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Caverject Impulse

Last reviewed on RxList: 11/28/2016
Caverject Impulse Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 2/17/2016

Caverject Impulse (alprostadil dual chamber system for injection) is a vasodilator that works by helping the blood flow into the penis to achieve and maintain an erection used to treat erectile dysfunction (impotence) and to help diagnose certain causes of this disorder. Alprostadil is also used to improve blood flow in newborn babies with a certain genetic heart condition. This medication guide addresses only the adult male use of Caverject Impulse in erectile disorders. Common side effects of Caverject Impulse include injection site reactions (mild/moderate pain, irritation, or slight bleeding), unusual discharge from your penis, mild pain in your penis/urethra/testicles, headache, dizziness, back pain, a rash on the skin of your penis, itching/warmth/numbness of your penis, cough, stuffy nose, cold symptoms, or flu symptoms.

The dose of Caverject is individualized by careful titration under supervision by the physician. Doses of greater than 60 mcg are not recommended. Caverject Impulse may interact with nitroglycerin, hydralazine, or blood thinners. Tell your doctor all medications and supplements you use. Caverject Impulse should not be used by women, therefore, it is unlikely to be used during pregnancy or while breastfeeding. Men should use a condom to prevent transfer of this medication to a sexual partner if she is pregnant or could become pregnant.

Our Caverject Impulse (alprostadil dual chamber system for injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Caverject Impulse Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using alprostadil and call your doctor at once if you have a serious side effect such as:

  • feeling light-headed, fainting;
  • trouble urinating, blood in your urine;
  • bleeding, bruising, or swelling where you injected the medication;
  • a painful erection that lasts 4 hours or longer;
  • severe pain or irritation of your penis or urethra; or
  • redness, lumps, tenderness, unusual shape or curving of the erect penis.

Less serious side effects may include:

  • unusual discharge from your penis; or
  • mild pain in your penis, urethra, or testicles;
  • headache, dizziness;
  • back pain;
  • a rash on the skin of your penis;
  • itching, warmth, or numbness of your penis;
  • cough, stuffy nose, cold symptoms, flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Your sexual partner may also have side effects such as burning, itching, or irritation of the body areas that come into contact with your penis.

Read the entire detailed patient monograph for Caverject Impulse (Alprostadil Dual Chamber System for Injection)

Caverject Impulse Professional Information

SIDE EFFECTS

The following are discussed in more detail in other sections of the labeling:

Clinical Trials Experience

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.

CAVERJECT IMPULSE was evaluated in 87 patients in an open-label crossover study of 6 weeks treatment duration that compared the formulation of alprostadil for injection contained in CAVERJECT IMPULSE with the formulation contained in CAVERJECT Sterile Powder. Doses used in this study ranged from 2.5 mcg to 20 mcg. Adverse reactions reported for the CAVERJECT IMPULSE formulation included: penis disorder (4.6%), prolonged erection (1.1%), injection site erythema (1.1%), rash (1.1%), dizziness (1.1%), and hematospermia (1.1%). Penis disorder included penile pain, post-injection pain, and pain with erection.

CAVERJECT IMPULSE was also evaluated in 63 patients in a single-dose, double-blind, crossover study that compared CAVERJECT IMPULSE with CAVERJECT Sterile Powder. Doses used in this study ranged from 2.5 mcg to 20 mcg. Adverse reactions reported for the CAVERJECT IMPULSE formulation included: penile pain (1.6%) and pruritis (1.6%).

In addition to the adverse reactions observed for CAVERJECT IMPULSE in these two studies, the following adverse reactions have been reported in clinical studies of CAVERJECT Sterile Powder:

Local Adverse Reactions

Local adverse reactions derived from 1861 patients in clinical studies of CAVERJECT Sterile Powder, including an 18-month, open-label study, are shown in Table 1.

Table 1: Local Adverse Reactions Reported by ≥ 1% of Patients Treated with CAVERJECT Sterile Powder for up to 18 Months

Penile pain 37%
Prolonged erection 4%
Penile fibrosis 3%
Injection site hematoma 3%
Penis disorder* 3%
Injection site ecchymosis 2%
Penile rash 1%
Penile edema 1%
* Penis disorder includes: numbness, irritation, sensitivity, pruritus, erythema, skin tear, discoloration, itching.

The following local adverse reactions were reported in < 1% of patients: injection site hemorrhage, injection site inflammation, injection site itching, injection site swelling, injection site edema, urethral bleeding, penile warmth, numbness, irritation, sensitivity, pruritus, erythema, painful erection, and abnormal ejaculation.

In these studies, no local adverse reactions were reported in the 294 patients who received placebo, except for penile pain (2%).

Penile Pain: In the majority of the cases, penile pain was rated mild or moderate in intensity. Three percent of patients discontinued treatment because of penile pain

Prolonged Erection/Priapism: Prolonged erection was defined as an erection that lasted for 4 to 6 hours; priapism was defined as an erection that lasted 6 hours or longer. In clinical studies, the frequency of prolonged erection after intracavernosal administration of CAVERJECT Sterile Powder was 4%, while the frequency of priapism was 0.4% [see WARNINGS AND PRECAUTIONS].

Penile Hematoma/Ecchymosis: In clinical studies the frequency of penile hematoma and ecchymosis was 3% and 2%, respectively.

Systemic Adverse Reactions: Systemic adverse reactions reported by ≥ 1% of subjects in clinical studies of CAVERJECT

Sterile Powder included: dizziness (1%).

The following systemic adverse reactions, were reported in < 1% of patients: testicular pain, scrotal edema, hematuria, pelvic pain, hypotension, vasodilation, vasovagal reaction, diaphoresis, rash, and non-application site pruritus. Three patients (0.2%) discontinued due to symptomatic hypotension. No systemic adverse reactions were reported in the 294 patients who received placebo.

Post-marketing Experience

The following additional adverse reactions have been reported: device malfunction/failure, drug ineffective and drug effect decreased.

Read the entire FDA prescribing information for Caverject Impulse (Alprostadil Dual Chamber System for Injection)

Related Resources for Caverject Impulse

Read the Caverject Impulse User Reviews »

© Caverject Impulse Patient Information is supplied by Cerner Multum, Inc. and Caverject Impulse Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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