Gianvi (Oral)

Drospirenone and ethinyl estradiol combination is used to prevent pregnancy. It is a birth control pill that contains two hormones, ethinyl estradiol and drospirenone, and when taken correctly, it prevents pregnancy. It works by stopping a woman's egg from fully developing each month. This means the egg cannot accept sperm, and fertilization (pregnancy) is prevented.

This medicine is also used to treat premenstrual dysphoric disorder (PMDD) and acne in women who are at least 14 years old. PMDD is a severe form of premenstrual syndrome (PMS). Women with PMDD may experience serious emotional and physical symptoms 10 to 14 days before their menstrual period begins.

No contraceptive method is 100 percent effective. Other birth control methods, like surgical sterilization or abstaining from sex, are more effective than birth control pills. Talk to your doctor about your birth control options.

This medicine does not protect against AIDS or other sexually transmitted diseases. It will not work as emergency contraception after unprotected sex.

This medicine is available only with a doctor's prescription.

It is very important for your doctor to check your progress at regular visits to ensure this medicine is working properly and does not cause unwanted effects. These visits will usually be every 6 to 12 months, but some doctors may require them more often. Your doctor may also want to check your blood pressure while you are taking this medicine.

Even though you are using this medicine to prevent pregnancy, you should know that using this medicine while you are pregnant could harm the unborn baby. If you think you might be pregnant while using this medicine, tell your doctor right away. Make sure your doctor knows if you have had a baby within 4 weeks before you start using this medicine.

Do not use this medicine with medicine to treat hepatitis C virus infection, including ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Technivie®, Viekira Pak®).

Vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when it is slight, or breakthrough bleeding when it is heavier.

• If this occurs, continue with your regular dosing schedule.
• The bleeding usually stops within 1 week. Check with your doctor if the bleeding continues for more than 1 week.
• If the bleeding continues after you have been taking hormonal contraceptives as directed and for more than 3 months, check with your doctor.

Check with your doctor right away if you miss a menstrual period. Missed periods may happen if you skip one or more tablets and have not taken your pills exactly as directed. If you miss two periods in a row, talk to your doctor. You might need a pregnancy test.

If you think you may be pregnant, check with your doctor immediately.

Do not use this medicine if you smoke cigarettes or if you are over 35 years of age. If you smoke while using birth control pills containing drospirenone, you increase your risk of having a blood clot, heart attack, or stroke. Your risk is even higher if you are over age 35, if you have diabetes, high blood pressure, high cholesterol, or if you are overweight. Talk with your doctor about ways to stop smoking. Keep your diabetes under control. Ask your doctor about diet and exercise to control your weight and blood cholesterol level.

Using this medicine may increase your risk of having blood clotting problems, especially in the first 6 months of use. This risk may be higher if you are using a birth control pill containing drospirenone and ethinyl estradiol. Check with your doctor right away if you have pain in the chest, groin, or legs, especially the calves, difficulty breathing, a sudden, severe headache, slurred speech, sudden unexplained trouble breathing, sudden loss of coordination, or vision changes while using this medicine.

Check with your doctor immediately if you wear contact lenses or if you have blurred vision, difficulty reading, or any other change in vision during or after treatment. Your doctor may want an eye doctor to check your eyes.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Check with your doctor before refilling an old prescription, especially after a pregnancy. You will need another physical examination, and your doctor may change your prescription.

Make sure any doctor or dentist who treats you knows that you are using this medicine. The results of some medical tests may be affected by this medicine. You may also need to stop using this medicine at least 4 weeks before and 2 weeks after having major surgery.

This medicine may cause skin discoloration. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

In deciding to use this medicine, you need to think about the risks versus the benefits. This is a choice you will make with your doctor. Consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare provider know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For over-the-counter products, read the label or package ingredients carefully.

Pediatric

Research on the effects of drospirenone and ethinyl estradiol combination in children has not been done. However, there are no expected specific problems that would limit the use of this medicine in teenagers. This medicine may be used for birth control in teenage females but should not be used before menstruation starts.

Geriatric

Research on the effects of drospirenone and ethinyl estradiol combination in older adults has not been done. This medicine is not meant for use in elderly women.

Breast Feeding

Studies indicate that this medicine poses minimal risk to infants when used during breastfeeding.

However, it may change milk production or composition. If no alternative is prescribed, monitor the infant for side effects and ensure adequate milk intake.

Interactions with Medicines

Some medicines should not be used together at all, while others can be used together even if an interaction might happen. In such cases, your doctor may adjust the dose or take other precautions. It is very important for your healthcare provider to know if you are taking any of the following medicines when you are on this medicine. The following interactions are selected based on their potential importance and may not include all possible interactions.

Using this medicine with any of the following is not recommended. Your doctor may decide not to prescribe this medicine or change your other medicines.

• Atazanavir
• Boceprevir
• Cobicistat
• Dasabuvir
• Ombitasvir
• Paritaprevir
• Ritonavir
• Tranexamic Acid

Using this medicine with any of the following is usually not recommended, but may be necessary in some cases. If both are prescribed together, your doctor may adjust the dose or how often you take one or both.

• Amifampridine
• Amobarbital
• Amoxicillin
• Ampicillin
• Amprenavir
• Anagrelide
• Apalutamide
• Aprepitant
• Armodafinil
• Artemether
• Bacampicillin
• Belzutifan
• Betamethasone
• Bexarotene
• Boceprevir
• Bosentan
• Bupropion
• Butabarbital
• Butalbital
• Carbamazepine
• Carbenicillin
• Cefaclor
• Cefadroxil
• Cefdinir
• Cefditoren
• Cefixime
• Cefpodoxime
• Cefprozil
• Ceftazidime
• Ceftibuten
• Cefuroxime
• Cenobamate
• Ceritinib
• Clobazam
• Cloxacillin
• Cobicistat
• Colesevelam
• Cyclacillin
• Cyclosporine
• Dabrafenib
• Darunavir
• Dexamethasone
• Dicloxacillin
• Dipyrone
• Donepezil
• Doxycycline
• Efavirenz
• Elagolix
• Elvitegravir
• Encorafenib
• Enzalutamide
• Eslicarbazepine Acetate
• Etravirine
• Felbamate
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Fostemsavir
• Glecaprevir
• Grazoprevir
• Griseofulvin
• Guar Gum
• Indinavir
• Iron
• Isotretinoin
• Ivosidenib
• Lesinurad
• Lixisenatide
• Lopinavir
• Lorlatinib
• Lumacaftor
• Mavacamten
• Mephobarbital
• Meropenem
• Methohexital
• Minocycline
• Mitapivat
• Mitotane
• Mobocertinib
• Modafinil
• Mycophenolate Mofetil
• Mycophenolic Acid
• Nafcillin
• Nelfinavir
• Nevirapine
• Nirmatrelvir
• Octreotide
• Oxacillin
• Oxcarbazepine
• Oxytetracycline
• Paclitaxel
• Paclitaxel Protein-Bound
• Paritaprevir
• Penicillin G
• Penicillin G Procaine
• Penicillin V
• Pentobarbital
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Pibrentasvir
• Piperaquine
• Pitolisant
• Prednisolone
• Prednisone
• Primidone
• Red Clover
• Rifabutin
• Rifampin
• Rifapentine
• Rilpivirine
• Ritonavir
• Rufinamide
• Saquinavir
• Secobarbital
• Simeprevir
• Somatrogon-ghla
• St John's Wort
• Sugammadex
• Sultamicillin
• Tazemetostat
• Telaprevir
• Telotristat Ethyl
• Tetracycline
• Theophylline
• Thiopental
• Thioridazine
• Ticarcillin
• Tigecycline
• Tipranavir
• Tirzepatide
• Tizanidine
• Topiramate
• Troglitazone
• Ulipristal
• Valproic Acid
• Voxilaprevir

Using this medicine with any of the following may increase the risk of certain side effects, but using both may be the best treatment for you. If both are prescribed together, your doctor may adjust the dose or how often you take one or both.

• Amitriptyline
• Atazanavir
• Atorvastatin
• Clomipramine
• Diazepam
• Doxepin
• Etoricoxib
• Ginseng
• Imipramine
• Lamotrigine
• Levothyroxine
• Licorice
• Liothyronine
• Lorazepam
• Parecoxib
• Roflumilast
• Selegiline
• Temazepam
• Tipranavir
• Triazolam
• Troleandomycin
• Valdecoxib
• Voriconazole
• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods or with specific types of food due to potential interactions. Using alcohol or tobacco with certain medicines may also cause interactions. The following interactions are selected based on their potential importance and may not include all possible interactions.

Using this medicine with any of the following may increase the risk of certain side effects, but this may be unavoidable in some situations. If used together, your doctor may adjust the dose or give special instructions about the use of food, alcohol, or tobacco.

• Caffeine

Other Medical Problems

Other medical issues may affect how this medicine works. Make sure to inform your doctor if you have any other medical conditions, especially:

• Abnormal or unusual vaginal bleeding or
• Blood clots (e.g., deep vein thrombosis, pulmonary embolism), or history of or
• Adrenal gland problems or
• Blood disorders (e.g., hypercoagulopathy) or
• Breast cancer, active or history of or
• Diabetes with kidney, eye, nerve, or blood vessel damage or
• Heart attack, history of or
• Heart or blood vessel disease (e.g., coronary artery disease, heart valve problems), or history of or
• Heart rhythm problems (atrial fibrillation) or
• Uncontrolled hypertension (high blood pressure) or
• Kidney disease or
• Liver disease, including tumors or cancer or
• New or worsening migraine headaches or a new type of headache or
• Problems with circulation or blood clots, current or past or
• History of stroke—Should not be used in patients with these conditions.

• Inherited angioedema (swelling of the face, tongue, or throat) or
• Cervical cancer or intraepithelial neoplasia or
• History of chloasma gravidarum (skin disorder during pregnancy) or
• History of cholestasis (bile problem) during pregnancy or
• History of depression or
• Diabetes or
• Uncontrolled dyslipidemia (high cholesterol or fats in the blood) or
• Gallbladder disease or
• Hyperkalemia (high potassium in the blood) or
• Controlled hypertension (high blood pressure)—Use with caution. May worsen these conditions.

Along with its beneficial effects, this medicine may also cause some unwanted effects. Not all of these side effects may occur, but if they do, you may need to seek medical help.

Contact your doctor right away if you experience any of the following side effects:

More common

• Breast pain or tenderness
• Severe and throbbing headache
• Heavy non-menstrual vaginal bleeding
• Irregular menstrual periods
• Nausea
• Normal menstrual bleeding happening earlier, possibly lasting longer than expected

Less common

• Longer or heavier menstrual periods
• Unusual tiredness or weakness
• Vomiting

Incidence not known

• Chills
• Clay-colored stools
• Dark urine
• Difficulty breathing
• Dizziness
• Fever
• Headache
• Itching
• Loss of appetite
• Pain in the chest, groin, or legs, especially the calves
• Rash
• Slurred speech
• Stomach pain
• Sudden loss of coordination
• Sudden, severe weakness or numbness in the arm or leg
• Unpleasant breath odor
• Unusual tiredness or weakness
• Changes in vision
• Vomiting blood
• Yellowing of the eyes or skin

Some side effects may occur that usually do not require medical attention. These side effects may go away as your body adjusts to the medicine. Your healthcare professional may also provide ways to prevent or lessen some of these side effects. Consult your healthcare professional if any of the following side effects persist, become bothersome, or if you have any questions about them:

Less common

• Crying
• Decreased interest in sexual intercourse
• Delusions of persecution, mistrust, suspiciousness, or combativeness
• False or unusual sense of well-being
• Inability to have or maintain an erection
• Irritability
• Decrease in sexual ability, desire, drive, or performance
• Mental depression
• Quick emotional reactions or overreactions
• Rapidly changing moods
• Weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Gianvi
• Loryna
• Nikki
• Ocella
• Syeda
• Vestura
• Yasmin
• YAZ
• Yaz 28
• Zarah

Available Dosage Forms:

• Tablet

Therapeutic Class: Monophasic Contraceptive Combination

Pharmacologic Class: Progestin

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To make using oral contraceptives as safe and reliable as possible, you should understand how and when to take them and what effects may be expected.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

This medicine is available in blister packs. Each blister pack contains 28 tablets with different colors that need to be taken in the same order as directed on the blister pack.

When you begin using this medicine, your body will require at least 7 days to adjust before a pregnancy will be prevented. Use a second form of contraception (eg, condom, spermicide, or diaphragm) for the first 7 days of your first cycle of pills.

Take this medicine at the same time each day, after the evening meal or at bedtime. You may take this medicine with or without food.

Do not skip or delay taking your pill by more than 24 hours. If you miss a dose, you could get pregnant. Ask your doctor for ways to help you remember to take your pills or about using another method of birth control.

You may have light bleeding or spotting when you first take the pill.

You may feel sick or nauseous, especially during the first few months that you take this medicine. If your nausea is continuous and does not go away, call your doctor.

If you vomit or have diarrhea within 3 to 4 hours of taking this medicine, treat this as a missed dose and follow the instructions in the patient leaflet or call your doctor.

If you are switching from a combination hormonal method (eg, another pill, patch, vaginal ring) to using Yasmin® or Yaz®, take the medicine on the day you would have usually taken your next pill If you do not start your period, see your doctor for a pregnancy test. If you have used a vaginal ring or patch, take the pill on the day the ring or patch is removed. You must also use a second method of birth control (eg, condom, diaphragm, spermicide) for the first 7 days you take this medicine.

If you are switching from a progestin-only method (eg, progestin-only pill, implant, injection, intrauterine system) to using Yasmin® or Yaz®, take the medicine on the day you would have taken your next progestin-only pill, or on the day your implant or IUD is removed, or on the day you would have your next injection. You must also use a second method of birth control (eg, condom, diaphragm, spermicide) for the first 7 days you take this medicine.

If you have a miscarriage or abortion after the second trimester or if you gave birth and chose not to breastfeed, you may start using this medicine after 4 weeks to prevent the risk of having blood clots.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of this medicine that is absorbed in the body.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Your doctor may ask you to begin your dose on the first day of your menstrual period (called Day 1 start) or on the first Sunday after your menstrual period starts (called Sunday start). When you begin on a certain day it is important that you follow that schedule, even if you miss a dose. Do not change your schedule on your own. If the schedule that you use is not convenient, check with your doctor about changing it. For a Sunday start, you need to use another form of birth control (eg, condom, diaphragm, spermicide) for the first 7 days.

You should begin your next and all subsequent 28-day regimens of therapy on the same day of the week as the first regimen began and follow the same schedule.

• For oral dosage form (tablets):For contraception (to prevent pregnancy), PMDD, or acne:Adults and teenagers— Yasmin®: One yellow tablet (active) taken at the same time each day for 21 consecutive days followed by one white (inert) tablet daily for 7 days per menstrual cycle. Yaz®: One pink tablet (active) taken at the same time each day for 24 consecutive days followed by one white (inert) tablet daily for 4 days per menstrual cycle. Children—Use and dose must be determined by your doctor.

Missed Dose

Call your doctor or pharmacist for instructions.

This medicine has specific patient instructions on what to do if you miss a dose. Read and follow these instructions carefully and call your doctor if you have any questions.

• Yasmin®: If you miss one yellow pill: Take the pill as soon as possible and take the next pill at your regular schedule. f you miss two yellow pills in week 1 or 2: Take the two pills as soon as possible and the next two pills the next day. Continue taking one pill a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose. If you miss two yellow pills in week 3 or 4, or if you miss three or more yellow pills in a row in any week: Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one pill a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. If you miss your menstrual period 2 months in a row, check with your doctor because you might be pregnant. If you miss any of the seven white pills in week 4: Throw away the pills you missed. Continue taking one pill a day until you finish the pack.
• Yaz®: If you miss one light pink tablet: Take the tablet as soon as possible and take the next tablet at your regular schedule. This means that you may take 2 pills in 1 day. Continue taking one tablet a day until you finish the pack. You do not need to use another form of birth control if you have sex. If you miss two light pink tablets in Week 1 or 2: Take the two tablets as soon as possible and the next two tablets the next day. Continue taking one tablet a day until you finish the pack. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose. If you miss two light pink tablets in Week 3 or 4: Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills. If you miss three or more light pink tablets: Day 1 start: Throw out the rest of the pack and start a new pack that same day. Sunday start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day. Use a second form of birth control (eg, condom, spermicide) for 7 days after you miss a dose, to prevent pregnancy. If you miss two periods in a row, call your doctor for a pregnancy test before you take any more pills. If you miss four white tablets in Week 4: Throw out the pill you missed. Keep taking one tablet each day until the pack is empty. You do not need to use another form of birth control if you have sex.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.