Nexplanon 68mg Imp

Manufacturer ORGANON Active Ingredient Etonogestrel(e toe noe JES trel) Pronunciation e toe noe JES trel
It is used to prevent pregnancy.
đŸˇī¸
Drug Class
Contraceptive
đŸ§Ŧ
Pharmacologic Class
Progestin
🤰
Pregnancy Category
Category X
✅
FDA Approved
Jul 2006
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Nexplanon is a small, flexible rod about the size of a matchstick that is inserted just under the skin of your upper arm. It slowly releases a hormone called etonogestrel, which prevents pregnancy for up to 3 years. It works by stopping ovulation (release of an egg), thickening cervical mucus to block sperm, and thinning the lining of the uterus.
📋

How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided to you. This medication is administered via a rod that is inserted under the skin in the upper arm through a minor surgical procedure. The rod must be replaced every 3 years.

Monitoring and Follow-up

It is essential to have regular blood tests as directed by your doctor. Discuss any concerns or questions with your doctor. If you consume grapefruit juice or eat grapefruit frequently, inform your doctor, as this may interact with the medication.

Regular Health Check-ups

Regular breast exams and gynecology check-ups are crucial while taking this medication. Additionally, perform breast self-exams as instructed by your doctor.

Potential Side Effects

High blood pressure is a possible side effect of this medication. Have your blood pressure checked regularly, as advised by your doctor.

Lab Tests and Interactions

This medication may affect certain lab test results. Inform all your healthcare providers and lab personnel that you are taking this medication.

Storage and Disposal

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.

Missed Dose

If you miss a dose, contact your doctor to determine the best course of action.
💡

Lifestyle & Tips

  • Do not smoke, especially if you are over 35 years old, as this increases the risk of serious cardiovascular side effects.
  • Attend all scheduled follow-up appointments for monitoring and removal/replacement.
  • Inform all healthcare providers that you have a Nexplanon implant, especially before any surgery or if you are prescribed new medications.
  • Be aware of the implant's location in your arm and contact your doctor if you cannot feel it or suspect it has moved.
💊

Available Forms & Alternatives

Available Strengths:

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: One 68 mg implant inserted subdermally into the upper arm for up to 3 years of continuous contraception.
Dose Range: 68 - 68 mg

Condition-Specific Dosing:

contraception: One implant for up to 3 years. Remove after 3 years or sooner if desired or if contraception is no longer needed. A new implant may be inserted at the time of removal.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not indicated before menarche. For post-menarcheal adolescents, dosing is the same as adults.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific data, but unlikely to require adjustment as it's an implant with slow release.

Hepatic Impairment:

Mild: Use with caution
Moderate: Use with caution
Severe: Contraindicated in severe hepatic impairment or liver tumors.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Etonogestrel, a progestin, primarily acts by inhibiting ovulation. It also increases the viscosity of the cervical mucus, making it more difficult for sperm to penetrate, and causes endometrial atrophy, which makes the endometrium unsuitable for implantation.
📊

Pharmacokinetics

Absorption:

Bioavailability: 100% (as it's directly absorbed from the implant)
Tmax: Approximately 1 week to reach steady-state concentrations; initial peak within days of insertion.
FoodEffect: Not applicable (implant)

Distribution:

Vd: Approximately 200 L
ProteinBinding: 95-98% (primarily to serum albumin and sex hormone-binding globulin [SHBG])
CnssPenetration: Limited (low levels detected in CSF, but not clinically significant for contraception)

Elimination:

HalfLife: Approximately 25-28 hours
Clearance: Approximately 7.5 L/hour
ExcretionRoute: Urine (approximately 40%) and feces (approximately 60%)
Unchanged: <1% (negligible)
âąī¸

Pharmacodynamics

OnsetOfAction: Within 24 hours of insertion (if inserted correctly within the first 5 days of menstrual cycle)
PeakEffect: Steady-state concentrations achieved within approximately 1 week, providing continuous contraceptive effect.
DurationOfAction: Up to 3 years

Safety & Warnings

âš ī¸

Side Effects

Serious Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction: rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellowing of the skin or eyes (jaundice).
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellowing of the skin or eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Signs of skin infection: oozing, heat, swelling, redness, or pain.
Weakness on one side of the body, difficulty speaking or thinking, changes in balance, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel.
Breast lump, breast pain or tenderness, or nipple discharge.
Flu-like symptoms.
Unusual vaginal bleeding.

This medication may also cause fluid retention, leading to swelling or weight gain. If you experience swelling, weight gain, or difficulty breathing, inform your doctor.

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms, contact your doctor:

Weight gain
Dizziness or headache
Acne (pimples)
Vaginal irritation
Changes in menstrual periods, including spotting between cycles or very light periods
Irritation at the site where the rod was inserted
Stomach pain
Throat irritation
Back pain
Upset stomach
Feeling nervous or excitable

This list is not exhaustive. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe pain, swelling, warmth, or redness in your leg (possible blood clot)
  • Sudden severe chest pain, shortness of breath, or coughing up blood (possible blood clot in lungs)
  • Sudden severe headache, vision changes, or numbness/weakness on one side of the body (possible stroke)
  • Yellowing of the skin or eyes (jaundice), dark urine, or severe abdominal pain (possible liver problems)
  • Signs of infection at the implant site (e.g., pus, severe pain, spreading redness)
  • If you cannot feel the implant in your arm or suspect it has moved
📋

Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
If you have a history of liver disease or liver tumors.
If you have experienced any of the following health issues in the past:
+ Blood clots
+ Breast cancer or other hormone-sensitive cancers
+ Heart attack
+ Stroke
If you are experiencing unexplained vaginal bleeding.
If you have given birth within the last 21 days.
If you are pregnant or think you might be pregnant. Do not take this medication if you are pregnant.
* If you have not yet started menstruating.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dosage of any medication without consulting your doctor first.
âš ī¸

Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Birth Control Precautions

After the implant is inserted, you may need to use a non-hormonal form of birth control, such as condoms, for a period of time. Discuss this with your doctor to determine the best course of action.

Potential Complications with the Implant

The implant may break or bend due to activities like contact sports or applying pressure to the area where it was inserted. If the implant breaks, it can move from its original position. If you are unable to feel the implant or suspect that it has broken, bent, or moved, consult your doctor immediately.

Risks Associated with Insertion and Removal

Complications can occur during the insertion or removal of the implant, including pain, burning, numbness, tingling, dizziness, fainting, bruising, bleeding, scarring, or infection. If you have any concerns or questions, discuss them with your doctor.

Pregnancy and Ectopic Pregnancy

If you become pregnant while taking this medication, your risk of having an ectopic pregnancy (a pregnancy that develops outside the uterus) may be increased. Consult your doctor to discuss this risk and any necessary precautions.

Blood Clots and Thrombosis

Blood clots have been reported in individuals taking this medication, and in some cases, these clots have been fatal. Consult your doctor to discuss your risk of blood clots, especially if you will be immobile for an extended period, such as during long trips, bed rest after surgery, or illness. Notify your doctor immediately if you experience any symptoms of a blood clot, including:

Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, or pain in a leg or arm
* Difficulty speaking or swallowing

Ovarian Cysts

There is a rare risk of developing an ovarian cyst while taking this medication.

Diabetes and Blood Sugar Control

If you have diabetes, inform your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.

Interactions with Other Medications and Health Conditions

Certain medications, herbal products, or health conditions may reduce the effectiveness of this medication. Inform your doctor about all your medications and health conditions to determine if you need to use a non-hormonal form of birth control, such as condoms.

Sexually Transmitted Infections

This medication does not protect against sexually transmitted infections, such as HIV or hepatitis. Use a latex or polyurethane condom during sexual activity to reduce your risk of infection. Consult your doctor if you have any questions or concerns.

Cancer Risks

Some studies suggest that the risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. Additionally, some studies have reported an increased risk of breast cancer with long-term use of hormone-based birth control, while others have not found this association. Discuss these risks with your doctor.

Pregnancy After Implant Removal

If the implant is removed and you do not wish to become pregnant, use birth control immediately after removal, as pregnancy can occur soon after the implant is removed. Consult your doctor to discuss the best form of birth control for your situation.

Pregnancy Testing

A pregnancy test will be performed before starting this medication to confirm that you are not pregnant. If you become pregnant while taking this medication, notify your doctor immediately.

Breastfeeding

If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
🆘

Overdose Information

Overdose Symptoms:

  • Overdose is highly unlikely with an implant due to its controlled release mechanism. Symptoms of excessive progestin exposure might include nausea, vomiting, breast tenderness, or vaginal bleeding.

What to Do:

If an overdose were suspected (e.g., accidental insertion of multiple implants), the implant(s) would need to be removed. For general concerns, call 1-800-222-1222 (Poison Control).

Drug Interactions

🔴

Major Interactions

  • Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampin, St. John's Wort, efavirenz, nevirapine, ritonavir, bosentan, rufinamide, aprepitant, barbiturates, primidone, topiramate, oxcarbazepine)
  • Certain HIV protease inhibitors (e.g., nelfinavir, ritonavir-boosted lopinavir/ritonavir, atazanavir/ritonavir)
🟡

Moderate Interactions

  • Moderate CYP3A4 inducers (e.g., griseofulvin, modafinil)
  • Certain antibiotics (e.g., rifabutin, though evidence for broad-spectrum antibiotics is weak and generally not considered clinically significant for efficacy)
đŸŸĸ

Minor Interactions

  • Not many clinically significant minor interactions listed for efficacy.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Pregnancy test

Rationale: To ensure patient is not pregnant before insertion.

Timing: Prior to insertion

Complete medical history and physical examination (including blood pressure, breast exam, and pelvic exam)

Rationale: To identify any contraindications or risk factors for use.

Timing: Prior to insertion

📊

Routine Monitoring

Blood pressure

Frequency: Annually or as clinically indicated

Target: Normal limits

Action Threshold: Significant elevation may warrant removal or alternative contraception.

Weight

Frequency: Annually or as clinically indicated

Target: Stable or within healthy range

Action Threshold: Significant or rapid weight gain may warrant evaluation.

Implant site check

Frequency: At follow-up visits and if patient reports issues

Target: No signs of infection, migration, or excessive pain

Action Threshold: Redness, swelling, pain, pus, or migration requires evaluation.

Review of side effects (e.g., bleeding patterns, mood changes, headache)

Frequency: Annually or as clinically indicated

Target: Patient tolerability

Action Threshold: Intolerable side effects may warrant removal.

đŸ‘ī¸

Symptom Monitoring

  • Changes in menstrual bleeding patterns (e.g., irregular, prolonged, heavy bleeding)
  • Headaches (especially new onset or severe)
  • Mood changes, depression
  • Breast tenderness or pain
  • Weight changes
  • Signs of venous thromboembolism (VTE) such as severe leg pain, swelling, warmth, redness; sudden chest pain, shortness of breath, coughing up blood
  • Signs of arterial thromboembolism (e.g., sudden severe headache, vision changes, weakness or numbness on one side of the body)
  • Signs of liver problems (e.g., yellowing of skin/eyes, dark urine, severe abdominal pain)
  • Signs of implant site complications (e.g., pain, swelling, redness, pus, migration, numbness, tingling)

Special Patient Groups

🤰

Pregnancy

Contraindicated in pregnancy. If pregnancy occurs while using Nexplanon, the implant should be removed.

Trimester-Specific Risks:

First Trimester: Exposure during early pregnancy is not expected to increase the risk of birth defects, but the implant should be removed once pregnancy is confirmed.
Second Trimester: Not applicable, implant should be removed.
Third Trimester: Not applicable, implant should be removed.
🤱

Lactation

Etonogestrel is excreted in breast milk. Use is generally considered compatible with breastfeeding, but it is recommended to wait until 4-6 weeks postpartum to allow breastfeeding to be well-established. Monitor the infant for any potential effects.

Infant Risk: L3 (Moderately safe). Small amounts of etonogestrel pass into breast milk. No adverse effects on infant growth or development have been observed in studies, but some reports of decreased milk production exist, though rare.
đŸ‘ļ

Pediatric Use

Not indicated for use before menarche. Safety and efficacy have been established for post-menarcheal adolescents.

👴

Geriatric Use

Not indicated for post-menopausal women. Safety and efficacy have not been established in geriatric populations.

Clinical Information

💎

Clinical Pearls

  • Nexplanon is one of the most effective forms of reversible contraception, with a failure rate of less than 1%.
  • Insertion and removal must be performed by a healthcare professional trained in the procedure. Proper insertion is crucial to ensure efficacy and prevent complications.
  • Irregular bleeding patterns (e.g., spotting, prolonged bleeding, amenorrhea) are the most common side effect and should be discussed with patients prior to insertion.
  • Patients should be able to feel the implant under their skin after insertion. If they cannot, or if they suspect it has moved, they should contact their healthcare provider immediately.
  • Weight gain is a commonly reported side effect, though studies show variable results regarding its direct causation by the implant.
  • Counsel patients on potential drug interactions, especially with enzyme-inducing medications, which can reduce the effectiveness of Nexplanon.
🔄

Alternative Therapies

  • Combined oral contraceptives (COCs)
  • Progestin-only pills (POPs)
  • Depot medroxyprogesterone acetate (DMPA) injection (Depo-Provera)
  • Intrauterine devices (IUDs) (e.g., Mirena, Skyla, Kyleena, Liletta, Paragard)
  • Contraceptive patch (Xulane)
  • Vaginal ring (NuvaRing, Annovera)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
💰

Cost & Coverage

Average Cost: $800 - $1300 (device only, procedure extra) per implant
Insurance Coverage: Often covered as Tier 1 or 2 by most insurance plans, including Medicaid, under the Affordable Care Act's contraceptive mandate. Patient out-of-pocket costs vary based on plan.
📚

General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs that provide a safe and environmentally friendly way to dispose of unwanted medications.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your medication. If you have any questions or concerns about your medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.

In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in prompt and effective treatment.