Patient Information Leaflet

Caverject 10 micrograms powder and solvent for solution for injection

Caverject 20 micrograms powder and solvent for solution for injection

Alprostadil

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What Caverject is and what it is used for

2. What you need to know before you start using Caverject

3. How to use Caverject

4. Possible side effects

5 Storage of Caverject

6. Contents of the pack and additional information

Caverject is a prostaglandin (E1) with vasodilatory action.

Caverject is indicated for the treatment of erectile dysfunction in adult males, including insufficient erections or impotence. Your doctor may also use it to, along with other tests, find the exact cause of your erectile dysfunction.

Do not use Caverject

• If you are allergic to alprostadil or any of the other components of this medication (listed in section 6).
• If you have sickle cell anemia (a disease that affects red blood cells), multiple myeloma (a form of bone marrow cancer, characterized by abnormal proliferation of plasma cells, which are the blood cells that produce antibodies, which protect us from infections and other foreign substances), leukemia (a disease of the bone marrow that causes an uncontrolled increase in white blood cells), drepanocytic trait or drepanocytic anemia (a disease that is transmitted from parents to children and in which red blood cells have an abnormal semilunar shape), thrombocytopenia (a disease characterized by a decrease in the number of platelets in the blood below normal levels), polycythemia (a disease characterized by an increase in hematocrit, the proportion of red blood cells in the blood), if you have a predisposition to develop venous thrombosis or any other disease that favors the appearance of priapism (prolonged erection).
• If you have an anatomical deformation of the penis, such as angulation, cavernous fibrosis or Peyronie's disease.
• If you have a penile implant.
• If you have a disease (such as severe heart disease) in which sexual activity is contraindicated or discouraged.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Caverject:

• If you or your partner have a sexually transmitted disease, such as AIDS, herpes or gonorrhea. The injection of Caverject may cause small hemorrhages at the injection site, which could increase the risk of transmitting these diseases. The use of Caverject does not protect against sexually transmitted diseases, so you should inform yourself about the necessary measures to avoid the transmission of these diseases.
• If you are being treated with anticoagulants such as warfarin or heparin, as bleeding may occur after the injection.
• If priapism (prolonged erection for more than six hours) appears during treatment, which should be reported to your doctor.
• If you have had a stroke or have any heart, blood vessel or lung disorder.
• If you have one or more cardiovascular risk factors (these may include high blood pressure, smoking, high blood glucose, high cholesterol, overweight and obesity).

High blood pressure, smoking, high blood glucose, high cholesterol, overweight and obesity may increase the risk of cardiovascular disease.

• If you have one or more risk factors for stroke (these may include high blood pressure, high cholesterol, coronary artery disease, irregular heart rhythm, diabetes).

High blood pressure, high cholesterol, coronary artery disease, irregular heart rhythm and diabetes may increase the risk of stroke.

• If a hardening (plaque) forms in a part of the penis that causes the penis to curve towards the side where the hard area is located (fibrosis, Peyronie's disease), which should be reported immediately to your doctor.
• If you have a history of psychiatric disorders or addiction.

Children and adolescents

Not applicable.

Use of Caverject with other medications

Inform your doctor or pharmacist if you are taking, have taken recently or may need to take any other medication.

Do not use other medications for erectile dysfunction at the same time as Caverject.

Certain medications may interact with Caverject; in these cases, it may be necessary to change the dose or discontinue treatment with one of them.

It is essential to inform your doctor if you are taking or have taken recently any of the following medications:

• Anticoagulants, such as warfarin or heparin, as you may bleed more when injecting.
• Antihypertensives, vasodilators, anticoagulants and platelet aggregation inhibitors, as Caverject may increase the effects of these medications.
• Sympathomimetics, as these medications may reduce the effect of Caverject.

Taking Caverject with food, drinks and alcohol

Not applicable.

Pregnancy, breastfeeding and fertility

Caverject is not indicated for women.

Driving and operating machinery

It is not expected that the ability to drive or operate machinery will be affected as a result of administering alprostadil. However, some patients treated with Caverject have experienced episodes of low blood pressure and syncope (fainting), so while you are being treated with this medication, it is recommended that you avoid situations in which you may be injured, including driving or operating hazardous machinery.

Caverject contains benzyl alcohol and sodium

Once reconstituted, this medication contains 8.4 mg of benzyl alcohol per ml. Benzyl alcohol may cause allergic reactions. Consult your doctor or pharmacist if you have liver or kidney disease. This is because large amounts of benzyl alcohol may accumulate in the body and cause adverse effects (metabolic acidosis).

This medication contains less than 23 mg of sodium (1 mmol) per ml, which is essentially "sodium-free".

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor or nurse will teach you how to administer the injection. Do not attempt to do it yourself until you have learned the correct way to administer it. If you forget how to do it, consult your doctor again. These instructions are only a reminder..

Each patient needs a different dose of Caverject for the treatment of erectile dysfunction.

Administer an injection of the prescribed dose by your doctor (5 to 20 micrograms of alprostadil). If you need an additional dose adjustment, you must consult your doctor. The maximum daily dose is 60 micrograms of alprostadil.

The administration frequency is no more than once a day and no more than three times a week. Do not use Caverject more often. Each time you use Caverject, change the side of the penis and the exact site where you administer the injection.

Caverject (sterile lyophilized) is packaged in 5 ml capacity vials. For reconstitution, the solvent contained in the attached syringe must be used.

After reconstitution by adding 1 ml of solvent, the resulting solution contains 10micrograms or 20micrograms of alprostadil per ml. (See Caverject Conservation).

The reconstituted solutions of alprostadil are for single use only. The syringe and remaining solution must be disposed of properly.

Erection usually appears between 5 and 15 minutes after injection. The duration of the same depends on the dose administered. The selected dose for treatment should provide you with an erection that allows you to have satisfactory sexual relations, maintained no more than 60 minutes. If the duration of the erection is greater than 60 minutes, a dose reduction will be necessary.Consult your doctor in case of prolonged erection, which persists for four hours or more.

The patient will attend the doctor's consultation every three months, for follow-up of the self-administration therapy. The reconstituted vial, syringe, and needles are intended for single use and must be disposed of after use.

Administration Instructions:

Dilution and Medication Extraction

1.Wash your hands with water and soap.

2.Remove the plastic cap from the vial.

3.Clean the rubber stopper of the vial using one of the alcohol wipes provided (the other will be needed later).

4.Remove the protective cover from the larger needle (labeled 22G1½) while keeping the plastic cover in place. Rotate the upper part of the white tamper-evident seal by breaking the seal. Place the needle in the syringe, turning it towards the syringe neck.

5.Pierce the needle through the central part of the rubber stopper of the vial and introduce the entire solvent.

6.Manipulate the syringe and vial as a unit, shaking until the powder is completely dissolved.

7.To extract the medication, place the vial with the syringe inserted in an inverted position. Extract the plunger of the syringe slowly until the solution reaches the recommended level by your doctor.

8.Tap the syringe to eliminate any possible bubbles or inject the solution back into the vial and extract it again slowly.

9.Remove the needle and syringe from the vial.

10.Replace the needle with the smaller one(labeled 30G½)to administer the self-injection.

Self-Injection

1. Undress and get comfortable. If your doctor has recommended using alcohol wipes, open one.

2.Make sure the needle is not bent. If it is, do not use it and discard it. Do not attempt to straighten it.

1. The solution will be injected into either of the two areas of the penis called corpora cavernosa. As shown in diagram A, the corpora cavernosa are located along the shaft (diaphysis) of the penis, one on each side.

Each time you use Caverject, alternate the injection sites: choose one side for this injection and the other for the next time. Within each site, the injection point should also be changed each time.

Hold the penis, placing your index and middle fingers underneath, near the testicles, and your thumb on top. Press the penis gently between your thumb and fingers so that the injection site protrudes. If you have a foreskin, make sure it is stretched.

1. Clean the skin area with an alcohol wipe and let it dry.
2. Hold the penis firmly with one hand and the syringe with the other, pierce the area that is swollen with the needle, passing through the skin with a continuous motion. Avoid visible veins and other blood vessels. Diagrams B and C show the correct angle, which should be 90º. Push the plunger firmly. If the solution does not pass easily, move the needle slightly and try again. Do not force the passage of Caverject solution through the needle.

6. Remove the needle. Press the alcohol wipe gently on the puncture site for 3 minutes. If bleeding appears, maintain pressure until it stops. Massage the penis to help alprostadil distribute through it.

7.Do not save what is left in the cartridge for a second injection. When you have finished with the needle, discard it carefully, as recommended by your doctor, so that no one sees it, uses it, or gets stuck with it.

If you think the action of Caverject is too strong or too weak, inform your doctor or pharmacist.

If you use more Caverject than you should

If you have used more Caverject than you should and experience an erection that lasts more than four hours, rapid breathing, feeling weak or dizzy, depressed, loose stools, or diarrhea, consult your doctor or pharmacist immediately, as you may need treatment.

In case of overdose or accidental administration, consult the Toxicology Information Service, Telephone 91 562 04 20, indicating the medication and the amount administered.

If you have any other questions about the use of thismedication, ask your doctor,pharmacistor nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have been reported with the approximate frequencies indicated:

Very common(can affect more than 1 in 10 people)

Common(can affect up to 1 in 10 people)

Uncommon(can affect up to 1 in 100 people)

Rare(can affect up to 1 in 1000 people)

Unknown frequency(cannot be estimated from available data)

Very common (can affect more than 1 in 10 people):

-Penile pain.

Common (can affect up to 1 in 10 people):

• Cardinal (hematoma).
• Eructation (skin redness).
• Cramps.
• Cicatrisation and angulation of the penis (fibrosis, angulation, fibrotic nodules, and Peyronie's disease), penile disorder, prolonged erection, in most cases, spontaneous reduction of this occurred.
• Red discoloration at the injection site due to blood extravasation in the tissues (ecchymosis), hematoma at the injection site, which have been related to the injection technique rather than the effect of Caverject.

Uncommon (can affect up to 1 in 100 people):

• Fungal infection, common cold symptoms.
• Sensation of reduced consciousness, without losing it (presyncope), decreased sense of touch (hypoesthesia), exaggerated sensation of tactile stimuli (hyperesthesia).
• Sensitivity of the eyes to intense light (mydriasis).
• Alteration of the heart rhythm known as supraventricular extrasystole, increased heart rate.
• Hypotension (including symptomatic hypotension), increased diameter of blood vessels (vasodilation), peripheral vascular disorders, venous disorders.
• Nausea, dry mouth.
• Erupción, increased sweating, pruritus.
• Accidental injection of Caverject into the urethra (the tube through which urine exits the penis) may cause blood in the urine or at the tip of the penis.
• Increased frequency of urination, even with urgency and pain, difficulties with urination.

• Prolonged erection for more than six hours (priapism), pelvic pain, swelling that can be felt in the scrotum (spermatocele), disorders of the testicles (pain, fluid accumulation, swelling), disorders of the scrotum (pain, fluid accumulation), scrotal redness, painful erection, balanitis, phimosis, repeated inability to achieve or maintain anerectionfirm enough to have asexual relationshipsatisfactory (erectile dysfunction), abnormal ejaculation.
• Bleeding, hemorrhage at the injection site, inflammation, inflammation at the injection site, sensation of heat at the injection site, fluid accumulation (edema) at the injection site, swelling at the injection site, pain at the injection site, irritation at the injection site, generalized weakness (asthenia), insensitivity of the injection site (anesthesia), fluid accumulation (edema), venous fluid accumulation, pruritus at the injection site.
• Increased creatinine in the blood.

Unknown frequency (cannot be estimated from available data):

• Headache
• Increased blood pressure (hypertension)
• Back pain
• Localized pain (buttocks, legs, genitals), weakness of the buttocks.
• Insufficient blood flow to the heart muscle through the coronary arteries
• Stroke

If the erection lasts more than 4 hours, consult your doctor who prescribed Caverject immediately. If you cannot contact your doctor, go to the emergency service of a hospital.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use Caverject after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

The reconstituted solution must be used immediately. Do not use the resulting solution if it presents turbidity, discoloration, or contains particles.

Medicines should not be thrown down the drains or in the trash.Dispose of the containers and medicines you no longer need at the SIGRE collection point of the pharmacy.If in doubt, ask your pharmacist how to dispose of the containers and medicines you no longer need. In this way, you will help protect the environment.

Composition of Caverject

- The active principle is alprostadil.

- The other components are:

Lactose monohydrate,alpha-cyclodextrin (Alfadex),sodium citrate dihydrate,sodium hydroxide (pH adjustment),hydrochloric acid (pH adjustment).

Water for injection with benzyl alcohol (E1519) at 0.9%

Appearance of the product and contents of the packaging

Caverject 10 micrograms powder and solvent for injection solution is presented in a single format of 1 vial of 5 ml capacity with 10 micrograms of sterile lyophilized powder and a pre-loaded syringe of 2.5 ml capacity with 1 ml of solvent.

Caverject 20 micrograms powder and solvent for injection solution is presented in a single format of 1 vial of 5 ml capacity with 20 micrograms of sterile lyophilized powder and a pre-loaded syringe of 2.5 ml capacity with 1 ml of solvent.

In both cases, the packaging also contains the following materials:

- 30G needle and 1/2 inch length (used for injecting the medication).

- 22G needle and 1 1/2 inch length (used for reconstituting the medication)

- 2 alcohol-impregnated wipes.

Holder of the marketing authorization and responsible for manufacturing

- Holder:

Pfizer, S.L.

Avda. de Europa 20-B

Parque Empresarial La Moraleja

28108 Alcobendas (Madrid)

SPAIN

- Responsible for manufacturing:

Pfizer Manufacturing Belgium NV

Rijksweg 12

2870 Puurs-Sint-Amands

BELGIUM

Last review date of this leaflet: June 2021

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)(AEMPS)http://www.aemps.gob.es/.