Tovorafenib
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From MedlinePlus, U.S. National Library of Medicine
Kinase Inhibitor
Dosing in kidney impairment
Renal Impairment No dose adjustment is recommended for patients with mild-to-moderate renal impairment (eGFR ≥ 30 mL/min/1.73 m 2 calculated by Schwartz equation or MDRD equation). OJEMDA has not been studied in patients with severe renal impairment (eGFR <30 mL/min/1.73 m 2 ) [see Clinical Pharmacology ] .
Dosing in liver impairment
Recommended Testing Before Initiating OJEMDA Before initiating OJEMDA, evaluate liver function tests, including ALT, AST and bilirubin [see Warnings and Precautions ].
Preparation and administration
Administration Take OJEMDA at a regularly scheduled time once weekly. OJEMDA may be taken with or without food [see Clinical Pharmacology ]. 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). Prepare the first bottle and administer dose prior to preparing the second bottle. 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.
| Body Surface Area (m2) | Dose Volume (mL)OJEMDA for oral suspension has a concentration of 25 mg/mL. Each bottle of OJEMDA for oral suspension delivers 300 mg/12 mL. | 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 weekly |
| BSA (m2) | First Dosage Reduction | Second Dosage Reduction | ||
|---|---|---|---|---|
| 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 |
Drug interactions
Check tovorafenib against a medication listLabel text (6 paragraphs)
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) ].
Contraindications
None . None. ( 4 )
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1) ], OJEMDA can cause fetal harm when administered to a pregnant woman. There are no available data on the use of OJEMDA in pregnant women. Oral administration of tovorafenib to pregnant rats during the period of organogenesis resulted in embryo lethality at exposures 0.8 times the human exposure at the recommended dose based on AUC ( see Data ). Advise pregnant women of the potential risk to a fetus. In the U.S.
general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In an embryo-fetal development study, once daily oral administration of tovorafenib to pregnant rats during the period of organogenesis from gestation days 7 through 17 at doses of 37.5, 75, and 150 mg/kg resulted in early resorptions and total litter loss at all doses. The dose of 37.5 mg/kg/day is approximately 0.8-fold the human exposure at the recommended dose based on AUC.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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