Pregnancy Prevention

Before you take CLARUS

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 birth defects (deformed babies). It can also cause miscarriage, premature birth, or death of the baby. There is an extremely high risk that your baby will be deformed if you are pregnant while taking Clarus or up to one month after treatment has stopped. This risk exists even if Clarus is taken for a short time. Therefore, adequate birth control measures are essential when taking Clarus.

Contraception: Effective contraception must be used for at least one month before starting Clarus treatment, during treatment and for at least one month following the the discontinuation of Clarus treatment.

It is recommended that two reliable forms (Primary and Barrier forms) of contraception be used simultaneously. At least one of these forms of contraception must be a primary form (i.e. oral contraceptive, contraceptive patch, vaginal ring, intra-uterine device), unless the patient has undergone a hysterectomy.

Remember, any birth control method can fail.

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

1

Do

Do discuss effective methods of birth control with your doctor before beginning Clarus therapy.

2

Don't

Do not become pregnant for one month before, during, or for one month after taking Clarus.

3

Do

Do have two blood or urine pregnancy tests in a licensed laboratory before starting Clarus therapy. The first pregnancy test should be done once 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.

4

Don't

Do not take Clarus if you are pregnant.

5

Do

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, even if you have a history of infertility or are not sexually active.

6

Don't

Do not take Clarus until you and your doctor are sure you are not pregnant.

7

Do

Do wait until the second or third day of your next normal menstrual period before you start Clarus.

8

Don't

Do not take Clarus if you have not had two negative pregnancy tests before starting Clarus.

9

Do

Do have a monthly pregnancy test while taking Clarus and one month after stopping Clarus.

10

Don't

Do not take Clarus if you cannot avoid pregnancy.

11

Do

Use two reliable methods of birth control together, even if you have a history of infertility or are not sexually active (unless you have had a hysterectomy).

12

Don't

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.

13

Do

Do remember that any method of birth control can fail.

14

Don't

Do not take Clarus if you are breastfeeding.

15

Do

Do let your doctor or pharmacist know what brand of birth control you are taking.

16

Don't

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
  • 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: 1-855-500-9991

Clarus_Clear_side_banner_FRE_updated_ENG

A Guide For Patients

All the information you need about your medicine in a handy booklet.

Birth Control Information

For more information about birth control or for confidential counselling call the toll-free number at 1-855-500-9991

CLARUS® is a registered trademark of Mylan Pharmaceuticals ULC, a Viatris company.
CLEAR™ is a trademark of Mylan Pharmaceuticals ULC, a Viatris company.
VIATRIS and VIATRIS & Design are registered trademarks of Mylan Inc., used under permission by Mylan Pharmaceuticals ULC, a Viatris company.
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