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Tips to Help Manage Possible Side Effects


Patients taking Erivedge may experience side effects. Although not all the possible side effects of Erivedge, below is a list of the most common ones, along with some tips you can try.

Talk to your doctor before trying any of these tips or if you experience any side effects that bother or concern you. Depending on how bothersome or serious the side effects are, your doctor may decide that you should take a break from treatment until they get better or go away.

So you know what to expect, you can also ask your doctor when side effects are likely to develop and how long they can last.

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.

Side Effects & Tips to Consider

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

Studies have shown that 72% of patients taking Erivedge experience muscle spasms. 

Tips to consider:

  • Stretch or massage the muscle
  • Drink lots of fluids

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.

Studies have shown that 64% of patients taking Erivedge experience hair loss.

Tips to consider: 

  • Wash your hair less often and use mild shampoo
  • Avoid heated hair treatments like curling or blow drying
  • Protect your hair and scalp from the sun by wearing hats or sunscreen

Taste changes can include a loss or changes in how things taste, such as a metallic or chemical taste.

Studies have shown that 55% of patients taking Erivedge experience changes in how things taste, while 11% experience a loss of taste. 

Tips to consider: 

  • Flavor your foods with herbs and spices or eat cold foods
  • Brush your teeth and tongue before meals

Weight loss can also cause you to lose muscle mass.

Studies have shown that 45% of patients taking Erivedge experience weight loss.

Tips to consider: 

  • Eat smaller meals more often
  • Maintain a high-calorie, well-balanced diet

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

Studies have shown that 40% of patients taking Erivedge experience tiredness.

Tips to consider:

  • Do activities during the time of day when you have more energy
  • Do important tasks first

Nausea or vomiting means feeling sick to your stomach or throwing up.

Studies have shown that 30% of patients taking Erivedge experience nausea, while 14% experience vomiting. 

Tips to consider:

  • Try relaxation techniques such as deep breathing
  • Ask your doctor if an antinausea medicine might help
  • Avoid foods that are greasy, fried, sweet, or spicy

Diarrhea is defined as having loose or watery bowel movements that happen several times in a day.

Studies have shown that 29% of patients taking Erivedge experience diarrhea. 

Tips to consider:

  • Eat foods that are easier to digest, like rice, apple sauce, or dry toast
  • Avoid greasy, fatty, or spicy foods
  • Drink clear, non-carbonated liquids and sports drinks

A decreased appetite can mean a change in how much or how often you eat, or in how hungry or full you feel.

Studies have shown that 25% of patients taking Erivedge experience decreased appetite. 

Tips to consider:

  • Snack on foods that are high in calories and protein like eggs, dried fruits, nuts, and yogurt
  • Keep food and fluids on hand, and snack when hungry

With constipation you may find that you have difficulty having a bowel movement.

Studies have shown that 21% of patients taking Erivedge experience constipation.

Tips to consider:

  • Eat high-fiber foods such as whole-grain breads and cereals, fruits and vegetables, nuts, or popcorn
  • Drink lots of fluids
  • Be physically active, if you can

Joint pain can interfere with function and daily activities.

Studies have shown that 16% of patients taking Erivedge experience joint pain.

Tips to consider:

  • Use hot or cold packs to ease pain
  • Maintain a healthy weight and be physically active, if you can

Important Safety Information and Indication

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.

Before taking Erivedge, tell your healthcare provider about all of your medical conditions, including:

  • 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?

  • Severe 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.

  • Muscle problems: Muscle problems are common with Erivedge, but can also sometimes be serious. Erivedge can increase your risk of muscle spasms or muscle pain. Tell your healthcare provider right away if you develop any new or worsening muscle pain, tenderness, or weakness during or after treatment with Erivedge. Your healthcare provider should do a blood test to check for muscle problems and to check your kidney function before you start taking Erivedge, and as needed during treatment if you develop muscle problems
  • 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.