How Subcutaneous Treatments are Helping to Redefine Cancer Care
(BPT) - For individuals living with cancer, navigating treatment can be a significant challenge, often requiring substantial time commitments and disruptions to daily life. Traditionally, immunotherapy treatments have been offered through intravenous (IV) infusions. For some, the administration part of these IV treatments could be time-consuming, and could potentially add burden to patients already managing their disease. However, advancements in oncology are paving the way for patient-centric options via subcutaneous injection (under the skin), which deliver the same medicine but with reduced administration time compared to corresponding IV regimens. It should be noted, however, that this may not impact a patient's time spent in the clinic overall.
Subcutaneous administration may help address an important need for patients facing a cancer diagnosis. The cancer patient population continues to evolve, now including younger patients who may seek treatments that have faster administration time. For appropriate patients, having the option of a subcutaneous immunotherapy could meet these patient needs. Additionally, eligible patients with difficult-to-find veins may find this to be an appropriate treatment method.
An example of this evolution is Opdivo Qvantig™ (nivolumab and hyaluronidase-nvhy), the first approved subcutaneous PD-1 inhibitor immunotherapy option that is indicated to treat certain cancers, such as in adult patients with advanced RCC who have received prior anti-angiogenic therapy. Opdivo Qvantig is an injection administered under the skin that is delivered in as little as 3-5 minutes* compared to a 30-minute infusion time of Opdivo® IV. This subcutaneous treatment is an immunotherapy that is delivered differently than IV. Both are designed to work with the immune system in the same way, but Opdivo Qvantig doesn't need to be administered at an infusion center and may be given by a healthcare professional at a doctor's office or a site closer to home. This treatment works with the immune system to help fight cancer.
Opdivo and Opdivo Qvantig are associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions including pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies, nephritis with renal dysfunction, dermatologic adverse reactions, other immune-mediated adverse reactions; complications of allogeneic hematopoietic stem cell transplantation (HSCT); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo or Opdivo Qvantig are added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials. Opdivo is associated with infusion related reactions. Please see Important Safety Information below.
Choosing the most appropriate treatment is an important decision that should always be made in close consultation with your healthcare team. By offering an additional administration method for certain cancers, Opdivo Qvantig is helping to redefine the patient experience in cancer care, empowering eligible individuals with a patient-centric treatment option that may offer the flexibility to receive treatment closer to home. Ask your doctor if a subcutaneous injection may be right for you or your loved one, and visit OpdivoQvantig.com to learn more.
*This does not account for all aspects of treatment. Does not include observation time. Actual clinic time may vary.
INDICATIONS
OPDIVO QVANTIG™ (nivolumab and hyaluronidase-nvhy) is a prescription medicine used alone as a first treatment for certain adults with kidney cancer that has spread (advanced renal cell carcinoma), after completing combination treatment with intravenous nivolumab and ipilimumab.
OPDIVO QVANTIG is a prescription medicine used in combination with cabozantinib as a first treatment for adults with kidney cancer that has spread (advanced renal cell carcinoma). Please read the Patient Information that comes with cabozantinib.
OPDIVO QVANTIG is a prescription medicine used to treat adults with kidney cancer (renal cell carcinoma) when your cancer has spread after treatment with other cancer medications.
OPDIVO QVANTIG is a prescription medicine used alone to treat adults and children 12 years of age and older who weigh 66 pounds (30 kg) or more with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO QVANTIG is a prescription medicine used alone to treat adults and children 12 years of age and older who weigh 66 pounds (30 kg) or more with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma), after completing combination treatment with intravenous nivolumab and ipilimumab.
OPDIVO QVANTIG is a prescription medicine used to treat a kind of skin cancer called melanoma. It may be used alone in adults and children 12 years of age and older who weigh 66 pounds (30 kg) or more with Stage IIB, Stage IIC, Stage III or Stage IV melanoma to help prevent melanoma from coming back after it has been completely removed by surgery.
OPDIVO QVANTIG is a prescription medicine used in combination with chemotherapy that contains platinum and another chemotherapy medicine, before you have surgery, for adults with early-stage lung cancer (called non-small cell lung cancer).
OPDIVO QVANTIG is a prescription medicine used in combination with chemotherapy that contains platinum and another chemotherapy medicine, before you have surgery, for adults with early stage lung cancer (called non-small cell lung cancer) that does not have an abnormal EGFR or ALK gene and then may be continued alone after surgery to help prevent your lung cancer from coming back.
OPDIVO QVANTIG is a prescription medicine used alone to treat adults with a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread and you have received chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal EGFR or ALK gene, you should have also received a FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
OPDIVO QVANTIG is a prescription medicine used alone to treat adults with head and neck cancer (squamous cell carcinoma) that has come back or spread and you have received chemotherapy that contains platinum and it did not work or is no longer working.
OPDIVO QVANTIG is a prescription medicine used alone to treat adults with cancer of the lining of the urinary tract (including the bladder, ureters, or renal pelvis) [urothelial carcinoma] to help prevent cancer of the urinary tract from coming back after it was removed by surgery.
OPDIVO QVANTIG is a prescription medicine used in combination with chemotherapy medicines cisplatin and gemcitabine, as a first line treatment for adults whose urinary tract cancer has spread (metastatic) or cannot be removed by surgery.
OPDIVO QVANTIG is a prescription medicine used alone to treat adults with cancer of the lining of the urinary tract (including the bladder, urethra, ureters, or renal pelvis) [urothelial carcinoma] when it has spread (locally advanced or metastatic) and you have received chemotherapy that contains platinum, and it did not work or is no longer working or your cancer worsened within 12 months of treatment with chemotherapy that contains platinum, either before or after surgery to remove your cancer.
OPDIVO QVANTIG is a prescription medicine used alone to treat adults and children 12 years of age and older who weigh 66 pounds (30 kg) or more with a type of colon or rectal cancer (colorectal cancer or CRC), after completing combination treatment with intravenous nivolumab and ipilimumab, when your cancer cannot be removed with surgery, or has spread, and is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
OPDIVO QVANTIG is a prescription medicine used alone to treat adults and children 12 years of age and older who weigh 66 pounds (30 kg) or more with a type of colon or rectal cancer (colorectal cancer or CRC) that has spread, is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
OPDIVO QVANTIG is a prescription medicine used alone as a first treatment for adults with a type of liver cancer called hepatocellular carcinoma (HCC) after completing combination treatment with intravenous nivolumab and ipilimumab, when your cancer cannot be removed with surgery or has spread.
OPDIVO QVANTIG is a prescription medicine used alone to treat adults with a type of liver cancer called hepatocellular carcinoma (HCC) after completing combination treatment with intravenous nivolumab and ipilimumab when your cancer cannot be removed with surgery or has spread), and you have received prior treatment with sorafenib.
OPDIVO QVANTIG is a prescription medicine used in adults to help prevent cancer of the tube that connects your throat to your stomach (esophageal cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer) from coming back after it has been treated with chemoradiation followed by surgery to completely remove the cancer, but some cancer cells were still present in the removed tumor or lymph nodes.
OPDIVO QVANTIG is prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum as a first treatment to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) when your cancer is a type called squamous cell carcinoma and cannot be removed with surgery or has spread and your tumors are positive for PD-L1.
OPDIVO QVANTIG is a prescription medicine used alone to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) if your esophageal cancer is a type called squamous cell carcinoma, and cannot be removed with surgery, and has come back or spread after you have received chemotherapy that contains fluoropyrimidine and platinum.
OPDIVO QVANTIG is a prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum to treat adults with cancer of the stomach (gastric), junction between the stomach and esophagus (gastroesophageal junction), and esophagus that is a type called esophageal adenocarcinoma and cannot be removed with surgery or has spread and your tumors are positive for PD-L1.
OPDIVO® (nivolumab) is a prescription medicine used to treat adults and children 12 years of age or older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO is a prescription medicine used in combination with YERVOY® (ipilimumab) to treat adults and children 12 years of age or older with a type of skin cancer called melanoma that has spread or cannot be removed by surgery (advanced melanoma).
OPDIVO is a prescription medicine used to treat a kind of skin cancer called melanoma. It may be used alone in adults and children 12 years and older with Stage IIB, Stage IIC, Stage III or Stage IV melanoma to help prevent melanoma from coming back after it has been completely removed by surgery.
OPDIVO is a prescription medicine used in combination with chemotherapy that contains platinum and another chemotherapy medicine, before you have surgery, for adults with early-stage lung cancer (called non-small cell lung cancer).
OPDIVO is a prescription medicine used in combination with chemotherapy that contains platinum and another chemotherapy medicine, before you have surgery, for adults with early stage lung cancer (called non-small cell lung cancer) that does not have an abnormal EGFR or ALK gene and then may be continued alone after surgery to help prevent your lung cancer from coming back.
OPDIVO is a prescription medicine used in combination with YERVOY as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread to other parts of your body (metastatic) and your tumors are positive for PD-L1, but do not have an abnormal EGFR or ALK gene.
OPDIVO is a prescription medicine used in combination with YERVOY and 2 cycles of chemotherapy that contains platinum and another chemotherapy medicine, as a first treatment for adults with a type of advanced stage lung cancer (called non-small cell lung cancer) when your lung cancer has spread or comes back, and your tumor does not have an abnormal EGFR or ALK gene.
OPDIVO is a prescription medicine used to treat adults with a type of advanced stage lung cancer (called non-small cell lung cancer) that has spread and you have received chemotherapy that contains platinum, and it did not work or is no longer working. If your tumor has an abnormal EGFR or ALK gene, you should have also received an EGFR or ALK inhibitor medicine and it did not work or is no longer working.
OPDIVO is a prescription medicine used in combination with YERVOY as a first treatment for adults with a type of cancer that affects the lining of the lungs and chest wall called malignant pleural mesothelioma which cannot be removed by surgery.
OPDIVO is a prescription medicine used in combination with YERVOY as a first treatment for certain adults with kidney cancer that has spread (advanced renal cell carcinoma).
OPDIVO is a prescription medicine used in combination with cabozantinib as a first treatment for adults with kidney cancer that has spread (advanced renal cell carcinoma). Please read the Patient Information that comes with cabozantinib.
OPDIVO is a prescription medicine used to treat people with kidney cancer (renal cell carcinoma) when your cancer has spread after treatment with other cancer medications.
OPDIVO is a prescription medicine used to treat people with head and neck cancer (squamous cell carcinoma) that has come back or spread and you have received chemotherapy that contains platinum and it did not work or is no longer working.
OPDIVO is a prescription medicine used to treat adults with cancer of the lining of the urinary tract (including the bladder, urethra, ureters, or renal pelvis) [urothelial carcinoma] when it has spread (locally advanced or metastatic) and you have received chemotherapy that contains platinum, and it did not work or is no longer working or your cancer worsened within 12 months of treatment with chemotherapy that contains platinum, either before or after surgery to remove your cancer.
OPDIVO is a prescription medicine used to treat adults with cancer of the lining of the urinary tract (including the bladder, ureters, or renal pelvis) [urothelial carcinoma] to help prevent cancer of the urinary tract from coming back after it was removed by surgery.
OPDIVO is a prescription medicine used in combination with chemotherapy medicines cisplatin and gemcitabine, as a first line treatment when your urinary tract cancer has spread (metastatic) or cannot be removed by surgery.
OPDIVO is a prescription medicine that may be used in combination with YERVOY to treat adults and children 12 years of age and older, with a type of colon or rectal cancer (colorectal cancer) that cannot be removed with surgery, or has spread, and is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).
OPDIVO is a prescription medicine that may be used alone to treat adults and children 12 years of age and older with a type of colon or rectal cancer (colorectal cancer) that has spread, and is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR), and you have received treatment with a fluoropyrimidine, oxaliplatin, and irinotecan, and it did not work or is no longer working.
OPDIVO is a prescription medicine used in combination with YERVOY as a first treatment for adults with a type of liver cancer called hepatocellular carcinoma that cannot be removed by surgery or has spread.
OPDIVO is a prescription medicine used in combination with YERVOY to treat adults with a type of liver cancer called hepatocellular carcinoma (HCC) when your liver cancer cannot be removed by surgery or has spread, and you have received prior treatment with sorafenib.
OPDIVO is a prescription medicine used to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) if your esophageal cancer is a type called squamous cell carcinoma, and cannot be removed with surgery, and has come back or spread after you have received chemotherapy that contains fluoropyrimidine and platinum.
OPDIVO is a prescription medicine that may be used in adults to help prevent cancer of the tube that connects your throat to your stomach (esophageal cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer) from coming back after it has been treated with chemoradiation followed by surgery to completely remove the cancer, but some cancer cells were still present in the removed tumor or lymph nodes.
OPDIVO is a prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum as a first treatment to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) when your cancer is a type called squamous cell carcinoma and cannot be removed with surgery or has spread, and your tumors are positive for PD-L1.
OPDIVO is a prescription medicine used in combination with YERVOY as a first treatment to treat adults with cancer of the tube that connects your throat to your stomach (esophageal cancer) when your cancer is a type called squamous cell carcinoma and cannot be removed with surgery or has spread, and your tumors are positive for PD-L1.
OPDIVO is a prescription medicine used in combination with chemotherapy that contains fluoropyrimidine and platinum to treat adults with cancer of the stomach (gastric), junction between the stomach and esophagus (gastroesophageal junction), and esophagus that is a type called adenocarcinoma and cannot be removed with surgery or has spread, and your tumors are positive for PD-L1.
It is not known if OPDIVO or OPDIVO QVANTIG is safe and effective in children younger than 12 years of age with melanoma or MSI-H or dMMR metastatic colorectal cancer.
It is not known if OPDIVO or OPDIVO QVANTIG is safe and effective in children for the treatment of any other cancers.
IMPORTANT SAFETY INFORMATION FOR OPDIVO QVANTIG (nivolumab and hyaluronidase-nvhy), OPDIVO (nivolumab), and YERVOY (ipilimumab)
What is the most important information I should know about OPDIVO QVANTIG, OPDIVO, and YERVOY?
OPDIVO QVANTIG, OPDIVO, and YERVOY are medicines that may treat certain cancers by working with your immune system. OPDIVO QVANTIG, OPDIVO, and YERVOY can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or can lead to death. These problems may happen anytime during treatment or even after your treatment has ended. You may have more than one of these problems at the same time. Some of these problems may happen more often when OPDIVO QVANTIG or OPDIVO are used in combination with another therapy.
Call or see your healthcare provider right away if you develop any new or worsening signs or symptoms, including:
Lung problems:cough; shortness of breath; chest pain
Intestinal problems:diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky, or have blood or mucus; severe stomach-area (abdominal) pain or tenderness
Liver problems:yellowing of your skin or the whites of your eyes; severe nausea or vomiting; pain on the right side of your stomach area (abdomen); dark urine (tea colored); bleeding or bruising more easily than normal
Hormone gland problems:headaches that will not go away or unusual headaches; eye sensitivity to light; eye problems; rapid heartbeat; increased sweating; extreme tiredness; weight gain or weight loss; feeling more hungry or thirsty than usual; urinating more often than usual; hair loss; feeling cold; constipation; your voice gets deeper; dizziness or fainting; changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems:decrease in your amount of urine; blood in your urine; swelling of your ankles; loss of appetite
Skin problems:rash; itching; skin blistering or peeling; swollen lymph nodes, painful sores or ulcers in mouth or nose, throat, or genital area; fever or flu-like symptoms
Eye problems:blurry vision, double vision, or other vision problems; eye pain or redness
Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with OPDIVO QVANTIG, OPDIVO, and YERVOY. Call or see your healthcare provider right away for any new or worsening signs or symptoms, which may include:
- Chest pain, irregular heartbeat, shortness of breath or swelling of ankles
- Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
- Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
- Persistent or severe muscle pain or weakness, muscle cramps
- Low red blood cells, bruising
Rejection of a transplanted organ or tissue.Your healthcare provider should tell you what signs and symptoms you should report and monitor you depending on the type of organ or tissue transplant that you have had.
Getting medical treatment right away may help keep these problems from becoming more serious.Your healthcare provider will check you for these problems during treatment with OPDIVO QVANTIG, OPDIVO, and YERVOY. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with OPDIVO QVANTIG, OPDIVO, or YERVOY, if you have severe side effects.
What are the possible side effects of OPDIVO QVANTIG, OPDIVO, and YERVOY?
OPDIVO QVANTIG, OPDIVO, and YERVOY can cause serious side effects, including:
- See "What is the most important information I should know about OPDIVO QVANTIG, OPDIVO, and YERVOY?"
- Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).These complications can be severe and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with OPDIVO QVANTIG, OPDIVO, or YERVOY. Your healthcare provider will monitor you for signs of complications if you have an allogeneic stem cell transplant.
OPDIVO and YERVOY can cause serious side effects, including:
- Severe infusion reactions.Tell your healthcare team right away if you get these symptoms during an infusion of OPDIVO or YERVOY: chills or shaking; itching or rash; flushing; shortness of breath or wheezing; dizziness; feel like passing out; fever; back or neck pain.
The most common side effects of OPDIVO QVANTIG when used alone in people with renal cell carcinoma include:pain in muscles, bones, and joints; feeling tired; itching; rash; low thyroid hormone levels; diarrhea; cough; stomach-area (abdominal) pain.
The most common side effects observed with nivolumab given into the vein (intravenous nivolumab), which may be experienced with OPDIVO QVANTIG, are shown below.
The most common side effects of OPDIVO, when used alone, include:feeling tired; rash; pain in muscles, bones, and joints; itching; diarrhea; nausea; weakness; cough; shortness of breath; constipation; decreased appetite; back pain; upper respiratory tract infection; fever; headache; stomach-area (abdominal) pain; vomiting; and urinary tract infection.
The most common side effects of OPDIVO, when used in combination with cabozantinib, include:diarrhea; feeling tired; liver problems; rash, redness, pain, swelling or blisters on the palms of your hands or soles of your feet; mouth sores; rash; high blood pressure; low thyroid hormone levels; pain in muscles, bones, and joints; decreased appetite; nausea; change in the sense of taste; stomach-area (abdominal) pain; cough; upper respiratory tract infection.
The most common side effects of OPDIVO, when used in combination with a platinum-containing chemotherapy and chemotherapy, include:nausea; feeling tired; pain in muscles, bones, and joints; constipation; decreased appetite; rash; vomiting; numbness, pain, tingling, or burning in your hands, and feet.
The most common side effects of OPDIVO when used in combination with platinum-containing chemotherapy and another chemotherapy medicine before having surgery for NSCLC include:nausea; constipation; feeling tired; decreased appetite; rash.
The most common side effects of OPDIVO, when used in combination with YERVOY, include:feeling tired; diarrhea; rash; itching; nausea; pain in muscles, bones, and joints; fever; cough; decreased appetite; vomiting; stomach-area (abdominal) pain; shortness of breath; upper respiratory tract infection; headache; low thyroid hormone levels (hypothyroidism); constipation; decreased weight; and dizziness.
The most common side effects of OPDIVO, when used in combination with YERVOY and a platinum-containing chemotherapy and another chemotherapy, include:feeling tired; pain in muscles, bones, and joints; nausea; diarrhea; rash; decreased appetite; constipation; and itching.
The most common side effects of OPDIVO when used in combination with fluoropyrimidine and platinum-containing chemotherapy include:nausea; numbness, pain, tingling, or burning in your hands or feet; decreased appetite; feeling tired; constipation; mouth sores; diarrhea; vomiting; stomach-area (abdominal) pain; pain in muscles bones, and joints.
These are not all the possible side effects. For more information, ask your healthcare provider or pharmacist. You are encouraged to report side effects of prescription drugs to FDA. Call 1-800-FDA-1088.
Before receiving OPDIVO QVANTIG or OPDIVO or YERVOY, tell your healthcare provider about all of your medical conditions, including if you:
- have immune system problems such as Crohn's disease, ulcerative colitis, or lupus.
- have received an organ or tissue transplant, including corneal transplant.
- have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic).
- have received radiation treatment to your chest area in the past and have received other medicines that are like OPDIVO, YERVOY, or OPDIVO QVANTIG.
- have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome.
- are pregnant or plan to become pregnant. OPDIVO QVANTIG, OPDIVO, and YERVOY can harm your unborn baby.
- are breastfeeding or plan to breastfeed. It is not known if OPDIVO QVANTIG, OPDIVO, or YERVOY pass into your breast milk. Do not breastfeed during treatment and for 5 months after your last dose of OPDIVO QVANTIG, OPDIVO, or YERVOY.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start receiving OPDIVO QVANTIG, OPDIVO, or YERVOY.
- You should use an effective method of birth control during treatment and for 5 months after your last dose of OPDIVO QVANTIG, OPDIVO, or YERVOY. Talk to your healthcare provider about birth control methods that you can use during this time.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with OPDIVO QVANTIG, OPDIVO, or YERVOY.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO QVANTIG. Please see U.S. Full Prescribing Information and Medication Guide for OPDIVO and YERVOY.
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OPDIVO®, OPDIVO Qvantig™, and the related logos are trademarks of Bristol-Myers Squibb Company.
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