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OJEMDA (tovorafenib) logo: 100 mg tablets 25 mg/mL for oral suspension

For US healthcare professionals only

Support and Resources

Patient Support Services

Support to get your patients started with OJEMDA

EveryDay Support From Day One™ provides comprehensive services and dosing support (for eligible patients) to help you manage the process, from helping initiate and maintain coverage for OJEMDA, to helping with affordability throughout the patient's treatment journey.

Our services include:

Dedicated Patient Navigators

Our Patient Navigators work alongside you and your staff to support your patients with personalized access and product support.

Insurance and Coverage Support

We provide coverage support to help your patients, their families, and your practice navigate health insurance requirements.

Financial Assistance

We provide financial assistance options to help eligible families pay for OJEMDA, including the OJEMDA Copay Program,* which can reduce patient out-of-pocket costs to as little as $0 per month, and the Patient Assistance Program, which may provide free OJEMDA to eligible families who don't have health insurance or are underinsured.†

Shipment and Medication Support

EveryDay Support From Day One and our specialty pharmacy partners work together throughout your patient's treatment journey to provide ongoing shipment and medication support.

Get started at EveryDaySupport.com or call 855‑DAY1‑BIO(855‑329‑1246) Monday‑Friday, 8 AM-8 PM ET

*Restrictions and eligibility requirements apply. Not available for those with government insurance. Maximum benefit applies. Please see EveryDaySupport.com for full terms and conditions.

†Additional terms and conditions may apply.

Find support options for OJEMDA

Resources

Discover useful materials for your practice and your patients

These guides and resources may be helpful to healthcare professionals or patients with pediatric low-grade glioma (pLGG) and their caregivers on their treatment journey

Resources for healthcare professionals

Dosing and AE Management Guide

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

Download resource

Product Fact Sheet

Download this fact sheet to learn more about OJEMDA, including dosing and administration, available specialty pharmacies, and storage information.

Download resource

Access and Reimbursement Guide

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

Download resource

EveryDay Support From Day One™ Brochure

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

Download resource

OJEMDA Patient Website

Introduce your patients to OJEMDA’s patient-friendly website to learn important details, including clinical trial results, side effects, and coverage support.

Visit OJEMDA Patient Site

AE=adverse event.

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IMPORTANT SAFETY INFORMATION and 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 recovered 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.

Please see full Prescribing Information.

Indication

OJEMDATM (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).