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Jadelle

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Jadelle

Indications
Dosage
How Supplied

INDICATIONS

Jadelle® (levonorgestrel implants (unavailable in us)) implants are indicated for the prevention of pregnancy and are a long-term (up to 5 years) reversible method of contraception. Both implants must be removed by the end of the fifth year. New implants may be inserted at that time if continuing contraceptive protection is desired. Following removal, fertility rates return to levels comparable to those in a population of similar women using no method of contraception.

Eight (8) pregnancies occurred within 5 years of Jadelle® (levonorgestrel implants (unavailable in us)) placement in multicenter clinical trials involving 1393 women. One of the eight pregnancies was ectopic. The following table shows pregnancy rate as Pearl Indices for each year.

Pearl Indices (Pregnancies per 100 woman-years) by Year for Jadelle (levonorgestrel implants (unavailable in us))

  Year 1 Year 2 Year 3 Year 4 Year 5
Annual Pearl Index 0.08 0.09 0.11 0.00 0.84
95% CI (0.00,0.43) (0.00, 0.50) (0.00, 0.61) (0.00, 0.50) (0.27, 1.95)
Cumulative Pearl Index 0.08 0.08 0.09 0.07 0.17
95% CI (0.00, 0.43) (0.01, 0.30) (0.02, 0.26) (0.01, 0.22) (0.07, 0.34)

Jadelle (levonorgestrel implants (unavailable in us)) is likely to be less effective in obese women. Mean serum levonorgestrel levels decrease as weight increases, and the risk of pregnancy increases as serum levonorgestrel levels decrease (see Pharmacokinetics section).

Typically, pregnancy rates with contraceptive methods are reported only for the first year of use, as shown in Table 2. The efficacy of these contraceptive methods, except for NORPLANT®, the intrauterine device (IUD), and sterilization, depends in part on the reliability of use. The efficacy of Jadelle® (levonorgestrel implants (unavailable in us)) implants does not depend on patient compliance. However, no contraceptive method is 100% effective.

TABLE 2: Percentage of Women Experiencing an Unintended Pregnancy During the First Year of Use of a Contraceptive Method

Method Typical Use Perfect Use
Chance 85 85
Spermicides 26 6
Periodic Abstinence 25  
  Calendar   9
  Ovulation   3
  Symptothermal   2
  Post-ovulation   1
Cap  
  Parous women 40 26
  Nulliparous women 20 9
Sponge  
Parous women 40 20
Nulliparous women 20 9
Diaphragm 20 6
Withdrawal 19 4
Condom  
  Female (Reality) 21 5
  Male 14 3
Pill 5  
  Progestin only   0.5
  Combined   0.1
IUD  
  Progesterone 2.0 1.5
  Copper T 380A 0.8 0.6
  LNg 20 0.1 0.1
Depo-Provera 0.3 0.3
NORPLANT® and NORPLANT® 2 0.05 0.05
Female sterilization 0.5 0.5
Male sterilization 0.15 0.1
From Hatcher RA et al., Contraceptive Technology, 17th Revised Edition. New York, NY: Irvington Publishers, 1998. Table 9-2

The gross cumulative rates of discontinuation and continuation in clinical trials of Jadelle® (levonorgestrel implants (unavailable in us)) are summarized in Table 3.

TABLE 3: Discontinuation and Continuation Rates (Cumulative Rates per 100 Users, n=1393)

  Year
Reasons for discontinuing 1 3 5
Pregnancy 0.10.1 0.30.2 1.10.4
Menstrual 4.50.6 14.11.0 19.31.2
Medical 4.70.6 14.71.0 23.11.3
Used other method 0.20.1 0.90.3 3.70.7
Plan pregnancy 1.10.3 9.70.9 18.60.3
Personal (other) 1.60.3 7.20.8 12.50.1
Continuation 88.30.9 60.61.3 41.51.3

DOSAGE AND ADMINISTRATION

Jadelle® (levonorgestrel implants (unavailable in us)) implants are a set of two flexible cylindrical implants, each containing 75 mg of the progestin levonorgestrel. The total administered (implanted) dose is 150 mg. Insertion of the two implants should be performed during the first 7 days following the onset of menses by a health-care professional familiar with the levonorgestrel implant insertion technique. It is strongly recommended that all health-care providers receive instruction in the proper insertion and removal procedures. Insertion is subdermal in the midportion of the inner surface of the upper arm about 8 to 10 cm above the medial epicondyle. The two implants should be placed in a "V" shape about 30 degrees apart. Proper insertion will facilitate removal. (See "Instructions for Insertion and Removal.")

HOW SUPPLIED

Jadelle® implants are supplied in a sterile package containing a set of two levonorgestrel-containing implants.

Store at room temperature, 15-30° C (59-86°F)

References available upon request.

Instructions For Insertion And Removal

Jadelle® implants are a set of two cylindrical levonorgestrel-releasing implants that are inserted subdermally in the medial aspect of the upper arm.

Jadelle® (levonorgestrel implants (unavailable in us)) implants provide up to 5 years of effective contraceptive protection.

The basis for successful use and subsequent removal of Jadelle® (levonorgestrel implants (unavailable in us)) implants is a correct and carefully performed subdermal insertion of the two implants. It is recommended that health-care professionals performing insertions or removals of Jadelle® (levonorgestrel implants (unavailable in us)) implants be instructed and supervised in proper techniques prior to attempting these procedures independently. During insertion, special attention should be given to the following:

-aseptic technique
-correct subdermal placement of the implants
-careful technique to minimize tissue trauma.

This will help to avoid infections and excessive scarring at the insertion area and will help keep the implants from being inserted too deeply in the tissue. If the implants are placed too deeply, they will be more difficult to remove than correctly placed subdermal implants.

Insertion Procedure

Insertion should be performed within 7 days from the onset of menses. However, Jadelle® (levonorgestrel implants (unavailable in us)) implants may be inserted at any time during the cycle provided that the possibility of ovulation and conception has been considered, pregnancy has been excluded, and a nonhormonal contraceptive method is used for at least 7 days. If ovulation and conception have already occurred, pregnancy may be established in the month of insertion. It is recommended that a complete history and physical examination, including a gynecologic examination, be performed before the insertion of Jadelle® (levonorgestrel implants (unavailable in us)) implants. Determine if the subject has any allergies to the antiseptic or anesthetic to be used or any contraindications to the use of levonorgestrel or any of the components of the implants. If none are found, the implants are inserted using the procedure outlined below.

One Jadelle® unit consists of two levonorgestrel implants in a sterile pouch. The insertion is performed under aseptic conditions using a trocar to place the implants under the skin.

Equipment for insertion - Illustration

Figure 1: The following equipment is recommended for the insertion:

— an examining table for the patient to lie on.
— sterile surgical drapes, sterile gloves (free of talc), antiseptic solution.
— local anesthetic, needles, and syringe.
— #11 scalpel, #10 trocar, forceps.
— skin closure, sterile gauze, and compresses.

Have the patient lie on her back on the examination table - Illustration

Figure 2: Have the patient lie on her back on the examination table with her nondominant arm flexed at the elbow and externally rotated so that her hand is lying by her head. The implants will be inserted subdermally and positioned in a "V" shape. The optimal insertion area is in the inner surface of the upper arm about 8 to 10 cm above the medial epicondyle.

Clean the patient’s upper arm with antiseptic solution and then frame the insertion area with a fenestrated drape - Illustration

Figure 3: Clean the patient's upper arm with antiseptic solution and then frame the insertion area with a fenestrated drape.

Open the Jadelle® package carefully - Illustration

Figure 4: Open the Jadelle® (levonorgestrel implants (unavailable in us)) package carefully by pulling apart the sheets of the pouch, allowing the two implants to fall onto a sterile drape.

Anesthetize the insertion area - Illustration

Figure 5: After determining the absence of known allergies to the anesthetic agent or related drugs, fill a 5-mL syringe with the local anesthetic. Since blood loss is minimal with this procedure, use of epinephrine-containing anesthetics is not considered necessary.

Anesthetize the insertion area by first inserting the needle under the skin and injecting a small amount of anesthetic. Then anesthetize two areas about 4.5 cm long, to mimic the V shape of the implantation site.

Use the scalpel to make a small incision - Illustration

Figure 6: Use the scalpel to make a small incision (about 2 mm) just through the dermis of the skin.

Alternatively, the trocar may be inserted directly through the skin without making an incision with the scalpel. The bevel of the trocar should always face up during the insertion.

The trocar has three marks on it - Illustration

Figure 7: The trocar has three marks on it. The mark closest to the hub indicates how far the trocar should be introduced under the skin to place the Jadelle® (levonorgestrel implants (unavailable in us)) implants. The middle mark (indicated by the small arrow) is not used with Jadelle® (levonorgestrel implants (unavailable in us)) insertions and should be ignored. The mark closest to the tip indicates how much of the trocar should remain under the skin following placement of the first implant.

Insert the tip of the trocar beneath the skin at a shallow angle - Illustration

Figure 8: Insert the tip of the trocar beneath the skin at a shallow angle. Throughout the insertion procedure, the trocar should be oriented with the bevel up. It is important to keep the trocar subdermal by tenting the skin with the trocar, as failure to do so may result in deep placement of the implants and could make removal more difficult. Advance the trocar gently under the skin to the mark nearest the hub of the trocar; be careful to use the appropriate mark. Do not force the trocar, and if resistance is encountered, try another direction.

Remove the obturator - Illustration

Figure 9: When the trocar has been inserted the appropriate distance, remove the obturator and load the first implant into the trocar using the thumb and forefinger.

Gently advance the implant with the obturator - Illustration

Figure 10: Gently advance the implant with the obturator towards the tip of the trocar until you feel resistance. Never force the obturator.

Withdraw the trocar to the mark closest to the trocar tip - Illustration

Figure 11: Then holding the obturator stationary, withdraw the trocar to the mark closest to the trocar tip. It is important to keep the obturator stationary and not to push the implant into the tissue. Do not completely remove the trocar until both implants have been placed. The trocar is withdrawn only to the mark closest to its tip.

Release of the implant can be checked by palpation - Illustration

Figure 12: The implant should have been released under the skin when the mark closest to the tip of the trocar is visible at the insertion point. Release of the implant can be checked by palpation.

Fix the position of the previous implant with the forefinger and middle finger - Illustration

Figure 13a: To place the second implant, align the trocar so that the second implant will be positioned at about a 30-degree angle relative to the first. Fix the position of the previous implant with the forefinger and middle finger of the free hand, and advance the trocar along the tips of the fingers. This will ensure a suitable distance of about 30 degrees between implants and keep the trocar from puncturing the previously inserted implant.

Leave a distance of about 5 mm between the incision and the tips of the implants - Illustration

Figure 13b: Leave a distance of about 5 mm between the incision and the tips of the implants. This will help avoid spontaneous expulsions.

A sterile gauze may be used to apply pressure briefly - Illustration

Figure 14: After placement of the second implant, a sterile gauze may be used to apply pressure briefly to the insertion site and ensure hemostasis. Palpate the distal ends of the implants to make sure that both have been properly placed.

Press the edges of the incision together, and close the incision with a skin closure - Illustration

Figure 15: Press the edges of the incision together, and close the incision with a skin closure. Suturing the incision should not be necessary.

Cover the placement area with a dry compress, and wrap gauze snugly around the arm - Illustration

Figure 16: Cover the placement area with a dry compress, and wrap gauze snugly around the arm to ensure hemostasis.

Observe the patient for a few minutes for signs of syncope or bleeding from the insertion site before she is discharged.

Advise the patient to keep the insertion area dry and avoid heavy lifting for 2 to 3 days. The gauze may be removed after 1 day, and the skin closure as soon as the insertion area has healed, ie, typically in 3 days.

Removal Procedure

Described below is a removal procedure which was used during the clinical trials for NORPLANT® implants and for Jadelle® (levonorgestrel implants (unavailable in us)) implants. As with many surgical procedures, variations of the technique have appeared and some have been published. No one particular procedure routinely appears to have advantage over another.

It is recommended that removals be scheduled so that preparations for carrying out the procedure can be facilitated.

Removal of the implants should be performed very gently and will take more time than insertion. Implants are sometimes nicked, cut, or broken during removal. The overall incidence of removal difficulties in the clinical trials, including damage to the implants, was 7.5%. If removal of the implant(s) proves difficult, close the incision and bandage the wound, and have the patient return for another visit. The remaining implant(s) will be easier to remove after the area is healed. It may be appropriate to seek consultation or provide referral for patients in whom initial attempts at implant removal prove difficult. A nonhormonal method of contraception should be used until both implants are completely removed.

The position of the patient and the need for aseptic technique are the same as for insertion.

Equipment is needed for the removal - Illustration

Figure 17: The following equipment is needed for the removal:

— an examining table for the patient to lie on.
— sterile surgical drapes, sterile gloves (free of talc), antiseptic solution.
— local anesthetic, needles, and syringe.
— #11 scalpel, forceps (straight and curved mosquito).
— skin closure, sterile gauze, and compresses.

Palpate the area to locate both implants - Illustration

Figure 18: Palpate the area to locate both implants. If the implants cannot be palpated, they may be located by ultrasound (7 MHz) or X-ray (soft tissue). Once both implants are located, clean the patient's upper arm with antiseptic solution and then frame the area with a fenestrated drape. You may mark the position of the Jadelle® (levonorgestrel implants (unavailable in us)) implants with a sterile marker.

Apply a small amount of local anesthetic - Illustration

Figure 19: Once both implants are located, apply a small amount of local anesthetic at the skin and under the ends of the implants nearest the original incision site. This will serve to raise the ends of the implants. Anesthetic injected over the implants will obscure them and make removal more difficult. Additional small amounts of the anesthetic can be used for removal of the second implant, if required.

Make a 4-mm incision with the scalpel - Illustration

Figure 20: Make a 4-mm incision with the scalpel close to the proximal ends of the implants (below the bottom of the "V"). Do not make a large incision.

Push each implant gently towards the incision with the fingers - Illustration

Figure 21: Push each implant gently towards the incision with the fingers. When the tip is visible or near to the incision, grasp it with a mosquito forceps.

Use the scalpel, the other forceps, or gauze to very gently open the tissue sheath - Illustration

Figure 22: Use the scalpel, the other forceps, or gauze to very gently open the tissue sheath that has formed around the implant.

Grasp the proximal end of the implant with the second forceps and gently remove it - Illustration

Grasp the proximal end of the implant with the second forceps and gently remove it - Illustration

Figures 23 and 24: Grasp the proximal end of the implant with the second forceps and gently remove it. Repeat the procedure for the second implant.

Incision is closed and bandaged - Illustration

Incision is closed and bandaged - Illustration

Figures 25 and 26: After the procedure is completed, the incision is closed and bandaged as with insertion. The upper arm should be kept dry for a few days.

Following removal, the contraceptive effects reverse quickly and a woman can become pregnant at a rate similar to women who have not used the method. If the patient wishes to continue using the method, a new set of Jadelle® (levonorgestrel implants (unavailable in us)) implants can be inserted through the same incision in the same or opposite direction.

Hints

Insertion

- Counselling of the patient on the benefits and side effects of the method and the insertion and removal procedures before insertion will greatly increase patient satisfaction.
- Correct subdermal placement of the implants will facilitate removal.
- Before insertion, apply the anesthetic just beneath the skin so as to raise the dermis above the underlying tissue.
- Never force the trocar.
- To ensure subdermal placement, the trocar should be held with the bevel up and should be supported by the index finger to raise the skin visibly at all times during insertion.
- To avoid damaging the first implant, stabilize it with your forefinger and middle finger and then advance the trocar alongside the fingertips at an angle of about 30 degrees.
-After insertion, make a drawing for the patient's file showing the location of the 2 implants and describe any variations in placement. This will greatly aid removal.
- Jadelle® (levonorgestrel implants (unavailable in us)) packaging contains stick-on labels identifying the lot number for both the provider's and the patient's records. Both the provider and the patient should retain these stick-on labels in case a need arises to determine which lot is being used by the woman. The stick-on label for the patient may be affixed to her copy of the patient information materials. Please also be sure to inform the patient on the patient package insert that she is to retain the stick-on label identifying the lot number in case of future problems with the lot.

Removal

- The removal of the implants will take more time than the insertion.
- Before initiating removal, the two implants should be located by palpation. If both implants cannot be palpated, they may be located by ultrasound (7 MHz) or X-ray (soft tissue).
- Before removal, apply the anesthetic under the ends of the implants nearest the original insertion site.
- If removal of the implants proves difficult, interrupt the procedure, close the incision and bandage the wound, and have the patient return for another visit. The remaining implant(s) will be easier to remove after the area is healed. It may be appropriate to seek consultation or provide referral for patients in whom initial attempts at implant removal prove difficult.

References provided on request. Manufacturer information: n/a. FDA rev date: n/a

Last reviewed on RxList: 12/29/2008
This monograph has been modified to include the generic and brand name in many instances.

Indications
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