Erivedge

Last reviewed on RxList: 8/13/2020
Erivedge Side Effects Center

What Is Erivedge?

Erivedge (vismodegib) is an inhibitor of the hedgehog (Hh) signaling pathway indicated for the treatment of adults with certain forms of skin cancer, including metastatic basal cell carcinoma or locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

What Are Side Effects of Erivedge?

Common side effects of Erivedge include:

Dosage for Erivedge

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

What Drugs, Substances, or Supplements Interact with Erivedge?

Erivedge may interact with antibiotics, ketoconazole, reserpine, quinidine, verapamil, antacids, HIV/AIDS medications, medicines used to prevent organ transplant rejection, or stomach acid reducers. Tell your doctor all medications and supplements you use.

Erivedge During Pregnancy and Breastfeeding

Erivedge can be harmful to unborn children and may cause severe birth defects. Women who can become pregnant should evaluate the risks of using Erivedge with their doctors. It is not known if Erivedge passes into breast milk. Women should decide with their health care providers whether to take Erivedge or breastfeed.

Additional Information

Our Erivedge Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Skin Cancer Symptoms, Types, Images See Slideshow
Erivedge Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you miss a menstrual period. This could be a side effect, or it may be a sign that you are pregnant.

Common side effects may include:

  • nausea, vomiting, decreased appetite;
  • diarrhea, constipation;
  • tired feeling;
  • joint pain, muscle spasms;
  • hair loss;
  • weight loss; or
  • decreased sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Erivedge (Vismodegib)

Erivedge Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Severe Cutaneous Adverse Reactions [see WARNINGS AND PRECAUTIONS]
  • Premature Fusion of the Epiphyses [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety data described below reflect exposure to ERIVEDGE in 138 patients with advanced basal cell carcinoma (BCC) who received ERIVEDGE at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials [Study SHH3925g, SHH4437g, SHH4476g and SHH4610g]. The median age of these patients was 61 years (range 21 to 101 years), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (range 21 days to 36 months); 111 patients received ERIVEDGE for 6 months or longer.

The most common adverse reactions (≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia (Table 1).

Table 1: Adverse Reactions Occurring in ≥ 10% of Patients with Advanced Basal Cell Carcinoma

Adverse ReactionERIVEDGE
(N = 138)
All Grades1 (%)Grade 3 (%)Grade 4 (%)
Gastrointestinal
Nausea30%0.7%-
Diarrhea29%0.7%-
Constipation21%--
Vomiting14%--
General
Fatigue40%5%0.7%
Investigations
Weight loss45%7%-
Metabolism and nutrition
Decreased appetite25%2.2%-
Musculoskeletal and connective tissue
Muscle spasms72%3.6%-
Arthralgias16%0.7%
Nervous system
Dysgeusia55%--
Ageusia11%--
Skin and subcutaneous tissue
Alopecia64%--
1 Grading according to National Cancer Institute-Common Terminology Criteria for Adverse Events version 3.0.

Amenorrhea

Among patients from the clinical trials included in the pooled safety data analysis, 30% of 10 pre-menopausal women developed amenorrhea while receiving ERIVEDGE.

Laboratory Abnormalities

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 this 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.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ERIVEDGE. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hepatobiliary disorders: Drug-induced liver injury

Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome/toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms [see WARNINGS AND PRECAUTIONS].

Read the entire FDA prescribing information for Erivedge (Vismodegib)

© Erivedge Patient Information is supplied by Cerner Multum, Inc. and Erivedge Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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