Nexplanon: Package Insert and Label Information (Page 4 of 5)

7 DRUG INTERACTIONS

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

7.1 Effects of Other Drugs on Hormonal Contraceptives

Substances decreasing the plasma concentrations of hormonal contraceptives (HCs) and potentially diminishing the efficacy of HCs:

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of HCs and potentially diminish the effectiveness of HCs or increase breakthrough bleeding.

Some drugs or herbal products that may decrease the effectiveness of HCs include efavirenz, phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between HCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure. Counsel women to use an alternative non-hormonal method of contraception or a back-up method when enzyme inducers are used with HCs, and to continue back-up non-hormonal contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability.

Substances increasing the plasma concentrations of HCs:

Co-administration of certain HCs and strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase the serum concentrations of progestins, including etonogestrel.

Human Immunodeficiency Virus (HIV)/Hepatitis C Virus (HCV) protease inhibitors and non-nucleoside reverse transcriptase inhibitors:

Significant changes (increase or decrease) in the plasma concentrations of progestin have been noted in cases of co-administration with HIV protease inhibitors (decrease [e.g., nelfinavir, ritonavir, darunavir/ritonavir, (fos)amprenavir/ritonavir, lopinavir/ritonavir, and tipranavir/ritonavir] or increase [e.g., indinavir and atazanavir/ritonavir])/HCV protease inhibitors (decrease [e.g., boceprevir and telaprevir]) or with non-nucleoside reverse transcriptase inhibitors (decrease [e.g., nevirapine, efavirenz] or increase [e.g., etravirine]). These changes may be clinically relevant in some cases.

Consult the prescribing information of anti-viral and anti-retroviral concomitant medications to identify potential interactions.

7.2 Effects of Hormonal Contraceptives on Other Drugs

Hormonal contraceptives may affect the metabolism of other drugs. Consequently, plasma concentrations may either increase (for example, cyclosporine) or decrease (for example, lamotrigine). Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

NEXPLANON is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant [see Contraindications (4)]. Epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose CHCs prior to conception or during early pregnancy. No adverse development outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses of 315 or 781 times the anticipated human dose (60 µg/day) (see Data).

NEXPLANON should be removed if maintaining a pregnancy.

Data

Animal Data

Teratology studies have been performed in rats and rabbits using oral administration up to 315 and 781 times the human etonogestrel dose (based upon body surface) and revealed no evidence of fetal harm due to etonogestrel exposure.

8.2 Lactation

Risk Summary

Small amounts of contraceptive steroids and/or metabolites, including etonogestrel are present in human milk. No significant adverse effects have been observed in the production or quality of breast milk, or on the physical and psychomotor development of breastfed infants (see Data).

Hormonal contraceptives, including etonogestrel, can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. When possible, advise the nursing mother about both hormonal and non-hormonal contraceptive options, as steroids may not be the initial choice for these patients. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for NEXPLANON and any potential adverse effects on the breastfed child from NEXPLANON or from the underlying maternal condition.

Data

The amount of etonogestrel contained within breast milk was measured in 38 lactating women who began using IMPLANON during the fourth to eighth week postpartum. The study evaluated Implanon versus another contraceptive, was not randomized and data were considered observational and exploratory; therefore, comparisons could not be made. Based on the findings of this study, during the first months after insertion of IMPLANON, when maternal blood levels of etonogestrel are highest, about 100 ng of etonogestrel may be ingested by the child per day based on an average daily milk ingestion of 658 mL. Based on daily milk ingestion of 150 mL/kg, the mean daily infant etonogestrel dose one month after insertion of IMPLANON is about 2.2% of the weight-adjusted maternal daily dose, or about 0.2% of the estimated absolute maternal daily dose. Adverse reactions were not observed in breastfed infants exposed to etonogestrel through breast milk. No adverse effects on the production or quality of breast milk were detected.

8.4 Pediatric Use

Safety and efficacy of NEXPLANON have been established in women of reproductive age. Safety and efficacy of NEXPLANON are expected to be the same for postpubertal adolescents. However, no clinical studies have been conducted in women less than 18 years of age. Use of this product before menarche is not indicated.

8.5 Geriatric Use

This product has not been studied in women over 65 years of age and is not indicated in this population.

8.6 Hepatic Impairment

No studies were conducted to evaluate the effect of hepatic disease on the disposition of NEXPLANON. The use of NEXPLANON in women with active liver disease is contraindicated [see Contraindications (4)].

8.7 Overweight Women

The effectiveness of the etonogestrel implant in women who weighed more than 130% of their ideal body weight has not been defined because such women were not studied in clinical trials. Serum concentrations of etonogestrel are inversely related to body weight and decrease with time after implant insertion. It is therefore possible that NEXPLANON may be less effective in overweight women, especially in the presence of other factors that decrease serum etonogestrel concentrations such as concomitant use of hepatic enzyme inducers.

10 OVERDOSAGE

Overdosage may result if more than one implant is inserted. In case of suspected overdose, the implant should be removed.

11 DESCRIPTION

NEXPLANON is a radiopaque, progestin-only, soft, flexible implant preloaded in a sterile, disposable applicator for subdermal use. The implant is white/off-white, non-biodegradable and 4 cm in length with a diameter of 2 mm (see Figure 19). Each implant consists of an ethylene vinyl acetate (EVA) copolymer (28% vinyl acetate, 43 mg) core, containing 68 mg of the synthetic progestin etonogestrel, barium sulfate ((15 mg), radiopaque ingredient), and magnesium stearate (0.1 mg), surrounded by an EVA copolymer skin. Once inserted subdermally, the release rate is 60-70 mcg/day in week 5-6 and decreases to approximately 35-45 mcg/day at the end of the first year, to approximately 30-40 mcg/day at the end of the second year, and then to approximately 25-30 mcg/day at the end of the third year. NEXPLANON is a progestin-only contraceptive and does not contain estrogen. NEXPLANON does not contain latex.

Figure 19
Figure 19 (Not to scale)

Etonogestrel [13-Ethyl-17-hydroxy-11-methylene-18,19-dinor-17α-pregn-4-en-20-yn-3-one], structurally derived from 19-nortestosterone, is the synthetic biologically active metabolite of the synthetic progestin desogestrel. It has a molecular weight of 324.46 and the following structural formula (Figure 20).

Figure 20
Figure 20

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The contraceptive effect of NEXPLANON is achieved by suppression of ovulation, increased viscosity of the cervical mucus, and alterations in the endometrium.

12.2 Pharmacodynamics

Exposure-response relationships of NEXPLANON are unknown.

12.3 Pharmacokinetics

Absorption

After subdermal insertion of the etonogestrel implant, etonogestrel is released into the circulation and is approximately 100% bioavailable.

In a three year clinical trial, NEXPLANON and the non-radiopaque etonogestrel implant (IMPLANON) yielded comparable systemic exposure to etonogestrel. For NEXPLANON, the mean (± SD) maximum serum etonogestrel concentrations were 1200 (± 604) pg/mL and were reached within the first two weeks after insertion (n=50). The mean (± SD) serum etonogestrel concentration decreased gradually over time, declining to 202 (± 55) pg/mL at 12 months (n=41), 164 (± 58) pg/mL at 24 months (n=37), and 138 (± 43) pg/mL at 36 months (n=32). For the non-radiopaque etonogestrel implant (IMPLANON), the mean (± SD) maximum serum etonogestrel concentrations were 1145 (± 577) pg/mL and were reached within the first two weeks after insertion (n=53). The mean (± SD) serum etonogestrel concentration decreased gradually over time, declining to 223 (± 73) pg/mL at 12 months (n=40), 172 (± 77) pg/mL at 24 months (n=32), and 153 (± 52) pg/mL at 36 months (n=30).

The pharmacokinetic profile of NEXPLANON is shown in Figure 21.

Figure 21: Mean (± SD) Serum Concentration-Time Profile of Etonogestrel After Insertion of NEXPLANON During 3 Years of Use

Figure 21
(click image for full-size original)

Distribution

The apparent volume of distribution averages about 201 L. Etonogestrel is approximately 32% bound to sex hormone binding globulin (SHBG) and 66% bound to albumin in blood.

Metabolism

In vitro data shows that etonogestrel is metabolized in liver microsomes by the cytochrome P450 3A4 isoenzyme. The biological activity of etonogestrel metabolites is unknown.

Excretion

The elimination half-life of etonogestrel is approximately 25 hours. Excretion of etonogestrel and its metabolites, either as free steroid or as conjugates, is mainly in urine and to a lesser extent in feces. After removal of the implant, etonogestrel concentrations decreased below sensitivity of the assay by one week.

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 24-month carcinogenicity study in rats with subdermal implants releasing 10 and 20 mcg etonogestrel per day (equal to approximately 1.8-3.6 times the systemic steady state exposure in women using NEXPLANON), no drug-related carcinogenic potential was observed. Etonogestrel was not genotoxic in the in vitro Ames/Salmonella reverse mutation assay, the chromosomal aberration assay in Chinese hamster ovary cells or in the in vivo mouse micronucleus test. Fertility in rats returned after withdrawal from treatment.

14 CLINICAL STUDIES

14.1 Pregnancy

In clinical trials of up to 3 years duration that involved 923 subjects, 18-40 years of age at entry, and 1756 women-years of use with the non-radiopaque etonogestrel implant (IMPLANON), the total exposures expressed as 28-day cycle equivalents by study year were:

Year 1: 10,866 cycles

Year 2: 8,581 cycles

Year 3: 3,442 cycles

The clinical trials excluded women who:

  • Weighed more than 130% of their ideal body weight
  • Were chronically taking medications that induce liver enzymes

In the subgroup of women, 18-35 years of age at entry, 6 pregnancies during 20,648 cycles of use were reported. Two pregnancies occurred in each of Years 1, 2, and 3. Each conception was likely to have occurred shortly before or within 2 weeks after removal of the non-radiopaque etonogestrel implant. With these 6 pregnancies, the cumulative Pearl Index was 0.38 pregnancies per 100 women-years of use.

14.2 Return to Ovulation

In clinical trials with the non-radiopaque etonogestrel implant (IMPLANON), the etonogestrel levels in blood decreased below sensitivity of the assay by one week after removal of the implant. In addition, pregnancies were observed to occur as early as 7 to 14 days after removal. Therefore, a woman should re-start contraception immediately after removal of the implant if continued contraceptive protection is desired.

14.3 Implant Insertion and Removal Characteristics

Out of 301 insertions of the NEXPLANON implant in a clinical trial, the mean insertion time (from the removal of the protection cap of the applicator until retraction of the needle from the arm) was 27.9 ± 29.3 seconds. After insertion, 300 out of 301 (99.7%) NEXPLANON implants were palpable. The single, non-palpable implant was not inserted according to the instructions.

For 112 out of 114 (98.2%) subjects in 2 clinical trials for whom insertion and removal data were available, NEXPLANON implants were clearly visible with use of two-dimensional x-ray after insertion. The two implants that were not clearly visible after insertion were clearly visible with two-dimensional x-ray before removal.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

NEXPLANON is supplied as follows:

NDC 78206-145-01

One NEXPLANON package consists of a single implant containing 68 mg etonogestrel, 15 mg of barium sulfate and 0.1 mg of magnesium stearate that is 4 cm in length and 2 mm in diameter, which is pre-loaded in the needle of a disposable applicator. The sterile applicator containing the implant is packed in a blister pack.

16.2 Storage and Handling

Store NEXPLANON (etonogestrel implant) Radiopaque at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF) [see USP Controlled Room Temperature]. Avoid storing NEXPLANON at temperatures above 30ºC (86ºF).

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information).

  • Counsel women about the insertion and removal procedure of the NEXPLANON implant. Provide the woman with a copy of the Patient Labeling and ensure that she understands the information in the Patient Labeling before insertion and removal. A USER CARD and consent form are included in the packaging. Have the woman complete a consent form and retain it in your records. The USER CARD should be filled out and given to the woman after insertion of the NEXPLANON implant so that she will have a record of the location of the implant in the upper arm and when it should be removed.
  • Counsel women to contact their healthcare professional immediately if, at any time, they are unable to palpate the implant.
  • Counsel women that NEXPLANON does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
  • Counsel women that the use of NEXPLANON may be associated with changes in their normal menstrual bleeding patterns so that they know what to expect.

Manufactured for: Organon USA LLC, a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA

Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA

For patent information: www.organon.com/our-solutions/patent/

Copyright © 2021 Organon Global Inc.
All rights reserved.

uspi-og8415-iptx-2107r001

FDA-Approved Patient Labeling

NEXPLANON® (etonogestrel implant)
Radiopaque Subdermal Use Only

NEXPLANON® does not protect against HIV infection (the virus that causes AIDS) or other sexually transmitted diseases.

Read this Patient Information leaflet carefully before you decide if NEXPLANON is right for you. This information does not take the place of talking with your healthcare provider. If you have any questions about NEXPLANON, ask your healthcare provider.

What is NEXPLANON?

NEXPLANON is a hormone-releasing birth control implant for use by women to prevent pregnancy for up to 3 years. The implant is a flexible plastic rod about the size of a matchstick that contains a progestin hormone called etonogestrel. It contains a small amount of barium sulfate (15 mg), so that the implant can be seen by X-ray, an ethylene vinyl acetate (EVA) copolymer (28% vinyl acetate, 43 mg) core, and magnesium stearate (0.1 mg). Your healthcare provider will insert the implant just under the skin of the inner side of your upper arm. You can use a single NEXPLANON implant for up to 3 years. NEXPLANON does not contain estrogen.

Figure
(click image for full-size original)

What if I need birth control for more than 3 years?

The NEXPLANON implant must be removed after 3 years. Your healthcare provider can insert a new implant under your skin after taking out the old one if you choose to continue using NEXPLANON for birth control.

What if I change my mind about birth control and want to stop using NEXPLANON before 3 years?

Your healthcare provider can remove the implant at any time. You may become pregnant as early as the first week after removal of the implant. If you do not want to get pregnant after your healthcare provider removes the NEXPLANON implant, you should start another birth control method right away.

How does NEXPLANON work?

NEXPLANON prevents pregnancy in several ways. The most important way is by stopping the release of an egg from your ovary. NEXPLANON also thickens the mucus in your cervix and this change may keep sperm from reaching the egg. NEXPLANON also changes the lining of your uterus.

How well does NEXPLANON work?

When the NEXPLANON implant is placed correctly, your chance of getting pregnant is very low (less than 1 pregnancy per 100 women who use NEXPLANON for 1 year). It is not known if NEXPLANON is as effective in very overweight women because studies did not include many overweight women.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Figure
(click image for full-size original)

Who should not use NEXPLANON?

Do not use NEXPLANON if you:

  • Are pregnant or think you may be pregnant

  • Have, or have had blood clots, such as blood clots in your legs (deep venous thrombosis), lungs (pulmonary embolism), eyes (total or partial blindness), heart (heart attack), or brain (stroke)
  • Have liver disease or a liver tumor
  • Have unexplained vaginal bleeding
  • Have breast cancer or any other cancer that is sensitive to progestin (a female hormone), now or in the past
  • Are allergic to anything in NEXPLANON

Tell your healthcare provider if you have or have had any of the conditions listed above. Your healthcare provider can suggest a different method of birth control.

In addition, talk to your healthcare provider about using NEXPLANON if you:

  • Have diabetes
  • Have high cholesterol or triglycerides
  • Have headaches
  • Have gallbladder or kidney problems
  • Have a history of depressed mood
  • Have high blood pressure
  • Have an allergy to numbing medicines (anesthetics) or medicines used to clean your skin (antiseptics). These medicines will be used when the implant is placed into or removed from your arm.

Interaction with Other Medicines

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Certain medicines may make NEXPLANON less effective, including:

  • aprepitant
  • barbiturates
  • bosentan
  • carbamazepine
  • felbamate
  • griseofulvin
  • oxcarbazepine
  • phenytoin
  • rifampin
  • St. John’s wort
  • topiramate
  • HIV medicines
  • Hepatitis C Virus medicines

Ask your healthcare provider if you are not sure if your medicine is one listed above.

If you are taking medicines or herbal products that might make NEXPLANON less effective, you and your healthcare provider may decide to leave NEXPLANON in place; in that case, an additional non-hormonal contraceptive should be used. Because the effect of another medicine on NEXPLANON may last up to 28 days after stopping the medicine, it is necessary to use the additional non-hormonal contraceptive for that long.

When you are using NEXPLANON, tell all of your healthcare providers that you have NEXPLANON in place in your arm.

How is the NEXPLANON implant placed and removed?

Your healthcare provider will place and remove the NEXPLANON implant in a minor surgical procedure in his or her office. The implant is placed just under the skin on the inner side of your non-dominant upper arm.

The timing of insertion is important. Your healthcare provider may:

  • Perform a pregnancy test before inserting NEXPLANON
  • Schedule the insertion at a specific time of your menstrual cycle (for example, within the first 5 days of your regular menstrual bleeding). If the implant is placed after the fifth day of menses, then you should use an additional contraceptive method (such as a condom) for the first 7 days after insertion.

Your healthcare provider will cover the site where NEXPLANON was placed with 2 bandages. Leave the top bandage on for 24 hours. Keep the smaller bandage clean, dry, and in place for 3 to 5 days.

Immediately after the NEXPLANON implant has been placed, you and your healthcare provider should check that the implant is in your arm by feeling for it.

If you cannot feel the implant immediately after insertion, the implant may not have been inserted, or it may have been inserted deeply. A deep insertion may cause problems with locating and removing the implant. Once the healthcare provider has located the implant, it should be removed.

If at any time you cannot feel the NEXPLANON implant, contact your healthcare provider immediately and use a non-hormonal birth control method (such as condoms) until your healthcare provider confirms that the implant is in place. You may need special tests to check that the implant is in place or to help find the implant when it is time to take it out. If the implant cannot be found in the arm after a thorough search, your healthcare provider may use x-rays or other imaging methods on your chest.

Depending on the exact position of the implant, removal may be difficult and may require surgery.

You will be asked to review and sign a consent form prior to inserting the NEXPLANON implant. You will also get a USER CARD to keep at home with your health records. Your healthcare provider will fill out the USER CARD with the date the implant was inserted and the date the implant is to be removed. Keep track of the date the implant is to be removed. Schedule an appointment with your healthcare provider to remove the implant on or before the removal date.

Be sure to have checkups as advised by your healthcare provider.

What are the most common side effects I can expect while using NEXPLANON?

Changes in Menstrual Bleeding Patterns (menstrual periods)

The most common side effect of NEXPLANON is a change in your normal menstrual bleeding pattern. In studies, one out of ten women stopped using the implant because of an unfavorable change in their bleeding pattern. You may experience longer or shorter bleeding during your periods or have no bleeding at all. The time between periods may vary, and in between periods you may also have spotting.

Tell your healthcare provider right away if:

  • You think you may be pregnant
  • Your menstrual bleeding is heavy and prolonged

Besides changes in menstrual bleeding patterns, other frequent side effects that caused women to stop using the implant include:

  • Mood swings
  • Weight gain
  • Headache
  • Acne
  • Depressed mood

Other common side effects include:

  • Headache
  • Vaginitis (inflammation of the vagina)
  • Weight gain
  • Acne
  • Breast pain
  • Viral infections such as sore throats or flu-like symptoms
  • Stomach pain
  • Painful periods
  • Mood swings, nervousness, or depressed mood
  • Back pain
  • Nausea
  • Dizziness
  • Pain
  • Pain at the site of insertion

Implants have been reported to be found in a blood vessel, including a blood vessel in the lung which can be associated with shortness of breath, cough and/or the coughing up of blood or blood-stained mucus.

This is not a complete list of possible side effects. For more information, ask your healthcare provider for advice about any side effects that concern you. You may report side effects to the FDA at 1-800-FDA-1088.

What are the possible risks of using NEXPLANON?

Problems with Insertion and Removal

The implant may not be placed in your arm at all due to a failed insertion. If this happens, you may become pregnant. Immediately after insertion, and with help from your healthcare provider, you should be able to feel the implant under your skin. If you can’t feel the implant, tell your healthcare provider.

Location and removal of the implant may be difficult or impossible because the implant is not where it should be. Special procedures, including surgery in the hospital, may be needed to remove the implant. If the implant is not removed, then the effects of NEXPLANON will continue for a longer period of time.

Implants have been found in the pulmonary artery (a blood vessel in the lung). If the implant cannot be found in the arm, your healthcare provider may use x-rays or other imaging methods on the chest. If the implant is located in the chest, surgery may be needed.

Other problems related to insertion and removal are:

  • Pain, irritation, swelling, or bruising at the insertion site
  • Numbness and tingling at the insertion site
  • Scarring, including a thick scar called a keloid around the insertion site
  • Infection
  • Scar tissue may form around the implant making it difficult to remove
  • The implant may come out by itself. You may become pregnant if the implant comes out by itself. Use a back-up birth control method and call your healthcare provider right away if the implant comes out.
  • The need for surgery in the hospital to remove the implant
  • Injury to nerves or blood vessels in your arm
  • The implant breaks making removal difficult

Ectopic Pregnancy

If you become pregnant while using NEXPLANON, you have a slightly higher chance that the pregnancy will be ectopic (occurring outside the womb) than do women who do not use birth control. Unusual vaginal bleeding or lower stomach (abdominal) pain may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancies can cause serious internal bleeding, infertility, and even death. Call your healthcare provider right away if you think you are pregnant or have unexplained lower stomach (abdominal) pain.

Ovarian Cysts

Cysts may develop on the ovaries and usually go away without treatment but sometimes surgery is needed to remove them.

Breast Cancer

It is not known whether NEXPLANON use changes a woman’s risk for breast cancer. If you have breast cancer now, or have had it in the past, do not use NEXPLANON because some breast cancers are sensitive to hormones.

Serious Blood Clots

NEXPLANON may increase your chance of serious blood clots, especially if you have other risk factors such as smoking. It is possible to die from a problem caused by a blood clot, such as a heart attack or a stroke.

Some examples of serious blood clots are blood clots in the:

  • Legs (deep vein thrombosis)
  • Lungs (pulmonary embolism)
  • Brain (stroke)
  • Heart (heart attack)
  • Eyes (total or partial blindness)

The risk of serious blood clots is increased in women who smoke. If you smoke and want to use NEXPLANON, you should quit. Your healthcare provider may be able to help.

Tell your healthcare provider at least 4 weeks before if you are going to have surgery or will need to be on bed rest. You have an increased chance of getting blood clots during surgery or bed rest.

Other Risks

A few women who use birth control that contains hormones may get:

  • High blood pressure
  • Gallbladder problems
  • Rare cancerous or noncancerous liver tumors

Broken or Bent Implant

Breakage or bending of the implant may occur due to external forces (e.g., manipulation of the implant or contact sports). A broken implant may move from the insertion site. If you feel that the implant may have broken or bent while in your arm, contact your healthcare provider.

When should I call my healthcare provider?

Call your healthcare provider right away if you have:

  • Pain in your lower leg that does not go away
  • Severe chest pain or heaviness in the chest
  • Sudden shortness of breath, sharp chest pain, or coughing blood
  • Symptoms of a severe allergic reaction, such as swollen face, tongue or throat; trouble breathing or swallowing
  • Sudden severe headache unlike your usual headaches
  • Weakness or numbness in your arm, leg, or trouble speaking
  • Sudden partial or complete blindness
  • Yellowing of your skin or whites of your eyes, especially with fever, tiredness, loss of appetite, dark colored urine, or light-colored bowel movements
  • Severe pain, swelling, or tenderness in the lower stomach (abdomen)
  • Lump in your breast
  • Problems sleeping, lack of energy, tiredness, or you feel very sad
  • Heavy menstrual bleeding

What if I become pregnant while using NEXPLANON?

You should see your healthcare provider right away if you think that you may be pregnant. It is important to remove the implant and make sure that the pregnancy is not ectopic (occurring outside the womb). Based on experience with other hormonal contraceptives, NEXPLANON is not likely to cause birth defects.

Can I use NEXPLANON when I am breastfeeding?

If you are breastfeeding your child, you may use NEXPLANON if 4 weeks have passed since you had your baby. A small amount of the hormone contained in NEXPLANON passes into your breast milk. The health of breast-fed children whose mothers were using the implant has been studied up to 3 years of age in a small number of children. No effects on the growth and development of the children were seen. If you are breastfeeding and want to use NEXPLANON, talk with your healthcare provider for more information.

Additional Information

This Patient Information leaflet contains important information about NEXPLANON. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider for information about NEXPLANON that is written for healthcare providers. You may also call 1-844-674-3200 or visit www.nexplanon.com.

Manufactured for: Organon USA LLC, a subsidiary of
ORGANON & Co.,
Jersey City, NJ 07302, USA

Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of Organon & Co., Jersey City, NJ 07302, USA

For patent information: www.organon.com/our-solutions/patent/

Copyright © 2021 Organon Global Inc.
All rights reserved.

Revised: 7/2021

usppi-og8415-iptx-2107r001

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