Alprostadil (Caverject)

Trade Name : Caverject

Pharmacia and Upjohn Company LLC

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 20.5 ug/mL

Storage and handling for Caverject

ALPROSTADIL Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [CS],Venous Vasodilation [PE]

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Alprostadil (Caverject) which is also known as Caverject and Manufactured by Pharmacia and Upjohn Company LLC. It is available in strength of 20.5 ug/mL per ml. Read more

Alprostadil (Caverject) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

Delivery Process

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You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

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Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

About GNH

No data

CAVERJECT is a prostaglandin E1 agonist indicated

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

No data

Determine the most suitable dose and formulation of CAVERJECT to use. Use a new vial for each dose of CAVERJECT ().
Administer first intracavernosal injections in the physician's office and titrate the dose for each patient to the lowest effective dose ().
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 ().
Recommended dosage for erectile dysfunction ():n
Follow dose titration procedures for each type of erectile dysfunction and determine the maintenance dosage for erectile dysfunction for patient home use in the physician's office ().
The recommended frequency of injection is no more than 3 times weekly, with at least 24 hours between each dose ().
While on self-injection treatment, the patient should visit the prescribing physician's office every 3 months to assess the efficacy and safety of the therapy ().
Follow the procedure for CAVERJECT syringe preparation ().
Follow procedure for CAVERJECT intracavernosal injection administration ().
To diagnose erectile dysfunction (pharmacologic testing), inject CAVERJECT intracavernosally and monitor patients for the occurrence of an erection ().

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

CAVERJECT is contraindicated:

Men who have known hypersensitivity to the drug ().
Men who have conditions that predispose them to priapism, such as sickle cell anemia or sickle cell trait, multiple myeloma, or leukemia ().
Treatment of erectile dysfunction in men with fibrotic conditions of the penis, such as anatomical deformation, angulation, cavernosal fibrosis, or Peyronie's disease ().
Men with penile implants ().

No data

Prolonged erection and priapism
Penile fibrosis
Hypotension:
Injection site bleeding
Cardiovascular risk related to underlying medical conditions:
Risks of use in combination with other vasoactive medications injected intracavernosally:
Needle breakage:
Benzyl alcohol:
Counseling patients about sexually transmitted diseases:

The following are described elsewhere in the labeling:
The most common (u226510%) adverse reaction is penile pain ().
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at (1-800-438-1985 and ) or FDA at 1-800-FDA-1088 or .

The potential for pharmacokinetic drug-drug interactions between alprostadil and other agents administered orally or intracavernosally has not been formally studied .

No data

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 E (PGE) and is designated chemically as (11u03b1,13E,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 115u00b0C and 116u00b0 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:

No data

No data

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 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 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F). The reconstituted solution should be used within 24 hours when stored at or below 25u00b0C (77u00b0F) and not refrigerated or frozen.
Store CAVERJECT 40 mcg vials between 2u00b0C to 8u00b0C (36u00b0 to 46u00b0F) until dispensed. Once dispensed, vials should be stored at or below 25u00b0C (77u00b0F) 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 25u00b0C (77u00b0F) 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:
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).

LAB-0764-3.0

CAVERJECT [KAV-er-jeckt]n (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:
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,
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
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
The most common side effect of CAVERJECT is
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:
Inactive ingredients:
LAB-1045-1.0
Revised: December 2017

CAVERJECT [KAV-er-jeckt]u00ae(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
Information about how to safely inject CAVERJECT:
CAVERJECT comes in 20 mcg or 40 mcg strengths. n
Prepare the Syringe
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.
LAB-0009-6.0
Revised December 2017

NDC 0009-3701-08
Pfizer
Caverjectn
20 mcg
For Intracavernosal Use Only
Single Dose Vial n n

NDC 0009-3701-05Contains 6 of NDC 0009-3701-08
Pfizern- Caverjectn
alprostadil forinjection
For Intracavernosal Use Only
6 Single-Dose Vials
20 mcg
Diluent to be used with this product shouldcontain benzyl alcohol as a preservative.
This Package Does NOT Contain Diluentn n

NDC 0009-7686-01
Pfizer
Caverjectn
40 mcg
For Intracavernosal Use Only
Single Dose Vialn n

NDC 0009-7686-04Contains 6 of NDC 0009-7686-01
Pfizern- Caverjectn
alprostadil forinjection
For Intracavernosal Use Only
6 Single-Dose Vials
40 mcg
Diluent to be used with this product shouldcontain benzyl alcohol as a preservative.
This Package Does NOT Contain Diluentn n

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