Oncology

Our experienced formulation experts are fully equipped to develop new formulations from scratch or optimize existing formulations. In process development, we always aim for scalable processes, semi-continuous or batched. We are experienced in the challenging aspects of method development for liposomal formulations. And finally, we manufacture liposomal product in our cGMP plant using scalable industrial processes. That is why we are known as an expert in liposomal development.

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  TOT Product Main Active Ingredient Contraindications Storage
Lipo-Dox Pegylated Liposomal Doxorubicin HCl 2 mg/mL) Lipo-Dox is contraindicated in patients who have a history hypersensitivity to doxorubicin HCl or the excipient of Lipo-Dox. (Please check the dropdown page for complete information) Refrigerate unopened vials at 2℃ to 8℃. Avoid freezing. After dilution with Dextrose 5% in Water, the diluted Lipo-Dox solution...(Please check the dropdown page for complete information)

INDICATIONS :

The treatment of AIDS-related Kaposi’s sarcoma in patients with low CD4 (<200 CD4 lymphocytes/mm³) and diseases in mucosa, skin and internal organs. The treatment of metastasis carcinoma of the ovary in patients with disease that is recurrent to both first-line platinum- and paclitaxel-based chemotherapy regimens. As monotherapy for patients with metastatic breast cancer, where there is an increased cardiac risk.

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Contraindication:

Women of childbearing age and their spouses should take contraceptive measures during Pegylated liposomal doxorubicin treatment and within 6 months after treatment discontinuation.

 

Storage:

Refrigerate unopened vials at 2℃ to 8℃. Avoid freezing. After dilution with Dextrose 5% in Water, the diluted Lipo-Dox solution should be used immediately or stored at 2℃ to 8℃for not longer than 24 hours. Discard the partially used vials.

UFUR Tegafur 100mg 。Uracil 224mg (1). Known severe allergy to ingredients of this medication. (2). Patients on medication of sorivudine. Store at room temperature.

INDICATIONS :

Gastric cancer, Colorectal cancer, Breast cancer, Squamous Cell Carcinoma of Head & Neck, and Combination with cisplatin is indicated for the treatment of patients with metastatic and advanced Lung cancer.
Thado Thalidomide 50mg Pregnancy: Category X (Please check the dropdown page and see the attachment for more information) This drug must be kept in a tight container, and stored under 25℃. Avoid heat, moisture and direct light exposure. Please keep out of the reach of children.

INDICATIONS :

Newly Diagnosed Multiple Myeloma: Thalidomide should be used in combination with prednisolone and oral melphalan, or with bone marrow transplant. Or be combined with pamidronate in patients after bone marrow transplant.

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TS-1 Tegafur(FT)、Gimeracil(CDHP)、Oteracil potassium (Oxo) (1). It should not be used in combination with antineoplastic agents of the Pyrimidine Fluoride class ...(Please check the dropdown page for complete information) Capsules: Store at room temperature in a tight container. Granules: Store at room temperature.

INDICATIONS :

Gastric cancer, Colorectal cancer, Head and Neck cancer, Non-small cell lung cancer, Inoperable or Recurrent breast cancer, Pancreatic cancer, Biliary tract cancer.

Contraindication:

(1). It should not be used in combination with antineoplastic agents of the Pyrimidine Fluoride class (5-FU Injection, Tegafur, capecitabine, etc,) or the antifungal agent Flucytosine, since severe hematologic disorders or other side effects may be induced.
(2). It may induce severe hepatic dysfunctions such as fulminant hepatitis, so regular examination of liver function and proper observation are required for early detection of hepatic dysfunction. Moreover, prodromal symptoms of hepatic dysfunction or fatigability accompanied by self-reported symptoms (ex: poor appetite) should be vigilantly watched for; drug should be discontinued immediately when jaundice (scleral icterus) is observed, followed by appropriate management.
(3). Pregnant or lactating women.
(4). Patients known to suffer from severe diarrhea and bone marrow suppression.

Painkyl Fentanyl citrate Since any dose of PAINKYL can induce life-threatening respiratory depression in opioid non-tolerant patients,...(Please check the dropdown page for complete information) Please store PAINKYL at a safe place out of reach of children and non-intended PAINKYL users at any time. ...(Please check the dropdown page for complete information)

INDICATIONS :

PAINKYL is a type of opioid analgesics indicated for breakthrough pain in cancer patients; the appropriate candidates should be those of 18 years of age or older, currently using opioid medication for potentially persistent cancer pain, and tolerant to opioid medication. The definition of opioid-tolerant patient is: having used oral morphine 60 mg/day, or percutaneous fentanyl 25  μg/hour, or oral oxycodone 30 mg/day, or oral hydromorphone 8 mg/day, or oral oxymorphone 25 mg/day, or an equianalgesic dose of any other opioid medication, for at least one week or longer. Patients taking PAINKYL should continue around-the-clock opioid medication. PAINKYL is contraindicated in opioid non-tolerant patients since life-threatening respiratory depression might develop in patients who are not under long-term opioid medication. Therefore, PAINKYL should not be used for acute or postoperative pain management, such as headache/migraine, toothache, or in the emergency setting. PAINKYL should be used for the care of opioid-tolerant cancer patients, and only to be employed by medical professionals who are knowledgeable about and expertise in cancer pain management with opioid-type second-grade controlled drugs.

Contraindication:

Since any dose of PAINKYL can induce life-threatening respiratory depression in opioid non-tolerant patients, it should not be used for acute or postoperative pain management, such as headache/migraine, toothache, or in the emergency setting. This medication is contraindicated for opioid non-tolerant patients.
The definition of opioid-tolerant patient is: having used oral morphine 60 mg/day, or percutaneous fentanyl 25  μg/hour, or oral oxycodone 30 mg/day, or oral hydromorphone 8 mg/day, or oral oxymorphone 25 mg/day, or an equianalgesic dose of any other opioid medication, for at least one week or longer.
PAINKYL is contraindicated for patients known to be intolerant or allergic to any ingredient in PAINKYL or fentanyl medication.
Patients who are documented to have systemic anaphylaxis and hypersensitivity reactions to other types of fentanyl in oral transmucosal formulations.

 

Storage

• Please store PAINKYL at a safe place out of reach of children and non-intended PAINKYL users at any time.

• Please prevent PAINKYL theft.

• Please keep PAINKYL at room temperature (15°C-30°C) until prepared for usage.

• Please do not freeze PAINKYL for storage.

• Please keep PAINKYL in dry condition.

Anazo Anastrozole 1mg Anazo F.C. Tablets or Anastrozole is contraindicated in: - premenopausal women. - pregnant or lactating women. …(Please check the dropdown page for complete information) Please keep the drug at room temperature (<25℃)

INDICATIONS :

Treatment of advanced breast cancer in postmenopausal women. Efficacy has not been demonstrated in estrogen receptor negative patients unless they had a previous positive clinical response to tamoxifen. Adjuvant treatment of postmenopausal women with hormone receptor positive early invasive breast cancer. Adjuvant treatment of early breast cancer in hormone receptor positive postmenopausal women who have received 2 to 3 years of adjuvant tamoxifen.

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 Contraindication

• premenopausal women.

• Pregnant or lactating women.

• Patients with severe renal impairment (creatinine clearance rate lower than 20 ml/min).

• Patients with moderate or severe hepatic disease.

• Patients with known hypersensitivity to Anastrozole or to any of the excipients as referenced in the list of excipients.

Oestrogen-containing therapies should not be co-administered with Anastrozole as they would negate its pharmacological action.

Asadin Arsenic Trioxide(As2O3) ASADIN is contraindicated in patients who are hypersensitive to arsenic. Do not use after expiration date printed on the label. Please store at room temperature and protected from light. Please keep out of reach of children.

INDICATIONS :

Arsenic Trioxide is indicated for acute promyelocytic leukemia ( APL ). Explanation: ASADIN is administered for induction of remission and consolidation in patients with acute promyelocytic leukemia ( APL ) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t ( 15 : 17 ) translocation or fusion protein PML/RARa gene expression. The efficacy of other acute myelogenous leukemia subtypes to Arsenic Trioxide has not been examined.
Epicin Epirubicin Hydrochloride 2.0mg Epirubicin should not be used in patients with myelosuppression induced by previous treatment with other antitumor agents or ...(Please check the dropdown page for complete information) Stored at 2-8℃ (avoid freezing) and protected from light.

INDICATIONS :

Mammary carcinoma, malignant lymphoma, soft tissue sarcoma, and gastric, lung, ovarian carcinomas.

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Contraindication:

Epirubicin should not be used in patients with myelosuppression induced by previous treatment with other antitumor agents or by radiotherapy. The drug is also contraindicated in patients with current or previous history of cardiac dysfunction. And in patients already treated with maximal cumulative doses of mitozantrone, mitomycin C, or other anthracyclines such as doxorubicin or daunorubicin.

Folina FOLINATE (CALCIUM)=L / Calcium Folinate Folina tablets should not be used for the treatment of pernicious anemia and other megaloblastic anemias secondary to the lack of vitamin B12. Store between 15~30℃. Keep out of the reach of children.

INDICATIONS :

To diminish the toxicity and counteract the effect of unintentional over dosage of folic acid antagonist. To treat Folate deficient megaloblastic anemias of infancy, pregnancy, sprue, and nutritional deficiencies.
Folina inj. LEUCOVORIN CALCIUM(ANHYDRIDE) Anemia without diagnosis, pernicious anemia, or anemia due to vitamin B12 deficiency. Please store it at 2-8℃ and protect it from light; do not freeze. Please keep it out of reach of children.

INDICATIONS :

Antidote indicated in folic acid antagonist (ex: Methotrexate) overdose.
Gemmis Gemcitabine 38mg Gemcitabine is contraindicated in those patients with a known hypersensitivity to the drug。 2°C to 8°C; it cannot be refrigerated.

INDICATIONS :

Its indications include non-small cell lung cancer (NSCLC), pancreatic cancer, and bladder cancer. Gemcitabine and paclitaxel may be combined for anthracycline-treated patients with locally–recurred breast cancer that is surgically non-resectable or metastatic. It can also be used in ovarian cancer that has been treated with platinum-based drugs but recurs at an interval of more than 6 months, as second-line therapy. – NSCLC Gemcitabine and combined use with cisplatin is the treatment for inoperable, locally-advanced (stage IIIa or IIIb) or metastatic (stage IV) NSCLC as the first-line drug. Gemcitabine is used for the palliative treatment of locally-advanced or metastatic NSCLC adult patients. – Pancreatic cancer Gemcitabine is a treatment of locally-malignant (inoperable stage II or III) or metastatic (stage IV) pancreatic adenocarcinoma as a first-line drug of choice. Gemcitabine can also be used in patients treated with 5-FU. – Bladder cancer: metastatic transitional cell carcinoma of the urothelium (TCC of the urothelium) Gemcitabine with combined use with cisplatin is a treatment of stage-4 (locally-advanced or metastatic) metastatic TCC of urothelium, as a first-line drug of choice.
Irino Irinotecan 20mg - A history of severe hypersensitivity reactions to irinotecan hydrochloride, trihydrate or to one of the excipients of Irino. ...(Please check the dropdown page for complete information) Store at temperature below 25°C. Protect from light.

INDICATIONS :

Irino is indicated for the treatment of patients with advanced colorectal cancer: - In combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for advanced disease. - As a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen.

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Contraindication

A history of severe hypersensitivity reactions to irinotecan hydrochloride, trihydrate or to one of the excipients of Irino.
A chronic inflammatory bowel disease and/or a bowel obstruction (see 【WARNINGS AND PRECAUTIONS】).
In pregnant or breast-feeding women (see 【WARNINGS AND PRECAUTIONS】,【PREGNANCY】and【NURSING MOTHERS】).
In patients with bilirubin > 1.5 times the ULN (see 【WARNINGS AND PRECAUTIONS】).
In patients with a severe bone marrow failure.
In patients presenting a risk factor, particularly those with a WHO performance status>2.

Megest megestrol acetate 40mg/ml Patients allergic to megestrol acetate or any ingredient in the formula. Patients known or suspected to be pregnant. Keep this product out of reach of children. Keep container tightly closed after use and store it at 25℃ away from light.

INDICATIONS :

Anorexia in patients with AIDS, and underweight due to AIDS and cancer-related cachexia.
Oxalip Oxaliplatin 50mg Oxaliplatin is contraindicated in patients who − with a history of know hypersensitivity to oxaliplatin. − are breast feeding. − have myelosuppression prior to starting first course, as evidenced by b Store under 25℃.

INDICATIONS :

In combination with 5-fluorouracil (5-FU) and folinic acid (FA) is indicated for: - Adjuvant treatment of stage III (Duke's C) colon cancer after complete resection of primary tumor. - Treatment of metastatic colorectal cancer. Oxaliplatin in combination with Capecitabine is indicated for the treatment of locally advanced and recurrent/metastatic gastric cancer.

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Otril Granisetron i Hydrochloride inj. 1mg/ml, 3ml/vial This product is prohibited in patients who are allergic to granisetron or other excipients in the product. Store at room temperature at 25℃ or lower and away from light. Please do not freeze.

INDICATIONS :

For treating and preventing nausea and vomiting induced by antineoplastic chemotherapy; for treating nausea and vomiting induced by antineoplastic radiotherapy. Preventing nausea and vomiting induced by systemic and half-systemic antineoplastic radiotherapy. Treating post-operative nausea and vomiting.
Tynen DOCETAXEL •Hypersensitivity to the active substance or to any of the excipients. ...(Please check the dropdown page for complete information) Store in the original package in order to protect from light. Docetaxel vial should be stored between 2℃~8℃ and...(Please check the dropdown page for complete information)

INDICATIONS :

Breast Cancer: Docetaxel in combination with doxorubicin and cyclophosphamide is indicated for the adjuvant treatment of patients with: - operable node-positive breast cancer. -operable node-negative breast cancer. For patients with operable node-negative breast cancer, adjuvant treatment should be restricted to patients eligible to receive chemotherapy according to internationally established criteria for primary therapy of early breast cancer Docetaxel in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition. Docetaxel in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy. Previous therapy should have included an anthracycline. Docetaxel monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer in whom previous therapy has failed. Prior therapy should have included an anthracycline unless clinically contraindicated. Non-Small Cell Lung Cancer: Docetaxel is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer even after failure of platinum-based chemotherapy. Docetaxel in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition. TAXOTERE in combination with carboplatin represents a treatment option to cisplatin-based therapy. Prostate Cancer: Docetaxel in combination with prednisone or prednisolone is indicated for the treatment of patients with hormone refractory metastatic prostatic cancer.  Gastric Adenocarcinoma: Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the treatment of patients with metastatic gastric adenocarcinoma, including adenocarcinoma of the gastroesophageal junction, who have not received prior chemotherapy for metastatic disease. Head and Neck Cancer: Docetaxel in combination with cisplatin and 5-fluorouracil is indicated for the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck.

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Contraindication:

 Hypersensitivity to the active substance or to any of the excipients.

 • Docetaxel should not be used in patients with baseline neutrophil count of <1,500 cells/mm³.

 • Docetaxel should not be used in pregnant or breast-feeding women.

 • Docetaxel should not be used in patients with severe liver impairment since there is no data available. (Please see Warning and precautions and Dosage and administration.)

 • Contraindications for other medical products also apply, when combined with docetaxel.

Storage:

Store in the original package in order to protect from light. Docetaxel vial should be stored between 2℃~8℃ and protected from light.  Docetaxel infusion solution The docetaxel infusion solution shoul.

Zobonic Zobonic lyophilized powder for solution for IV infusion 4mg The zoledronic acid powder for infusion solution preparation should not be administered to pregnant women, lactating women, and ...(Please check the dropdown page for complete information) Store at 25℃ or lower.

INDICATIONS :

Approved by the Ministry of Health and Welfare: used in combination with standard treatment of malignancy in patients with multiple myeloma and solid tumor with bone metastases. When used for prostate cancer with bone metastases, the patient should have received at least one type of hormone therapy and the disease continued to progress. Treating hypercalcemia complications in malignancies(HCM).

Contraindication:

The zoledronic acid powder for infusion solution preparation should not be administered to pregnant women, lactating women, and patients who show clinically significant allergic phenomenon to zoledronic acid, other bisphosphonates, or any excipient in zoledronic acid.