE contains alprostadil a synthetic form of prostaglandin E1 (PGE1) and is designated chemically as (11α,13E,15S)-11,15-dihydroxy-9-oxoprost-13-en-1-oic acid. The molecular weight is 354.49.

Alprostadil is a white to off-white crystalline powder with a melting point between 115° and 116°C. Its solubility at 35°C is 8000 micrograms (mcg) per 100 milliliter double distilled water.

The structural formula of alprostadil is represented below:

CAVERJECT IMPULSE is available as a disposable, single-dose, dual chamber syringe system. The system includes a glass cartridge which contains sterile, freeze-dried alprostadil in the front chamber and sterile bacteriostatic water for injection in the rear chamber. The alprostadil is reconstituted with the sterile bacteriostatic water just before injection. CAVERJECT IMPULSE is available in two strengths for intracavernosal administration:

10 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 10 micrograms (mcg) of alprostadil, 324.7 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol.

20 microgram – The reconstituted solution has a volume of 0.64 mL. The delivered volume, 0.5 mL, contains 20 micrograms (mcg) of alprostadil, 649.3 mcg of alpha cyclodextrin, 45.4 mg of lactose, 23.5 mcg of sodium citrate, and 4.45 mg of benzyl alcohol.

During manufacture, the pH of the alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.

Mechanism of Action

Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries. This leads to expansion of lacunar spaces and entrapment of blood by compressing the venules against the tunica albuginea, a process referred to as the corporal veno-occlusive mechanism.

Who should not use Caverject Impulse?

Do not use Caverject Impulse if you have:

• certain medical problems that might cause you to have an erection that lasts for more than 4 hours, such as sickle cell anemia, sickle cell trait, multiple myeloma, leukemia.
• a deformed penis shape
• a penile implant

What should I tell my healthcare provider before use Caverject Impulse?

Before you use Caverject Impulse, tell your healthcare provider if you:

• have had an erection that lasted more than 4 hours
• have sickle cell trait or sickle cell anemia
• have or have had a blood cell cancer called multiple myeloma or leukemia
• have a deformed penis shape
• have a penile implant
• have low blood pressure (hypotension)
• have bleeding problems
• have or have had heart problems such as a heart attack, irregular heartbeat, angina, chest pain, narrowing of the aortic valve or heart failure
• have any other medical conditions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Caverject Impulse may affect the way other medicines work, and other medicines may affect the way Caverject Impulse works causing side effects.

Especially tell your healthcare provider if you take any other medicines that are injected into your penis (intracavernosally) or certain medicines called anticoagulant medicines (such as heparin or warfarin).

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

How should I use Caverject Impulse?

• See the detailed Instructions of use that comes with your Caverject Impulse for information about how to prepare and inject Caverject Impulse the right way.
• Use Caverject Impulse exactly as your healthcare provider tells you to.
• Your healthcare provider will tell you how much Caverject Impulse to use and when to use it.
• Your healthcare provider may change your dose if needed. Do not change your dose of Caverject Impulse without first talking to your healthcare provider.
• Your healthcare provider should show you how to prepare and inject Caverject Impulse the right way before you inject it for the first time.
• Caverject Impulse should not be used more than 3 times per week.
• Caverject Impulse should not be used more than 1 time every 24 hours.
• Change the exact place and side of the penis that you inject Caverject Impulse each time you use it.
• Caverject Impulse is for one use only and should be thrown away properly after a single use.

You should see your healthcare provider every 3 months for check-ups to be sure that Caverject Impulse is working the right way and to change your Caverject Impulse dose if needed.

What are the possible side effects of Caverject Impulse?

Caverject Impulse may cause serious side effects, including:

• an erection that will not go away. If you have an erection that lasts more than 4 hours, get medical help right away. If it is not treated right away, this condition can permanently damage your penis.
• deformed penis shape (penile fibrosis). Your healthcare provider should check your penis regularly for signs of penile fibrosis. You should not continue to use Caverject Impulse if you get penile fibrosis.
• low blood pressure (hypotension)
• injection site bleeding. People who take certain medicines called anticoagulants (such as heparin or warfarin) may have a risk for increased bleeding at the injection site.
• increased risk of heart problems. Sexual activity can put an extra strain on your heart, especially if your heart is weak from a heart attack or heart disease. Ask your healthcare provider if your heart is healthy enough to handle the extra strain of having sex. Stop sexual activity and get medical help right away if you get symptoms of a heart problem such as chest pain, dizziness or nausea.
• needle breakage. There is a possibility of needle breakage with use of Caverject Impulse. To best avoid breaking the needle, you should pay careful attention to your healthcare provider’s instructions and try to handle the syringe and needle properly. If the needle is bent at any time, do not attempt to straighten it and do not use it. A bent and re-straightened needle is predisposed to breakage. Remove the needle from the syringe, discard, and attach a new, unused sterile needle to the syringe. If the needle breaks during injection and you are able to see and grasp the broken end, you should remove it and contact your healthcare provider. If you cannot see or cannot grasp the broken end, you should promptly contact your healthcare provider
• benzyl alcohol toxicity. Benzyl alcohol is a preservative in Caverject Impulse. Benzyl alcohol has caused serious side effects, including death, in children, especially premature and low-birth weight infants, who have received the preservative benzyl alcohol. Caverject Impulse is not meant for use in children.

Caverject Impulse does not protect you or your partner from getting sexually transmitted infections, including HIV-the virus that causes AIDS.

The most common side effects of Caverject Impulse include:

• penile pain
• erection lasting 4 to 6 hours (prolonged erection)
• penile fibrosis (deformed penis shape)
• bruising at the injection site
• penile numbness, irritation, sensitivity, itching, swelling and discoloration
• skin tears of the penis
• penile rash

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Caverject Impulse. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Caverject Impulse

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Caverject Impulse for a condition for which it was not prescribed. Do not give Caverject Impulse to other people even if they have the same symptoms that you have. It may harm them.

This Patient Information summarizes the most important information about Caverject Impulse. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Caverject Impulse that is written for health professionals.

For more information, go to www.pfizer.com or call 1-800-438-1985.

How should I store Caverject Impulse?

• Store the unreconstituted product at 68°F to 77°F (20°C to 25°C); excursions permitted to 59°F to 86°F (15°C to 30°C) [see USP Controlled Room Temperature].
• The reconstituted solution should be used within 24 hours when stored between 36–77°F (2°C to 25°C).
• Do not freeze.

What are the ingredients in Caverject Impulse?

Active ingredient: alprostadil

Inactive ingredients: alpha cyclodextrin, lactose, sodium citrate, benzyl alcohol and hydrochloric and/or sodium hydroxide for pH adjustment.

Label

PRINCIPAL DISPLAY PANEL – 10 MICROGRAM SYRINGE LABEL

• Caverject Impulse®
• Dual Chamber System
  alprostadil for injection
• 10 micrograms
• KEEP OUT OF REACH OF CHILDREN
• Pharmacia & Upjohn Co
  DIVISION OF PFIZER INC, NY, NY 10017
  MADE IN BELGIUM
• 8Q3129
• LOT/EXP

PRINCIPAL DISPLAY PANEL – 20 MICROGRAM SYRINGE LABEL