VISMODEGIB (vis-mo-de’-gib) Erivedge
Classification: ANTINEOPLASTIC; BIOLOGICAL RESPONSE MODIFIER; SIGNAL TRANSDUCTION INHIBITOR; HEDGEHOG PATHWAY INHIBITOR
Therapeutic: ANTINEOPLASTIC
Pregnancy Category: D
AVAILABILITY
Capsule
ACTION & THERAPEUTIC EFFECT
Inhibits the Hedgehog pathway which is needed to produce angiogenic factors and decrease activity of apoptotic genes that allow for tumor expansion. Slow basal cell tumor growth and development.
USES
Treatment of adults with metastatic basal cell carcinoma, or locally advanced basal cell carcinoma.
CONTRAINDICATIONS
Pregnancy (category D), lactation.
CAUTIOUS USE
Renal and hepatic impairment. Safety and efficacy in children younger than 18 y are not established.
ROUTE & DOSAGE
Basal Cell Carcinoma
ADMINISTRATION
Oral
- May be given without regard to food.
- Ensure that capsules are swallowed whole. They should not be opened or crushed.
- Store at 15°–30° C (59°–86° F).
ADVERSE EFFECTS (≥10%)
Body as a Whole: Alopecia, fatigue. GI: Ageusia, constipation, diarrhea, dysgeusia, nausea, vomiting. Metabolic: Azotemia, decreased appetite, hypokalemia, hyponatremia, weight loss. Musculoskeletal: Arthralgias, muscle spasms.
INTERACTIONS
Drug: Coadministration with drugs that inhibit P-glycoprotein (e.g. clarithromycin, erythromycin, azithromycin) may increase the levels of vismodegib. Drugs that alter the pH of the upper GI tract (e.g. PROTON PUMP INHIBITORS, H2-RECEPTOR ANTAGONISTS, and ANTACIDS) may decrease the bioavailability of vismodegib.
PHARMACOKINETICS
Absorption: 32% bioavailability. Distribution: Greater than 99% plasma protein bound. Metabolism: In the liver. Elimination: Primarily fecal (82%). Half-Life: 4 days.
NURSING IMPLICATIONS
Black Box Warning
Vismodegib has been associated with embryo-fetal death and severe birth defects.
Assessment & Drug Effects
- Ensure that women and men understand the risks associated with fetal exposure to this drug during a pregnancy.
- Montior lab tests: Baseline pregnancy test within 7 d before start of therapy; repeat pregnancy test anytime the possibility of a pregnancy arises.
Patient & Family Education
- If a dose is missed, skip the dose and wait for the next scheduled dose.
- Women should use a highly effective means of birth control during therapy and for at least 7 mo following completion of therapy. Contact your prescriber immediately if you become pregnant during treatment.
- Men (even those with a vasectomy) should always use a condom with a spermicide during sex with female partners during treatment and for 2 mo following completion of therapy. Report to prescriber immediately if your partner becomes pregnant or thinks she is pregnant while you are taking this drug.
- Do not breast-feed while receiving this drug.
Artikel keren lainnya:
Vismodegib (GDC-0449) is a potent, novel and specific inhibitor of hedgehog with IC50 of 3 nM and also inhibitor of P-gp with IC50 of 3.0 μM. Vismodegib
ReplyDelete