Market Overview

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

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– 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 –

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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