FRUZAQLA

FRUZAQLA
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rithish Nimmagadda,MBBS

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Overview

FRUZAQLA is a {{{drugClass}}} that is FDA approved for the treatment of FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy.. Common adverse reactions include Most common adverse reactions ( are hypertension, palmar-plantar erythrodysesthesia, proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

First dose reduction - 4 mg orally once daily Second dose reduction- 3 mg orally once daily

Off-Label Use and Dosage (Adult)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FRUZAQLA FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Contraindications

There is limited information regarding FRUZAQLA Contraindications in the drug label.

Warnings

Hypertension -FRUZAQLA can cause hypertension. Hypertension occurred in 450 of 911 (49%) patients with mCRC treated with FRUZAQLA, including Grade 3-4 events in 19%, and hypertensive crisis in three patients (0.3%). The median time to first onset of hypertension was 14 days from first dose of FRUZAQLA. -Do not initiate FRUZAQLA unless blood pressure is adequately controlled. Monitor blood pressure weekly the first month, at least monthly thereafter and as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue FRUZAQLA based on the severity of hypertension [see DOSAGE AND ADMINISTRATION (2.2)].

Hemorrhagic Events -FRUZAQLA can cause serious hemorrhagic events, which may be fatal. In 911 patients with mCRC treated with FRUZAQLA, 6% of patients experienced a gastrointestinal hemorrhage, including 13 patients (1%) with a Grade ≥3 event and 2 patients with fatal hemorrhages. -Permanently discontinue FRUZAQLA in patients with severe or life-threatening hemorrhage. Monitor the International Normalized Ratio (INR) levels in patients receiving anticoagulants [see DOSAGE AND ADMINISTRATION (2.2)].

Infections -FRUZAQLA can cause an increased risk of infections, including fatal infections. In 781 patients treated with FRUZAQLA across three randomized, placebo-controlled trials, the overall incidence of infections was higher (18% vs. 12%) including for fatal infections (1% vs. 0.3%) as compared to the placebo arms (n=391). -In 911 patients with mCRC treated with FRUZAQLA, the most common infections were urinary tract infections (6.8%), upper respiratory tract infections (3.2%) and pneumonia (2.5%); fatal infections included pneumonia (0.4%), sepsis (0.2%), bacterial infection (0.1%), lower respiratory tract infection (0.1%), and septic shock (0.1%).

Withhold FRUZAQLA for Grade 3 or 4 infections, or worsening infection of any grade. Resume FRUZAQLA at the same dose when the infection has resolved.

Gastrointestinal Perforation -FRUZAQLA can cause gastrointestinal perforation. In 911 patients with mCRC treated with FRUZAQLA, 12 patients (1.3%) experienced a Grade ≥3 gastrointestinal perforation, including one fatal event. -Permanently discontinue FRUZAQLA in patients who develop gastrointestinal perforation or fistula.

Hepatotoxicity -FRUZAQLA can cause liver injury. In 911 patients with mCRC treated with FRUZAQLA, 48% experienced increased ALT or AST, including Grade ≥3 events in 5%, and fatal events in 0.2%. Median time to first onset of elevated liver enzymes was 29 days from first dose of FRUZAQLA. -Monitor liver function tests (ALT, AST, and bilirubin) before initiation and periodically throughout treatment with FRUZAQLA. Temporarily hold and then reduce or permanently discontinue FRUZAQLA depending on the severity and persistence of hepatotoxicity as manifested by elevated liver function tests [see DOSAGE AND ADMINISTRATION (2.2) and USE IN SPECIFIC POPULATIONS (8.6)].

Proteinuria -FRUZAQLA can cause proteinuria. In 911 patients with mCRC treated with FRUZAQLA, 36% experienced proteinuria and 2.5% of patients experienced Grade ≥3 events. Median time to first onset of proteinuria was 22 days from first dose of FRUZAQLA. -Monitor for proteinuria before initiation and periodically throughout treatment with FRUZAQLA. For proteinuria ≥2 g/24 hours, withhold FRUZAQLA until improvement to ≤Grade 1 proteinuria, resume FRUZAQLA at a reduced dose. Discontinue FRUZAQLA in patients who develop nephrotic syndrome [see DOSAGE AND ADMINISTRATION (2.2)].

Palmar-Plantar Erythrodysesthesia (PPE) -FRUZAQLA can cause PPE. In 911 patients with mCRC treated with FRUZAQLA, PPE occurred in 35%, including 8% with Grade 3 events. Median time to first onset of PPE was 19 days from first dose of FRUZAQLA. -Based on severity, withhold FRUZAQLA and then resume at the same or reduced dose [see DOSAGE AND ADMINISTRATION (2.2)].

Posterior Reversible Encephalopathy Syndrome (PRES) -FRUZAQLA can cause PRES, a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI. PRES occurred in one of 911 patients with mCRC treated with FRUZAQLA. -Perform an evaluation for PRES in any patient presenting with seizures, headache, visual disturbances, confusion or altered mental function. Discontinue FRUZAQLA in patients who develop PRES.

Impaired Wound Healing -Impaired wound healing can occur in patients who receive drugs that inhibit the vascular endothelial growth factor (VEGF) signaling pathway. In 911 patients with mCRC treated with FRUZAQLA, 1 patient experienced a Grade 2 event of wound dehiscence. -Do not administer FRUZAQLA for at least 2 weeks prior to major surgery. -Do not administer FRUZAQLA for at least 2 weeks after major surgery and until adequate wound healing. The safety of resumption of FRUZAQLA after resolution of wound healing complications has not been established.

5.10. Arterial Thromboembolic Events FRUZAQLA may increase the risk of arterial thromboembolic events. In 911 patients with mCRC treated with FRUZAQLA, 7 patients (0.8%) experienced an arterial thromboembolic event; additionally, FRUZAQLA studies excluded patients with clinically significant cardiovascular disease, uncontrolled hypertension, or with thromboembolic events within the prior 6 months. Initiation of FRUZAQLA in patients with a recent history of thromboembolic events should be carefully considered. In patients who develop arterial thromboembolism discontinue FRUZAQLA.

5.11. Allergic Reactions to FD&C Yellow No. 5 (Tartrazine) and No. 6 (Sunset Yellow FCF) FRUZAQLA 1 mg capsules contain FD&C Yellow No. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. -FRUZAQLA 1 mg contains FD&C Yellow No. 6 (sunset yellow FCF), which may cause allergic reactions.

5.12. Embryo-Fetal Toxicity Based on findings in animal studies and its mechanism of action, FRUZAQLA can cause fetal harm when administered to pregnant women. In an embryo-fetal developmental study in rats, embryotoxic and teratogenic effects were observed at exposures below the clinical exposure [see USE IN SPECIFIC POPULATIONS (8.1)]. -Advise pregnant women of the potential risk to a fetus. Advise females of childbearing potential and males with female partners of childbearing potential to use effective contraception during treatment with FRUZAQLA and for 2 weeks after the last dose [see USE IN SPECIFIC POPULATIONS

Adverse Reactions

Clinical Trials Experience

Hypertension Hemorrhagic Events Infections Gastrointestinal Perforation Proteinuria Palmar-Plantar Erythrodysesthesia (PPE) Posterior Reversible Encephalopathy Syndrome (PRES)

Postmarketing Experience

There is limited information regarding FRUZAQLA Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding FRUZAQLA Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Avoid concomitant use of drugs that are strong CYP3A inducers with FRUZAQLA.ased on findings in animal studies and its mechanism of action, FRUZAQLA can cause fetal harm when administered to a pregnant woman. In an embryo-fetal developmental study in pregnant rats, oral administration of fruquintinib during the period of organogenesis resulted in teratogenicity and embryo lethality at exposures below the clinical exposure (see DATA). There are no data on the use of FRUZAQLA in pregnant women. Advise pregnant women of the potential risk to a fetus.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of FRUZAQLA in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of FRUZAQLA during labor and delivery.

Nursing Mothers

There are no data regarding the presence of fruquintinib or its metabolites in human milk or its effects on a breastfed child or on milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with FRUZAQLA and for 2 weeks after the last dose.

Pediatric Use

The safety and efficacy of FRUZAQLA in patients younger than 18 years of age have not been established.

Geriatic Use

There were no observed overall differences in safety and effectiveness of FRUZAQLA in geriatric compared to younger patients.

Gender

There is no FDA guidance on the use of FRUZAQLA with respect to specific gender populations.

Race

There is no FDA guidance on the use of FRUZAQLA with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of FRUZAQLA in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of FRUZAQLA in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of FRUZAQLA in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of FRUZAQLA in patients who are immunocompromised.

Administration and Monitoring

Administration

1 mg: size 3 hard gelatin capsule with standard yellow opaque cap and white opaque body, imprinted with “HM013” over “1 mg” on the body in black ink. 5 mg: size 1 hard gelatin capsule with a red opaque cap and white opaque body, imprinted with “HM013” over “5 mg” on the body in black ink.

Monitoring

There is limited information regarding FRUZAQLA Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of FRUZAQLA and IV administrations.

Overdosage

There is limited information regarding FRUZAQLA overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding FRUZAQLA Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding FRUZAQLA Mechanism of Action in the drug label.

Structure

There is limited information regarding FRUZAQLA Structure in the drug label.

Pharmacodynamics

There is limited information regarding FRUZAQLA Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding FRUZAQLA Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding FRUZAQLA Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding FRUZAQLA Clinical Studies in the drug label.

How Supplied

There is limited information regarding FRUZAQLA How Supplied in the drug label.

Storage

There is limited information regarding FRUZAQLA Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding FRUZAQLA Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-FRUZAQLA interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

FRUZAQLA™

Look-Alike Drug Names

There is limited information regarding FRUZAQLA Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.