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Erivedge

"June 8, 2012 -- Roche's Erivedge, newly approved for advanced basal cell carcinoma, is "the greatest advance in therapy yet seen for this disease," according to an editorial in the New England Journal of Medicine.

"It is a land"...

Erivedge

Erivedge

Erivedge Side Effects Center

Medical Editor: Melissa Conrad Stöppler, MD

Erivedge (vismodegib) is 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. The most commonly seen side effects from the use of Erivedge were muscle spasms, hair loss (alopecia) weight loss, fatigue, diarrhea, constipation, joint pain, and vomiting.

Erivedge is administered orally in capsule form. 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.

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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Erivedge FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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.

ERIVEDGE capsule was administered as monotherapy at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials enrolling a total of 138 patients with advanced basal cell carcinoma (BCC). The median age of these patients was 61 years (range 21 to 101), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (305 days; range 0.7 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 Advanced BCC Patients

MedDRA Preferred Term2 All aBCC1 Patients (N = 138)
All Grades3 (%) Grade 3 (%) Grade 4 (%)
Gastrointestinal disorders
  Nausea 42 (30.4%) 1 (0.7%) -
  Diarrhea 40 (29.0%) 1 (0.7%) -
  Constipation 29 (21.0%) - -
  Vomiting 19 (13.8%) - -
General disorders and administration site conditions
  Fatigue 55 (39.9%) 7 (5.1%) 1 (0.7%)
Investigations
  Weight loss 62 (44.9%) 10 (7.2%) -
Metabolism and nutrition disorders
  Decreased appetite 35 (25.4%) 3 (2.2%) -
Musculoskeletal and connective tissue disorders
  Muscle spasms 99 (71.7%) 5 (3.6%) -
  Arthralgias 22 (15.9%) 1 (0.7%)
Nervous system disorders
  Dysgeusia 76 (55.1%) - -
  Ageusia 15 (10.9%) - -
Skin and subcutaneous tissue disorders
  Alopecia 88 (63.8%) - -
1aBCC = Advanced Basal Cell Carcinoma.
2MedDRA = Medical Dictionary for Regulatory Activities.
3Grading according to NCI-CTCAE v3.0.

Amenorrhea

In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea while receiving ERIVEDGE [see Non-Clinical Toxicology].

Laboratory Abnormalities

Treatment-emergent Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%).

Read the entire FDA prescribing information for Erivedge (Vismodegib) »

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Additional Erivedge Information

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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