What are the ingredients in KOSELUGO?

Active ingredient: selumetinib.

Inactive ingredients:

• Capsule contains: vitamin E polyethylene glycol succinate.
• The 10 mg capsule shell contains: hypromellose, carrageenan, potassium chloride, titanium dioxide, carnauba wax, and purified water.
• The 10 mg capsule printing ink contains: shellac, iron oxide black, propylene glycol, and ammonium hydroxide.
• The 25 mg capsule shell contains: hypromellose, carrageenan, potassium chloride, titanium dioxide, FD&C blue 2, ferric oxide yellow, purified water, carnauba wax and/or corn starch.
• The 25 mg printing ink contains: ferric oxide red, ferric oxide yellow, FD&C Blue 2 aluminum lake, carnauba wax, shellac, glyceryl monooleate.

Dosage & Administration

Standard Dosing:

• 25 mg/m² twice daily (approx. every 12 hours), based on body surface area (BSA), until disease progresses or toxicity occurs.

• Doses are rounded to the nearest 5 mg or 10 mg, using different capsule strengths as needed (max 50 mg/dose).

Examples by BSA:

• 0.70–0.89 m² → 20 mg twice daily

• 0.90–1.09 m² → 25 mg twice daily

• ≥1.90 m² → 50 mg twice daily.

Administration Guidelines:

• Can be taken with or without food; capsules must be swallowed whole, not chewed or opened.

• Missed dose: Take as soon as possible unless less than 6 hours remain until next dose—then skip.

• Vomiting: Do not repeat the dose; continue next scheduled dose only.

Cardiac Monitoring:

• Decreased left ventricular ejection fraction (LVEF) (≥10% drop) occurred in ~23% of pediatric patients in trials.

• Perform echocardiograms before starting treatment, every 3 months in the first year, then every 6 months as needed

Eye Safety:

• Risk of eye toxicity: blurred vision, retinal detachment or vein occlusion.

• Baseline eye exam before starting, and repeat at intervals or if symptoms occur. Discontinue upon retinal vein occlusion .

Bleeding Risk:

• Capsules contain high-dose vitamin E, which may impair platelet function and increase bleeding risk.

• Caution with vitamin K antagonists or anti-platelet drugs; monitor INR closely and avoid supplementation exceeding safe vitamin E intake .

How to Take KOSELUGO

• Take KOSELUGO exactly as prescribed by your doctor.

• Do not adjust your dose or stop taking it without medical advice.

• Your dose is based on your child’s weight or body surface area.

• Take KOSELUGO twice daily, about 12 hours apart, at the same time each day.

• Can be taken with or without food.

• Swallow capsules whole with water—do not chew, open, or crush them.

Missed a dose?

• Take it as soon as you remember unless it’s less than 6 hours to your next dose—then skip it.

• Do not double dose.

Vomiting after a dose?

• Do not retake the missed dose. Wait and take your next dose as scheduled.

What to Avoid

While taking KOSELUGO, do not consume:

• Grapefruit or grapefruit juice

• St. John’s Wort supplements
  These can affect how the medicine works in your body.

Liver Impairment:

• Moderate hepatic impairment (Child–Pugh B): Reduce dose to 20 mg/m² twice daily.

• Severe impairment (Child–Pugh C): Safety not established.

Drug Interactions:

• Avoid grapefruit or St. John’s Wort, and strong/moderate CYP3A4 inhibitors (e.g. fluconazole), as they can alter drug levels and increase side effects .

 Common & Serious Side Effects

Frequent Side Effects (≥40% of pediatric subjects):

• Vomiting, abdominal pain, nausea, diarrhea

• Rash (dermatitis acneiform, eczema), dry skin

• Musculoskeletal pain, fatigue, fever, headaches, mouth sores, paronychia, pruritus .

Serious Adverse Events:

• Heart-related: symptomatic heart failure or reduced heart pumping capacity

• Eye toxicity: retinal detachment, vein occlusion

• Muscle injury: elevated creatine phosphokinase (CPK), possible rhabdomyolysis.

Patient-Reported Real‑World Experiences:

• Fatigue: up to 56% report significant tiredness, sometimes affecting daily life.

• Dermatologic issues: severe acne and rash are common; often require dermatology management.

• Rare vision effects: some have reported reversible vision loss and retinal issues requiring dose interruption.

Clinical Benefits

• In pediatric trials, about 66% achieved at least 20% tumor volume reduction, with 82% maintaining that response ≥ 12 months .

• Symptom improvement may include reduced pain, better mobility, less disfigurement, and improved respiratory or airway-related symptoms.

Before You Start Taking KOSELUGO

Tell your doctor if you have any of the following:

• Heart problems

• Eye issues (e.g. vision changes)

• Liver problems

• Are pregnant or may become pregnant

  • KOSELUGO can harm an unborn baby.

  • Females must use effective birth control during treatment and for 1 week after the last dose.

  • Males with female partners who may become pregnant must also use birth control during and for 1 week after treatment.

  • Your doctor may do a pregnancy test before starting.

• Are breastfeeding

  • Do not breastfeed during treatment and for 1 week after stopping KOSELUGO.

  • Ask your doctor about safe alternatives for feeding your baby.

• All medicines and supplements you are taking, including:

  • Prescription and over-the-counter drugs

  • Vitamins and herbal supplements (especially aspirin, blood thinners, or St. John’s Wort)

How to Store KOSELUGO

• Store at room temperature (68°F to 77°F or 20°C to 25°C)

• Keep in the original bottle with the desiccant packet inside to reduce moisture

• Keep tightly closed and out of reach of children