Ojemda
Pronunciation: oh-JEM-dah
Generic name: tovorafenib
Dosage form: tablet (100mg), oral suspension (25mg/mL)
What is Ojemda?
Ojemda is a medicine used to treat a pediatric low-grade glioma (pLGG), it may help to stabilize or shrink the tumor. Ojemda (tovorafenib) is used when the patient has an altered gene called a BRAF fusion or rearrangement, or BRAF V600 mutation, and their cancer has relapsed after earlier treatment or has not responded to treatment. Pediatric low-grade glioma is the most common brain tumor diagnosed in children.
Changes in genes, called BRAF fusion or rearrangement or BRAF V600 mutation, promote cancer growth and survival. Ojemda is a type II pan-RAF kinase inhibitor that works by blocking a protein called Type II RAF kinase.
Ojemda FDA approval was received on April 23, 2024, for patients 6 months of age and older who have relapsed or refractory pediatric low-grade glioma (LGG) with a BRAF fusion or rearrangement or BRAF V600 mutation.
Ojemda tablets or liquid is taken once a week with or without food.
Ojemda side effects
Common Ojemda side effects
The most common Ojemda side effects include rash, hair color changes, fatigue, viral infection, vomiting, headache, hemorrhage, fever, dry skin, constipation, nausea, dermatitis acneiform, and upper respiratory tract infections, these affect up up to 30% patients in clinical trials.
Ojemda may cause laboratory abnormalities, including decreases in phosphate, hemoglobin, lymphocytes, leukocytes, albumin, potassium, and sodium levels and increases in creatinine phosphokinase, alanine aminotransferase, and aspartate aminotransferase. These were Grade 3 or 4 laboratory abnormalities that affected up to 2% of patients.
Serious Ojemda side effects
Ojemda may cause serious side effects, including:
Bleeding problems (hemorrhage) are common and serious side. Tell your healthcare provider if you develop any signs or symptoms of bleeding, including:
- headache, dizziness or feeling weak
- coughing up blood or blood clots
- vomiting blood or your vomit looks like “coffee grounds”
- red or black stools that look like tar
Skin reactions, including sensitivity to sunlight (photosensitivity), patients should limit direct ultraviolet exposure and use precautionary measures such as sunscreen, sunglasses and protective clothing during treatment with this medicine. Skin reaction side effects can become severe. Tell your healthcare provider if you get new or worsening skin reactions, including:
- Rash
- peeling, redness, or irritation
- bumps or tiny papules
- blisters
- Acne
Liver problems. Your healthcare provider will do blood tests to check your liver function before and during treatment with this medicine. Tell your healthcare provider right away if you develop any of the following symptoms
- yellowing of your skin or your eyes
- tiredness
- dark or brown (tea-colored) urine
- bruising
- nausea or vomiting
- bleeding
- loss of appetite
- pain in your upper right stomach area
Slowed growth in children. Growth will be checked routinely during treatment with this medicine.
Other side effects
Ojemda may cause fertility problems in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.
This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Warning
Embryo-Fetal Toxicity: Ojemda can cause fetal harm. There is a potential risk to the fetus. Patients who are able to become pregnant should use effective non-hormonal contraception during treatment and for 28 days after the last dose. Ojemda may cause some hormonal contraceptives to be ineffective . Male patients with female partners who are able to become pregnant should use effective nonhormonal contraception during treatment and for 2 weeks after the last dose.
NF1-Associated Tumors: Ojemda may promote tumor growth in patients with NF1 tumors, it is important to confirm evidence of a BRAF alteration before starting treatment with this medicine.
Also, see “Serious Side Effects.”
Before taking this medicine
Tell your healthcare provider about all of your or your child’s medical conditions, including if:
- have bleeding problems
- have skin problems
- have liver problems
Pregnancy
Ojemda can harm your unborn baby. Tell your healthcare provider if you are pregnant or planning a pregnancy.
Females who are able to become pregnant:
- Your healthcare provider will do a test to see if you are pregnant before starting treatment with Ojemda.
You should use effective non-hormonal birth control (contraception) during treatment and for 28 days after your last dose of this medicine. -
Birth control methods that contain hormones (such as birth control pills, injections, or transdermal systems) may not work as well during treatment with Ojemda, and you could become pregnant. You should use another nonhormonal, effective method of birth control during treatment with Ojemda.
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Talk to your healthcare provider about birth control methods that may be right for you during this time.
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Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with Ojemda.
Males with female partners who are able to become pregnant
- Males should use effective non-hormonal birth control (contraception) during treatment with this medicine and for 2 weeks after their last dose.
Breastfeeding
Tell your healthcare provider if you are breastfeeding or planning to breastfeed. It is not known if Ojemda passes into your breast milk. Do not breastfeed during treatment and for 2 weeks after your last dose of this medicine. Talk to your healthcare provider about the best way to feed your baby during this time.
What to avoid
Limit the amount of time you spend in sunlight as Ojemda can make your skin sensitive to the sun (photosensitivity). Use sun protection measures, such as sunscreen, sunglasses and wear protective clothes that cover your skin during your treatment with this medicine.
How should I take or give Ojemda?
Ojemda is available as a tablet or oral suspension.
Take or give Ojemda once a week at a regularly scheduled time. This medicine can be taken with or without food.
Ojemda tablets are swallowed whole with water. Do not chew, cut, or crush the tablets. Tablets should not be removed from blisters until immediately before use.
Ojemda oral suspension can be taken or given by mouth or through a feeding tube (minimum 12 French). Read instructions on how to prepare, measure, and take or give a dose of Ojemda oral suspension. Your or your child’s dose may require preparing two bottles of Ojemda for oral suspension. The suspension is supplied as a powder that needs to be reconstituted with water. Once prepared, it should be administered immediately or discarded 15 minutes after preparation.
If vomiting happens right after taking a dose of this medicine, take or give the dose again. If you are not sure if you should take or give another dose, contact your healthcare provider.
Take or give this medicine exactly as your healthcare provider tells you to. Do not change you or your child’s dose or stop taking this medicine unless your healthcare provider tells you.
Your healthcare provider may change you or your child’s dose, temporarily stop, or completely stop your treatment with Ojemda if you develop certain side effects.
Ojemda Dosing Information
The recommended Ojemda dose is based on body surface area (BSA) is 380 mg/m2 orally once weekly, up to a maximum recommended dosage of 600 mg orally once weekly.
A recommended dosage for patients with BSA less than 0.3 m2 has not been established.
Duration of treatments is until disease progression or intolerable toxicity.
What happens if I miss a dose?
If you miss a weekly dose by:
- 3 days or less, take or give the missed dose as soon as you remember. Take or give the next dose of Ojemda on the next regularly scheduled day.
- more than 3 days, skip the missed dose and take or give the next dose of Ojemda on the next regularly scheduled day.
Interactions
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get any new medicine.
Ojemda may interact with medicines that are:
- moderate and strong CYP2C8 Inhibitors, avoid coadministration with this medicine.
- moderate and strong CYP2C8 Inducers, avoid coadministration with this medicine.
- certain CYP3A substrates, avoid coadministration of this medicine with CYP3A substrates where minimal concentration changes can cause reduced efficacy.
- hormonal contraceptives, avoid coadministration with this medicine.
Not all possible interactions are listed here.
Storage
Ojemda tablets
- Store at 20°C to 25°C (68°F to 77°F)
- Dispense the product in the original package.
- Tablets should not be removed from blisters until immediately before use.
Ojemda for oral suspension
- Store at 20°C to 25°C (68°F to 77°F);
- Do not use if the safety seal under the cap is broken or missing.
- Suspension must be used immediately after reconstitution. Discard the bottle (including any unused portion) and syringe
Ingredients
Active ingredient: tovorafenib
Inactive ingredients:
Tablet: copovidone, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and Opadry® Orange.
For oral suspension: artificial strawberry flavor, colloidal silicon dioxide, copovidone, maltodextrin, mannitol, microcrystalline cellulose, simethicone, sodium lauryl sulfate, and sucralose.
Company
Manufactured for
Day One Biopharmaceuticals, Inc. 2000, Sierra Point Parkway, Suite 501, Brisbane CA 94005.
Manufactured by (tablets):
Quotient Sciences – Philadelphia LLC, 3 Chelsea Parkway, Suite 305, Boothwyn PA 19061.
Manufactured by (oral suspension):
Quotient Sciences – Philadelphia LLC, 3080 McCann Farm Dr., Garnet Valley, PA 19060.
References
More about Ojemda (tovorafenib)
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
