Two rods, each with 75mg of the contraceptive levonorgestrel
INFORMATION FOR THE PROVIDER AND PATIENT
The BioPlanon contraceptive implant is a set of two flexible, cylindrical rods made of milky-white, medical-grade silicone elastomer. Each rod contains 75 mg of levonorgestrel, the active ingredient, for a total of 150mg.The rods are inserted into tubes composed of a colorless, transparent form of silicone elastomer. Both ends of each tube are sealed with an adhesive.
Levonorgestrel, a progestin, is a synthetic hormone. It mimics progesterone, a potent inhibitor of sex hormones secreted by the pituitary gland. Like progesterone, levonorgestrel suppresses ovulation. It also thickens cervical mucus, which impedes the migration of sperm. Finally, it thins the endometrium, and this interferes with the implantation of the fertilized egg.
The BioPlanon contraceptive implant is indicated for women of childbearing age who wish to use a long-acting method of contraception.
The BioPlanon contraceptive implant is contraindicated for pregnant women and for breastfeeding women during the first six weeks postpartum (Medical Eligibility Criteria for contraceptive use, World Health Organization〔WHO〕, update 2008). BioPlanon should not be inserted in patient with acute or chronic hepatitis, nephritis, a history of breast cancer, diabetes, hyperthyroidism, high blood pressure, thrombus, sickle cell anemia, unexplained vaginal bleeding, serious liver disease or jaundice, rheumatic disease, or epilepsy. Women who suspect they may be pregnant should not have BioPlanon inserted. Women who take anticoagulants should not use this product.
Dosage and administration
The two BioPlanon contraceptive rods are usually inserted during the first week of a woman’s menstrual cycle (starting from the first day of menstruation). A 0.2 cm-long incision is made in the skin of the upper arm or inside of the thigh, and the rods are implanted beneath the skin with a trocar (surgical instrument), under local anesthesia and aseptic conditions. An adhesive bandage is applied to cover the surface of the incision and then the limb is wrapped with gauze. BioPlanon provides effective contraception for a period of four years.
Irregular menstrual bleeding is the most frequently reported side effect of the BioPlanon of contraceptive implant. Bleeding irregularities diminish, however, with continuing use of BioPlanon. Following are some of the undesirable side effects that may occur with BioPlanon contraceptive implant use:
●Fatigue, back pain, or generalized pain;
●Weight loss or gain;
●Mood swings; decreased libido; depression;
●Pain or itching at the insertion site;
●Inflammation of the cervix; ovarian cysts;
●Urinary tract infections;
●Benign breast jumps; breast discharge;
●A woman who already have acne or excess hair on her face or body could experience worsening of these problems: hair loss; rash, itching, or mild skin discoloration.
Rarely reported side effects:
●High blood pressure; palpitations; chest pain;
●Difficulty in breathing;
Women should tell their doctors about any undesirable side effects not mentioned in this leaflet that they may experience.
Precaution and warnings
The following are important considerations for women using or contemplating use of BioPlanon as their method of contraception:
●Women with a history of irregular periods, or women over 45 years of age should not use BioPlanon.
●If a patient experiences intolerable side effects from BioPlanon, she should see a doctor for help in managing them. The implant may be removed, if necessary.
●Women who have their implants removed and who use no other form of contraception can expect fertility to return promptly (Medical Eligibility Criteria for Contraceptive Use, WHO, update 2008).
●Insertion, follow-up, and removal of BioPlanon should be conducted in a county-level hospital or a family planning clinic and should be performed by qualified professionals who have received specialized training in the procedures.
●Women who receive the BioPlanon contraceptive implant should return regularly to the above-described medical facilities for follow-up visits.
●Women who become pregnant while using BioPlanon should consult with a doctor. Women who plan to carry the pregnancy to term should have their implants removed.
●The implants must be removed at the end of 4 years because they become less effective. It can be removed at any time within the 4-year period, however, if a woman wants to stop using the method for any reason.
●Care should be taken to avoid damaging the implants during removal.
Even though BioPlanon is not taken orally, doctors and their patients must consider all medications that the patients may be taking. This is because certain drugs may reduce BioPlanon’s contraceptive effectiveness.
Among the medications that interfere with BioPlanon are barbiturates, phenytoin, carbamazepine, oxcarbazepine, primidone, topiramate, and rifampicin. Herbal products containing St. John’s Wort (Hypericum perforatum) may also diminish BioPlanon’s effectiveness. If a woman takes any one of these medications, she should supplement BioPlanon with an additional method of contraception during that period and for 28 days after discontinuing it. Doctors and patients should discuss this matter before combining BioPlanon with any of these medications.
Duration of use: 4 years
How to use: