Cadangan Safety – Etapidi

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Patient Information Prescribing Information

Prescribing Information Contact a Rep

This site is inteded for health care proffesional.

Lung

Lung Problems

New or worsening cough
Shortness of breath
Chest pain

Kidney problems

Decrease in your amount of urine
Blood in your urine
Swelling of your ankles
Loss of appetite

Important Safety Information & FDA-Approved Indications

Important Safety Information

Etapidi is a medicine that may threat certain cancers by working with your immune system. Etapidi can cause your immune system to attack normal organs and tissues in any area of body and can effect the way they work. These problem 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 treatment or even after your treatment has ended.

Call or see your healthcare provider right away for new or woersening symptoms, including:

Lung problems

new or worsening cough
shorthness of breath
chest pain

Intestinal problems

diarrhea (loose stools) or more bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
severe stomatch-area (abdomen) pain or tenderness

Liver problems

yellowing of yout skin or the whites of your eyes
severe nausea or vomiting
pain on the right side of your stomatch area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal

Hormone gland problems

headaches that will not go away or unusual headaches
eye sensitivity to light
eye problems
rapid heartbeat
increased sweating
extreme tiredness
weight gain or weight loss
feeling more hungry or thirsty than usual
urinating more often than usual
hair loss
feeling cold
constipation
your voice gets deeper
dizziness of fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness

Kidney problems

decrease in your amount of urine
blood in your urine
swelling in your ankles
loss of appetite

Skin problems

rash
itching
skin blistering or peeling
painful sores or ulcers in your mouth or in your nose, throat, or genital area
fever or flu-like symptoms
swollen lymph nodes

Problems can also happen in other organs and tissues. These are not all of the signs and symptoms of immune system problems that can happen with etapidi. Call or see your healthcare provider right away for new or worsening symptoms, which may include:

chest pain, irregular heartbeat, shortness of breath, swelling of ankles
confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
persistent or severe muscle pain or weakness, muscle cramps
low red blood cells, bruising

Infusion reactions that can sometimes be severe or life-threatening. Signs or symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain

Infusion reactions that can sometimes be severe or life-threatening. Signs or symptoms of infusion reactions may include:

chills or shaking
itching or rash
flushing
shortness of breath or wheezing
dizziness
feeling like passing out
fever
back or neck pain

Rejection of a transplanted organ or tissue. Your healthcare provider should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.

Complications, including graft-versus-host-disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic). These complications can be serious and can lead to death. These complications may happen if you underwent transplantation either before or after being treated with etapidi. Your healthcare provider will monitor you for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. Your healthcare provider will check you for these problems during your treatment with etapidi. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may also need to delay or completely stop treatment with etapidi if you have severe side effects.

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

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus
have received an organ or tissue transplant, including corneal transplant
have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
have received radiation treatment to your chest area
have a condition that affects your nervous system, such as myasthenia gravis or Guillain-Barré syndrome
are pregnant or plan to become pregnant. etapidi can harm your unborn baby. Females who are able to become pregnant:
- Your healthcare provider will do a pregnancy test before you start treatment with etapidi.
- You should use an effective method of birth control during your treatment and for 4 months after your last dose of etapidi. Talk to your healthcare provider about birth control methods that you can use during this time.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with etapidi.
are breastfeeding or plan to breastfeed. It is not known if etapidi passes into your breast milk. Do not breastfeed during treatment with etapidi and for 4 months after your last dose of etapidi.

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

What are the possible side effects of etapidi?etapidi may cause serious side effects. See “What is the most important information I should know about etapidi?”

The most common side effects of etapidi when used in combination with platinum-containing chemotherapy include: decreased red blood cell count (anemia); decreased white blood cell count; tiredness; decreased appetite; nausea; constipation; decreased weight; diarrhea; numbness, pain, tingling, or burning in your hands or feet; decreased albumin in the blood; decreased salt (sodium) in your blood; vomiting; mouth sores; and decreased potassium in your blood.

The most common side effects of etapidi in combination with platinum and fluoropyrimidine-based chemotherapy include: nausea; tiredness; decreased appetite; decreased red blood cell count (anemia); numbness, pain, tingling or burning in your hands or feet; decreased platelet count; decreased white blood cell counts; increase in certain liver blood tests; stomach area (abdominal) pain; decreased weight; and fever.

The most common side effects of etapidi when used alone include: increased blood sugar, decreased red blood cell and white blood cell counts, decreased salt (sodium) in your blood, decreased albumin in the blood, increase in certain liver blood tests, tiredness; muscle and bone pain, decreased weight, and cough.

These are not all the possible side effects of ETAPIDI. Talk to your health care provider for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.id.etanabiotech.com etana or call (+6221) 4608808.

FDA-Approved Indications

ETAPIDI is a prescription medicine used to treat adults with:

cancer of the tube that connects your throat to your stomach (esophageal cancer).
- ETAPIDI may be used in combination with chemotherapy that contains platinum as your first treatment when your esophageal cancer:
  - is a type called squamous cell carcinoma, and
  - cannot be removed with surgery or has spread to other parts of the body (metastatic), and
  - your tumor tests positive for “PD-L1.”
- ETAPIDI may be used alone when your esophageal cancer:
  - is a type called squamous cell carcinoma, and
  - cannot be removed with surgery or has spread to other parts of the body (metastatic), and
  - you have had previous treatment that did not include a PD-(L)1 inhibitor medicine.
cancer of the stomach (gastric cancer) or cancer where the esophagus joins the stomach (gastroesophageal junction cancer).
- ETAPIDI may be used in combination with chemotherapy that contains platinum and fluoropyrimidine as your first treatment when your gastric or gastroesophageal junction cancer:
  - cannot be removed with surgery or has spread to other parts of the body (metastatic), and
  - your tumor tests positive for “PD-L1.”

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

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Email: info.corporate@id.etanabiotech.com

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