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GemVax & KAEL

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Product NameRIAVAX™ inj.

IngredientTertomotide Hydrochloride

IndicationLocally advanced or metastatic pancreatic cancer patients having eotaxin level in serum higher than 81.02pg/mL

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Appearance
White freeze-dried powder contained in colorless transparent glass vial
Ingredient Content
1 vial contains; Tertomotide 0.84mg
Dosage and Usage
Administer RIAVAX™ inj. in combination with Gemcit®abine/Capecitabine.
Before administering RIAVAX, administer Leukine®, which is adjuvant immunotherapy, in the following manner.
Leukine®(sargramostim, rhGM-CSF) 0.15mL (75㎍, 0.42 x 106 IU/day, 0.5mg/mL) is administered intradermally on the lower abdomen. After 10~15 minutes, RIAVAX 0.20 mL (0.56 mg, 2.8 mg/mL) solution must be administered intradermally at the same site as Leukine®(sargramostim, rhGM-CSF). RIAVAX is administered on day (1, 3, 5) in the first week and on day (8, 15, 22, 36) in the second, third, fourth and sixth week, after that, once 4 weeks at the same site every time.
Gemcitabine: 1000mg/m² Gemcitabine must be given intravenously over 30minutes on day 1,8,15 followed by 7days’ rest from the beginning of 1st day of Tertomotide administration. This cycle is repeated every 4 weeks. In such cases, dose reduction or delay prescription according to the patient’s progression of adverse event refers to Gemcitabine labeling information.
Capecitabine: 830 mg/m² Capecitabine must be administered orally morning and evening daily for 21days followed by 7days’ rest from the beginning of 1st day of Tertomotide administration. This cycle is repeated every 4 weeks. Capecitabine tablets should be swallowed whole with water within 30minutes after meal. Dose adjustment of Capecitabine due to toxicity should be modified according to label of Capecitabine.
Special warnings and precautions for use

1. Warning

1)RIAVAX™ must only be prescribed by prescribers who are registered with the Registry Program in REMS (Risk Evaluation and Mitigation Strategies). Also, RIAVAX™ must only be dispensed by a pharmacy registered with the Registry Program in REMS and must only be dispensed to patients who are registered and meet all the requirements of Registry Program. The manufacturer must provide detailed information about this program to patients, and the patients must comply with the information provided in REMS. 2)This medication is injected with Gemcitabine, Capecitabine, and Leukine® (sargramostim, rhGM-CSF). Healthcare providers should read ‘An Operation Manual for Healthcare Professionals’ in REMS and domestic authorizations of each drug before the administration of the 3-drug combination. 3)‘Risk Mitigation Strategies’ of REMS must be followed because Leukine® (sargramostim, rhGM-CSF) is not approved in Korea.

2. Contraindications

1)Hypersensitivity to active and inactive ingredients of RIAVAX™, Leukine® (sargramostim, rhGM-CSF), Gemcitabine, or Capecitabine 2)Pregnancy, breastfeeding, or the women of childbearing potential. (See also 6 Use in specific populations: Pregnancy and Lactation of product label) 3)Moderate or severe liver dysfunction or severe kidney dysfunction (CrCl < 30 mL/min) 4)Brain metastases or cancerous meningioma 5)Uncontrolled angina pectoris 6)Radiation therapy within 4 weeks of using this medication 7)Malabsorption syndrome 8)Other medications affecting the immune system. (Exception; temporary use of steroid in order to mitigate symptoms from tumor)

3. Precautions for Use

1)Mild to moderate kidney disorder (weakened kidney function may cause adverse events more easily) 2)The elderly

4. Adverse Event

1)Mild and temporary injection site reaction (erythema, soreness and pain) may occur and that is usual after vaccine administration. 2)All adverse events occurring in 10% or more of 1,062 patients on phase 3 pancreatic cancer clinical study (TeloVac study) are listed below, and they are classified by system organ class and absolute frequency. The occurrence of all adverse events is indicated by the number of the patients (percentage) for the control group (Gemcitabine/Capecitabine, N=358) and experimental group (Gemcitabine/Capecitabine/Leukine®/RIAVAX™, N=354). Frequencies are defined as: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (>1/10,000 to ≤1/1,000); very rare (≤1/10,000). 3)All adverse events occurring in 2% or more of 1,062 patients with grade 3 or greater CTCAE v3.0 adverse events are listed below, and they are classified by system organ class and absolute frequency. The occurrence of all adverse events is indicated by the number of the patients (percentage) for the control group (Gemcitabine/Capecitabine, N=358) and experimental group (Gemcitabine/Capecitabine/Leukine®/ RIAVAX™, N=354). Frequencies are defined as: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (>1/10,000 to ≤1/1,000); very rare (≤1/10,000). 4)15 patients (4.19%) of control group (Gemcitabine/Capecitabine group, N=358) and 13 patients (3.67%) of experimental group (Gemcitabine/Capecitabine/Leukine®/RIAVAX™, N=354) discontinued treatment due to adverse reaction on phase 3 pancreatic cancer clinical studies.
Size
Packaging unit by company
Storage
Hermetic container, -25℃~ -15℃ storage (refrigerated)
Use Period
36 months from the manufactured date