Starting a new medicine can feel overwhelming, but understanding what to expect with Koselugo can help you feel informed and prepared as you or your child begin the Koselugo journey.
Everyone's journey is unique. Talk to your doctor about what you or your child may experience during Koselugo treatment.
Everyone's journey is unique. Talk to your doctor about what you or your child may experience during Koselugo treatment.
The timeline below uses data from the SPRINT Phase 2 Stratum 1 study to visualize what children and teens may experience during their first year of taking Koselugo.
The SPRINT study was conducted by the National Cancer Institute to test Koselugo in 50 children and teens with neurofibromatosis type 1 (NF1) and plexiform neurofibromas, also called plexiforms, that caused symptoms and could not be completely removed by surgery.
In the SPRINT study, 66% (33/50) of children and teens saw results (plexiform shrinkage of 20% or more) with Koselugo.✱
The SPRINT study was conducted by the National Cancer Institute to test Koselugo in 50 children and teens with neurofibromatosis type 1 (NF1) and plexiform neurofibromas, also called plexiforms, that caused symptoms and could not be completely removed by surgery.
In the SPRINT study, 66% (33/50) of children and teens saw results (plexiform shrinkage of 20% or more) with Koselugo.✱
*The best response recorded as of June 2018. The median time to onset of response was 7.2 months (range: 3.3 months to 1.6 years). Median is defined as the middlemost point in a dataset.
†For 33 children and teens who responded to Koselugo by June 2018. The remaining person achieved at least 20% plexiform shrinkage after about a year and a half of treatment.
‡As of 2019.
†For 33 children and teens who responded to Koselugo by June 2018. The remaining person achieved at least 20% plexiform shrinkage after about a year and a half of treatment.
‡As of 2019.
Any of the results or side effects may occur at any time during treatment. Your child’s doctor will monitor for side effects throughout treatment.
The most common side effects of Koselugo in children and teens were vomiting, diarrhea, increased level of an enzyme called creatine phosphokinase (CPK) in the blood, dry skin, redness around the fingernails, nausea, skin bumps that look like acne, and fever. Koselugo capsules contain vitamin E, which may increase your child's risk of bleeding. Tell your doctor if your child is taking a supplement containing vitamin E, aspirin, blood thinners, or other medicines to treat blood clots.
These are not all the possible side effects of Koselugo. Your child’s doctor may change your child’s dose, temporarily stop, or ask your child to permanently stop taking Koselugo if they experience certain side effects.
The most common side effects of Koselugo in children and teens were vomiting, diarrhea, increased level of an enzyme called creatine phosphokinase (CPK) in the blood, dry skin, redness around the fingernails, nausea, skin bumps that look like acne, and fever. Koselugo capsules contain vitamin E, which may increase your child's risk of bleeding. Tell your doctor if your child is taking a supplement containing vitamin E, aspirin, blood thinners, or other medicines to treat blood clots.
These are not all the possible side effects of Koselugo. Your child’s doctor may change your child’s dose, temporarily stop, or ask your child to permanently stop taking Koselugo if they experience certain side effects.
The timeline below uses data from the KOMET study to visualize what adults may experience during their first year of taking Koselugo. Please note that everyone can respond differently.
The KOMET study compared the effect of Koselugo on plexiform shrinkage with the effect of a placebo (a treatment that doesn't contain medicine).
The study included 145 adults with NF1 and plexiforms that could not be completely removed by surgery. The adults were split into 2 groups: 1 group received Koselugo treatment, while the other received a placebo. After 12 months of treatment, all adults were given Koselugo.
After 16 months of treatment with Koselugo, 20% (14/71) of adults saw results (plexiform shrinkage of at least 20%) from the start of the study, compared with only 5% (4/74) of adults taking a placebo.
The KOMET study compared the effect of Koselugo on plexiform shrinkage with the effect of a placebo (a treatment that doesn't contain medicine).
The study included 145 adults with NF1 and plexiforms that could not be completely removed by surgery. The adults were split into 2 groups: 1 group received Koselugo treatment, while the other received a placebo. After 12 months of treatment, all adults were given Koselugo.
After 16 months of treatment with Koselugo, 20% (14/71) of adults saw results (plexiform shrinkage of at least 20%) from the start of the study, compared with only 5% (4/74) of adults taking a placebo.
§For the 14 adults whose plexiform shrank by 20% or more with Koselugo from the start of the study to the end of 16 months of treatment, the median onset to response was 3.7 months (range: 3.6 months to 11.2 months).
¶As of August 5, 2024. The side effects shown are a combination of the serious side effects, side effects experienced in the KOMET study by at least 20% of adults, and clinically relevant side effects experienced by less than 20% of adults, for which information about when the side effects started is available. “Rash” includes all types of rash.
¶As of August 5, 2024. The side effects shown are a combination of the serious side effects, side effects experienced in the KOMET study by at least 20% of adults, and clinically relevant side effects experienced by less than 20% of adults, for which information about when the side effects started is available. “Rash” includes all types of rash.
Any of the results or side effects may occur at any time during treatment. Your doctor will monitor for side effects throughout treatment.
The most common side effects of Koselugo in adults were rash, skin bumps that look like acne, and diarrhea. These are not all the possible side effects of Koselugo. Your doctor may change your dose, temporarily stop, or ask you to permanently stop taking Koselugo if you experience certain side effects.
The most common side effects of Koselugo in adults were rash, skin bumps that look like acne, and diarrhea. These are not all the possible side effects of Koselugo. Your doctor may change your dose, temporarily stop, or ask you to permanently stop taking Koselugo if you experience certain side effects.
Koselugo offers 2 dosing formulations with a twice-daily schedule for a consistent daily routine.
Koselugo capsules are for children and adults who are able to swallow a whole capsule.
- Can be taken with or without food
- Available in 10-mg or 25-mg capsules
Koselugo oral granules are for children and adults who have difficulty swallowing whole capsules.
- Oral granules contained in capsules for opening
- Available in 5-mg or 7.5-mg capsules for opening
Koselugo oral granules should be sprinkled on a small amount (about 1 to 3 teaspoons) of smooth yogurt or fruit puree containing the following fruits: apple, banana, pear, or strawberry.
Please see Instructions for Use in the full Prescribing Information for information on how to take Koselugo oral granules.
Whether you choose capsules or oral granules, this guide has everything you need to know about taking Koselugo
- Koselugo is taken by mouth twice a day, about 12 hours apart
- It can be made part of a consistent daily routine
- The recommended dose of Koselugo is 25 mg/m2 and will depend on your or your child's body surface area, which is measured by weight and height
As treatment with Koselugo continues, your doctor might adjust the dose based on how you or your child responds.
IMPORTANT SAFETY INFORMATION
What are the possible side effects of Koselugo?
Koselugo may cause serious side effects, including:
Before taking Koselugo, tell your healthcare provider about all your medical conditions, including if you:
What should I avoid while taking Koselugo?
Avoid St John’s wort, grapefruit or grapefruit juice, and Seville oranges during treatment.
Most common side effects in children include: vomiting, diarrhea, increased level of an enzyme called creatine phosphokinase (CPK) in your blood, dry skin, redness around the fingernails, nausea, skin bumps that look like acne, fever.
Most common side effects in adults include: rash, diarrhea, skin bumps that look like acne.
These are not all the possible side effects of Koselugo. Call your healthcare provider for medical advice about 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?
Koselugo is a prescription medicine that is used to treat adults and children 1 year of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cause symptoms and cannot be completely removed by surgery.
It is not known if Koselugo is safe and effective in children under 1 year of age.
Please see Patient Information and Instructions for Use in the full Prescribing Information for Koselugo (selumetinib) or at https://alexion.com/Documents/koselugo_uspi.pdf.
What are the possible side effects of Koselugo?
Koselugo may cause serious side effects, including:
- Heart problems. Koselugo can lower the amount of blood pumped by your heart, which can 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 new or worsening vision changes, including: blurred vision, loss of vision, dark spots in your vision (floaters), other changes to your vision.
- Stomach, intestine, and mouth (gastrointestinal) problems. Koselugo can cause diarrhea, vomiting, nausea, and mouth sores. Diarrhea can be severe with Koselugo. 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 problems. Koselugo can cause severe skin rashes. Tell your healthcare provider if you get any of the following signs of skin problems: rash that covers a large area of your body, flat skin rash, raised bumps on your skin, skin bumps that look like acne, blisters, peeling skin, itchy rash, hair thinning or hair loss (alopecia).
- Increased level of an enzyme called creatine phosphokinase (CPK) in your blood and muscle problems. Koselugo can cause severe muscle problems. Treatment with Koselugo may increase the level of an enzyme in your blood called creatine phosphokinase (CPK), which may be a sign of muscle damage. Increased level of CPK in the blood is common during treatment and can also be severe. Your healthcare provider should do a blood test to check your blood 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.
- Females who are able to become pregnant:
- Your healthcare provider should check to see if you are pregnant before you begin treatment.
- You should use effective birth control (contraception) during treatment 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.
- Males with female partners who are able to become pregnant:
- You should use effective birth control (contraception) during treatment and for 1 week after your last dose.
- 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.
What should I avoid while taking Koselugo?
Avoid St John’s wort, grapefruit or grapefruit juice, and Seville oranges during treatment.
Most common side effects in children include: vomiting, diarrhea, increased level of an enzyme called creatine phosphokinase (CPK) in your blood, dry skin, redness around the fingernails, nausea, skin bumps that look like acne, fever.
Most common side effects in adults include: rash, diarrhea, skin bumps that look like acne.
These are not all the possible side effects of Koselugo. Call your healthcare provider for medical advice about 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?
Koselugo is a prescription medicine that is used to treat adults and children 1 year of age and older with neurofibromatosis type 1 (NF1) who have plexiform neurofibromas that cause symptoms and cannot be completely removed by surgery.
It is not known if Koselugo is safe and effective in children under 1 year of age.
Please see Patient Information and Instructions for Use in the full Prescribing Information for Koselugo (selumetinib) or at https://alexion.com/Documents/koselugo_uspi.pdf.
NF1=neurofibromatosis type 1; PN=plexiform neurofibromas.