What type of cancer is Vismodegib used to treat?
Vismodegib is approved to treat: Basal cell carcinoma (a type of skin cancer). It is used in adults whose disease has metastasized (spread to other parts of the body). It is also used in adults with locally advanced disease that has recurred (come back) after surgery or who cannot be treated with surgery or radiation.
What is the difference between Erivedge and Vismodegib?
Erivedge is the trade for the generic chemotherapy drug Vismodegib. In some cases, health care professionals may use the generic name Vismodegib when referring to the trade name Erivedge. Drug type: Erivedge is a targeted therapy.
What is Arimidex (Vismodegib)?
(vismodegib) capsule is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation.
What is the history of Vismodegib (diphenhydramine)?
An Investigational New Drug application for vismodegib was filed with the U.S. Food and Drug Administration in September 2006, leading to launch of a first-in-human phase I clinical trial at 3 U.S. sites in January 2007. Focused Phase I Development
What type of drug is vismodegib?
Vismodegib is in a class of medications called hedgehog pathway inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply.
How long do you take vismodegib for?
In a clinical study of 104 adults with advanced BCC, 96 of whom were evaluated for overall response rate, half of the patients took Erivedge for more than 10 months, and half took Erivedge for less than 10 months. Patients stayed on Erivedge anywhere from 3 weeks to 19 months.
Is fluorouracil chemotherapy or immunotherapy?
Chemotherapy drugs, such as gemcitabine, cisplatin, fluorouracil and mitomycin-C, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.
Is Erivedge chemotherapy?
Erivedge is the trade for the generic chemotherapy drug Vismodegib. In some cases, health care professionals may use the generic name Vismodegib when referring to the trade name Erivedge. Drug type: Erivedge is a targeted therapy. It is a hedgehog pathway inhibitor- (For more detail, see "How this drug works," below.)
How effective is vismodegib?
At 3 months after the start of vismodegib, the probability of partial response was 94.6% (95% CI, 84.4–99.0) and probability of complete response after 6 months of treatment was 33.9% (95% CI, 20.6–52.5), with a median duration of complete response of 10.3 months (95% CI, 4.5–22.1).
What are side effects of vismodegib?
Incidence not knownBlack, tarry stools.blistering, peeling, loosening of the skin.diarrhea.itching skin.red irritated eyes.sores, ulcers, or white spots in the mouth or on the lips.sore throat.swollen glands.
Is 2 weeks long enough for fluorouracil?
Adults—Apply to the affected area 2 times a day for 2 to 4 weeks.
How successful is fluorouracil?
Only two to five patients in each group withdrew. A modified intention-to-treat analysis found that fluorouracil had the best results, with a cumulative success rate of 75% (compared with 54% for imiquimod, 38% for methyl aminolevulinate with photodynamic therapy, and only 29% for ingenol mebutate).
How long does it take for skin to heal after fluorouracil?
This usually takes about 2 to 4 weeks. However, the lesions may not be completely healed until 1 or 2 months after you stop using fluorouracil. If you are using fluorouracil to treat basal cell carcinoma, you should continue using it until the lesions are gone.
How much does vismodegib cost?
COST AND AVAILABILITY Genentech has set the price of vismodegib at $7,500 for a month's supply of once-daily capsules––or approximately $250 per capsule.
What kills basal cell carcinoma?
Cryotherapy (cryosurgery) Cryotherapy is used most often for pre-cancerous conditions such as actinic keratosis and for small basal cell and squamous cell carcinomas. For this treatment, the doctor applies liquid nitrogen to the tumor to freeze and kill the cells.
Do you need chemo for basal cell carcinoma?
Basal cell carcinoma very rarely reaches an advanced stage, so systemic chemotherapy is not typically used to treat these cancers. Advanced basal cell cancers are more likely to be treated with targeted therapy.
How much does vismodegib cost?
COST AND AVAILABILITY Genentech has set the price of vismodegib at $7,500 for a month's supply of once-daily capsules––or approximately $250 per capsule.
Does erivedge cause hair loss?
Your hair may become thin, brittle, or may fall out. This typically begins two to three weeks after treatment starts. This hair loss can be all body hair, including pubic, underarm, legs/arms, eyelashes, and nose hairs.
How do you take erivedge?
Read the Medication Guide provided by your pharmacist before you start taking vismodegib and each time you get a refill. If you have any questions, ask your doctor or pharmacist. Take this medication by mouth with or without food as directed by your doctor, usually once daily. Swallow the capsules whole.
What is Vismodegib used for?
It is used in adults whose disease has metastasized (spread to other parts of the body). It is also used in adults with locally advanced disease that has recurred (come back) after surgery or who cannot be treated with surgery or radiation.
Is Vismodegib being studied in the treatment of other types of cancer?
Vismodegib is also being studied in the treatment of other types of cancer.
How does Vismodegib work?
Vismodegib is in a class of medications called hedgehog pathway inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.
What are the side effects of Vismodegib?
Vismodegib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: 1 muscle spasms 2 joint pain 3 tiredness 4 hair loss 5 change in how things taste or loss of taste 6 decreased appetite 7 weight loss 8 nausea 9 vomiting 10 diarrhea 11 constipation 12 missed menstrual periods
Why is this medicine prescribed?
Vismodegib is in a class of medications called hedgehog pathway inhibitors. It works by blocking the action of a protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells and may help shrink tumors.
What should I know about storage and disposal of this medication?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).
How long after Vismodegib can you donate blood?
Do not donate blood while you are taking vismodegib and for 7 months after your treatment.
Does Vismodegib cause weight loss?
Vismodegib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away: muscle spasms. joint pain. tiredness. hair loss. change in how things taste or loss of taste. decreased appetite. weight loss.
Can you take Vismodegib while pregnant?
Vismodegib should not be taken by women who are pregnant or who may become pregnant. There is a risk that vismodegib will cause loss of the pregnancy or will cause the baby to be born with birth defects (physical problems that are present at birth).
What is Vismodegib approved for?
Food and Drug Administration. It is also the first agent of any class approved for the treatment of metastatic or locally advanced unresectable basal cell carcinoma (BCC). Its rapid path to market was based in large part on the strengths of a non-randomized pivotal 104 patient study with a primary endpoint of response rate. Data from this study were buttressed by substantial and supportive efficacy, safety, pharmacokinetic and pharmacodynamic data from other sources. This approval came almost precisely 5 years after the date of first human administration of vismodegib. The pathway to approval of vismodegib represents an interesting case study in the era of molecularly targeted drug development, and demonstrates the willingness of regulatory agencies to consider alternative registration strategies, beyond the traditional randomized phase III study focused on overall survival, in unusual circumstances and in rare disease contexts.
How long does Vismodegib last?
Allometric scaling of preclinical animal models suggested estimates of vismodegib half-life in humans as short as 13.6 hours (12), and in fact the original phase I study design allowed for consideration of twice daily dosing. However, single dose administration followed by 7-day washout in patients revealed minimal decline in plasma drug concentrations between days 2 and 8, suggesting an exceptionally long terminal half life (13). Vismodegib is highly protein bound, and total drug levels closely parallel blood levels of alpha 1-acid glycoprotein (13). With continuous daily dosing, steady state plasma concentrations averaging 22 µM were achieved within 7 – 14 days independent of dose: indistinguishable levels of vismodegib were observed in all three dose cohorts (11). Based on the observed similar steady state plasma concentrations among initial dose cohorts, and the clear signal of biological efficacy, no further dose escalation has been explored. The lowest daily dose level tested, 150 mg, was suggested as the recommended phase II dose.
What is the hedgehog inhibitor?
The first small molecule inhibitor of the Hedgehog pathway, the naturally occurring compound cyclopamine, was identified in 2000 (6). This discovery, together with rapidly accumulating evidence implicating the Hedgehog pathway in oncogenesis, led to focused efforts by multiple biotechnology and pharmaceutical companies to develop cyclopamine derivatives with improved pharmacologic properties, or to develop agents that effectively out-competed cyclopamine for binding to the critical cell surface activator of Hedgehog signaling, the 7-transmembrane G protein-coupled-like receptor, SMO.
Is BCC incurable?
Advanced and surgically incurable BCC can occur spontaneously, or in association with an inherited genetic syndrome affecting the Hedgehog pathway, basal cell nevus syndrome (BCNS; discussed below) (9). One patient with advanced BCC was included in each of the 3 dose levels explored in phase I. After BCC responses were seen, the trial was amended to include expansion cohorts focusing on patients with advanced BCC. Of the 68 patients ultimately enrolled on this phase I study, 33 had locally advanced or metastatic BCC, and of these 33 BCC patients, objective responses were observed in 18 (10). Enrichment of the phase I trial to substantially oversample BCC patients provided both an important proof of principle regarding the single agent efficacy of this novel inhibitor, and an immediate framework for the subsequent phase II study supporting registration.
Is Vismodegib a cyclopamine?
Vismodegib is a member of this second class: structurally unrelated to cyclopamine but able to bind with high affinity and specificity to SMO, leading to potent suppression of Hedgehog signaling in reporter systems and in a preclinical model of Hedgehog-dependent disease (7). An Investigational New Drug application for vismodegib was filed with the U.S. Food and Drug Administration in September 2006, leading to launch of a first-in-human phase I clinical trial at 3 U.S. sites in January 2007.
Does Vismodegib cause muscle spasms?
In the phase II BCC registration study of vismodegib, muscle spasms or cramps were experienced by 68% of subjects; alopecia, 64%; dysgeusia, 51%; weight loss, 46%; and fatigue, 36%. Between 20 and 30% of patients experienced nausea, decreased appetite, or diarrhea. For all of these adverse effects, a large majority reported only grade 1 – 2 (mild - moderate) toxicity. Severe toxicity was rare and without evident consistency or pattern: only 4 severe adverse events considered to be possibly related to vismodegib, including one patient each with cholestasis, pulmonary embolus, dehydration/syncope, and cardiac failure with pneumonia. No deaths on study were attributable to vismodegib.
Who has CMR previously consulted for?
Disclosure of potential conflicts of interest:CMR has previously consulted for Genentech.
What is Vismodegib?
Vismodegib is a type of medicine called a targeted therapy. This medicine is a hedgehog pathway inhibitor. It acts to block certain cell signals to help keep cells from growing.
Possible Late Effects
Some patients may experience long-term or late effects of treatment that may continue or develop months or years after treatment ends. Possible late effects due to vismodegib include:
Tips for Families
Be sure to discuss these and other recommendations with your doctor or pharmacist.
What is the Mechanism of Erivedge – vismodegib?
Vismodegib is a Hedgehog Pathway Inhibitor. By disrupting the hedgehog pathway signal which drives cancer cell growth, Erivedge prevents the cancer from growing. Hedgehog pathways may also be responsible for many of the side effects of Erivedge. For example, Sonic Hedgehog signaling is required for hair follicle development in a fetus and for regulating hair follicle growth and cycling in the adult.
What is Visomodegib capsule?
Erivedge and Erivedge or visomodegib capsule is a prescription oral chemotherapy medication for adults with basal cell carcinoma skin cancer that has spread to other parts of the body or that has come back after surgery or cannot be treated with surgery or radiation. At Bauman Medical, chemo hair loss expert Dr.
What are the side effects of Erivedge?
What are some known side effects of Erivedge visomodegib? In addition to loss of taste, muscle pain, muscle spasms, nausea, vomiting, birth defects, fetal death, diarrhea and fatigue, Hair Loss and Erivedge Medication for Cancer. Erivedge and seems to be one of the more common side effects of this chemotherapy drug.
Can vismodegib cause hair loss?
If vismodegib is causing temporary alopecia or hair loss, the use of a 3D-Printed Cranial Prosthesis or non-surgical medical-grade hair replacement system may be an excellent option. A CNC hair prosthesis functions beyond a typical medical wig or hair replacement system.
What is Erivedge therapy?
Drug type: Erivedge is a targeted therapy. It is a hedgehog pathway inhibitor- (For more detail, see "How this drug works," below.)
What is the generic name for Erivedge?
Generic name: Vismodegib. Erivedge is the trade for the generic chemotherapy drug Vismodegib. In some cases, health care professionals may use the generic name Vismodegib when referring to the trade name Erivedge. Drug type: Erivedge is a targeted therapy.
How is erivedge given?
How Erivedge Is Given: Erivedge is a capsule, taken by mouth, once daily. It can be taken with or without food. Take Erivedge exactly as prescribed. Swallow Erivedge whole. Do not crush, dissolve or open capsules. Do not change your dose or stop Erivedge unless your health care provider tells you to.
What are the side effects of erivedge?
The following side effects are common (occurring in greater than 30%) for patients taking Erivedge: Muscle spasms. Hair loss.
Can you take aspirin while taking erivedge?
Do not receive any kind of immunization or vaccination without your doctor's approval while taking Erivedge. Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment.
Can you change your Erivedge dose?
Do not change your dose or stop Erivedge unless your health care provider tells you to.
What is the prescription for Vismodegib?
Indication. (vismodegib) capsule is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation.
How to report side effects of Genentech?
You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555. Please see full Prescribing Information, for additional Important Safety Information, including serious side effects, and the Medication Guide.
What should I avoid while taking Erivedge?
Do not donate blood or blood products while you are taking Erivedge and for 24 months after your final dose
Does erivedge cause bone growth?
Bone growth problems . Bone growth problems have happened in children who have been exposed to Erivedge. These problems may continue even after stopping treatment with Erivedge
Is there a registry for Erivedge?
There is a Pregnancy Exposure Registry for females taking Erivedge who become pregnant. The purpose of this registry is to monitor the health of you and your unborn baby. If you think that you or your female partner may have been exposed to Erivedge during pregnancy, talk to your healthcare provider right away.
What is erivedge therapy?
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, ...
Does erivedge interact with antibiotics?
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.
Can erivedge be used while pregnant?
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.
What is the prescription for erivedge?
Indication. Erivedge. ®. (vismodegib) capsule is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation.
What are the side effects of erivedge?
These problems may continue even after stopping treatment with Erivedge. The most common side effects of Erivedge are: Muscle spasms. Hair loss. Change in how things taste or loss of taste. Weight loss.
What should I avoid while taking Erivedge?
Do not donate blood or blood products while you are taking Erivedge and for 24 months after your final dose
How to report side effects of Genentech?
Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.
Does erivedge cause bone growth?
Bone growth problems . Bone growth problems have happened in children who have been exposed to Erivedge. These problems may continue even after stopping treatment with Erivedge
