FRUZAQLA^® (fruquintinib) patient profiles*

Each of your patients with metastatic colorectal cancer (mCRC) has a unique, evolving story with shifting treatment needs.

Younger patients on the rise
The fastest-growing demographic for mCRC is now adult patients under 50.¹
Benefits beyond survival
Convenient oral dosing saves you and your patient time.
Seeking balance
Treatment decisions must balance efficacy and safety with the specific needs of patients living with mCRC.

Explore 3 potential mCRC patient types, and learn how they may benefit from treatment with FRUZAQLA.

Learn about Mark’s treatment needs

Download Mark’s Profile

Mark*

64-year-old patient with mCRC presenting with myelosuppression

Diagnosis

High-risk Stage III adenocarcinoma of the colon
Molecular profiling of primary tumor:
- Microsatellite stable; MMR proficient with no actionable mutation

Treatment history

Surgery with 12 cycles of subsequent FOLFOX adjuvant therapy
CT scan 7 months after completion of adjuvant therapy revealed recurrence in the liver and progressive disease in lymph nodes
Initiated treatment with FOLFIRI + bevacizumab with progression after 4 months
Blood test results demonstrated:
- Neutropenia (ANC 700/mm³) that persisted for >30 days, which required repeated treatment holds despite G-CSF
- Thrombocytopenia (platelet count 70,000/mm³) that persisted for more than 30 days, also requiring treatment holds

ECOG PS 0

Management approach

Mark needs a treatment that may:

Offer greater flexibility within his daily routine
Demonstrate tolerability, particularly with a low risk of inducing myelosuppression
Maintain disease control while his bone marrow recovers
Offer convenient dosing that doesn’t require infusion center visits for treatment

Learn about Barbara’s treatment needs

Download Barbara’s Profile

Barbara*

58-year-old patient with mCRC and liver metastasis^†

Diagnosis

Unresectable left-sided mCRC 23 months ago
Presented with metastasis in multiple sites, including liver
Molecular profiling of primary tumor:
- Microsatellite stable; MMR proficient with no actionable mutation

Treatment history

Initiated treatment with FOLFOX + bevacizumab
CT scans at 2 months and 4 months showed decreased size of liver lesions
CT scan at 14 months revealed disease progression
- Greater degree of metastasis, with an increase in liver lesion size
- Progressive disease in the lymph nodes
Subsequent treatment with FOLFIRI + bevacizumab
Disease progression after 6 months on her most recent treatment, with evidence of new lesions and pulmonary metastasis

ECOG PS 1

Management approach

Barbara needs a treatment that may:

Stabilizes disease and extends survival
Offer greater flexibility within her daily routine
Offer convenient dosing that doesn't require infusion center visits for treatment
Keeps her clinical trial eligible

Learn about the US veteran population

Download US Veteran Brochure

US veteran population

1,000,000 US veterans are at risk of developing CRC²

Many have shared characteristics that put them at increased risk:

Tobacco use: Nearly 3 in 10 veterans use tobacco products^‡3,4
Poor diet: Veterans may be more likely to have a poor diet (high in red and processed meats and low in fruits and vegetables)^4,5
Assigned male at birth: 97% of veterans diagnosed were men^§4,6
Age ≥50 years: 97% of veterans diagnosed were ≥50 years of age^§‖4,6

CRC is also recognized by the VA as a presumptive cancer for Gulf War and post-9/11 veterans who were exposed to burn pits.^#7-9

Evolving patient unmet needs in mCRC

Learn how shifting demographics and daily activity considerations are shaping the treatment needs of patients with metastatic colorectal cancer.

Understand patient needs

Clinical results with FRUZAQLA

Learn about the efficacy results from the FRESCO and FRESCO-2 studies in patients with previously treated mCRC.

Explore efficacy data

FRUZAQLA safety profile

Learn about the safety profile from the FRESCO and FRESCO-2 studies in patients with previously treated mCRC.

Explore safety data

*Hypothetical patient. Individual patient results may vary.
^†FRUZAQLA should not be used in patients with severe hepatic impairment (total bilirubin >3 times ULN and any AST). Please see full Prescribing Information for more information.¹⁰
^‡Pooled data collected by the National Survey on Drug Use and Health from 2010-2015.³
^§Data collected by the Veterans Affairs Central Cancer Registry from 12,551 VA patients diagnosed with CRC nationwide from 2009-2012.⁶
^‖‖91% of VA patients are male.⁶
^#Large areas where tons of waste products (including trash, plastics, wood, metal, paints, solvents, munitions, and medical and human waste) were burned in the open air.¹¹

ALT=alanine aminotransferase; ANC=absolute neutrophil count; CRC=colorectal cancer; CT=computed tomography; ECOG PS=Eastern Cooperative Oncology Group performance status; FOLFIRI=leucovorin, fluorouracil, and irinotecan; FOLFOX=leucovorin, fluorouracil, and oxaliplatin; G-CSF=granulocyte colony-stimulating factor; MMR=mismatch repair; mCRC=metastatic colorectal cancer; ULN=upper limit of normal.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hypertension occurred in 49% of 911 patients with mCRC treated with FRUZAQLA, including Grade 3-4 events in 19%, and hypertensive crisis in three patients (0.3%). Do not initiate FRUZAQLA unless blood pressure is adequately controlled. Monitor blood pressure weekly for the first month and at least monthly thereafter as clinically indicated. Initiate or adjust anti-hypertensive therapy as appropriate. Withhold, reduce dose, or permanently discontinue FRUZAQLA based on severity of hypertension.

Hemorrhagic Events including serious, fatal events can occur with FRUZAQLA. In 911 patients with mCRC treated with FRUZAQLA, 6% of patients experienced gastrointestinal hemorrhage, including 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.

Infections. FRUZAQLA can increase the risk of infections, including fatal infections. 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 occurred in patients treated with FRUZAQLA. In 911 patients with mCRC treated with FRUZAQLA, 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% of patients. 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.

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. Monitor for proteinuria before initiation and periodically throughout treatment with FRUZAQLA. For proteinuria ≥2g/24 hours, withhold FRUZAQLA until improvement to ≤Grade 1 proteinuria and resume FRUZAQLA at a reduced dose. Discontinue FRUZAQLA in patients who develop nephrotic syndrome.

Palmar-Plantar Erythrodysesthesia (PPE) occurred in 35% of 911 patients treated with FRUZAQLA, including 8% with Grade 3 events. Based on severity of PPE, withhold FRUZAQLA and then resume at the same or reduced dose.

Posterior Reversible Encephalopathy Syndrome (PRES), a syndrome of subcortical vasogenic edema diagnosed by characteristic finding on MRI, occurred in one of 911 patients 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. 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.

Arterial Thromboembolic Events. In 911 patients with mCRC treated with FRUZAQLA, 0.8% of patients experienced an arterial thromboembolic event. Initiation of FRUZAQLA in patients with a recent history of thromboembolic events should be carefully considered. In patients who develop arterial thromboembolism, discontinue FRUZAQLA.

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. FRUZAQLA 1 mg contains FD&C Yellow No. 6 (sunset yellow FCF), which may cause allergic reactions.

Embryo-Fetal Toxicity. Based on findings in animal studies and its mechanism of action, FRUZAQLA can cause fetal harm when administered to pregnant women. Advise pregnant women of the potential risk to a fetus.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥20%) following treatment with FRUZAQLA included hypertension, palmar-plantar erythrodysesthesia (hand-foot skin reactions), proteinuria, dysphonia, abdominal pain, diarrhea, and asthenia.

DRUG INTERACTIONS

Avoid concomitant administration of FRUZAQLA with strong or moderate CYP3A inducers.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during treatment with FRUZAQLA and for 2 weeks after the last dose.

Females and Males of Reproductive Potential

Pregnancy Testing: Verify pregnancy status of females of reproductive potential prior to initiating FRUZAQLA.
Contraception: Females of childbearing potential and males with female partners of childbearing potential should use effective contraception during treatment and for 2 weeks after the last dose of FRUZAQLA.
Infertility: Advise females of reproductive potential that FRUZAQLA may cause post-implantation loss.

To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-844-662-8532 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see FRUZAQLA (fruquintinib) full Prescribing Information.

FRUZAQLA^® (fruquintinib) patient profiles*

Each of your patients with metastatic colorectal cancer (mCRC) has a unique, evolving story with shifting treatment needs.

Explore 3 potential mCRC patient types, and learn how they may benefit from treatment with FRUZAQLA.

Mark*

64-year-old patient with mCRC presenting with myelosuppression

ECOG PS 0

Barbara*

58-year-old patient with mCRC and liver metastasis^†

ECOG PS 1

US veteran population

1,000,000 US veterans are at risk of developing CRC²

Evolving patient unmet needs in mCRC

Clinical results with FRUZAQLA

FRUZAQLA safety profile

IMPORTANT SAFETY INFORMATION AND INDICATION

WARNINGS AND PRECAUTIONS

ADVERSE REACTIONS

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

INDICATION

Each of your patients with metastatic colorectal cancer (mCRC) has a unique, evolving story with shifting treatment needs.

Explore 3 potential mCRC patient types, and learn how they may benefit from treatment with FRUZAQLA.

Mark*

64-year-old patient with mCRC presenting with myelosuppression

ECOG PS 0

Barbara*

58-year-old patient with mCRC and liver metastasis†

ECOG PS 1

US veteran population

1,000,000 US veterans are at risk of developing CRC​2

Evolving patient unmet needs in mCRC

Clinical results with FRUZAQLA

FRUZAQLA safety profile

IMPORTANT SAFETY INFORMATION AND INDICATION

58-year-old patient with mCRC and liver metastasis^†

1,000,000 US veterans are at risk of developing CRC²