Erivedge

Erivedge is a prescription medication used to treat adults with basal cell carcinoma, a type of skin cancer. Erivedge belongs to a group of drugs called hedgehog pathway inhibitors, which help stop or slow the spread of cancer cell and shrink tumors.

This medication comes in capsule form and is taken once a day, with or without food.

Common side effects include muscle spasms, baldness, and weight loss.

Erivegde is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery. Erivegde may be used when surgery or radiation is not an option.

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

• Genentech, Inc.

See "Black Box Warning" and "Precautions" sections.

The most common side effects of Erivegde are:

• muscle spasms
• hair loss
• change in how things taste or loss of taste
• weight loss
• tiredness
• nausea
• diarrhea
• decreased appetite
• constipation
• vomiting
• joint aches

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Erivegde. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antacids
• certain antibiotics such as azithromycin (Z-Pak, Zithromax), clarithromycin (Biaxin, in Prevpac), and erythromycin (E.E.S., Eryc, Ery-Tab, Erythrocin, PCE)
• a medication for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid), and ranitidine (Zantac)
• and proton-pump inhibitors such as dexlansoprazole (Dexilant), lansoprazole (Prevacid, in Prevpac), omeprazole (Prilosec, Zegerid), pantoprazole (Protonix), and rabeprazole (AcipHex)

This is not a complete list of Erivegde drug interactions. Ask your doctor or pharmacist for more information.

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.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Erivegde there are no specific foods that you must exclude from your diet when receiving Erivegde.

Before taking Erivegde, tell your healthcare provider if you:

• are pregnant or plan to become pregnant. 
• 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.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. It has been shown that use of Erivegde in pregnant women caused some babies to be born with problems. However, in some serious situations, the benefit of using this medication may be greater than the risk of harm to the baby.

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.

• Take Erivegde exactly as your healthcare provider tells you.
• You can take Erivegde with or without food.
• Swallow Erivegde capsules whole. Do not open or crush the capsules.
• Take Erivegde one time each day.
• If you miss a dose, skip the missed dose. Just take your next scheduled dose.

Take Erivegde exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Erivegde is 150 mg taken orally once daily until disease progression or until unacceptable toxicity.

If you take too much Erivegde call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• 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.

WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS

Erivegde capsule can result in embryo-fetal death or severe birth defects. Erivegde is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations.

Verify pregnancy status prior to the initiation of Erivegde. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of Erivegde exposure through semen