Erivedge

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Vismodegib is a cancer medicine that interferes with the growth of certain cancer cells in the body.

Vismodegib is used to treat basal cell carcinoma that has spread to other parts of the body.

Vismodegib may also be used for purposes not listed in this medication guide.

Do not use vismodegib if you are pregnant, or if you are a man and your sexual partner is pregnant. Vismodegib use by either parent may cause severe birth defects or death of a baby. If you are pregnant and your sexual partner is taking vismodegib, do not have sex without using a latex condom and spermicide during treatment and for 3 months after your partner stops taking vismodegib.

For Women: Use effective birth control while taking vismodegib and for 7 months after your last dose. Call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: Always use a latex condom and spermicide when having sex, even if you have had a vasectomy. Continue using condoms and spermicide for at least 3 months after you stop taking vismodegib.

You should not use vismodegib if you are allergic to it.

To make sure vismodegib is safe for you, tell your doctor if you have:

• liver disease; or
• kidney disease.

You will need to have a negative pregnancy test within 7 days before you start taking vismodegib.

Do not use vismodegib if you are pregnant, or if you are a man and your sexual partner is pregnant. You must prevent pregnancy while you are taking vismodegib, whether you are a man or a woman. Vismodegib can cause severe birth defects or death of a baby if either parent is using this medicine at the time of conception or during pregnancy.

For Women: Use effective birth control while taking vismodegib and for 7 months after your last dose. The birth control method you use must be proven highly effective (at least 99\%), such as: hormonal birth control (pills, vaginal ring, implants, or injections), an intrauterine device (IUD), or a tubal ligation. Call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: While you are taking vismodegib you must not have unprotected sex with a pregnant woman, or cause a woman to become pregnant. Vismodegib can affect your sperm and may cause harm to the baby at conception or during pregnancy. Always use a latex condom and spermicide when having sex, even if you have had a vasectomy. Continue using condoms and spermicide for at 3 months after you stop taking vismodegib.

Call your doctor at once if a pregnancy occurs while either sexual partner is taking vismodegib.

It is not known whether vismodegib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using vismodegib and for 7 months after your last dose.

Included as part of the PRECAUTIONS section.

Erivegde can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.

For females who can become pregnant:

• You should talk with your healthcare provider about the risks of Erivegde to your unborn child.
• Your healthcare provider should do a pregnancy test within 7 days before you start taking Erivegde to find out if you are pregnant.
• In order to avoid pregnancy, you should start using highly effective birth control before you start Erivegde, and continue to use highly effective birth control during treatment, and for 7 months after your last dose of Erivegde. Talk with your healthcare provider about what birth control method is right for you during this time.
• Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed.
• Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.

For males:

• You should always use a condom with a spermicide, even if you have had a vasectomy, during sex with female partners while you are taking Erivegde and for 2 months after your last dose to protect your female partner from being exposed to Erivegde.
• Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Erivegde.

Exposure to Erivegde during pregnancy:

If you think that you or your female partner may have been exposed to Erivegde during pregnancy, talk to your healthcare provider right away. Pregnant women are encouraged to participate in a program that collects information about exposure to Erivegde during pregnancy, and the effects on the mother and her unborn child. This program is called the Erivegde pregnancy pharmacovigilance program. You may participate in this program by calling the Genentech Adverse Event Line at 1-888-835-2555.

Do not donate blood or blood products while you are taking Erivegde and for 7 months after your last dose.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Erivegde passes into your breast milk. You and your healthcare provider should decide if you will take Erivegde or breastfeed. You should not do both.

• Store Erivegde at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Erivegde and all medicines out of the reach of children.

Do not take this medication if you are pregnant. Vismodegib can cause severe birth defects or death of a baby if the mother or the father is taking this medication at the time of conception or during pregnancy. You must use an effective form of birth control to prevent pregnancy while you are taking vismodegib, whether you are a man or a woman. Vismodegib use by either parent may cause birth defects.

If you are pregnant and your sexual partner is taking vismodegib, do not have sex without using a latex condom and spermicide. Continue using condoms and spermicide for at least 2 months after your partner stops taking vismodegib.

For Women: Use effective birth control while taking vismodegib and for at least 7 months after your treatment ends. Call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men:Always use a latex condom and spermicide when having sex, even if you have had a vasectomy. Continue using condoms and spermicide for at least 2 months after you stop taking vismodegib.

Call your doctor at once if a pregnancy occurs while either sexual partner is taking vismodegib.

Skip the missed dose and wait until your next scheduled dose to take the medication. Do not take extra medicine to make up the missed dose.

You should not use vismodegib if you are allergic to it, or:

• if you are pregnant or breast-feeding.

You will need to have a negative pregnancy test within 7 days before you start taking vismodegib.

Do not use vismodegib if you are pregnant, or if you are a man and your sexual partner is pregnant. Vismodegib can cause severe birth defects or death of a baby if either parent is using this medicine at the time of conception or during pregnancy.

You must prevent pregnancy while you are taking vismodegib, whether you are a man or a woman.

For Women: Use effective birth control while taking vismodegib and for 7 months after your last dose. The birth control method you use must be proven highly effective (at least 99%), such as: hormonal birth control (pills, vaginal ring, implants, or injections), an intrauterine device (IUD), or a tubal ligation. Call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: While you are taking vismodegib you must not have unprotected sex with a pregnant woman, or cause a woman to become pregnant. Vismodegib can affect your sperm and may cause harm to the baby at conception or during pregnancy. Always use a latex condom and spermicide when having sex, even if you have had a vasectomy. Continue using condoms and spermicide for at 3 months after you stop taking vismodegib.

Call your doctor at once if a pregnancy occurs while either sexual partner is taking vismodegib.

To make sure vismodegib is safe for you, tell your doctor if you have:

• liver disease; or

• kidney disease.

It is not known whether vismodegib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using vismodegib and for 7 months after your last dose.

Skip the missed dose and wait until your next scheduled dose to take the medication. Do not take extra medicine to make up the missed dose.

Minimally metabolized by CYP2C9 and 3A4/5.1

Inhibitor of CYP2C8, 2C9, and 2C19; does not induce CYP1A2, 2B6, or 3A4/5.1

Substrate of P-glycoprotein (P-gp).1

Inhibitor of breast cancer resistance protein (BCRP).1

Drugs Affecting Hepatic Microsomal Enzymes

Pharmacokinetic interactions unlikely when used concomitantly with drugs that induce or inhibit CYP isoenzymes.1

Inhibitors of P-glycoprotein Transport

Potential increased vismodegib exposure and toxicity.1

Drugs Transported by Breast Cancer Resistance Protein

Potential for increased plasma concentration of drugs transported by BCRP.1 11

Drugs Affecting Gastric Acidity

Potential for decreased vismodegib exposure.1 Clinical data are lacking, but increased dosages of vismodegib unlikely to overcome interaction.1 Effect of concomitant use on efficacy of vismodegib unknown.1

Specific Drugs

In the U.S.

• Erivedge

Available Dosage Forms:

• Capsule

Therapeutic Class: Antineoplastic Agent

• It is used to treat skin cancer.

Erivedge capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

Erivedge (vismodegib) capsules, 150 mg. The capsule has a pink opaque body and a grey opaque cap, with "150 mg" printed on the capsule body and "VISMO" printed on the capsule cap in black ink.

See FDA-approved patient labeling (Medication Guide).

Administration Instructions

• Advise patients to swallow Erivedge capsules whole and not to crush or open the capsules.

Embryo-Fetal Toxicity

• Advise pregnant women of the potential risk to a fetus [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1)].
• Advise females of reproductive potential to use effective contraception during therapy with and for 24 months after the final dose of Erivedge [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3)].
• Advise males, even those with prior vasectomy, to use condoms to avoid potential drug exposure in both pregnant partners and female partners of reproductive potential during therapy with and for 3 months after the final dose of Erivedge [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3)].
• Advise female patients and female partners of male patients to contact their healthcare provider with a known or suspected pregnancy. Report pregnancies to Genentech at 1-888-835-2555 [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1, 8.3)].

Semen Donation

• Advise males not to donate semen during therapy with and for 3 months after the final dose of Erivedge.

Lactation

• Advise women that breastfeeding is not recommended during therapy with Erivedge and for 24 months after the final dose [see Use in Specific Populations (8.2)].

Blood Donation

• Advise patients not to donate blood or blood products while taking Erivedge and for 24 months after the final dose of Erivedge.

Premature Fusion of the Epiphyses

• Advise patients and caregivers that premature fusion of the epiphyses has been reported in pediatric patients exposed to Erivedge. In some cases, fusion progressed after drug discontinuation.

Erivedge® [vismodegib] capsule

Manufactured by:
Patheon, Inc.
Mississauga, Canada

Erivedge is a registered trademark of Genentech, Inc.
©2017 Genentech, Inc. All rights reserved.

Distributed by:
Genentech USA, Inc.
A Member of the Roche Group
1 DNA Way
South San Francisco, CA 94080-4990

Representative sample of labeling (see the HOW SUPPLIED section for complete listing):

You should not use Erivedge if you are allergic to vismodegib, or:

• if you are pregnant or breast-feeding.

You will need to have a negative pregnancy test within 7 days before you start taking Erivedge.

Do not use this medicine if you are pregnant, or if you are a man and your sexual partner is pregnant. Vismodegib can cause severe birth defects or death of a baby if either parent is using this medicine at the time of conception or during pregnancy.

You must prevent pregnancy while you are taking Erivedge, whether you are a man or a woman.

For Women: Use effective birth control while taking Erivedge and for 7 months after your last dose. The birth control method you use must be proven highly effective (at least 99%), such as: hormonal birth control (pills, vaginal ring, implants, or injections), an intrauterine device (IUD), or a tubal ligation. Call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.

For Men: While you are taking Erivedge you must not have unprotected sex with a pregnant woman, or cause a woman to become pregnant. Vismodegib can affect your sperm and may cause harm to the baby at conception or during pregnancy. Always use a latex condom and spermicide when having sex, even if you have had a vasectomy. Continue using condoms and spermicide for at 3 months after you stop taking vismodegib.

Call your doctor at once if a pregnancy occurs while either sexual partner is taking vismodegib.

To make sure this medicine is safe for you, tell your doctor if you have:

• liver disease; or

• kidney disease.

It is not known whether vismodegib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using Erivedge and for 7 months after your last dose.