Pregnancy Prevention Before you take CLARUS®   Warning — Before you decide to take Clarus® you must have discussed the consequences of becoming pregnant during Clarus® therapy with your doctor, and clearly understood them.   Clarus® can cause deformed babies, loss of a baby before birth (miscarriage), death of the baby, and early (premature) births, There is an extremely high risk that your baby will be deformed if you are pregnant while taking Clarus® . This risk exists even if Clarus® is taken for a short time during pregnancy or if you become pregnant within one month after stopping Clarus® . If you are a female of childbearing age, your physician should have discussed this risk with you, and explained how to avoid becoming pregnant while taking Clarus® .   Some birth defects commonly associated with taking isotretinoin during pregnancy are: Low-set, deformed or absent ears Wide-set eyes Depressed bridge of nose Enlarged head Small chin   More severe birth defects are: Mental retardation Internal defects affecting the brain, heart, lymph glands, and nervous system  Do’s and Don’ts of taking CLARUS™ for women Do Don’t Do discuss effective methods of birth control with your doctor before beginning  Clarus® therapy. Do not become pregnant for one month before, during, or for one month after taking  Clarus® . Do have two blood or urine pregnancy tests in a licensed laboratory before starting Clarus® therapy. The first pregnancy test should be done after you and your doctor have decided to use  Clarus® . The second pregnancy test should be done within 11 days before starting Clarus® . Wait until the second or third day of your next period before starting Clarus® . Do not take Clarus® if you are, or may become pregnant during your Clarus®  treatment. Do use two reliable methods of birth control at the same time for at least one month before you start Clarus® , while you are taking Clarus® , and for at least one month after you stop taking Clarus® . Do not take Clarus® until you and your doctor are sure you are not pregnant. Do wait until the second or third day of your next normal menstrual period before you start Clarus® . Do not take Clarus® if you have not had two negative pregnancy tests before starting  Clarus® Do have a monthly pregnancy test while taking Clarus® and one month after stopping Clarus® . Do not take CLARUS™ if you cannot avoid pregnancy. Do abstain from sexual intercourse or use two reliable methods of birth control together, even if you think you can’t get pregnant (unless you have had a hysterectomy). Do not have sex if you are not using two reliable methods of birth control at the same time for at least one month before you start Clarus® , while you are taking  Clarus® , and for one month after you stop taking Clarus® . Do remember that any method of birth control can fail. Do not take CLARUS™ if you are breastfeeding.  Do check the brand of birth control pills that you are taking or ask your doctor or pharmacist if you are not sure what type you are using. Do not take low-dose, progestogen-only birth control pills (also known as ‘mini pills’) Progestogen-only birth control pills may not work while you are taking Clarus® . Stop taking CLARUS™ and contact your doctor immediately if: You become pregnant while taking Clarus® or during the first month after treatment has stopped. You missed your period. Your period is abnormal in length (shorter or longer than usual) and intensity, You have sex without using effective birth control.   Safety information about Clarus® and pregnancy Important information about Clarus® and pregnancy, and confidential counselling is available:   Toll-free phone number: 1-877-776-7711