Addressing Certain Side Effects of JEVTANA
Life during chemotherapy treatment
JEVTANA®
(cabazitaxel) Injection targets cancer cells, but it can also damage some normal
cells.
This can cause side effects. Here are some helpful hints for addressing certain
side effects.
You may experience side effects in different ways. Ask your doctors
what to do about any side effects that bother you.
If you have advanced prostate cancer and are making new treatment decisions with
your doctor, you should weigh the potential side effects of JEVTANA against its
ability to fight your cancer.
Important Safety Information for JEVTANA®
- JEVTANA may cause serious side effects, including low white blood
cells. Low white blood cells can cause you to get serious infections, and may lead
to death. The earliest sign of infection may be fever, so tell your doctor right
away if you have a fever. People who are 65 years or older may be more likely to
have these problems. JEVTANA should not be given to patients with low white blood
cell counts.
- JEVTANA can also cause severe allergic reactions. Severe allergic
reactions can happen within a few minutes after your infusion of JEVTANA starts,
especially during the first and second infusions. Your doctor should prescribe medicines
before each infusion to help prevent severe allergic reactions.
- You should not take JEVTANA if you have had a severe allergic reaction to
JEVTANA or other medicines that contain polysorbate 80. Ask your doctor
if you are not sure.
Before starting JEVTANA, make sure to tell your doctor about any medicines you're
taking, including prescription medications, over-the-counter therapies, vitamins,
herbal remedies, and supplements.
Addressing serious side effects
Two of the more serious side effects of JEVTANA are low white blood cell count (neutropenia)
and diarrhea. Make sure to talk to your healthcare team about any side effects you
experience that don't go away or are bothersome.
Working with your healthcare team, there are some ways to reduce the risk of infection
if you have neutropenia:
- Wash thoroughly. If you're at a higher risk of infection, make
sure to wash your hands often with soap and water. Wash before cooking and eating,
and after you use the bathroom, blow your nose, cough, sneeze, or touch pets. You
may want to carry hand sanitizer with you at all times
- Avoid crowds, as well as people who are sick. This includes children
who've received “live virus” vaccines for diseases such as chickenpox or polio
- Brush your teeth regularly. Using a soft toothbrush, brush after
every meal and before bed. Use alcohol-free mouth rinse. This can help protect your
mouth from infection
- Discuss with your doctor whether or not you should get a flu shot.
Vaccines may contain a live virus, which you should not be exposed to
- Wash vegetables and fruits, and don't eat undercooked foods. Meat,
fish, eggs, and raw vegetables and fruits can carry bacteria that cause infections
- Take medication. Specifically, your doctor may prescribe an injectible
medicine called G-CSF (granulocyte colony-stimulating factor) to help increase your
white blood cell count
Call your doctor or nurse right away if you think you have an infection. Be sure
you know how to reach your doctor after office hours and on weekends.
Learn more about side effects of JEVTANA,
including an increased risk of infection
There are several things your doctor can do to help get your diarrhea under control,
including prescribing you medications and adjusting your dose of JEVTANA. Here are
a few other strategies you may want to consider:
- Change how you eat. Eat 5 to 6 small meals instead of
3 large ones. Think of your meals as snacks
- Change what you eat. Try low-fiber foods such as bananas,
white rice, white toast, and plain or vanilla yogurt. Eggs (fully cooked to avoid
infection), skinless boiled potatoes, skinless poultry or fish, and gelatin are
also good choices for an upset stomach
- Change what you drink. Avoid anything caffeinated—such
as coffee, soda, and black tea—as well as anything alcoholic
- Drink more liquids to replenish what you lose. Drink 8
to 12 cups of clear, non-carbonated, room-temperature liquids each day. These liquids
can include water, sports drinks, ginger ale, and
chicken broth
- Ask your doctor about medications that can help. There may be options
available to you
Common side effects
Common side effects of JEVTANA include low white blood cell count, low red blood
cell count (anemia), low blood platelet count, tiredness, nausea, vomiting, diarrhea,
constipation, weakness, blood in the urine, back pain, decreased appetite, fever,
shortness of breath, stomach (abdominal) pain, change in your sense of taste, cough,
joint pain, hair loss, numbness, tingling, burning or decreased sensation in your
hands or feet.
It's important to talk to your doctors and nurses about any side effects you are
experiencing. They are your best resource for dealing with certain side effects.
Here are a few ways to address certain common side effects of JEVTANA:
- Low red blood cell count (anemia). Anemia can make you
feel tired, so get plenty of rest. Accept more help from others. Also, talk to your
doctors about a well-balanced diet that can help you get the calories and protein
you need. The right diet may help you keep your weight up and help your body repair
damaged tissue. Your doctor will routinely check your red blood cell count and may
recommend treatment if it is too low
- Low blood platelets, or thrombocytopenia. JEVTANA
can cause a drop in the number of blood platelets. Low blood platelets can lead
to excessive bleeding, because the blood cannot clot properly. Your doctor may recommend
treatment
- Nausea and vomiting. Stay away from foods with strong tastes and
smells. Eat smaller meals of easy-to-digest foods like crackers and toast
- Constipation. Drink at least 8 cups of water every day. Be more
active, or as active as is comfortable for you. Talk to your healthcare team about
a high-fiber diet that can help you have more bowel movements
- Fatigue. Give yourself plenty of time to rest—at least 8 hours
of sleep per night—but also make an effort to be active regularly. Try going for
short walks every day. You may also want to keep a journal of your energy level
- Kidney and bladder problems. Drink plenty of fluids, and drink
less caffeine
- Muscle or joint pain. Talk about your pain with your doctors, describing
it on a scale from 1 to 10. Mention where it occurs, how long it lasts, and whether
anything makes it feel better (an ice pack, a heating pad, etc.). If your doctor
gives you medicine for your pain, do not skip any doses
- Hair loss. If you want to buy a wig or hair piece, try to do so
while you still have hair. That way, you can match your hair's color and style easily.
Remember that you may feel cooler with less hair, so keep a hat around
IMPORTANT SAFETY INFORMATION FOR JEVTANA® (CABAZITAXEL) INJECTION
WARNING
JEVTANA may cause serious side effects, including low white blood cells. Low
white blood cells can cause you to get serious infections, and may lead to death.
The earliest sign of infection may be fever, so tell your doctor right away if you
have a fever. People who are 65 years or older may be more likely to have these
problems. JEVTANA should not be given to patients with low white blood cell counts.
Your doctor:
- Will do blood tests regularly to check your white blood cell counts during
your treatment with JEVTANA
- May lower your dose of JEVTANA, change how often you receive it, or stop
JEVTANA until you have enough white blood cells
- May prescribe a medicine for you to help prevent complications if your white
blood cell count is too low
JEVTANA can also cause severe allergic reactions. Severe allergic reactions
can happen within a few minutes after your infusion of JEVTANA starts, especially
during the first and second infusions. Your doctor should prescribe medicines before
each infusion to help prevent severe allergic reactions.
- Symptoms of severe allergic reactions may include rash or itching, skin
redness, feeling dizzy or faint, breathing problems, chest or throat tightness,
swelling of face. Tell your doctor right away if you have any of these symptoms.
Your doctor will stop your JEVTANA treatment right away and treat your allergic
reaction.
You should not take JEVTANA if you have had a severe allergic reaction to JEVTANA
or other medicines that contain polysorbate 80. Ask your doctor if you are not sure.
JEVTANA can also cause gastrointestinal symptoms.
Nausea, vomiting and diarrhea can happen when you take JEVTANA. Severe vomiting
and diarrhea with JEVTANA can lead to loss of too much body fluid (dehydration),
or too much of your body salts (electrolytes). Death has happened from having severe
diarrhea and losing too much body fluid or body salts with JEVTANA. Tell your doctor
if you have vomiting or diarrhea. Your doctor will prescribe medicines to prevent
or treat vomiting and diarrhea, as needed with JEVTANA. You may need to go to the
hospital for treatment.
Kidney failure may happen with JEVTANA.
Kidney failure may happen because of severe infection, loss of too much body fluid
(dehydration), or for other reasons, which may lead to death. Your doctor will check
you for this problem and treat you if needed. Tell your doctor if you develop:
- Swelling of your face or body
- Decrease in the amount of urine that your body makes each day
Before receiving JEVTANA, tell your doctor if you:
- had allergic reactions in the past
- have kidney or liver problems. JEVTANA should not be given to patients with liver
problems (hepatic impairment)
- are age 65 or older as these patients:
-
— may be more likely to experience certain adverse reactions, including low
white blood cell count
with or without fever, tiredness, weakness, fever,
dizziness, urinary tract infection and
dehydration
- have any other medical conditions
- if you are female and:
- — are pregnant or plan to become pregnant as JEVTANA can harm your unborn
baby
- — are breastfeeding or plan to breastfeed
Serious side effects of JEVTANA include low white blood cell counts
that could lead to serious or life-threatening infections, severe allergic reactions,
gastrointestinal symptoms (nausea, severe vomiting and diarrhea) that could lead
to death, and kidney failure.
Common side effects of JEVTANA include:
- Low white blood cell count
- Low red blood cell count (anemia). Symptoms of anemia include shortness
of breath and tiredness
- Low blood platelet count. Tell your doctor if you have any unusual
bruising or bleeding
- Tiredness
- Nausea
- Vomiting
- Diarrhea
- Constipation
- Weakness
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- Blood in the urine
- Back pain
- Decreased appetite
- Fever
- Shortness of breath
- Stomach (abdominal) pain
- Change in your sense of taste
- Cough
- Joint pain
- Hair loss
- Numbness, tingling, burning or decreased sensation in your hands or feet
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Tell your doctor if you have any side effect that bothers you or that does not go
away. These are not all the possible side effects of JEVTANA. For more information,
ask your doctor or pharmacist. You may report side effects to FDA at
1-800-FDA-1088.
Remember, your doctor is the single best source of information regarding your
health. Please consult your doctor if you have any questions about your health or
your medicine.
For more information, go to www.sanofi.us
or call 1-800-633-1610.
See
Full Prescribing Information including Boxed WARNING.