Erivedge

Vimodegib (Erivedge) Instructions
Common name: vismodegib
Trade name: Erivedge
Full names: Vimodegib, Erivedge, vismodegib

Indications:
For patients with locally advanced cutaneous basal cell carcinoma who cannot undergo surgery or radiotherapy and patients whose tumors have metastasized. This is the first drug ever approved to treat basal cell carcinoma.

Usage and dosage:
The recommended dose is 150 mg orally once a day. Swallow capsule whole with or without food; do not open or crush capsule. If dose is missed, resume next scheduled dose.

Adverse reactions:
> 10%
Muscle cramps (71.7%)
Hair loss (63.8%)
Dysgeusia (55.1%)
Weight loss (44.9%)
Fatigue (39.9%)
Nausea (30.4%)
Diarrhea (2 9%)
Decreased appetite (25.4%)
Constipation (21%)
Arthralgias (15.9%)
Vomiting (13.8%)
Ageusia (10.9%)

1-10%
Hyponatremia (4%)
Azotemia (2%)
Hypokalemia (1%)

Frequency undefined
Amenorrhea
Premature epiphyseal fusion
Increased serum creatinine phosphokinase

On sale Post-report
Drug-induced liver injury

Contraindications:
Not clear

Precautions:
(1) Embryo-fetal death and serious birth defects: ERIVEDGE may cause embryo-fetal death or serious birth defects.
(2) Blood Donation: Patients are advised not to donate blood or blood products while receiving ERIVEDGE and for at least 7 months after the last dose of ERIVEDGE.
(3) Use in special groups:
Pregnancy: May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus.
Nursing Mothers: Discontinuing Drugs or Breastfeeding Consider the Importance of the Drug to the Mother.
Female Reproductive Potential and Men: Counseling Men and Women on Pregnancy Prevention and Planning.

Storage:
Store at room temperature 20-25°C (68-77°F); short trips allowed between 15-30°C (59-86°F)

Mechanism of Action:
Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signaling.

Efficacy and Safety:
The safety and effectiveness of Erivedge were evaluated in a multicenter clinical trial involving 96 patients with locally advanced or metastatic cutaneous basal cell carcinoma. The primary endpoint is objective response rate (ORR), or the percentage of patients who experience complete and partial tumor shrinkage or complete disappearance of cancerous lesions after treatment. Among patients with metastatic basal cell carcinoma treated with Erivedge, the partial response rate was 30%; among patients with locally advanced basal cell carcinoma, the complete plus partial response rate was 43%