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Erivedge® (vismodegib) Side Effects and Safety

Erivedge side effects and tips

Below, you’ll find a list of the most common side effects of Erivedge, along with some tips you can try. If you have questions or concerns about side effects, you should talk to your doctor.

Muscle spasms side effect icon

Muscle spasms are when the muscle tightens, like with a cramp. They may be painful.

Some tips you can try: 

  • Drink plenty of fluids
  • Apply heat when the muscle spasm begins, and ice after it has passed
  • Exercise within your ability
  • Stretch to improve flexibility
Hair loss side effect icon

Hair loss (also called alopecia) may happen on any part of the body. It may happen suddenly or a little at a time and may cause the hair to become thin, dry, or dull.

Some tips you can try: 

  • Use a mild shampoo, and try not to wash your hair each day
  • Avoid perming, curling, straightening, or blow-drying with high heat
  • Apply a broad-spectrum sunscreen to the scalp, or cover the scalp with a sun-protective hat or scarf when outside
Taste changes side effect icon

You may experience changes in how things taste, or a loss of taste can also occur. Some people may notice a metallic or chemical taste.

Some tips you can try: 

  • Try cold or frozen foods, rather than hot foods—remember that different food temperatures work for different people. Be sure to do what works best for you
  • Flavor foods with herbs and spices or by marinating them in juices or salad dressings
  • Drink fluids to rinse away unpleasant tastes. Fruit-flavored drinks work well
  • Try using plastic utensils and containers if you have a metallic taste in your mouth
  • Keep your mouth clean by brushing and flossing more often during the day
  • Try foods again. Something may have tasted funny yesterday but will taste better later
Weight loss side effect icon

Weight loss is another side effect that may be caused by your treatment. For example, if foods or drinks do not taste good, you may eat less and lose weight. 

Some tips you can try: 

  • Eat smaller meals more often
  • Drink healthy high-calorie fluids between meals. Try nutritional supplement drinks, such as instant breakfast mixes or powdered shakes
  • Eat foods that are nutritious and high in calories, such as dried fruit, yogurt, or granola bars, or add maple syrup to your favorite snacks
Fatigue and tiredness side effect icon

Fatigue is a feeling of being tired or exhausted that may affect your ability to perform normal activities.

Some tips you can try: 

  • Be physically active each day if your doctor or other healthcare provider approves. This may help improve appetite, strength, and weight
  • Do activities during the time of day when you have more energy
  • Do the most important tasks first
Nausea or vomiting side effect icon

Some patients will experience nausea or vomiting. This means feeling sick to your stomach or throwing up.

Some tips you can try: 

  • Try relaxation techniques, such as deep breathing or thinking of a positive image or scene, to distract you from feeling sick to your stomach
  • Ask your doctor or other healthcare provider if an antinausea medicine might help
  • Avoid foods that are greasy, fried, salty, sweet, or spicy
  • If the smell of a food bothers you, try cooling it down before eating it
Diarrhea side effect icon

When you have diarrhea, it means you have loose or watery bowel movements that happen 3 or more times in a day.

Some tips you can try: 

  • Choose nutritious foods, rather than foods that are greasy, fatty, or spicy
  • Eat small, frequent meals of foods that are easy to digest, such as rice, applesauce, or canned fruit
  • Drink plenty of clear, noncarbonated fluids
  • Eat foods high in potassium, such as bananas or potatoes, or drink sports drinks
Decreased appetite side effect icon

You may also experience a change in appetite. This can include changes in how much or how often you eat, or in how hungry or full you feel.

Some tips you can try: 

  • Keep food and fluids on hand, and snack when you are hungry
  • Eat snacks that are high in calories and protein, such as dried fruit, nuts, yogurt, eggs, and cheese
  • Try asking a friend or family member to cook for you if you do not feel well
Constipation side effect icon

You may become constipated during treatment and find that you have difficulty having a bowel movement.

Some tips you can try: 

  • Drink plenty of liquids
  • Eat high-fiber foods, such as whole-grain breads and cereals, fruits and vegetables, and nuts, seeds, and popcorn
  • Be physically active if you can
Joint pain side effect con

Joint pain may occur. For some patients this may be mild, and for others it can be more severe.

Some tips you can try: 

  • Try hot or cold packs to ease pain and reduce swelling
  • Be physically active if you can
  • Try to maintain a healthy weight
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Indication

Erivedge® (vismodegib) capsule 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 or that your healthcare provider decides cannot be treated with surgery or radiation.

It is not known if Erivedge is safe and effective in children.

Serious Side Effects

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

Important Safety Information

What is the most important information I should know about Erivedge?

Erivedge 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 Erivedge to your unborn child
  • Your healthcare provider will do a pregnancy test within 7 days before you start taking Erivedge
  • In order to avoid pregnancy, you should use birth control during treatment and for 24 months after your final dose of Erivedge. 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:

  • Erivedge is present in semen. Do not donate semen while you are taking Erivedge and for 3 months after your final dose
  • You should always use a condom, even if you have had a vasectomy, during sex with female partners who are pregnant or who are able to become pregnant, during treatment with Erivedge, and for 3 months after your final dose to protect your female partner from being exposed to Erivedge
  • Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Erivedge

Pregnancy Exposure Registry:

There is a Pregnancy Exposure Registry for females taking Erivedge who become pregnant. The purpose of this registry is to monitor the health of you and your unborn baby. If you think that you or your female partner may have been exposed to Erivedge during pregnancy, talk to your healthcare provider right away. If you become pregnant during treatment with Erivedge, you or your healthcare provider should report your pregnancy to Genentech at (888) 835-2555.

What should I tell my healthcare provider before taking Erivedge?

  • If you are pregnant or plan to become pregnant
  • If you are breastfeeding or plan to breastfeed. It is not known if Erivedge passes into your breast milk. You should not breastfeed during treatment and for 24 months after your final dose of Erivedge. Talk to your healthcare provider about the best way to feed your baby during this time
  • About all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements

What should I avoid while taking Erivedge?

  • Do not donate blood or blood products while you are taking Erivedge and for 24 months after your final dose
  • Do not donate semen while you are taking Erivedge and for 3 months after your final dose

What are the possible side effects of Erivedge?

  • Serious skin reactions: Severe skin reactions have happened in some people taking Erivedge. You may need to be treated in a hospital because these severe skin reactions can be life-threatening or lead to death. Tell your healthcare provider right away if you develop any of the following signs or symptoms of a severe skin reaction, including:
    • Blisters or peeling of your skin
    • Blisters on your lip, or around your mouth or eyes
    • Mouth sores or genital sores
    • High fever or flu-like symptoms
    • Enlarged lymph nodes
    • Skin pain and burning

Your healthcare provider may permanently stop Erivedge if you develop a severe skin reaction.

  • Bone growth problems. Bone growth problems have happened in children who have been exposed to Erivedge. These problems may continue even after stopping treatment with Erivedge
  • The most common side effects of Erivedge are:
    • Muscle spasms
    • Hair loss
    • Change in how things taste or loss of taste
    • Weight loss
    • Tiredness
    • Nausea
    • Diarrhea
    • Decreased appetite
    • Constipation
    • Joint pain
    • Vomiting

Erivedge can cause absence of menstrual periods (amenorrhea) in females who are able to become pregnant. It is not known if amenorrha is permanent. Talk to your healthcare provided if you have concerns about fertility. 

These are not all of the possible side effects of Erivedge. Because everyone is different, it is not possible to predict what side effects any one person will have or how severe they may be. Call your doctor for medical advice about side effects. 

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. 

Please see full Prescribing Information, for additional Important Safety Information, including serious side effects, and the Medication Guide.