What is Nikki? Uses, warnings & side effects

Please read the package insert and follow the instructions for taking this medicine.

Take one pill daily at the same time each day. Do not miss doses.

• There are 24 pink tablets containing hormones and four inert white tablets. Take all the tablets in the blister pack, including the white tablets.

• Take each tablet in order.

• Take the first tablet (number 1) on the day your period starts or the first Sunday after your period starts.

• If you are taking Nikki after using another form of birth control, take the first pill on the day you would have started a new blister pack, replaced a vaginal ring or patch, or the day an implant or IUD is removed.

• When the last pill is taken, take the first pink pill in the next pack the next day.

• Take the first pill of a new blister pack on the same day of the week each cycle.

Swallow tablets whole with a drink of water.

• Do not crush, break, or chew the tablet.

• Tablets can be taken on an empty stomach or with food.

If you have diarrhea, use backup birth control until you talk to the prescriber.

Store Nikki at room temperature in the original carton.

Missed doses increase the risk of pregnancy.

If you vomit three to four hours after taking a Nikki tablet, treat it like a missed dose. 

If a pink pill is missed:

• Take it as soon as it’s remembered. Take the next dose at its normal time.

• Two doses can be taken on the same day to make up for a missed dose. 

• Backup birth control is not necessary.

If you miss two pink pills in a row in the first two weeks:

• Take two pills on the day you remember and two pills the next day.

• Use backup birth control for the next seven days.

If you miss two pink pills in a row in the third week: 

• Day 1 starters should throw out the old blister pack and start a new one. 

• Sunday starters should continue to take the pink pills from the old pack and use backup birth control. Start a new pack on Sunday.

• You can get pregnant in the first seven days of starting a new kit. Use backup birth control for those seven days.

If you miss three or more pink pills in a row in any week:

• Day 1 starters should throw out the old blister pack and start a new one. 

• Sunday starters should continue to take the pink pills from the old pack and use backup birth control. Start a new pack on Sunday.

• You can get pregnant in the first seven days of starting a new kit. Use backup birth control for those seven days.

If you’re not sure about a missed dose, continue taking pills and use backup birth control.

This medicine is not safe for everyone. 

Do not use Nikki if you are:

• Pregnant

• Older than 35 and smoke

• Older than 35 have focal headaches or migraines with aura

Do not use Nikki if you have blood clots, a history of blood clots, a history of stroke, or certain conditions that can cause blood clots:

• Coronary artery disease

• Blood vessel problems in the brain (cerebrovascular disease)

• High blood pressure that is not controlled by medications

• Certain types of heart valve problems or irregular heartbeats

• Diabetes with nerve, kidney, eye, or blood vessel damage

Do not use Nikki if you have:

• Vaginal bleeding that has not been examined by a healthcare provider

• Liver disease or liver tumors

• Current or past breast cancer that is hormone-sensitive

• Kidney impairment

• Adrenal gland insufficiency

Tell other healthcare providers who treat you that you are using this medicine, especially before a medical or dental procedure. 

• Oral contraceptives can alter the results of important blood tests. 

• Nikki will need to be stopped at least four weeks before major surgery and can’t be taken for at least two weeks following major surgery.

Your doctor may need regular visits and lab tests to monitor side effects. Keep all appointments.

Immediately inform the prescriber if you become pregnant, think you’re pregnant, or miss two periods in a row. 

Before starting Nikki, tell the prescriber if you:

• Are pregnant

• Think you’re pregnant

• Have missed two periods in a row

• Have given birth within the last four weeks 

• Are breastfeeding

• Smoke

Tell the prescriber if you have:

• Heart problems

• Blood vessel problems

• High blood pressure

• Diabetes

• High cholesterol and fats

• Migraines

• Depression

• Face, neck, and throat swelling (angioedema) due to a hereditary condition

Tell the prescriber about any problems that occurred during a previous pregnancy, particularly:

• Skin yellowing (jaundice) 

• Dark patches on your face (chloasma)

Nikki can cause serious problems, including:

• Increased risk of blood clots, heart attack, and stroke

• Increased risk of breast or cervical cancer

• Liver problems

• Gallbladder problems

• High blood pressure

• High cholesterol and fats

• Severe or persistent headaches

• High potassium

Some women may develop dark patches on their faces when using Nikki. Avoid sunlamps and tanning beds, and use sunscreen when outdoors. 

Oral contraceptives do not protect women from HIV/AIDS or other sexually transmitted diseases. If infection is a risk, use barrier methods such as condoms.

Nikki can reduce milk production in women who are breastfeeding. Consult with the prescriber.

Never take Nikki or similar birth control pills along with any hepatitis C drug that contains ombitasvir/paritaprevir/ritonavir.

Before starting Nikki, tell the prescriber about all the prescription drugs, over-the-counter medications, and supplements regularly used, particularly: 

• Macrolide antibiotics

• Antifungal drugs 

• Drugs that treat seizures

• Barbiturates

• Antiviral drugs that treat hepatitis C or HIV/AIDS

• Thyroid hormones

• Blood pressure drugs called ACE inhibitors or angiotensin II receptor blockers (ARBs) 

• Potassium-sparing diuretics

• Heparin blood thinners

• NSAIDs (daily rather than occasional use)

• Potassium supplements

• Salt substitutes containing potassium

• St. John’s wort

• Acetaminophen, aprepitant, ascorbic acid, atorvastatin, bosentan, colesevelam, cyclosporine, diltiazem, rifampin, rosuvastatin, verapamil

Some of these drug interactions increase the risk of pregnancy. Women may need to use backup birth control when taking certain types of drugs.

Avoid grapefruit and grapefruit juice when taking Nikki.

Tell other healthcare providers you are using this medicine before they prescribe new medications.