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PG2 Lyo.Injection 500mg

PG2 Lyo.Injection 500mg

Drug permit license number

Department of Health license no. 058837

Active pharmaceutical ingredients

PhytoHealth PG2® Lyo. Injection consists of polysaccharides of Astragalus membranaceus, which are extracted,isolated and purified from the traditional Chinese medicinal herb huang qi, as its active ingredient. Each vial of this product contains 500 mg of APS extract.

Mechanism of action

Stimulates bone marrow hematopoiesis and enhances immune function.

Pharmacological and Toxicological effects

Pharmacological research (both animal and in vitro testing) has showed that PhytoHealth PG2® Lyophilized Injection can regulate the immune system and stimulate hematopoiesis in bone marrow. PhytoHealth PG2® Lyophilized Injection is capable of stimulating the proliferation of spleen cells, encouraging human peripheral blood mononuclear cells (PBMCs) to secrete a variety of cellular hormones which regulate immune function. The treatment 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, thus eliminating mortality when exposed to semi-lethal doses of X-ray radiation and cytomegalovirus (CMV) and extending the survival period in a variety of circumstances. In addition, PhytoHealth PG2® Lyophilized Injection can also promote the proliferation and maturation of precursor cells in bone marrow and the spleen, facilitating the recovery of white blood cells, red blood cells, and platelets, as well as effectively reducing the adverse side effects caused by toxic substances. PhytoHealth PG2® Lyophilized Injection has received complete toxicological test results that confirm the safety of a clinical dose. Genotoxicity testing showed no toxic reactions, while acute toxicity testing found no toxic reactions when rats were administered a dosage equivalent to 30 times of what would be typically administered to human beings, and repeated dose toxicity testing found that, when 36 times the dosage of what would typically be applied to humans continuously for 90 days was administered, dogs showed no toxic reaction.

Clinical efficacy results

1. Pivotal Clinical Trial

Focusing on palliative care of advanced cancer patients with moderate to severe fatigue symptoms in cases where treatment with curative drugs was no longer effective, Phase III clinical trial with randomized, double-blind and placebo-controlled design was conducted using treatment with either PhytoHealth PG2® Injection or a placebo for 4 weeks, with 3 treatments per week and 1 infusion per treatment, in order to assess the efficacy of the PhytoHealth PG2® Injection. 

This study used the Brief Fatigue Inventory (BFI) to accurately verify and assess fatigue in patients. Patients with a reduction in BFI scores by 10% or more were defined as having an improvement in the fatigue symptoms. Results demonstrated:

(1) 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, with a difference of 20%.

(2) 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, with a difference of 18%.
 

2. Post-Marketing Phase IV Clinical Trial

Focusing on palliative care of 323 advanced cancer patients with moderate to severe fatigue symptoms in cases where treatment with curative drugs was no longer effective, this clinical trial with randomized, and double-blind design was conducted using treatment with either PhytoHealth PG2® Injection 500 mg or 250 mg for 4 weeks, with 3 treatments per week and 1 infusion per treatment, in order to assess the efficacy of the PhytoHealth PG2® Injection.

This study used the Brief Fatigue Inventory (BFI) to accurately verify and assess fatigue in patients. The study was designed as a descriptive statistical analysis with no placebo group. The results were not intended to prove the superior or non-inferior efficacy of the high dose (500 mg) as compared to that of the low dose (250 mg) of PhytoHealth PG2® Injection as well as the superior efficacy of the high dose (500 mg) of PhytoHealth PG2® Injection as compared to that of placebo. Results demonstrated:

(1) Based on Per-Protocol (PP) population: Patients with a reduction in BFI scores by at least 10% or 20% were defined as having an improvement in the fatigue symptoms. At least 10% and 20 % improvements in fatigue score were observed in 67% and 54% of subjects receiving high dose (500 mg) of PhytoHealth PG2® Injection; such improvements were observed in 65% and 47% of subjects receiving low dose (250 mg) of PhytoHealth PG2® Injection.

(2) 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 the fatigue symptoms. At least 10% and 20 % improvements in fatigue score were observed in 66% and 51% of subjects receiving high dose (500 mg) of PhytoHealth PG2® Injection; such improvements were observed in 65% and 47% of subjects receiving low dose (250 mg) of PhytoHealth PG2® Injection.

Route and dosage

In adults, 500 mg per dose of the product was infused intravenously for 2.5-3.5 h 2-4 times per week for a total of 2-4 weeks.

Adverse reactions

Based on the results of the post-marketing phase IV clinical trial, the most common (2% and above) adverse events included rash (9.21%), pyrexia (7.24%), feeling cold (5.26%), chills (2.63%), and hypersensitivity (2.63%) in patients receiving 500 mg of PhytoHealth PG2® Injection. The most common (2% and above) observed adverse events were pyrexia (3.23%) and rash (2.58%) in patients receiving 250 mg of PhytoHealth PG2® Injection. The incidence of all drug-related adverse events was higher in subjects receiving high dose (500 mg) of PhytoHealth PG2® Injection than those treated with low dose (250 mg) of PhytoHealth PG2® Injection. Considering more than 1% incidence of hypersensitivity occurred among patients being treated, physicians should pay careful attention to possible adverse events during clinical uses.

It should carefully monitor patient's condition during and after infusion. When an infusion reaction occurs, the infusion should be interrupted and the patient should be symptomatically treated by the physician. The reaction can be relieved by stopping infusion and/or treating 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.

Precautions

Use of this product by pregnant or nursing women and children younger than 18 years should be avoided, as safety and efficacy have not yet been established.

Storage

The sealed product should be stored at 25℃ or below in a dry place away from direct sunlight.