Fruquintinib Dosage

Medically reviewed by Drugs.com. Last updated on Jan 26, 2024.

Usual Adult Dose for Colorectal Cancer

5 mg orally once a day for the first 21 days of each 28-day cycle
Duration of therapy: Until disease progression or unacceptable toxicity

Use: For the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based
chemotherapy, an anti-VEGF (vascular endothelial growth factor therapy), and, if RAS (rat sarcoma) wild-type and medically appropriate, an anti-EGFR (epidermal growth factor receptor) therapy

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

• Mild Liver Dysfunction (total bilirubin less than or equal to the upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST): No dosage adjustment
• Moderate Liver Dysfunction (total bilirubin greater than 1.5 times and less than 3 times ULN and any AST): This drug has not been sufficiently studied in these patients
• Severe Liver Dysfunction (total bilirubin greater than 3 times ULN and any AST): Not recommended

HEPATOTOXICITY:
If ALT and/or AST is greater than 3 times the upper limit of normal [3 x ULN] and total bilirubin is 2 x ULN or less:

• Therapy should be withheld, and AST/ALT and total bilirubin should be monitored until resolved to grade 1 or baseline.
• This drug should be restarted at the next lower dose upon recovery.

If ALT and/or AST is greater than 3 x ULN and total bilirubin is greater than 2 x ULN (in the absence of cholestasis or hemolysis) OR if AST/ALT is greater than 20 x ULN or bilirubin is greater than 10 x ULN:

• This drug should be permanently discontinued.

Dose Adjustments

Adverse reactions should be managed as follows: Therapy may be restarted or escalated up to the starting dose as clinically appropriate. This drug should be discontinued in patients unable to tolerate 3 mg orally once a day.

HYPERTENSION:
If the severity is at grade 3:

• Therapy should be withheld if hypertension persists despite optimal anti-hypertensive therapy.
• This drug should be restarted at the next lower dose if hypertension fully resolves or recovers to grade 1.

If the severity is at grade 4:

• This drug should be permanently discontinued.

HEMORRHAGIC EVENTS:
If the severity is at grade 2:

• Therapy should be withheld until bleeding fully resolves or recovers to grade 1.
• This drug should be restarted at the next lower dose upon recovery.

If the severity is at grade 3 or 4:

• This drug should be permanently discontinued.

PROTEINURIA:
If 2 grams or more proteinuria occurs in 24 hours:

• Therapy should be withheld until proteinuria fully resolves or is less than 1 gram/24 hours.
• This drug should be restarted at the next lower dose upon recovery.
• This drug should be permanently discontinued for nephrotic syndrome or if proteinuria does not recover to less than 1 gram/24 hours.

PALMAR-PLANTAR ERYTHRODYSESTHESIA:
If the severity is at grade 2 or 3:

• Therapy should be withheld and supportive treatment should be initiated.
• This drug should be restarted at the same dose if toxicity fully resolves or recovers to grade 1.
• Resume at the next lower dose for grade 3 severity.

OTHER ADVERSE REACTIONS:
If the severity is at grade 3:

• Therapy should be withheld.
• This drug should be restarted at the next lower dose if toxicity fully resolves or recovers to grade 1.

If the severity is at grade 4:

• This drug should be discontinued.
• Consider resuming this drug at the next lower dose only if the toxicity is non-life threatening and fully resolves or recovers to grade 1 and the potential benefit outweighs the risks.

Precautions

CONTRAINDICATIONS: None

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• This drug should be swallowed whole, without regard to food, at approximately the same time each day.
• A missed dose should be taken if less than 12 hours have passed since the scheduled dose was missed. Two doses should not be taken on the same day to make up for a missed dose.
• An additional dose should not be taken if vomiting occurs after taking this drug; the patient should take the next scheduled dose.

Storage requirements:

• Store at 20C to 25C (68F to 77F); brief exposure permitted to 15C to 30C (59F to 86F).

Monitoring:

• Cardiovascular: Blood pressure (weekly for the first month; monthly and as clinically required thereafter)
• Hepatic: Liver function (prior to and periodically during treatment)
• Renal: Proteinuria (prior to and periodically during treatment)

Patient advice:

• Read the US FDA-approved patient labeling (Patient Information).
• Contact your healthcare provider immediately if you have:
• Signs of infection such as fever
• Nausea, vomiting, or severe abdominal pain
• Dark-colored urine, yellowing of your skin
• Swelling of your face, hands, and feet
• Bleeding, blisters, or bruising
• Headaches, seizures, or vision changes
• Rash, hives, or trouble breathing
• Women of reproductive potential should contact their healthcare provider if they become pregnant or suspect a pregnancy.
• Women of reproductive potential should use effective contraception during treatment and for at least 2 weeks after the last dose.
• Males with female partners of reproductive potential should use effective contraception during treatment and for at least 2 weeks after the last dose.
• Breastfeeding is not recommended during treatment and for at least 2 weeks after the last dose.
• This drug contains certain inactive ingredients that may cause allergic-type reactions. Inform your health care provider if you have an allergy to aspirin.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer