-
Heart problems. Koselugo can lower the amount of blood
pumped by your heart, which is common and can also be severe. Your healthcare
provider will do tests before and during treatment to check how well your
heart is working. Tell your healthcare provider right away if you get any
of the following signs or symptoms: persistent coughing or wheezing, shortness
of breath, swelling of your ankles and feet, tiredness, increased heart
rate.
-
Eye problems. Koselugo can cause eye problems that can
lead to blindness. Your healthcare provider will check your vision before
and during treatment. Tell your healthcare provider right away if you get
any of the following signs or symptoms: blurred vision, loss of vision,
dark spots in your vision (floaters), other changes to your vision.
-
Severe diarrhea. Diarrhea is common with Koselugo and
can also be severe. Tell your healthcare provider right away the first
time that you get diarrhea during treatment. Your healthcare provider may
give you medicine to help control your diarrhea and may tell you to drink
more fluids.
-
Skin rash. Skin rashes are common with Koselugo and can
also be severe. Tell your healthcare provider if you get any of the following
signs or symptoms: rash that covers a large area of your body, peeling
skin, blisters.
-
Muscle problems (rhabdomyolysis).
Muscle problems are common with Koselugo and can also be severe. Treatment
with Koselugo may increase the level of a muscle enzyme in your blood called
creatine phosphokinase (CPK) and may be a sign of muscle damage. Your healthcare
provider should do a blood test to check your muscle enzyme levels of CPK
before you start taking Koselugo and during treatment. Tell your healthcare
provider right away if you get any of the following signs or symptoms:
muscle aches or pain; muscle spasms and weakness; dark, reddish urine.
Before taking Koselugo, tell your healthcare provider about all
your medical conditions, including if you:
- have heart problems.
- have eye problems.
- have liver problems.
-
are pregnant or plan to become pregnant. Koselugo can harm your
unborn baby. Your healthcare provider should verify if you/your
partner are pregnant before beginning treatment. Ensure you/your
partner use effective birth control (contraception) during
treatment and for 1 week after your last dose if there is
possibility pregnancy could occur. Tell your healthcare provider
right away if you/your partner think you may be pregnant.
-
are breastfeeding or plan to breastfeed. It is not known if
Koselugo passes into your breast milk. Do not breastfeed during
treatment and for 1 week after your last dose. Talk to your
healthcare provider about the best way to feed your baby during
this time.
Tell your healthcare provider about all the medicines you
take,
including prescription, over-the-counter medicines, vitamins, or
herbal supplements. Especially tell your healthcare provider if
you are taking aspirin, blood thinners, or other medicines to
treat blood clots. Koselugo contains vitamin E, which may increase
risk of bleeding.
What should I avoid while taking Koselugo?
Do not drink grapefruit juice, eat grapefruit, or take supplements
with grapefruit or St. John’s Wort during treatment.
Most common side effects include: vomiting, stomach-area pain, nausea, dry skin, muscle and bone
pain, feeling of tiredness or lacking energy, fever, sores in your
mouth, headache, redness around the fingernails, itching.
These are not all the possible side effects of Koselugo. Call your
healthcare provider for medical advice about side effects. Your
healthcare provider may change your dose, temporarily stop, or
permanently ask you to stop taking Koselugo if you have any of
these side effects.
You may report side effects to AstraZeneca at 1-800-236-9933 or
at
https://
us-aereporting.astrazeneca.com
or FDA at
1-800-FDA-1088
or
www.fda.gov/medwatch.
Indication
What is Koselugo?
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unless otherwise noted.
