Skip To Main Content
For Patients

Erivedge Side Effects & Tips

Quick Links

Serious side effects
Common adverse reactions
Management strategies for most common adverse reactions
Additional most common adverse reactions (>10%) associated with Erivedge

Serious side effects

These warnings and precautions are detailed in the Important Safety Information and may include:5

  • Embryo-fetal toxicity 
  • Severe cutaneous adverse reactions
  • Musculoskeletal adverse reactions
  • Premature fusion of the epiphyses in pediatric patients

Common adverse reactions

Patients taking Erivedge may experience adverse reactions.5 Adverse reactions of any grade, including mild to moderate in severity (Grade 1 or 2), may affect the course of a patient’s treatment.16

Strategies to consider when adverse reactions become a treatment challenge

  • Educating patients about potential adverse reactions from the start can help them understand what to expect and provide the opportunity for you and your patients to work together to help manage them16
  • Withhold Erivedge for up to 8 weeks for intolerable adverse reactions until improvement or resolution. Treatment interruptions prior to 8 weeks of continuous therapy were not studied5
  • Permanently discontinue Erivedge if patients experience severe cutaneous adverse reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms5
  • Interrupt Erivedge for severe or intolerable musculoskeletal adverse reactions. Permanently discontinue Erivedge for recurrent, severe, or intolerable musculoskeletal adverse reactions5
ERIVANCE Phase II pivotal trial design
STEVIE post-approval study

Most Common Adverse Reactions Associated With Erivedge1,5,17

Incidence ≥10% associated with Erivedge: Pooled analysis of 4 studies (N=138)

 

All advanced BCC patients (N=138)

Adverse reactions occurring in ≥10% of advanced BCC patients 

Grade 1 (%) (Mild)

Grade 2 (%) (Moderate)

Grade 3 (%) (Severe)

Grade 4 (%) (Disabling or life-threatening)

All grades (%) 

Muscle spasms

51.4%

16.7%

3.6%

-

72%

Alopecia

49.3%

14.5%

N/A

N/A

64%

Change in taste (dysgeusia)

34.1%

21.0%

N/A

N/A

55%

Weight loss

25.4%

12.3%

7%

N/A

45%

Fatigue

27.5%

6.5%

5%

0.7%

40%

Nausea

23.9%

5.8%

0.7%

-

30%

Diarrhea

21.7%

6.5%

0.7%

-

29%

Decreased appetite 

15.2%

8.0%

2.2%

-

25%

Constipations

17.4%

3.6%

-

-

21%

Arthralgias

11.6%

3.6%

0.7%

-

16%

Vomiting

10.9%

2.9%

-

-

14%

Loss of taste (ageusia)

8.0%

2.9%

N/A

N/A

11%

Adverse reactions reported using Medical Dictionary for Regulatory Activities preferred terms and graded using National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 for assessment of toxicity.
N/A=not applicable, this grade does not exist for this adverse reaction.

  • Amenorrhea can occur in females of reproductive potential. Reversibility of amenorrhea is unknown. In clinical trials, 30% of 10 pre-menopausal women developed amenorrhea while receiving Erivedge
  • Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia (4%), azotemia (2%), and hypokalemia (1%)
  • Additionally, in a post-approval clinical trial conducted in 1232 patients with locally advanced or metastatic BCC treated with Erivedge, a subset of 29 patients had baseline values for blood creatine phosphokinase (CPK) reported. Within the subset of patients, 38% had a shift from baseline, including Grade 3 (3%) increased CPK. Grade 3 or 4 increased CPK occurred in 2.4% of the 453 patients across the entire study population with any CPK measurement
  • Twenty-nine patients (28%) experienced adverse reactions that led to treatment interruption

Management Strategies for Most Common Adverse Reactions

Muscle spasms are the most frequently observed adverse reactions during treatment with Erivedge.5 Although they can happen anywhere in the body, they tend to occur more frequently in the muscles of the lower leg and foot. They are also most common at night.1,16,17

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

72%

 51.4% 16.7% 3.6%

0%

STRATEGIES TO CONSIDER

  • Sports drinks that replace electrolytes16
  • Adequate hydration18
  • Gentle physical activity16
ERIVANCE19 STEVIE (exploratory analysis)1
Median time to onset 1.89 months (95% CI, 1.35-2.73)

Median time to resolution* (after treatment discontinuation)

1.51 months (95% CI, 1.25-1.94)

 

*11.9% (36/303) of patients had ongoing muscle spasms at the time of 12-month follow-up.1

STEVIE limitations: Because clinical trials are conducted under widely varying conditions, time to onset and resolution of adverse reactions observed in the clinical trials of a drug cannot be directly compared to those observed in other clinical trials of that drug and may not reflect actual clinical practice. This endpoint is exploratory and no formal inferences can be drawn.

Patients may lose hair on the scalp, eyebrows, eyelashes, and beard.16 Hair texture and quality may also be affected. Alopecia caused by Erivedge is different from chemotherapy-related hair loss. By inhibiting hedgehog pathway signaling, Erivedge may also affect hair follicle stem cells regulated by the same pathway, preventing new hair growth.1,17,20

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

64%

49.3%

Thinning or patchy

14.5%

Complete

N/A

N/A

STRATEGIES TO CONSIDER

  • Zinc-based or mild shampoo18,21
  • Avoiding washing hair daily21
  • Avoiding hair treatments (eg, blow drying with high heat, curling)21
  • Sun protection (eg, using sunscreen on the scalp, wearing hats or scarves)21
ERIVANCE19 STEVIE (exploratory analysis)1

Median time to onset 

3.38 months

(95% CI, 2.83-4.11)

Median time to resolution* (after treatment discontinuation)

5.82 months (95% CI, 4.80-6.11)

 

*28.9% (87/301) of patients had ongoing alopecia at the time of 12-month follow-up.1

STEVIE limitations: Because clinical trials are conducted under widely varying conditions, time to onset and resolution of adverse reactions observed in the clinical trials of a drug cannot be directly compared to those observed in other clinical trials of that drug and may not reflect actual clinical practice. This endpoint is exploratory and no formal inferences can be drawn.

Taste disturbances such as dysgeusia can be difficult to assess, since it can be subjective, and can affect oral intake. Observed weight loss, however, may not be attributable to changes in taste.1,16,17

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

55%

34.1%

Altered taste but no change in diet 

21%

Altered taste with change in diet (eg, oral supplements); noxious or unpleasant taste; loss of taste

N/A

N/A

STRATEGIES TO CONSIDER

  • Zinc gluconate lozenges18
  • Flavor enhancers (eg, adding lemon or spicy ingredients, or marinating meat)16
  • Brushing teeth and tongue before meals16
  • Baking soda-salt wash or antibacterial mouthwash16
  • Cold foods16
ERIVANCE19 STEVIE (exploratory analysis)1

Median time to onset 

1.48 months (95% CI, 0.99-2.07)

Median time to resolution* (after treatment discontinuation)

3.09 months (95% CI, 2.83-3.32)

 

*16.2% (40/247) of patients had ongoing dysgeusia at the time of 12-month follow-up.1

STEVIE limitations: Because clinical trials are conducted under widely varying conditions, time to onset and resolution of adverse reactions observed in the clinical trials of a drug cannot be directly compared to those observed in other clinical trials of that drug and may not reflect actual clinical practice. This endpoint is exploratory and no formal inferences can be drawn.

Patients who experience weight loss may also lose muscle mass. There is no known correlation between weight loss and taste disturbances.1,16,17

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

45%

25.4%

5% to <10% from baseline; intervention not indicated 

12.3%

10% to <20% from baseline; nutritional support indicated

7%

≥20% from baseline; tube feeding or TPN indicated

N/A

STRATEGIES TO CONSIDER

  • Evaluation by a nutritionist or dietitian22
  • Nutritional supplement beverages18,22
  • Fish oil supplements16
  • Eating smaller meals more often21
  • A high calorie, well-balanced diet18
ERIVANCE19 STEVIE (exploratory analysis)1
Median time to onset 6.13 months (95% CI, 4.50-7.36)

Median time to resolution* (after treatment discontinuation)
8.11 months (95% CI, 6.24-12.06)

 

*38.6% (66/171) of patients had ongoing weight loss at the time of 12-month follow-up.1

STEVIE limitations: Because clinical trials are conducted under widely varying conditions, time to onset and resolution of adverse reactions observed in the clinical trials of a drug cannot be directly compared to those observed in other clinical trials of that drug and may not reflect actual clinical practice. This endpoint is exploratory and no formal inferences can be drawn.

Patients’ fatigue may be influenced by other adverse reactions, such as interrupted sleep due to muscle spasms or decreased caloric intake because of taste disturbances.1,16,17

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

40%

27.5%

Mild fatigue over baseline

6.5%

Moderate or causing difficulty performing some ADL

5%

Severe fatigue interfering with ADL

0.7%

Disabling

STRATEGIES TO CONSIDER

  • Addressing contributing factors and comorbidities16
  • Being physically active each day, with physician approval21
  • Doing activities at a time when your patient has more energy21
  • Physical activity/exercise (eg, yoga)16
  • Doing important tasks first21
ERIVANCE19 STEVIE (exploratory analysis)1

Median time to onset 

2.79 months

(95% CI, 1.35-3.75)

Median time to resolution* (after treatment discontinuation)

6.18 months (95% CI, 3.35-15.51)

 

*40.8% (20/49) of patients had ongoing fatigue at the time of 12-month follow-up.1

STEVIE limitations: Because clinical trials are conducted under widely varying conditions, time to onset and resolution of adverse reactions observed in the clinical trials of a drug cannot be directly compared to those observed in other clinical trials of that drug and may not reflect actual clinical practice. This endpoint is exploratory and no formal inferences can be drawn.

Nausea is one of the most common gastrointestinal-related adverse reactions associated with Erivedge.23,24

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

30%

23.9%

Loss of appetite without alteration in eating habits

5.8%

Oral intake decreased without significant weight loss, dehydration, or malnutrition; IV fluids indicated <24 hrs

0.7%

Inadequate oral caloric or fluid intake; IV fluids, tube feedings, or TPN indicated ≥24 hrs

-

Life-threatening consequences

STRATEGIES TO CONSIDER

  • Acidic beverages prior to and with meals (eg, lemonade, orange juice)18
  • Relaxation techniques (eg, deep breathing, positive imagery)21
  • Clear liquids21
ERIVANCE19 STEVIE (exploratory analysis)1

Median time to onset 

2.14 months

(95% CI, 0.59-6.67)

Median time to resolution* (after treatment discontinuation)

1.71 months (95% CI, 1.22-2.83)

 

*12.5% (4/32) of patients had ongoing nausea at the time of 12-month follow-up.1

STEVIE limitations: Because clinical trials are conducted under widely varying conditions, time to onset and resolution of adverse reactions observed in the clinical trials of a drug cannot be directly compared to those observed in other clinical trials of that drug and may not reflect actual clinical practice. This endpoint is exploratory and no formal inferences can be drawn.

Symptoms of diarrhea include the frequent passage of watery or loose stools, which can cause dehydration.1,17,20,29

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

29%

21.7%

Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline

6.5%

Increase of 4 to 6 stools per day over baseline; IV fluids indicated <24 hrs; moderate increase in ostomy output compared to baseline; not interfering with ADL

0.7%

Increase of ≥7 stools per day over baseline; incontinence; IV fluids ≥24 hrs; hospitalization; severe increase in ostomy output compared to baseline; interfering with ADL

-

Life-threatening consequences (eg, hemodynamic collapse)

STRATEGIES TO CONSIDER

  • Avoiding greasy, fatty, or spicy foods21
  • Small, frequent meals that are easy to digest (eg, rice, apple sauce, canned fruit)21
  • Clear, non-carbonated liquids and sports drinks21
  • Foods high in potassium (eg, bananas, potatoes)21
ERIVANCE19 STEVIE (exploratory analysis)1

Median time to onset 

4.47 months

(95% CI, 2.27-6.51)

Median time to resolution* (after treatment discontinuation)

1.97 months (95% CI, 1.22-2.60)

 

*17.1% (6/35) of patients had ongoing diarrhea at the time of 12-month follow-up.1

STEVIE limitations: Because clinical trials are conducted under widely varying conditions, time to onset and resolution of adverse reactions observed in the clinical trials of a drug cannot be directly compared to those observed in other clinical trials of that drug and may not reflect actual clinical practice. This endpoint is exploratory and no formal inferences can be drawn.

Ongoing appetite loss may lead to serious complications. These include weight loss, not getting the nutrients that the body needs, and fatigue and weakness from muscle loss.1,17,25

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

25%

15.2%

Loss of appetite without alteration in eating habits

8%

Oral intake altered without significant weight loss or malnutrition; oral nutritional supplements indicated

2.2%

Associated with significant weight loss or malnutrition (eg, inadequate oral caloric and/or fluid intake); IV fluids, tube feedings, or TPN indicated

-

Life-threatening
consequences

STRATEGIES TO CONSIDER

  • Keep food and fluids on hand, and snack when hungry25
  • Ask a friend or relative to cook if not feeling well25
  • Eat snacks that are high in calories and protein, such as dried fruits, nuts, yogurt, eggs, and cheese25
ERIVANCE19 STEVIE (exploratory analysis)1

Median time to onset 

2.87 months

(95% CI, 1.38-4.50)

Median time to resolution* (after treatment discontinuation)

2.99 months (95% CI, 2.53-3.45)


*18.8% (16/85) of patients had ongoing decreased appetite at the time of 12-month follow-up.1

STEVIE limitations: Because clinical trials are conducted under widely varying conditions, time to onset and resolution of adverse reactions observed in the clinical trials of a drug cannot be directly compared to those observed in other clinical trials of that drug and may not reflect actual clinical practice. This endpoint is exploratory and no formal inferences can be drawn.

ADL=activities of daily living; CI=confidence interval; GI=gastrointestinal; IV=intravenous; N/A=not applicable, this grade does not exist for this adverse reaction; TPN=total parenteral nutrition.

Additional Most Common Adverse Reactions (>10%) Associated With Erivedge

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

21%

17.4%

Occasional or intermittent symptoms; occasional use of stool softeners, laxatives, dietary modification, or enema

3.6%

Persistent symptoms with regular use of laxatives or enemas indicated

-

Symptoms interfering with ADL; obstipation with manual evacuation indicated

-

Life-threatening consequences (eg, obstruction, toxic megacolon)

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

16%

11.6%

Mild pain not interfering with function

3.6%

Moderate pain; pain or analgesics interfering with function, but not interfering with ADL

0.7%

Severe pain; pain or analgesics severely interfering with ADL

-

Disabling

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

14%

10.9%

1 episode in 24 hrs

2.9%

2 to 5 episodes in
24 hrs; IV fluids
indicated <24 hrs

-

6 episodes in
24 hrs; IV fluids
or TPN indicated ≥24 hrs

-

Life-threatening consequences

ALL GRADES

GRADE 1

(MILD)

GRADE 2

(MODERATE)

GRADE 3

(SEVERE)

GRADE 4

(DISABLING OR LIFE-THREATENING)

11%

8%

Loss of taste but no change in diet

2.9%

Loss of taste with change in diet (eg, oral supplements)

N/A

N/A

Incidence of common adverse reactions (≥10%): Pooled analysis of 4 studies (N=138). Adverse reactions reported using Medical Dictionary for Regulatory Activities preferred terms and graded using National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 for assessment of toxicity.

NEXT: Important Safety Information

Indication and Important Safety Information

Indication

Erivedge 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.

Important Safety Information

BOXED WARNING: EMBRYO-FETAL TOXICITY

  • Erivedge can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. Erivedge is embryotoxic, fetotoxic, and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations
  • Verify the pregnancy status of females of reproductive potential within 7 days prior to initiating Erivedge. Advise pregnant women of the potential risks to a fetus. Advise females of reproductive potential to use effective contraception during and after Erivedge
  • Advise males of the potential risk of Erivedge exposure through semen and to use condoms with a pregnant partner or a female partner of reproductive potential
Warnings and Precautions
 
Embryo-Fetal Toxicity
  • Females of Reproductive Potential: Use contraception during therapy with Erivedge and for 24 months after the final dose
  • Males: Use condoms, even after a vasectomy, to avoid potential drug exposure in pregnant partners and female partners of reproductive potential during and for 3 months after the final dose of Erivedge. Do not donate semen during and for 3 months after the final dose of Erivedge
  • Blood Donation: Advise patients not to donate blood or blood products while receiving Erivedge and for 24 months after the final dose of Erivedge
  • 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 (888) 835-2555
Severe Cutaneous Adverse Reactions
  • Severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening or fatal, have been reported during treatment with Erivedge. Permanently discontinue Erivedge in patients with these reactions
Musculoskeletal Adverse Reactions
  • Musculoskeletal adverse reactions, which may be accompanied by serum creatine phosphokinase (CPK) elevations, have occurred with Erivedge and other drugs which inhibit the hedgehog (Hh) pathway. In the pooled safety population in clinical trials of Erivedge, musculoskeletal and connective tissue adverse reactions occurred in 78% of patients treated, with 7% (9/138) reported as Grade 3. The most frequent manifestations of musculoskeletal and connective tissue adverse reactions (all grades) reported were muscle spasms (72%) and arthralgias (16%). In a post-approval clinical trial of 1232 patients, Grade 3 or 4 elevations in serum CPK laboratory values occurred in 2.4% of the 453 patients who had any CPK measurement
  • Obtain baseline serum creatine phosphokinase (CPK) and creatinine levels and as clinically indicated (e.g., if muscle symptoms are reported). Depending on the severity of symptoms, temporary dose interruption or discontinuation may be required for musculoskeletal adverse reactions or serum CPK elevation
Premature Fusion of the Epiphyses
  • Premature fusion of the epiphyses has been reported in pediatric patients exposed to Erivedge. In some cases, fusion progressed after drug discontinuation. Erivedge is not indicated for pediatric patients

Adverse Reactions

  • The most common adverse reactions (≥10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia
  • Amenorrhea can occur in females of reproductive potential. Reversibility of amenorrhea is unknown. In clinical trials, 30% of 10 pre-menopausal women developed amenorrhea while receiving Erivedge
  • Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia (4%), azotemia (2%), and hypokalemia (1%)
  • Additionally, in a post-approval clinical trial conducted in 1232 patients with locally advanced or metastatic BCC treated with Erivedge, a subset of 29 patients had baseline values for blood creatine phosphokinase (CPK) reported. Within the subset of patients, 38% had a shift from baseline, including Grade 3 (3%) increased CPK. Grade 3 or 4 increased CPK occurred in 2.4% of the 453 patients across the entire study population with any CPK measurement
  • Adverse reactions identified during post-approval use: drug-induced liver injury, Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms

Use in Specific Populations

Lactation

  • No data are available regarding the presence of vismodegib in human milk, the effects of the drug on the breastfed child, or the effects of the drug on milk production. Advise women that breastfeeding is not recommended during therapy with Erivedge and for 24 months after the final dose

 

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, including the BOXED WARNING, for a complete discussion of the risks associated with Erivedge.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

    • FDA approves Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinoma [press release]. San Francisco, CA: Genentech, Inc.; January 30, 2012.

      FDA approves Erivedge (vismodegib) capsule, the first medicine for adults with advanced basal cell carcinoma [press release]. San Francisco, CA: Genentech, Inc.; January 30, 2012.

    • Epstein EH. Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer. 2008;8(10):743-754.

      Epstein EH. Basal cell carcinomas: attack of the hedgehog. Nat Rev Cancer. 2008;8(10):743-754.

    • Scales SJ, de Sauvage FJ. Mechanisms of Hedgehog pathway activation in cancer and implications for therapy. Trends Pharmacol Sci. 2009;30(6):303-312.

      Scales SJ, de Sauvage FJ. Mechanisms of Hedgehog pathway activation in cancer and implications for therapy. Trends Pharmacol Sci. 2009;30(6):303-312.

    • Erivedge® (vismodegib) capsule Prescribing Information. Genentech, Inc. March 2023.

      Erivedge® (vismodegib) capsule Prescribing Information. Genentech, Inc. March 2023.

    • Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012;366(23):2171-2179.

      Sekulic A, Migden MR, Oro AE, et al. Efficacy and safety of vismodegib in advanced basal-cell carcinoma. N Engl J Med. 2012;366(23):2171-2179.

    • Von Hoff DD, LoRusso PM, Rudin CM, et al. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med. 2009;361(12):1164-1172.

      Von Hoff DD, LoRusso PM, Rudin CM, et al. Inhibition of the hedgehog pathway in advanced basal-cell carcinoma. N Engl J Med. 2009;361(12):1164-1172.

    • LoRusso PM, Rudin CM, Reddy JC, et al. Phase I trial of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with refractory, locally advanced or metastatic solid tumors. Clin Cancer Res. 2011;17(8):2502-2511.

      LoRusso PM, Rudin CM, Reddy JC, et al. Phase I trial of hedgehog pathway inhibitor vismodegib (GDC-0449) in patients with refractory, locally advanced or metastatic solid tumors. Clin Cancer Res. 2011;17(8):2502-2511.

    • Gupta S, Takebe N, LoRusso P. Targeting the hedgehog pathway in cancer. Ther Adv Med Oncol. 2010;2(4):237-250.

      Gupta S, Takebe N, LoRusso P. Targeting the hedgehog pathway in cancer. Ther Adv Med Oncol. 2010;2(4):237-250.

    • Cancer.org. How Targeted Therapies Are Used to Treat Cancer. https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/targeted-therapy/what-is.html. Accessed April 26, 2022.

      Cancer.org. How Targeted Therapies Are Used to Treat Cancer. https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/targeted-therapy/what-is.html. Accessed April 26, 2022.

    • Lear JT, Corner C, Dziewulski P, et al. Challenges and new horizons in the management of advanced basal cell carcinoma: a UK perspective. Br J Cancer. 2014;111(8):1476-1481.

      Lear JT, Corner C, Dziewulski P, et al. Challenges and new horizons in the management of advanced basal cell carcinoma: a UK perspective. Br J Cancer. 2014;111(8):1476-1481.

    • Ibrahim SF. Advanced basal cell carcinoma: treatment overview. The Dermatologist. 2014;22(3). https://www.hmpgloballearningnetwork.com/site/thederm/site/cathlab/event/advamced-basa-cell-carcinoma-treatment-overview. Published March 10, 2014. Accessed February 24, 2023.

      Ibrahim SF. Advanced basal cell carcinoma: treatment overview. The Dermatologist. 2014;22(3). https://www.hmpgloballearningnetwork.com/site/thederm/site/cathlab/event/advamced-basa-cell-carcinoma-treatment-overview. Published March 10, 2014. Accessed February 24, 2023.

    • Levine A, Markowitz O. Update on advanced basal cell carcinoma diagnosis and treatment. Dermatology Times. https://www.dermatologytimes.com/view/update-advanced-basal-cell-carcinoma-diagnosis-and-treatment. Accessed March 29, 2023.

      Levine A, Markowitz O. Update on advanced basal cell carcinoma diagnosis and treatment. Dermatology Times. https://www.dermatologytimes.com/view/update-advanced-basal-cell-carcinoma-diagnosis-and-treatment. Accessed March 29, 2023.

    • Amin SP, Russell KJ. Diagnosing, managing aBCC in elderly patients. Dermatology Times. https://www.dermatologytimes.com/view/diagnosing-managing-abcc-elderly-patients. Accessed March 29, 2023.

      Amin SP, Russell KJ. Diagnosing, managing aBCC in elderly patients. Dermatology Times. https://www.dermatologytimes.com/view/diagnosing-managing-abcc-elderly-patients. Accessed March 29, 2023.

    • Erivedge® (vismodegib) capsule European Medicines Agency Assessment Report. September 15, 2016.

      Erivedge® (vismodegib) capsule European Medicines Agency Assessment Report. September 15, 2016.

    • Lacouture ME, Dréno B, Ascierto PA, et al. Characterization and management of hedgehog pathway inhibitor-related adverse events in patients with advanced basal cell carcinoma. Oncologist. 2016;21(10):1218-1229.

      Lacouture ME, Dréno B, Ascierto PA, et al. Characterization and management of hedgehog pathway inhibitor-related adverse events in patients with advanced basal cell carcinoma. Oncologist. 2016;21(10):1218-1229.

    • National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v3.0. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed August 26, 2022.

      National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v3.0. https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcaev3.pdf. Accessed August 26, 2022.

    • Solomon JA, Chever D, Iarrobino A, Caldwell C. Successful control of adverse events associated with vismodegib treatment of advanced basal cell carcinoma by recognition of hedgehog pathway activity in normal adult tissue. Poster presented at: International Investigative Dermatology Meeting; May 8-11, 2013; Edinburgh, Scotland, United Kingdom. Abstract 1088.

      Solomon JA, Chever D, Iarrobino A, Caldwell C. Successful control of adverse events associated with vismodegib treatment of advanced basal cell carcinoma by recognition of hedgehog pathway activity in normal adult tissue. Poster presented at: International Investigative Dermatology Meeting; May 8-11, 2013; Edinburgh, Scotland, United Kingdom. Abstract 1088.

    • Sekulic A, Migden MR, Lewis K, et al. Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC. J Am Acad Dermatol. 2015;72(6):1021-1026.

      Sekulic A, Migden MR, Lewis K, et al. Pivotal ERIVANCE basal cell carcinoma (BCC) study: 12-month update of efficacy and safety of vismodegib in advanced BCC. J Am Acad Dermatol. 2015;72(6):1021-1026.

    • Fife K, Herd R, Lalondrelle S, et al. Managing adverse events associated with vismodegib in the treatment of basal cell carcinoma. Future Oncol. 2017;13(2):175-184.

      Fife K, Herd R, Lalondrelle S, et al. Managing adverse events associated with vismodegib in the treatment of basal cell carcinoma. Future Oncol. 2017;13(2):175-184.

    • Ibrahim SF. Treating advanced basal cell carcinoma. https://www.the-dermatologist.com/content/treating-advanced-basal-cell-carcinoma. Accessed April 26, 2022.

      Ibrahim SF. Treating advanced basal cell carcinoma. https://www.the-dermatologist.com/content/treating-advanced-basal-cell-carcinoma. Accessed April 26, 2022.

    • Le Moigne M, Saint-Jean M, Jirka A, et al. Dysgeusia and weight loss under treatment with vismodegib: benefit of nutritional management. Support Care Cancer. 2016;24(4):1689-1695.

      Le Moigne M, Saint-Jean M, Jirka A, et al. Dysgeusia and weight loss under treatment with vismodegib: benefit of nutritional management. Support Care Cancer. 2016;24(4):1689-1695.

    • Sekulic A, Migden MR, Basset-Séguin N, et al; for the ERIVANCE BCC Investigators. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study. BMC Cancer. 2017;17(1):332. doi:10.1186/s12885-017-3286-5.

      Sekulic A, Migden MR, Basset-Séguin N, et al; for the ERIVANCE BCC Investigators. Long-term safety and efficacy of vismodegib in patients with advanced basal cell carcinoma: final update of the pivotal ERIVANCE BCC study. BMC Cancer. 2017;17(1):332. doi:10.1186/s12885-017-3286-5.

    • Mohan SV, Chang AL. Management of cutaneous and extracutaneous side effects of smoothened inhibitor therapy for advanced basal cell carcinoma. Clin Cancer Res. 2015;21(12):2677-2683.

      Mohan SV, Chang AL. Management of cutaneous and extracutaneous side effects of smoothened inhibitor therapy for advanced basal cell carcinoma. Clin Cancer Res. 2015;21(12):2677-2683.

    • American Society of Clinical Oncology. Appetite Loss. https://www.cancer.net/coping-with-cancer/physical-emotional-and-social-effects-cancer/managing-physical-side-effects/appetite-loss. Accessed April 26, 2022.

      American Society of Clinical Oncology. Appetite Loss. https://www.cancer.net/coping-with-cancer/physical-emotional-and-social-effects-cancer/managing-physical-side-effects/appetite-loss. Accessed April 26, 2022.

    • Basset-Séguin N, Hauschild A, Kunstfeld R, et al. Vismodegib in patients with advanced basal cell carcinoma: primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017;86:334-348.

      Basset-Séguin N, Hauschild A, Kunstfeld R, et al. Vismodegib in patients with advanced basal cell carcinoma: primary analysis of STEVIE, an international, open-label trial. Eur J Cancer. 2017;86:334-348.

    • Ozgur OK, Yin V, Chou E, et al. Hedgehog pathway inhibition for locally advanced periocular basal cell carcinoma and basal cell nevus syndrome. Am J Ophthalmol. 2015;160(2):220-227.e2. doi:10.1016/j.ajo.2015.04.040

      Ozgur OK, Yin V, Chou E, et al. Hedgehog pathway inhibition for locally advanced periocular basal cell carcinoma and basal cell nevus syndrome. Am J Ophthalmol. 2015;160(2):220-227.e2. doi:10.1016/j.ajo.2015.04.040

    • Clinicaltrials.gov. STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma. https://clinicaltrials.gov/ct2/show/NCT01367665. Accessed August 30, 2022.

      Clinicaltrials.gov. STEVIE: A Study of Vismodegib in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma. https://clinicaltrials.gov/ct2/show/NCT01367665. Accessed August 30, 2022.

    • National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v4.0. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed August 30, 2022.

      National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE) v4.0. https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03/CTCAE_4.03_2010-06-14_QuickReference_5x7.pdf. Accessed August 30, 2022.

    • Erivedge® (vismodegib) capsule European Medicines Agency Assessment Report. September 15, 2016.

      Erivedge® (vismodegib) capsule European Medicines Agency Assessment Report. September 15, 2016.