Etonogestrel

• If you have an allergy to etonogestrel or any other part of etonogestrel.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have blood clots or have had blood clots in the past.
• If you have liver tumors.
• If you have liver disease.
• If you have unexplained vaginal bleeding.
• If you have ever had breast cancer or another cancer where hormones make it grow.
• If you have given birth within the last 21 days.
• If you are pregnant or may be pregnant. Do not take this medicine if you are pregnant.
• If you have not started your period.

This is not a list of all drugs or health problems that interact with etonogestrel.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take etonogestrel. This includes your doctors, nurses, pharmacists, and dentists.
• Be sure to have regular breast exams and gynecology check-ups. Your doctor will tell you how often to have these. You will also need to do breast self-exams as your doctor has told you. Talk with your doctor.
• After this medicine has been put in, use a non-hormone type of birth control like condoms until the placement of etonogestrel has been checked. Talk with your doctor.
• If you feel that the implant has been broken or bent while in your arm, talk with the doctor.
• Blood clots have happened with this medicine. Sometimes, these blood clots have been deadly. Talk with the doctor.
• Talk with your doctor if you will need to be still for long periods of time like long trips, bedrest after surgery, or illness. Not moving for long periods may raise your chance of blood clots.
• A cyst on the ovary may rarely happen.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• High blood pressure has happened with etonogestrel. Have your blood pressure checked as you have been told by your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take this medicine.
• If you drink grapefruit juice or eat grapefruit often, talk with your doctor.
• Certain drugs, herbal products, or health problems could cause etonogestrel to not work as well. Be sure your doctor knows about all of your drugs and health problems.
• This medicine may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this medicine with your other drugs.
• This medicine does not stop the spread of diseases like HIV or hepatitis that are passed through blood or having sex. Do not have any kind of sex without using a latex or polyurethane condom. Do not share needles or other things like toothbrushes or razors. Talk with your doctor.
• If etonogestrel is removed and you do not want to get pregnant, use birth control right after it is removed. Pregnancy has happened shortly after this medicine was removed. Talk with the doctor.
• A pregnancy test will be done to show that you are NOT pregnant before starting etonogestrel. If you get pregnant while taking this medicine, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about etonogestrel, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about etonogestrel. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using etonogestrel.

Review Date: October 4, 2017

(e toe noe JES trel)

• Contraceptive
• Progestin

Contraception: Prevention of pregnancy

There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Subdermal: For subdermal insertion by health care providers trained in the insertion and removal procedure. Insert implant subdermally at the inner side of the nondominant upper arm ~8 to 10 cm (3 to 4 inches) above the medial epicondyle of the humerus just under the skin. Implant must be palpable after insertion. X-ray, CT scan, ultrasound scanning, or MRI may also be used to confirm the location of the implant if it is not palpable. Use of a nonhormonal contraceptive (eg, condom) is required until the presence of the implant can be verified.

When removing the implant, confirm that the entire implant has been removed by measuring its length (4 cm). Remove all pieces if implant has broken. A new implant may be inserted in the same arm through the same incision.

Refer to the manufacturer's product labeling for complete administration, removal, and reinsertion instructions. A User Card (to give to the patient), consent form (to keep on file), and patient product information are provided with the device. Materials related to the insertion and removal of etonogestrel implant are available from the manufacturer (877-467-5266).

>10%:

Central nervous system: Headache (25%)

Dermatologic: Acne vulgaris (14%)

Endocrine & metabolic: Menstrual disease (<3 episodes/90 days: 34%; prolonged menstrual bleeding lasting >14 days: 18%; >5 episodes/90 days: 7%), amenorrhea (no bleeding in 90 days: 22%), weight gain (14%)

Gastrointestinal: Abdominal pain (11%)

Genitourinary: Vaginitis (15%), mastalgia (13%)

Respiratory: Pharyngitis (11%)

1% to 10%:

Central nervous system: Dizziness (7%), emotional lability (7%), depression (6%), nervousness (6%), pain (6%)

Dermatologic: Localized erythema (implant site: ≤3%)

Endocrine & metabolic: Dysmenorrhea (7%)

Gastrointestinal: Nausea (6%)

Genitourinary: Leukorrhea (10%)

Hypersensitivity: Hypersensitivity reaction (5%)

Local: Application site reaction (implant site: 4% to 9%), local pain (implant site: 1% to 5%), hematoma at injection site (implant site: ≤3%), bruising at injection site (implant site: 2%)

Neuromuscular & skeletal: Back pain (7%)

Respiratory: Flu-like symptoms (8%)

<1% (Limited to important or life-threatening): Alopecia, anaphylaxis, angioedema (including exacerbation of hereditary angioedema), cerebrovascular accident, convulsions, hypertension, migraine, myocardial infarction, ovarian cyst, pulmonary embolism, seizure

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

•Patient may experience weight gain, acne, vaginal irritation, menstrual changes, application site irritation, pharyngitis, back pain, nausea, or anxiety. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice), signs of high blood sugar (confusion, fatigue, increased thirst, increased hunger, polyuria, flushing, fast breathing, or breath that smells like fruit), signs of severe cerebrovascular disease (change in strength on one side is greater than the other, difficulty speaking or thinking, change in balance, or vision changes), signs of blood clots (numbness or weakness on one side of the body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; angina; shortness of breath; tachycardia; or coughing up blood), shortness of breath, swelling of arms or legs, excessive weight gain, depression, mood changes, severe headache, severe dizziness, passing out, contact lens discomfort, flu-like symptoms, vaginal bleeding, severe abdominal pain, vision changes, eye pain, severe eye irritation, blindness, lump in breast, or breast pain or soreness (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.