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Wednesday, Nov 1, 2017

Genentech to Present New Data Across a Range of Blood Diseases at The American Society of Hematology (ASH) 2017 Annual Meeting

Further results from emicizumab Phase III studies in people with hemophilia A with inhibitors will be featured

New data for polatuzumab vedotin in a difficult-to-treat blood cancer, which led to FDA Breakthrough Therapy and EMA PRIME Designations, also to be presented

South San Francisco, CA -- November 1, 2017 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced today that new data on its approved and investigational medicines for blood diseases will be presented at the 59th American Society of Hematology (ASH) Annual Meeting from December 9-12 in Atlanta. Ten Genentech medicines will be featured in over 75 abstracts, including 26 oral presentations, across eight blood diseases.

“At ASH this year, we look forward to presenting a wealth of data highlighting potential advances across the spectrum of blood diseases, from rare conditions like hemophilia A to common blood cancers like lymphoma,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Our ongoing development program in hematology is one of the largest in this area, underscoring our commitment to developing practice-changing medicines and improving outcomes for people with diseases of the blood.”

Among Genentech’s clinical data to be featured at ASH are results from the ongoing trials for the investigational medicine emicizumab. Updated data with an additional six months of follow-up from the Phase III HAVEN 1 and HAVEN 2 studies evaluating the safety and efficacy of emicizumab in adults, adolescents and children with hemophilia A with inhibitors will be presented. The HAVEN 2 study will be highlighted as part of ASH’s official press program on December 9 at 7:30 A.M. ET. Additional results from the emicizumab clinical development program will be presented during the meeting, including preliminary data from the Phase III HAVEN 4 study exploring emicizumab prophylaxis administered every four weeks in people with hemophilia A with and without inhibitors, as well as real-world data from a non-interventional study in children under 12 years of age with hemophilia A with inhibitors.

Genentech will also be sharing data for medicines in late-stage development for a range of blood cancers. Highlights include results from a randomized Phase II study evaluating polatuzumab vedotin, an investigational anti-CD79b antibody drug conjugate, in combination with Rituxan® (rituximab) and bendamustine versus Rituxan and bendamustine for the treatment of people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Based on data from this study, polatuzumab vedotin was recently granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and had previously received the PRIME (PRIority MEdicines) designation in Europe.

Additionally, results from studies of Gazyva® (obinutuzumab), including new data from the Phase III GALLIUM study in previously untreated follicular lymphoma, and data from the Phase III PrefMab study evaluating patient preference for Rituxan Hycela™ (rituximab and hyaluronidase human) as a treatment for DLBCL and follicular lymphoma will also be shared. Genentech and Biogen collaborate on Rituxan and Gazyva in the United States. Finally, results from multiple studies assessing the safety and efficacy of Venclexta™ (venetoclax) across chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and acute myeloid leukemia (AML) will be presented. Venclexta is being developed by AbbVie and Genentech.

Key abstracts featuring Genentech medicines that will be presented at ASH can be found in the table below.

Follow Genentech on Twitter via @Genentech and keep up to date with ASH Annual Meeting news and updates by using the hashtag #ASH17.

Overview of key presentations featuring Genentech medicines at ASH 2017

Medicine

Abstract title

Abstract number

/Presentation details

Emicizumab (investigational)

Emicizumab Prophylaxis in Adolescent/Adult Patients with Hemophilia A Previously Receiving Episodic or Prophylactic Bypassing Agent Treatment: Updated Analyses from the HAVEN 1 Study

#1071

Poster (session 322)

Dec. 9, 2017

5:30-7:30 PM ET

 

HAVEN 2 Updated Analysis: Multicenter, Open-Label, Phase 3 Study to Evaluate Efficacy, Safety and Pharmacokinetics of Subcutaneous Administration of Emicizumab Prophylaxis in Pediatric Patients with Hemophilia A with Inhibitors

#85

Oral presentation (session 322)

Dec. 9, 2017

9:45 AM ET

(9:30-11:00 AM ET)

 

Emicizumab Subcutaneous Dosing Every 4 Weeks for the Management of Hemophilia A: Preliminary Data from the Pharmacokinetic Run-In Cohort of a Multicenter, Open-Label, Phase 3 Study (HAVEN 4)

#86

Oral presentation (session 322)

Dec. 9, 2017

10:00 AM ET

(9:30-11:00 AM ET)

 

Bleeding Events and Safety Outcomes in Pediatric Persons with Hemophilia A with Inhibitors: The First Non-Interventional Study (NIS) from a Real-World Setting

#1089

Poster (session 322)

Dec. 9, 2017

5:30-7:30 PM ET

Polatuzumab vedotin (investigational)

Addition of Polatuzumab Vedotin to Bendamustine and Rituximab (BR) Improves Outcomes in Transplant-Ineligible Patients with Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) Versus BR Alone: Results from a Randomized Phase 2 Study

#2821

Poster (session 626)

Dec. 10, 2017

6:00-8:00 PM ET

Gazyva (investigational use)

 

Influence of Baseline Disease Characteristics and Exposure to Obinutuzumab on Clinical Outcome in Patients with Previously Untreated Advanced Follicular Lymphoma Treated with Obinutuzumab-based Immunochemotherapy in the GALLIUM Trial

#3848

Poster (session 605)

Dec. 11, 2017

6:00-8:00 PM ET

 

Early Disease Progression Predicts Poorer Survival in Patients with Follicular Lymphoma (FL) in the GALLIUM Study

#1490

Poster (session 623)

Dec. 9, 2017

5:30-7:30 PM ET

Rituxan Hycela (approved use; updated study results)

Efficacy and Safety of Subcutaneous or Intravenous Administration of Rituximab in Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Final Results of the Randomized, Open-Label, Crossover, PrefMab Study

#2834

Poster (session 626)

Dec. 10, 2017

6:00-8:00 PM ET

Venclexta (investigational use)

Preliminary Safety and Efficacy of a Combination of Venetoclax and Obinutuzumab in Patients with Previously Untreated Chronic Lymphocytic Leukemia – Updated Results from a Phase 1b Study (GP28331)

#430

Oral presentation (session 642)

Dec. 10, 2017

12:45 PM ET

(12:00-1:30 PM ET)

 

Preliminary Results from a Phase Ib/II Study Evaluating Venetoclax in Combination with Cobimetinib or Idasanutlin in Patients with Relapsed or Refractory (R/R) AML

#813

Oral presentation (session 616)

Dec. 11, 2017

5:00 PM ET

(4:30-6:00 PM ET)

Updated Safety and Efficacy of Venetoclax with Decitabine or Azacitidine in Treatment-Naive, Elderly Patients with Acute Myeloid Leukemia

#2628

Poster

Dec. 10, 2017 (session 616)

6:00-8:00 PM ET

Phase 1/2 Study of Venetoclax with Low-Dose Cytarabine in Treatment-Naive, Elderly Patients with Acute Myeloid Leukemia Unfit for Standard Induction Therapy: Long-Term Outcomes

#890

Oral presentation (session 616)

Dec. 11, 2017

6:30 PM ET

(6:15-7:45 PM ET)

 

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.

What are the 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 see the Rituxan full Prescribing Information, including BOXED WARNINGS and the Medication Guide, for additional important safety information at http://www.Rituxan.com.

Report side effects to the FDA at (800) FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Gazyva Indications

Gazyva® (obinutuzumab) is a prescription medicine used:

  • With the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.
  • With the chemotherapy drug, bendamustine, followed by Gazyva alone for follicular lymphoma (FL) in adults who did not respond to a rituximab-containing regimen, or whose FL returned after such treatment.

Important Safety Information

Patients must tell their doctor right away about any side effects they experience. Gazyva can cause side effects that can become serious or life threatening, including:

Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If a patient has had history of hepatitis B infection, Gazyva could cause it to return. Patients should not receive Gazyva if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen for hepatitis B before, and monitor the patient for hepatitis during and after, treatment with Gazyva. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes.

Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. A patient’s weakened immune system could put the patient at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems.

Additional possible serious side effects of Gazyva:

Patients must tell their doctor right away about any side effects they experience. Gazyva can cause side effects that may become severe or life threatening, including:

  • Infusion Reactions: These side effects may occur during or within 24 hours of any Gazyva infusion. Some infusion reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. If a patient has a reaction, the infusion is either slowed or stopped until the patient’s symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion reaction is serious, the infusion of Gazyva will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each Gazyva treatment. Signs of infusion reactions may include: tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, breathing problems, and chest pain
  • Tumor Lysis Syndrome (TLS): Tumor lysis syndrome, including fatal cases, has been reported in patients receiving Gazyva. Gazyva works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart, and may lead to kidney failure requiring the need for dialysis treatment. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness
  • Infections: While a patient is taking Gazyva, the patient may develop infections. Some of these infections may be severe. Fatal infections have been reported, so the patient should be sure to talk to the doctor if the patient thinks the patient has one. Patients with active infection should not be treated with Gazyva. The patient’s risk for infections may continue even after the patient stops taking Gazyva. The patient’s doctor may prescribe medications to help prevent infections. Symptoms of infection include fever and cough
  • Low White Blood Cell Count: When a patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking Gazyva, the patient’s doctor will do blood work to check the patient’s white blood cell counts. Severe and life-threatening neutropenia can develop during or after treatment with Gazyva. Some cases of neutropenia can last for more than one month. If a patient’s white blood cell count is low, the patient’s doctor may prescribe medication to help prevent infections
  • Low Platelet Count: Platelets help stop bleeding or blood loss. Gazyva may reduce the number of platelets the patient has in the blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While the patient is taking Gazyva, the patient’s doctor will do blood work to check the patient’s platelet count. Severe and life-threatening thrombocytopenia can develop during or after treatment with Gazyva. If the patient’s platelet count gets too low, the treatment may be delayed or reduced

Most common side effects of Gazyva

The most common side effects of Gazyva in CLL are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.

The safety of Gazyva was evaluated based on 392 patients with indolent NHL (iNHL) of whom 81 percent had follicular lymphoma. In patients with follicular lymphoma, the most common side effects that were seen were consistent with the overall population who had iNHL.

The most common side effects of Gazyva are infusion reactions, low white blood cell counts, nausea, fatigue, cough, diarrhea, constipation, fever, low platelet counts, vomiting, upper respiratory tract infection, decreased appetite, joint or muscle pain, sinusitis, low red blood cell counts, general weakness, and urinary tract infection.

Before receiving Gazyva, patients should talk to their doctor about:

Immunizations: Before receiving Gazyva therapy, the patient should tell the patient’s healthcare provider if the patient has recently received or is scheduled to receive a vaccine. Patients who are treated with Gazyva should not receive live vaccines.

Pregnancy: A patient should tell the doctor if the patient is pregnant, plans to become pregnant, or is breastfeeding. Gazyva may harm the unborn baby. Mothers who have been exposed to Gazyva during pregnancy should discuss the safety and timing of live virus vaccinations for their infants with their child’s healthcare providers. It is not known if Gazyva may pass into the patient’s breast milk. The patient should speak to the doctor about using Gazyva if the patient is breastfeeding.

Patients must tell their doctor about any side effects.

These are not all of the possible side effects of Gazyva. For more information, patients should ask their doctor or pharmacist.

Gazyva is available by prescription only.

Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch. Report side effects to Genentech at (888) 835-2555.

Please visit http://www.Gazyva.com for the Gazyva full Prescribing Information, including Boxed WARNINGS, for additional Important Safety Information.

Rituxan Hycela Indications

Rituxan Hycela™ (rituximab/hyaluronidase human) is a prescription medicine used to treat adults with:

  • Follicular Lymphoma (FL) as a single-agent therapy in patients whose disease recurred or did not respond to initial treatment
  • Follicular Lymphoma as an initial treatment with chemotherapy and, in patients whose initial treatment was successful, as a single-agent follow-up therapy
  • Follicular Lymphoma as a single-agent follow-up therapy for patients who did not progress on initial treatment with CVP chemotherapy
  • Diffuse Large B-Cell Lymphoma (DLBCL) as an initial treatment in combination with CHOP or other anthracycline-based chemotherapy regimens
  • Chronic Lymphocytic Leukemia (CLL) in combination with FC chemotherapy as an initial treatment or as a treatment after disease has recurred

Patients can only receive Rituxan Hycela after at least one full dose of intravenous (IV) Rituxan® (rituximab). Read the IV Rituxan Medication Guide for more information about severe infusion reactions, which usually happen during the first dose with IV Rituxan.

Rituxan Hycela is not for use to treat medical conditions other than cancers.

It is not known if Rituxan Hycela is safe and effective in children.

Important Safety Information

Rituxan Hycela can cause serious side effects that can lead to death, including:

  • Severe skin and mouth reactions: Patients must tell their healthcare provider or get medical help right away if they get any of these symptoms at any time during treatment with Rituxan Hycela: painful sores or ulcers on the skin, lips, or in the mouth; blisters; peeling skin; rash or pustules.
  • Hepatitis B virus (HBV) reactivation: Before a patient receives Rituxan Hycela, the patient’s doctor will do blood tests to check for HBV infection. If the patient has had hepatitis B or is a carrier of hepatitis B virus, receiving Rituxan Hycela could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems including liver failure and death. The patient’s healthcare provider will monitor for hepatitis B infection during and for several months after the patient stops receiving Rituxan Hycela. Patients must tell their healthcare provider right away if they get worsening tiredness, or yellowing of the skin or white part of the eyes during treatment with Rituxan Hycela.
  • Progressive Multifocal Leukoencephalopathy (PML): PML is a rare, serious brain infection caused by a virus that can happen in people who receive Rituxan Hycela. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML. Patients must tell their healthcare provider right away if they have any new or worsening symptoms or if anyone close to them notices these symptoms: confusion; dizziness or loss of balance; difficulty walking or talking; decreased strength or weakness on one side of the body; vision problems, such as blurred or loss of vision.
  • Serious allergic reactions and other severe reactions:

Serious allergic reactions, and reactions due to release of certain substances by the body that can lead to death, can happen with rituximab products, including Rituxan Hycela.

Skin reactions at or near the injection site (local), including injection site reactions can happen with Rituxan Hycela. Symptoms at or near the injection site may include: pain, swelling, hardness, redness, bleeding, itching, and rash. These reactions sometimes happen more than 24 hours after an injection of Rituxan Hycela.

Patients must tell their healthcare provider or get medical help right away if they get any of these symptoms during or after an injection of Rituxan Hycela: hives (red itchy welts) or rash; itching; swelling of the lips, tongue, throat, or face; sudden cough; shortness of breath, difficulty breathing, or wheezing; weakness; dizziness or feeling faint; palpitations (feeling the heart is racing or fluttering); chest pain; fever; chills or shaking chills.

What are possible side effects of Rituxan Hycela?

Rituxan Hycela can cause serious side effects, including:

  • Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause the patient to have kidney failure, the need for dialysis treatment, and an abnormal heart rhythm. TLS can happen within 12 to 24 hours after an injection of Rituxan Hycela. The patient’s healthcare provider may do blood tests to check for TLS. The patient’s healthcare provider may give medicine to help prevent TLS. Patients must tell their healthcare provider right away if they have any of the following signs or symptoms of TLS: nausea, vomiting, diarrhea, or lack of energy.
  • Serious Infections: Serious infections can happen during and after treatment with Rituxan Hycela and can lead to death. Rituximab products can increase the risk of getting infections and can lower the ability of the immune system to fight infections. Types of serious infections that can happen with Rituxan Hycela include bacterial, fungal, and viral infections. After receiving Rituxan Hycela, some people have developed low levels of certain antibodies in their blood for a long period of time (longer than 11 months). Some of these people with low antibody levels developed infections. Patients must tell their healthcare provider right away if they have any symptoms of infection: fever; cold symptoms, such as runny nose or sore throat that do not go away; flu symptoms, such as cough, tiredness, and body aches; earache or headache; pain during urination; white patches in the mouth or throat; cuts, scrapes, or incisions that are red, warm, swollen, or painful.
  • Heart Problems: Rituxan Hycela may cause chest pain, irregular heartbeats, and heart attack. The patient’s healthcare provider may monitor the patient’s heart during and after treatment with Rituxan Hycela if they have symptoms of heart problems or have a history of heart problems. Patients must tell their healthcare provider right away if they have chest pain or irregular heartbeats during treatment with Rituxan Hycela.
  • Kidney Problems: Rituxan Hycela can cause severe kidney problems that can lead to death. The patient’s healthcare provider should do blood tests to check how well the patient’s kidneys are working.
  • Stomach and serious bowel problems that can sometimes lead to death: Bowel problems, including blockage or tears in the bowel, can happen if the patient receives Rituxan Hycela with chemotherapy medicines. Patients must tell their healthcare provider right away if they have severe stomach-area (abdomen) pain or repeated vomiting during treatment with Rituxan Hycela.

The patient’s healthcare provider will stop treatment with Rituxan Hycela if the patient has severe, serious, or life-threatening side effects.

The most common side effects of Rituxan Hycela in people with:

  • FL: infections, low white blood cell count, nausea, constipation, cough, and tiredness.
  • DLBCL: infections, low white blood cell count, loss of hair, nausea, and low red blood cell count.
  • CLL: infections, low white blood cell count, nausea, low platelet count, fever, vomiting, and injection site redness.

Additional Important Safety Information

Before receiving Rituxan Hycela, patients must tell their healthcare provider about all of their medical conditions, including if they:

  • Have had a severe reaction to a rituximab product or Rituxan Hycela.
  • Have had a recent vaccination or are scheduled to receive vaccinations. Patients should not receive certain vaccines before or during treatment with Rituxan Hycela.
  • Are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed. Patients should talk to their healthcare provider about the risks to their unborn baby if they receive Rituxan Hycela during pregnancy. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Rituxan Hycela and for 12 months after the last dose of Rituxan Hycela. Patients should talk to their healthcare provider about effective birth control. It is not known if Rituxan Hycela passes into the patient’s breast milk. Patients must not breastfeed during treatment and for at least 6 months after receiving their last dose of Rituxan Hycela.

These are not all of the possible side effects with Rituxan Hycela. Patients should call their doctor for medical advice about side effects.

Please see the full Prescribing Information , including BOXED WARNINGS and Medication Guide, for additional Important Safety Information. 

Report side effects to the FDA at (800) FDA-1088 or http:// www.fda.gov/medwatch .

Report side effects to Genentech at (888) 835-2555.

Venclexta Indication

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 http://www.fda.gov/medwatch . Patients and caregivers may also report side effects to Genentech at (888) 835-2555.

Please visit http://www.Venclexta.com for the Venclexta full Prescribing Information, including Patient Information, for additional Important Safety Information.

About Genentech In Hematology

For more than 20 years, Genentech has been developing medicines with the goal to redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. In addition to approved medicines, Genentech’s pipeline of investigational hematology medicines includes an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388). Genentech’s dedication to developing novel medicines for blood diseases expands beyond oncology, with the development of the investigational hemophilia A treatment emicizumab. For more information visit http://www.gene.com/hematology .

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

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