IMPORTANT SAFETY INFORMATION
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, vomiting, and nausea are 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 problems. Koselugo can cause skin rashes that can be severe. Skin rashes are common with Koselugo. 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. Muscle problems are common with Koselugo and can also be severe. 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. 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. Certain medicines may affect the way Koselugo works. Especially tell your healthcare provider if you are taking a supplement containing vitamin E, aspirin, blood thinners, or other medicines to treat blood clots. Koselugo capsules contain vitamin E, which may increase risk of bleeding.
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 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.
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.
Please see Patient Information and Instructions for Use in the full Prescribing Information for Koselugo (selumetinib).
INDICATION
What is Koselugo?
Koselugo is a prescription medicine that is used to treat 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 in the full Prescribing Information for Koselugo (selumetinib).
