Helping your patients and caregivers access the care they need

OneSource™ is a free, personalized patient support program offered by Alexion. Whether your patient is newly diagnosed or has had their condition for some time, our specialists are available for patients and their caregivers. We can help them make sense of their health insurance coverage, answer questions about treatment with Koselugo and connect them to community resources.

icon image

Koselugo comes with a team

At OneSource, our team of specialists are trained in NF1 and are ready to give your patients the support they deserve—whatever their care plan may be

icon image

Patient Education Manager (PEM)

  • Hosts local patient educational initiatives
  • Conducts treatment education sessions for patients
  • Is available to help your patients understand more about NF1
  • Provides educational materials, including a Koselugo Parent Readiness Kit
icon image

Case Manager

  • Answers questions about Koselugo and NF1
  • Provides support during treatment
  • Helps answer any questions your patients may have about Koselugo, their insurance coverage, and more
  • Helps get patients and caregivers involved with the NF1 community through events and meetings
insurance icon

Health insurance can be complicated. We’re here to help make sense of it all.

OneSource can help by:

  • Providing information that explains your patient’s insurance coverage for Koselugo
  • Addressing financial concerns or gaps in coverage

We're committed to helping your patients start and stay on track with their prescribed treatment.

To learn more or to contact a dedicated PEM or Case Manager, patients and caregivers can call 1-888-765-4747, Monday through Friday, 8:30 AM–8 PM ET, or visit www.AlexionOneSource.com.

navigator image

Alexion Access Navigator

Alexion Access Navigator is a dedicated resource website for US healthcare professionals and their offices that contains downloadable access and reimbursement materials for Koselugo. Visit www.alexionaccessnavigator.com/
koselugo to learn more.

NF1=neurofibromatosis type 1; US=United States.

Useful tools for you and your patients

Helpful resources

Use these guides and resources to learn more about how you can help your patients with NF1 PN.

Icon Card

Treatment Initiation Guide

Prepare your patients to start treatment with the help of this guide

DOWNLOAD

Icon Card

HCP Therapy Management Guide

A convenient guide filled with information to help nursing staff guide patients and caregivers through their journeys

DOWNLOAD

COMING SOON

Icon Card

Dosing & AE Management Guide

A guide that provides dosing information and presents how specific toxicities were managed in the SPRINT study, based on institutional policies and guidelines

DOWNLOAD

Resources for your patients

Share these guides and resources to help your patients with NF1 PN and their caregivers navigate their treatment journeys.

Icon Card

Patient Q&As

Your patients may have questions about their condition and their treatment. This Q&A guide can help them find the answers they need

DOWNLOAD

Icon Card

Treatment Tracking Journal

Help your patients and their caregivers keep track of their treatment experience with this helpful guide

DOWNLOAD

Icon Card

Caregivers Basics Brochure

A brochure to help educate caregivers about neurofibromatosis type 1 (NF1) plexiform neurofibromas (PN) and treatment with Koselugo

DOWNLOAD

image treating

The benefits of Koselugo

Hear from Dr Prasad, Pediatric Hematologist Oncologist at Children’s Hospital of New Orleans, about her experience treating NF1 PN patients with Koselugo.

View Important Safety Information.

View Prescribing Information.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Cardiomyopathy. A decrease in left
ventricular ejection fraction (LVEF) ≥10% below baseline occurred in pediatric
patients who received Koselugo in SPRINT with some experiencing decreased LVEF below the institutional lower limit of normal
(LLN), including one patient with Grade 3.
All patients with decreased LVEF were asymptomatic and identified during routine echocardiography. The safety of Koselugo has not been established in patients with a history of impaired LVEF or a baseline ejection fraction that is below the institutional LLN. Assess ejection fraction by echocardiogram prior to initiating treatment, every 3 months during the first year of treatment, every 6 months thereafter, and as clinically indicated. Withhold, reduce dose, or permanently discontinue Koselugo based on severity of adverse reaction. In patients who interrupt Koselugo for decreased LVEF, obtain an echocardiogram or a cardiac MRI every 3 to 6 weeks. Upon resolution of decreased LVEF, obtain an echocardiogram or a cardiac MRI every 2 to 3 months.

Ocular Toxicity. Blurred vision,
photophobia, cataracts, and ocular hypertension occurred. Retinal pigment epithelial detachment (RPED) occurred in the pediatric population during treatment with single agent Koselugo and resulted in permanent discontinuation. Conduct ophthalmic assessments prior to initiating Koselugo, at regular intervals during treatment, and for new or worsening visual changes. Permanently discontinue Koselugo in patients with retinal vein occlusion (RVO). Withhold Koselugo in patients with RPED, conduct ophthalmic assessments every 3 weeks until resolution, and resume Koselugo at a reduced dose.

Gastrointestinal Toxicity. Diarrhea
occurred, including Grade 3. Diarrhea resulting in permanent discontinuation, dose interruption or dose reduction occurred. Advise patients to start an anti-diarrheal agent (eg, loperamide) and to increase fluid intake immediately after the first episode of diarrhea. Withhold, reduce dose, or permanently discontinue Koselugo based on severity of adverse reaction.

Skin Toxicity. Rash occurred in 91% of 74 pediatric patients. The most frequent rashes included dermatitis acneiform (54%), maculopapular rash (39%), and eczema (28%). Grade 3 rash occurred, in addition to rash resulting in dose interruption or dose reduction. Monitor for severe skin rashes. Withhold, reduce dose, or permanently discontinue Koselugo based on severity of adverse reaction.

Increased Creatine Phosphokinase (CPK). Increased CPK occurred, including Grade 3 or 4 resulting in dose reduction. Increased CPK concurrent with myalgia occurred, including one patient who permanently discontinued Koselugo for myalgia. Obtain serum CPK prior to initiating Koselugo, periodically during treatment, and as clinically indicated. If increased CPK occurs, evaluate for rhabdomyolysis or other causes. Withhold, reduce dose, or permanently discontinue Koselugo based on severity of adverse reaction.

Increased Levels of Vitamin E and Risk of Bleeding. Koselugo capsules contain
vitamin E which can inhibit platelet aggregation and antagonize vitamin K-dependent clotting factors. Supplemental vitamin E is not recommended if daily vitamin E intake (including the amount of vitamin E in Koselugo and supplement) will exceed the recommended or safe limits due to increased risk of bleeding. An increased risk of bleeding may occur in patients who are coadministered vitamin-K antagonists or anti-platelet antagonists with Koselugo. Monitor for bleeding in these patients and increase international normalized ratio (INR) in patients taking a vitamin-K antagonist. Perform anticoagulant assessments more frequently and adjust the dose of vitamin K antagonists or anti-platelet agents as appropriate.

Embryo-Fetal Toxicity. Based on findings from animal studies, Koselugo can cause fetal harm when administered during pregnancy. In animal studies, administration of selumetinib to mice during organogenesis caused reduced fetal weight, adverse structural defects, and effects on embryo-fetal survival at approximate exposures >5 times the human exposure at the clinical dose of 25 mg/m2 twice daily. Advise patients of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with Koselugo and for 1 week after the last dose.

ADVERSE REACTIONS

Common adverse reactions ≥40% include vomiting, rash (all), abdominal pain, diarrhea, nausea, dry skin, musculoskeletal pain, fatigue, pyrexia, acneiform rash, stomatitis, headache, paronychia, and pruritus.

DRUG INTERACTIONS

Effect of Other Drugs on Koselugo

Concomitant use of Koselugo with a strong
or moderate CYP3A4 inhibitor or
fluconazole increased selumetinib plasma concentrations, which may increase the risk of adverse reactions. Avoid coadministration with Koselugo. If coadministration cannot be avoided, reduce Koselugo dosage.

Concomitant use of Koselugo with a strong or moderate CYP3A4 inducer decreased selumetinib plasma concentrations, which may reduce Koselugo efficacy. Avoid concomitant use with Koselugo.

SPECIAL POPULATIONS

Pregnancy & Lactation. Verify the
pregnancy status of patients of reproductive potential prior to initiating Koselugo. Due to the potential for adverse reactions in a breastfed child, advise patients not to breastfeed during treatment with Koselugo and for 1 week after the last dose.

INDICATION

KOSELUGO is indicated for the treatment of pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable PN neurofibromas (PN).

To report SUSPECTED ADVERSE REACTIONS, contact AstraZeneca
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 full Prescribing Information for Koselugo® (selumetinib).