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

For US healthcare professionals only

Dosing

Administration

The only once-weekly oral targeted therapy for R/R pLGG with the flexibility to be taken with or without food1

The recommended dosage of OJEMDA is 380 mg/m2 taken orally once weekly

Convenient once-weekly oral dosing

Available as a tablet and as an oral suspension

Taken with or without food

  • The recommended dosage of OJEMDA is based on body surface area (BSA). The maximum recommended dosage is 600 mg orally once weekly
  • Tablets are recommended for BSA ≥0.9 m2 unless oral suspension is clinically indicated
  • A recommended dosage for patients with BSA less than 0.3 m2 has not been established
  • The oral suspension formulation of OJEMDA is strawberry flavored, and can be administered either through an oral dosing syringe or feeding tube
  • Continue to treat until disease progression or intolerable toxicity

Once-weekly oral dosing offers the possibility of fewer daily interruptions in children’s and families’ lives

Information on missed doses with OJEMDA

If a weekly dose of OJEMDA is missed by

Three days or less
  • The missed dose should be taken as soon as possible
  • The next dose should be taken on the regularly scheduled day
More than 3 days
  • The missed dose should be skipped
  • The next dose should be taken on the regularly scheduled day

If vomiting occurs immediately after taking a dose, the dose should be repeated

Images of products not actual size.

Tablets

Tablets should be swallowed whole with water. The tablets should not be chewed, cut, or crushed.

Images of products not actual size.

Oral Suspension

Ensure that caregivers and patients read and understand the “Instructions for Use” before preparing, measuring, and administering OJEMDA.

For your patients and caregivers preparing the liquid dose of OJEMDA

Download Oral Suspension Instructions

Dosage Modifications

Dosage modifications for OJEMDA vary across adverse event grades

Recommended dosage modifications of OJEMDA for adverse reactions

Severity of ADR

Dosage
modification

Hemorrhage

Intolerable grade 2
Any grade 3

Withhold OJEMDA.

  • If improved to grade 0-1, resume at lower dosage
  • If not improved, consider permanent discontinuation

First occurrence of any grade 4

Withhold OJEMDA.

  • If improved to grade 0-1, resume at a lower dosage, OR
  • Permanently discontinue OJEMDA

Recurrent grade 4

  • Permanently discontinue OJEMDA
Skin toxicity including photosensitivity

Intolerable grade 2
Grade 3 or 4

Withhold OJEMDA.

  • If improved to grade 0-1, resume at lower dosage
  • If not improved, consider permanent discontinuation
Hepatotoxicity

Grade 3 AST or ALT
Grade 3 bilirubin

Withhold OJEMDA.

  • If improved to grade ≤2 or baseline, resume as follows:
  • If laboratory abnormality resolves within 8 days, resume OJEMDA at the same dose
  • If laboratory abnormality does not resolve within 8 days, resume OJEMDA at lower dosage

First occurrence of any grade 4

Withhold OJEMDA.

  • If improved to grade 0-1, resume at lower dosage, OR
  • Permanently discontinue OJEMDA

Recurrent grade 4

  • Permanently discontinue OJEMDA
Other adverse reactions

Intolerable grade 2
Any grade 3

Withhold OJEMDA.

  • If improved to grade 0-1, resume at lower dosage
  • If not improved, consider permanent discontinuation

First occurrence of any grade 4

Withhold OJEMDA.

  • If improved to grade 0-1, resume at lower dosage, OR
  • Permanently discontinue OJEMDA

Recurrent grade 4

  • Permanently discontinue OJEMDA

Drug Interactions

Coadministration with other drugs that affect the use of OJEMDA

Strong or moderate CYP2C8 inhibitors

Prevention or management

  • Avoid coadministration with a strong or moderate CYP2C8 inhibitor

Mechanism and clinical effect(s)

  • Tovorafenib is a CYP2C8 substrate, which may increase the risk of adverse reactions with OJEMDA
Strong or moderate CYP2C8 inducers

Prevention or management

  • Avoid coadministration with a strong or moderate CYP2C8 inducer

Mechanism and clinical effect(s)

  • Tovorafenib is a CYP2C8 substrate, which may reduce the effectiveness of OJEMDA

Coadministration with OJEMDA that affects the use of other drugs1

CYP3A substrates

Prevention or management

  • Hormonal contraceptives: Avoid coadministration of hormonal contraceptives with OJEMDA. If coadministration is unavoidable, use an additional effective nonhormonal contraceptive method during coadministration and for 28 days after discontinuation of OJEMDA
  • Other CYP2C8 substrates: Avoid coadministration of OJEMDA with certain CYP3A substrates. If coadministration is unavoidable, monitor patients for loss of efficacy unless otherwise recommended in the Prescribing Information for CYP3A substrates

Mechanism and clinical effect(s)

  • Tovorafenib is a CYP2C8 inducer that is predicted to decrease exposure of certain CYP3A substrates and may reduce the effectiveness of these substrates
  • Coadministration with hormonal contraceptives (CYP3A substrate) may decrease progestin-x and ethinyl estradiol exposure, which may lead to contraceptive failure and/or an increase in breakthrough bleeding

ADR=adverse drug reaction; ALT=alanine aminotransferase; AST=aspartate aminotransferase; BSA=body surface area; R/R pLGG=relapsed/refractory pediatric low-grade glioma.

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Reference

  • 1. OJEMDA™ [Package Insert]. Brisbane, CA: Day One Biopharmaceuticals, Inc.; 2024.

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).