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
Safety information about CLARUS and pregnancy
* To ensure that you are using two reliable methods of birth control at the same time.
† Duration of therapy is typically 3-4 months.
‡ To ensure that you are using two reliable methods of birth control at the same time and to detect any side effects that you may have from treatment.
A Guide For Patients
All the information you need about your medicine in a handy booklet.
Download PDF here
Birth Control Information
For more information about birth control or for confidential counselling call the toll-free number at 1-877-776-7711