Koselugo is the FIRST and ONLY FDA-approved treatment shown to reduce the size of plexiform neurofibromas (PN)*
WHAT IS KOSELUGO?
Visit the Koselugo Frequently Asked Questions page
Do you have questions about Koselugo? Talk to your child's doctor and download our
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CAN KOSELUGO HELP SHRINK PLEXIFORM TUMORS?
KOSELUGO HAS BEEN SHOWN TO SHRINK PLEXIFORM TUMORS IN CHILDREN AGED 2 YEARS AND OLDER
In a clinical study, Koselugo was proven to work for children with NF1 who have plexiform neurofibromas (PN) that cannot be completely removed by surgery:
66% or 33 of 50 patients in the clinical study saw their plexiform neurofibromas (PN) shrink*
82% or 27 of 33 patients who responded continued to benefit for at least one year.
What did people taking Koselugo treatment experience in a clinical study?
See their journeys*Patients saw a 20% or more decrease in the size of their plexiform neurofibromas, confirmed by 3D magnetic resonance imaging scan.
NF1=neurofibromatosis type 1.
IS THERE A SUPPORT PROGRAM TO HELP MY CHILD ACCESS TREATMENT?
OneSource™ Support Services
Your dedicated Patient Access Navigator is here to guide and give you the support you deserve—whatever your care plan may be. They can:
- Answer questions about neurofibromatosis type 1 (NF1) plexiform neurofibromas (PN), Koselugo, your insurance coverage, and more
- Provide support during treatment
- Help you avoid interruptions in your child’s treatment during insurance changes, travel plans, or other life events
- Help you to get involved with the rare disease community through events and meetings
To learn more or to contact your dedicated Patient Access Navigator, please call 1-888-765-4747, Monday through Friday, 8:30 AM–8 PM ET, or visit www.AlexionOneSource.com.
IMPORTANT SAFETY INFORMATION
Before taking Koselugo, tell your healthcare provider about all of 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
- Females who could become pregnant and males with female partners who could become pregnant should use effective birth control (contraception) during treatment with Koselugo and for 1 week after your last dose
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Koselugo
-
Tell your healthcare provider right away if you become pregnant or
think you may be pregnant during treatment with Koselugo
- Do not breastfeed during treatment with Koselugo 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 and 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 your risk of bleeding.
Koselugo may cause serious side effects, including:
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 with Koselugo 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 with Koselugo. 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 with Koselugo. 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, which may be a sign of muscle damage. Your healthcare provider should do a blood test to check your muscle enzyme levels 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
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.
The most common side effects of Koselugo are:
- 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.
-
are pregnant or plan to become pregnant. Koselugo can harm your unborn
baby
- Females who could become pregnant and males with female partners who could become pregnant should use effective birth control (contraception) during treatment with Koselugo and for 1 week after your last dose
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Koselugo
-
Tell your healthcare provider right away if you become pregnant or
think you may be pregnant during treatment with Koselugo
- Do not breastfeed during treatment with Koselugo 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 and 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 your risk of bleeding.
Koselugo may cause serious side effects, including:
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 with Koselugo 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 with Koselugo. 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 with Koselugo. 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, which may be a sign of muscle damage. Your healthcare provider should do a blood test to check your muscle enzyme levels 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
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.
The most common side effects of Koselugo are:
- 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.