LuciTuca 150 mg Tablet

Q: Can LuciTuca be taken with food?

Yes, with or without food, consistently timed doses.

Q: What if I miss a dose?

If it is within 8 hours of the next dose, take it; otherwise, skip the dose and resume the schedule, avoiding double dosing.

Q: Is LuciTuca chemotherapy?

No, it’s a targeted TKI therapy, not traditional chemotherapy.

Q: Does it work on brain metastases?

Yes, it demonstrated a 52% reduction in progression risk for intracranial disease.

Q: What monitoring is needed?

Regular liver function tests (every 3 weeks) and early monitoring for diarrhea are essential.

Molecule: Tucatinib

Strength: 150 mg

Quantity: 60 Tablets

Form: Tablet

Packaging Type: Bottle

Manufacturer/Marketed By: Lucius Pharma

Country of Origin: Laos

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Description

LuciTuca 150 mg Tablet is an advanced cancer therapy containing Tucatinib, a highly selective oral small-molecule inhibitor targeting the HER2 (human epidermal growth factor receptor 2) tyrosine kinase. HER2 is a protein that promotes the growth of cancer cells and is overexpressed in approximately 20% of breast cancers. Tucatinib 150 mg works by specifically blocking HER2 signaling, thereby halting the proliferation of tumor cells while minimizing off-target effects seen with less selective agents. LuciTuca 150 mg tablet, developed by Lucius Pharmaceuticals, is approved for use in combination with trastuzumab and capecitabine for the treatment of adults with advanced or metastatic HER2-positive breast cancer, including patients whose disease has spread to the brain. It is especially beneficial for individuals who have previously received one or more lines of HER2-targeted therapies such as trastuzumab, pertuzumab, or T-DM1. LuciTuca provides a powerful oral treatment option with demonstrated efficacy in delaying disease progression and extending overall survival, including in cases with central nervous system involvement.

Benefits

Proven Survival Advantage: In the pivotal HER2CLIMB clinical trial, patients receiving tucatinib plus Trastuzumab and Capecitabine achieved a median progression-free survival (PFS) of 7.8 months, compared to 5.6 months in the placebo group. Additionally, overall survival (OS) improved to 21.9 months vs 17.4 months, translating to a 34% reduction in the risk of death.
Brain Metastases Benefit: LuciTuca 150 mg showed significant efficacy in patients with brain metastases, reducing the risk of disease progression or death by 52%. It is one of the few targeted oral therapies with robust intracranial activity.
Oral Chemotherapy-Free Option: As a selective HER2 tyrosine kinase inhibitor, LuciTuca 150 mg tablets offer an oral, targeted therapy option that avoids traditional systemic chemotherapy and its associated toxicity, making it a more tolerable and convenient choice for long-term treatment.

Indications and Usage

LuciTuca 150 mg Tucatinib Tablets is indicated for the treatment of adults with HER2-positive, unresectable, or metastatic breast cancer, including patients with active or stable brain metastases who have received at least one prior anti-HER2-based regimen in the metastatic setting.

LuciTuca is used in combination with trastuzumab and capecitabine, following current clinical guidelines, to maximize treatment efficacy and provide a comprehensive blockade of the HER2 pathway.

This combination therapy is an established standard of care for patients whose disease has progressed despite treatment with trastuzumab, pertuzumab, or antibody-drug conjugates, such as T-DM.

How it Works

Tucatinib, the active ingredient in LuciTuca 150 mg Tablets, is a potent and highly selective small-molecule inhibitor that targets the intracellular domain of the HER2 receptor, a protein known to drive the aggressive growth of tumors in HER2-positive cancers.

By blocking HER2’s kinase activity, tucatinib disrupts key downstream signaling pathways, including the PI3K/AKT and MAPK pathways, that promote cell proliferation and survival.

Unlike older tyrosine kinase inhibitors, tucatinib exhibits minimal activity against the epidermal growth factor receptor (EGFR), reducing the likelihood of EGFR-associated side effects such as rash and diarrhea.

Moreover, tucatinib can cross the blood–brain barrier, enabling it to reach and treat HER2-positive metastases in the central nervous system, an area often resistant to other therapies.

Dosage & Administration

The recommended dose of LuciTuca is 150 mg taken orally twice daily, approximately 12 hours apart. It can be taken with or without food, but should be swallowed whole with a glass of water. Do not crush, chew, or split the tablets.
Combination regimen:

Trastuzumab: Administered either intravenously or subcutaneously based on clinical guidelines.
Capecitabine: An oral chemotherapy agent typically taken twice daily within 30 minutes after a meal.

Side Effects

LuciTuca (Tucatinib), like many cancer therapies, may cause side effects, some of which can be managed effectively with supportive care or dose adjustments.
Patients should be closely monitored throughout treatment.
Common side effects (≥20% of patients):

Gastrointestinal issues: Diarrhea (most common), nausea, vomiting, stomatitis (mouth sores), decreased appetite, and abdominal pain
Fatigue and headache: General weakness and headaches are frequently reported
Skin and soft tissue reactions: Rash, hand-foot syndrome (palmar-plantar erythrodysesthesia)
Liver function abnormalities: Elevated liver enzymes (ALT, AST), which may indicate hepatotoxicity
Hematologic effects: Anemia and other blood count reductions may occur

These effects are generally manageable with supportive medications, dose modifications, or temporary treatment interruptions. Prompt communication with the healthcare provider is essential if symptoms worsen or become intolerable.

Common adverse events (all regimens):

Diarrhea, nausea, fatigue, hepatotoxicity (elevated liver enzymes), stomatitis, vomiting, decreased appetite, abdominal pain, headache, anemia, rash, hand-foot syndrome.

Warning and Precaution

Liver Toxicity (Hepatotoxicity):
Tucatinib may cause elevated transaminase levels (ALT/AST) and bilirubin. Liver function should be monitored every 3 weeks, especially during the first two months of therapy.
Warning signs: yellowing of the skin or eyes (jaundice), dark urine, upper abdominal pain, or intense itching (pruritus).
Severe Diarrhea:
Diarrhea can become serious or life-threatening if not managed promptly, leading to dehydration and kidney dysfunction. Initiate anti-diarrheal treatment (e.g., loperamide) at the first sign of loose stools and increase fluid intake.
Embryo-Fetal Toxicity:
Tucatinib may harm the developing fetus. It is contraindicated during pregnancy, and effective contraception must be used during treatment and for at least one week after the last dose. Pregnancy testing should be done before initiating therapy in individuals of childbearing potential.
Drug Interactions:
Tucatinib is metabolized primarily by CYP3A4. Use caution when taking potent CYP3A inhibitors (e.g., ketoconazole) or inducers (e.g., rifampin), as these can affect the blood levels of tucatinib. Also, avoid St. John’s wort, a known enzyme inducer that may reduce the effectiveness of Tucatinib. Always review the complete list of medications with a healthcare provider.
Fertility Considerations:
Tucatinib may impair fertility in both men and women. Patients planning to conceive should consult their oncologist for fertility preservation options or alternate planning before starting treatment.

Patient Guidance

Store tablets at 20–25 °C (68–77 °F), away from moisture, heat, and out of children’s reach.
Swallow the tablets whole; do not crush, chew, or split them.
Maintain hydration; treat diarrhea early with medical guidance.
Keep a list of all medications and supplements to share with your healthcare provider.

Clinical Trial & Approvals

HER2CLIMB Clinical Trial (Phase 2/3 – NCT02614794)

The efficacy and safety of tucatinib were established in the landmark HER2CLIMB trial, a randomized, double-blind, placebo-controlled, multicenter study involving 612 patients with HER2-positive metastatic breast cancer who had all received prior HER2-targeted treatments, including trastuzumab, pertuzumab, and/or T-DM1.

Patients were randomized to receive either:

Tucatinib + trastuzumab + capecitabine
OR Placebo + trastuzumab + capecitabine

Key Outcomes:

Progression-Free Survival (PFS):
The median PFS was 7.8 months in the tucatinib group compared to 5.6 months in the placebo group.
(Hazard Ratio [HR] = 0.54; 95% CI, 0.42–0.71; p < 0.001), indicating a 46% reduction in disease progression risk.
Overall Survival (OS):
The median OS improved to 21.9 months compared to 17.4 months in the placebo group.
(HR = 0.66; 95% CI, 0.50–0.88; p = 0.005), Equating to a 34% reduction in risk of death.
Brain Metastases Subgroup:
In patients with active or stable brain metastases (about 48% of participants), tucatinib demonstrated a 52% reduction in the risk of intracranial progression or death, a major advancement, as CNS disease remains a significant challenge in HER2+ breast cancer.

Regulatory Milestones

U.S. FDA Approval:
April 17, 2020 – Approved as part of a combination regimen for HER2-positive unresectable or metastatic breast cancer, including patients with brain metastases who have received at least one prior anti-HER2 therapy.
Other International Approvals:
- Australia: Approved by the Therapeutic Goods Administration (TGA) in August 2020
- European Union (EU): Marketing Authorization granted by the European Medicines Agency (EMA) in February 2021