Implant Nexplanon

Product description

Indication

NEXPLANON is recommended for the prevention of pregnancy in females.

Selected Safety Data

Contraindications

NEXPLANON should not be used in women who are pregnant or who have a known or suspected pregnancy; who have a current or prior history of thrombosis or thromboembolic disorders; who have benign or malignant liver tumors or active liver disease; who have undiagnosed abnormal genital bleeding; who have a known or suspected breast cancer, personal history of breast cancer, or any other progestin-sensitive cancer, now or in the past; and/or who have an allergic reaction to any of the components of NEXPLANON.

Warnings and cautionary notes

Insertion and Removal Complications

NEXPLANON should be placed subdermally so that it is perceptible immediately after insertion, as verified by palpation soon following insertion. Failure to correctly implant NEXPLANON may be overlooked unless palpated shortly upon insertion. Failure to put the implant properly may result in an unwanted pregnancy. Failure to remove the implant may result in the continuation of etonogestrel’s effects, including impaired fertility, ectopic pregnancy, or the persistence or recurrence of a drug-related adverse event.

Complications associated with insertion and removal operations may include discomfort, paresthesia, bleeding, hematoma, scarring, and infection. If NEXPLANON is implanted deeply (intramuscularly or through the fascia), it can cause neurological or vascular harm. Implant removal may be challenging or impossible if the implant was not put properly, was implanted too profoundly, was not perceptible, was encased in fibrous tissue, or had migrated. If the implant cannot be palpated throughout the procedure, it should be localized and removed.

Postmarketing reports of implants being discovered inside arm and pulmonary artery vessels, which may be connected to deep or intravascular insertions. Extraction may need endovascular or surgical techniques.

Menstrual Bleeding Patterns Modifications

Following NEXPLANON treatment, women’s menstrual bleeding patterns are likely to shift. Changes in frequency, intensity, or duration may be involved. Abnormal bleeding should be addressed case-by-case to rule out any pathologic disorders or pregnancy. Changes in the bleeding pattern were the most often reported cause for discontinuing therapy in clinical trials of the non-radiopaque etonogestrel implant (11.1 percent). Therefore, women should be advised about any changes in their bleeding patterns that may occur.

Pregnancies that occur outside the womb

Keep an eye out for the likelihood of an ectopic pregnancy in women on NEXPLANON who get pregnant or have lower abdominal discomfort.

Thrombotic and Other Vascular Events Thrombotic and Other Vascular Events

Combination hormonal contraceptives increase the risk of vascular events, such as arterial (strokes and myocardial infarctions) or profound venous thrombotic events (venous thromboembolism, deep venous thrombosis, retinal vein thrombosis, and pulmonary embolism). Women with recognized risk factors for venous and arterial thromboembolism should be carefully evaluated. Postmarketing reports significant arterial and venous thromboembolic events in women receiving etonogestrel implants, including pulmonary emboli (some fatal), deep vein thrombosis, myocardial infarction, and strokes. If thrombosis occurs, NEXPLANON should be discontinued. NEXPLANON should not be taken before 21 days postpartum due to the risk of thromboembolism during pregnancy and soon after delivery. Women with a history of thromboembolic diseases should be informed of the risk of recurrence. Consider removing the NEXPLANON implant if you will be immobilized for an extended period due to surgery or sickness.

Cysts of the ovary

If follicular development occurs, atresia of the follicle is sometimes delayed, and the follicle may continue to grow more significantly than it would in a typical cycle. However, in most cases, these swollen follicles vanish on their own. Therefore, surgery is not always necessary.

Breast and Reproductive Organ Adenocarcinoma

According to specific research, combining hormonal contraceptives may raise the risk of breast cancer, cervical cancer, or intraepithelial neoplasia. Therefore, breast nodules should be followed closely in women with a family history of breast cancer or developing them.

Chronic Hepatitis

If jaundice appears, discontinue the use of NEXPLANON.

Hypertension

If blood pressure levels drastically increase and become uncontrolled, the NEXPLANON implant should be removed.

A disease of the Gallbladder

According to studies, users of combination hormonal contraceptives have a little higher relative chance of having gallbladder disease. However, it is unknown if progestin-only approaches such as NEXPLANON provide a comparable danger.

Metabolic Effects of Carbohydrate and Lipid

Women who are prediabetic or diabetic should be closely monitored while taking NEXPLANON.

Mood Suffering

Women who have a history of mood disorders should be closely monitored. Patients who get seriously depressed might consider discontinuing NEXPLANON.

Return to the Ovulatory Cycle

One week following implant removal in clinical studies using the non-radiopaque etonogestrel implant (IMPLANON), etonogestrel levels in the blood had fallen below the assay’s sensitivity. Additionally, pregnancies have been detected as early as seven to fourteen days after removal. As a result, if continuous contraceptive protection is required after implant removal, a woman should promptly resume contraception.

Retaining Fluid

Hormonal contraceptives may induce fluid retention to a certain extent. Therefore, they should be given with caution and monitored closely in individuals with illnesses that may be exacerbated by fluid retention. The mechanism of action of NEXPLANON is uncertain.

Lenses Contouring

Contact lens users with changes in their vision or lens tolerance should see an ophthalmologist.

An implant that is cracked or bowed

There have been cases of implant fractures or bends caused by external forces (e.g., implant manipulation or contact sports) while the implant is in the patient’s arm. Additionally, a damaged implant piece has been reported to migrate throughout the arm. According to in vitro evidence, the rate of etonogestrel release may be somewhat enhanced when an implant is damaged or twisted. Therefore, it is critical to remove an implant completely.

Unexpected reactions

Experience in Clinical Trials

In clinical studies, the most often seen adverse response that resulted in the cessation of implant usage was a change in monthly bleeding patterns, particularly irregular menses (11.1 percent ). The most frequently reported adverse events (10%) in clinical studies were headache (24.9%), vaginitis (14.5%), weight gain (13.7%), acne (13.5%), breast discomfort (12.8%), stomach pain (10.9%), and pharyngitis (10.5 percent).

Additional Drug Interactions with Hormonal Contraceptives

Substances that reduce hormonal contraceptives’ plasma concentrations and, therefore, their efficacy:

Particular drugs or herbal preparations that activate certain enzymes, such as cytochrome P450 3A4 (CYP3A4), may lower the plasma concentrations of hormonal contraceptives, hence reducing their efficacy or increasing breakthrough bleeding. Therefore, when enzyme inducers are used with hormonal contraceptives, women should utilize an alternate non-hormonal form of contraception or a backup technique and should continue using the backup non-hormonal method for 28 days after ceasing the enzyme inducer.

Substances that augment hormonal contraceptive plasma concentrations:

Concurrent use of various hormonal contraceptives and potent or moderate CYP3A4 inhibitors may increase progestin serum concentrations, including etonogestrel.

Protease inhibitors and non-nucleoside reverse transcriptase inhibitors for the Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV)

Progestin plasma concentrations have been seen to fluctuate significantly (increase or decrease) in the presence of HIV protease inhibitors, HCV protease inhibitors, or non-nucleoside reverse transcriptase inhibitors. Therefore, clinically significant alterations may occur.

Other Drug Interactions with Hormonal Contraceptives

Hormonal contraceptives have the potential to interfere with the metabolism of other medications. As a result, plasma concentrations of some drugs may either rise or decrease (for example, Cyclosporine) (for example, lamotrigine).

Applications to particular populations

Pregnancy

Before injecting NEXPLANON, rule out pregnancy.

Lactation

Human milk contains trace levels of hormonal contraceptives and/or their metabolites, including etonogestrel. However, no detrimental effects on breast milk supply or quality or breastfed babies’ physical and psychomotor development have been documented.

Hormonal contraceptives, such as etonogestrel, may cause nursing women to produce less milk. This is less likely to occur when breastfeeding is established, although it may happen at any time in particular women.

Usage in Childhood

NEXPLANON’s safety and effectiveness in women of reproductive age have been demonstrated and are predicted to be similar in postpubertal teenagers. However, no research involving females under the age of 18 has been undertaken. Therefore, it is not recommended to use this medicine before menarche.

Female Obesity

NEXPLANON’s effectiveness in women who weighed more than 130 percent of their target body weight was not established since such women were not tested in research studies. In addition, Etonogestrel serum concentrations are inversely proportional to body weight and decline over time after implant placement. As a result, NEXPLANON’s efficacy may be reduced in obese women.

Resources for patient counseling

Advise women to immediately call their health care physician if they cannot palpate the implant at any point throughout the procedure.

NEXPLANON is neither an anti-HIV nor anti-STD medication.