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

For US healthcare professionals only

THIS CHILD HAS A BRAIN TUMOR

Help him move forward with OJEMDA™

Joseph, lives with pLGG

The first and only type II RAF inhibitor for BRAF alterations in relapsed or refractory pediatric low-grade glioma (R/R pLGG)1

Second line starts with OJEMDA

SHRINKAGE

Clinically meaningful response seen in BRAF-altered R/R pLGG1

SPEED

Rapid responses seen in the clinical trial

SAFETY

OJEMDA was generally well tolerated in the clinical trial2

SIMPLICITY

Once-weekly oral dosing taken with or without food1

OJEMDA is a type II RAF inhibitor that targets BRAF alterations in R/R pLGG1

See the types of patients who may be appropriate for OJEMDA

EXPLORE OUR PATIENT PROFILES

Comprehensive support for your patients

OJEMDA has wide payer coverage for most pLGG patients.1,2

We provide comprehensive services to help you manage the process, from initiating and maintaining coverage for OJEMDA, to helping with affordability, to dosing and medication support throughout the patient's treatment journey. Our services include:

  • Dedicated patient navigators
  • Insurance and coverage support
  • Financial assistance to help eligible families pay for OJEMDA
  • Shipment and medication support

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

SEE SUPPORT

BRAF=v-Raf murine sarcoma viral oncogene homolog B1; RAF=rapidly accelerated fibrosarcoma.

References

  • 1. OJEMDA™ [Package Insert]. Brisbane, CA: Day One Biopharmaceuticals, Inc.; 2024.
  • 2. Kilburn LB, Khuong-Quang DA, Hansford JR, et al. The type II RAF inhibitor tovorafenib in relapsed/refractory pediatric low-grade glioma: the phase 2 FIREFLY-1 trial. Nat Med. 2024;30(1):207-217. doi:10.1038/s41591-023-02668-y
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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).