SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 5, 2024-- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will present more than 40 abstracts across nine blood disorders at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, held December 7-10, 2024 in San Diego, California. The data underscore Genentech’s commitment to advance patient outcomes in lymphoma with long-term follow-up of its approved medicines Polivy^® (polatuzumab vedotin-piiq), Lunsumio^® (mosunetuzumab-axgb) and Columvi^® (glofitamab-gxbm) as well as new investigational combination data.

Key presentations include:

• Five-year data from the Phase III POLARIX study (abstract #469) reinforce the potential of Polivy in combination with Rituxan^® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) to provide durable and lasting remissions and for the first time show a positive trend in overall survival (OS) for people with first-line diffuse large B-cell lymphoma (DLBCL), an area that previously had little advancement in nearly two decades.
• Extended follow-up data of up to four years from the pivotal GO29781 study of Lunsumio (abstract #4407) and NP30179 study of Columvi (abstract #865) show long-lasting remissions and immune system recovery after the end of treatment, supporting the use of fixed-duration bispecific antibodies for third-line or later (3L+) follicular lymphoma (FL) and DLBCL, respectively.
• First presentation of data for a subcutaneous formulation of Lunsumio monotherapy from the pivotal Phase II GO29781 study (abstract #1645) show high rates of deep and durable responses and low rates and severity of cytokine release syndrome in people with 3L+ FL. Subcutaneously administered Lunsumio could further improve the patient experience by combining shorter administration time with the existing benefits of a fixed-duration and outpatient therapy.
• New patient-reported outcomes data from the Phase III STARGLO study (abstract #5132) indicate comparable health-related quality of life between treatment arms, despite higher median number of cycles received with the Columvi combination (11 versus 4). Together with the significant improvement in OS observed in the study, these data support the potential benefit for patients with second-line or later DLBCL.
• New and updated data from investigational study combinations of Polivy with bispecific antibodies Lunsumio and Columvi in relapsed or refractory DLBCL, including the Phase Ib/II NP39488 (abstract #988) and Phase II GO40516 (abstract #989) studies, add to the growing body of evidence demonstrating the potential of novel bispecific antibody/Polivy combinations in earlier treatment lines, and support their ongoing Phase III development.

Overview of key presentations featuring Genentech medicines

*Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States.

About Polivy^® (polatuzumab vedotin-piiq)

Polivy is a first-in-class anti-CD79b antibody-drug conjugate (ADC). The CD79b protein is expressed specifically in the majority of B cells, an immune cell impacted in some types of non-Hodgkin’s lymphoma (NHL), making it a promising target for the development of new therapies. Polivy binds to cancer cells such as CD79b and destroys these B cells through the delivery of an anti-cancer agent, which is thought to minimize the effects on normal cells. Polivy is being developed by Genentech using Seagen ADC technology and is currently being investigated for the treatment of several types of NHL.

Polivy U.S. Indication

Polivy is a prescription medicine used with other medicines (a rituximab product, cyclophosphamide, doxorubicin, and prednisone) as a first treatment for adults who have moderate to high risk diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) or high-grade B-cell lymphoma (HGBL).

Polivy is a prescription medicine used with other medicines, bendamustine and a rituximab product, to treat DLBCL in adults who have progressed after at least 2 prior therapies.

Important Safety Information

Possible serious side effects

Everyone reacts differently to Polivy therapy, so it’s important to know what the side effects are. Some people who have been treated with Polivy have experienced serious to fatal side effects. Your doctor may stop or adjust your treatment if any serious side effects occur. Be sure to contact your healthcare team if there are any signs of these side effects.

• Nerve problems in your arms and legs: This may happen as early as after your first dose and may worsen with every dose. Your doctor will monitor for signs and symptoms, such as changes in your sense of touch, numbness or tingling in your hands or feet, nerve pain, burning sensation, any muscle weakness, or changes to your walking pattern
• Infusion-related reactions: You may experience fever, chills, rash, breathing problems, low blood pressure, or hives within 24 hours of your infusion
• Low blood cell counts: Treatment with Polivy can cause severe low blood cell counts. Your doctor will monitor your blood counts throughout treatment with Polivy
• Infections: If you have a fever of 100.4°F (38°C) or higher, chills, cough, or pain during urination, contact your healthcare team. Your doctor may also give you medication before giving you Polivy, which may prevent some infections
• Rare and serious brain infections: Your doctor will monitor closely for signs and symptoms of these types of infections. Contact your doctor if you experience confusion, dizziness or loss of balance, trouble talking or walking, or vision changes
• Tumor lysis syndrome: Caused by the fast breakdown of cancer cells. Signs include nausea, vomiting, diarrhea, and lack of energy
• Potential harm to liver: Some signs include tiredness, weight loss, pain in the abdomen, dark urine, and yellowing of your skin or the white part of your eyes. You may be at higher risk if you already had liver problems or you are taking other medication

Side effects seen most often

The most common side effects during treatment were

• Nerve problems in arms and legs
• Nausea
• Tiredness or lack of energy
• Diarrhea
• Constipation
• Hair loss
• Redness and sores of the lining of the mouth, lips, throat, and digestive tract

Polivy may lower your red or white blood cell counts and increase uric acid levels.

Polivy may not be for everyone. Talk to your doctor if you are

• Pregnant or think you are pregnant: Data have shown that Polivy may harm your unborn baby
• Planning to become pregnant: Women should avoid getting pregnant while taking Polivy. Women should use effective contraception during treatment and for 3 months after their last Polivy treatment. Men taking Polivy should use effective contraception during treatment and for 5 months after their last Polivy treatment
• Breastfeeding: Women should not breastfeed while taking Polivy and for 2 months after the last dose

These may not be all the side effects. Talk to your healthcare provider for more information about the benefits and risks of Polivy treatment.

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

Please see the full Prescribing Information and visit https://www.Polivy.com for additional Important Safety Information.

About Lunsumio^® (mosunetuzumab-axgb)

Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development program for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin’s lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, and other blood cancers.

Lunsumio U.S. Indication

Lunsumio (mosunetuzumab-axgb) is a prescription medicine used to treat adults with follicular lymphoma whose cancer has come back or did not respond to previous treatment, and who have already received two or more treatments for their cancer.

It is not known if Lunsumio is safe and effective in children.

The conditional approval of Lunsumio is based on response rate. There are ongoing studies to establish how well the drug works.

What is the most important information I should know about Lunsumio?

Lunsumio may cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Lunsumio and can also be severe or life-threatening.

Get medical help right away if you develop any signs or symptoms of CRS at any time, including:

• fever of 100.4°F (38°C) or higher
• chills
• low blood pressure
• fast or irregular heartbeat
• tiredness or weakness
• difficulty breathing
• headache
• confusion
• feeling anxious
• dizziness or light-headedness
• nausea
• vomiting

Due to the risk of CRS, you will receive Lunsumio on a “step-up dosing schedule.”

• The step-up dosing schedule is when you receive smaller “step-up” doses of Lunsumio on Day 1 and Day 8 of your first cycle of treatment
• You will receive a higher dose of Lunsumio on Day 15 of your first cycle of treatment
• If your dose of Lunsumio is delayed for any reason, you may need to repeat the step-up dosing schedule
• Before each dose in Cycle 1 and Cycle 2, you will receive medicines to help reduce your risk of CRS

Your healthcare provider will check you for CRS during treatment with Lunsumio and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Lunsumio, if you have severe side effects.

What are the possible side effects of Lunsumio?

Lunsumio may cause serious side effects, including:

• Neurologic problems. Your healthcare provider will check you for neurologic problems during treatment with Lunsumio. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems during or after treatment with Lunsumio, including:
  • headache
  • numbness and tingling of the arms, legs, hands, or feet
  • dizziness
  • confusion and disorientation
  • difficulty paying attention or understanding things
  • forgetting things or forgetting who or where you are
  • trouble speaking, reading, or writing
  • sleepiness or trouble sleeping
  • tremors
  • loss of consciousness
  • seizures
  • muscle problems or muscle weakness
  • loss of balance or trouble walking

• Serious infections. Lunsumio can cause serious infections that may lead to death. Your healthcare provider will check you for signs and symptoms of infection before and during treatment. Tell your healthcare provider right away if you develop any signs or symptoms of infection during treatment with Lunsumio, including:
  • fever of 100.4° F (38° C) or higher
  • chest pain
  • tiredness
  • shortness of breath
  • painful rash
  • sore throat
  • pain during urination
  • feeling weak or generally unwell

• Low blood cell counts. Low blood cell counts are common during treatment with Lunsumio and can also be severe. Your healthcare provider will check your blood cell counts during treatment with Lunsumio. Lunsumio may cause the following low blood cell counts:
  • low white blood cell counts (neutropenia). Low white blood cells can increase your risk for infection
  • low red blood cell counts (anemia). Low red blood cells can cause tiredness and shortness of breath
  • low platelet counts (thrombocytopenia). Low platelet counts can cause bruising or bleeding problems

• Growth in your tumor or worsening of tumor related problems (Tumor flare). Lunsumio may cause serious or severe worsening of your tumor. Tell your healthcare provider if you develop any of these signs or symptoms of tumor flare during your treatment with Lunsumio: tender or swollen lymph nodes, chest pain, cough, trouble breathing, and pain or swelling at the site of the tumor

Your healthcare provider may temporarily stop or permanently stop treatment with Lunsumio if you develop severe side effects.

The most common side effects of Lunsumio include: tiredness, rash, fever, and headache.

The most common severe abnormal lab test results with Lunsumio include: decreased phosphate, increased glucose, and increased uric acid levels.

Before receiving Lunsumio, tell your healthcare provider about all of your medical conditions, including if you:

• have ever had an infusion reaction after receiving Lunsumio
• have an infection, or have had an infection in the past which lasted a long time or keeps coming back
• have or have had Epstein-Barr Virus
• are pregnant or plan to become pregnant. Lunsumio may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Lunsumio

Females who are able to become pregnant:

• your healthcare provider should do a pregnancy test before you start treatment with Lunsumio
• you should use an effective method of birth control during your treatment and for 3 months after the last dose of Lunsumio
• are breastfeeding or plan to breastfeed. It is not known if Lunsumio passes into your breast milk. Do not breastfeed during treatment and for 3 months after the last dose of Lunsumio

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving Lunsumio?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of CRS or neurologic problems.

These are not all the possible side effects of Lunsumio. Talk to your healthcare provider for more information about the benefits and risks of Lunsumio.

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

Please see Important Safety Information, including Serious Side Effects, as well as the Lunsumio full Prescribing Information and Medication Guide or visit https://www.Lunsumio.com .

About Columvi^® (glofitamab-gxbm)

Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. A clinical development program for Columvi is ongoing, investigating the molecule as a monotherapy and in combination with other medicines for the treatment of people with B-cell non-Hodgkin’s lymphomas, including diffuse large B-cell lymphoma and other blood cancers.

Columvi U.S. Indication

Columvi (glofitamab-gxbm) is a prescription medicine to treat adults with certain types of diffuse large B-cell lymphoma (DLBCL) or large B-cell lymphoma (LBCL) that has come back (relapsed) or that did not respond to previous treatment (refractory), and who have received 2 or more prior treatments for their cancer.

It is not known if Columvi is safe and effective in children.

The conditional approval of Columvi is based on response rate and durability of response. There are ongoing studies to establish how well the drug works.

What is the most important information I should know about Columvi?

Columvi can cause Cytokine Release Syndrome (CRS), a serious side effect that is common during treatment with Columvi, and can also be serious and lead to death.

Call your healthcare provider or get emergency medical help right away if you develop any signs or symptoms of CRS, including:

• fever of 100.4°F (38°C) or higher
• chills or shaking
• fast or irregular heartbeat
• dizziness or light-headedness
• trouble breathing
• shortness of breath

Due to the risk of CRS, you will receive Columvi on a “step-up dosing schedule”.

• A single dose of a medicine called obinutuzumab will be given to you on the first day of your first treatment cycle (Day 1 of Cycle 1).
• You will start the Columvi step-up dosing schedule a week after the obinutuzumab dose. The step-up dosing schedule is when you receive smaller “step-up” doses of Columvi on Day 8 and Day 15 of Cycle 1. This is to help reduce your risk of CRS. You should be hospitalized during your infusion and for 24 hours after receiving the first step-up dose on Day 8. You should be hospitalized during your infusion and for 24 hours after receiving the second step-up dose on Day 15 if you experienced CRS during the first step-up dose.
• You will receive your first full dose of Columvi a week after the second step-up dose (this will be Day 1 of Cycle 2).
• If your dose of Columvi is delayed for any reason, you may need to repeat the “step-up dosing schedule”.
• If you had more than mild CRS with your previous dose of Columvi, you should be hospitalized during and for 24 hours after receiving your next dose of Columvi.
• Before each dose of Columvi, you will receive medicines to help reduce your risk of CRS and infusion-related reactions.

Your healthcare provider will monitor you for CRS during treatment with Columvi and may treat you in a hospital if you develop signs and symptoms of CRS. Your healthcare provider may temporarily stop or completely stop your treatment with Columvi if you have severe side effects.

Carry the Columvi Patient Wallet Card with you at all times and show it to all of your healthcare providers. The Columvi Patient Wallet Card lists the signs and symptoms of CRS you should get emergency medical help for right away.

What are the possible side effects of Columvi?

Columvi may cause serious side effects, including:

• Cytokine Release Syndrome.
• Neurologic problems. Columvi can cause serious neurologic problems that may lead to death. Your healthcare provider will monitor you for neurologic problems during treatment with Columvi. Your healthcare provider may also refer you to a healthcare provider who specializes in neurologic problems. Tell your healthcare provider right away if you develop any signs or symptoms of neurologic problems, including:
  • headache
  • confusion and disorientation
  • difficulty paying attention or understanding things
  • trouble speaking
  • sleepiness
  • memory problems
  • numbness, tingling, or weakness of the hands or feet
  • dizziness
  • shaking (tremors)

• Serious Infections. Columvi can cause serious infections that may lead to death. Your healthcare provider will monitor you for signs and symptoms of infection and treat you as needed. Tell your healthcare provider right away if you develop any signs of an infection, including: fever, chills, weakness, cough, shortness of breath, or sore throat.
• Growth in your tumor or worsening of tumor related problems (tumor flare). Tell your healthcare provider if you get any of these signs or symptoms of tumor flare:
  • tender or swollen lymph nodes
  • pain or swelling at the site of the tumor
  • chest pain
  • cough
  • trouble breathing

The most common side effects of Columvi include: CRS, muscle and bone pain, rash, and tiredness.

The most common severe abnormal lab test results with Columvi include: decreased white blood cells, decreased phosphate (an electrolyte), increased uric acid levels, and decreased fibrinogen (a protein that helps with blood clotting).

Your healthcare provider may temporarily stop or completely stop treatment with Columvi if you develop certain side effects.

Before receiving Columvi, tell your healthcare provider about all of your medical conditions, including if you:

• have an infection
• have kidney problems
• are pregnant or plan to become pregnant. Columvi may harm your unborn baby
• Females who are able to become pregnant:
  • Your healthcare provider should do a pregnancy test before you start treatment with Columvi.
  • You should use effective birth control (contraception) during treatment and for 1 month after your last dose of Columvi. Talk to your healthcare provider about what birth control method is right for you during this time.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Columvi.
• are breastfeeding or plan to breastfeed. Columvi may pass into your breast milk. Do not breastfeed during treatment and for 1 month after your last dose of Columvi.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What should I avoid while receiving Columvi?

Do not drive, operate heavy machinery, or do other dangerous activities if you develop dizziness, confusion, shaking (tremors), sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems.

These are not all the possible side effects of Columvi. Talk to your health care provider for more information about the benefits and risks of Columvi.

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

Please see Important Safety Information, including Serious Side Effects, as well as the Columvi full Prescribing Information and Medication Guide or visit https://www.Columvi.com.

About Venclexta^® (venetoclax)

Venclexta is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumors, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta blocks the BCL-2 protein and works to help restore the process of apoptosis.

Venclexta is being developed by AbbVie and Genentech, a member of the Roche Group. It is jointly commercialized by the companies in the United States and commercialized by AbbVie outside of the United States. Together, the companies are committed to research with Venclexta, which is currently being studied in clinical trials across several types of blood cancers.

Venclexta U.S. Indications

Venclexta is a prescription medicine used:

• to treat adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
• in combination with azacitidine, or decitabine, or low-dose cytarabine to treat adults with newly-diagnosed acute myeloid leukemia (AML) who:

‒ are 75 years of age or older, or

‒ have other medical conditions that prevent the use of standard chemotherapy.

It is not known if Venclexta is safe and effective in children.

Important Safety Information

What is the most important information patients should know about Venclexta?

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. The patient’s doctor will do tests to check their risk of getting TLS before they start taking Venclexta. The patient will receive other medicines before starting and during treatment with Venclexta to help reduce the risk of TLS. The patient may also need to receive intravenous (IV) fluids into their vein.

The patient’s doctor will do blood tests to check for TLS when the patient first starts treatment and during treatment with Venclexta. It is important for patients to keep appointments for blood tests. Patients 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 or joint pain.

Patients should drink plenty of water during treatment with 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 the first dose on the day of the first dose of Venclexta, and each time a dose is increased.

The patient’s doctor may delay, decrease the dose, or stop treatment with Venclexta if the patient has side effects. When restarting Venclexta after stopping for 1 week or longer, the patient’s doctor may again check for the risk of TLS and change the patient’s dose.

What patients should not take Venclexta?

Certain medicines must not be taken when the patient first starts taking Venclexta and while the dose is being slowly increased because of the risk of increased TLS.

• 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 must not start new medicines during treatment with Venclexta without first talking with their doctor.

Before taking Venclexta, patients must tell their doctor about all of their medical conditions, including if they:

• Have kidney or liver problems.
• Have problems with body salts or electrolytes, such as potassium, phosphorus, or calcium.
• Have a history of high uric acid levels in the blood or gout.
• Are scheduled to receive a vaccine. Patients should not receive a “live vaccine” before, during, or after treatment with Venclexta, until the patient’s doctor tells them it is okay. If the patient is not sure about the type of immunization or vaccine, the patient 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 the patient is able to become pregnant, the patient’s doctor should do a pregnancy test before the patient starts treatment with Venclexta, and the patient should use effective birth control during treatment and for at least 30 days after the last dose of Venclexta. If the patient becomes pregnant or thinks they are pregnant, the patient should tell their doctor right away.
• Are breastfeeding or plan to breastfeed. It is not known if Venclexta passes into the patient’s breast milk. Patients are instructed to not breastfeed during treatment with Venclexta and for 1 week after the last dose.

What to avoid while taking Venclexta:

Patients 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.

What are the possible side effects of Venclexta?

Venclexta can cause serious side effects, including:

• Low white blood cell counts (neutropenia). Low white blood cell counts are common with Venclexta, but can also be severe. The patient’s doctor will do blood tests to check their blood counts during treatment with Venclexta and may pause dosing.
• Infections. Death and serious infections such as pneumonia and blood infection (sepsis) have happened during treatment with Venclexta. The patient’s doctor will closely monitor and treat the patient right away if they have a fever or any signs of infection during treatment with Venclexta.

Patients should tell their doctor right away if they have a fever or any signs of an infection during treatment with Venclexta.

The most common side effects of Venclexta when used in combination with obinutuzumab or rituximab or alone in people with CLL or SLL include low white blood cell count; low platelet count; low red blood cell count; diarrhea; nausea; upper respiratory tract infection; cough; muscle and joint pain; tiredness; and swelling of arms, legs, hands, and feet.

The most common side effects of Venclexta in combination with azacitidine or decitabine or low-dose cytarabine in people with AML include nausea; diarrhea; low platelet count; constipation; low white blood cell count; fever with low white blood cell count; tiredness; vomiting; swelling of arms, legs, hands, or feet; fever; infection in lungs; shortness of breath; bleeding; low red blood cell count; rash; stomach (abdominal) pain; infection in your blood; muscle and joint pain; dizziness; cough; sore throat; and low blood pressure.

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 call their doctor for medical advice about side effects.

Report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Report side effects to Genentech at 1-888-835-2555.

Please see the Venclexta full Prescribing Information , including the Medication Guide , for additional Important Safety Information or visit https://www.venclexta.com/ .

About Hemlibra

Hemlibra is a bispecific factor IXa- and factor X-directed antibody. It is designed to bring together factor IXa and factor X, proteins required to activate the natural coagulation cascade and restore the blood clotting process for hemophilia A patients. Hemlibra is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once weekly, every two weeks or every four weeks. Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed globally by Chugai, Roche and Genentech.

Hemlibra U.S. Indication

Hemlibra is a prescription medicine used for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children, ages newborn and older, with hemophilia A with or without factor VIII inhibitors.

Important Safety Information

What is the most important information to know about Hemlibra?

Hemlibra increases the potential for blood to clot. People who use activated prothrombin complex concentrate (aPCC; Feiba^®) to treat breakthrough bleeds while taking Hemlibra may be at risk of serious side effects related to blood clots.

These serious side effects include:

• Thrombotic microangiopathy (TMA), a condition involving blood clots and injury to small blood vessels that may cause harm to one’s kidneys, brain, and other organs
• Blood clots (thrombotic events), which may form in blood vessels in the arm, leg, lung, or head

Patients should talk to their doctor about the signs and symptoms of these serious side effects, which can include

• Confusion
• Stomach, chest, or back pain
• Weakness
• Nausea or vomiting
• Swelling, pain, or redness
• Feeling sick or faint
• Decreased urination
• Swelling of arms and legs
• Yellowing of skin and eyes
• Eye pain, swelling, or trouble seeing
• Fast heart rate
• Numbness in your face
• Headache
• Shortness of breath
• Coughing up blood

If patients experience any of these symptoms during or after treatment with Hemlibra, they should get medical help right away.

Patients should carefully follow their healthcare provider’s instructions regarding when to use an on demand bypassing agent or factor VIII, and the dose and schedule to use for breakthrough bleed treatment. If aPCC (Feiba^®) is needed, patients should talk to their healthcare provider in case they feel they need more than 100 U/kg of aPCC (Feiba^®) total.

Patients’ bodies may make antibodies against Hemlibra, which may stop Hemlibra from working properly. Patients should contact their healthcare provider immediately if they notice that Hemlibra has stopped working for them (e.g., increase in bleeds).

The most common side effects of Hemlibra include: injection site reactions (redness, tenderness, warmth, or itching at the site of injection), headache, and joint pain. These are not all of the possible side effects of Hemlibra. Patients can speak with their healthcare provider for more information.

What else should patients know about Hemlibra?

Patients should see the detailed “Instructions for Use” that comes with Hemlibra for information on how to prepare and inject a dose of Hemlibra, and how to properly throw away (dispose of) used needles and syringes.

• Patients should stop taking their prophylactic bypassing therapy the day before they start Hemlibra
• Patients may continue taking their prophylactic factor VIII for the first week of Hemlibra

Hemlibra may interfere with laboratory tests that measure how well blood is clotting and create an inaccurate result. Patients should speak with their healthcare provider about how this may affect their care.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Patients should only use Hemlibra for the condition it was prescribed. Patients should not give Hemlibra to other people, even if they have the same symptoms that they have. It may harm them.

Patients should tell their healthcare provider about all the medicines they take, including prescription medicines, over-the-counter medicines, vitamins, or herbal supplements. Patients should keep a list of them to show their healthcare provider and pharmacist.

Before using Hemlibra, patients should tell their healthcare provider about all of their medical conditions, including if they are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

Since Hemlibra was tested in males, there is no information on whether Hemlibra may impact an unborn baby or breast milk. Females who are able to become pregnant should use birth control during treatment.

Side effects may be reported to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. Side effects may also be reported to Genentech at (888) 835-2555.

Please see Important Safety Information, including Serious Side Effects, as well as the Hemlibra full Prescribing Information and Medication Guide or visit https://www.hemlibra.com/.

Indications & Important Safety Information

What is PIASKY?

PIASKY is a prescription medicine used to treat a disease called paroxysmal nocturnal hemoglobinuria (PNH) in adults and children 13 years of age or older who weigh at least 88 pounds (40 kg).

It is not known if PIASKY is safe and effective in children under 13 years of age and in people who weigh less than 88 pounds (40kg).

What is the most important information I should know about PIASKY?

PIASKY is a medicine that can affect your immune system. PIASKY may lower the ability of your immune system to fight infections

• PIASKY increases your chance of getting serious infections caused by Neisseria meningitidis. Meningococcal infections may quickly become life-threatening or cause death if not recognized and treated early.

• You must complete or update your meningococcal vaccines at least 2 weeks before your first dose of PIASKY.

• If your healthcare provider decides that immediate treatment with PIASKY is needed and your meningococcal vaccination is not up to date, you should receive meningococcal vaccination as soon as possible, and receive antibiotics for as long as your healthcare provider tells you.

• If you have been given a meningococcal vaccine in the past, you might need additional vaccines before starting PIASKY. Your healthcare provider will decide if you need additional meningococcal vaccine.

• Meningococcal vaccines do not prevent all meningococcal infections. Call your healthcare provider or get emergency medical care right away if you get any of these signs and symptoms of a serious meningococcal infection:
  • fever
  • fever and a rash
  • fever with a high heart rate
  • fever with a headache
  • headache with nausea or vomiting
  • headache with a stiff neck or stiff back
  • confusion
  • muscle aches, with flu-like symptoms
  • eyes sensitive to light

• Your healthcare provider will give you a Patient Safety Card about the risk of serious meningococcal infection. Carry it with you at all times during treatment and for 11 months after your last dose of PIASKY. Your risk of meningococcal infection may continue for several months after your last dose of PIASKY. It is important to show this card to any healthcare provider who treats you. This will help them diagnose and treat you quickly.
• PIASKY is only available through a program called the PIASKY Risk Evaluation and Mitigation Strategy (PIASKY REMS). Before you can receive PIASKY, your healthcare provider must:
  • enroll in the PIASKY REMS program.
  • counsel you about the risk of serious meningococcal infection.
  • give you information about the signs and symptoms of serious meningococcal infection.
  • make sure that you are vaccinated with a meningococcal vaccine and that you receive antibiotics if you need to start PIASKY right away if you are not up to date on your vaccines.
  • give you a Patient Safety Card about your risk of meningococcal infection.

• Immune system reactions called Type III hypersensitivity reactions are common during treatment with PIASKY and can be serious. If you are currently being treated with or have been treated with another C5 inhibitor medicine and you switch to PIASKY, PIASKY may cause Type III hypersensitivity reactions. People may also develop Type III hypersensitivity reactions when they switch from PIASKY to another C5 inhibitor medicine. If you have been treated with another C5 inhibitor medicine and you switch to PIASKY, or if you have been treated with PIASKY and you switch to another C5 inhibitor medicine, your healthcare provider should monitor you for 30 days after you switch medicines. Call your healthcare provider or go to the nearest emergency room right away if you have any signs or symptoms of Type III hypersensitivity reaction including:
  • joint pain
  • muscle or bone pain
  • rash or skin problems
  • itching
  • headache
  • kidney problems
  • numbness and tingling or a feeling of pins and needles especially of the hands and feet
  • fever
  • weakness, tiredness, or lack of energy
  • stomach trouble or pain

• PIASKY may also increase the risk of other types of serious infections, including infections caused by Neisseria spp., Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria gonorrhoeae.
  • If you receive treatment with PIASKY, you should receive vaccines against Streptococcus pneumoniae.
  • If your child receives treatment with PIASKY, your child should receive vaccines against Streptococcus pneumoniae and may receive vaccines against Haemophilus influenzae, depending on their age.

• Call your healthcare provider right away if you have any new signs or symptoms of infection such as:

• fever of 100.4°F (38°C) or higher
• cough
• chest pain
• tiredness
• feeling short of breath
• painful rash
• sore throat
• burning pain when passing urine
• feeling weak or generally unwell

Who should not receive PIASKY?

Do not receive PIASKY if you:

• Have a serious meningococcal infection caused by Neisseria meningitidis when you are starting PIASKY treatment.
• Are allergic to crovalimab or any of the ingredients in PIASKY.

Before receiving PIASKY tell your healthcare provider about all of your medical conditions, including if you:

• have an infection or fever.
• are pregnant or plan to become pregnant. It is not known if PIASKY may harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if PIASKY passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. PIASKY and other medicines can affect each other, causing side effects. Especially tell your healthcare provider if you are currently being treated with or have ever been treated with any other complementary C5 inhibitor (C5 inhibitor) medicine. PIASKY is a C5 inhibitor medicine. Know the medicines you take and the vaccines you receive. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I receive PIASKY?

• Your healthcare provider will give you your PIASKY treatment.
• Your first dose will be given through a vein by intravenous (IV) infusion on Day 1 by your healthcare provider. This is the first loading dose.
• Another loading dose will be given as an injection under the skin (subcutaneous) on Days 2, 8, 15, and 22.
• Your maintenance doses will begin on Day 29 and then will be given every 4 weeks as a subcutaneous injection.
• Your healthcare provider will prescribe the dose based on your weight. If your weight changes, tell your healthcare provider.
• Talk to your healthcare provider if you miss receiving your dose of PIASKY.
• If you are changing treatment from another C5 inhibitor such as eculizumab or ravulizumab to PIASKY, you should receive your first loading dose of PIASKY no sooner than the time you would have received your next scheduled dose of eculizumab or ravulizumab.
• If you stop taking PIASKY and do not switch to another treatment for your PNH, your healthcare provider will need to monitor you closely for at least 20 weeks after stopping PIASKY. Stopping treatment with PIASKY may cause a breakdown of red blood cells due to PNH.

Symptoms or problems that can happen due to red blood cell breakdown include:

• a lower number of red blood cells (anemia)
• blood in your urine or dark urine
• feeling short of breath
• feeling tired or low energy (fatigue)
• stomach pain
• blood clotting (thrombosis)
• difficulty swallowing
• difficulty getting or keeping an erection (erectile dysfunction)
• kidneys not working properly

What are the possible side effects of PIASKY?

PIASKY can cause serious side effects including:

• Infusion- and injection-related reactions. Infusion- or injection-related reactions may happen during or after your PIASKY administration. Symptoms may include headache, pain at infusion or injection site or in other parts of your body, swelling, bruising or bleeding, red skin, itching and rash. PIASKY can also cause serious allergic reactions. Tell your healthcare provider right away or go to the nearest emergency room if you get any of the following symptoms or symptoms of a serious allergic reaction:
  • shortness of breath or trouble breathing
  • pain or tightness in your chest
  • wheezing
  • feeling dizzy or lightheaded
  • swelling of the throat, lips, tongue, or face
  • skin itching, hives, or rash
  • fever or chills

• The most common side effects of PIASKY are:
  • infusion-related reactions
  • respiratory tract infections including infections of the lungs, cold symptoms, and pain or swelling of the nose or throat
  • viral infections
  • Type III hypersensitivity reactions

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of PIASKY. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please see the full Prescribing Information and Medication Guide for additional Important Safety Information, including Serious Side Effects, or visit https://www.piasky.com/.

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. 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 and 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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Source: Genentech