On May 7, 2018 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that new data from early and late-stage clinical studies on more than 19 approved and investigational cancer medicines, will be presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place from June 1-5 in Chicago (Press release, Genentech, MAY 7, 2018, View Source [SID1234526180]). More than 90 abstracts have been accepted across 13 cancer types, including two "late breakers" and 15 oral presentations.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"New data to be presented from our industry-leading oncology portfolio, including lung and hematology programs, will demonstrate how our science-driven approach aims to improve outcomes for people living with cancer," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "At ASCO (Free ASCO Whitepaper), we look forward to sharing our progress and commitment to build the future of personalized healthcare in oncology."
Key presentations in lung cancer
Key data to be presented at ASCO (Free ASCO Whitepaper) cover advances from Genentech’s lung cancer program, including a combination approach using the cancer immunotherapy Tecentriq (atezolizumab) with targeted therapies and a range of different chemotherapies.
Updated overall survival (OS) data and new patient-reported outcomes (PROs) data from the Phase III IMpower150 study of Tecentriq plus Avastin (bevacizumab) and chemotherapy (carboplatin and paclitaxel) in people with previously-untreated, metastatic non-squamous non-small cell lung cancer (NSCLC), will be presented. The U.S. Food and Drug Administration (FDA) recently granted Priority Review for this combination in the same patient population.
New progression-free survival (PFS) results from the Phase III IMpower131 study of Tecentriq plus chemotherapy (carboplatin and Abraxane [albumin-bound paclitaxel; nab -paclitaxel]) as an initial (first-line) treatment for people with advanced squamous NSCLC. The IMpower131 data will be featured as part of ASCO (Free ASCO Whitepaper)’s official press program on Saturday, June 2.
Additional results in lung cancer including longer follow-up data from the Phase III ALEX study of Alecensa (alectinib) versus crizotinib in people with previously untreated anaplastic lymphoma kinase (ALK)-positive NSCLC will be shared. These data build on the primary results from the ALEX study first presented at ASCO (Free ASCO Whitepaper) 2017, which demonstrated a significant reduction in the risk of disease progression or death versus crizotinib. New data that utilize the application of a real-world endpoint to identify and characterize genetic profiles of people with a poor prognosis in advanced NSCLC will also be presented at the congress.
Additional presentations with cancer immunotherapy
Additional cancer immunotherapy data presentations of note include new Tecentriq plus Avastin PROs from the Phase III IMmotion151 study in advanced renal cell carcinoma (RCC), and the Phase Ib data for the combination of Tecentriq plus Avastin in first-line hepatocellular carcinoma (HCC). These studies add to the growing body of evidence that support the use of Tecentriq plus Avastin across multiple tumor types. New tumor mutational burden (TMB) data from two studies of Tecentriq will also be presented, including blood-based TMB data from the Phase II B-F1RST study in advanced NSCLC, and tissue-based TMB data across multiple tumor types including NSCLC, metastatic urothelial carcinoma and melanoma.
Key presentations in blood cancers
Data from pivotal studies in hematology will also be presented at ASCO (Free ASCO Whitepaper). Additional analysis on minimal residual disease (MRD) rates will be shared from the Phase III MURANO study evaluating Venclexta (venetoclax) plus Rituxan (rituximab) compared to bendamustine plus Rituxan in people with relapsed or refractory chronic lymphocytic leukemia (CLL). An sNDA based on the MURANO data was granted Priority Review by the FDA, with an action date of June 28, 2018.
Additional data will also be presented from the Phase Ib M14-358 study of Venclexta plus azacitidine or decitabine in people with previously untreated acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. Venclexta is being developed by AbbVie and Genentech.
Data from the randomized Phase II study evaluating polatuzumab vedotin in combination with bendamustine chemotherapy and Rituxan in people with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) will also be presented at the congress.
Key presentations in breast cancer
Updates from two investigational medicines in breast cancer will be presented at ASCO (Free ASCO Whitepaper). Data includes results from the Phase III SANDPIPER study of taselisib (GDC-0332) and fulvestrant compared to fulvestrant alone in estrogen receptor (ER)-positive, PIK3CA-mutant, locally advanced or metastatic breast cancer, and updated OS data from the LOTUS trial of ipatasertib (GDC-0068, RG7440) and paclitaxel for previously untreated, locally advanced or metastatic triple-negative breast cancer. The SANDPIPER data will be featured as part of ASCO (Free ASCO Whitepaper)’s official press program on Saturday, June 2.
Visit View Source for resources and perspectives from scientists, doctors and others in the cancer community on important topics at ASCO (Free ASCO Whitepaper). Follow Genentech on Twitter via @genentech and keep up to date with ASCO (Free ASCO Whitepaper) 2018 Annual Meeting news and updates by using the hashtag #ASCO18.
Abraxane is a registered trademark of Abraxis Bioscience, LLC, a wholly owned subsidiary of Celgene Corporation.
About Alecensa
Alecensa is a kinase inhibitor approved for the treatment of people with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test.
Important Safety Information
Everyone reacts differently to treatment with Alecensa. It’s important to know the most serious and most common side effects with Alecensa.
A doctor may lower the dose or stop treatment with Alecensa if any serious side effects occur. Patients taking Alecensa should contact their doctor right away if they have any of the following side effects.
Alecensa may cause serious side effects, including:
Liver problems (hepatotoxicity). Alecensa may cause liver injury. A doctor will do blood tests at least every 2 weeks for the first 3 months and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they experience any of the following signs and symptoms:
Feeling tired
Feeling less hungry than usual
Yellowing of the skin or whites of the eyes
Dark urine
Itchy skin
Nausea or vomiting
Pain on the right side of stomach area
Bleeding or bruising more easily than normal
Lung problems. Alecensa may cause severe or life-threatening swelling (inflammation) of the lungs during treatment. Symptoms may be similar to those symptoms from lung cancer. Patients taking Alecensa should tell their doctor right away if they have any new or worsening symptoms, including:
Trouble breathing
Shortness of breath
Fever
Cough
Kidney problems. Alecensa may cause severe or life-threatening kidney problems. Tell your healthcare provider right away if you have a change in the amount or color of your urine, or if you get new or worsening swelling in your legs or feet.
Slow heartbeat (bradycardia). Alecensa may cause very slow heartbeats that can be severe. A doctor will check a patient’s heart rate and blood pressure during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they feel dizzy, lightheaded, or faint during treatment with Alecensa. Patients taking Alecensa should tell their doctor if they take any heart or blood pressure medicines.
Muscle pain, tenderness, and weakness (myalgia). Muscle problems are common with Alecensa and can be severe. A doctor will do blood tests at least every 2 weeks for the first month and as needed during treatment with Alecensa. Patients taking Alecensa should tell their doctor right away if they have any new or worsening signs and symptoms of muscle problems, including unexplained muscle pain or muscle pain that does not go away, tenderness, or weakness.
Before taking Alecensa, patients should tell their doctor about all medical conditions, including if they:
Have liver problems
Have lung or breathing problems
Have a slow heartbeat
Are pregnant or plan to become pregnant. Alecensa can harm an unborn baby. Patients taking Alecensa should tell their doctor right away if they become pregnant during treatment with Alecensa or think they may be pregnant
Women who are able to become pregnant should use effective birth control during treatment with Alecensa and for one week after the final dose of Alecensa
Men who have female partners that are able to become pregnant should use effective birth control during treatment with Alecensa and for three months after the final dose of Alecensa
Are breastfeeding or plan to breastfeed. It is not known if Alecensa passes into breast milk. A patient should not breastfeed during treatment with Alecensa and for one week after the final dose of Alecensa. Patients should talk with their doctor about the best way to feed their baby during this time.
Patients taking Alecensa should tell their doctor about all the medicines they take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
Patients taking Alecensa should avoid spending time in the sunlight during treatment with Alecensa and for seven days after the final dose of Alecensa. Patients taking Alecensa may burn more easily and get severe sunburns. Patients taking Alecensa should use sunscreen and lip balm with a SPF 50 or greater to help protect against sunburn.
The most common side effects of Alecensa include:
Tiredness
Constipation
Swelling in hands, feet, ankles, and eyelids
Low red blood cell count
These are not all of the possible side effects of Alecensa. For more information, patients should ask their doctor or pharmacist. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at (800) FDA-1088 or View Source Patients and caregivers may also report side effects to Genentech at (888) 835-2555.
Please see additional Important Safety Information in full Prescribing Information, including Patient Information .
About Rituxan
Rituxan Indications
Rituxan (rituximab) injection, for intravenous use, is indicated for the treatment of patients with:
Low-grade or follicular CD20-positive non-Hodgkin’s lymphoma as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
Follicular CD20-positive non-Hodgkin’s lymphoma as an initial treatment with chemotherapy, and in patients whose initial treatment was successful, as a single-agent follow-up therapy
Low-grade CD20-positive non-Hodgkin’s lymphoma as a single-agent follow-up therapy for patients who did not progress on initial treatment with CVP chemotherapy
CD20-positive diffuse large B-cell non-Hodgkin’s lymphoma as an initial treatment in combination with CHOP chemotherapy
CD20-positive chronic lymphocytic leukemia in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred
People with serious infections should not receive Rituxan.
It is not known if Rituxan is safe or effective in children.
Important Safety Information:
Patients must tell their doctor right away about any side effects they experience. Rituxan can cause serious side effects that can lead to death, including:
Infusion Reactions: may occur during or within 24 hours of the infusion. The patient’s doctor should give the patient medicines before their treatment. Symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart, or chest pain.
Severe Skin and Mouth Reactions: symptoms can include painful sores, ulcers, or blisters on the skin, lips or mouth; peeling skin; rash; or pustules.
Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems including liver failure and death. If patients have had hepatitis B or are carriers of HBV, receiving Rituxan could cause the virus to become an active infection again. Patients should not receive Rituxan if they have active HBV liver disease. The patient’s doctor will do blood tests to check for HBV infection prior to treatment and will monitor the patient during and for several months following their treatment.
Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection that can lead to severe disability and death and for which there is no known prevention, treatment or cure. Symptoms can include difficulty thinking, loss of balance, changes in speech or walking, weakness on one side of the body, or blurred or lost vision.
Additional possible serious side effects of Rituxan:
Patients must tell their doctor right away about any side effects they experience. Rituxan can cause serious side effects that can lead to death, including:
Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, and can lead to death. The patient’s doctor may give the patient medicines before their treatment to help prevent TLS.
Serious Infections: can happen during and after treatment and can lead to death. These infections may be bacterial, fungal, or viral. Symptoms can include fever; cold or flu symptoms; earache or headache; pain during urination; white patches in the mouth or throat; cuts or scrapes that are red, warm, swollen or painful.
Heart Problems: symptoms can include chest pain and irregular heartbeats that may require treatment. The patient’s doctor may need to stop their treatment.
Kidney Problems: the patient’s doctor should do blood tests to check how well the patient’s kidneys are working.
Stomach and Serious Bowel Problems: can include blockage or tears in the bowel that can lead to death. Stomach area pain during treatment can be a symptom.
Low Blood Cell Counts: the patient’s blood cell counts may be monitored during treatment.
The most common side effects of Rituxan are infusion reactions, chills, infections, body aches, tiredness, and low white blood cells.
Other side effects with Rituxan include:
aching joints during or within hours of receiving an infusion
more frequent upper respiratory tract infection
Patients must tell their doctor if they are pregnant, plan to become pregnant, or are breastfeeding. It is not known if Rituxan may harm the patient’s unborn baby or pass into the patient’s breast milk. Women should use birth control while using Rituxan and for 12 months after treatment.
Patients must tell their doctor about any side effect that bothers them or that does not go away. These are not all of the possible side effects of Rituxan. For more information, patients should ask their doctor or pharmacist.
Please visit View Source for the Rituxan full Prescribing Information, including BOXED WARNINGS and the Medication Guide, for additional Important Safety Information.
Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.
About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Tecentriq U.S. Indication (pronounced ‘tē-SEN-trik’)
Tecentriq is a prescription medicine used to treat:
a type of bladder and urinary tract cancer called urothelial carcinoma.
Tecentriq may be used when your bladder cancer:
has spread or cannot be removed by surgery (advanced urothelial carcinoma), and
you are not able to take chemotherapy that contains a medicine called cisplatin, or
you have tried chemotherapy that contains platinum, and it did not work or is no longer working
The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.
A type of lung cancer called non-small cell lung cancer (NSCLC).
Tecentriq may be used when your lung cancer:
has spread or grown, and
you have tried 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 tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
It is not known if Tecentriq is safe and effective in children.
Important Safety Information
Important Information About Tecentriq
Tecentriq can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life threatening and can lead to death.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
Tecentriq can cause serious side effects, including:
Lung problems (pneumonitis ) – signs and symptoms may include new or worsening cough, shortness of breath, and chest pain
Liver problems (hepatitis) – signs and symptoms of hepatitis may include yellowing of the skin or the whites of the eyes, severe nausea or vomiting, pain on the right side of the stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual
Intestinal problems (colitis) – signs and symptoms of colitis may include diarrhea (loose stools) or more bowel movements than usual, blood or mucous in the stools or dark, tarry, sticky stools, and severe stomach area (abdomen) pain or tenderness
Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary) – signs and symptoms that the hormone glands are not working properly may include headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior (such as decreased sex drive, irritability, or forgetfulness), feeling cold, constipation, voice gets deeper, urinating more often than usual, nausea or vomiting, and stomach area (abdomen) pain
Problems in other organs – signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
Severe infections – signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating, and frequent urination or back pain
Severe infusion reactions – signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of the face or lips, dizziness, fever, feeling like passing out, and back or neck pain
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat a patient with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if a patient has severe side effects.
Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:
Have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus); have had an organ transplant; have lung or breathing problems; have liver problems; have a condition that affects their nervous system (such as myasthenia gravis or Guillain-Barre syndrome); or are being treated for an infection
Are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby. If patients are able to become pregnant, they should use an effective method of birth control during treatment and for at least 5 months after the last dose of Tecentriq
Are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into the breast milk. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of Tecentriq in people with urothelial carcinoma include:
feeling tired
decreased appetite
nausea
constipation
urinary tract infection
diarrhea
fever
The most common side effects of Tecentriq in people with non-small cell lung cancer include:
feeling tired
decreased appetite
muscle pain
cough
shortness of breath
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.
These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects.
Report side effects to the FDA at 1-800-FDA-1088 or View Source Report side effect to Genentech at 1-888-835-2555.
Please visit View Source for the Tecentriq full Prescribing Information for additional Important Safety Information.
About Avastin (bevacizumab)
Avastin is a prescription-only medicine that is a solution for intravenous infusion. It is a biologic antibody designed to specifically bind to a protein called vascular endothelial growth factor (VEGF) that plays an important role throughout the lifecycle of the tumor to develop and maintain blood vessels, a process known as angiogenesis. Avastin is designed to interfere with the tumor blood supply by directly binding to the VEGF protein to prevent interactions with receptors on blood vessel cells. The tumor blood supply is thought to be critical to a tumor’s ability to grow and spread in the body (metastasize).
Avastin Indications:
Metastatic colorectal cancer (mCRC) for first- or second-line treatment in combination with intravenous 5-fluorouracil–based chemotherapy. It is also approved to treat mCRC for second-line treatment when used with fluoropyrimidine-based (combined with irinotecan or oxaliplatin) chemotherapy after cancer progresses following a first-line treatment that includes Avastin.
Avastin is not approved for use after the primary treatment of colon cancer that has not spread to other parts of the body.
Advanced nonsquamous non–small cell lung cancer (NSCLC) in combination with carboplatin and paclitaxel in people who have not received chemotherapy for their advanced disease.
Metastatic kidney cancer (mRCC) when used with interferon alfa.
Glioblastoma (GBM) in adult patients whose cancer has progressed after prior treatment (recurrent or rGBM).
Advanced cervical cancer (CC) in combination with paclitaxel and cisplatin or paclitaxel and topotecan is approved to treat persistent, recurrent, or metastatic cancer of the cervix.
Recurrent ovarian cancer (rOC) Avastin in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan, is approved to treat platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer (prOC) in women who received no more than two prior chemotherapy treatments. Avastin, either in combination with carboplatin and paclitaxel or with carboplatin and gemcitabine, followed by Avastin alone, is approved for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer (psOC).
Possible serious side effects
Everyone reacts differently to Avastin therapy. So it’s important to know what the side effects are. Although some people may have a life-threatening side effect, most do not. Their doctor will stop treatment if any serious side effects occur.Patients should talk to their doctor if there are any signs of these side effects.
Most serious side effects (not common, but sometimes fatal):
GI perforation. A hole that develops in the stomach or intestine. Symptoms include pain in the abdomen, nausea, vomiting, constipation, or fever
Wounds that don’t heal. A cut made during surgery can be slow to heal or may not fully heal. Avastin should not be used for at least 28 days before or after surgery and until surgicalwounds are fully healed
Serious bleeding. This includes vomiting or coughing up blood; bleeding in the stomach, brain, or spinal cord; nosebleeds; and vaginal bleeding. If a patient has recently coughed up blood or had serious bleeding, they should be sure to tell their doctor
Other possible serious side effects
Abnormal passage in the body. This type of passage—known as a fistula—is an irregular connection from one part of the body to another and can sometimes be fatal
Severe high blood pressure. Blood pressure that severely spikes or shows signs of affecting the brain. Blood pressure should be monitored every 2 to 3 weeks while on Avastin and after stopping treatment
Kidney problems. These may be caused by too much protein in the urine and can sometimes be fatal
Infusion reactions. These were uncommon with the first dose (less than 3% of patients). 0.2% of patients had severe reactions. Infusion reactions include high blood pressure or severe high blood pressure that may lead to stroke, trouble breathing, decreased oxygen in red blood cells, a serious allergic reaction, chest pain, headache, tremors, and excessive sweating. The patient’s doctor or nurse will monitor for signs of infusion reactions
Severe stroke or heart problems. These may include blood clots, mini-stroke, heart attack, chest pain, and the heart may become too weak to pump blood to other parts of the body (congestive heart failure). These can sometimes be fatal
Nervous system and vision problems. Signs include headache, seizure, high blood pressure, sluggishness, confusion, and blindness
Side effects seen most often
In clinical studies across different types of cancer, some patients experienced the following side effects:
High blood pressure
Too much protein in the urine
Nosebleeds
Rectal bleeding
Back pain
Headache
Taste change
Dry skin
Inflammation of the skin
Inflammation of the nose
Watery eyes
Avastin is not for everyone
Patients should talk to their doctor if they are:
Undergoing surgery. Avastin should not be used for 28 days before or after surgery and until surgical wounds are fully healed
Pregnant or think they are pregnant. Data have shown that Avastin may harm a woman’s unborn baby. Birth control should be used while patients are on Avastin. If Avastin is stopped, patients should keep using birth control for 6 months before trying to become pregnant
Planning to become pregnant. Taking Avastin could cause a woman’s ovaries to stop working and may impair her ability to have children
Breastfeeding. Breastfeeding while on Avastin may harm the baby and is therefore not recommended
Patients should talk with their doctor if they have any questions about their condition or treatment.
Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.
For full Prescribing Information on Avastin please visit View Source
About Venclexta
Venclexta (venetoclax) is a prescription medicine used to treat people with chronic lymphocytic leukemia (CLL) with 17p deletion who have received at least one prior treatment.
Venclexta was approved based on response rate. There is an ongoing study to find out how Venclexta works over a longer period of time.
It is not known if Venclexta is safe and effective in children.
Important Safety Information
Patients must tell their doctor right away about any side effects they experience.
Venclexta can cause serious side effects, including tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure, the need for dialysis treatment, and may lead to death. A patient’s doctor will do tests for TLS. It is important for patients taking Venclexta to keep their appointments for blood tests. Patients will receive other medicines before starting and during treatment with Venclexta to help reduce their risk of TLS. Patients may also need to receive intravenous (IV) fluids into their vein. Patients taking Venclexta should tell their doctor right away if they have any symptoms of TLS during treatment with Venclexta, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness or muscle pain or joint pain.
Patients should drink plenty of water when taking Venclexta to help reduce the risk of getting TLS. Patients should drink 6 to 8 glasses (about 56 ounces total) of water each day, starting 2 days before their first dose, on the day of their first dose of
Venclexta, and each time the dose is increased.
Certain medicines must not be taken when patients first start taking Venclexta and while their dose is being slowly increased.
Patients should tell their doctor about all the medicines they take , including prescription and over-the-counter medicines, vitamins, and herbal supplements. Venclexta and other medicines may affect each other, causing serious side effects.
Patients should not start new medicines during treatment with Venclexta without first talking with their doctor.
Before taking Venclexta, patients should tell their doctor about all of their medical conditions, including if they:
Have any kidney or liver problems.
Have problems with their body salts or electrolytes, such as potassium, phosphorus, or calcium.
Have a history of high uric acid levels in their blood or gout.
Are scheduled to receive a vaccine. Patients should not receive a "live vaccine" before, during, or after treatment with Venclexta, until their doctor tells them it is okay. If a patient is unsure about the type of immunization or vaccine, they should ask their doctor. These vaccines may not be safe or may not work as well during treatment with Venclexta.
Are pregnant or plan to become pregnant. Venclexta may harm an unborn baby. If a patient is able to become pregnant, the doctor should do a pregnancy test before they start treatment with Venclexta, and they should use effective birth control during treatment and for 30 days after the last dose of Venclexta.
Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into breast milk. Patients should not breastfeed during treatment with Venclexta.
Patients taking Venclexta should not drink grapefruit juice or eat grapefruit, Seville oranges (often used in marmalades), or starfruit while they are taking Venclexta. These products may increase the amount of Venclexta in the patient’s blood.
Venclexta can cause serious side effects, including:
Low White Blood Cell Count (neutropenia): Low white blood cell counts are common with Venclexta, but can also be severe. A doctor will do blood tests to check a patient’s blood counts during treatment with Venclexta. Patients should tell their doctor right away if they have a fever or any signs of an infection.
The most common side effects of Venclexta include low white blood cell count, diarrhea, nausea, low red blood cell count, upper respiratory tract infection, low platelet count, and feeling tired.
Venclexta may cause fertility problems in males. This may affect the ability to father a child. Patients should talk to their doctor if they have concerns about fertility.
These are not all the possible side effects of Venclexta. Patients should tell their doctor if they have any side effect that bothers them or that does not go away.
Report side effects to the FDA at (800) FDA-1088 or View Source Patients and caregivers may also report side effects to Genentech at (888) 835-2555.
Please visit View Source for the Venclexta full Prescribing Information, including Patient Information, for additional Important Safety Information.