OJEMDA Tablet / Oral suspension Ref.[109717] Active ingredients: Tovorafenib

Source: FDA, National Drug Code (US) Revision Year: 2024

1. Indications and Usage

OJEMDA 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 [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

2. Dosage and Administration

2.1 Patient Selection

Confirm the presence of BRAF fusion or rearrangement, or BRAF V600 mutation prior to initiation of treatment with OJEMDA [see Warnings and Precautions (5.6), Clinical Studies (14)]. An FDA approved test for the detection of BRAF fusion or rearrangement, or BRAF V600 mutation in relapsed or refractory pediatric LGG is not currently available.

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/m² 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 tablet (see Table 1) or as an oral suspension (see Table 2). A recommended dosage for patients with BSA less than 0.3 m² has not been established.

Table 1. Recommended OJEMDA Tablets Dosage Based on Body Surface Area:

Body Surface Area (m²)	Recommended Dosage
0.30-0.89	Administer OJEMDA oral suspension once weekly (see Table 2)
0.90-1.12	400 mg once weekly
1.13-1.39	500 mg once weekly
≥1.40	600 mg once weekly

Table 2. Recommended Dosage for OJEMDA for Oral Suspension Based on Body Surface Area:

Body Surface Area (m²)	Dose Volume (mL)¹	Dosage
0.30-0.35	5	125 mg once weekly
0.36-0.42	6	150 mg once weekly
0.43-0.48	7	175 mg once weekly
0.49-0.54	8	200 mg once weekly
0.55-0.63	9	225 mg once weekly
0.64-0.77	11	275 mg once weekly
0.78-0.83	12	300 mg once weekly
0.84-0.89	14	350 mg once weekly
0.90-1.05	15	375 mg once weekly
1.06-1.25	18	450 mg once weekly
1.26-1.39	21	525 mg once weekly
≥1.40	24	600 mg once weekly¹

¹ OJEMDA for oral suspension has a concentration of 25 mg/mL. Each bottle of OJEMDA for oral suspension delivers 300 mg/12 mL.

Continue once weekly dosing until disease progression or intolerable toxicity.

2.4 Administration

Take OJEMDA at a regularly scheduled time once weekly.
OJEMDA may be taken with or without food [see Clinical Pharmacology (12.3)].

If a dose is missed by:

3 days or less, take the missed dose as soon as possible, and take the next dose on its regularly scheduled day.
more than 3 days, skip the missed dose and take the next dose on its regularly scheduled day.

If vomiting occurs immediately after taking a dose, repeat that dose.

OJEMDA tablets:

Swallow tablets whole with water.
Do not chew, cut, or crush.

OJEMDA for oral suspension:

Prior to first time use of OJEMDA for oral suspension, ensure that caregivers (and if appropriate, patients) read and understand the "Instructions for Use" before preparing, measuring, and administering OJEMDA.

Preparation and Administration

Reconstitute the powder in each supplied bottle with exactly 14 mL of room temperature water to form the OJEMDA for oral suspension. After reconstitution each mL contains 25 mg of tovorafenib. Product foaming after reconstitution reduces the deliverable volume.
Each bottle delivers 300 mg of tovorafenib in 12 mL. For doses greater than 300 mg, reconstitute two bottles to achieve the dose. Split the dose as equally as possible between the two bottles (e.g., 6 mL and 7 mL for a 325 mg dose).
Administer OJEMDA for oral suspension using the supplied oral dosing syringe or feeding tube (minimum 12 French) immediately after preparation.
If the OJEMDA for oral suspension is not administered within 15 minutes after preparation, instruct the patient to discard it.

2.5 Dosage Modifications for Adverse Reactions

The recommended dosage reductions for adverse reactions for OJEMDA tablets are provided in Table 3 and OJEMDA for oral suspension in Table 4.

Table 3. OJEMDA Tablets: Recommended Dosage Reductions for Adverse Reactions:

BSA (m²)	First Dosage Reduction	Second Dosage Reduction
0.30-1.12	Administer the oral suspension once weekly (see Table 4)
1.13-1.39	400 mg once weekly	Administer OJEMDA oral suspension once weekly (see Table 4)
≥1.40	500 mg once weekly	400 mg once weekly

Table 4. OJEMDA for Oral Suspension: Recommended Dosage Reductions for Adverse Reactions:

BSA (m²)	First Dosage Reduction		Second Dosage Reduction
BSA (m²)	Volume (mL)	Dose (mg)	Volume (mL)	Dose (mg)
0.30-0.35	4	100 mg once weekly	3	75 mg once weekly
0.36-0.42	5	125 mg once weekly	4	100 mg once weekly
0.43-0.48	6	150 mg once weekly	5	125 mg once weekly
0.49-0.54	7	175 mg once weekly	6	150 mg once weekly
0.55-0.63	8	200 mg once weekly	6	150 mg once weekly
0.64-0.77	9	225 mg once weekly	8	200 mg once weekly
0.78-0.83	10	250 mg once weekly	8	200 mg once weekly
0.84-0.89	12	300 mg once weekly	10	250 mg once weekly
0.90-1.05	13	325 mg once weekly	11	275 mg once weekly
1.06-1.25	15	375 mg once weekly	13	325 mg once weekly
1.26-1.39	18	450 mg once weekly	15	375 mg once weekly
≥1.40	20	500 mg once weekly	16	400 mg once weekly

The recommended dosage modifications of OJEMDA for adverse reactions are in Table 5.

Table 5. Recommended Dosage Modifications for Adverse Reactions:

Severity of ADR^a	Dosage Modification^b
Hemorrhage [see Warnings and Precautions (5.1)]
• Intolerable Grade 2 • Any Grade 3	Withhold OJEMDA. • If improved to Grade 0-1, resume at lower dosage. • If not improved, consider permanent discontinuation of OJEMDA.
• 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.
Skin Toxicity including Photosensitivity [see Warnings and Precautions (5.2)]
• 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 of OJEMDA.
Hepatotoxicity [see Warnings and Precautions (5.3)]
• 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 OJEDMA 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 [see Adverse Reactions (6.1)]
• Intolerable Grade 2 • Any Grade 3	Withhold OJEMDA. • If improved to Grade 0-1, resume at lower dosage. • If not improved, consider permanent discontinuation of OJEMDA.
• 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.

^a National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.
^b See Table 3 and Table 4 for recommended dosage reductions.

16.2. Storage and Handling

OJEMDA tablets:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Dispense 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); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Do not use if safety seal under cap is broken or missing.

Suspension must be used immediately after reconstitution.

Discard the bottle (including any unused portion) and syringe after dosing.

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