Type of Drug:

Long-term (less than 5 years), reversible birth-control system; progestin­containing contraceptive system.

How the Drug Works:

Levonorgestrel appears to prevent pregnancy by preventing ovulation. It also causes changes in the inner lining of the uterus, preventing implantation should fertilization occur.

Uses:

To prevent pregnancy for up to 5 years. The implants should be removed by the end of the fifth year; new implants may be inserted at that time if continuing contraceptive protection is desired. Approximately 0.2 (patients weighing less than 110 Ibs) to 8.5 (patients weighing 154 Ibs or more) of 100 women using levonorgestrel implants become pregnant. The effectiveness of this method is not dependent on proper use, but does appear to vary in accordance with body weight.

Precautions:

Contact lens wearers: If you develop changes in vision or lens tolerance, contact your eye care specialist. Consider temporarily or permanently stopping contact lens wear.

Delayed follicular atresia: If the development of an ovarian follicle occurs, growth beyond the size attained in a normal cycle may occur. These enlarged follicles cannot be distinguished clinically from ovarian cysts. Usually they will spontaneously disappear; rarely, they may twist or rupture, possibly requiring surgery.

Ectopic pregnancy: Ectopic pregnancies have occurred among levonorgostrel implant users, although studies have shown no increase in the ringleader yom CIS With users of no method of contraception or of intrauterine progesterone (IUDs).

Impaired liver function: If jaundice (yellowing of skin or eyes) develops, removal of the implants should be considered. Steroid hormones may be poorly metabolized in patients with impaired liver function.

Fluid retention: Steroid contraceptives may cause fluid retention. There­fore, they should be used with caution in patients with conditions that might be aggravated by fluid retention (eg, high blood pressure, heart failure).

Pregnancy: Do not use during pregnancy. The risk of use in a pregnant woman clearly outweighs any possible benefit.

Breastfeeding: Levonorgestrel appears in breast milk. Consult your doctor before you begin breastfeeding.

Children: Safety and effectiveness have been established in women of reproductive age. Safety and effectiveness are expected to be the same for postpubertal adolescents 16 years of age or younger. Use of this product before the onset of first menstruation is not indicated.

Drug Interactions:

Tell your doctor or pharmacist if you are taking or if you are planning to take any over-the-counter or prescription medications or dietary supplements with levonorgestrel implants. Doses of one or both drugs may need to be modified or a different drug may need to be prescribed. The following drugs and drug classes interact with levonorgestrel implants:

• Carbamazepine (eg, Tegretol)
• Phenytoin (eg, Dilantin)
• Rifampin (eg, Rifadin)

Side Effects:

Every drug is capable of producing side effects. Many levonorgestrel implant users experience no, or minor, side effects. The frequency and severity of side effects depend on many factors including duration of therapy and individual susceptibility. Possible side effects include:

Insertion site reactions: Pain; swelling; bruising; infection; blistering; ulceration; itching; skin sloughing; excessive scarring; discoloration; arm pain; numbness and tingling; nerve injury; removal difficulties; vein inflammation.

Urinary and Reproductive Tract: Change (typically a decrease) in menstrual flow; spotting; lack of menstrual bleeding; breast pain; breast discharge; inflammation of the vagina or cervix; vaginal discharge; enlarged ovarian follicles; prolonged, frequent, or irregular menstrual bleeding.

Digestive Tract: Nausea; vomiting; appetite changes; stomach ache. Nervous System: Headache; anxiety; ­tives monograph in this chapter.

Guidelines for Use:

• Carefully read the patient package insert available with this product.
• Capsules will be inserted beneath the skin of the upper arm.
• Capsules should be implanted or removed only by a health care professional thoroughly instructed in the insertion and removal technique.
• Pregnancy must be ruled out prior to insertion. Conduct pregnancy tests whenever pregnancy is suspected. If pregnancy occurs, the implants must be removed.
• Insertion of the levonorgestrel implants should be performed during the first 7 days after the beginning of menstruation or immediately following an abortion. If performed at any other time during the cycle, a non­hormonal contraceptive method (eg, condom, diaphragm) should be used for the remainder of that cycle. Insertion is not recommended until 6 weeks after childbirth in breastfeeding women.
• Removal of the implants should be considered in women who will be immobilized for a prolonged period of time due to surgery or illness.
• Implants must be removed at the end of the 5-year period. If new implants are not inserted at the same time, the patient’s previous level of fertility will return and pregnancy can occur at any time.
• Some change in menstruation patterns can be expected, especially during the first year.
• Notify your doctor if you experience stomach or pelvic pain, persistent headache, visual disturbances, depression, or yellowing of the skin or eyes.
• Diabetic patients - Levonorgestrel implants may alter glucose tolerance. Monitor your blood glucose closely.
• Bruising may occur at the implant site during insertion or removal. Darkening of the skin over the implant site may occur in some women but is usually reversible upon removal.
• Levonorgestrel implants do not protect against HIV infection (the virus that causes AIDS) or any other sexually transmitted diseases.