Kyleena

KYLEENA- levonorgestrel intrauterine device
Bayer HealthCare Pharmaceuticals Inc.

1 INDICATIONS AND USAGE

Kyleena is indicated to prevent pregnancy for up to 5 years. Replace the system after 5 years if continued use is desired.

2 DOSAGE AND ADMINISTRATION

2.1 Dosing Over Time

Kyleena contains 19.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 17.5 mcg/day after 24 days. This rate decreases progressively to 9.8 mcg/day after 1 year and to 7.4 mcg/day after 5 years. The average in vivo release rate of LNG is approximately 12.6 mcg/day over the first year and 9.0 mcg/day over a period of 5 years. [See Clinical Pharmacology (12.3).]

Kyleena must be removed by the end of the fifth year and can be replaced at the time of removal with a new Kyleena if continued contraceptive protection is desired.

Kyleena can be physically distinguished from other intrauterine systems (IUSs) by the combination of the visibility of the silver ring on ultrasound and the blue color of the removal threads.

Kyleena is supplied in a sterile package within an inserter that enables single-handed loading (see Figure 1). Do not open the package until required for insertion [see Description (11.2)]. Do not use if the seal of the sterile package is broken or appears compromised. Use strict aseptic techniques throughout the insertion procedure [see Warnings and Precautions (5.3)].

Kyleena and Inserter
(click image for full-size original)

2.2. Insertion Instructions

Obtain a complete medical and social history to determine conditions that might influence the selection of a levonorgestrel-releasing intrauterine system (LNG IUS) for contraception. If indicated, perform a physical examination and appropriate tests for any forms of genital or other sexually transmitted infections. [See Contraindications (4) and Warnings and Precautions (5.10).] Because irregular bleeding/spotting is common during the first months of Kyleena use, exclude endometrial pathology (polyps or cancer) prior to the insertion of Kyleena in women with persistent or uncharacteristic bleeding [see Warnings and Precautions (5.8)].
Follow the insertion instructions exactly as described to ensure proper placement and avoid premature release of Kyleena from the inserter. Once released, Kyleena cannot be re-loaded.
Check expiration date of Kyleena prior to initiating insertion.
Kyleena should be inserted by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion instructions before attempting insertion of Kyleena.
Insertion may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia), or with seizure, especially in patients with a predisposition to these conditions. Consider administering analgesics prior to insertion.

Timing of Insertion

Table 1: When to Insert Kyleena

Starting Kyleena in women not currently using hormonal or intrauterine contraception

Insert Kyleena any time there is reasonable certainty that the woman is not pregnant. Consider the possibility of ovulation and conception prior to initiation of this product [see Contraindications (4)].
If Kyleena is inserted during the first seven days of the menstrual cycle or immediately after a first trimester abortion, back-up contraception is not needed.
If Kyleena is not inserted during the first seven days of the menstrual cycle, a barrier method of contraception should be used, or the patient should abstain from vaginal intercourse for seven days to prevent pregnancy.

Switching to Kyleena from an oral, transdermal or vaginal hormonal contraceptive

Insert Kyleena at any time, including during the hormone-free interval of the previous method.
If inserted during active use of the previous method, continue that method for 7 days after Kyleena insertion or until the end of the current treatment cycle.
If the woman was using continuous hormonal contraception, discontinue that method seven days after Kyleena insertion.

Switching to Kyleena from an injectable progestin contraceptive

Insert Kyleena at any time; a non-hormonal back-up birth control (such as condoms or spermicide) should also be used for 7 days if Kyleena is inserted more than 3 months (13 weeks) after the last injection.

Switching to Kyleena from a contraceptive implant or another IUS

Insert Kyleena on the same day the implant or IUS is removed.
Insert Kyleena at any time during the menstrual cycle.

Inserting Kyleena after first trimester abortion or miscarriage

Insert Kyleena immediately after a first-trimester abortion or miscarriage, unless it is a septic abortion [see Contraindications (4)].

Inserting Kyleena after childbirth or second-trimester abortion or miscarriage

Immediate insertion after childbirth or second-trimester abortion or miscarriage
Insert Kyleena after removal of the placenta. Back-up contraception is not needed. [See Contraindications (4), Warnings and Precautions (5.5, 5.6), Adverse Reactions (6.2)].

Interval insertion following complete involution of the uterus

Wait a minimum of 6 weeks or until the uterus is fully involuted before inserting Kyleena [see Warnings and Precautions (5.5, 5.6), Adverse Reactions (6.2)].
Insert Kyleena any time there is reasonable certainty the woman is not pregnant.
If Kyleena is not inserted during the first 7 days of the menstrual cycle, a back-up method of contraception should be used, or the woman should abstain from vaginal intercourse for 7 days to prevent pregnancy [see Contraindications (4), Warnings and Precautions (5.2)].

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