Haloette

Brand Name

Haloette

Common Name

etonogestrel - ethinyl estradiol slow release vaginal ring

In this drug factsheet:

• How does this medication work? What will it do for me?
• How should I use this medication?
• What form(s) does this medication come in?
• Who should NOT take this medication?
• What side effects are possible with this medication?
• Are there any other precautions or warnings for this medication?
• What other drugs could interact with this medication?

How does this medication work? What will it do for me?

This combination product contains 2 active medications: etonogestrel and estradiol. Etonogestrel belongs to a class of medications called progestins. It is a man-made hormone similar to the hormone progesterone, produced by the ovaries. Estradiol belongs to the class of medications called estrogen. It is also a hormone produced by the ovaries. Together, etonogestrel (progestin) and ethinyl estradiol (estrogen) belong to the class of medications called combination hormonal contraceptives.

Etonogestrel - ethinyl estradiol is used to prevent pregnancy by preventing ovulation (the release of an egg by the ovaries), changing the mucus produced by the cervix, making it difficult for sperm to enter the uterus and changing the lining of the uterus, and making it difficult for a fertilized egg to anchor and grow.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are being given this medication, speak to your doctor. Do not stop using this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to use this medication if their doctor has not prescribed it.

How should I use this medication?

A ring is inserted into the vagina for 3 weeks at a time, then removed for a 1-week break, during which time a menstrual period usually occurs. A new ring is inserted 1 week after the last ring is removed. When you first start using this medication, your health care professional will advise you on which is the best day of your cycle to insert the ring, depending of whether or not you have been previously using hormonal contraceptives.

Inserting the ring

Choose the position that is most comfortable for you (standing with one leg up, squatting, or lying down), as agreed upon by you and your doctor.

• Wash and dry your hands thoroughly.
• Remove the ring from its foil pouch. (Keep the foil pouch for proper disposal of the ring after use.)
• Hold the ring between your thumb and index finger and press the opposite sides of the ring together.
• Gently push the folded ring into your vagina.

The exact position of the ring is not important for it to work. When the ring is in place, most women do not feel it. If you feel uncomfortable, use your finger to gently push the ring further into your vagina. There is no danger of the ring being pushed too far up in the vagina or getting lost. The ring can only be inserted as far as the end of the vagina, where the cervix will block the ring from going any further.

Removing the ring

Remove the vaginal ring 3 weeks after insertion on the same day of the week as it was inserted and at about the same time. To remove the vaginal ring:

• Wash and dry your hands thoroughly.
• Hook your index finger under the forward rim or by holding the rim between the index and middle finger and pull it out.
• Place the used ring in the foil pouch and properly dispose of it in a waste container that is kept out of the reach of children and pets.

Do not flush the ring down the toilet.

Your menstrual period will usually start 2 to 3 days after you remove the ring, and may not end before the new ring is inserted. For continuous protection against pregnancy, you must insert a new ring one week after one was removed, even if your menstrual period has not stopped.

If the ring slips out of the vagina and is replaced within 3 hours, you should still be protected from pregnancy. Rinse the ring with cool or lukewarm water and re-insert it as soon as possible.

If the ring has been out of the vagina for more than 3 hours in the first or second week, protection from pregnancy may no longer be adequate and there is a possibility that you could become pregnant. Reinsert the ring as soon as you remember and use a second method of birth control, such as condoms, until the ring has been in place for 7 days in a row. Use it on the same schedule as you would have used the one that you were originally using.

If the ring has been out of the vagina for more than 3 hours in the third week, protection from pregnancy may be reduced. Throw the ring away and either:

• Insert a new ring immediately, starting the next 3-week period of use - you may not experience a menstrual period, or you may experience spotting or breakthrough bleeding; or
• Have your period and insert a new ring no more than 7 days after the previous ring was removed or expelled - use this option only if the ring was in place continuously for the previous 7 days.

If the ring has been left in your vagina for an extra week or less (up to 4 weeks total), remove it, take a 1-week break, and re-insert a new ring. If the ring has been left in place for more than 4 weeks total, there is a possibility that you may become pregnant. To prevent pregnancy, you must use an extra method of birth control, such as condoms until a new ring has been in place for 7 days in a row. Additionally, if the ring-free interval has been extended beyond 7 days, there is a possibility that you may become pregnant. An extra method of birth control, such as condoms, should be used until a new ring has been in place for 7 days in a row.

While using this medication, you should be examined by your doctor at least once a year.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is important to use this medication exactly as prescribed by your doctor.

Store this medication at room temperature, protect it from sunlight, and keep it out of the reach of children. This medication should be used within 4 months of receiving from the pharmacy.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

Each ring has an outer diameter of 54 mm and a cross-sectional diameter of 4 mm, and contains 11.7 mg of etonogestrel and 2.7 mg of  ethinyl estradiol. Each ring delivers 120 µg of etonogestrel and 15 µg of ethinyl estradiol per day. Nonmedicinal ingredients:  ethylene vinyl acetate copolymers (28% and 9% vinyl acetate) and magnesium stearate.

Who should NOT take this medication?

Do not use this medication if you:

• are allergic to etonogestrel, ethinyl estradiol, or any ingredients of the medication
• are pregnant or suspect you may be pregnant
• are a smoker and over the age of 35 years
• experience migraines with vision problems (aura)
• have recently had or are planning to have surgery that will limit your ability to move around
• have very high blood pressure
• have existing or have had blood vessel or blood clotting disorders (including deep vein thrombosis, pulmonary embolism, thrombophlebitis, cerebrovascular disease such as stroke, heart attack, and coronary artery disease)
• have any eye problems caused by blood vessel disease in the eye (such as partial or complete loss of vision or other vision changes)
• have heart disease involving the valves of the heart
• have a blood condition that makes you more likely to develop clots
• have risk factors for blood clotting disorders
• have active liver disease
• have severe cholesterol problems
• have diabetes with blood vessel changes
• have a history of pancreatitis with high levels of triglycerides
• have or have had a heart attack, chest pain (angina pectoris), or other circulatory disorders
• have or have had breast cancer or cancer of the uterus or other reproductive organs
• have or have had cancers that are caused by or enhanced by estrogen (e.g., breast cancer, endometrial cancer)
• have or have had eye diseases, eye lesions or defects, or loss of vision caused by blood vessel disease in the eye
• have or have had liver tumours
• have or have had unusual vaginal bleeding that has not been evaluated by a doctor
• are taking the following medications for Hepatitis C treatment: ombitasvir, paritaprevir, and ritonavir with or without dasabuvir; glecaprevir, and pibrentasvir

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• Acne
• back pain
• breast tenderness
• can feel the device in place
• changes in usual menstrual period (flow, menstrual cramps)
• decreased interest in sexual activity
• diarrhea
• expulsion of device
• headache
• intolerance to contact lenses
• mood changes
• nausea
• problems during intercourse due to feeling the ring
• vaginal discharge
• vomiting
• weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal pain or swelling
• breast lumps
• discharge from the breasts
• growth of preexisting fibroid tumours of the uterus
• severe headache or worsening headache or migraine
• signs of a blood clot in the arm or leg (tenderness, pain, swelling, warmth, or redness in the arm or leg) or lungs (difficulty breathing, sharp chest pain that is worst when breathing in, coughing, coughing up blood, sweating, or passing out)
• signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
• signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
• swelling hands, legs or feet
• symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
• unusual or unexpected vaginal bleeding or spotting
• vaginal itching or unusual or increased vaginal discharge

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
• signs of a heart attack (e.g., chest pain or pressure, pain extending through shoulder and arm, nausea and vomiting, sweating)
• signs of stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: As with any hormonal contraceptives, there is a risk of developing blood clots. Tell your doctor if you have a history of blood clots or are at risk of developing blood clots. Inform your doctor if you are planning an upcoming surgery, as there is an increased risk of blood clot formation when using combination hormonal contraceptives. Stroke symptoms, such as confusion, difficulty speaking, loss of coordination, sudden headache or vision changes may occur as a result of a clot blocking blood flow to the brain. Symptoms of blood clots in other parts of the body include: sharp pain in the chest, pain in the calf, sudden shortness of breath, or coughing up blood. If you experience any of these symptoms, contact your doctor immediately, as blood clots can be life threatening.

Blood pressure: People with high blood pressure should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You may need to visit your doctor more frequently to have your blood pressure checked while using this medication.

Occasionally, high blood pressure may develop with the use of hormonal contraceptives. This may require stopping this medication.

Cigarette smoking and heart disease: Cigarette smoking increases the risk of serious heart disease and death. Hormonal contraceptives such as the ring also increase this risk, particularly as a woman gets older. Women over 35 years of age who are smokers should not use hormonal birth control. All women are urged not to smoke while taking this medication.

Other factors that increase your risk of heart disease include diabetes, high blood pressure, abnormal cholesterol levels, or a family history of these conditions. It is unclear whether taking the birth control pill increases this risk. Talk to your doctor if you have concerns.

Diabetes: This medication may cause an increase in blood sugar levels (may cause a loss of blood glucose control) and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.

If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Depression: Hormones, such as etonogestrel - ethinyl estradiol, have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication contact your doctor as soon as possible.

Eye disorders: Women who are using hormonal contraceptives such as this ring may experience fluid buildup in the cornea of the eye that can cause vision changes. This fluid buildup may also mean that your contact lenses may not fit as well as they used to, especially if you have hard contact lenses. Soft contact lenses usually do not cause problems. If your contact lenses feel uncomfortable, talk to your eye doctor.

Fibroid tumours: This medication may worsen fibroid tumours (noncancerous growths in the uterus), causing sudden enlargement, pain, or tenderness. If you notice these effects, contact your doctor.

Gallbladder disease: The use of hormonal contraceptives increases the risk of developing gallbladder disease. People with a history of gallbladder disease should discuss with their doctor how this medication may affect their medical condition and whether any special monitoring is needed. You will probably need to have regular tests to ensure that this medication is not making your condition worse.

Heart disease: Like other hormonal contraceptives, etonogestrel - ethinyl estradiol causes several effects in the body that can contribute to heart disease. If you have heart disease or are at risk of developing heart disease, discuss with your doctor how this medication may affect the medical condition, how the medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Contact your doctor as soon as possible if you develop symptoms of heart problems such as shortness of breath, chest pain, rapid heartbeat, or swollen ankles.

Liver cancer: Although extremely rare, the use of hormonal contraceptives has been associated with the growth of liver tumours. Talk to your doctor if you have any concerns.

Liver disease: Women who have or have had hepatitis, jaundice or other liver disease or who are at high risk for it should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You will probably need to have regular liver tests while you are using this medication.

Other medical conditions: Women with conditions affecting the vagina, such as prolapsed (dropped) uterus, may be more likely to have the ring slip out of the vagina. If the ring slips out repeatedly, consult your doctor.

People with high cholesterol, kidney disease, or epilepsy should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You will probably need to have regular blood tests to ensure that this medication is not making your condition worse.

People with heart disease, migraine headaches, or mental depression should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. You will probably need to have regular appointments with your doctor to ensure that this medication is not making your condition worse.

Return to fertility: There may be a delay in menstrual periods after stopping hormonal contraceptives. There is no evidence that the use of the contraceptive vaginal ring leads to decrease in fertility. After stopping use of the ring, you should delay pregnancy until at least one normal menstrual cycle has occurred in order to date the pregnancy. An alternative birth control method should be used during this time. If you do not menstruate for 6 months or more after stopping hormonal birth control, such as the ring, notify your doctor.

Risk of cancer: The use of hormonal contraceptives increases the risk of breast and cervical cancer in women before menopause (around age 50). If you have been using hormonal contraceptives for a long time (more than 8 years), started using them at an early age, or have a family history of cancer (mother or sister), you are at an increased risk of cancer, and should be examined by your doctor on a yearly basis.

If you are using hormonal birth control, you should learn how to do a breast self-exam. Notify your doctor any time you detect a lump. In a few women, the use of birth control pills may speed up the growth of a breast cancer that has not yet been diagnosed. A yearly clinical breast examination is also recommended because, if a breast cancer should develop, medications that contain estrogen may cause the cancer to grow quickly.

Seizures: Estrogens may increase the risk of seizures in people with seizure disorders. If you have a history of epilepsy or medical conditions that increase the risk of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Sexually transmitted infections (STIs): This medication, as with other combined hormonal contraceptives, does not protect against HIV/AIDS and other STIs (formerly known as sexually transmitted diseases or STDs). It is recommended that latex condoms be used in combination with this medication for protection against these infections.

Pregnancy: This medication should not be used during pregnancy. If you become pregnant while taking this medication, or think that you may be pregnant, contact your doctor as soon as possible.

Breast-feeding: This medication passes into breast milk. If you are a breast-feeding mother and are using the etonogestrel - ethinyl estradiol vaginal ring, it may affect the quality and amount of breast milk produced. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. This medication should not be used by females less than 18 years of age.

What other drugs could interact with this medication?

There may be an interaction between etonogestrel - ethinyl estradiol and any of the following:

• acetaminophen
• acetylsalicylic acid (ASA)
• anastrozole
• ampicillin
• antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
• apixaban
• aprepitant
• "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
• barbiturates (e.g., phenobarbital, butalbital)
• benzodiazepines (e.g., diazepam, lorazepam, oxazepam)
• beta-blockers (e.g., propranolol, metoprolol, atenolol)
• bosentan
• caffeine
• celecoxib
• chloral hydrate
• cholestyramine
• cladribine
• cobicistat
• colesevelam
• colestipol
• oral corticosteroids (e.g., dexamethasone, hydrocortisone, prednisone)
• cyclosporine
• dabigatran
• deferasirox
• dehydroepiandrosterone
• diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, linagliptin, lixisenatide, metformin, rosiglitazone)
• elagolix
• enzalutamide
• exemestane
• folic acid
• flibanserin
• heparin
• hepatitis C antiviral medications (e.g., glecaprevir, ledipasvir, pibrentasvir, sofosbuvir)
• lidocaine
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• lenalidomide
• lomitapide
• low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• melatonin
• mifepristone
• modafinil
• mycophenolate
• nitrofurantoin
• ospimifene
• penicillin
• pitolisant
• pomalidomide
• protein kinase inhibitors (e.g., dabrafenib, idelalisib, vemurafenib)
• rifabutin
• rifampin
• rivaroxaban
• roflumilast
• ropinirole
• St. John's wort
• seizure medications (e.g., carbamazepine, gabapentin, levetiracetam, phenytoin, rufinamide, topiramate)
• selegiline
• somatostatin-like medications (e.g., lanreotide, octreotide, pasireotide)
• sulfamethoxazole
• tacrolimus
• thalidomide
• theophyllines (e.g., aminophylline, theophylline)
• thyroid replacements (e.g., dessicated thyroid, levothyroxine)
• tizanidine
• tocilizumab
• tranexamic acid
• ulipristal
• ursodiol
• vitamin B12
• vitamin E
• warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2024. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Haloette