CARY, N.C.--(BUSINESS WIRE)--Biologics, Inc. is pleased to announce the launch of the YERVOY® (ipilimumab) Education & Support (Y.E.S.) Program - designed by Biologics and sponsored by Bristol-Myers Squibb to provide a high-touch support system for patients during their YERVOY therapy. YERVOY is an IV prescription medicine, approved in March 2011, for use in adults to treat melanoma (a kind of skin cancer) that has spread or cannot be removed by surgery. It is not known if YERVOY is safe and effective in patients less than 18 years of age.
YERVOY patients enrolled in the Y.E.S. Program will be assigned a dedicated Metastatic Melanoma Nurse Specialist with extensive disease experience who will serve as an additional resource for patients – proactively reaching out to patients to provide education and support during their treatment with YERVOY. In addition, the program is designed to provide communication back to the treating oncologist, as needed. These Nurse Specialists will not provide medical advice and patients will be advised to speak to their doctors about questions relating to their health.
“Our mission at Biologics is to help deliver better support for cancer patients,” said Dan Duffy, Chief Business Development Officer. “Through our collaboration with Bristol-Myers Squibb, we believe this program will provide an extra layer of support to YERVOY patients outside of the infusion facility.”
Important Safety Information
YERVOY (ipilimumab) can cause serious side effects in many parts of your body which can lead to death. These serious side effects may include: inflammation of the intestines (colitis) that can cause tears or holes (perforation) in the intestines; inflammation of the liver (hepatitis) that can lead to liver failure; inflammation of the skin that can lead to severe skin reaction (toxic epidermal necrolysis); inflammation of the nerves that can lead to paralysis; inflammation of hormone glands (especially the pituitary, adrenal, and thyroid glands) that may affect how these glands work; and inflammation of the eyes.
These side effects are most likely to begin during treatment; however, side effects can show up months after your last infusion. Your healthcare provider should perform blood tests, such as liver and thyroid function tests, before starting and during treatment with YERVOY. Your oncologist may decide to delay or stop YERVOY.
Call your healthcare provider if you have any signs or symptoms or they get worse. Even seemingly mild symptoms can lead to severe or even life-threatening conditions if not addressed. Do not try to treat symptoms yourself.
Please see additional Important Safety Information, including Boxed WARNING regarding immune-mediated side effects, on the following pages and the accompanying Full Prescribing Information.
Important Safety Information
Serious side effects may include:
Inflammation of the intestines (colitis) that can cause tears or
holes (perforation) in the intestines. Signs and symptoms of
colitis may include:
- diarrhea (loose stools) or more bowel movements than usual
- blood in your stools or dark, tarry, sticky stools
- stomach pain (abdominal pain) or tenderness
Inflammation of the liver (hepatitis) that can lead to liver
failure. Signs and symptoms of hepatitis may include:
- yellowing of your skin or the whites of your eyes
- dark urine (tea colored)
- nausea or vomiting
- pain on the right side of your stomach
- bleeding or bruise more easily than normal
Inflammation of the skin that can lead to severe skin reaction
(toxic epidermal necrolysis). Signs and symptoms of severe skin
reactions may include:
- skin rash with or without itching
- sores in your mouth
- your skin blisters and/or peels
Inflammation of the nerves that can lead to paralysis. Symptoms
of nerve problems may include:
- unusual weakness of legs, arms, or face
- numbness or tingling in hands or feet
Inflammation of hormone glands (especially the pituitary, adrenal,
and thyroid glands) that may affect how these glands work. Signs
and symptoms that your glands are not working properly may include:
- persistent or unusual headaches
- unusual sluggishness, feeling cold all the time, or weight gain
- changes in mood or behavior such as decreased sex drive, irritability, or forgetfulness
- dizziness or fainting
Inflammation of the eyes. Symptoms may include:
- blurry vision, double vision, or other vision problems
- eye pain or redness
Pregnancy and Nursing:
- Tell your healthcare provider if you are pregnant or plan to become pregnant. YERVOY® (iplimumab) may cause stillbirth, premature delivery, and/or death of your unborn baby. Before starting YERVOY, tell your healthcare provider if you are breast- feeding. It is advised that nursing mothers do not breast feed while taking YERVOY.
Tell your healthcare provider about:
Your health problems if you:
- have an active condition where your immune system attacks your body (autoimmune disease), such as ulcerative colitis, Crohn’s disease, lupus, or sarcoidosis.
- had an organ transplant, such as a kidney transplant
- have liver damage from diseases or drugs
- have any other medical conditions
All the medicines you take including:
- all prescription and non-prescription medicines
- steroids or other medicines that lower your immune response
- herbal supplements
You should not start a new medicine before you talk with your healthcare provider who prescribes you YERVOY.
Most Common Side Effects:
The most common side effects of YERVOY include: tiredness, diarrhea, itching, and rash.
These are not all of the possible side effects of YERVOY. If you have any questions about your health or medicines, talk to your healthcare provider.
Biologics, Inc. is an oncology services company that empowers healthcare providers, payers and Biopharma to optimize cancer care for the best possible outcomes – clinical, financial and emotional. Unifying fragmented healthcare services, Biologics brings efficiency and humanity to oncology care management by focusing on the patient’s best interest as the surest path to managing cost and risk. Biologics is at the center of a rapidly changing oncology environment and supports patients across all treatment modalities. Since it was founded in 1994, Biologics has been dedicated to improving the lives of those fighting cancer. Privately held, Biologics maintains headquarters and operations in Cary, North Carolina. For more information, visit www.biologicsinc.com.