Medicines (Rx) 
PG2® Lyo.
Injection 500 mg
PG2® Lyo. Injection 500mg
Indications: Indicated to alleviate moderate to severe cancer-related fatigue
Drug permit license: no. 058837
Active pharmaceutical ingredients
PhytoHealth PG2® Lyo. Injection consists of polysaccharides extracted, isolated, and purified from Astragalus membranaceus. Each vial of this product contains 500 mg of APS extract.
Mechanism of action
Stimulates bone marrow hematopoiesis and enhances immune function.
Route and dosage
In adults, 500 mg per dose of the product is infused intravenously for 2.5 to 3.5 hours, 2 - 4 times a week, for 2 - 4 weeks.
Storage
The sealed product should be stored at 25℃ or below in a dry place away from direct sunlight.
Pharmacological and Toxicological effects
- Pharmacological effects
- PhytoHealth PG2® Injection can regulate the immune system and stimulate hematopoiesis in bone marrow. It is capable of stimulating the proliferation of spleen cells in mice, encouraging human peripheral blood mononuclear cells (PBMCs) to secrete a variety of cellular hormones that regulate immune function.
- PhytoHealth PG2® Injection enhances the activity of natural killer cells (NK cells) and has been found to improve the immunity of normal mice by regulating the immune system. Drastically lowering mortality rates of mices when exposed to semi-lethal doses of X-ray radiation and cytomegalovirus (CMV). Additionally, treatment extended the survival period under a variety of circumstances.
- PhytoHealth PG2® Injection can also promote the proliferation and maturation of precursor cells in bone marrow and the spleen. This facilitates the recovery of white blood cells, red blood cells, and platelets and effectively reduces the adverse side effects caused by toxic substances, such as the side effects of therapeutic drugs.
- Toxicological effects
- PhytoHealth PG2® Injection has received complete toxicological test results that confirm the safety of a clinical dose.
- Genotoxicity testing showed no toxic reactions.
- Acute toxicity testing found no toxic reactions when rats were administered a dosage equivalent to 30 times what would be typically administered to human beings.
- Repeated dose toxicity testing found that dogs showed no toxic reaction when exposed to 36 times the typical human dosage continuously for 90 days.
Clinical efficacy results
- Pivotal Clinical Trial
The pivotal clinical trial focused on palliative care for advanced cancer patients with moderate to severe fatigue in cases where treatment with curative drugs was no longer effective. To assess the efficacy of PhytoHealth PG2® Injection, patients were treated with either PhytoHealth PG2® Injection or a placebo for 4 weeks. Patients were administered 3 treatments per week at 1 infusion per treatment.
This study utilized the Brief Fatigue Inventory (BFI) to accurately verify and assess patients' fatigue. Patients with a 10% or higher reduction in BFI scores were defined as having an improvement in fatigue symptoms. Results demonstrated:
- Based on Per-Protocol (PP) population: 60% of the patients in the treatment group showed improvement in fatigue symptoms, whereas only 40% of the patients in the placebo control group showed improvement. A difference of 20%.
- Based on Intention-to-Treat (ITT) population: 56% of the patients in the treatment group showed improvement in fatigue symptoms, whereas only 38% of the patients in the placebo control group showed improvement. A difference of 18%.
- Post-Marketing Phase IV Clinical Trial
The post-marketing phase IV trial focused on palliative care of 323 advanced cancer patients with moderate to severe fatigue in cases where treatment with curative drugs was no longer effective. Patients were treated with either PhytoHealth PG2® Injection 500 mg or 250 mg for 4 weeks. Both dosages were administered with 3 treatments per week at 1 infusion per treatment.
This study used the Brief Fatigue Inventory (BFI) to verify and assess fatigue in patients accurately. Results demonstrated:
- Based on Per-Protocol (PP) population: Patients with a reduction in BFI scores by at least 10% were defined as having an improvement in fatigue symptoms. In the study, 67% of patients receiving a high dose (500 mg) of PhytoHealth PG2® Injection showed 10% or more improvement, with 54% of patients reporting higher than 20% improvement. For patients given low doses (250 mg), 65% reported 10% or more improvement, with 47% of patients reporting higher than 20% improvement.
- Based on Intention-to-Treat (ITT) population: Patients with a reduction in BFI scores by at least 10% or 20% were defined as having an improvement in fatigue symptoms. Of patients receiving high doses (500 mg), 66% reported a 10% improvement, with 51% reporting more than 20% improvement. For low-dose patients (250 mg), 65% reported a 10% improvement, with 47% reporting a 20% or higher improvement.
Adverse reactions
The most common adverse effects in patients receiving 500 mg of PhytoHealth PG2® Injection (with a prevalence of 2% or above) based on the post-marketing phase IV clinical trial results included rash (9.21%), pyrexia (7.24%), feeling cold (5.26%), chills (2.63%), and hypersensitivity (2.63%). The most common adverse effects in patients receiving 250 mg of PhytoHealth PG2® Injection (with a prevalence of 2% or above) were pyrexia (3.23%) and rash (2.58%).
The incidence of all drug-related adverse events was higher in subjects receiving a high dose (500 mg) of PhytoHealth PG2® Injection than those treated with a low dose (250 mg) of PhytoHealth PG2® Injection. With more than 1% of cases indicating hypersensitivity among patients being treated, physicians should carefully monitor any possible adverse events during clinical uses.
All patients should be closely monitored during and after infusion. If any adverse symptoms appear, the infusion should be suspended, and a physician should symptomatically treat the patient. Most reactions can be relieved by stopping the infusion and/or treatment with antihistamines, antipyretics, and/or steroids. Antihistamines given before the infusion and/or time of the infusion extension can be considered as means for prophylaxis of adverse events.