What Do Elevated Platelets Indicate?

Recombinant human thrombopoietin injection, the indication is 1. This product is suitable for the treatment of thrombocytopenia caused by chemotherapy of solid tumors. The applicable object is platelet less than 50 × 10 9 / L and the doctor thinks that it is necessary to increase platelet therapy. Patient. 2. This product is used for the adjuvant treatment of idiopathic thrombocytopenic purpura (ITP), and the applicable object is glucocorticoid treatment with platelets lower than 20 × 10 9 / L. Ineffective patients who have not received splenectomy. This product is only used for patients with thrombocytopenia and clinical risk of increased bleeding, and should not be used to try to increase the platelet count to a normal value.

Recombinant human thrombopoietin injection, the indication is 1. This product is suitable for the treatment of thrombocytopenia caused by chemotherapy of solid tumors. The applicable object is platelet less than 50 × 10 9 / L and the doctor thinks that it is necessary to increase platelet therapy. Patient. 2. This product is used for the adjuvant treatment of idiopathic thrombocytopenic purpura (ITP), and the applicable object is glucocorticoid treatment with platelets lower than 20 × 10 9 / L. Ineffective patients who have not received splenectomy. This product is only used for patients with thrombocytopenia and clinical risk of increased bleeding, and should not be used to try to increase the platelet count to a normal value.
Drug Name
Recombinant human thrombopoietin injection
Drug type
Prescription drugs, work injury drugs

Composition of recombinant human thrombopoietin injection

Recombinant human thrombopoietin (made from Chinese hamster ovary (CHO) cells with high expression of human thrombopoietin gene after cell culture, isolation and high purification)
Excipients: human blood albumin, sodium chloride.

Traits of recombinant human thrombopoietin injection

This product is a clear, colorless liquid with no insoluble matter visible to the naked eye.

Indications of recombinant human thrombopoietin injection

1. This product is suitable for the treatment of thrombocytopenia caused by chemotherapy of solid tumors. It is suitable for patients whose platelets are lower than 50 × 10 9 / L and the doctor thinks it is necessary to increase platelet therapy.
2. This product is used for the adjuvant treatment of idiopathic thrombocytopenic purpura (ITP), and the applicable object is glucocorticoid treatment with platelets lower than 20 × 10 9 / L. Ineffective patients who have not received splenectomy. This product is only used for patients with thrombocytopenia and clinical risk of increased bleeding, and should not be used to try to increase the platelet count to a normal value.

Recombinant human thrombopoietin injection specifications

1.0ml per bottle.
7500 units / 1ml (7500U / 1ml),
15000 units / 1ml (15000U / 1ml).

Dosage and Administration of Recombinant Human Thrombopoietin Injection

This product should be used under the guidance of a clinician. The specific usage, dosage and course of treatment vary depending on the disease. The recommended dosage and method are as follows:
1. For chemotherapy of malignant solid tumors, when the dose of the drug is expected to cause thrombocytopenia and induce bleeding, and the platelet needs to be raised, this product can be injected subcutaneously at a dose of 300U per kilogram of body weight 6 to 24 hours after the end of administration. Once a day for 14 consecutive days; should be discontinued when the platelet count recovers to more than 100 × 10 9 / L or the absolute value of the platelet count increases 50 × 10 9 / L during the medication. This product can be used in combination with recombinant human granulocyte colony-stimulating factor (rhG-CSF) or recombinant human erythropoietin (rhEPO) when severe leukocyte reduction or anemia occurs during chemotherapy.
2. Idiopathic thrombocytopenic purpura (ITP) ineffective for glucocorticoid therapy (see related content under [Clinical Trials])
When glucocorticoid treatment is ineffective (including the scope covered by Article 2 of the above indications), this product can be injected subcutaneously at a dose of 300U per kg of body weight per day once daily for 14 consecutive days; if less than 14 days When the count has risen to 100 × 10 9 / L, stop using this product. If bleeding occurs in the mouth, nose, or internal organs, emergency treatment such as platelet transfusion, antifibrinolytic hemostatic drugs can be given.

Adverse reactions of recombinant human thrombopoietin injection

1. Fewer adverse reactions, occasional fever, muscle soreness, dizziness, etc., generally do not need to be treated, and can be recovered on their own. Individual symptoms can be treated symptomatically. There were no serious adverse reactions in this phase III clinical trial. Twelve of the 311 subjects (3.86%) had a total of 18 adverse reactions related to rhTPO medication, including 4 cases of fever, 2 cases of chills, 1 case of general discomfort, 2 cases of fatigue, and 2 knee pains. There were 2 cases of headache, 3 cases of dizziness, and 2 cases of elevated blood pressure. The symptoms were mostly mild and no special treatment was needed. Laboratory examination of rhTPO had no effect on the recovery of hemoglobin and white blood cell count after chemotherapy, and had no significant effect on platelet morphology, platelet aggregation function, coagulation function, liver and kidney organ functions. 74 patients received dynamic antibody detection during the treatment cycle, and 3 patients (4%) tested low-titer (1: 5) non-neutralizing anti-rhTPO antibodies in serum on days 21 and 28 after administration, No effect was found on rhTPO's effect on platelet elevation.
Adverse reactions related to rhTPO (311 cases tested)

2. RhTPO-related adverse reactions in clinical trials of ITP ineffective in glucocorticoid therapy were performed in a multicenter, randomized controlled trial (the experiment was divided into two phases: the first phase of treatment was 14 days, and the experimental group was given rhTPO + danazol, control The group was given danazol; the treatment file of the second-stage experimental group was unchanged; the platelet count in the control group was still 20 × 10 9 / L plus rhTPO treatment. A total of 138 subjects were included in the safety analysis set (test group 73 Cases, control group 65 cases), the incidence of adverse events in the experimental group and the control group were 34.25% and 26.15% during the experiment. A total of 122 subjects underwent rhTPO treatment in the two phases (73 in the test group and 49 in the control group), of which 4 were adverse events and 2 were in the control group (1 each for abnormal liver function and oral bleeding) ); 2 cases in the test group (1 case of II degree intracranial hemorrhage for 9 days of medication, 1 case of IV degree intracranial hemorrhage for 1 day of medication), and 1 case of death from bleeding in the test group.
The incidence of adverse events associated with rhTPO treatment among the 122 subjects receiving rhTPO treatment in the two study groups was 15.07% and 4.08%, respectively. Trial-related adverse events were 2 cases of mild drowsiness and 2 cases of mild dizziness. 1 case of severe paroxysmal visual field damage, 1 case of mild allergic reaction, 1 case of mild rash, 2 cases of mild weakness, and 1 case of mild diarrhea. There were 2 cases of mild hypertension and 2 cases of injection site pain. The adverse events related to the control group were moderate urticaria and mild lower extremity pain. rhTPO had no significant effect on changes in hemoglobin, white blood cell count, and coagulation function. RhTPO-related adverse reactions in clinical studies of glucocorticoid ineffective ITP (cases /%)

Taboo of recombinant human thrombopoietin injection

1. Those who are allergic to the ingredients of this product;
2. Patients with severe heart and cerebrovascular diseases;
3. Those who suffer from other hypercoagulable diseases and those who have recently suffered from thrombosis;
4. For patients with severe infection, this product should be controlled after infection.

Precautions for recombinant human thrombopoietin injection

1. Excessive application of this product or routine application to specific constitutions can cause excessive platelet elevation, which must be used in a tertiary hospital and under the guidance of an experienced clinician;
2. This product is used to treat thrombocytopenia caused by chemotherapy of solid tumors for patients whose platelets are below 50 * 10 9 / L and the doctor thinks that it is necessary to increase platelet therapy;
This product is effective for patients with idiopathic thrombocytopenic purpura (ITP) who are ineffective for glucocorticoid therapy. The target patients are patients with platelets lower than 20 * 10 9 / L or doctors think it is necessary to increase platelet therapy. Conditions or medications that may increase the risk of bleeding should also continue to be avoided.
3. Thrombocytopenia caused by body tumor chemotherapy should be used 6-24 hours after the end of chemotherapy;
4. The risk of bone marrow reticulum formation or bone marrow fibrosis; literature reports that similar preparations abroad (Nplate) can increase the risk of reticular fibrous deposition in the bone marrow. Clinical studies have not ruled out the risk of osteopenia associated with myelofibrosis. Careful examination of peripheral blood smears before applying this product to establish baseline levels of abnormal cell morphology. It is recommended to periodically check the peripheral blood smears and blood routines during application in order to detect new or abnormal cell morphology (such as teardrop shape and nucleated red blood cells, naive white blood cells or leukopenia). If the patient has the above situation, the treatment of this product should be discontinued and consider bone marrow aspiration, including fiber staining.
5. The worsening of thrombocytopenia after discontinuation of drug; literature of similar preparations abroad reports that thrombocytopenia may occur more severely after discontinuation than before treatment. The worsening of thrombocytopenia can increase the risk of bleeding in patients, especially when patients stop taking anticoagulants and antiplatelet drugs. This exacerbation of thrombocytopenia can be alleviated within 14 days. It is recommended that a routine blood test including platelet count be performed at least two weeks a week after discontinuation of the drug, and revised treatment options be considered in accordance with current treatment guidelines for exacerbated thrombocytopenia.
6. Concurrent thrombosis / thrombosis: Excessive increase in platelet count may lead to concurrent thrombosis / thrombosis. Excessive or incorrect use of this product may increase platelet counts to levels that can cause concurrent thrombosis / thrombosis. In order to minimize the risk of thrombosis / thromboembolism, the use of this product should not be attempted to achieve a normal platelet count.
7. Those who are responsive to the substrate or unable to maintain the platelet response should further look for predisposing factors, including neutralizing antibodies or bone marrow fibrosis of this product. If the platelet count is not elevated enough to avoid clinically severe bleeding, discontinue medication. Examination results of 74 patients (including ITP patients and tumor patients) in the clinical study of this product showed that 3 (4%, 3/74) had anti-TPO antibodies with a titer of 1: 5, and had no neutralizing effect.
8. Malignant tumors and malignant tumors worsen: The stimulation of TPO receptors on the surface of hematopoietic cells by this product may increase the risk of malignant hematological diseases. Except for the treatment of idiopathic thrombocytopenic purpura (ITP), which is ineffective for glucocorticoid therapy, this product is not used for the treatment of thrombocytopenia caused by spinal dysplasia syndrome (MDS) or other reasons.
9. The blood routine should be checked regularly during the use of this product, usually once every other day. Pay close attention to the changes in peripheral platelet count. When the platelet count reaches the required index, the drug should be discontinued in time. Monitor blood routines including platelet counts (peripheral blood smears) before, during and after follow-up. In the application of this product to check the peripheral blood classification, establish baseline levels of abnormal red blood cell and white blood cell morphology. Regularly check the blood routine, including platelet count. 4. The blood routine should be checked regularly during the use of this product, usually once every other day. Pay close attention to changes in the peripheral platelet count. When the platelet count reaches the required index, the drug should be promptly discontinued. Monitor regularly for at least two weeks after discontinuation.

Recombinant human thrombopoietin injection for pregnant and lactating women

The safety of medication for pregnant and lactating women has not been established, so it should not be applied in principle.

Recombinant human thrombopoietin injection for children

still not clear.

Recombinant human thrombopoietin injection for the elderly

still not clear.

Drug interactions of recombinant human thrombopoietin injection

still not clear.

Recombinant human thrombopoietin injection drug overdose

According to foreign literature reports, excessive use of this product can cause an excessive increase in platelet counts and lead to concurrent thrombosis / thrombosis. In this case, discontinue this product and test the platelet count.

Clinical trial of recombinant human thrombopoietin injection

1. Phase I clinical research. Phase I 27 normal people received a single subcutaneous injection tolerance test. The doses were 75U / kg, 150U / kg, 300U / kg, and 600U / kg in 4 groups. The number of cases in each group. They are 3, 6, 9, and 9 respectively. A single subcutaneous injection of rhTPO has a dose-dependent platelet-raising effect. At a dose of 150U / kg ~ 600U / kg, the average increase is 24% -52% compared with that before administration, and individual subjects increase 100%. The platelet count rose to a peak on the 10th to 14th day after the administration, and dropped back to the pre-dose level on the 21st day after the administration. One case had transient hypothermia and fatigue, and one case had drowsiness, which all subsided naturally. One case had a transient elevation of ALT and AST, which returned to normal after one week. Seven patients with stage I hematological tumors underwent a continuous subcutaneous injection tolerance test at a dose of 300 U / kg once a day for 7 to 14 consecutive days. The subject's platelet count increased to varying degrees, reaching a peak on the 14th to 28th days after the start of administration. One subject developed right tibia pain on the 7th day of administration, and the pain eased after two days of symptomatic treatment. No further pain occurred during subsequent administration. One case had a transient increase in ALT and AST, and returned to normal after one week. .
2. A phase II clinical study of 62 patients with solid tumors undergoing chemotherapy using a randomized cross-control method. The treatment cycle was subcutaneously injected with rhTPO 300U / kg 6 to 24 hours after the end of chemotherapy, once a day for 7 to 14 days. The control cycle After chemotherapy, rhTPO was not injected as a self-control. The lowest values of platelet reduction after chemotherapy in the treatment cycle and control cycle were 61 ± 51 × 10 9 / L and 48 ± 35 × 10 9 / L (P <0.05), and the highest values after platelet count recovery after chemotherapy were 260 ± 164 × 10 9 / L and 152 ± 81 × 10 9 / L (P <0.001). The median days of platelet recovery to 75 × 109 / L after chemotherapy were 14 days and 18 days (P <0.001). The adverse reactions of rhTPO were few and slight. Two patients had adverse reactions related to rhTPO, which showed fever after administration, up to 38.8 ° C, which could subside naturally or return to normal temperature after the administration. rhTPO had no effect on the recovery of hemoglobin, red blood cell count, and white blood cell count after chemotherapy, and had no significant effect on platelet shape, platelet aggregation function, and functions of liver and kidney organs. Seven patients received dynamic detection of anti-rhTPO antibodies during the medication cycle, and one patient detected low titer (1: 5) antibodies in serum on day 14 after rhTPO administration, and no effect was found on rhTPO's platelet-elevating effect. .
3. Phase III clinical study Among 311 subjects in a multi-center phase III clinical trial, 92 patients with solid tumors with reduced lamina after chemotherapy received a randomized crossover self-control method. The treatment cycle was 6 to 24 hours after the end of chemotherapy. Subcutaneous injection of rhTPO 300U / kg once daily for 7 to 14 days. RhTPO was not injected as a control in the control cycle of chemotherapy. The lowest values of platelet reduction after chemotherapy in the treatment and control cycles were 66 ± 41 × 10 9 / L and 55 ± 27 × 10 9 / L (P [0.001), and the highest values after platelet count recovery after chemotherapy were 266 ± 126 × 10 9 / L and 146 ± 56 × 10 9 / L (P <0.001). The median days after platelet recovery to 75 × 10 9 / L after chemotherapy were 11 days and 16 days (P [0.001). The results show that rhTPO can significantly increase platelet count, reduce the minimum value of platelet decline, and accelerate the recovery of platelet count when platelet reduction after chemotherapy. In 92 patients with solid tumors, 42 patients had a significant decrease in platelets after chemotherapy in the control cycle (less than 50 × 10 9 / L). The statistical results of this group showed that the lowest median platelet decrease after chemotherapy in the treatment cycle and the control cycle 50 × 10 9 / L and 32 × 10 9 / L (P [0.001), and the highest values after platelet count recovery after chemotherapy were 204 × 10 9 / L and 114 × 10 9 / L (P <0.001) ), The median platelets below 50 × 10 9 / L after chemotherapy were 1 day and 6 days, respectively (P [0.001). For related adverse reactions in the phase III clinical trial, see [Adverse Reactions].

4. Clinical study of idiopathic thrombocytopenic purpura (ITP) ineffective in glucocorticoid therapy. A total of 140 subjects were included in a multicenter, randomized, open-label controlled trial. Patients who failed glucocorticoid therapy (platelet count) 20 * 10 9 / L) stratified and randomized according to whether or not they had received splenectomy. The experiment was divided into two phases; the first 14 days were the first phase, and the test group (rhTPO + danazol) rhTPO 1.0ug / kg (300U / kg) was injected subcutaneously once a day for 14 days. The control group (danazol) can be treated with rhTPO in the second stage if the platelet count is still 20 * 10 9 / L after the first stage of treatment (14 days after the start of the test). The dose and method are the same as those in the test group. The results show that according to the effective criteria in the ITP efficacy judgment standard formulated by the Second National Hematological Conference (ie, "significant effect plus effective, that is, platelets rose above 50 * 10 9 / L or increased by 30 * 10 9 / L compared with the original level, No or almost no bleeding symptoms "), the first stage (within 14 days of the start of the trial), rhTPO treatment in the experimental group achieved significant results (platelet rose to 100 * 10 9 / L) accounted for 38.36%, significantly higher than the control group 7.94% (P = 0.0002). Those who achieved good results in the test group (platelet rose to 50 * 10 9 / L or 30 * 10 9 / L above the original level) was 21.92%, which was equivalent to the control group (28.57%). The recent effective rate (significant effect + good effect) of the experimental group reached 60.27%, which was significantly higher than the control group of 36.51% (P = 0.0104)
Other indicators showed that the highest platelet count in the test group was 113.73 ± 155.26 (* 10 9 / L), and the elevated value (highest value-baseline value) was 101.23 ± 155.81 (* 10 9 / L), which were significantly higher than the control The group was 43.78 ± 55.67 (* 10 [sup] 9 [/ sup] / L) and 33.31 ± 55.54 (* 10 9 / L) (p = 0.0000). The effective time for 25% of patients in the test group was 7 days, and the control group was 10 days.
Subgroup analysis showed that the effective rate of the test group was 57.81% in subjects who did not receive splenectomy (FAS set 64.55) and 32.37% in the control group. There was a significant difference between the two groups. Subjects received splenectomy (FAS set 8: 9) The number of cases is too small to evaluate. For subjects whose limit is less than 10 * 10 [sup] 9 [/ sup] / L, the experimental group effective rate (FAS) is 54.05% (20/37), and the control group is 41.67% (5/12). The differences were not statistically significant.
Please refer to [Adverse Reactions] section for rhTPO related adverse reactions in clinical trials.

Pharmacology and Toxicology of Recombinant Human Thrombopoietin Injection

1. Pharmacological thrombopoietin (TPO) is an endogenous cytokine that stimulates the growth and differentiation of megakaryocytes. It has a stimulating effect on all stages of megakaryocyte production, including the proliferation of precursor cells and polyploid megakaryocytes. Development and maturation, thereby increasing platelet numbers. Recombinant human thrombopoietin (rhTPO) is a full-length glycosylated thrombopoietin expressed from Chinese hamster ovary cells and purified by genetic recombination technology. It has similar platelet pharmacological effects to endogenous thrombopoietin. .
After a large dose of 60Co g-rays was irradiated into the macaque monkeys to cause a bone marrow suppression model, rhTPO 150U / Kg, 600 U / Kg and human serum albumin 20mg / Kg were injected subcutaneously, once a day for 20 consecutive days. The experimental results show that rhTPO increases the average platelet count in the trough phase, shortens the time at which the platelet count is at a low value, and increases the peripheral platelet aggregation rate in the bone marrow suppression trough phase. The minimum effective dose is 150 U / Kg per day.
Balb / c mice were injected with carboplatin 150mg / kg intraperitoneally to cause a thrombocytopenia model. RhTPO 1.1 × 102U, 1.1 × 103U, 1.1 × 104U / kg and normal saline were administered intraperitoneally, and rhTPO 1.1 was administered continuously continuously Each dose group above × 103U / kg can significantly slow down the decrease of platelet count caused by carboplatin.
The addition of rhTPO to HEL and DAMI cell lines with megakaryocyte antigen expression and normal human bone marrow cells can specifically increase the expression of CD41 antigen in megakaryocytes and normal human bone marrow mononuclear cells, and promote megakaryocyte colonies (CFU -Meg) formation.
2. Toxicology (1) Acute toxicity: rhTPO 1.35 × 105U / kg and 2.25 × 105U / kg (corresponding to 900 and 1500 times the clinically recommended dose) were given to rats and mice by slow injection in the tail vein, respectively. There was no toxic reaction or death in the animals immediately after and within 14 days. Visceral histopathological examination showed no abnormalities. In addition, rats and mice were subcutaneously injected with rhTPO at 1.8 × 105 U / kg and 4.5 × 105 U / kg (equivalent to clinically recommended doses of 1200 and 3000 times), and the animals had no significant toxic reaction after administration. No toxicity and death were observed in the animals for 14 days. Histopathological examination showed no abnormalities in all major organs.
(2) Chronic toxicity: Wistar rats were subcutaneously injected with rhTPO for 35 consecutive days at doses of 1.5 × 104U / kg, 7.5 × 103U / kg and 1.5 × 103U / kg (respectively equivalent to 100 times and 50 times the clinically recommended dose And 10 times), the two control groups were injected with 0.5% human albumin and saline, respectively. The general condition of rats, feed utilization, white blood cell classification, clotting time, urine routine and pathological examination showed that there was no significant difference between rhTPO groups and control groups at different time points. After three weeks of administration, the total number of peripheral platelets continued to decrease significantly with the increase in the number of weeks of administration, and the decrease was more significant in the high-dose group. The recovery of megakaryocytes in the bone marrow of the high and medium dose groups was slow. This shows that the high- and medium-dose groups have significant cumulative toxicity after two weeks of administration. In the low-dose group, accumulated toxicity occurred after four weeks of administration, but the drug was restored to its pre-dose level after two weeks of discontinuation, and the bone marrow megakaryocyte system also returned to normal. rhTPO 1.5 × 103U / kg should be regarded as a dose with no significant toxic and side effects when administered subcutaneously in rats.
24 cats were subcutaneously injected with rhTPO 9 × 102U / kg, 1.8 × 103U / kg, 5.4 × 103U / kg (corresponding to 6 times, 12 times, 36 times the clinically recommended dosage), 0.5% human albumin, Normal saline, 30 days after administration to 28 days after withdrawal, observations showed that the general conditions of male and female aging, appetite, weight, body temperature, serum ten biochemical and urine ten tests, electrocardiogram and pathological histology were not obvious in each group difference. Among them, the medium and high dose administration for 30 days caused the macaque monkey to increase sharply from the total number of peripheral platelets in the early period of administration to the rapid decrease of the total number of platelets after administration, and the total number of platelets recovered slowly. It is shown that large-dose, long-term continuous administration can cause platelet formation disorder in megakaryocytic system after promoting rapid platelet production. The low-dose group did not produce significant cumulative toxicity to rhesus monkeys for 30 days. rhTPO 9 × 102U / kg should be regarded as a dose that has no obvious toxic and side effects on ruminants.
(3) Mutagenic toxicity: rhTPO has no effect on the increase of micronucleus rate in bone marrow polychromatic red blood cells of NIH mice. RhTPO 3 × 103U, 1.5 × 103U, 7.5 × 102U, 3.8 × 102U, 1.9 × 102U did not induce mutations in Salmonella typhimurium. rhTPO has no chromosome aberration effect on human diploid cells at a dose of 2.4 × 104 U / ml. This product is negative in routine micronucleus test, Ames test and chromosome test.

Pharmacokinetics of recombinant human thrombopoietin injection

A single subcutaneous injection of rhTPO in pharmacokinetics of normal people: The subjects were randomly divided into three dose groups of 150U / kg, 300U / kg, and 600U / kg, with 8 cases in each group and 24 cases in total. The linear kinetic characteristics were basically consistent with the elimination process. The T 1 / 2Ka of the three dose groups were 2.5 ± 1.1h, 3.2 ± 2.6h, and 4.2 ± 2.4h, and the Tmax was 9.0 ± 1.9h, 10.8 ± 2.4h, and 11.8. ± 5.4h. The elimination of rhTPO is slow and the half-life in vivo is long. The elimination half-lives of the three dose groups were similar, being 46.3 ± 6.9h, 40.2 ± 9.4h, and 38.7 ± 11.9h.
Pharmacokinetics of multiple subcutaneous injections of rhTPO: 8 patients were divided into alternate-day administration groups (subcutaneous injection of rhTPO 1.0 mg / kg every other day, equivalent to 300 U / kg for 7 times) and daily administration groups (daily subcutaneous 1.0 mg / kg rhTPO was injected, equivalent to 300 U / kg, 14 times in total) in two groups, 4 cases in each group. With the increase of the number of administrations, the blood concentration of each subject increased accordingly. The trough concentration (Cmin) of the alternate-day administration group and the daily administration group reached steady state after 5 and 7 administrations, respectively. The horizontal and steady state Cmin were 1637 ± 969pg / ml and 2096 ± 1736pg / ml, respectively. The change trend of the peak concentration (Cmax) of the two groups was similar to the trough concentration. The steady-state peak Cmax was 2135 ± 1095 pg / ml and 4193 ± 3436 pg / ml, respectively. The pharmacokinetic parameters such as AUC and Tpeak and t1 / 2 of each subject after the first administration were not significantly different from those after the last administration, that is, there was no time-dependent pharmacokinetic change. With multiple subcutaneous injections of rhTPO, the elevated plasma concentration is positively correlated with the cumulative dose administered. Within 14 doses, the drug has no tendency to accumulate in the body.

Storage of recombinant human thrombopoietin injection

Store at 2 ~ 8 , protected from light.

Recombinant human thrombopoietin injection packaging

1 bottle, Xilin bottle.

Expiry date of recombinant human thrombopoietin injection

36 months

Standard for Recombinant Human Thrombopoietin Injection

WS4- (S-024) -2010Z [1]

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