– The REGENCY study met its primary endpoint,
demonstrating statistically significant and clinically meaningful
treatment benefits in people with active lupus nephritis –
– Gazyva is designed to target an underlying
cause of lupus nephritis, aiming to prevent or delay progression to
end-stage kidney disease –
– Lupus nephritis is a potentially
life-threatening manifestation of an autoimmune disease affecting
1.7 million people worldwide, primarily women; up to one-third of
people on current treatments will progress to end-stage kidney
disease within 10 years –
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX:
RHHBY), announced today positive topline results from the Phase III
REGENCY study of Gazyva® (obinutuzumab) in people with active lupus
nephritis. In the study, a higher proportion of people treated with
Gazyva plus standard therapy (mycophenolate mofetil and
glucocorticoids) achieved a complete renal response (CRR) at 76
weeks compared to those treated with standard therapy alone. Safety
was in line with the well-characterized profile of Gazyva. No new
safety signals were identified.
“Gazyva achieved a robust complete renal response rate in lupus
nephritis, which is associated with long-term preservation of
kidney function and delay or prevention of end-stage kidney
disease,” said Levi Garraway, M.D., Ph.D., chief medical officer
and head of Global Product Development. “Since dialysis or
transplants are often required for patients with advanced kidney
disease, these findings could represent an important step forward
for people living with this devastating disease.”
“I am very excited about today’s announcement that the Phase III
REGENCY study has met its primary endpoint,” said Dr. Brad H.
Rovin, Director of Nephrology and Medical Director of the Center
for Clinical Research Management at The Ohio State University
Wexner Medical Center, and investigator for the REGENCY study. “The
results of REGENCY are compelling. Obinutuzumab could offer the
lupus community an effective new treatment option for controlling
this difficult disease that can be associated with high morbidity
for individuals living with lupus.”
Two key secondary endpoints showed statistically significant and
clinically meaningful benefits with Gazyva – the endpoint
proportion of patients achieving CRR with a successful reduction of
corticosteroid use, and an improvement in proteinuric response
(both at 76 weeks). These endpoints are important indicators for
achieving better disease control in lupus nephritis. Other
secondary endpoints were not statistically significant, but
numerically greater responses were observed for Gazyva in several
endpoints.*
Data are being shared with health authorities, including the
U.S. Food and Drug Administration (FDA) and the European Medicines
Agency, with the goal of making this potential new treatment option
for lupus nephritis available as soon as possible. Data are also
being submitted for publication in a medical journal and
presentation at a future medical congress.
Lupus nephritis is a potentially life-threatening manifestation
of an autoimmune disease that affects approximately 1.7 million
people worldwide, predominantly women and mostly women of color and
childbearing age. In lupus nephritis, disease-causing B cells drive
persistent inflammation that damages the kidneys. Despite current
treatment options, up to a third of people will develop end-stage
kidney disease within 10 years, where dialysis or transplant are
the only available options and the risk of mortality is high. Data
suggest that Gazyva depletes disease-causing B cells, helping to
limit further damage to the kidneys and potentially preventing or
delaying progression to end-stage kidney disease.
Gazyva was granted Breakthrough Therapy Designation by the FDA
in 2019, based on data from the Phase II NOBILITY study.
Breakthrough Therapy Designation is designed to accelerate the
development and regulatory review of medicines intended to treat
serious or life-threatening conditions where preliminary clinical
evidence has indicated they may demonstrate substantial improvement
over existing therapies.
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 also includes RG6299 (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 and RG6382, a
CD19xCD3 T-cell engaging bispecific antibody being investigated in
SLE.
*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.
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 the United States, Gazyva is part of a collaboration
between Genentech and Biogen.
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 U.S. 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.
- 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 http://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 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
- cough
- 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.
PiaSky U.S. Indication
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
https://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 South San Francisco, California.
For additional information about the company, please visit
http://www.gene.com.
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Advocacy Contact: Meg Harrison, (617) 694-7060
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