Why is this medication prescribed?

Koselugo (selumetinib) is a medication that was being investigated and studied for the treatment of neurofibromatosis type 1 (NF1) in children. NF1 is a genetic disorder that causes tumors to develop on nerve tissue throughout the body. Selumetinib is a selective inhibitor of a specific protein involved in the MAPK signaling pathway, which plays a role in cell growth and division.

Selumetinib was being studied specifically for the treatment of plexiform neurofibromas, which are complex tumors that can occur in individuals with NF1. These tumors can cause various complications and impairments, depending on their size and location. Koselugo was being investigated as a potential targeted therapy to shrink or slow the growth of these tumors in children with NF1.

How should this medicine be used?

Koselugo (selumetinib) is typically taken orally as a tablet or capsule. The specific dosage and treatment duration will be determined by your doctor based on various factors, such as your age, weight, overall health, and the severity of your condition. It’s important to follow your healthcare provider’s instructions regarding the dosing schedule and duration of treatment.

Generally, Koselugo is taken once or twice daily with or without food, as directed by your doctor. It’s essential to swallow the tablet or capsule whole without crushing, chewing, or breaking it, unless otherwise instructed.

If you miss a dose, take it as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

It’s crucial to adhere to the prescribed treatment regimen and not alter the dosage or frequency of Koselugo without consulting your doctor. If you have any questions or concerns about the proper use of Koselugo, it’s best to reach out to your healthcare provider for clarification and guidance. They can provide you with personalized instructions based on your specific condition and medical history.

Other uses for this medicine

As for other uses, Koselugo is currently approved specifically for the treatment of symptomatic, inoperable PNs associated with NF1 and does not have other approved indications. Its use should be limited to the intended population as determined by a healthcare provider.

What special precautions should I follow?

Regarding special precautions, it is important to note that medications can have various considerations and precautions associated with their use. These precautions may include:

• Medical History: It is essential to inform your healthcare professional about your complete medical history, including any pre-existing medical conditions, previous or ongoing treatments, allergies, and medications you are currently taking. Certain medical conditions or medications may interact with Koselugo or require dose adjustments or monitoring.
• Pregnancy and Breastfeeding: The use of Koselugo during pregnancy or breastfeeding may not have been well-studied, and its safety in these situations may not be established. It is crucial to discuss the potential risks and benefits with your healthcare professional if you are pregnant, planning to become pregnant, or breastfeeding.
• Side Effects: Like any medication, Koselugo may be associated with certain side effects. Common side effects reported in clinical trials include vomiting, diarrhea, nausea, rash, abdominal pain, and increased creatinine levels. However, it is important to note that the specific side effects and their severity may vary among individuals. It is recommended to report any unusual or severe side effects to your healthcare professional.
• Drug Interactions: Koselugo may interact with other medications, including prescription drugs, over-the-counter medications, and herbal supplements. These interactions can potentially affect the safety and efficacy of either Koselugo or the other medications. Inform your healthcare professional about all the medications you are taking to avoid potential interactions.

It is crucial to consult with a healthcare professional or refer to the most recent prescribing information, including the medication’s package insert, for comprehensive and up-to-date information about alternative uses, precautions, and potential side effects associated with Koselugo.

What special dietary instructions should I follow?

There are no specific dietary restrictions associated with Koselugo. However, it’s important to maintain a healthy and balanced diet to support overall well-being. Eating a variety of fruits, vegetables, whole grains, lean proteins, and staying hydrated is generally recommended.

What should I do if I forget a dose?

If you forget to take a dose of Koselugo, it is important to contact your healthcare provider or pharmacist for guidance. They will provide you with instructions on what to do in this situation. It’s generally recommended to take the missed dose as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, it’s usually advised to skip the missed dose and resume your regular dosing schedule. Do not take a double dose to make up for a missed one unless specifically instructed by your healthcare provider.

What side effects can this medication cause?

Koselugo (selumetinib) is a medication that may cause side effects in some individuals. It’s important to note that not everyone will experience these side effects, and their severity can vary from person to person. It’s always advisable to discuss any concerns or questions about side effects with your healthcare provider. Here are some potential side effects associated with Koselugo:

Common side effects may include:

• Vomiting
• Diarrhea
• Nausea
• Rash
• Abdominal pain
• Allergic reactions
• Swelling or puffiness in the face or extremities (edema)
• Changes in taste
• Dry skin
• Fatigue
• Cough
• Fever
• Headache
• Muscle or joint pain
• Eye problems, such as blurred vision or increased tearing

These are not all the possible side effects of Koselugo. Serious side effects may occur, and it is important to seek medical attention if you experience any severe or persistent symptoms while taking the medication.

It’s worth noting that this list is not exhaustive, and there may be other side effects associated with Koselugo. Always consult your healthcare provider or refer to the medication’s prescribing information for a comprehensive list of potential side effects.

Additionally, if you experience any unexpected or concerning side effects while taking Koselugo, it’s essential to notify your healthcare provider promptly. They can evaluate your condition and provide appropriate guidance.

What should I know about storage and disposal of this medication?

Storage and disposal of Koselugo:

• Storage: Koselugo should be stored at room temperature, typically between 20°C to 25°C (68°F to 77°F). It is recommended to keep the medication in its original container, away from excessive heat, moisture, and light. Do not freeze the medication. Always store it out of reach of children and pets.
• Disposal: It is advisable to follow local regulations or guidelines for the proper disposal of medication. If your healthcare provider or pharmacist does not provide specific instructions, you can check with your local pharmacy or waste management authorities for guidance on how to safely dispose of unused or expired medication.

In case of emergency/overdose

In the case of an emergency or suspected overdose, immediately contact emergency services or go to the nearest emergency room. It is also important to inform them about the medication taken and the amount ingested, if known. If possible, take the medication packaging or information leaflet with you to aid medical professionals in providing appropriate treatment.

What other information should I know?

• Inform your healthcare provider about any other medications, supplements, or herbal products you are taking, as they can potentially interact with Koselugo.
• Attend regular check-ups and follow-up appointments as scheduled by your healthcare provider to monitor your progress and evaluate any potential side effects.
• It’s important to use effective contraception during treatment with Koselugo, as the medication may harm an unborn baby.
• Inform your healthcare provider if you have any pre-existing medical conditions, such as liver or kidney problems, or if you are breastfeeding.
• Do not change the dose or stop taking Koselugo without consulting your healthcare provider.

Remember, the information provided here is not exhaustive, and it’s crucial to consult your healthcare provider or refer to the medication’s prescribing information for comprehensive and personalized instructions based on your specific situation.