Koselugo 25mg Capsule

Composition Selumetinib (25mg)
Rx Prescription Required
Pack bottle of 60 capsules
Storage Store below 30°C
Chemical Class Benzimidazoles
Action Class MEK inhibitor
Habbit Forming
Manufacturer AstraZeneca
Manufacturer address Corporate & Registered Office, Block N1, 12th Floor, Manyata Embassy Business Park, Rachenahalli, Outer Ring Road, 560045, Bangalore

Koselugo 25mg Capsule is used to treat children aged 2 years and older with neurofibromatosis type 1 (NF1), a genetic condition that causes the growth of tumors on nerve tissues. It works by targeting a protein involved in tumor growth. It helps slow the growth of tumors and provides relief from the symptoms.

Koselugo 25mg Capsule can be taken with or without food. It should be taken exactly as prescribed by the doctor. It should be taken regularly and at the same time each day for the best outcomes. To maximize the benefits, follow all instructions carefully and get regular check-ups to monitor the progress of the treatment.

Common side effects of Koselugo 25mg Capsule include nausea, vomiting, diarrhea, abdominal pain, fatigue, musculoskeletal pain, fever, and rashes. For mild side effects, the doctor may recommend staying hydrated or resting when feeling fatigued. However, for severe or persistent symptoms, such as extreme stomach pain, yellowing of the skin or eyes, or difficulty breathing, seek immediate medical attention.

While on treatment with Koselugo 25mg Capsule, grapefruit or grapefruit juice should be avoided, as it can interfere with how the medication works. This medicine should be used cautiously in patients who have a history of liver or heart problems. Additionally, activities that may increase the risk of infections or injury should be avoided, as the medicine can sometimes weaken the immune system or make the patient more prone to bruising.

Treatment of Neurofibromatosis type 1 (NF1)

Take this medicine in the dose and duration as advised by your doctor. Koselugo 25mg Capsule may be taken with or without food, but it is better to take it at a fixed time.

Koselugo 25mg Capsule works by blocking a protein called MEK, which is part of a system in the body that controls cell growth. In neurofibromatosis type 1 (NF1), this system can become too active because of a genetic change, causing tumors called plexiform neurofibromas to grow. By turning off MEK, Koselugo 25mg Capsule helps slow down or shrink these tumors, reducing symptoms like pain or difficulty moving, and improving the patient’s daily life.

Q: What if you forget to take Koselugo Capsule?
A: If you miss a dose of Koselugo 25mg Capsule, take it as soon as you remember. However, if it is less than 6 hours before your next scheduled dose, take your next dose at your regular time. Do not make up for the missed dose.

Take Koselugo 25mg Capsule exactly as prescribed and at the same time each day for maximum benefits.

Inform your doctor about all the medicines and supplements you are taking, and any preexisting medical conditions, to make sure it is safe for you.

Drink plenty of water and stay hydrated to manage nausea or diarrhea, and rest a good rest if you feel tired.

Make sure to attend all scheduled check-ups for blood tests and heart evaluations to track your progress and detect any potential issues early.

If you are of childbearing age, use reliable contraception during treatment and for a period of 1 week after stopping Koselugo 25mg Capsule.

Q. What is Koselugo 25mg Capsule used for?

Koselugo 25mg Capsule is used to treat children aged 2 years and older with neurofibromatosis type 1 (NF1). It is specifically prescribed for symptomatic, inoperable plexiform neurofibromas—benign tumors that can cause pain, disfigurement, or other complications.

Q. How should I take Koselugo 25mg Capsule?

Take Koselugo 25mg Capsule exactly as prescribed by your doctor. It may be taken with or without food. Swallow the capsules whole with water; do not crush or chew them.

Q. Can Koselugo 25mg Capsule be taken with other medicines?

Some medicines and supplements may interact with Koselugo 25mg Capsule, affecting how it works or increasing side effects. Let your doctor know about all the medicines you are taking, including over-the-counter drugs, vitamins, and herbal supplements.

Q. Can Koselugo 25mg Capsule be taken during pregnancy or breastfeeding?

Koselugo 25mg Capsule can harm an unborn baby and is not recommended during pregnancy. If you are pregnant, planning to become pregnant, or breastfeeding, discuss this with your doctor. Effective contraception should be used during treatment and for 1 week after the last dose.

Q. How will my doctor monitor my treatment?

Your doctor will perform regular check-ups, including blood tests and heart function evaluations, to ensure the medication is working and to monitor for potential side effects. These tests help adjust the dosage if needed and ensure your safety.

Q. Can Koselugo 25mg Capsule cure Neurofibromatosis type 1 (NF1)?

Koselugo 25mg Capsule is not a cure for NF1. It is a treatment to help manage symptoms, reduce the tumor size, and improve the quality of life for patients.

Q. How long will I need to take Koselugo 25mg Capsule?

The duration of treatment depends on how your body responds to the medicine. Your doctor will regularly assess your progress and decide the best course of action.

Q. What should I avoid while taking Koselugo 25mg Capsule?

While on treatment with Koselugo 25mg Capsule, avoid St. John’s wort, grapefruit, or grapefruit juice. Additionally, avoid activities that might increase your risk of infection or injury. Be cautious if you have underlying liver or heart conditions, and keep your doctor informed of any changes in your health.

Q. Can adults take Koselugo 25mg Capsule for NF1?

Koselugo 25mg Capsule is primarily approved for children aged two years and older. Adults with NF1 should consult their doctor to determine if this treatment is appropriate for them.

In Treatment of Neurofibromatosis type 1 (NF1)

Koselugo 25mg Capsule is used to treat children aged 2 years and above with neurofibromatosis type 1 (NF1), particularly those with symptomatic, inoperable tumors. Koselugo 25mg Capsule helps slow tumor growth and reduce the size of tumors. This results in reduced pain, improved physical function, and decreased disfigurement caused by these benign growths. This improvement in tumor size and symptoms can improve mobility and reduce the need for invasive surgeries. When taken in the right dose and duration, Koselugo 25mg Capsule helps improve the overall quality of life for patients and allows them to engage more fully in daily activities with less discomfort.

Headache

Paronychia

Itching

Vomiting

Rash

Abdominal pain

Diarrhea

Nausea

Dry skin

Fatigue

Musculoskeletal (bone, muscle or joint) pain

Fever

Stomatitis (Inflammation of the mouth)

Alcohol:CONSULT YOUR DOCTOR

It is not known whether it is safe to consume alcohol with Koselugo 25mg Capsule. Please consult your doctor.

Pregnancy:CONSULT YOUR DOCTOR

Koselugo 25mg Capsule is unsafe to use during pregnancy as there is definite evidence of risk to the developing baby. However, the doctor may rarely prescribe it in some life-threatening situations if the benefits are more than the potential risks. Please consult your doctor.

Breast feeding:CONSULT YOUR DOCTOR

Information regarding the use of Koselugo 25mg Capsule during breastfeeding is not available. Please consult your doctor.Due to the potential for side effects in a breastfed child, advise women not to breastfeed during treatment with Koselugo 25mg Capsule and for 1 week after the last dose.

Driving:UNSAFE

Koselugo 25mg Capsule may cause side effects which could affect your ability to drive.Patients may experience fatigue and visual disturbances during treatment with Koselugo 25mg Capsule, do not drive or operate heavy machinery if you experience such symptoms.

Kidney:SAFE IF PRESCRIBED

Koselugo 25mg Capsule is safe to use in patients with kidney disease. No dose adjustment of Koselugo 25mg Capsule is recommended.

Liver:CAUTION

Koselugo 25mg Capsule should be used with caution in patients with liver disease. Dose adjustment of Koselugo 25mg Capsule may be needed. Please consult your doctor.

Selumetinib [Prescribing Information]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2024. [Accessed 19/12/2024] (online) Available from: View
Selumetinib [Product Monograph]. Mississauga, Ontario: AstraZeneca Canada Inc.; 2022. [Accessed 19/12/2024] (online) Available from: View
AstraZeneca Rare Disease. Selumetinib [Information Guide]. 2022. [Accessed 19/12/2024] (online) Available from: View
AstraZeneca Rare Disease. Selumetinib [Information Guide]. 2022. [Accessed 19/12/2024] (online) Available from: View