Tovorafenib: uses, dosing, side effects & brands
Tovorafenib is a medicine sold in the U.S. under one brand, for glioma. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
Key facts
- Treats (across its forms)
- Glioma
- Available as
- Tablet · Kit
- Sold as
- Ojemda
- Prescription?
- Prescription only
- Generic available?
- Not in our catalog
How tovorafenib is dosed
From the FDA label for Ojemda (application NDA218033). Other tovorafenib products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Confirm the presence of BRAF fusion or rearrangement, or BRAF V600 mutation prior to initiation of treatment with OJEMDA. ( 2.1 ) Recommended dosage of OJEMDA is based on body surface area ( see Tables 1 and 2 ). ( 2.3 ) Administer OJEMDA orally, once weekly, with or without food. ( 2.3 , 2.4 ). Tablets : Swallow tablets whole with water. Do not chew, cut, or crush. ( 2.4 ) For Oral Suspension : See full prescribing information for preparation and administration instructions. ( 2.4 ) 2.1 Patient Selection Select patients for treatment with OJEMDA based on the presence of BRAF fusion or rearrangement, or BRAF V600 mutation in tumor specimens [see Clinical Studies (14) ]. Information on FDA-approved tests for the detection of BRAF fusions, BRAF rearrangements, and BRAF V600 mutations is available at http://www.fda.gov/companiondiagnostics . 2.2 Recommended Testing Before Initiating OJEMDA Before initiating OJEMDA, evaluate liver function tests, including ALT, AST and bilirubin [see Warnings and Precautions (5.3) ]. 2.3 Recommended Dosage The recommended dosage of OJEMDA based on body surface area (BSA) is 380 mg/m 2 orally once weekly (the maximum recommended dosage is 600 mg orally once weekly) with or without food [see Administration (2.4) and Clinical Pharmacology (12.3) ] until disease progression or intolerable toxicity. OJEMDA may be administered as an immediate release…
Tovorafenib side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Hemorrhage [see Warnings and Precautions (5.1) ] Skin Toxicity Including Photosensitivity [see Warnings and Precautions (5.2) ] Hepatotoxicity [see Warnings and Precautions (5.3) ] Effect on Growth [see Warnings and Precautions (5.4) ] 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. ( 6.1 ) The most common Grade 3 or 4 laboratory abnormalities (≥2%) were decreased phosphate, decreased hemoglobin, increased creatine phosphokinase, increased alanine aminotransferase, decreased albumin, decreased lymphocytes, decreased leukocytes, increased aspartate aminotransferase, decreased potassium, and decreased sodium. To report SUSPECTED ADVERSE REACTIONS, contact Day One Biopharmaceuticals at toll-free phone # 1-877-204-2820 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety population described in WARNINGS AND…
Who shouldn’t take tovorafenib
None . None. ( 4 )
Tovorafenib drug interactions
Moderate and Strong CYP2C8 Inhibitors : Avoid coadministration with OJEMDA. ( 7.1 ). Moderate and Strong CYP2C8 Inducers : Avoid coadministration with OJEMDA. ( 7.1 ). Certain CYP3A Substrates : Avoid coadministration of OJEMDA with CYP3A substrates where minimal concentration changes can cause reduced efficacy. ( 7.2 ). Hormonal contraceptives : Avoid coadministration with OJEMDA. ( 7.2 ). 7.1 Effects of Other Drugs on OJEMDA Table 8 describes drug interactions where coadministration with another drug affects OJEMDA. Table 8 Coadministration with Other Drugs that Affect the Use of OJEMDA Strong or Moderate CYP2C8 Inhibitors Prevention or Management Avoid coadministration of OJEMDA with a strong or moderate CYP2C8 inhibitor. Mechanism and Clinical Effect(s) Tovorafenib is a CYP2C8 substrate. Strong or moderate CYP2C8 inhibitors are predicted to increase tovorafenib exposure based on a mechanistic understanding of its elimination [see Clinical Pharmacology (12.3) ], which may increase the risk of adverse reactions with OJEMDA. Strong or Moderate CYP2C8 Inducers Prevention or Management Avoid coadministration of OJEMDA with a strong or moderate CYP2C8 inducer. Mechanism and Clinical Effect(s) Tovorafenib is a CYP2C8 substrate. Strong or moderate CYP2C8 inducers are predicted to decrease tovorafenib exposure based on a mechanistic understanding of its elimination [see Clinical Pharmacology (12.3) ], which may reduce the effectiveness of OJEMDA. 7.2 Effects of OJEMDA on Other Drugs Table 9 describes drug interactions where coadministration with OJEMDA affects another drug. Table 9 Coadministration with OJEMDA that Affects the Use of Other Drugs 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 CYP3A Substrates: Avoid coadministration of OJEMDA with certain CYP3A substrates where minimal concentration changes may lead to serious therapeutic failures. 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 CYP3A inducer. Tovorafenib is predicted to decrease exposure of certain CYP3A substrates where minimal concentration changes may lead to serious therapeutic failures [see Clinical Pharmacology (12.3) ], which 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 [see Warnings and Precautions (5.5) , Use in Specific Populations (8.3) ].
Every tovorafenib product we track (1)
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
Only one: Ojemda.
What tovorafenib pills look like
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| 100;D101 | 100 mg | orange | oval | — |
Can you crush or split tovorafenib?
At least one tovorafenibproduct is labelled to be swallowed whole — crushing an extended-release tablet releases the whole day’s dose at once. Which applies depends on the form you were given.
What each tovorafenib label says about crushing, splitting and chewingWhat people report to the FDA about tovorafenib
The FDA Adverse Event Reporting System (FAERS) collects reports from patients and clinicians. It holds 14 reports naming tovorafenib, and the FDA flagged 79% of those reports as serious. The effects reported most often — leaving out reports about overdose, misuse or the condition being treated, which dominate the raw list for common medicines:
- adrenal insufficiency1 reports
- arthralgia1 reports
- asthenia1 reports
- confusional state1 reports
- cystitis1 reports
- dermatitis acneiform1 reports
- fall1 reports
- fatigue1 reports
Read these as a signal, not a rate. A report does not mean tovorafenib caused the effect — anyone can file one, and many describe people taking several medicines for several conditions. Crucially there is no denominator: FAERS does not record how many people took the drug, so these counts cannot be turned into “X% of patients” — a bigger number often just means a more widely used or more talked-about drug. Duplicates exist, and publicity drives reporting. For what is actually established, read the FDA label section above.
Source: openFDA drug/event (FAERS), retrieved July 26, 2026.
Related calculators
Frequently asked questions
What is tovorafenib?
Ojemda (Tovorafenib) is a medication used to treat Glioma.
Can you take tovorafenib with other medicines?
It depends on the medicine. We check it against the FDA labels rather than guessing: our interaction checker searches each drug's own label for the other and quotes what it says, naming the section it came from. Run tovorafenib against whatever else you take — and remember that a label not naming a drug is not the same as that combination being safe.
What forms does tovorafenib come in?
Across the brands we track, tovorafenib is currently marketed as tablet and kit, per the FDA's National Drug Code Directory. Each form is dosed differently — follow the label for the exact product you were prescribed.
Is there a generic tovorafenib?
We do not currently list a generic-labelled tovorafenib product. That does not always mean none exists — it means none appears under a generic name in the FDA data we track. Ask your pharmacist.
Cite this page
- APA
- pharmaranks. (2026, July 24). Tovorafenib: uses, dosing, side effects & brands. https://pharmaranks.com/drugs/tovorafenib
- MLA
- “Tovorafenib: uses, dosing, side effects & brands.” pharmaranks, 24 July 2026, https://pharmaranks.com/drugs/tovorafenib.
We summarise public FDA and NIH sources — for a clinical claim, cite the primary source we link to as well.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Read the full FDA label for tovorafenib on DailyMed (NIH) ↗.