These Highlights Do Not Include All The Information Needed To Use Caverject Safely And Effectively. See Full Prescribing Information For Caverject.

CAVERJECT [KAV-er-jeckt]^®

(alprostadil)

for injection, for intracavernosal use

Read this Patient Information before you start using CAVERJECT and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is CAVERJECT?

CAVERJECT is a prescription medicine used:

• •
  to treat erectile dysfunction (ED).
• •
  with other medical tests to diagnose ED.

CAVERJECT is not meant for use in women or children.

Do not use CAVERJECT if you:

• •
  are allergic to alprostadil or any of the ingredients in CAVERJECT. See the end of this leaflet for a complete list of ingredients in CAVERJECT
• •
  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
• •
  have a deformed penis shape
• •
  have a penile implant

Before you use CAVERJECT, tell your healthcare provider about all your other medical conditions, especially 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

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

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

Especially tell your healthcare provider if you take any other medicines that are treatments for ED, other medicines 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?

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

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

What are the possible side effects of CAVERJECT?

CAVERJECT may cause serious side effects, including:

• •
  an erection that will not go away (priapism). 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 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. To best avoid breaking the needle, you should pay careful attention to your healthcare provider's instructions and 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 more likely to break. 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 that is present in CAVERJECT when it is mixed. 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 is not meant for use in children.

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

The most common side effect of CAVERJECT is penile pain

These are not all the possible side effects of CAVERJECT.

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

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

You can ask your pharmacist or healthcare provider for information about CAVERJECT that is written for health professionals.

What are the Ingredients in CAVERJECT?

Active ingredient: alprostadil

Inactive ingredients: lactose, sodium citrate, benzyl alcohol (contained in the final solution) and hydrochloric acid and/or sodium hydroxide for pH adjustment.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com

LAB-1045-3.0

Revised: March 2023

Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology

• •
  Initiate dosing with 2.5 mcg of CAVERJECT intracavernosally, as recommended [see Dosage and Administration (2.4)].
• •
  If there is a partial response at 2.5 mcg, administer another dose of 2.5 mcg within 1 hour. Use a new vial for each dose of CAVERJECT.
• •
  During titration, no more than 2 doses should be given within a 24-hour period.
• •
  If additional titration is required, administer doses in increments of 5 to 10 mcg at least 24 hours apart.
• •
  The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.
• •
  The patient must stay in the health care provider’s office until complete detumescence occurs.

Repeat the titration as necessary until the optimal dose is achieved. Doses greater than 60 mcg are not recommended.

Store CAVERJECT 20 mcg vials between 20°C to 25°C (68°F to 77°F). The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.

Store CAVERJECT 40 mcg vials between 2°C to 8°C (36° to 46°F) until dispensed. Once dispensed, vials should be stored at or below 25°C (77°F) for up to 3 months or until the expiration date, whichever occurs first. The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.

When reconstituted and used as directed, the deliverable amount of alprostadil is 20 micrograms or 40 micrograms, respectively. Only bacteriostatic water for injection, should be used when reconstituting CAVERJECT.

CAVERJECT is available in the following packages:

The following supplies are needed for injection and are not supplied with CAVERJECT:

• •
  1 mL of the diluent (bacteriostatic water for injection)
• •
  1 mL to 3 mL syringe, dependent on the titrated dose
• •
  21 to 27 gauge needle for reconstitution
• •
  29 or 30 gauge one-half inch needle for injection
• •
  alcohol swabs

Overdosage was not observed in clinical trials with CAVERJECT. If intracavernous overdose of CAVERJECT occurs, the patient should be under medical supervision until any systemic effects have resolved and/or until penile detumescence has occurred. Treatment of any systemic symptoms (e.g., hypotension) would be appropriate.

CAVERJECT is not indicated for use in females.

CAVERJECT is not indicated for use in females.

CAVERJECT 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°C and 116° C. CAVERJECT is available as a sterile freeze-dried powder for intracavernosal use in sizes: 20 mcg and 40 mcg per vial. When reconstituted as directed with 1 mL of bacteriostatic water for injection, the volume of the reconstituted solution is 1.13 mL. Each mL of CAVERJECT contains 20.5 mcg or 41.1 mcg of alprostadil depending on vial strength, 172 mg of lactose, 47 mcg of sodium citrate and 8.4 mg of benzyl alcohol. The deliverable amount of alprostadil is 20 mcg or 40 mcg per mL because approximately 0.5 mcg for the 20 mcg strength and 1.1 mcg for the 40 mcg strength is lost due to adsorption to the vial and syringe. During manufacture, the pH of alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.

The structural formula of alprostadil is represented below:

Intracavernous injections of CAVERJECT can increase peripheral blood levels of alprostadil which can result in hypotension. Avoid use of CAVERJECT in patients with known cavernosal venous leakage.

Safety and effectiveness have not been established in pediatric patients [see Warnings and Precautions (5.8)].

A total of 341 subjects included in clinical studies were 65 and older. No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between elderly and younger patients.

CAVERJECT is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

The efficacy of CAVERJECT was investigated in men with a diagnosis of erectile dysfunction due to psychogenic, vasculogenic, neurogenic, and/or mixed etiology in two double-blind, placebo-controlled studies (Study 1 and Study 2) and in one 6-month open-label study (Study 3). In clinical studies (Study 1 and Study 3), over 80% of patients experienced an erection sufficient for sexual intercourse after intracavernosal injection of CAVERJECT.

CAVERJECT is contraindicated:

• •
  in men who have a known hypersensitivity to the drug [see Adverse Reactions (6.1)]
• •
  in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia [see Warnings and Precautions (5.1)]
• •
  for the treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease [see Warnings and Precautions (5.2)]
• •
  in men with penile implants.

The overall incidence of penile fibrosis reported in clinical studies with CAVERJECT was 3%. In one self-injection clinical study where duration of use was up to 18 months, the incidence of penile fibrosis was 7.8%.

Physical examination of the penis should be performed periodically, to detect signs of penile fibrosis. Treatment with CAVERJECT should be discontinued in patients who develop penile angulation or cavernosal fibrosis.

Separate needles should be used for reconstitution and administration. A superfine needle is used for administration of CAVERJECT. As with all superfine needles, the possibility of needle breakage exists. Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, has required hospitalization and surgical removal. Careful instruction in proper patient handling and injection techniques may minimize the potential for needle breakage [see Dosage and Administration (2.3) and Adverse Reactions (6.2)].

The following are described elsewhere in the labeling:

• •
  Prolonged Erection and Priapism [see Warnings and Precautions (5.1)]
• •
  Penile Fibrosis [see Warnings and Precautions (5.2)]

The potential for pharmacokinetic drug-drug interactions between alprostadil and other agents administered orally or intracavernosally has not been formally studied [see Warnings and Precautions (5.6)].

CAVERJECT [KAV-er-jeckt]®

(alprostadil)

for injection, for intracavernosal use

Your healthcare provider should show you how to prepare and inject CAVERJECT the right way before you inject it for the first time. Do not try to inject yourself until you have been shown the right way to give your injections by your healthcare provider.

Information about how to safely inject CAVERJECT:

• •
  Read and follow these instructions so that you inject CAVERJECT the right way. Call your healthcare provider if you have any questions about the right way to inject CAVERJECT.
• •
  Separate needles should be used for reconstitution and administration. Do not use damaged or bent needles to inject CAVERJECT.
• •
  If you accidentally bend a needle, do not attempt to straighten it.
• •
  Using bent or re-straightened needles may cause part of the needle to break off and remain in the penis. Some people have reported needle breakage in their penis during the injection and, in some cases, had to go to hospital for surgery to remove the needle.
• •
  If you accidentally bend the needle while preparing your CAVERJECT injection, remove it from the syringe, throw it away, and attach a new, needle to the syringe as described under "Prepare the Dose" below. (See "Dispose of your used CAVERJECT syringe and needle" at the end of these Instructions).
• •
  Do not share your needles or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
• •
  Use the needles, syringe, alcohol swabs, and vials only 1 time then safely throw away the supplies and any unused solution in a puncture resistant container (See "Dispose of your used CAVERJECT syringe and needle" at the end of these instructions). Ask your healthcare provider or pharmacist where you can get a puncture resistant or sharps container.

CAVERJECT comes in 20 mcg or 40 mcg strengths. Make sure you have the right strength vial of CAVERJECT that your healthcare provider prescribed for you.

Prepare the Syringe

After your injection:

Dispose of your used CAVERJECT syringe and needles.

• •
  Put your used CAVERJECT syringe and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away loose needles and syringes in your household trash.
• •
  If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • o
    made of a heavy-duty plastic
  • o
    can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • o
    upright and stable during use
  • o
    leak-resistant
  • o
    properly labeled to warn of hazardous waste inside the container
• •
  When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share your needles or syringes with other people. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• •
  Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store CAVERJECT?

CAVERJECT 20 mcg vial storage information

• 1.
  Store CAVERJECT 20 mcg vials between 20°C to 25°C (68°F to 77°F).
• 2.
  The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.

CAVERJECT 40 mcg vial storage information

• 1.
  Store CAVERJECT 40 mcg vials between 2°C to 8°C (36°F to 46°F) until dispensed. Once dispensed, vials should be stored at or below 25°C (77°F) for up to 3 months or until the expiration date, whichever occurs first.
• 2.
  The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.

Keep CAVERJECT and all medicines out of the reach of children.

This Patient Information and Instructions for Use has been approved by the U.S Food and Drug Administration.

LAB-0009-8.0

Revised March 2023

CAVERJECT is a prostaglandin E1 agonist indicated

• •
  For the treatment of erectile dysfunction (1.1).
• •
  As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).

CAVERJECT is indicated for the treatment of erectile dysfunction.

Alprostadil (PGE1) is a prostaglandin with a wide variety of pharmacological actions including vasodilation and inhibition of platelet aggregation. Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries by binding to its receptors and increasing intracellular cyclic adenosine monophosphate (cAMP) levels via modulation of adenylate cyclase. 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. Alprostadil also attenuates presynaptic noradrenaline release in the corpus cavernosum.

Studies in vitro have shown that alprostadil relaxed isolated preparations of human corpus cavernosum and spongiosum, as well as cavernous arterial segments contracted by either noradrenaline or PGF2α. In pigtail monkeys (Macaca nemestrina), alprostadil increased cavernous arterial blood flow in a dose-dependent manner in vivo.

• •
  Prolonged erection and priapism have occurred in patients receiving CAVERJECT. To minimize the chances of this occurring, titrate CAVERJECT slowly to the lowest effective dose (2.1). Advise patients to seek immediate medical assistance for an erection that persists longer than 4 hours (5.1).
• •
  Penile fibrosis has occurred in patients receiving CAVERJECT. Follow patients regularly to detect signs of penile fibrosis. Discontinue in patients who develop penile angulation or cavernosal fibrosis (5.2).
• •
  Hypotension: Injections of CAVERJECT can lead to increased peripheral blood levels of alprostadil, especially in patients with significant corpora cavernosa venous leakage. Avoid use in patients with known cavernosal venous leakage (5.3).
• •
  Injection site bleeding may occur in patients taking anticoagulants, such as warfarin or heparin. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes (5.4).
• •
  Cardiovascular risk related to underlying medical conditions: Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy (5.5).
• •
  Risks of use in combination with other vasoactive medications injected intracavernosally: Safety and efficacy of combinations of CAVERJECT and other vasoactive agents have not been systematically studied. Use of such combinations is not recommended (5.6).
• •
  Needle breakage: A superfine needle is used for administration of CAVERJECT and cases of needle breakage have been reported. Careful instruction in proper patient handling and injection techniques may minimize this risk (5.7).
• •
  Benzyl alcohol: Serious and fatal adverse reactions can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved formulations in infusion solutions, including CAVERJECT. CAVERJECT is not indicated in neonates and infants (5.8).
• •
  Counsel patients about sexually transmitted diseases: Counsel patients about the protective measures necessary to guard against sexually transmitted disease including the Human Immunodeficiency Virus (HIV) (5.9).

• •
  Determine the most suitable dose and presentation of CAVERJECT to use. Use a new vial for each dose of CAVERJECT (2.1).
• •
  Administer first intracavernosal injections in the health care provider’s office and titrate the dose for each patient to the lowest effective dose (2.1).
• •
  Instruct the patient on proper use and assess that they are well trained in the self-injection technique prior to initiation of at-home use (2.1).
• •
  Recommended dosage for erectile dysfunction (2.2):
  • •
    Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology: Initiate dosing with 2.5 mcg
  • •
    Erectile dysfunction of pure neurogenic etiology (spinal cord injury): Initiate dosing with 1.25 mcg
• •
  Follow dose titration procedures for each type of erectile dysfunction and determine the maintenance dosage for patient home use in the health care provider’s office (2.2).
• •
  The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose (2.2).
• •
  While on self-injection treatment, the patient should visit the prescribing health care provider’s office every 3 months to assess the efficacy and safety of the therapy (2.1).
• •
  Follow the procedure for CAVERJECT syringe preparation (2.3).
• •
  Follow procedure for CAVERJECT intracavernosal injection administration (2.4).
• •
  To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT intracavernosally and monitor patients for the occurrence of an erection (2.2).

For injection: 20 mcg/vial and 40 mcg/vial lyophilized powder in single-dose vials for reconstitution.

The following adverse reaction has been identified during post-approval use of CAVERJECT.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Injury and procedural complications: Needle breakage during administration of CAVERJECT. In some instances, surgical removal of the needle was required.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

• •
  Use a 29 or 30 gauge one-half inch needle for injecting each dose.
• •
  The patient should be in a sitting or slightly reclined position when injecting a dose.
• •
  Retract the foreskin in uncircumcised patients.
• •
  Grasp the head of the penis with the thumb and forefinger and stretch it lengthwise along the thigh.
• •
  The site of injection is either the right or left lateral penis. See Figures A and B below.

• •
  Wipe the intended injection site with an alcohol swab prior to injection.
• •
  Insert needle perpendicular to the long dorsolateral penile axis in the proximal third of penis. Avoid angulation of the syringe and do not bend the needle.
• •
  Avoid visible veins during injection.
• •
  With each use of CAVERJECT, alternate the side of the penis that is injected.
• •
  Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.
• •
  CAVERJECT is intended for single patient use only and should be discarded after use.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Prolonged erection, defined as erection lasting between 4 to 6 hours in duration, occurred in 4% of 1,861 patients treated up to 18 months in studies of CAVERJECT. The incidence of priapism (erections lasting more than 6 hours in duration) was 0.4%. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

To minimize the chances of prolonged erection or priapism, titrate CAVERJECT to the lowest effective dose [see Dosage and Administration (2.1)]. In addition, do not use CAVERJECT in patients who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia [see Contraindications (4)].

CAVERJECT is a lyophilized powder supplied in vials containing 23.2 or 46.4 mcg of alprostadil for intracavernosal administration. When reconstituted as directed with 1 milliliter of bacteriostatic water for injection, the delivered amount of alprostadil is 20 mcg or 40 mcg.

NDC 0009-3701-08

Pfizer

Caverject^®

(alprostadil) for injection

20 mcg

For Intracavernosal Use Only

Single Dose Vial

Rx only

NDC 0009-7686-01

Pfizer

Caverject^®

(alprostadil) for injection

40 mcg

For Intracavernosal Use Only

Single Dose Vial

Rx only

NDC 0009-3701-05

Contains 6 of NDC 0009-3701-08

Pfizer



Caverject^®

(alprostadil) for

injection

For Intracavernosal Use Only

6 Single-Dose Vials

20 mcg

Diluent to be used with this product should

contain benzyl alcohol as a preservative.

This Package Does NOT Contain Diluent

Rx only

NDC 0009-7686-04

Contains 6 of NDC 0009-7686-01

Pfizer

Caverject^®

(alprostadil) for

injection

For Intracavernosal Use Only

6 Single-Dose Vials

40 mcg

Diluent to be used with this product should

contain benzyl alcohol as a preservative.

This Package Does NOT Contain Diluent

Rx only

• •
  Alprostadil is available in different strengths and presentations. Determine the most suitable dose and presentation for each patient.
• •
  CAVERJECT is available in single-dose vials containing 20 mcg or 40 mcg of alprostadil. Make sure a new, correct strength vial of CAVERJECT is used for each patient dosage preparation.
• •
  Titrate the dose of CAVERJECT for each patient to the lowest effective dose.
• •
  CAVERJECT doses greater than 60 mcg are not recommended.
• •
  Administer the first injections of CAVERJECT in the health care provider’s office by medically trained personnel.
• •
  Instruct the patient on proper use and assess that they are well trained in the self-injection technique prior to initiation of home use. Refer to the Patient Information and Instructions for Use.
• •
  Re-evaluate patients regularly (every 3 months or as clinically appropriate) and determine if dosage adjustments are needed.

The use of CAVERJECT offers no protection against sexually transmitted diseases. Counsel patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV).

Patients on anticoagulants, such as warfarin or heparin, may have increased propensity for injection site bleeding after intracavernosal injection with CAVERJECT. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.

There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including CAVERJECT, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. In addition, the evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.

When reconstituted using the recommended diluent, the solution contains benzyl alcohol. Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved formulations in infusion solutions, including CAVERJECT. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. CAVERJECT is not indicated for use in pediatric patients.

The safety and efficacy of combinations of CAVERJECT and other vasoactive agents injected intracavernosally have not been established in clinical studies. The risks of prolonged erection, priapism, and hypotension may be increased.

Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology

• •
  Initiate dosing with 2.5 mcg of CAVERJECT intracavernosally, as recommended [see Dosage and Administration (2.4)].
• •
  If there is a partial response at 2.5 mcg, administer another dose of 2.5 mcg within 1 hour. Use a new vial for each dose of CAVERJECT.
• •
  During titration, no more than 2 doses should be given within a 24-hour period.
• •
  If additional titration is required, administer doses in increments of 5 to 10 mcg at least 24 hours apart.
• •
  The optimal dose should produce an erection suitable for intercourse that does not exceed a duration of 1 hour.
• •
  The patient must stay in the health care provider’s office until complete detumescence occurs.

Repeat the titration as necessary until the optimal dose is achieved. Doses greater than 60 mcg are not recommended.

Store CAVERJECT 20 mcg vials between 20°C to 25°C (68°F to 77°F). The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.

Store CAVERJECT 40 mcg vials between 2°C to 8°C (36° to 46°F) until dispensed. Once dispensed, vials should be stored at or below 25°C (77°F) for up to 3 months or until the expiration date, whichever occurs first. The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.

When reconstituted and used as directed, the deliverable amount of alprostadil is 20 micrograms or 40 micrograms, respectively. Only bacteriostatic water for injection, should be used when reconstituting CAVERJECT.

CAVERJECT is available in the following packages:

The following supplies are needed for injection and are not supplied with CAVERJECT:

• •
  1 mL of the diluent (bacteriostatic water for injection)
• •
  1 mL to 3 mL syringe, dependent on the titrated dose
• •
  21 to 27 gauge needle for reconstitution
• •
  29 or 30 gauge one-half inch needle for injection
• •
  alcohol swabs

Overdosage was not observed in clinical trials with CAVERJECT. If intracavernous overdose of CAVERJECT occurs, the patient should be under medical supervision until any systemic effects have resolved and/or until penile detumescence has occurred. Treatment of any systemic symptoms (e.g., hypotension) would be appropriate.

CAVERJECT is not indicated for use in females.

CAVERJECT is not indicated for use in females.

CAVERJECT 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°C and 116° C. CAVERJECT is available as a sterile freeze-dried powder for intracavernosal use in sizes: 20 mcg and 40 mcg per vial. When reconstituted as directed with 1 mL of bacteriostatic water for injection, the volume of the reconstituted solution is 1.13 mL. Each mL of CAVERJECT contains 20.5 mcg or 41.1 mcg of alprostadil depending on vial strength, 172 mg of lactose, 47 mcg of sodium citrate and 8.4 mg of benzyl alcohol. The deliverable amount of alprostadil is 20 mcg or 40 mcg per mL because approximately 0.5 mcg for the 20 mcg strength and 1.1 mcg for the 40 mcg strength is lost due to adsorption to the vial and syringe. During manufacture, the pH of alprostadil for injection was adjusted with hydrochloric acid and/or sodium hydroxide before lyophilization.

The structural formula of alprostadil is represented below:

Intracavernous injections of CAVERJECT can increase peripheral blood levels of alprostadil which can result in hypotension. Avoid use of CAVERJECT in patients with known cavernosal venous leakage.

Safety and effectiveness have not been established in pediatric patients [see Warnings and Precautions (5.8)].

A total of 341 subjects included in clinical studies were 65 and older. No overall differences in safety and effectiveness were observed between these subjects and younger subjects, and the other reported clinical experience has not identified differences in responses between elderly and younger patients.

CAVERJECT is indicated as an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction.

The efficacy of CAVERJECT was investigated in men with a diagnosis of erectile dysfunction due to psychogenic, vasculogenic, neurogenic, and/or mixed etiology in two double-blind, placebo-controlled studies (Study 1 and Study 2) and in one 6-month open-label study (Study 3). In clinical studies (Study 1 and Study 3), over 80% of patients experienced an erection sufficient for sexual intercourse after intracavernosal injection of CAVERJECT.

CAVERJECT is contraindicated:

• •
  in men who have a known hypersensitivity to the drug [see Adverse Reactions (6.1)]
• •
  in men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia [see Warnings and Precautions (5.1)]
• •
  for the treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease [see Warnings and Precautions (5.2)]
• •
  in men with penile implants.

The overall incidence of penile fibrosis reported in clinical studies with CAVERJECT was 3%. In one self-injection clinical study where duration of use was up to 18 months, the incidence of penile fibrosis was 7.8%.

Physical examination of the penis should be performed periodically, to detect signs of penile fibrosis. Treatment with CAVERJECT should be discontinued in patients who develop penile angulation or cavernosal fibrosis.

Separate needles should be used for reconstitution and administration. A superfine needle is used for administration of CAVERJECT. As with all superfine needles, the possibility of needle breakage exists. Needle breakage, with a portion of the needle remaining in the penis, has been reported and, in some cases, has required hospitalization and surgical removal. Careful instruction in proper patient handling and injection techniques may minimize the potential for needle breakage [see Dosage and Administration (2.3) and Adverse Reactions (6.2)].

The following are described elsewhere in the labeling:

• •
  Prolonged Erection and Priapism [see Warnings and Precautions (5.1)]
• •
  Penile Fibrosis [see Warnings and Precautions (5.2)]

The potential for pharmacokinetic drug-drug interactions between alprostadil and other agents administered orally or intracavernosally has not been formally studied [see Warnings and Precautions (5.6)].

CAVERJECT [KAV-er-jeckt]^®

(alprostadil)

for injection, for intracavernosal use

Read this Patient Information before you start using CAVERJECT and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is CAVERJECT?

CAVERJECT is a prescription medicine used:

• •
  to treat erectile dysfunction (ED).
• •
  with other medical tests to diagnose ED.

CAVERJECT is not meant for use in women or children.

Do not use CAVERJECT if you:

• •
  are allergic to alprostadil or any of the ingredients in CAVERJECT. See the end of this leaflet for a complete list of ingredients in CAVERJECT
• •
  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
• •
  have a deformed penis shape
• •
  have a penile implant

Before you use CAVERJECT, tell your healthcare provider about all your other medical conditions, especially 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

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

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

Especially tell your healthcare provider if you take any other medicines that are treatments for ED, other medicines 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?

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

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

What are the possible side effects of CAVERJECT?

CAVERJECT may cause serious side effects, including:

• •
  an erection that will not go away (priapism). 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 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. To best avoid breaking the needle, you should pay careful attention to your healthcare provider's instructions and 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 more likely to break. 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 that is present in CAVERJECT when it is mixed. 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 is not meant for use in children.

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

The most common side effect of CAVERJECT is penile pain

These are not all the possible side effects of CAVERJECT.

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

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

You can ask your pharmacist or healthcare provider for information about CAVERJECT that is written for health professionals.

What are the Ingredients in CAVERJECT?

Active ingredient: alprostadil

Inactive ingredients: lactose, sodium citrate, benzyl alcohol (contained in the final solution) and hydrochloric acid and/or sodium hydroxide for pH adjustment.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com

LAB-1045-3.0

Revised: March 2023

CAVERJECT [KAV-er-jeckt]®

(alprostadil)

for injection, for intracavernosal use

Your healthcare provider should show you how to prepare and inject CAVERJECT the right way before you inject it for the first time. Do not try to inject yourself until you have been shown the right way to give your injections by your healthcare provider.

Information about how to safely inject CAVERJECT:

• •
  Read and follow these instructions so that you inject CAVERJECT the right way. Call your healthcare provider if you have any questions about the right way to inject CAVERJECT.
• •
  Separate needles should be used for reconstitution and administration. Do not use damaged or bent needles to inject CAVERJECT.
• •
  If you accidentally bend a needle, do not attempt to straighten it.
• •
  Using bent or re-straightened needles may cause part of the needle to break off and remain in the penis. Some people have reported needle breakage in their penis during the injection and, in some cases, had to go to hospital for surgery to remove the needle.
• •
  If you accidentally bend the needle while preparing your CAVERJECT injection, remove it from the syringe, throw it away, and attach a new, needle to the syringe as described under "Prepare the Dose" below. (See "Dispose of your used CAVERJECT syringe and needle" at the end of these Instructions).
• •
  Do not share your needles or syringes with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them.
• •
  Use the needles, syringe, alcohol swabs, and vials only 1 time then safely throw away the supplies and any unused solution in a puncture resistant container (See "Dispose of your used CAVERJECT syringe and needle" at the end of these instructions). Ask your healthcare provider or pharmacist where you can get a puncture resistant or sharps container.

CAVERJECT comes in 20 mcg or 40 mcg strengths. Make sure you have the right strength vial of CAVERJECT that your healthcare provider prescribed for you.

Prepare the Syringe

After your injection:

Dispose of your used CAVERJECT syringe and needles.

• •
  Put your used CAVERJECT syringe and needles in a FDA-cleared sharps disposal container right away after use. Do not throw away loose needles and syringes in your household trash.
• •
  If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
  • o
    made of a heavy-duty plastic
  • o
    can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
  • o
    upright and stable during use
  • o
    leak-resistant
  • o
    properly labeled to warn of hazardous waste inside the container
• •
  When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. Do not reuse or share your needles or syringes with other people. For more information about the safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: http://www.fda.gov/safesharpsdisposal.
• •
  Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.

How should I store CAVERJECT?

CAVERJECT 20 mcg vial storage information

• 1.
  Store CAVERJECT 20 mcg vials between 20°C to 25°C (68°F to 77°F).
• 2.
  The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.

CAVERJECT 40 mcg vial storage information

• 1.
  Store CAVERJECT 40 mcg vials between 2°C to 8°C (36°F to 46°F) until dispensed. Once dispensed, vials should be stored at or below 25°C (77°F) for up to 3 months or until the expiration date, whichever occurs first.
• 2.
  The reconstituted solution should be used within 24 hours when stored at or below 25°C (77°F) and not refrigerated or frozen.

Keep CAVERJECT and all medicines out of the reach of children.

This Patient Information and Instructions for Use has been approved by the U.S Food and Drug Administration.

LAB-0009-8.0

Revised March 2023

CAVERJECT is a prostaglandin E1 agonist indicated

• •
  For the treatment of erectile dysfunction (1.1).
• •
  As an adjunct to other diagnostic tests in the diagnosis of erectile dysfunction (1.2).

CAVERJECT is indicated for the treatment of erectile dysfunction.

Alprostadil (PGE1) is a prostaglandin with a wide variety of pharmacological actions including vasodilation and inhibition of platelet aggregation. Alprostadil induces erection by relaxation of trabecular smooth muscle and by dilation of cavernosal arteries by binding to its receptors and increasing intracellular cyclic adenosine monophosphate (cAMP) levels via modulation of adenylate cyclase. 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. Alprostadil also attenuates presynaptic noradrenaline release in the corpus cavernosum.

Studies in vitro have shown that alprostadil relaxed isolated preparations of human corpus cavernosum and spongiosum, as well as cavernous arterial segments contracted by either noradrenaline or PGF2α. In pigtail monkeys (Macaca nemestrina), alprostadil increased cavernous arterial blood flow in a dose-dependent manner in vivo.

• •
  Prolonged erection and priapism have occurred in patients receiving CAVERJECT. To minimize the chances of this occurring, titrate CAVERJECT slowly to the lowest effective dose (2.1). Advise patients to seek immediate medical assistance for an erection that persists longer than 4 hours (5.1).
• •
  Penile fibrosis has occurred in patients receiving CAVERJECT. Follow patients regularly to detect signs of penile fibrosis. Discontinue in patients who develop penile angulation or cavernosal fibrosis (5.2).
• •
  Hypotension: Injections of CAVERJECT can lead to increased peripheral blood levels of alprostadil, especially in patients with significant corpora cavernosa venous leakage. Avoid use in patients with known cavernosal venous leakage (5.3).
• •
  Injection site bleeding may occur in patients taking anticoagulants, such as warfarin or heparin. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes (5.4).
• •
  Cardiovascular risk related to underlying medical conditions: Underlying treatable medical causes of erectile dysfunction should be diagnosed and treated prior to initiation of therapy (5.5).
• •
  Risks of use in combination with other vasoactive medications injected intracavernosally: Safety and efficacy of combinations of CAVERJECT and other vasoactive agents have not been systematically studied. Use of such combinations is not recommended (5.6).
• •
  Needle breakage: A superfine needle is used for administration of CAVERJECT and cases of needle breakage have been reported. Careful instruction in proper patient handling and injection techniques may minimize this risk (5.7).
• •
  Benzyl alcohol: Serious and fatal adverse reactions can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved formulations in infusion solutions, including CAVERJECT. CAVERJECT is not indicated in neonates and infants (5.8).
• •
  Counsel patients about sexually transmitted diseases: Counsel patients about the protective measures necessary to guard against sexually transmitted disease including the Human Immunodeficiency Virus (HIV) (5.9).

• •
  Determine the most suitable dose and presentation of CAVERJECT to use. Use a new vial for each dose of CAVERJECT (2.1).
• •
  Administer first intracavernosal injections in the health care provider’s office and titrate the dose for each patient to the lowest effective dose (2.1).
• •
  Instruct the patient on proper use and assess that they are well trained in the self-injection technique prior to initiation of at-home use (2.1).
• •
  Recommended dosage for erectile dysfunction (2.2):
  • •
    Erectile dysfunction of vasculogenic, psychogenic, or mixed etiology: Initiate dosing with 2.5 mcg
  • •
    Erectile dysfunction of pure neurogenic etiology (spinal cord injury): Initiate dosing with 1.25 mcg
• •
  Follow dose titration procedures for each type of erectile dysfunction and determine the maintenance dosage for patient home use in the health care provider’s office (2.2).
• •
  The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose (2.2).
• •
  While on self-injection treatment, the patient should visit the prescribing health care provider’s office every 3 months to assess the efficacy and safety of the therapy (2.1).
• •
  Follow the procedure for CAVERJECT syringe preparation (2.3).
• •
  Follow procedure for CAVERJECT intracavernosal injection administration (2.4).
• •
  To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT intracavernosally and monitor patients for the occurrence of an erection (2.2).

For injection: 20 mcg/vial and 40 mcg/vial lyophilized powder in single-dose vials for reconstitution.

The following adverse reaction has been identified during post-approval use of CAVERJECT.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Injury and procedural complications: Needle breakage during administration of CAVERJECT. In some instances, surgical removal of the needle was required.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

• •
  Use a 29 or 30 gauge one-half inch needle for injecting each dose.
• •
  The patient should be in a sitting or slightly reclined position when injecting a dose.
• •
  Retract the foreskin in uncircumcised patients.
• •
  Grasp the head of the penis with the thumb and forefinger and stretch it lengthwise along the thigh.
• •
  The site of injection is either the right or left lateral penis. See Figures A and B below.

• •
  Wipe the intended injection site with an alcohol swab prior to injection.
• •
  Insert needle perpendicular to the long dorsolateral penile axis in the proximal third of penis. Avoid angulation of the syringe and do not bend the needle.
• •
  Avoid visible veins during injection.
• •
  With each use of CAVERJECT, alternate the side of the penis that is injected.
• •
  Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.
• •
  CAVERJECT is intended for single patient use only and should be discarded after use.

Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).

Prolonged erection, defined as erection lasting between 4 to 6 hours in duration, occurred in 4% of 1,861 patients treated up to 18 months in studies of CAVERJECT. The incidence of priapism (erections lasting more than 6 hours in duration) was 0.4%. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.

To minimize the chances of prolonged erection or priapism, titrate CAVERJECT to the lowest effective dose [see Dosage and Administration (2.1)]. In addition, do not use CAVERJECT in patients who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia [see Contraindications (4)].

CAVERJECT is a lyophilized powder supplied in vials containing 23.2 or 46.4 mcg of alprostadil for intracavernosal administration. When reconstituted as directed with 1 milliliter of bacteriostatic water for injection, the delivered amount of alprostadil is 20 mcg or 40 mcg.

NDC 0009-3701-08

Pfizer

Caverject^®

(alprostadil) for injection

20 mcg

For Intracavernosal Use Only

Single Dose Vial

Rx only

NDC 0009-7686-01

Pfizer

Caverject^®

(alprostadil) for injection

40 mcg

For Intracavernosal Use Only

Single Dose Vial

Rx only

NDC 0009-3701-05

Contains 6 of NDC 0009-3701-08

Pfizer



Caverject^®

(alprostadil) for

injection

For Intracavernosal Use Only

6 Single-Dose Vials

20 mcg

Diluent to be used with this product should

contain benzyl alcohol as a preservative.

This Package Does NOT Contain Diluent

Rx only

NDC 0009-7686-04

Contains 6 of NDC 0009-7686-01

Pfizer

Caverject^®

(alprostadil) for

injection

For Intracavernosal Use Only

6 Single-Dose Vials

40 mcg

Diluent to be used with this product should

contain benzyl alcohol as a preservative.

This Package Does NOT Contain Diluent

Rx only

• •
  Alprostadil is available in different strengths and presentations. Determine the most suitable dose and presentation for each patient.
• •
  CAVERJECT is available in single-dose vials containing 20 mcg or 40 mcg of alprostadil. Make sure a new, correct strength vial of CAVERJECT is used for each patient dosage preparation.
• •
  Titrate the dose of CAVERJECT for each patient to the lowest effective dose.
• •
  CAVERJECT doses greater than 60 mcg are not recommended.
• •
  Administer the first injections of CAVERJECT in the health care provider’s office by medically trained personnel.
• •
  Instruct the patient on proper use and assess that they are well trained in the self-injection technique prior to initiation of home use. Refer to the Patient Information and Instructions for Use.
• •
  Re-evaluate patients regularly (every 3 months or as clinically appropriate) and determine if dosage adjustments are needed.

The use of CAVERJECT offers no protection against sexually transmitted diseases. Counsel patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV).

Patients on anticoagulants, such as warfarin or heparin, may have increased propensity for injection site bleeding after intracavernosal injection with CAVERJECT. Compress the site of injection with an alcohol swab or sterile gauze for 5 minutes.

There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including CAVERJECT, generally should not be used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status. In addition, the evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.

When reconstituted using the recommended diluent, the solution contains benzyl alcohol. Serious and fatal adverse reactions including "gasping syndrome" can occur in neonates and low birth weight infants treated with benzyl alcohol-preserved formulations in infusion solutions, including CAVERJECT. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. CAVERJECT is not indicated for use in pediatric patients.

The safety and efficacy of combinations of CAVERJECT and other vasoactive agents injected intracavernosally have not been established in clinical studies. The risks of prolonged erection, priapism, and hypotension may be increased.