CAVERJECT- alprostadil injection, powder, lyophilized, for solution
Pharmacia and Upjohn Company LLC
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CAVERJECT safely and effectively. See full prescribing information for CAVERJECT.
CAVERJECT ® (alprostadil) for injection, for intracavernosal use
Initial U.S. Approval: 1981
INDICATIONS AND USAGE
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
For injection: 20mcg and 40mcg lyophilized powder in single-dose vials for reconstitution (3).
WARNINGS AND PRECAUTIONS
The most common (≥10%) adverse reaction is penile pain (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at (1-800-438-1985 and www.pfizer.com) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
FULL PRESCRIBING INFORMATION: CONTENTS*
Erectile Dysfunction of Vasculogenic, Psychogenic, or Mixed Etiology
If additional titration is required, doses in increments of 5 to 10 mcg may be given at least 24 hours apart. Repeat the titration as necessary until the optimal dose is achieved. Doses greater than 60 mcg are not recommended.
Erectile Dysfunction of Pure Neurogenic Etiology (e.g., Spinal Cord Injury).
If additional titration is required, a dose of 5 mcg may be given during the next 24 hours. Thereafter, doses in increments of 5 mcg may be given at least 24 hours apart until the optimal dose is reached. Doses greater than 60 mcg are not recommended.
Maintenance Dosage for Patient Home Use
Supplies Needed and Not Supplied With CAVERJECT
|20 mcg Vial||40 mcg Vial|
|Dose||Volume to Inject||Dose||Volume to Inject|
|1.25 mcg||0.06 mL||1.25 mcg||---|
|2.5 mcg||0.125 mL||2.5 mcg||---|
|5 mcg||0.25 mL||5 mcg||0.125 mL|
|10 mcg||0.5 mL||10 mcg||0.25 mL|
|15 mcg||0.75 mL||15 mcg||0.375 mL|
|20 mcg||1 mL||20 mcg||0.5 mL|
|25 mcg||---||25 mcg||0.625 mL|
|30 mcg||---||30 mcg||0.75 mL|
|40 mcg||---||40 mcg||1 mL|
Refer to the Patient Information and Instructions for Use in the FDA-approved patient labeling for the complete detailed instructions on reconstitution and needle preparation steps.
|Figure A||Figure B|
As an adjunct to the diagnosis of erectile dysfunction, inject CAVERJECT intracavernosally and monitor patients for the occurrence of an erection. Extensions of this testing are the use of CAVERJECT as an adjunct to laboratory investigations, such as duplex or Doppler ultrasound imaging. For any of these tests, use a single dose of CAVERJECT that induces a rigid erection.
For injection: 20 mcg and 40 mcg lyophilized powder in single-dose vials for reconstitution.
CAVERJECT is contraindicated:
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, CAVERJECT should be titrated slowly 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)].
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.
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.
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.
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.
Separate needles should be used for reconstitution and administration. CAVERJECT uses a superfine needle for administration. 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, 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)].
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 neonates or infants.
The use of CAVERJECT offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV) is advised.
The following are described elsewhere in the labeling:
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.
Local Adverse Reactions: Local adverse reactions derived from 1861 patients in clinical studies of CAVERJECT, including an 18-month, open-label study, are shown in Table 2.
|Injection site hematoma||3%|
|Injection site ecchymosis||2%|
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 was 4%, while the frequency of priapism was 0.4% [see Warnings and Precautions (5.1)].
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 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.
In addition to the adverse reactions observed for CAVERJECT, the following adverse reactions have been reported in clinical studies of CAVERJECT IMPULSE:
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. 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. 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%).
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)].
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.
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 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 preserved with benzyl alcohol 0.945% w/v, gives 1.13 mL of reconstituted solution. 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:
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.
Absorption: For the treatment of erectile dysfunction, alprostadil is administered by injection into the corpora cavernosa. The absolute bioavailability of alprostadil has not been determined.
Distribution: Following intracavernosal injection of 20 mcg alprostadil, mean peripheral plasma concentrations of alprostadil at 30 and 60 minutes after injection (89 picograms/mL and 102 picograms/mL, respectively) were not significantly greater than baseline levels of endogenous alprostadil (96 picograms/mL). Plasma levels of alprostadil were measured using a radioimmunoassay method. Alprostadil is bound in plasma primarily to albumin (81% bound) and to a lesser extent α-globulin IV-4 fraction (55% bound). No significant binding to erythrocytes or white blood cells was observed.
Metabolism: Alprostadil is converted to compounds which are further metabolized prior to excretion. Following intravenous administration, approximately 80% of circulating alprostadil is metabolized in one pass through the lungs, primarily by beta- and omega-oxidation. Following intracavernosal injection of 20 mcg alprostadil, peripheral levels of the major circulating metabolite, 13, 14-dihydro-15-oxo-PGE1, increased to reach a peak 30 minutes after injection and returned to pre-dose levels by 60 minutes after injection.
Excretion: The metabolites of alprostadil are excreted primarily by the kidney, with almost 90% of an administered intravenous dose excreted in urine within 24 hours post-dose. The remainder of the dose is excreted in the feces. There is no evidence of tissue retention of alprostadil or its metabolites following intravenous administration.
Pharmacokinetics in Specific Populations
Geriatric: The potential effect of age on the pharmacokinetics of alprostadil has not been formally evaluated.
Race: The potential effect of race on the pharmacokinetics of alprostadil has not been formally evaluated.
Alprostadil was negative in bacterial mutation (Ames), alkaline elution, rat micronucleus, sister chromatid exchange, CHO/HGPRT mammalian cell forward gene mutation, and unscheduled DNA synthesis (UDS) assays.
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.
Study 1: A total of 153 men with ED with a mean age of 53 years (range 23–69 years) were enrolled. The study had three phases: a 2.5 week, randomized, double-blind, placebo-controlled crossover phase in which each man received in-office injections of placebo or 2.5 mcg, 5 mcg, 7.5 mcg, or 10 mcg of CAVERJECT; a 2 week, open-label, in-office dose-titration phase to identify the optimum home-use dose (the latter dose was defined as a dose inducing an erection sufficient for intercourse and lasting ≤ 60 minutes); and a 4-week open-label, at-home phase. In the double-blind placebo-controlled, crossover phase, each dose of CAVERJECT was significantly more effective than placebo by clinical evaluation ("full penile rigidity") and by RigiScan criteria (≥ 70% rigidity for at least 10 minutes); there was no response to placebo. The percentage of responders increased with increasing doses of CAVERJECT. The overall response rates in the crossover and dose-titration phases were 76% (117/153) by clinical evaluation and 51% (78/152) by RigiScan criteria. Seventy-three percent of the injections in 102 men who used CAVERJECT in the at-home phase resulted in satisfactory intercourse. Seventy-five percent of the men who used CAVERJECT in the at-home phase remained on the dose identified as optimum for them during the dose-titration phase; 17% and 8% of the men decreased or increased their dose, respectively. The mean duration of erection per injection was 70.8 minutes.
Study 2: A total of 296 men with ED with a mean age of 54 years (range 21–74 years) were enrolled in this double-blind, placebo controlled, parallel-arm design study. The men were randomly assigned to one of five groups and received either a single dose of placebo, 2.5 mcg, 5 mcg, 10 mcg, or 20 mcg of CAVERJECT. No patient responded to placebo. The differences in the response rates in both the clinical and the RigiScan evaluations between each of the doses of CAVERJECT and placebo were statistically significant. There was also a statistically significant dose-response relationship with higher clinical response rates and higher RigiScan response rates with increasing doses of CAVERJECT (with exception of the 10-mcg dose). The mean duration of erection after injection ranged from 12 minutes after the 2.5-mcg dose to 44 minutes after the 20-mcg dose and the relationship was linear (p = .025, linear regression analysis).
Study 3: The efficacy of CAVERJECT was further evaluated in a 6-month, open-label, at-home study in 683 men with ED with a mean age of 58 years (range 20–79 years). The optimum dose of CAVERJECT was established by titration in 89% of men (606/683). A total of 471/683 men (69%) completed the 6-month study. Eighty-seven percent of the 13,762 injections of CAVERJECT administered resulted in satisfactory sexual activity. The mean duration of erection was 67.5 minutes.
The formulation of alprostadil contained in CAVERJECT IMPULSE was compared to CAVERJECT in 87 men with ED in a single-blind, crossover study. The doses used by the patients in the study ranged from 2.5 mcg to 20 mcg and were the same for both formulations. The efficacy of the two formulations was shown to be comparable, as assessed by the 30-point erectile function (EF) domain score from the International Index of Erectile Function (IIEF) and by a physician-assessment score for erectile response. The mean EF domain scores for CAVERJECT and the formulation contained in CAVERJECT were 26.6 (SD=5.3) and 27.6 (SD=3.8), respectively. The mean physician's assessment scores for CAVERJECT and the formulation contained in CAVERJECT IMPULSE were 2.6 (SD=0.6) and 2.7 (SD=0.5), respectively, based on a scale of 0 (no tumescence) to 3 (full rigidity).
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 preserved with benzyl alcohol 0.945% w/v, the delivered amount of alprostadil is 20 mcg or 40 mcg.
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 preserved with benzyl alcohol 0.945% w/v, should be used when reconstituting CAVERJECT.
CAVERJECT is available in the following packages:
|Package of six 20 mcg vials||NDC 0009-3701-05|
|Package of six 40 mcg vials||NDC 0009-7686-04|
The following supplies are needed for injection and are not supplied with CAVERJECT:
Advise the patient to read the FDA-approved patient labeling (Patient Information and Instructions for Use).
Dosing and Self-Administration
To ensure safe and effective use of CAVERJECT, instruct and train the patient in the self-injection technique before he begins intracavernosal treatment with CAVERJECT, at home. Inform the patient the initial dose administration and dose titration will take place in the physician's office [see Dosage and Administration (2.1)].
Once the home dose of CAVERJECT has been established instruct the patient not to change the dose without consulting their physician.
The patient may expect an erection to occur within 5 minutes to 20 minutes and it should last no longer than 1 hour. CAVERJECT should be used no more than 3 times per week, with at least 24 hours between each use [see Dosage and Administration (2.2)].
Inform the patient that they must visit the physician's office for regular check-ups for assessment of the therapeutic benefit and safety of treatment with CAVERJECT.
Advise patients that needle breakage has occurred during self-injection of CAVERJECT. Advise patients to insert the needle perpendicular to the long access of the penis to avoid bending or breakage of the needle [see Dosage and Administration (2.4), Warnings and Precautions (5.7) and Adverse Reactions (6.2)].
Advise patients that the most frequently occurring side-effect is penile pain after injection, and is usually mild to moderate in severity [see Adverse Reactions (6.1)].
A potentially serious adverse reaction with intracavernosal therapy of CAVERJECT is priapism. Instruct the patient to seek immediate medical assistance if an erection persists for longer than 4 hours [see Warnings and Precautions (5.1)].
Penile fibrosis has been reported in clinical studies with CAVERJECT. Advise the patient to report any penile pain that was not present before or that increased in intensity, as well as the occurrence of nodules or hard tissue in the penis or curvature of the erect penis to his physician as soon as possible. [see Warnings and Precautions (5.2)].
Injection Site Reactions
Inform the patient that injection of CAVERJECT can induce a small amount of bleeding at the site of injection and that hematoma and ecchymosis may occur. Advise the patient to report any persistent redness, tenderness or swelling [see Warnings and Precautions (5.4)].
Sexually Transmitted Disease
Use of intracavernosal CAVERJECT offers no protection from the transmission of sexually transmitted diseases. Advise the patient about the protective measures that are necessary to guard against the spread of sexually transmitted diseases, including the human immunodeficiency virus (HIV) [see Warnings and Precautions (5.9)].
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:
CAVERJECT is not meant for use in women or children.
Do not use CAVERJECT if you:
Before you use CAVERJECT, tell your healthcare provider about all your other medical conditions, especially if you:
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?
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:
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: alpha cyclodextrin, lactose, sodium citrate, benzyl alcohol (contained in the final solution) and hydrochloric acid and/or sodium hydroxide for pH adjustment.
Revised: December 2017
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:
|Supplies you will need to give your CAVERJECT injection (Figure A)||Figure A: Supplies you will need for your Injection.|
|Follow the instructions below to prepare and give your injection. Figure B explains the parts of the needle and syringe that are referred to in the instructions.||Figure B: Parts of the needle and syringe|
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
|Wash your hands thoroughly, and dry them with a clean towel.|
|Assemble the needle and syringe as follows:||Figure C: Remove the syringe|
Figure D: Open the needle wrapper
|Keeping hold of the needle assembly, remove the plastic syringe cap from the syringe tip (Figure E). Do not touch the syringe tip.||Figure E: Remove the syringe cap|
|Hold the needle assembly (still in the paper wrapper). Firmly attach the needle to the syringe tip. Turn it clockwise, like tightening a screw to lock it in place (Figure F).||Figure F: Attach the needle to the syringe|
|Mixing the powder and liquid to prepare the dose|
|Remove the plastic cap from the vial of CAVERJECT and remove any cover from the diluent (Figure G).||Figure G: Remove the vial cap|
|Wipe the rubber stoppers on the vials of CAVERJECT and diluent with 1 alcohol swab. Throw away the alcohol swab.|
|Carefully hold the syringe by the barrel and remove the needle cover (Figure H).||Figure H: Remove the needle cover|
|Hold the syringe with the needle attached and push the needle through the center of the diluent vial's rubber stopper (Figure I). Be careful not to bend the needle.||Figure I: Push the needle into the diluent vial|
|Push the syringe plunger to the 1mL mark on the syringe. This will remove air and extra liquid back into vial.|
Grasp the side of the syringe barrel (not the plunger) and pull the needle from the diluent vial in a straight line to avoid bending the needle (Figure K).
|Figure K: Adjust the amount of liquid in the syringe|
|Holding the syringe with the needle attached in a straight line with the vial of CAVERJECT, push the needle through the center of the rubber stopper of the vial of CAVERJECT. Be careful not to bend the needle.||Figure L: Push the needle into the CAVERJECT vial|
|Without removing the needle or touching the needle or stopper, gently swirl (do not shake) the vial until all the powder is dissolved in the liquid. Then turn the vial and needle/syringe upside down and gently swirl the vial to dissolve any powder in the neck of the vial. Do not use the solution if it is cloudy, colored, or contains particles.|
|Keeping the needle in the vial, firmly hold the vial and syringe upside down in one hand.|
|If there are air bubbles, gently tap the syringe barrel until the bubbles float to the top of the liquid (see Figure N).|
|Carefully replace the needle used to mix the liquid with a new 29 to 30 gauge one half inch needle for your injection.|
|How to give the injection|
|The injection will go into the part of the penis shown as the shaded area in Figure O. Do not inject CAVERJECT into the white areas because there may be blood vessels in the white areas. (See Figure P).||Figure O: Top view of the penis showing injection sites (shaded areas).|
|Wipe the area for injection with an alcohol swab and let it dry.|
|Do not throw away the swab; you will need to use it again after you give your injection. (See Step 23).|
|If your penis is not circumcised, pull the foreskin back. Take hold of the tip of your penis with your thumb and forefinger; stretch it length-wise along your thigh.|
|Gently squeeze your penis between your thumb and finger so that the injection site bulges out.|
|Remove the cover from the needle. Position your penis firmly against your thigh to keep it from moving during the injection.|
|Keeping a firm grip on your penis, take the syringe in your other hand, and push the needle straight into the selected injection site (See Figure Q).|
|Holding the syringe barrel between two fingers, move your thumb or finger to the top of the plunger and, with a steady motion, push down on the plunger so that the entire contents of the syringe is slowly injected (Figure R).||Figure R: Inject the contents of the syringe.|
|After completing the injection, carefully pull the needle out of your penis. Press gently on the injection site with the alcohol swab for about 5 minutes or until bleeding stops.|
After your injection:
Dispose of your used CAVERJECT syringe and needles.
How should I store CAVERJECT?
CAVERJECT 20 mcg vial storage information
CAVERJECT 40 mcg vial storage information
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.
Revised December 2017