Kyleena (Page 3 of 10)

Important information to consider during or after insertion

If you suspect that Kyleena is not in the correct position, check placement (for example, using transvaginal ultrasound). Remove Kyleena if it is not positioned completely within the uterus. Do not reinsert a removed Kyleena.
If there is clinical concern, exceptional pain or bleeding during or after insertion, take appropriate steps (such as physical examination and ultrasound) immediately to exclude perforation.

2.3 Patient Follow-up

Reexamine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

2.4 Removal of Kyleena

Timing of Removal

Kyleena should not remain in the uterus after 5 years.
If pregnancy is not desired, remove Kyleena during the first 7 days of the menstrual cycle, provided the woman is still experiencing regular menses. If removal will occur at other times during the cycle or the woman does not experience regular menses, she is at risk of pregnancy; start a new contraceptive method a week prior to removal for these women. [See Dosage and Administration (2.5).]

Tools for Removal

Preparation
Gloves
Speculum
Procedure
Sterile forceps

Removal Procedure

Remove Kyleena by applying gentle traction on the threads with forceps (Figure 9).
Removal
(click image for full-size original)

Figure 9. Removal of Kyleena

If the threads are not visible, determine location of Kyleena by ultrasound [see Warnings and Precautions (5.10)].
If Kyleena is found to be in the uterine cavity on ultrasound exam, it may be removed using a narrow forceps, such as an alligator forceps. This may require dilation of the cervical canal. After removal of Kyleena, examine the system to ensure that it is intact.
Removal may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or seizure, especially in patients with a predisposition to these conditions.

2.5 Continuation of Contraception after Removal

If pregnancy is not desired and if a woman wishes to continue using Kyleena, a new system can be inserted immediately after removal any time during the cycle.
If a patient with regular cycles wants to start a different contraceptive method, time removal and initiation of the new method to ensure continuous contraception. Either remove Kyleena during the first 7 days of the menstrual cycle and start the new method immediately thereafter or start the new method at least 7 days prior to removing Kyleena if removal is to occur at other times during the cycle.
If a patient with irregular cycles or amenorrhea wants to start a different contraceptive method, start the new method at least 7 days before removal.

3 DOSAGE FORMS AND STRENGTHS

Kyleena is a LNG-releasing IUS (a type of intrauterine device, or IUD) consisting of a T-shaped polyethylene frame with a steroid reservoir containing a total of 19.5 mg LNG.

4 CONTRAINDICATIONS

The use of Kyleena is contraindicated when one or more of the following conditions exist:

Pregnancy or suspicion of pregnancy [see Warnings and Precautions (5.2), Use in Specific Populations (8.1)]
For use as post-coital contraception (emergency contraception)
Congenital or acquired uterine anomaly, including fibroids, that distorts the uterine cavity
Acute pelvic inflammatory disease (PID) or a history of PID unless there has been a subsequent intrauterine pregnancy [see Warnings and Precautions (5.4)]
Postpartum endometritis or infected abortion in the past 3 months
Known or suspected uterine or cervical malignancy
Known or suspected breast cancer or other progestin-sensitive cancer, now or in the past
Uterine bleeding of unknown etiology
Untreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled
Acute liver disease or liver tumor (benign or malignant)
Conditions associated with increased susceptibility to pelvic infections [see Warnings and Precautions (5.4)]
A previously inserted intrauterine device (IUD) that has not been removed
Hypersensitivity to any component of this product [see Adverse Reactions (6.2) and Description (11.1)]

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Ectopic Pregnancy

Evaluate women for ectopic pregnancy if they become pregnant with Kyleena in place because the likelihood of a pregnancy being ectopic is increased with Kyleena. Approximately one-half of pregnancies that occur with Kyleena in place are likely to be ectopic. Also consider the possibility of ectopic pregnancy in the case of lower abdominal pain, especially in association with missed menses or if an amenorrheic woman starts bleeding.

The incidence of ectopic pregnancy in clinical trials with Kyleena, which excluded women with a history of ectopic pregnancy, was approximately 0.2% per year. The risk of ectopic pregnancy in women who have a history of ectopic pregnancy and use Kyleena is unknown. Women with a previous history of ectopic pregnancy, tubal surgery or pelvic infection carry a higher risk of ectopic pregnancy. Ectopic pregnancy may result in loss of fertility.

5.2 Risks with Intrauterine Pregnancy

If pregnancy occurs while using Kyleena, remove Kyleena because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal of Kyleena or probing of the uterus may also result in spontaneous abortion. In the event of an intrauterine pregnancy with Kyleena, consider the following:

Septic abortion

In patients becoming pregnant with an IUS in place, septic abortion—with septicemia, septic shock, and death—may occur.

Continuation of pregnancy

If a woman becomes pregnant with Kyleena in place and if Kyleena cannot be removed or the woman chooses not to have it removed, warn her that failure to remove Kyleena increases the risk of miscarriage, sepsis, premature labor and premature delivery. Advise her of isolated reports of virilization of the female fetus following local exposure to LNG during pregnancy with an LNG IUS in place [see Use in Specific Populations (8.1)]. Follow her pregnancy closely and advise her to report immediately any symptom that suggests complications of the pregnancy.

5.3 Sepsis

Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of a LNG-releasing IUS. In some cases, severe pain occurred within hours of insertion followed by sepsis within days. Because death from GAS is more likely if treatment is delayed, it is important to be aware of these rare but serious infections. Aseptic technique during insertion of Kyleena is essential in order to minimize serious infections such as GAS.

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