Erivedge® (Vismodegib)- mBCC & laBCC | HongKong DengYue Medicine

ERIVEDGE Vismodegib Application Scope

Erivedge® (vismodegib) is indicated for the treatment of adults with metastatic basal cell carcinoma (mBCC) or with locally advanced basal cell carcinoma (laBCC) that has recurred following surgery, or in patients who are not candidates for surgery or radiation.

ERIVEDGE Vismodegib Characteristics

• Ingredients: Vismodegib, a hedgehog pathway inhibitor that antagonizes the smoothened (SMO) protein.

• Properties: Orally active small molecule; inhibits SMO to disrupt Hedgehog signaling, suppressing the growth of basal cell carcinoma.

• Packaging Specification: 150 mg immediate-release hard gelatin capsules.

• Storage: Store below 30 °C; maintain in original container to protect from moisture. 24-month shelf life typical.

• Expiry Date: As listed on container (typically up to 24 months).

• Executive Standard: Conforms to FDA, EMA, and other regional pharmacopeial standards. (Implied by approvals.)

• Approval Number: FDA approval granted January 2012 (NDA 203,388) for advanced BCC.

• Date of Revision: Not specified

• Manufacturer: Genentech (Roche subsidiary)

Guidelines for the Use of ERIVEDGE Vismodegib

• • Dosage and Administration:

  • Recommended dose is one 150 mg capsule orally, once daily, until disease progression or unacceptable toxicity.

• Common Adverse Reactions: Muscle spasms, hair loss, taste disturbances (dysgeusia), weight loss, fatigue, nausea.

• Serious Adverse Reactions: Embryo-fetal toxicity (teratogenic), muscle cramps, dehydration, amenorrhea in women of reproductive potential.

• Contraindications: Pregnancy—high risk of fetal malformation; women of reproductive potential must undergo pregnancy testing and use effective contraception during treatment and for 7 months after last dose. Male patients should use condoms during treatment and for 3 months after.

• Precautions: Monitor for signs of dehydration, weight loss, and other adverse effects; avoid use in successfully treated BCC where surgical options remain viable.

ERIVEDGE Vismodegib Interactions

• Elevated gastric pH (from PPIs/H2-blockers/antacids) may reduce its absorption, possibly impacting effectiveness.

 

Note:

• If there is a new packaging for the drug, the new packaging shall prevail. The above information is sourced from DengYue Medicine.
•  This content is for reference only. Prescription drugs must be used under a doctor’s guidance and purchased from authorized sources.