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YERVOY® (Ipilimumab)

Trade name: Ipilimumab

Generic name: YERVOY®

Therapeutic Class: monoclonal antibody  

Manufacturer / Distributor: Bristol-Myers Squibb Eeig  

Availability: YERVOY® is available by prescription only  

Mode of Action (MOA): Ipilimumab is a new anticancer drug. It works as an antibody by interacting with the cytotoxic lymphocyte antigen 4 (CTLA-4), thus causing the death of tumor cells.  

Indication: YERVOY® is indicated for the treatment of patients with unresectable or metastatic melanoma after failure of at least one line of treatment. Scientists are also working on implementing the drug in the treatment of lung cancer and prostate cancer. In the last debates held in the presence of a representative of the National League against Cancer, the marketer of drug offered promising perspective in its use against advanced melanoma.  

 

A Phase 3 study conducted in patients with metastatic melanoma who have received at least one treatment line showed an overall 1-year survival of 46% in patients treated with ipilimumab. The most frequently reported side effects are diarrhea, skin reactions and other potentially severe immunological reactions that reflect the mode of action of the drug. This drug is currently the subject of a first-line treatment of metastatic melanoma, as well as other cancers, in combination with other anticancer drugs.  

 

The use of Ipilimumab seems favorable in Europe. The French Agency for the Safety of Health Products (AFSSaPS) said that the European Medicines Agency (EMA) issued a positive opinion on May 19, 2011 for the granting of a marketing authorization for the drug to the laboratory Bristol-Myers Squibb Pharma EEIG. A risk management plan will be implemented as part of the placing on the market, particularly to monitor the immunological adverse ractions of the medication on patients.  

Dosage form: YERVOY is given by infusion into a vein (intravenous, IV). 

Dosage: YERVOY is recommenmded to be taken at a dose of 3 mg / kg by intravenous infusion over a 90 minute period, every 3 weeks, for a total of 4 doses. Except in case of intolerance or complications, it is highly recommended that patients complete the entire therapy, regardless of development of new lesions or growth of existing lesions. The response of the tumor to the drug should be assessed at the end of the therapy.  

Precautions: Ipilimumab may cause damage to the liver and the tyrpid gland. Thyroid and liver functions should be evaluated prior to initiation of treatment with YERVOY and before each administration. In addition, any signs or symptoms of immunological side effects, such as diarrhea and colitis, must be assessed during the treatment with the medication.  

Side Effects: Common side effects of Ipilimumab include:

Irritability

Forgetfulness

Dizziness

Weight gain

Darkness of urine

Stomach pain

Sluggishness

Low sex drive

Persisten headaches

Eye pain or redness

Blurred and/or double vision

Diarrhea or frequent bowel movements

Bloody or black, tarry, sticky stools

Stomach pain or tenderness

Yellowing of the skin or eyes

Nausea or vomiting

Easy bruising or bleeding

Skin rash which can be itchy

Blistering or peeling skin

Sores in the mouth

Unusual weakness of the legs, arms, or face

Numbness or tingling in the hands or feet

Feeling cold all the time. 

Warnings: Ipilimumab may cause severe or life-threatening side effects such as fainting; inflammation of the intestine; damage or inflammation of the liver, inflammation of the skin, and damage to the nerves: paralysis, loss of ability to move all or part of the body. See your oncologist immediately I you experience any of the following symptoms.

 

 

References:  

  1. "FDA Rubber-Stamps Bristol-Myers Squibb’s Melanoma mAb". Genetic Engineering & Biotechnology News. 2011-03-28. Retrieved 2011-03-28. 
  2. Lacroix, Marc (2014). Targeted Therapies in Cancer. Hauppauge , NY: Nova Sciences Publishers. ISBN 978-1-63321-687-7.  
  3. USAN. "STATEMENT ON A NONPROPRIETARY NAME ADOPTED BY THE USAN COUNCIL - ipilimumab" (Press release). American Medical Association (AMA). Retrieved 2013-01-12. 
  4. Clinical trial number NCT00527735 at ClinicalTrials.gov Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC)  
  5. Antoni Ribas (28 June 2012). "Tumor immunotherapy directed at PD-1". New England Journal of Medicine 366 (26): 2517–9. doi:10.1056/nejme1205943.  
  6. Clinical trial number NCT01524991 at ClinicalTrials.gov  
  7. Clinical trial number NCT00323882 at ClinicalTrials.gov Phase I/II Study of MDX-010 in Patients With Metastatic Hormone-Refractory Prostate Cancer (MDX010-21) (COMPLETED)  
  8. Breakthrough of the Year: Cancer Immunotherapy, Science 20 December 2013, Vol. 342 no. 6165 pp. 1432-1433, DOI: 10.1126/science.342.6165.1432, Jennifer Couzin-Frankel  
  9. Jefferson E (2011-03-25). "FDA approves new treatment for a type of late-stage skin cancer" (Press release). U.S. Food and Drug Administration (FDA). Retrieved 2011-03-25.  
  10. Pollack, Andrew (2011-03-25). "Approval for Drug That Treats Melanoma". The New York Times. Retrieved 2011-03-27.  
  11. Notice of Decision for YERVOY  
  12. "Bristol-Myers Squibb Receives Positive Decision from National Institute of Health and Clinical Excellence (NICE) for YERVOY® (ipilimumab)" (Press release). November 1, 2012. Retrieved December 17, 2012.  
  13. http://www.nlm.nih.gov/medlineplus/druginfo/meds/a611023.html