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Resources for healthcare professionals

Dosing and Adverse Reactions Management Guide

Download this guide for nurse practitioners and other healthcare team members on the preparation, administration, and management of OJEMDA.

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Access and Reimbursement Guide

Download this brochure to learn more about how to help your patients and their families access OJEMDA.

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Patient resources

Resources for your patients

A Guide for
Considering OJEMDA

Your patients can explore clinical trial results, possible side effects, and available patient support tailored to their needs.

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What to Know When Starting OJEMDA

Your patients can learn more about how to take OJEMDA, treatment routine tips, and potential side effects and how to manage them.

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Step-by-Step Guide for Preparing a Liquid Dose of OJEMDA

Need to learn how to prepare and give a liquid dose of OJEMDA? Master the step-by-step process for preparing your patient’s liquid medicine with this guide.

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Watch: The Instructional Video for preparing a liquid dose of OJEMDA

The video and step-by-step guide for preparing an oral suspension of OJEMDA allow you and your patients to learn in the style you choose.

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EveryDay Support From Day One™ Brochure

Learn more about personalized support for your patients with EveryDay Support From Day One™.

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A Guide to Learn About Side Effects of OJEMDA

This in-depth guide will help your patients prepare for possible side effects with comprehensive tips to manage some of them.

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IMPORTANT SAFETY INFORMATION
INDICATION

INDICATION

Warnings and Precautions

Hemorrhage

Hemorrhage, including major hemorrhage defined as symptomatic bleeding in a critical area or organ, can occur with OJEMDA. Advise patients and caregivers of the risk of hemorrhage during treatment with OJEMDA. Monitor for signs and symptoms of hemorrhage and evaluate as clinically indicated. Withhold and resume at reduced dose upon improvement, or permanently discontinue based on severity.

Skin Toxicity Including Photosensitivity

OJEMDA can cause rash, including maculopapular rash and photosensitivity. Monitor for new or worsening skin reactions. Consider dermatologic consultation and initiate supportive care as clinically indicated. Withhold, reduce the dose, or permanently discontinue OJEMDA based on severity of adverse reaction.

Photosensitivity

Advise patients to use precautionary measures against ultraviolet exposure such as use of sunscreen, sunglasses, and/or protective clothing during treatment with OJEMDA. Withhold, reduce the dose, or permanently discontinue OJEMDA based on severity of adverse reaction.

Hepatotoxicity

OJEMDA can cause hepatotoxicity. Monitor liver function tests, including ALT, AST and bilirubin, before initiation of OJEMDA, one month after initiation and then every three months thereafter and as clinically indicated. Withhold and resume at the same or reduced dose upon improvement, or permanently discontinue OJEMDA based on the severity.

Effect on Growth

OJEMDA can cause reductions in growth velocity. Growth velocity improved after interruption of treatment with OJEMDA. Routinely monitor patient growth during treatment with OJEMDA.

Embryo-Fetal Toxicity

Based on findings from animal studies and its mechanism of action, OJEMDA may cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus.

Advise females of reproductive potential to use effective nonhormonal contraception during treatment with OJEMDA and for 28 days after the last dose, since OJEMDA can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective nonhormonal contraception during treatment with OJEMDA and for 2 weeks after the last dose.

NF1 Associated Tumors

Based on nonclinical data in NF1 models without BRAF alterations, tovorafenib may promote tumor growth in patients with NF1 tumors. Confirm evidence of a BRAF alteration prior to initiation of treatment with OJEMDA.

Adverse Reactions

The most common adverse reactions (≥30%) were rash, hair color changes, fatigue, viral infection, vomiting, headache, hemorrhage, pyrexia, dry skin, constipation, nausea, dermatitis acneiform, and upper respiratory tract infection.

INDICATION

OJEMDA^TM (tovorafenib) is indicated for the treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation.

This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Please see full Prescribing Information.