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Avastin 400mg
Common side effects of Avastin
● Exfoliative dermatitis
● High blood pressure
● Nosebleeds
● Protein in urine
● Decreased appetite
● Electrolyte imbalance
● Peripheral sensory neuropathy
● Breathlessness
● Thromboembolism
● Wound healing complications
● Ovarian failure
●Decreased white blood cell count (lymphocytes)
● Low blood platelets
● Mucosal inflammation
● Abscess
● Cellulitis
● Hypersensitivity
● Rectovaginal fistula
Avastin 400mg Injection is an effective medicine, first-line option when used together with other cancer medicines. It is given as an infusion. That means you get it through a small needle in your vein or through a port, which is a device placed under your skin. The doctor will decide your dose and duration and will check you for signs of an infusion reaction such as high blood pressure and trouble breathing. You keep taking Avastin 400mg Injection as long as your disease is controlled and your side effects are manageable. Your doctor will determine whether you should stop taking it or not. You may be advised to check blood pressure and levels of protein in urine while you are taking this medication.
The most common side effects of this medicine include rectal bleeding, taste change, and headache. Inform your doctor that you are taking this medication before undergoing any surgical procedure, as the drug has ability to lower the ability of wound healing. Other than this, it also enhances your risk of bleeding thus if you notice any unusual bleeding or bleeding consult with your doctor immediately.
Inform your doctor if you are pregnant, planning pregnancy or breastfeeding. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using.
Side effects of Avastin Injection
Most side effects do not require any medical attention and disappear as your body adjusts to the medicine. Consult your doctor if they persist or if you’re worried about them
How to use Avastin Injection
Your doctor or nurse will give you this medicine.
Kindly do not self administer.
Imfinzi
How does Imfinzi work?
Some cancer cells have a protein called PD-L1 on the outside of the cells which can hide it from the immune system so cancer cells can survive and multiply. Imfinzi works by binding and blocking the PD-L1 protein so your immune system can find and attack the cancer cells, which may help slow cancer spreading and increase survival.
Imfinzi mechanism of action (MOA) is as a programmed death-ligand 1 (PD-L1) blocking antibody. It binds and blocks PD-L1, so there is no interaction with PD-1 and CD80. This means that the immune response is now activated to work against the cancer cells.
What is Imfinzi used for?
Imfinzi is a prescripton medicine that is FDA-approved to treat:
● non-small cell lung cancer (NSCLC) in patients whose tumors cannot be removed by
surgery, and whose cancer has not progressed after treatment with chemotherapy and radiation (chemoradiation). It may also be used in combination with Imjudo (tremelimumab-actl) and platinum-based chemotherapy to treat NSCLC that has spread (metastatic NSCLC)
● small cell lung cancer (SCLC) in combination with the chemotherapy medicines etoposide and carboplatin or cisplatin when cancer has spread within your lungs or to other parts of the body
● biliary tract cancer (including cancer of the bile ducts and gallbladder cancer) in combination with the chemotherapy medicines gemcitabine and cisplatin when cancer has spread to nearby tissues or other parts of the body.
●hepatocellular carcinoma (unresectable) in combination with Imjudo (tremelimumab-actl)
● endometrial cancer that has spread (advanced) or come back (recurrent) and tests show
the tumor is mismatch repair deficient (dMMR), Imfinzi is used with carboplatin plus paclitaxel followed by single-agent Imfinzi.
Imfinzi (durvalumab) is a cancer immunotherapy that may increase overall survival, lower the chance of cancer spreading, and help shrink tumors, depending on the type of cancer. It works by helping the immune system find, recognize, and fight cancer cells.
Imfinzi is used to treat types of non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (ES-SCLC), bile ducts and gallbladder cancer, unresectable hepatocellular carcinoma and advanced or recurrent dMMR endometrial cancer.
Imfinzi is given as an infusion into a vein every 2, 3, or 4 weeks, depending on your condition. Other medicines may be part of your treatment plan, depending on your cancer type.
Imfinzi became an FDA-approved medicine on May 1, 2017, for the company AstraZeneca.
Common side effects of Imfinzi
When used as a single agent for Stage III NSCLC, common Imfinzi side effects include cough, fatigue, pneumonitis/radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.
Common Imfinzi side effects when used with other cancer treatments may include nausea, constipation, decreased appetite, feeling weak or tired, bone or muscle pain, cough, feeling short of breath, cold symptoms such as stuffy nose, sneezing, sore throat, abdominal pain, fever, itchy skin, rash, painful urination, hair loss, vomiting, nerve inflammation (causing symptoms such as numbness, weakness, tingling, or burning), changes blood tests including decreased magnesium, increased ALT, and increased AST. Side effects profiles are dependent on the specific combination of therapies.
Immune-mediated hypothyroidism was reported in 14% of people receiving Imfinzi in combination with carboplatin and paclitaxel. Events resolved in some patients, but all required endocrine therapy.
Serious Imfinzi side effects
Get emergency medical help if you have signs of an allergic reaction to this medicine: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Some side effects may occur during the Imfinzi injection. Tell your caregiver right away if you feel light-headed or itchy or if you have a fever, chills, neck or back pain, trouble breathing, or flushing (warmth, redness, or tingly feeling).
This medicine causes your immune system to attack tumor cells, but it could also attack healthy organs and tissues in your body. This could lead to serious or life-threatening side effects on your lungs, liver, pancreas, kidneys, intestines, thyroid, or adrenal glands.
Call your doctor at once if you have:
● chest pain, new or worsening cough, feeling short of breath.
● severe stomach pain, diarrhea, bloody or tarry stools.
● new or worsening skin rash, itching, or blistering.
● fever, flu-like symptoms.
● pain or burning when you urinate.
● problems in other organs – mood or behavior changes, neck stiffness, confusion, eye pain
or redness, vision problems.
● liver problems – loss of appetite, upper stomach pain, drowsiness, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes).
● kidney problems – little or no urination, red or pink urine, swelling in your feet or ankles.
● transplant rejection – rash with blisters and peeling, watery diarrhea, stomach pain, vomiting, loss of appetite, fever, bruising or bleeding, jaundice, pain or swelling near your transplanted organ.
Kisqali 200mg
Common side effects that I need to call my doctor about right away?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
● Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
● Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
● Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
● Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
● Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
● Dizziness or passing out.
● Fast or abnormal heartbeat.
● Feeling very tired or weak.
● Any unexplained bruising or bleeding.
● Swelling in the arms or legs.
● Some people have had lung problems with Kisqali (200 MG Dose) (ribociclib). Sometimes, this has been deadly. Call your doctor right away if you have signs of lung problems like shortness of breath or other trouble breathing, cough that is new or worse, or fever.
What are some other side effects of Kisqali?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
● Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
● Hair loss.
● Feeling tired or weak.
● Mouth irritation or mouth sores.
● Headache.
● Back pain.
● Trouble sleeping.
What do I do if I miss a dose?
● Skip the missed dose and go back to your normal time.
● Do not take 2 doses at the same time or extra doses.
It is used to treat a type of breast cancer.
What do I need to tell my doctor BEFORE I take Kisqali?
●If you are allergic to Kisqali (200 MG Dose) (ribociclib); any part of Kisqali (200 MG Dose) (ribociclib); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
● If you have any of these health problems: Electrolyte problems (like calcium, magnesium, phosphorous, or potassium), heart problems like heart failure or a certain type of chest pain (unstable angina), long QT on ECG, or slow or abnormal heartbeat.
● If you have had a recent heart attack.
● If you are taking any drugs that can cause a certain type of heartbeat that is not normal
(prolonged QT interval). There are many drugs that can do this. Ask your doctor or
pharmacist if you are not sure.
● If you take any drugs (prescription or OTC, natural products, vitamins) that must not be
taken with Kisqali (200 MG Dose) (ribociclib), like certain drugs that are used for HIV, infections, or seizures. There are many drugs that must not be taken with Kisqali (200 MG Dose) (ribociclib).
● If you are breast-feeding. Do not breast-feed while you take Kisqali (200 MG Dose) (ribociclib) and for 3 weeks after your last dose.
● This is not a list of all drugs or health problems that interact with Kisqali (200 MG Dose)
(ribociclib).
● Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural
products, vitamins) and health problems. You must check to make sure that it is safe for you to take Kisqali (200 MG Dose) (ribociclib) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take Kisqali?
● Tell all of your health care providers that you take Kisqali (200 MG Dose) (ribociclib). This includes your doctors, nurses, pharmacists, and dentists.
● An unsafe heartbeat that is not normal (long QT on ECG) has happened with Kisqali (200 MG Dose) (ribociclib). This may raise the chance of sudden death. Talk with the doctor.
● You will need an ECG before starting Kisqali (200 MG Dose) (ribociclib) and during treatment. Talk with your doctor.
● If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
● Have blood work checked as you have been told by the doctor. Talk with the doctor.
● You may have more chance of getting an infection. Wash hands often. Stay away from
●people with infections, colds, or flu.
● Avoid grapefruit and grapefruit juice.
● This medicine may affect being able to father a child. Talk with the doctor.
● This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start Kisqali (200 MG Dose) (ribociclib) to show that you are NOT pregnant.
● Women must use birth control while taking Kisqali (200 MG Dose) (ribociclib) and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
How is this medicine (Kisqali) best taken?
Use Kisqali (200 MG Dose) (ribociclib) as ordered by your doctor. Read all information given to you. Follow all instructions closely.
● Take with or without food.
● Take in the morning.
● Take Kisqali (200 MG Dose) (ribociclib) at the same time of day.
● Swallow whole. Do not chew, break, or crush.
● Do not take chipped or broken tablets.
● Take as you have been told by your doctor.
● Keep taking Kisqali (200 MG Dose) (ribociclib) as you have been told by your doctor or
other health care provider, even if you feel well.
● If you throw up after taking a dose, do not repeat the dose. Take your next dose at your
normal time.
SPINRAZA
The most common side effects of SPINRAZA
include lower respiratory infection, fever, constipation, headache, vomiting, back pain, and post-lumbar puncture syndrome.
These are not all of the possible side effects of SPINRAZA. Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Before taking SPINRAZA, tell your healthcare provider if you are pregnant or plan to become pregnant.
What do I do if I miss a dose?
● Skip the missed dose and go back to your normal time.
● Do not take 2 doses at the same time or extra doses.
SPINRAZA® (nusinersen) is a prescription medicine used to treat spinal muscular atrophy (SMA) in pediatric and adult patients.
IMPORTANT SAFETY INFORMATION
Increased risk of bleeding complications has been observed after administration of similar medicines. Your healthcare provider should perform blood tests before you start treatment with SPINRAZA and before each dose to monitor for signs of these risks. Seek medical attention if unexpected bleeding occurs.
Increased risk of kidney damage, including potentially fatal acute inflammation of the kidney, has been observed after administration of similar medicines. Your healthcare provider should perform urine testing before you start treatment with SPINRAZA and before each dose to monitor for signs of this risk.
What is Spinraza and what is it used for?
Spinraza is a medicine used to treat 5q spinal muscular atrophy (SMA), a genetic disease that causes weakness and wasting of the muscles including the lung muscles. The disease is linked to a defect on chromosome 5q and symptoms usually start shortly after birth.
Because the number of patients with SMA is low, the disease is considered ‘rare’, and Spinraza was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 2 April 2012. Spinraza contains the active substance nusinersen.
How is Spinraza used?
Spinraza can only be obtained with a prescription and treatment should be started by a doctor with experience in the treatment of SMA.
The medicine is available as a solution for injection in 12 mg vials. It is given by intrathecal injection (into the lower back, directly into the spine) by a doctor or nurse experienced in carrying out this procedure. The patient may need to be sedated (given a medicine to calm them) before they are given Spinraza.
Keytruda
Keytruda (pembrolizumab) is an immunotherapy medication that may be used to treat at least 18 different types of cancer such as melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), classical Hodgkin Lymphoma, endometrial carcinoma, triple- negative breast cancer, and some colorectal cancers.
Keytruda may be used alone or together with other medicines, including chemotherapy, depending on the specific type of cancer.
Melanoma: Unresectable or metastatic melanoma OR as adjuvant treatment for Stage IIB, IIC, or III melanoma following complete resection.
Non-small cell lung cancer (NSCLC): First-line treatment for metastatic NSCLC with high PD-L1 expression OR in combination with chemotherapy for various NSCLC subtypes.
Head and neck squamous cell cancer (HNSCC): Unresectable, recurrent, or metastatic HNSCC in combination with platinum and FU OR as a single agent for some other types of HNSCC.
Classical Hodgkin lymphoma (cHL): Refractory or relapsed cHL.
Primary Mediastinal Large B-Cell Lymphoma (PMBCL): Refractory or relapsed PMBCL.
Urothelial cancer: Advanced or metastatic urothelial carcinoma in combination with other treatments or alone, and for some types of Bacillus Calmette-Guerin (BCG)-unresponsive urothelial cancers.
Verzenio
Verzenio (abemaciclib) is a prescription medicine used in combination with other cancer treatments to treat certain patients with HR-positive, HER2-negative breast cancer. It is used in adults when the cancer has progressed or has spread to other parts of the body (metastatic) after other treatments have failed. Abemaciclib belongs to a class of medications called kinase inhibitors.
Verzenio is a targeted treatment known as a CDK4/6 inhibitor. It works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells.
Verzenio is used in combination with an aromatase inhibitor such as anastrozole (Arimidex), exemestane (Aromasin), or letrozole (Femara) to treat a certain type of hormone receptor- positive, early breast cancer.
Verzenio is also used along with fulvestrant (Faslodex) to treat a certain type of hormone receptor-positive, advanced breast cancer (breast cancer that depends on hormones such as estrogen to grow) or breast cancer that has spread to other parts of the body after treatment with an antiestrogen medication such as tamoxifen.
Verzenio is also used along with anastrozole (Arimidex), exemestane (Aromasin), or letrozole (Femara) as a first treatment of hormone receptor-positive, advanced breast cancer or breast cancer that has spread to other parts of the body.
Verzenio is also used alone to treat a certain type of hormone receptor-positive, advanced breast cancer or breast cancer that has spread to other parts of the body in people who have already been treated with an antiestrogen medication and chemotherapy.
Abemaciclib works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.
When Verzenio is used in combination with fulvestrant, tamoxifen, or an aromatase inhibitor, also read the Patient Information for the associated prescribed medicine. Ask your healthcare provider if you are not sure.
Warnings
Verzenio can cause severe diarrhea, which can lead to dehydration or infection. Call your doctor right away if you have diarrhea. Drink extra fluids and start taking anti-diarrhea medicine such as loperamide (Imodium).
TECENTRIQ
What is the most important information about TECENTRIQ?
TECENTRIQ can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time. These problems may happen anytime during your treatment or even after your treatment has ended.
TECENTRIQ is a prescription medicine used to treat:
Adults with a type of lung cancer called non-small cell lung cancer (NSCLC).
TECENTRIQ may be used alone as a treatment for your lung cancer:
to help prevent your lung cancer from coming back after your tumor(s)
has been removed by surgery and you have received platinum-based chemotherapy, and
you have stage 2 to stage 3A NSCLC (talk to your healthcare provider about what these stages mean), and
your cancer tests positive for “PD-L1”.
TECENTRIQ may be used alone as your first treatment when your lung cancer:
has spread or grown, and
your cancer tests positive for “high PD-L1”, and
your tumor does not have an abnormal “EGFR” or “ALK” gene.
TECENTRIQ may be used with the medicines bevacizumab, paclitaxel, and carboplatin as your first treatment when your lung cancer:
has spread or grown, and
is a type called “non-squamous NSCLC”, and
your tumor does not have an abnormal “EGFR” or “ALK” gene.
TECENTRIQ may be used with the medicines paclitaxel protein-bound and carboplatin as your first treatment when your lung cancer:
has spread or grown, and
is a type called “non-squamous NSCLC”, and
your tumor does not have an abnormal “EGFR” or “ALK” gene.
TECENTRIQ may be used alone when your lung cancer: has spread or grown, and
you have tried chemotherapy that contains platinum, and it did not work or is no longer working.
If your tumor has an abnormal “EGFR” or “ALK” gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
Adults with a type of lung cancer called small cell lung cancer (SCLC). TECENTRIQ may be used with the chemotherapy medicines carboplatin and etoposide as your first treatment when your lung cancer:
● is a type called “extensive-stage small cell lung cancer,” which means that it has spread or grown.
Adults with a type of liver cancer called hepatocellular carcinoma (HCC). TECENTRIQ may be
used with the medicine bevacizumab when your liver cancer:
● has spread or cannot be removed by surgery, and
● you have not received other medicines by mouth or injection through your vein
(IV) to treat your cancer.
Adults with a type of skin cancer called melanoma. TECENTRIQ may be used with the medicines cobimetinib and vemurafenib when your melanoma:
● has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene. Your healthcare provider will
perform a test to make sure this TECENTRIQ combination is right for you. It is not known if TECENTRIQ is safe and effective when used:
● In children for the treatment of NSCLC, SCLC, HCC or melanoma.
LYNPARZA
How should I take LYNPARZA?
Take LYNPARZA tablets exactly as your healthcare provider tells you
Do not change your dose or stop taking LYNPARZA unless your healthcare provider tells you to. Your healthcare provider may temporarily stop treatment with LYNPARZA or change your dose of LYNPARZA if you experience side effects
Your healthcare provider will decide how long you stay on treatment
Take LYNPARZA by mouth 2 times a day with or without food
Each dose should be taken about 12 hours apart
Swallow LYNPARZA tablets whole. Do not chew, crush, dissolve, or divide the
tablets
receptor-positive disease, you should continue to take hormonal therapy during your
If you are taking LYNPARZA for early breast cancer and you have hormonereceptor-positive disease, you should continue to take hormonal therapy during your treatment with LYNPARZA
including if you:
have lung or breathing problems
have kidney problems
are pregnant, become pregnant, or plan to become pregnant. LYNPARZA can
harm your unborn baby and may cause loss of pregnancy (miscarriage)
●are breastfeeding or plan to breastfeed. It is not known if LYNPARZA passes into your breast milk. Do not breastfeed during treatment with LYNPARZA and for 1 month after receiving the last dose of LYNPARZA. Talk to your healthcare provider about the best way to feed your baby during this time
If you are able to become pregnant, your healthcare provider may do a pregnancy test before you start treatment with LYNPARZA
Females who are able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 6 months after the last dose of LYNPARZA. Talk to your healthcare provider about birth control methods that may be right for you. Tell your healthcare provider right away if you become pregnant or think you might be pregnant following treatment with LYNPARZA
Males with female partners who are pregnant or able to become pregnant should use effective birth control (contraception) during treatment with LYNPARZA and for 3 months after the last dose of LYNPARZA
Do not donate sperm during treatment with LYNPARZA and for 3 months after your last dose
Tell your healthcare provider about all the medicines you take, including prescription and over- the-counter medicines, vitamins, and herbal supplements. Taking LYNPARZA and certain other medicines may affect how LYNPARZA works and may cause side effects.
LYNPARZA is a prescription medicine used to treat adults who have:
advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used alone as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of abnormal BRCA gene or a positive laboratory tumor test for genomic instability called HRD. LYNPARZA is used in combination with another anti-cancer medicine, bevacizumab, as maintenance treatment after the cancer has responded to your first treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
ovarian cancer, fallopian tube cancer, or primary peritoneal cancer with a certain type of inherited (germline) or acquired (somatic) abnormal BRCA gene. LYNPARZA is used as maintenance treatment when the cancer has come back. LYNPARZA is used after the cancer has responded to treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
human epidermal growth factor receptor 2 (HER2)-negative early breast cancer with a certain type of inherited (germline) abnormal BRCA gene. LYNPARZA is given after surgery (treatment after surgery is called adjuvant therapy). You should have received chemotherapy medicines before or after surgery to remove the tumor. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
a certain type of abnormal inherited BRCA gene, human epidermal growth factor receptor 2 (HER2)-negative breast cancer that has spread to other parts of the body (metastatic). You should have received chemotherapy medicines, either before or after your cancer has spread. If you have hormone receptor (HR)-positive disease, you should have been treated with hormonal therapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
metastatic pancreatic cancer with a certain type of abnormal inherited BRCA gene. LYNPARZA is used as a maintenance treatment after your cancer has not progressed on at least 16 weeks of treatment with platinum-based chemotherapy. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you
prostate cancer with certain inherited or acquired abnormal genes called homologous recombination repair (HRR genes). LYNPARZA is used when the cancer has spread to other parts of the body (metastatic), and no longer responds to a medical or surgical treatment that lowers testosterone, and has progressed after treatment with enzalutamide or abiraterone. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you, prostate cancer with a certain type of abnormal inherited or acquired BRCA gene that has spread to other parts of the body (metastatic) and no longer responds to a medical or surgical treatment that lowers testosterone. LYNPARZA is used in combination with another anti-cancer medicine, abiraterone, together with the steroid medicine, prednisone or prednisolone. Your healthcare provider will perform a test to make sure that LYNPARZA is right for you. It is not known if LYNPARZA is safe and effective in children.
IMPORTANT SAFETY INFORMATION
LYNPARZA may cause serious side effects, including:
Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have received previous treatment with chemotherapy, radiotherapy, or certain other medicines for their cancer have developed MDS or AML during treatment with LYNPARZA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with LYNPARZA.
Symptoms of low blood cell counts are common during treatment with LYNPARZA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include weakness, weight loss, fever, frequent infections, blood in urine or stool, shortness of breath, feeling very tired, bruising or bleeding more easily.
Your healthcare provider will do blood tests to check your blood cell counts:
before treatment with LYNPARZA
every month during treatment with LYNPARZA
weekly if you have low blood cell counts that last a long time. Your healthcare
provider may stop treatment with LYNPARZA until your blood cell counts improve
Lung problems (pneumonitis). Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. Your healthcare provider may temporarily or completely stop treatment if you develop pneumonitis. Pneumonitis may lead to death.
Blood clots (venous thromboembolism). Some people may develop a blood clot in a deep vein, usually in the leg (venous thrombosis) or a clot in the lungs (pulmonary embolism), which may be severe or lead to death. Tell your healthcare provider right away if you have any symptoms such as pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal (tachypnea), or heart beats faster than normal (tachycardia). Your healthcare provider will monitor you for these symptoms and may prescribe blood thinner medicine.
Before taking LYNPARZA, tell your healthcare provider about all of your medical conditions,
Ocrevus
What is Ocrevus used for?
Ocrevus and Ocrevus Zunovo is a prescription medicine approved by the FDA to treat:
● relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting disease,
and active secondary progressive disease in adults.
● primary progressive MS in adults.
It is not known if it is safe and effective in children.
Ocrevus Side Effects
Ocrevus may cause serious side effects, including:
● see “What is the most important information I should know about Ocrevus?” above
● risk of cancers (malignancies) including breast cancer. Follow your healthcare provider’s
instructions about standard screening guidelines for breast cancer.
● Inflammation of the colon, or colitis: Tell your healthcare provider if you have any
symptoms of colitis, such as:
○ Diarrhea (loose stools) or more frequent bowel movements than usual
○ Stools that are black, tarry, sticky or have blood or mucus
○ Severe stomach-area (abdomen) pain or tenderness
Important information
Ocrevus can cause serious side effects, including:
● Infusion reactions: Infusion reactions are a common side effect of this medication, which
can be serious and may require you to be hospitalized. You will be monitored during your infusion and for at least 1 hour after each infusion for signs and symptoms of an infusion reaction. Tell your healthcare provider or nurse if you get any of these symptoms:
○ itchy skin
○ rash
○ hives
○ tiredness
○ coughing or wheezing
○ trouble breathing
○ throat irritation or pain
○ feeling faint
○ fever
○ redness on your face (flushing)
○ nausea
○ headache
○ swelling of the throat
○ dizziness
○ shortness of breath
○ fatigue
○ fast heart beat
These infusion reactions can happen for up to 24 hours after your infusion. It is important that you call your healthcare provider right away if you get any of the signs or symptoms listed above after each infusion.
If you get infusion reactions, your healthcare provider may need to stop or slow down the rate of your infusion.
Ocrevus (ocrelizumab) is a monoclonal antibody treatment for relapsing and progressive multiple sclerosis (MS) to help reduce relapses and slow disability progression. Ocrevus is given an infusion over a couple of hours. Ocrevus Zunovo is given as an injection under the skin (subcutaneous injection) for approximately 10 minutes. Both are given twice a year as a maintenance dose, by your healthcare professional.
It’s not known exactly how Ocrevus works in people with MS, but it targets and binds to B-cells expressing CD20 on their surface, which results in their destruction via antibody-dependent cellular cytolysis and complement-mediate lysis. B cells are a type of white blood cell that contributes to the development and ongoing disease process involved in MS in a number of ways. The CD20 antigen is mainly found on the surface of B cells, which are also known as B lymphocytes, making it a good target for MS and certain other conditions affecting B cells.
Signs of infection can happen during treatment or after you have received your last dose of this medication. Tell your healthcare provider right away if you have an infection. Your healthcare provider should delay your treatment with Ocrevus until your infection is gone.
○ Hepatitis B virus (HBV) reactivation: Before starting treatment with this medication, your healthcare provider will do blood tests to check for hepatitis B viral infection. If you have ever had hepatitis B virus infection, the hepatitis B virus may become active again during or after treatment with Ocrevus. Hepatitis B virus becoming active again (called reactivation) may cause serious liver problems including liver failure or death. Your healthcare provider will monitor you if you are at risk for hepatitis B virus reactivation during treatment and after you stop receiving this medication.
○ Weakened immune system: Ocrevus taken before or after other medicines that weaken the immune system could increase your risk of getting infections.
● Progressive Multifocal Leukoencephalopathy (PML): PML is a rare brain infection that usually leads to death or severe disability, and has been reported with this medication. Symptoms of PML get worse over days to weeks. It is important that you call your healthcare provider right away if you have any new or worsening neurologic signs or symptoms that have lasted several days, including problems with:
○ thinking
○ eyesight
○ strength
○ balance
○ weakness on 1 side of your body
○ using your arms or legs
● Decreased immunoglobulins: Ocrevus may cause a decrease in some types of immunoglobulins. Your healthcare provider will do blood tests to check your blood immunoglobulin levels.
● Infection:
Ocrevus increases your risk of getting upper respiratory tract infections, lower
respiratory tract infections, skin infections, and herpes infections. Infections are a common side effect, which can be serious. Tell your healthcare provider if you have an infection or have any of the following signs of infection including fever, chills, or a cough that does not go away.
◆ Signs of herpes infection include:
◆ cold sores
◆ shingles
◆ genital sores
◆ skin rash
◆ pain
◆ itching
◆ Signs of a more serious herpes infection include:
◆ changes in vision
◆ eye redness or eye pain
◆ severe or persistent headache
◆ stiff neck
◆ confusion
Imbruvica
What is Imbruvica used for?
Imbruvica is FDA-approved for:
● chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) in adults
● chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL) with 17p deletion
in adults
● Waldenström’s macroglobulinemia (WM) in adults
● chronic graft versus host disease (cGVH), after failure of one or more lines of systemic
therapy for adult and pediatric patients aged 1 year and older.
Before taking this medicine to make sure Imbruvica is safe for you, tell your doctor if you have ever had:
● an infection
● bleeding problems
● take a blood thinner such as warfarin
● a heart rhythm disorder
● risk factors for heart disease (such as diabetes, smoking, being overweight, having high blood pressure or high cholesterol)
● low blood cell counts
● recent surgery or plan to have surgery, medical or dental procedure
Imbruvica (ibrutinib) is used to treat Waldenström’s macroglobulinemia (WM), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and chronic graft versus host disease (cGVHD) in certain patients. Imbruvica is used to help slow cancer or disease progression in WM, CLL, SLL and cGVHD. Imbruvica is taken once a day as a capsule, tablet or oral suspension.
Imbruvica works by blocking an enzyme called Bruton’s tyrosine kinase (BTK) which lowers the survival of cancerous B cells and slows the spread of CLL or SLL. In WM Imbruvica helps abnormal B cells move out of the nourishing environments in the lymph nodes, bone marrow, and other organs, and Imbruvica also inhibits specific immune cells that are involved in cGVHD. Imbruvica’s mechanism of action is by directly inhibiting an enzyme, called Bruton’s tyrosine kinase (BTK). It forms a covalent bond with a cysteine residue on the enzyme, preventing its activity. BTK works as a signaling molecule for the B-cell antigen receptor (BCR) and cytokine receptor pathways. Activation of these pathways causes the proliferation of B cells and other interactions, and inhibition has been shown to reduce the growth and spread of malignant B cells. It belongs to the class of medicines known as BTK inhibitors.
Common side effects of Imbruvica
Common Imbruvica side effects may include diarrhea, nausea, stomach pain, fever, cough, trouble breathing, mouth sores, feeling tired, low blood cell counts (including low platelets, low red and white blood cell counts), muscle spasms, bruising, rash; or muscle, joint, or bone pain. Serious side effects of Imbruvica
Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.
Imbruvica may cause a brain infection that can lead to disability or death. Tell your doctor if you
have problems with speech, thought, vision, or muscle movement. These symptoms can get worse quickly.
Liver problems, which may be severe or life-threatening, or lead to death, can happen in people treated with Imbruvica. Your healthcare provider will do blood tests to check your liver before and during treatment. Tell your healthcare provider or get medical help right away if you have any signs of liver problems, including stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.
Second primary cancers. New cancers have happened during treatment with Imbruvica, including cancers of the skin or other organs.
You may get infections more easily, even serious or fatal infections. Call your doctor right away if you have signs of infection such as:
● fever, chills, sore throat
● mouth sores, red or swollen gums;
● pale skin, easy bruising, unusual bleeding; or
● chest discomfort, wheezing, dry cough or hack, rapid weight loss.
Imbruvica can cause you to bleed more easily. Call your doctor or seek emergency medical attention if you have:
● easy bruising, unusual bleeding, or any bleeding that will not stop.
● bleeding inside your body – weakness, dizziness; pink or brown urine; abnormal vaginal
bleeding, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.
or
● bleeding in your brain – sudden weakness (especially on one side of the body), severe
headache, problems with speech or vision.
● Imbruvica may cause serious side effects. Call your doctor at once if you have:
● severe or ongoing diarrhea.
● heart problems – swelling, rapid weight gain, feeling short of breath.
● heart rhythm disorders – dizziness, chest pain, shortness of breath, fast or irregular heart rate, feeling light-headed.
● high blood pressure- severe headache, blurred vision, pounding in your neck or ears.
● low blood cell counts – fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.
● kidney problems – swelling, urinating less, feeling tired or short of breath.
● liver problems – stomach pain or discomfort, dark-colored urine, or yellow skin and eyes.
● signs of tumor cell breakdown – tiredness, weakness, muscle cramps, nausea, vomiting,
diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.
● Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.
Xtandi
Warnings
Although not for use by women, Xtandi can cause birth defects if the mother or the father is taking this medicine. Use a condom and one other form of birth control to prevent pregnancy during your treatment and for at least 3 months after your treatment ends.
Xtandi may cause side effects on your spinal cord. Stop taking this medicine and call your doctor at once if you have severe lower back pain, trouble walking or standing up, pain or weakness in your lower body, severe and worsening numbness or tingling, or sudden loss of bladder or bowel control.
Before taking this medicine
You should not use Xtandi if you are allergic to enzalutamide.
To make sure Xtandi is safe for you, tell your doctor if you have ever had:
● a seizure;
● a head injury, stroke, or brain tumor;
● heart disease, circulation problems;
● high blood pressure;
● diabetes; or
● high cholesterol or triglycerides (a type of fat in the blood).
Although not for use by women, Xtandi can cause birth defects if the mother or the father is taking this medicine. Do not use this medicine if you are pregnant.
If you are taking Xtandi and your sexual partner could become pregnant, use a condom and one other form of birth control to prevent pregnancy during treatment. Keep using these birth control methods for at least 3 months after your treatment ends. Tell your doctor at once if a pregnancy occurs while either parent is being treated with enzalutamide.
Although this medicine is not for use by women, it is not known whether enzalutamide passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using this medicine.
Xtandi is an androgen receptor inhibitor used to treat certain prostate cancers. Xtandi works by preventing the actions of androgens (male hormones), to help control cancer growth and decrease tumor size.
Xtandi is used when prostate cancer no longer responds to hormone therapy or surgical treatment. Xtandi is also used when prostate cancer has spread to other parts of the body, and it responds to hormone therapy or surgical treatment to lower testosterone. Xtandi is also used for patients who have cancer that responds to hormone therapy or surgical treatment to lower testosterone, and their cancer has not spread to other parts of the body, but they are at high risk of cancer spreading to other parts of the body.
How should I take Xtandi?
Take Xtandi exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.
You may take Xtandi with or without food. Take the medicine at the same time each day.
You may need to take two 80mg tablets or four 40mg tablets or capsules at the same time once a day to get a full dose.
Swallow the Xtandi tablet or capsule whole. Do not break, chew, or crush a tablet. Do not chew, open, or dissolve a capsule.
Prostate cancer is sometimes treated with a combination of drugs. Use all medications as directed by your doctor. Do not change your doses or medication schedule without your doctor’s advice.
Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.
Dosing information
Usual Adult Dose for Prostate Cancer: 160 mg (four 40 mg capsules) orally once a day. Comments:
Patients with castration-resistant prostate cancer (CRPC) or metastatic castration-sensitive prostate cancer (mCSPC) receiving Xtandi should also receive a gonadotropic-releasing hormone (GnRH) analog concurrently or should have had bilateral orchiectomy.
Patients with non-metastatic castration-sensitive prostate cancer (nmCSPC) with a high risk of biochemical recurrence (BCR) may be treated with Xtandi with or without a GnRH analog. For patients who receive Xtandi with or without a GnRH analog, treatment can be suspended if the prostate-specific antigen (PSA) is undetectable (< 0.2 ng/mL) after 36 weeks of therapy. Reinitiate treatment when PSA has increased to ≥ 2.0 ng/mL for patients who had prior radical prostatectomy or ≥ 5.0 ng/mL for patients who had prior primary radiation therapy