Quaterna: Uses, Side Effects and Dosage

Serious Warnings and Precautions

What is QUATERNA used for?

QUATERNA is used for the prevention of pregnancy in women (18 years of age and older). QUATERNA should be used in women who have had their first menstrual period (menarche).

How does QUATERNA work?

QUATERNA is a birth control pill. It is considered to be a combination oral contraceptive. This is because it contains two female sex hormones, levonorgestrel and ethinyl estradiol. It has been shown to be highly effective in preventing pregnancy when taken as prescribed by your healthcare professional.

Combination hormonal contraceptives like QUATERNA work in two ways:

1. 1. To stop the monthly release of an egg by the ovaries.
2. 2. To change the mucus produced by the cervix. This slows the movement of the sperm through the mucus and through the uterus (womb).

Effectiveness of Birth Control Pills

Combination birth control pills are more than 99 percent effective in preventing pregnancy when:

• the pill is TAKEN AS DIRECTED, and
• the amount of estrogen is 20 micrograms or more.

A 99 percent effectiveness rate means that if 100 women used birth control pills for one year, one woman in the group would get pregnant. The chance of becoming pregnant increases if QUATERNA is not used correctly.

Other Ways to Prevent Pregnancy

Other methods of birth control are available to you. They are usually less effective than birth control pills. When used properly, however, other methods of birth control are effective enough for many women.

The following table gives reported pregnancy rates for various forms of birth control, including no birth control. The reported rates represent the number of women out of 100 who would become pregnant in one year.

Reported Pregnancies per 100 Women per Year:

There are differences in these pregnancy rates. This is because not all people use birth control as carefully or as regularly as they should. This does not apply to subdermal implants or IUDs since these are implanted under the skin or in the uterus. If you are careful and use your birth control regularly, pregnancy rates should be lower. Some types of birth control will require more effort than taking a single pill every day.

What are the ingredients in QUATERNA?

Medicinal ingredients:

Bluish-green tablets: levonorgestrel and ethinyl estradiol

Yellow tablets: ethinyl estradiol

Non-medicinal ingredients:

Bluish-green tablets: D&C Yellow No. 10, FD&C Blue No. 1 aluminum lake, FD&C Yellow No. 6, lactose monohydrate, magnesium stearate, and polacrilin potassium.

Yellow tablets: anhydrous and monohydrate lactose, D&C Yellow No. 10 aluminum, dl-α-tocopherol, FD&C Yellow No. 6/Sunset yellow FCF aluminum lake, isopropyl alcohol (in traces), magnesium stearate, microcrystalline cellulose, polacrilin potassium, and povidone.

QUATERNA comes in the following dosage forms:

QUATERNA tablets are available in Extended-Cycle Tablet Blister Cards. Altogether, the Extended-Cycle Tablet Blister Card holds 91 tablets consisting of 84 bluish-green tablets (each containing 0.15 mg of levonorgestrel and 0.03 mg ethinyl estradiol) and 7 yellow tablets (each containing 0.01 mg ethinyl estradiol).

Do not use QUATERNA if:

• you have or have a history of blood clots in the legs or somewhere else in your body
• you have a history of a stroke, heart attack, or coronary artery disease (including angina pectoris), or a condition that may be a first sign of a stroke (such as a ministroke or small reversible stroke)
• you have a disease of the heart valves with complications

• you have the following risk factors for blood clots:

  • severe high blood pressure
  • diabetes with complications

  • known abnormalities of the blood clotting system such as:

    • Factor V Leiden mutation
    • activated protein C (APC) resistance
    • antithrombin-III-deficiency
    • protein C deficiency
    • protein S deficiency
    • hyperhomocysteinaemia
    • prothrombin mutation G20210A
    • antiphospholipid-antibodies
  • very high blood cholesterol or triglyceride levels
  • you have or will have a major surgery (including to the legs, pelvis or nervous system)
  • you cannot stand or move for long periods of time, including prolonged bed rest
  • smoke heavily (more than 15 cigarettes per day) and are over age 35
• known abnormalities of the blood clotting system that increases your risk for developing blood clots
• you have or have a history of migraine headaches with focal aura (flashes or light, blind spots and other vision changes)
• you have liver disease
• you have or have had liver tumours (cancerous or non-cancerous)
• you have or have had jaundice. This is where the skin or whites of the eyes turn yellow. This may have been related to other medicines you were taking or may have happened during pregnancy.
• you have or think you have cancer of the breast or uterus (womb) or other estrogen-dependent cancer
• you have unusual vaginal bleeding without a known reason
• you have loss of vision due to blood vessel disease of the eye
• you are pregnant or think you might be pregnant
• you have or have a history of pancreatitis (inflammation of the pancreas) associated with high levels of fatty substances in your blood
• you are allergic to ethinyl estradiol, levonorgestrel or to any of the non-medicinal ingredients in QUATERNA (see What are the ingredients in QUATERNA?)
• you are using antiviral medications to treat Hepatitis C Virus (HCV) which contain the combination of glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir

To help avoid side effects and ensure proper use, talk to your healthcare professional before you take QUATERNA. Talk about any health conditions or problems you may have, including if you:

• smoke
• have a history of breast disease (such as breast lumps) or a family history of breast cancer
• have high blood pressure
• have high cholesterol
• have or have a family history of diabetes
• have or have a history of heart, liver or kidney problems
• have a history of seizures/epilepsy
• have a history of depression
• have cholestasis. This is a condition where bile flow from the liver is decreased.
• wear contact lenses
• have uterine fibroids (benign tumours of the uterus)
• are breast feeding
• have systemic lupus erythematosus. This is a disease of the immune system that affects the joints, skin, kidneys, blood cells, brain, heart and lungs.
• have inflammatory bowel disease such as Crohn’s disease or ulcerative colitis
• have hemolytic uremic syndrome. This is when there is an abnormal breakdown of blood cells, which clogs the kidneys.
• have sickle cell disease. This is a disease that affects haemoglobin, a molecule in red blood cells that delivers oxygen throughout the body.
• have any problems with the valves in your heart and/or have an irregular heart rhythm
• have been told that you have a condition called hereditary or acquired angioedema or if you have had episodes of swelling in body parts such as hands, feet, face, or airway passages
• have a history of a skin condition called chloasma (hyperpigmentation)
• are overweight
• have a family history of blood clot disorders, heart attacks or strokes

Other warnings you should know about:

Blood Clot in Legs, Lungs, Heart, Eyes or Brain

Women who use birth control that contains hormones are more likely to develop blood clots. Blood clots are the most common serious side effects of birth control pills. The risk for clots is highest during the first year a woman uses a hormonal birth control. The risk is also high if a woman restarts the same or new hormonal birth control. Clots can occur in many areas of the body and can lead to blindness or impaired vision as well as damage to or loss of a limb and death.

While you are taking QUATERNA, if you have any of the below symptoms, talk to your healthcare professional right away. These are signs of blood clots.

• sharp pain in your chest
• coughing up blood
• sudden shortness of breath
• crushing chest pain or chest heaviness
• irregular heartbeat
• sudden severe or worsening headache
• feeling full
• vomiting
• dizziness, trouble walking
• fainting, seizures
• anxiety, confusion
• changes in vision
• changes in speech
• pain and / or swelling in your calf
• weakness or numbness in your face, arm or leg
• sudden pain, swelling and slight blue or red discoloration of an arm or leg
• discomfort radiating to your back, jaw, throat or stomach

Blood clots can develop whether or not you are using hormones for birth control. They can also happen if you are pregnant. The risk is higher in users of combined hormonal contraceptives (CHCs), including QUATERNA than in nonusers, but it is not as high as the risk during pregnancy. You should talk to your healthcare professional about the available options.

Cancer

Using birth control pills may increase the risk of certain cancers including cancer of the breast, cervix and liver.

Breast cancer: The risk of breast cancer in women increases as you get older. It also increases if there is family history of breast cancer, meaning if your mother or sister have or had breast cancer. Other factors that increase your risk for breast cancer are being obese, never having children, or having your first full-term pregnancy at a late age.

If you have breast cancer now, or had it in the past, do not use birth control pills. The hormones in these pills can affect some cancers.

Some women who use birth control pills may have a higher risk of developing breast cancer before menopause. These women may have used birth control pills for a long time (more than eight years), or may have started using birth control pills at an early age.

In a few women, using of birth control pills can speed up the growth of a breast cancer that has not yet been found. Finding breast cancer early can reduce the effect of the cancer on a woman’s life expectancy. The risks for breast cancer related to using birth control pills seem to be small. You should, however, have a healthcare professional check your breasts at least once per year.

While you are taking QUATERNA, check your breasts often. See your healthcare professional if you notice any changes, such as:

• dimpling or sinking of the skin
• changes in the nipple
• any lumps you can see or feel

Cervical cancer: Human Papilloma Virus (HPV) is an important risk factor for cervical cancer. However, it is possible that women who use birth control pills may have a higher chance of getting cervical cancer.

Liver cancer: Liver cancer (hepatocellular carcinoma) and liver tumors may be linked to oral birth control pills. The risk for liver cancer increases the longer these pills are used. However, liver tumors are extremely rare. If you feel severe abdominal pain or find a lump in your abdomen, talk to your healthcare professional right away. Do not use QUATERNA if you have a history of liver tumors (cancerous or noncancerous).

Gallbladder disease

The risk for gallbladder disease that needs surgery is higher in women using birth control pills. The risk is highest in the first year of use and increases the longer these pills are used.

Pregnancy, Breastfeeding, Miscarriage and Abortions

Use in pregnancy: Birth control pills should not be taken by pregnant women. Stop taking QUATERNA if you get pregnant. You should talk to your healthcare professional about risks to your unborn child from any medication take during pregnancy.

Use after pregnancy, miscarriage or an abortion: You will be at an increased risk for blood clots. Your healthcare professional will tell you when to start using QUATERNA after childbirth, miscarriage or an abortion.

Pregnancy after stopping QUATERNA: You will have a menstrual period when you stop using QUATERNA. Wait until after your next period before getting pregnant. This will help to better date the pregnancy. Talk to your healthcare professional about other forms of birth control you can use during this time.

Breast-feeding: If you are breast-feeding, talk to your healthcare professional before starting the birth control pill. Other types of birth control, instead of a birth control pill, are recommended until your baby has stopped breast-feeding. The hormones in the pill may lower the amount and quality of your breast milk. This may not happen, however, if you wait until after breast-feeding is established.

Skin conditions

Chloasma may develop while you are using QUATERNA. This appears as yellowish-brown patches on the skin, particularly of the face. It is more likely to happen if you have previously had chloasma gravidarum. This is when these patches appear on the skin of the face during pregnancy. This is commonly known as “the mask of pregnancy”. If you have or had chloasma, avoid too much exposure to the sun while using QUATERNA.

Surgery

Tell your healthcare professional if you are scheduled for major surgery. You may need to stop using QUATERNA four weeks before surgery. You may need to wait a time period after surgery or bedrest before restarting QUATERNA. Talk to your healthcare professional about other forms of birth control you can use during this time.

Vaginal bleeding

You should expect to have more bleeding or spotting between your menstrual periods than if you were taking an oral contraceptive with a 28-day treatment cycle. During the first QUATERNA treatment you may have 20 or more days of unplanned bleeding or spotting (bleeding when you are taking the pink pills). This bleeding or spotting tends to decrease during late cycles. Do not stop taking QUATERNA because of the bleeding. If the spotting continues for more than a few days or if the bleeding is heavy, talk to your healthcare professional.

While you are taking QUATERNA you should have your period when you are taking the yellow pills. If you were not taking QUATERNA as directed by your healthcare professional or miss your period, you should have a pregnancy test. This will rule out if the missed period is because you are pregnant.

Check-Ups and Tests

Before starting QUATERNA, you will need to have examinations and tests. Your healthcare professional will conduct a physical exam. They will examine your breasts, liver, arms and legs. They will conduct a pelvic exam which includes a PAP smear. Your healthcare professional will also ask you some questions about your personal health history and that of your close relatives. They will also measure your blood pressure and do blood tests.

While you are taking QUATERNA, you will need regular check-ups with your healthcare professional to identify side effects associated with its use. Your first check-up should be about three months after starting QUATERNA. Afterward, you will see your healthcare professional at least once a year.

If you are scheduled for any laboratory tests, be sure to tell your healthcare professional that you are taking QUATERNA. This is because birth control pills can affect some blood tests.

If you see a different healthcare professional be sure to tell them that you are taking QUATERNA.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Certain drugs may interact with birth-control pills (including QUATERNA) and prevent them from working properly. This can make them less effective in preventing pregnancy or cause unexpected bleeding (spotting or breakthrough bleeding). Birth control pills may also interfere with how other drugs work. If you are taking medicines or herbal products that might make QUATERNA less effective, a barrier method of birth control should also be used.

The following may interact with QUATERNA:

• drugs used for the treatment of epilepsy including, primidone, phenytoin, barbiturates, carbamazepine, lamotrigine, oxcarbazepine, topiramate, felbamate, ethosuximide and phenobarbital
• drug used for the treatment of tuberculosis including rifampin and rifabutin
• drugs used for the treatment of HIV infection including ritonavir and nevirapine
• drugs used to treat bacterial infections including, penicillins, tetracyclines, cotrimoxazole, ampicillin, rifabutin, rifampin, chloramphenicol, metronidazole, neomycin, nitrofurantoin, sulfonamides, troleandomycin
• drugs used to prevent organ rejection including cyclosporine
• drugs used to treat fungal infections including griseofulvin
• St. John’s Wort, an herbal product used to treat depression and other conditions
• drugs used to lower cholesterol including clofibrate
• drugs used to treat high blood pressure including guanethidine, beta blockers, reserpine and methyldopa
• antidiabetic drugs and insulin (for diabetes)
• drugs used to help you relax and sleep including benzodiazepines, barbiturates, chloral hydrate, glutethimide, meprobamate, chlordiazepoxide, lorazepam, oxazepam, and diazepam
• drugs used to treat fever, pain or inflammation including meperidine, prednisone, phenylbutazone, acetaminophen, antipyrine and ASA
• drugs used to treat depression including clomipramine
• some nutritional supplements including Vitamin E, Vitamin B12 and folic acid
• antacids
• hepatitis C drug combinations containing, glecaprevir/pibrentasvir and sofosbuvir/velpatasvir/voxilaprevir
• alpha-II adrenoreceptor agents including clonidine
• aminocaproic acid, used to help treat bleeding
• drugs used to treat lung problems including theophylline
• drugs used to allergies including antihistamines
• drugs used to treat migraine headaches
• drugs used to prevent blood clots
• drugs used to mental health problems including phenothiazines

This is not a complete list of possible drug interactions with QUATERNA. Talk to your healthcare professional for more information about drug interactions.

Antacids may affect how QUATERNA is absorbed in your body. If you need to use antacids, like TUMS, take them 2 hours before or 2 hours after taking QUATERNA.

The effects of caffeine and alcohol may be increased. This is because birth control pills affect how these are metabolized.

Do not use QUATERNA if you have Hepatitis C and are being treated with glecaprevir / pibrentasvir or sofosbuvir / velpatasvir / voxilaprevir. Using these drugs at the same time as QUATERNA can cause problems with your liver, such as an increase in the ALT liver enzyme. You can usually start QUATERNA about 2 weeks after finishing treatment with these combination drugs used for Hepatitis C, but talk to your healthcare professional before taking QUATERNA.

How to take QUATERNA:

1. 1.

   BE SURE TO READ THESE DIRECTIONS:

   1. • Before you start taking your pills.
   2. • Anytime you are not sure what to do.
2. 2. Decide with your healthcare professional what time of day is best for you to start taking your first pill. It is important that you take the pill at about the same time each day. Pick a time of day that will be easy to remember.
3. 3.

   Look at your Extended-Cycle Tablet Blister Card. The QUATERNA Extended-Cycle Tablet Blister Card has 3 trays with cards that hold 91 individual pills. The 91 pills consist of 84 bluish-green pills that contain 2 hormones and 7 yellow pills that contain 1 hormone. Tray 1 and Tray 2 each contain 28 bluish-green pills. Tray 3 contains 28 bluish-green pills and 7 yellow pills (35 pills in total). Check the pill pack for:

   1. • where to start taking pills
   2. • in what order to take the pills
4. 4. Your healthcare professional will tell you to start taking the pills on the first Sunday after your period begins. If your period starts on a Sunday, start the same day.
5. 5. Take 1 pill at approximately the same time every day for 91 days. Begin a new Extended-Cycle Tablet Blister Card the next day, NOT MISSING ANY DAYS. Your period should occur during the last seven days of using the pill pack, while you are taking the yellow pills. You should expect to have 4 menstrual periods a year.
6. 6.

   Taking QUATERNA:

   1. • Take QUATERNA exactly as directed by your healthcare professional.
   2. • Take your pill at approximately the same time every day. Try to associate taking your pill with a regular activity like eating a meal or going to bed. This will help you remember to take it.
   3. • Start taking QUATERNA the first Sunday after your period starts. If your period starts on Sunday, start that same day.
   4. •

      Take QUATERNA according to this schedule:

      • Take 1 bluish-green pill each day for 84 days in a row. You should always begin a pack by starting with the bluish-green colored pills. You should always take the bluish-green colored pills first.
      • Then, take 1 yellow pill for 7 days in a row.
      • Start the next pack on the day after your last yellow pill. Do not wait any days between packs.
   5. • Be sure to take all the pills in each pack.
   6. • Do not skip any of the pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach.
   7. • Do not skip pills even if you do not have sex very often.
   8. • Use another barrier method of birth control (such as a condom) for the first 7 days of your first cycle of QUATERNA.

QUATERNA may not work as well as it should to prevent pregnancy if you:

• miss pills
• don’t take your pills as directed by your healthcare professional
• have gastrointestinal problems such as vomiting or diarrhea
• are taking certain medicines

If this happens, you should use another method of birth control, like condoms (barrier method). Do this while taking QUATERNA and until you start a new pack of QUATERNA. Talk to your healthcare professional if you are not sure.

You might notice bleeding or spotting during the first few months of taking QUATERNA. Do not stop taking your pills even if you have irregular bleeding. If the bleeding lasts for more than a few days, talk to your healthcare professional.

If you do not get your period when you are taking the yellow pills, talk to your healthcare professional. You might be pregnant.

If you vomit within 4 hours after taking a bluish-green pill, take a new pill as soon as possible. A new pill should be taken within 24 hours of the usual dose time. Take the next pill at the usual dose time. If it has been more than 24 hours since the last pill was taken, see “Missed Dose” below for more instructions.

Switching to QUATERNA from a different type of birth control:

• For any switch, always use a second barrier method of birth control (such as condoms) for the first 7 days of taking QUATERNA.
• If you are switching from another combined oral birth control pill, talk to your healthcare professional about when to start taking QUATERNA.
• If you are switching from minipill (progestogen only) birth control, start taking QUATERNA on the next day.
• If you are switching from a type of birth control that is implanted, start taking QUATERNA on the day the implant is taken out.
• If you switch from a type of birth control that is injected into your body, start taking QUATERNA on the day the next injection would happen.

Usual dose:

Take 1 bluish-green pill a day. When all 84 bluish-green pills are done, take 1 yellow pill a day for 7 days.

Overdose:

Symptoms of overdose may include:

• nausea
• vomiting
• breast tenderness
• dizziness
• abdominal pain
• drowsiness, fatigue
• vaginal bleeding.

Missed Dose:

If you miss bluish-green coloured pills, you could get pregnant. The more bluish-green pills you miss, the more likely you are to get pregnant. If you miss one or more bluish-green coloured pills and do not have a period that month, you may be pregnant. If this happens, talk to your healthcare professional.

Missing pills can cause spotting or light bleeding, even when you make up these missed pills.

If you forget more than one pill two months in a row, talk to your healthcare professional about ways to make pill-taking easier or about using another method of birth control.

Always be sure to have on hand a back-up method of birth control. These are types that do not include hormones, like latex or polyurethane condoms and spermicidal foam or gel. You will need back-up birth control if you miss pills and in some other situations. Always talk to your healthcare professional if you are not sure whether you need to use back-up birth control.

If you MISS 1 bluish-green pill:

1. 1. Take the missed pill as soon as possible and take the next pill at the usual time. This means you take 2 pills in 1 day. On the days you take 2 pills to make up for the missed pill, you could feel a little sick to your stomach.
2. 2. Keep taking 1 pill a day until the pack is finished.

If you MISS 2 bluish-green pills in a row:

1. 1. Take 2 pills on the day you remember and 2 pills the next day.
2. 2. Then take 1 pill a day until you finish the pack.
3. 3. Use a back-up barrier method of birth control (such as condoms or spermicide) if you have sex in the 7 days after you miss the pills.

If you MISS 3 OR MORE bluish-green pills in a row:

1. 1. Do not remove the missed pills from the pack as they will not be taken. Keep taking 1 pill every day as indicated on the pack until you have completed all of the pills in the pack. For example: if you resume taking the pill on Thursday, take the pill under “Thursday” and do not take the previous missed pills. You may experience bleeding during the week following the missed pills.
2. 2. Use a back-up barrier method of birth control (such as condoms or spermicide) if you have sex in the 7 days after you miss the pills. If you miss your period when you are taking the yellow pills, you might be pregnant. Talk to your healthcare professional right away.

If you MISS ANY of the 7 yellow pills:

1. 1. Safely dispose of the pills you have missed.
2. 2. Keep taking 1 pill each day until the pack is empty.
3. 3. You do not need a back-up method of birth control.

If you are not sure about the number or the colour of pills missed:

Talk to your healthcare professional right away.

What are possible side effects from using QUATERNA?

These are not all the possible side effects you may have when taking QUATERNA. If you experience any side effects not listed here, tell your healthcare professional.

The following side effects may occur:

• bleeding or spotting between periods
• nausea, vomiting, feeling sick to the stomach
• diarrhea, flatulence, constipation
• abdominal pain, cramps or bloating
• migraine or severe headache
• changes in weight, changes in appetite
• breast tenderness
• hot flushes
• dizziness
• insomnia
• changes in libido
• flu-like symptoms (fever, cough, sore throat, runny nose, feeling tired)
• back and pelvic pain
• muscle cramps
• acne
• rash
• urinary tract infections or inflammation
• vaginal infection
• upper respiratory tract infections (colds, bronchitis, runny or stuffy nose, sore throat)
• darkening of the skin, particularly the face
• amenorrhea (lack of period or breakthrough bleeding)
• difficulty wearing contact lenses
• loss of scalp hair

Some of these side effects, especially bleeding or spotting, nausea, vomiting, and feeling sick to the stomach may subside within the first 3 months of use. If the problem doesn’t go away, talk to your healthcare professional.

Serious side effects and what to do about them

Serious side effects and what to do about them

Serious side effects and what to do about them

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Store at room temperature (15°C to 30°C).

Keep out of reach and sight of children and pets.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If you want more information about QUATERNA:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.mylan.ca or by calling 1-844-596-9526.

Last Revised SEP 19, 2024