FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
Genentech announced FDA acceptance of supplemental Biologics License Application (sBLA) for Gazyva to treat lupus nephritis. The application is based on positive Phase III REGENCY study results, where Gazyva plus standard therapy showed superior complete renal response compared to standard therapy alone.
Gazyva is the first anti-CD20 monoclonal antibody in a randomized Phase III study demonstrating complete renal response benefit. The study results, presented at World Congress of Nephrology and published in New England Journal of Medicine in February 2025, showed nearly 50% of patients on Gazyva plus standard therapy achieved complete renal response.
The FDA decision is expected by October 2025. Lupus nephritis affects 1.7 million people globally, with up to one-third of patients on current treatments progressing to end-stage kidney disease within 10 years. Gazyva received FDA Breakthrough Therapy Designation in 2019 based on Phase II NOBILITY study data.
Genentech ha annunciato l'accettazione da parte della FDA della domanda di licenza biologica supplementare (sBLA) per Gazyva per il trattamento del nefrite lupica. La domanda si basa sui risultati positivi dello studio REGENCY di Fase III, dove Gazyva in combinazione con la terapia standard ha mostrato una risposta renale completa superiore rispetto alla sola terapia standard.
Gazyva è il primo anticorpo monoclonale anti-CD20 in uno studio randomizzato di Fase III a dimostrare un beneficio in termini di risposta renale completa. I risultati dello studio, presentati al Congresso Mondiale di Nefrologia e pubblicati nel New England Journal of Medicine nel febbraio 2025, hanno mostrato che quasi il 50% dei pazienti trattati con Gazyva e terapia standard ha raggiunto una risposta renale completa.
Si prevede una decisione della FDA entro ottobre 2025. La nefrite lupica colpisce 1,7 milioni di persone a livello globale, con fino a un terzo dei pazienti in trattamento attuale che progrediscono verso la malattia renale allo stadio terminale entro 10 anni. Gazyva ha ricevuto la Designazione di Terapia Innovativa dalla FDA nel 2019 sulla base dei dati dello studio di Fase II NOBILITY.
Genentech anunció la aceptación por parte de la FDA de la solicitud de licencia biológica suplementaria (sBLA) para Gazyva para tratar la nefritis lúpica. La solicitud se basa en los resultados positivos del estudio REGENCY de Fase III, donde Gazyva más la terapia estándar mostró una respuesta renal completa superior en comparación con la terapia estándar sola.
Gazyva es el primer anticuerpo monoclonal anti-CD20 en un estudio aleatorizado de Fase III que demuestra un beneficio en la respuesta renal completa. Los resultados del estudio, presentados en el Congreso Mundial de Nefrología y publicados en el New England Journal of Medicine en febrero de 2025, mostraron que casi el 50% de los pacientes tratados con Gazyva más la terapia estándar lograron una respuesta renal completa.
Se espera una decisión de la FDA para octubre de 2025. La nefritis lúpica afecta a 1,7 millones de personas en todo el mundo, con hasta un tercio de los pacientes en tratamientos actuales que progresan a enfermedad renal en etapa terminal en un plazo de 10 años. Gazyva recibió la Designación de Terapia Innovadora de la FDA en 2019 basada en los datos del estudio de Fase II NOBILITY.
Genentech는 Gazyva의 루푸스 신염 치료를 위한 보완 생물학적 라이센스 신청(sBLA)이 FDA에 의해 수용되었다고 발표했습니다. 이 신청은 3상 REGENCY 연구의 긍정적인 결과를 바탕으로 하며, Gazyva와 표준 치료의 조합이 단독 표준 치료에 비해 완전한 신장 반응에서 우수한 결과를 보였습니다.
Gazyva는 완전한 신장 반응의 이점을 입증한 무작위 3상 연구에서 첫 번째 항-CD20 단클론 항체입니다. 이 연구 결과는 세계 신장학 회의에서 발표되었고 2025년 2월 New England Journal of Medicine에 게재되었습니다. Gazyva와 표준 치료를 받는 환자의 거의 50%가 완전한 신장 반응을 달성했습니다.
FDA의 결정은 2025년 10월까지 예상됩니다. 루푸스 신염은 전 세계적으로 170만 명에게 영향을 미치며, 현재 치료를 받는 환자의 최대 3분의 1이 10년 이내에 말기 신장 질환으로 진행됩니다. Gazyva는 2019년에 2상 NOBILITY 연구 데이터를 기반으로 FDA의 혁신 치료 지정(Breakthrough Therapy Designation)을 받았습니다.
Genentech a annoncé l'acceptation par la FDA de la demande de licence biologique complémentaire (sBLA) pour Gazyva afin de traiter la néphrite lupique. La demande est basée sur des résultats positifs de l'étude REGENCY de Phase III, où Gazyva associé à la thérapie standard a montré une réponse rénale complète supérieure par rapport à la thérapie standard seule.
Gazyva est le premier anticorps monoclonal anti-CD20 dans une étude randomisée de Phase III à démontrer un bénéfice en termes de réponse rénale complète. Les résultats de l'étude, présentés au Congrès Mondial de Néphrologie et publiés dans le New England Journal of Medicine en février 2025, ont montré que près de 50 % des patients sous Gazyva et thérapie standard ont atteint une réponse rénale complète.
La décision de la FDA est attendue d'ici octobre 2025. La néphrite lupique affecte 1,7 million de personnes dans le monde, avec jusqu'à un tiers des patients sous traitements actuels progressant vers une maladie rénale terminale dans les 10 ans. Gazyva a reçu la désignation de thérapie révolutionnaire de la FDA en 2019 sur la base des données de l'étude de Phase II NOBILITY.
Genentech hat die Annahme des ergänzenden Antrags auf Biologika-Lizenz (sBLA) für Gazyva zur Behandlung von Lupusnephritis durch die FDA bekannt gegeben. Der Antrag basiert auf positiven Ergebnissen der Phase-III-Studie REGENCY, in der Gazyva in Kombination mit der Standardtherapie eine überlegene vollständige renale Antwort im Vergleich zur Standardtherapie allein zeigte.
Gazyva ist der erste anti-CD20 monoklonale Antikörper in einer randomisierten Phase-III-Studie, der einen Nutzen in Bezug auf die vollständige renale Antwort zeigt. Die Ergebnisse der Studie, die auf dem Weltkongress für Nephrologie präsentiert und im New England Journal of Medicine im Februar 2025 veröffentlicht wurden, zeigten, dass fast 50 % der Patienten, die Gazyva und die Standardtherapie erhielten, eine vollständige renale Antwort erreichten.
Die Entscheidung der FDA wird bis Oktober 2025 erwartet. Lupusnephritis betrifft weltweit 1,7 Millionen Menschen, wobei bis zu ein Drittel der Patienten unter aktuellen Behandlungen innerhalb von 10 Jahren zu einer terminalen Nierenerkrankung fortschreiten. Gazyva erhielt 2019 die Breakthrough-Therapie-Bezeichnung der FDA basierend auf den Daten der Phase-II-Studie NOBILITY.
- FDA accepted sBLA for Gazyva in lupus nephritis treatment
- Phase III REGENCY showed 50% complete renal response rate
- Demonstrated superiority over standard therapy
- Consistent benefits across all patient subgroups
- Safety profile aligned with existing indications
- FDA approval decision not expected until October 2025
- 33% of current treatment patients progress to end-stage kidney disease within 10 years
– Gazyva is the only anti-CD20 monoclonal antibody in a randomized Phase III study to demonstrate a complete renal response benefit –
– The filing application is based on data from the Phase III REGENCY study, where Gazyva showed superiority over standard therapy alone in people with active lupus nephritis –
– Lupus nephritis affects 1.7 million people worldwide; up to one-third of people on current treatments will progress to end-stage kidney disease within 10 years –
“In people with lupus nephritis, Gazyva demonstrated a complete renal response benefit, a meaningful clinical outcome linked to preservation of kidney function, and slowing or prevention of end-stage kidney disease,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “The FDA’s sBLA acceptance for Gazyva recognizes the need to provide a more effective treatment option for people living with this devastating disease.”
“Lupus nephritis is a debilitating and potentially life-threatening condition that can lead to kidney failure and require dialysis or transplantation,” said Louise Vetter, President and Chief Executive Officer, Lupus Foundation of America. “Given the relatively young age of onset, people with lupus nephritis experience more years of disease-related complications and decreased quality of life due to the significant burden of this illness. We are hopeful for a new treatment option that can effectively reduce these risks and improve the health of all people affected by this disease.”
The Phase III REGENCY results, which were simultaneously presented at the World Congress of Nephrology (WCN) and published in the New England Journal of Medicine in February 2025, showed that nearly half of patients on Gazyva plus standard therapy achieved a CRR, with a statistically significant and clinically meaningful improvement, compared with standard treatment alone. This was accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, markers of disease activity and inflammation. A pre-specified subgroup analysis showed consistent CRR benefit across patient subgroups, highlighting treatment potential for a broad patient population with a high unmet need. Gazyva’s safety profile was consistent with the well-characterized profile observed in its hematology-oncology indications.
Data from the Phase III REGENCY study are also being used for a filing submission with the European Medicines Agency.
Gazyva is the only anti-CD20 monoclonal antibody in a randomized Phase III study to demonstrate a CRR benefit in lupus nephritis. In 2019, Gazyva was granted Breakthrough Therapy Designation by the FDA based on data from the Phase II NOBILITY study. In addition to REGENCY, Gazyva is being investigated in children and adolescents with lupus nephritis, people with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus (SLE), an autoimmune disease that commonly affects the kidneys and can lead to lupus nephritis.
Our pipeline in immunological kidney and related diseases also includes Sefaxersen (ASO factor B), an antisense oligonucleotide therapy being investigated in people with primary immunoglobulin A nephropathy at high risk of progression, Lunsumio® (mosunetuzumab), a first-in-class CD20xCD3 T-cell engaging bispecific antibody being investigated in SLE, PiaSky® (crovalimab), a novel recycling monoclonal antibody being investigated in atypical hemolytic uremic syndrome, RG6382, a CD19xCD3 T-cell engaging bispecific antibody being investigated in SLE, and P-CD19CD20-ALLO1, an allogeneic dual CAR-T.
About Gazyva in Kidney Diseases
Gazyva® (obinutuzumab) is a Type II engineered humanized monoclonal antibody designed to attach to CD20, a protein found on certain types of B cells. In lupus nephritis, disease-causing B cells drive persistent inflammation that damages the kidneys. We can target an underlying cause of lupus nephritis to help gain better control of the disease by depleting disease-causing B cells with Gazyva, aiming to protect the kidneys from further damage and potentially prevent or delay progression to end-stage kidney disease.
Gazyva is already approved in 100 countries for various types of lymphoma. In
About the REGENCY Study
REGENCY [NCT04221477] is a Phase III, randomized, double-blind, placebo-controlled, multicenter study investigating the efficacy and safety of Gazyva® (obinutuzumab) plus standard therapy (mycophenolate mofetil and glucocorticoids) in people with active/chronic International Society of Nephrology/Renal Pathology Society 2003 proliferative Class III or IV lupus nephritis, with or without Class V. The study enrolled 271 people, who were randomized 1:1 to receive either biannual intravenous dosing of Gazyva plus standard therapy or placebo plus standard therapy. REGENCY was designed based on robust Phase II data and conducted during the COVID-19 pandemic. The study population was representative of the real-world population of people with lupus nephritis. The primary endpoint was the proportion of people who achieved complete renal response (CRR) at 76 weeks. Key secondary endpoints included the proportion of people who achieved CRR at week 76 with successful reduction of corticosteroid use (prednisone taper); the proportion who achieved proteinuric response at 76 weeks; mean change in estimated glomerular filtration rate at 76 weeks; death or renal related events through week 76 and overall renal response at 50 weeks. Safety and tolerability were also assessed.
About Lupus Nephritis
Lupus nephritis is a potentially life-threatening manifestation of systemic lupus erythematosus, an autoimmune disease that commonly affects the kidneys. Lupus nephritis affects approximately 1.7 million people worldwide. Lupus nephritis has a profound impact on the lives and outlook of those affected and even with the latest treatments, the damage caused to the kidneys usually gets worse over time, with up to a third of people progressing to end-stage kidney disease within 10 years, where the only options are dialysis or transplant. Lupus nephritis predominantly affects women, mostly women of color and usually of childbearing age. Currently, there is no cure.
Gazyva
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.
- In combination with chemotherapy, followed by Gazyva alone in those who responded, to treat stage II bulky, III, or IV FL in adults who have not had previous FL treatment.
Important Safety Information
The most important safety information patients should know about Gazyva
Patients must tell their doctor right away about any side effect 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 the patient has a 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 them for hepatitis B before, and monitor the patient for hepatitis during and after, their 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. The patient’s weakened immune system could put them 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.
Who should not receive Gazyva:
Patients should NOT receive Gazyva if they have had an allergic reaction (e.g., anaphylaxis or serum sickness) to Gazyva. Patients must tell their healthcare provider if they have had an allergic reaction to obinutuzumab or any other ingredients in Gazyva in the past.
Additional possible serious side effects of Gazyva:
Patients must tell their doctor right away about any side effect 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 the patient has a reaction, the infusion is either slowed or stopped until their symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion reaction is life-threatening, 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. Symptoms of infusion reactions may include: fast heartbeat, tiredness, dizziness, headache, redness of the face, nausea, chills, fever, vomiting, diarrhea, rash, high blood pressure, low blood pressure, difficulty breathing, and chest discomfort.
- Hypersensitivity Reactions Including Serum Sickness: Some patients receiving Gazyva may have severe or life-threatening allergic reactions. This reaction may be severe, may happen during or after an infusion, and may affect many areas of the body. If an allergic reaction occurs, the patient’s doctor will stop the infusion and permanently discontinue Gazyva.
- 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 the patient is taking Gazyva, they may develop infections. Some of these infections may be fatal and severe, so the patient should be sure to talk to their doctor if they think they have an infection. Patients administered Gazyva in combination with chemotherapy, followed by Gazyva alone are at a high risk of infections during and after treatment. Patients with a history of recurring or chronic infections may be at an increased risk of infection. Patients with an active infection should not be treated with Gazyva. Patients taking Gazyva plus bendamustine may be at higher risk for fatal or severe infections compared to patients taking Gazyva plus CHOP or CVP.
- Low White Blood Cell Count: When the patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking Gazyva, their doctor will do blood work to check their white blood cell count. 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 the patient’s white blood cell count is low, their 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 their blood; having low platelet count is called thrombocytopenia. This may affect the clotting process. While the patient is taking Gazyva, their doctor will do blood work to check their platelet count. Severe and life-threatening thrombocytopenia can develop during treatment with Gazyva. Fatal bleeding events have occurred in patients treated with Gazyva. If the patient’s platelet count gets too low, their treatment may be delayed or reduced.
- Disseminated Intravascular Coagulation (DIC): Fatal and severe DIC has been reported in people receiving GAZYVA. DIC is a rare and serious abnormal blood clotting condition that should be monitored and managed by your doctor as it can lead to uncontrollable bleeding.
The most common side effects of Gazyva in CLL were infusion-related reactions and low white blood cell counts.
The most common side effects seen with GAZYVA in a study that included relapsed or refractory NHL, including FL patients were infusion-related reactions, fatigue, low white blood cell counts, cough, upper respiratory tract infection, and joint or muscle pain.
The most common side effects seen with GAZYVA in a study that included previously untreated FL patients were infusion-related reactions, low white blood cell count, upper respiratory tract infections, cough, constipation and diarrhea.
Before receiving Gazyva, patients should talk to their doctor about:
- Immunizations: Before receiving Gazyva therapy, the patient should tell their healthcare provider if they have recently received or are scheduled to receive a vaccine. Patients who are treated with Gazyva should not receive live vaccines.
- Pregnancy: The patient should tell their doctor if they are pregnant, think that they might be pregnant, or plan to become pregnant. Gazyva may harm their unborn baby. The patient should speak to their doctor about using Gazyva while they are pregnant. The patient should talk to their doctor or their child’s doctor about the safety and timing of live virus vaccinations to their infant if they received Gazyva during pregnancy. Patients of childbearing potential should use effective contraception while taking Gazyva and for 6 months after your Gazyva treatment.
- Breastfeeding: Because of the potential risk of serious side reactions in breastfed children, patient should not breastfeed while taking Gazyva and for 6 months after your last dose.
Patients should 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 https://www.Gazyva.com for the Gazyva full Prescribing Information, including BOXED WARNINGS, 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
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:
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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
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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
- cough
- chest pain
- tiredness
- shortness of breath
- painful rash
- sore throat
- pain during urination
- feeling weak or generally unwell
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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.
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
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
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
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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.
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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.
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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.
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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
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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 http://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 Kidney Diseases
For 20 years, we have combined innovation, scientific expertise and commitment to patients to address unmet needs in kidney diseases. Our industry-leading pipeline includes several ongoing Phase I-III clinical studies of immune-mediated investigational therapies with the aim of bringing innovative new treatment options to people living with kidney and kidney-related diseases, including lupus nephritis, membranous nephropathy, immunoglobulin A nephropathy, atypical hemolytic uremic syndrome, childhood-onset idiopathic nephrotic syndrome and systemic lupus erythematosus, an autoimmune disease that can lead to lupus nephritis.
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
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Source: Genentech
FAQ
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