TM Owner Day One Biopharmaceuticals
Ojemda Suspension 25mg/mL (reconstituted; delivers 300mg in 12mL) Oral Suspension
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Indications & Clinical Uses
- Ojemda oral suspension (the approved concentration is 25 mg/mL, reconstituted to deliver 300 mg in 12 mL - see Precautions for a note on this catalogue's 15 mg/mL listing) contains tovorafenib, a type II RAF/MEK-pathway kinase inhibitor.
- It is indicated in the United States for patients 6 months of age and older with relapsed or refractory pediatric-type low-grade glioma (LGG) whose tumour carries a BRAF fusion or rearrangement, or a BRAF V600 mutation, and was granted FDA accelerated approval based on tumour response rate and duration of response.
- The European Union has also granted Ojemda a conditional marketing authorisation for patients 6 months and older who have progressed after prior systemic therapy, marketed there by Ipsen Pharma; Day One Biopharmaceuticals is the US license holder.
- The oral suspension is intended for younger children and anyone unable to swallow the 100 mg tablet, and is prescribed and monitored only by a paediatric oncology or neuro-oncology specialist.
Side Effects
- Ojemda commonly causes hair colour changes (about three-quarters of patients), rash, fatigue, viral infection, vomiting, headache, bleeding, fever, dry skin, constipation, nausea, acne-like skin reactions, and upper respiratory infection, each affecting 30% or more of patients in clinical trials.
- There is no boxed warning on the current label.
- More serious effects include hepatotoxicity, with raised liver enzymes in up to three-quarters of patients (occasionally severe), photosensitivity skin reactions in around 1 in 8 patients, and bleeding events, reported in over 40% of patients, which can occasionally be serious.
- Report any yellowing of the skin or eyes, unusual bruising or bleeding, or a severe sunburn-like reaction promptly.
- Children should avoid unprotected sun exposure and use protective clothing and sunscreen throughout treatment, and growth should be checked regularly, as slowed growth has been reported in over 40% of younger patients.
Precautions & Warnings
- Liver function tests should be checked before starting Ojemda oral suspension and monitored regularly during treatment because of the risk of hepatotoxicity; dose interruption or reduction may be needed if liver enzymes rise significantly.
- Growth should be assessed periodically in children, since treatment-related growth effects have been reported, and specialists may pause treatment if growth is affected.
- Sun protection is essential because of the risk of photosensitivity reactions.
- Ojemda may harm a developing baby, so caregivers of adolescents of reproductive potential should discuss effective non-hormonal contraception with the specialist, because tovorafenib can make hormonal contraceptives less effective.
- Breastfeeding should be avoided during treatment and for 2 weeks after the last dose.
- The reconstituted suspension must be measured only with the dosing syringe supplied in the kit, used immediately, and any leftover suspension discarded - it must never be substituted milligram-for-milligram with the tablet without specialist guidance, since the two forms are not interchangeable.
Avoid Interactions
- Ojemda oral suspension is affected by drugs that alter CYP2C8 activity: strong or moderate CYP2C8 inhibitors and inducers should be avoided, as they can raise or lower tovorafenib levels and change its effectiveness or safety.
- Ojemda itself induces CYP3A enzymes and is predicted to reduce blood levels of medicines broken down by CYP3A, causing some combined medicines to work less well; this specifically includes hormonal contraceptives, so a non-hormonal method should be used instead if relevant.
- Tell the treating specialist about every prescription medicine, over-the-counter medicine, herbal product, and supplement being used, since many are CYP2C8 inhibitors or inducers.
- The oral suspension must be measured with the supplied dosing syringe and never mixed with other liquid medicines or foods other than as directed in the administration instructions.
References
Frequently Asked Questions
Ojemda oral suspension (tovorafenib) treats relapsed or refractory low-grade glioma, a childhood brain tumor, in patients aged 6 months and older whose tumor has a BRAF fusion, rearrangement, or V600 mutation. It is used for younger children or anyone who cannot swallow tablets.
The powder is reconstituted by a pharmacist into a 25 mg/mL suspension. The dose is measured with the syringe supplied in the kit and given by mouth once weekly, on the same day each week, with or without food as directed.
The most common side effects are hair color changes, rash, fatigue, vomiting, headache, bleeding, and fever, each affecting around a third or more of patients. Serious effects include raised liver enzymes, sun-sensitivity skin reactions, and slowed growth, so regular liver tests and growth checks are needed.
Avoid strong CYP2C8 inhibitors or inducers, since they change tovorafenib levels. Ojemda also makes hormonal contraceptives less effective, so a non-hormonal method should be used if relevant. Avoid unprotected sun exposure, as Ojemda can cause photosensitivity reactions; use sunscreen and protective clothing.
Store the unopened kit at 20°C to 25°C. Once the pharmacist reconstitutes the suspension, use it right away for each dose; discard any leftover suspension after use and never save it for a later dose.
Yes, it is approved from 6 months of age and treatment can continue as long as it is working and tolerated. Because it can slow growth in children, doctors check growth and liver function regularly and may adjust or pause dosing if needed.
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