Vantas (Histrelin Acetate Implant) - Indications and Dosage

INDICATIONS AND USAGE

Vantas is indicated in the palliative treatment of advanced prostate cancer .

DOSAGE AND ADMINISTRATION

The recommended dose of Vantas is one implant for 12 months. Each implant contains 50 mg histrelin acetate. The implant is inserted subcutaneously in the inner aspect of the upper arm and provides continuous release of histrelin for 12 months of hormonal therapy.

Vantas must be removed after 12 months of therapy. At the time an implant is removed, another implant may be inserted to continue therapy (see Insertion and Removal Procedures).

Insertion and Removal Procedures

The Vantas implant is supplied in a sterile vial within an opaque plastic bag, which in turn is in a carton. The implant should be kept refrigerated (2-8° C / 36-46° F) until the day of the procedure. A kit, containing all the supplies necessary to insert and/or explant the implant is provided with the implant. The kit itself does not require refrigeration.

It is important to use aseptic techniques to minimize any chance of infection. Sterile gloves are required for the insertion procedure and subsequent removal of the implant. The implant is inserted using the procedure outlined below:

Identifying the Insertion Site

The patient should be on his back, with the arm least used (e.g., left arm for a right-handed person) flexed so the physician has ready access to the inner aspect of the upper arm. Prop the arm with pillows so the patient can easily hold that position. The optimum site for insertion is approximately half way between the shoulder and the elbow and in the crease between the bicep and triceps.

Contents of the Sterile Kit

The sterile kit contains:

• 1 #11 disposable scalpel
• 1 syringe
• 1 25 gauge 1.5" needle
• 1 S/S mosquito clamp
• 1 package betadine swabs
• 1 package alcohol swabs
• 1 fenestrated drape
• 1 sachet antiseptic ointment
• 1 package gauze sponges 4"
• 1 package surgical closure strips
• 1 vicryl sutures – coated
• 1 package elastoplast
• 1 ampule lidocaine HCl 1% w/epinephrine
• 1 implant insertion tool in sterile bag

Loading the Insertion Tool

Load the insertion tool prior to prepping the insertion field and insertion. Remove the insertion tool from its sterile bag. The tool is shipped with the cannula fully extended. Verify this by inspecting the position of the green retraction button. The button should be all the way forward, towards the cannula, away from the handle.

Remove the metal band from the vial, remove the rubber stopper and use the mosquito clamp to grasp either tip of the implant. AVOID GRABBING OR CLAMPING THE MIDDLE OF THE IMPLANT TO PREVENT DISTORTION OF THE IMPLANT.

Insert the implant into the insertion tool. It will seat in cannula so that just the tip is visible at the bottom of the bevel.

Inserting the Implant

• 1.Swab the insertion area with the betadine swabs,then lay the fenestrated drape over the insertion site (for clarity of illustration, the accompanying photos do not show the drape).
  

Anesthetic

• 2.Determine that the patient has no lidocaine/epinephrine allergies. Inject a few cc's of the anesthetic, starting at the planned incision site, then infiltrating up to the length of the implant, 32 mm, in a fan like fashion.

Incision

• 3.Using the scalpel, make a 2-3 mm incision immediately subcutaneous and perpendicular to the shoulder.

Insertion

• 4.Grasp the insertion tool by its handle, as shown.
  
• 5.Insert the tip of the insertion tool into the incision with the bevel up and advance the tool subcutaneously along the path of the anesthetic, up to the inscribed line on the cannula. To ensure subcutaneous placement, the implanter should visibly raise the skin at all times during insertion. Be sure that the implanter doesn't enter muscle tissue
  
• 6.Hold the insertion tool in place as you move your thumb to the green retraction button. Press the button down to release the locking mechanism, then draw the button back to the back stop, all the while holding the tool in place. The cannula will withdraw from the incision, leaving the implant in the dermis. Withdraw the implanter from the incision. Release of the implant can be checked by palpation.
  
  NOTE: Do not try to push the tool in deeper once the retraction process has started to avoid severing the implant. If you wish to re-start the process, withdraw the tool, grasp the implant by the tip to extract it, reset the retraction button to its most forward position, reload the implant and start again.
  

  After placement, sterile guaze may be used to apply pressure briefly to the insertion site to ensure hemostasis.

Closing the Incision

• 7.To close the incision, use one to two sutures (optional), knots facing inside the incision. Apply a light coating of antibiotic ointment directly onto the incision. Close with two surgical strips. Apply one or two of the 4" gauze pads over the incision and secure with elastoplast.

Patient Instructions- Aftercare

Give the patient the Patient Summary Information. Instruct the patient to refrain from wetting the arm with the implant for 24 hours. The pressure bandage can be removed at that time. The patient should not remove the surgical strips; rather, the strips should be allowed to fall off on their own after several days. Patients should refrain from heavy lifting and strenuous physical activity of the inserted arm for 7 days to allow the incision to fully close.

Removal Procedure and New Implant Insertion

The Vantas implant must be removed after 12 months of therapy. The techniques and instruments required are the same as found in the Vantas kit for implantation (see kit contents). If a new Vantas implant will be inserted, the new kit sent with the new implant will provide all necessary instruments and anesthesia/antiseptics. Otherwise, assemble all the necessary implements prior to the procedure.

Locating the Implant

The implant may be located by palpating the area near the incision from the prior year. Generally, the implant is readily palpated. Press the distal end of the implant to determine the proximal tip's location relative to the old incision.

In the event the implant is difficult to locate, ultrasound can be used. If ultrasound fails to locate the implant, other imaging techniques such as CT or MRI may be used to locate it.

Preparing the Site

• 1.Patient position and site preparation are the same as for the initial insertion. Swab the area above and around the implant with the betadine swabs. Drape the area with a fenestrated drape.

Anesthetic

• 2.After determining the absence of known allergies to the anesthetic agent, press down on the implant tip furthest from the old incision to determine the location of the tip closest to the incision. Inject a small amount of lidocaine/epinephrine at the tip near the incision, then advance the needle along the length, but beneath the implant, steadily injecting a small amount of anesthetic along the way. The anesthetic will raise up the implant within the dermis. If you are inserting a new implant, you have the option of either putting the new one in the same "pocket" as the removed one, or using the same incision, insert the new implant in the opposite direction. If placing the implant in the opposite direction, apply anesthetic along the length of the path for the new implant prior to explantation.

Incision/Explantation

• 3.Using the #11 scalpel, make a 2-3 mm incision near the tip and about 1-2 mm deep. Generally, the tip of the implant will be visible through a thin pseudo- capsule of tissue. If not, push down on the distal tip of the implant and massage it forward towards the incision. Carefully "nick" the pseudo capsule to reveal the polymer tip.
• 4.Grasp the tip with the mosquito clamp and extract the implant.
• 5.Dispose of the implant in a proper manner, treating it like any other bio-waste.

IF INSERTING A NEW IMPLANT - PROCEED ACCORDING TO "LOADING THE INSERTION TOOL", "INSERTION" AND "CLOSING THE INCISION" SECTIONS. The new implant may be placed through the same incision site. Alternatively, the contralateral arm may be used.

• 6.Provide the patient the patient instructions-aftercare card found in the kit.

HOW SUPPLIED

Vantas (NDC 55592-500-01) is supplied in a carton containing 2 inner cartons, one for the Vantas implant and one for the Vantas implantation kit:

The Vantas implant carton contains a cold pack for refrigerated shipment and a small carton containing an amber plastic pouch. Inside the pouch is a glass vial with a teflon-coated stopper and an aluminum seal, containing the implant immersed in 2 mL of 1.8% sterile sodium chloride.

Upon receipt, refrigerate the small carton containing the amber plastic pouch and glass vial (with the implant inside) until the day of insertion.

Store the implant refrigerated, 2-8 °C (36-46 °F), in the unopened glass vial with the 1.8% sterile sodium chloride solution, overwrapped in the amber plastic pouch and carton. Protect from light. Do not freeze.

The Vantas implantation kit carton contains one each of the following (individually wrapped in sterile packaging): Vantas implantation device, #11 scalpel, syringe, 25g 1.1/2" needle, mosquito hemostat, Betadine swabs, alcohol swab, fenestrated drape, Neosporin, gauze sponges, adhesive skin closures, vicryl sutures (coated), elastoplast, and lidocaine HCl 1% with epinephrine.

A physician insert with insertion and removal instructions and patient instructions are provided in the carton.

Rx Only

For more information, call 1-888-282-5372 or visit www.vantasimplant.com

Manufactured by
Valera Pharmaceutical Inc.
Cranbury, NJ 08512 U.S.A.

PK000003 Rev 00 October 2004