KOSELUGO is indicated for the treatment of pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).1
Field Reimbursement Managers
Resource that explains how Alexion Field Reimbursement Managers (FRMs) provide education and support to healthcare providers and their offices to help facilitate patient access to prescribed Alexion therapies.
KOSELUGO Prescription and Enrollment Form
A combined form that allows healthcare providers to prescribe KOSELUGO and enroll the patient in Alexion OneSource, Alexion’s personalized patient support program. The form can be submitted to OneSource or KOSELUGO’s sole contracted specialty pharmacy.
How to Access KOSELUGO
Resource that provides education to healthcare providers and their offices on the administrative aspects of the KOSELUGO access process, including benefit investigations, prior authorizations, reauthorizations, and Alexion support resources.
Getting Started on KOSELUGO
Resource that provides education to healthcare providers and their offices on how to get their patients started on KOSELUGO, including the ordering process through KOSELUGO’s sole contracted specialty pharmacy, available patient support services, and coding and billing information.
KOSELUGO Coding Resource
Resource that presents coding, billing, and claims information to help healthcare providers and their offices with access and reimbursement for KOSELUGO in NF1.
KOSELUGO Common Prior Authorization Criteria
Resource that outlines common payer criteria for prior authorization of KOSELUGO in NF1 and explains the prior authorization process for healthcare providers and their offices.
KOSELUGO Letter of Medical Necessity
A template letter healthcare providers can use when responding to insurance requests for a letter of medical necessity for KOSELUGO in NF1.
Compendium of NF1 PN References for KOSELUGO
Resource that compiles key references for KOSELUGO in NF1, including Prescribing Information, FDA approval letter, and publicly available evidence for healthcare providers.
Peer-to-Peer Medical Review
Resource that provides education and guidance for healthcare providers and their offices on peer-to-peer reviews as a step before submitting a formal appeal.
Reauthorization Guide
Resource that provides education and support for healthcare providers, their offices, and infusion centers about the reauthorization process, including health plan requirements and timing implications for reauthorizations.
Get your patients started with OneSource
OneSource, a personalized patient support program offered by Alexion, is available Monday through Friday, 8:30 AM - 8 PM ET.
WARNINGS AND PRECAUTIONS
Cardiomyopathy. Cardiomyopathy, defined as a decrease in left ventricular ejection fraction (LVEF) ≥10% below baseline can occur with Koselugo. Grade 2 LVEF decrease occurred in 17% of evaluable patients of the 134 patients in the NF1 PN pediatric pool. Decreased LVEF of ≥20% occurred in 0.7% of patients and resulted in dose interruption and dose reduction. The median time to first occurrence of LVEF decrease was approximately 12 months. 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 until resolution. Upon resolution of decreased LVEF, obtain an echocardiogram or a cardiac MRI every 2 to 3 months.
Ocular Toxicity. Blurred vision, photophobia, cataracts, ocular hypertension, and retinal tear occurred in 13% of the 134 patients in the NF1 PN pediatric pool. Blurred vision resulted in dose interruption. 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. Gastrointestinal toxicities, including diarrhea and Grade 3 diarrhea, vomiting, nausea and stomatitis occurred in 59% of the 134 patients in the NF1 PN pediatric pool. Diarrhea resulting in permanent discontinuation and dose interruption occurred. The median time to first onset of diarrhea was approximately 2 months and the median duration was 5 days. 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 68% of 134 pediatric patients in the NF1 pediatric pool. The most frequent rashes included dermatitis acneiform (47%) and maculopapular rash (31%). Pruritus (30%), alopecia (26%), and eczema (24%) occurred. Grade 3 rash occurred, in addition to rash resulting in dose interruption and 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, including Grade 3 or 4, occurred in 55% of the 134 patients in the NF1 PN pediatric pool and resulted in dose interruption and dose reduction in 4% of patients. 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). 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 co-administered vitamin-K antagonists or anti-platelet antagonists with Koselugo capsules. Monitor for bleeding in these patients and increase international normalized ratio (INR) monitoring 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. Koselugo oral granules do not contain vitamin E.
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, diarrhea, increased CPK, dry skin, paronychia, nausea, dermatitis acneiform, and pyrexia.
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.
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.
INDICATION
KOSELUGO is indicated for the treatment of pediatric patients 1 year of age and older with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas (PN).
Please see full Prescribing Information for Koselugo (selumetinib).