What Caverject is used for and how to use it
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Caverject - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Erectile Dysfunction, Patent Ductus Arteriosus
Class: Impotence agents, Vasodilators
Form: Liquid solution, Subcutaneous (SC)
Ingredients: alprostadil, lactose monohydrate, sodium citrate dihydrate, benzyl alcohol, hydrochloric acid and/or sodium hydroxide to adjust the pH

(Alprostadil for Injection)

About This Medication

What the Medication Is Used For

CAVERJECT (Alprostadil for injection) is used:

  • In treatment for erectile dysfunction in male adults. Erectile dysfunction is a condition when a man cannot achieve and/or maintain an erection; and
  • As an adjunct to diagnostic tests to confirming of erectile dysfunction

CAVERJECT should not be given to patients under 18 years of age. See Warnings and Precautions section of this leaflet.

What It Does

CAVERJECT (Alprostadil for injection) relaxes the smooth muscles of the penis. This allows more blood to flow into the penis and helps achieve and/or maintain an erection.

When It Should not be Used

Do not use CAVERJECT if you have any of the following conditions:

  • an allergy to alprostadil or any of the other ingredients in CAVERJECT;
  • sickle cell anemia or a history of sickle cell anemia (abnormality of the red blood cells), multiple myeloma (cancer of the bone marrow) or leukemia;
  • an erection that lasted more than 4 hours;
  • a deformed penis or Peyronie’s disease;
  • a penile implant;

CAVERJECT is not to be used in men for whom sexual activity is inadvisable or contraindicated.

CAVERJECT is not recommended for use in women, newborns and children under 18 years of age.

What the Medicinal Ingredient Is

Alprostadil

What the Nonmedicinal Ingredients Are

Lactose monohydrate, sodium citrate dihydrate, benzyl alcohol, hydrochloric acid and/or sodium hydroxide to adjust the pH.

What Dosage Form It Comes In

CAVERJECT comes in a vial that that contains 20 micrograms (mcg) of alprostadil sterile powder (see details in the “Proper Use of this Medication” section of this leaflet).

Warnings and Precautions

CAVERJECT may cause prolonged erection (4 to 6 hours) or priapism (over 6 hours).

You should seek immediate medical help for an erection that lasts more than 3 hours.

You must be properly trained by your doctor on how to use CAVERJECT.

CAVERJECT is used with a very thin needle that could break easily. If the needle breaks during use and you can see and touch the broken end, remove it and contact your doctor. If you cannot remove the broken end, seek medical help right away.

If the needle is bent, do not use it and do not try to straighten it before using it. This could make it more likely to break. If the needle is bent, remove it from the syringe, discard it, and attach a new needle to the syringe. See the ″Proper Use of this Medication″ section of this leaflet.

CAVERJECT DOES NOT PROTECT against sexually transmitted infections (STIs), including HIV/AIDS. For Protection against STIs, it is advisable to use protective measures.

Before or while you use CAVERJECT talk to your doctor if you have any of the following conditions:

  • sickle cell anemia or a history of sickle cell anemia (abnormality of the red blood cells), multiple myeloma (cancer of the bone marrow) or leukemia;
  • an erection that lasted more than 4 hours;
  • a deformed penis or Peyronie’s disease;
  • a penile implant;
  • blood clotting problems or on medicines to prevent blood clotting such as warfarin or heparin.

CAVERJECT should not be used in children and newborns. CAVERJECT contains benzyl alcohol which can cause death in children, especially in babies born early, and in babies who have a low weight when they are born.

Interactions With This Medication

Before and while taking CAVERJECT, tell your doctor or pharmacist about all other medications you take including medications that you bought without prescription, vitamins, and natural products.

Proper Use of This Medication

Usual Dose

For Erectile Dysfunction:

CAVERJECT is to be injected into either of two areas of the corpora cavernosa (spongy tissue of penis).

CAVERJECT must be given to you first by your doctor in his/her office to determine a dose of CAVERJECT that works for you. This dose of CAVERJECT should help you achieve and/or maintain an erection not longer than 1 hour. This process is called dosage titration.

When a dose has been selected, your doctor should show you how to safely inject CAVERJECT. And you should also be familiar with the following instructions before giving yourself an injection. If you have any questions, please ask your doctor.

CAVERJECT should be injected not more than once daily and not more than 3 times a week, with at least 24 hours between each dose. Maximum daily dose should not be more than 60 mcg. Do not inject CAVERJECT into an erect penis.

A case of CAVERJECT has enough drug for one injection. The number of cases you need will depend on the length of your therapy.

CAVERJECT Case Supplies (see Diagram 1)

CAVERJECT is supplied in boxes that contain five cases. Each case contains the following:

  • One vial of CAVERJECT sterile powder in strength of 20 mcg.
  • One pre–filled syringe containing bacteriostatic water. This is sterile water containing a preservative and is used to dissolve CAVERJECT. This solution does not contain active drug. You will use this syringe after attaching the needle, to inject the drug into your penis.
  • A 27–gauge, 0.5 inch needle. Keep the plastic cover on the needle until ready to inject.
  • Two alcohol swabs. It is important to use the swabs to provide hygienic conditions and prevent infection.
Diagram 1: Vial containing CAVERJECT STERILE POWDER.; Syringe containing bacteriostatic water for injection (diluent); Needle with cover; Two alcohol swabs

Self–injection Method

Preparing the Medication

  1. Wash your hands thoroughly with soap and water.
  2. Pull back on tabs of needle package to expose open end of needle. Do not let this end touch any surface.
  3. Hold syringe tip upwards and remove rubber end cover. Continue to hold syringe upright in one hand. With free hand, pick up needle by covered end.
  4. With needle cover still on, attach open end of needle to syringe tip by pushing down and twisting into place (see Diagram 2). Make sure the needle fits tightly.

    Diagram 2: Joining the needle to the syringe
  5. Remove the plastic cap from the vial.
  6. Wipe the rubber stopper of the vially hold syringe and vial as a unit, and gently swirl the two (do not shake) until the powder dissolves cl, using one of the swabs provided (see Diagram 3). Discard the used swab (the second swab is needed later).

    Diagram 3: Wiping the rubber stopper of the vial
  7. Handle the syringe by the barrel only. Remove needle cover carefully from the syringe. Do not allow needle to touch any surface.
  8. Holding the syringe with needle pointing upward, push plunger to the 1–cc (mL) line marked on the syringe. (This will remove a slight amount of overfill in the syringe.)
  9. Pierce needle through the centre portion of the vial's rubber cap. Push down plunger and inject entire contents of syringe (bacteriostatic ( bak–te–reo–stat–ik) water) into the vial. (See Diagram 4).

    Diagram 4: Injecting bacteriostatic water into the vial

    Carefully hold syringe and vial as a unit, and gently swirl the two (do not shake) until the powder dissolves completely. DO NOT USE if the resulting solution is cloudy or coloured, or if it contains particles.

Withdrawing the medication

  1. To withdraw the medication, turn the vial (and syringe) upside down. Keep tip of needle below the level of the fluid. Then slowly withdraw syringe plunger until the amount of solution is level with the line recommended by your doctor (see Diagram 5).

    Diagram 5: Withdrawing the medication
  2. If there are air bubbles in the syringe, tap syringe gently to remove them, or inject the solution back into the vial and slowly withdraw again. (See Diagram 6)

    Diagram 6: Tapping the syringe to remove air bubbles
  3. Remove needle from bottle and carefully replace needle cover. DO NOT puncture the vial more than once, you could contaminate the solution.

    Diagram A. Cross–section of penis showing injection sites

Diagram B. Top view of penis showing injection sites (shaded areas).

Self–injecting the medication

The medication must be injected into either of two areas of the corpora cavernosa (spongy tissue of penis). As you can see from diagrams A and B above, the corpora cavernosa run down both sides of the penis.

Follow these instructions carefully to ensure you inject the medication correctly.

  1. Perform the self–injection while sitting in an upright or slightly reclining position and under good lighting.
  2. Only use the injection areas shown in diagrams A and B. DO NOT inject the very top or underside of your penis. Change the injection site each time you use CAVERJECT. (i.e. choose the right side for this injection, use the left side next time, and so on.) Within either area, the injection point should also be changed each time.
  3. Grasp the head of your penis with your thumb and forefinger. Stretch your penis tautly and hold it firmly against your thigh so that it does not slip. In uncircumcised men, the foreskin must be pulled back to assure proper placement of the injection.
  4. Clean the injection area thoroughly with a new alcohol swab. Put swab to one side; you will need to use it again.
  5. Hold syringe between thumb and index finger. Do not put your thumb on the plunger. With syringe at a right angle (90) to your penis, insert needle to penetrate the skin at the injection site. (See Diagram 7) This is a sensitive area, so expect a little discomfort. Avoid any area where veins are clearly visible.

    Once the needle pierces the skin and resistance is felt, push needle firmly forward until a distinct ″give″ is felt and insert the needle all the way in with a steady, continuous motion.



    Diagram 7: Inserting the needle into the injection site
  6. Move your thumb or forefinger to the top of plunger and press down. Inject the entire contents of the syringe using a slow, steady motion. (See Diagram 8)

    Diagram 8: Injecting the contents of the syringe
  7. Withdraw the needle from your penis and replace needle cover. Squeeze both sides of your penis immediately, and apply pressure with the alcohol swab to the injection site for about 3 minutes. If bleeding occurs, maintain pressure until the bleeding stops.

As long as you use your doctor's recommended dose, expect an erection to occur within 5 to 20 minutes after an injection.

A standard treatment goal is to produce an erection lasting up to an hour. If an erection is extremely painful (or persists after 3 hours) or if you have other adverse effects that concern you, consult your doctor immediately.

Disposal of Used Materials

Always safely dispose of the used syringe (needle), vial and swabs. To help you, the CAVERJECT case is designed as a safe and convenient disposal unit that should be locked. (As another option, your pharmacist may supply a disposal box especially for syringes.)

Diagram 9: Snapping shut the CAVERJECT container.Pushing down the locking device to close the CAVERJECT container permanently
  1. Remove red plastic lock from its holder inside the case. Put this to the side.
  2. Place used syringe, needle, vial and used swabs in the plastic case. Close firmly so the case snaps shut.
  3. Remove centre part of CAVERJECT label (perforated area) to show the keyhole.
  4. To lock case, push the red lock through the hole in the case top. The case is now locked.

NOTE: ONCE LOCKED, THE CAVERJECT CONTAINER WILL BE PERMANENTLY CLOSED.

You can now safely dispose of the case. Due to the contents, this is not a recyclable product; DO NOT place in a recycle bin.

If you have any questions about the benefits and risks of using CAVERJECT, ask your doctor.

Overdose

An erection lasting longer than 3 hours is not a ″normal″ length of time for the penis to stay rigid. If this occurs, you have probably overdosed. Report this to your doctor immediately. Treat as a medical emergency.

In case of drug overdose, contact your doctor, or a poison control centre, or go to the emergency room of the hospital near you immediately, even if there are no symptoms.

Side Effects and What to Do About Them

If you have an erection lasting longer than 2 hours, try to reduce the erection using methods suggested by your doctor. Do not wait, it is easier to reduce the erection if you treat it earlier rather than later.

If your penis is still hard after 3 hours see your doctor immediately or go to emergency. Write on a piece of paper the name of the drug, the dose and the time you took it and bring this with you to emergency.

Erections that last more than 6 hours can cause serious and permanent damage.

The most common adverse effect is mild to moderate pain in the penis after injection or during an erection. About one–third of patients experience this effect. Other patients may experience a ″burning sensation″, ″discomfort″ or ″tension″ in the penis.

Occasionally you may have blood blisters (hematoma, ecchymosis) at the site of injection. These relate to improper injection technique rather than the effects of CAVERJECT. If this occurs, ask your doctor to re–instruct you. Pressing down on the injection site will help avoid blood blisters.

Other local adverse effects include: fibrosis (formation of scar tissue in the penile tissues), irritation, sensitivity, penile rash and penile edema (fluid in the tissues).

Rarely occurring are: pain in the testicles or at the base of the penis, erythema (redness of the skin), penile lumps, tenderness, abnormal ejaculation, curved erections, balanitis (inflammation of the tip of the penis) and itching, swelling, inflammation or bleeding at the injection site, urethral bleeding and injuries resulting from poor injection technique.

Rare whole–body effects include: changes in blood pressure, irregular heartbeat, increased pulse rate, dizziness, headache, faintness.

Call your doctor if you notice any of the above or if you experience anything not listed here. Tell your doctor if you have a condition or are taking a medicine that interferes with blood clotting.

Symptom / effectTalk with your
doctor or
pharmacist
Stop taking
drug and
call your
doctor or
pharmacist
Only if
severe
In all
cases
Common–Prolonged erection
–Pain in the penis after injection or during an erection
– Burning sensation, discomfort or tension in the penis.
Uncommon–Blood blisters (hematoma, ecchymosis) at the site of injection
–Formation of scar tissue in the penile tissues, irritation, sensitivity, penile rash and fluid in the tissues (penile edema).
Rare– Pain in the testicles or at the base of the penis
– Redness of the skin (erythema)
–Penile lumps
–Tenderness
–Abnormal ejaculation
–Curved erections
– Inflammation of the tip of the penis (balanitis)
– Itching
– Swelling
–Inflammation or bleeding at the injection site
– Urethral bleeding
– Injuries resulting from poor injection technique
– Changes in blood pressure
– Irregular heartbeat
– Increased pulse rate
– Dizziness
– Headache
– Faintness
–Broken needle that cannot be removed from penis

This is not a complete list of side effects. For any unexpected effects while taking CAVERJECT, contact your doctor or pharmacist.

How to Store It

Storage and handling

  1. You can store unused vials of CAVERJECT Sterile Powder 20 mcg between 2°C to 30°C. Do not freeze.
  2. Do not use vials after the expiry date listed on the label.
  3. Once dissolved, the CAVERJECT solution must be used immediately. Do not freeze solution.
  4. Use contents of each vial only once. Throw out unused solution. See ″Disposal of Used Materials″ in ″Proper Use of this Medication″.
    IMPORTANT: Failure to comply with the following antiseptic measures may lead to infection
  5. To ensure sterile conditions, never contaminate the needle. The disposable needle and syringe require no sterilization steps if the package is intact.
  6. DO NOT reuse needles or syringes.DO NOT give used needles or syringes to others.

Reporting Suspected Side Effects

To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had a serious or unexpected reaction to this drug you may notify Canada Vigilance:

Your can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

Report online at www.healthcanada.gc.ca/medeffect

Call toll-free at 1-866-234-2345

Complete a Canada Vigilance Reporting Form and:

  • Fax toll-free to 1-866-678-6789, or
  • Mail to: Canada Vigilance Program
    Health Canada
    Postal Locator 0701D
    Ottawa, ON K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found at:
http://www.pfizer.ca.
or by contacting the Pfizer at:
1-800-463-6001 (Medical Information)