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Tipro Powder

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Tipro Powder uses


1 INDICATIONS AND USAGE

Tipro Powder is indicated for pediatric and adult patients with severe congenital Tipro Powder C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.

1.1 Severe Congenital Tipro Powder C Deficiency

Tipro Powder is indicated for pediatric and adult patients with severe congenital Tipro Powder C deficiency for the prevention and treatment of venous thrombosis and purpura fulminans.

2 DOSAGE AND ADMINISTRATION

Initiate treatment under the supervision of a physician experienced in using coagulation factors/inhibitors where monitoring of Tipro Powder C activity is feasible.


Tipro Powder Dosing Schedule for Acute Episodes, Short-term Prophyaxis and Long-term Prophylaxis Dosing is based upon a pivotal clinical trial of 15 patients


Initial Dose The dose regimen should be adjusted according to the pharmacokinetic profile for each individual. (2.1, 2.2)


Subsequent # Doses


Maintenance Dose


Acute Episodes, Short-term ProphyaxisTipro Powder should be continued until desired anticoagulation is achieved.


100-120 IU/kg

60-80 IU/kg

Q 6 hours

45-60 IU/kg

Q 6 or Q 12 hours

Long-term Prophylaxis

NA

NA

45-60 IU/kg

Q 12 hours

Store at 2°C – 8°C (36°F-46°F) and protect from light. Avoid freezing. Administer via intravenous injection within 3 hours of reconstitution. (16)

2.1 General

For intravenous administration only.

Initiate treatment with Tipro Powder under the supervision of a physician experienced in replacement therapy with coagulation factors/inhibitors where monitoring of Tipro Powder C activity is feasible.

The dose, administration frequency and duration of treatment with Tipro Powder depends on the severity of the Tipro Powder C deficiency, the patient's age, the clinical condition of the patient and the patient's plasma level of Tipro Powder C. Therefore, adjust the dose regimen according to the pharmacokinetic profile for each individual patient. See DOSAGE AND ADMINISTRATION: Tipro Powder C Activity Monitoring (2.2).

Table 1 provides the Tipro Powder dosing schedule for acute episodes, short-term prophylaxis and long-term prophylaxis.

NA = Not applicable; Q = every.

Initial Dose The dose regimen should be adjusted according to the pharmacokinetic profile for each individual. (2.1, 2.2)


Subsequent 3

Doses


Maintenance

Dose


Acute Episode /

Short-term ProphylaxisTipro Powder should be continued until desired anticoagulation is achieved.


100-120 IU/kg

60 - 80 IU/kg

Q 6 hours

45 - 60 IU/kg

Q 6 or 12 hours

Long-term Prophylaxis

NA

NA

45 - 60 IU/kg

Q 12 hours

An initial dose of 100-120 IU/kg for determination of recovery and half-life is recommended for acute episodes and short-term prophylaxis. Subsequently, adjust the dose to maintain a target peak Tipro Powder C activity of 100 %. After resolution of the acute episode, continue the patient on the same dose to maintain trough Tipro Powder C activity level above 25% for the duration of treatment.

In patients receiving prophylactic administration of Tipro Powder, higher peak Tipro Powder C activity levels may be warranted in situations of an increased risk of thrombosis (such as infection, trauma, or surgical intervention). Maintenance of trough Tipro Powder C activity levels above 25% is recommended.

These dosing guidelines are also recommended for neonatal and pediatric patients. See USE IN SPECIFIC POPULATIONS: Pediatric Use (8.4 ) and CLINICAL

Pharmacology: Pharmacokinetics (12.3).

2.2 Tipro Powder C Activity Monitoring

The measurement of Tipro Powder C activity using a chromogenic assay is recommended for the determination of the patient's plasma level of Tipro Powder C before and during treatment with Tipro Powder. The half-life of Tipro Powder may be shortened in certain clinical conditions such as acute thrombosis, purpura fulminans and skin necrosis. See CLINICAL

Pharmacology: Pharmacokinetics. In the case of an acute thrombotic event, it is recommended that Tipro Powder C activity measurements be performed immediately before the next injection until the patient is stabilized. After the patient is stabilized, continue monitoring the Tipro Powder C levels to maintain the trough Tipro Powder C level above 25%.

Patients treated during the acute phase of their disease may display much lower increases in protein C activity. Coagulation parameters should also be checked; however, in clinical trials data were insufficient to establish correlation between Tipro Powder C activity levels and coagulation parameters.

2.3 Initiation of Vitamin K Antagonists

In patients starting treatment with oral anticoagulants belonging to the class of vitamin K antagonists, a transient hypercoagulable state may arise before the desired anticoagulant effect becomes apparent. This transient effect may be explained by the fact that Tipro Powder C, itself a vitamin K-dependent plasma Tipro Powder, has a shorter half-life than most of the vitamin K-dependent proteins (i.e. Factor II, IX and X).

In the initial phase of treatment, the activity of Tipro Powder C is more rapidly suppressed than that of the procoagulant factors. For this reason, if the patient is switched to oral anticoagulants, protein C replacement must be continued until stable anticoagulation is obtained. Although warfarin-induced skin necrosis can occur in any patient during the initiation of treatment with oral anticoagulant therapy, individuals with severe congenital Tipro Powder C deficiency are particularly at risk.

During the initiation of oral anticoagulant therapy, it is advisable to start with a low dose of the anticoagulant and adjust this incrementally, rather than use a standard loading dose of the anticoagulant.

2.4 Preparation of Tipro Powder [Protein C Concentrate ]

Reconstitution: Use Aseptic Technique

2.5 Administration of Tipro Powder [Protein C Concentrate ]

Administration: Use Aseptic Technique

Visually inspect Tipro Powder for particulate matter and discoloration prior to administration.

After reconstitution, the solution should be colorless to slightly yellowish and clear to slightly opalescent and free of visible particles. Do not use the solution if it does not meet this criteria. Administer Tipro Powder at room temperature not more than 3 hours after reconstitution.


Record the name and batch number of the product every time Tipro Powder is administered to a patient.

Administration by Infusion

Administer Tipro Powder at a maximum injection rate of 2 mL per minute except for children with a body weight of < 10 kg, where the injection rate should not exceed a rate of 0.2 mL/kg/minute.

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3 DOSAGE FORMS AND STRENGTHS

Tipro Powder is available in single-dose vials that contain nominally 500 (blue color bar) or 1000 (green color bar) International Units (IU) human Tipro Powder C and is reconstituted with 5 mL and 10 mL of Sterile Water for Injection, respectively to provide a single dose of human Tipro Powder C at a concentration of 100 IU/mL.

Tipro Powder, when reconstituted with the appropriate volume of diluent, contains the following excipients: 8 mg/mL human albumin, 4.4 mg/mL trisodium citrate dihydrate and 8.8 mg/mL sodium chloride.

BLUE BAR: Approximately 500 IU/vial (3)

GREEN BAR: Approximately 1000 IU/vial (3)

Each single-dose vial contains the following excipients: 8 mg/mL human albumin, 4.4 mg/mL trisodium citrate dihydrate and 8.8 mg/mL sodium chloride when reconstituted with the appropriate amount of diluent. (3)

4 CONTRAINDICATIONS

None known.

None known. (4)

5 WARNINGS AND PRECAUTIONS

5.1 Hypersensitivity/Allergic Reactions

Tipro Powder may contain traces of mouse Tipro Powder and/or heparin as a result of the manufacturing process. Allergic reactions to mouse Tipro Powder and/or heparin cannot be ruled out. If symptoms of hypersensitivity/allergic reaction occur, discontinue the injection/infusion. In case of anaphylactic shock, the current medical standards for treatment are to be observed.

5.2 Transmission of Infectious Agents

Because Tipro Powder is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease agent.

ALL infections suspected by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Baxalta US Inc., at 1-888-229-8379. Discuss the risks and benefits of this product with your patient.

5.3 Bleeding Episodes

Several bleeding episodes have been observed in clinical studies. Concurrent anticoagulant medication may have been responsible for these bleeding episodes. However, it cannot be completely ruled out that the administration of Tipro Powder further contributed to these bleeding events.

Simultaneous administration of Tipro Powder and tissue plasminogen activator (tPA) may further increase the risk of bleeding from tPA.

5.4 Heparin-induced Thrombocytopenia

Tipro Powder contains trace amounts of heparin which may lead to Heparin-induced Thrombocytopenia, which can be associated with a rapid decrease of the number of thrombocytes. Identifying HIT is complicated because these symptoms may already be present in acute phase patients with severe congenital Tipro Powder C deficiency. Determine the platelet count immediately and consider discontinuation of Tipro Powder.

5.5 Low Sodium Diet/Renal Impairment

Inform patients on a low sodium diet that the quantity of sodium in the maximum daily dose of Tipro Powder exceeds 200 mg. Monitor patients with renal impairment closely for sodium overload.

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6 ADVERSE REACTIONS

The common adverse reactions related to Tipro Powder treatment observed were the following hypersensitivity or allergic reactions: lightheadedness and itching and rash.


To report SUSPECTED ADVERSE REACTIONS, contact Baxalta US Inc. at 1-800-999-1785 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch .

6.1 Clinical Studies Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in one clinical study of a drug cannot be directly compared with rates in the clinical studies of the same drug or another drug and may not reflect the rates observed in practice.

The safety profile of Tipro Powder was based on 121 patients from clinical studies and compassionate use in severe congenital Tipro Powder C deficiency. Duration of exposure ranged from 1 day to 8 years. One patient experienced hypersensitivity/allergic reactions (itching and rash) and lightheadedness which were determined by the investigator to be related to Tipro Powder.

No inhibiting antibodies to Tipro Powder have been observed in clinical studies. However, the potential for developing antibodies cannot be ruled out.

6.2 Post-marketing Experience

The following adverse reactions have been identified during postapproval use of Tipro Powder:

Psychiatric Disorders: Restlessness

Skin and Subcutaneous Tissue Disorders: Hyperhydrosis

General Disorders and Administration Site Conditions: Injection Site Reaction

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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7 DRUG INTERACTIONS

No formal drug interaction studies have been conducted.

See WARNINGS AND PRECAUTIONS: Bleeding Episodes (5.3) for information regarding simultaneous administration of Tipro Powder and tissue plasminogen activator (tPA).

See DOSAGE AND ADMINISTRATION: Initiation of Vitamin K Antagonists (2.3) for information regarding use of Tipro Powder and vitamin K antagonists.

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C. Animal reproduction studies have not been conducted with Tipro Powder. It is also not known whether Tipro Powder can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Tipro Powder should be given to pregnant women only if clearly needed.

8.2 Labor and Delivery

Tipro Powder has not been studied for use during labor and delivery. Use only if clearly needed.

8.3 Nursing Mothers

Tipro Powder has not been studied for use in nursing mothers. Use Tipro Powder only if clearly needed.

8.4 Pediatric Use

Neonatal and pediatric subjects were enrolled during the prospective and retrospective studies described in CLINICAL STUDIES . Of the 18 subjects enrolled during the prospective study, 1 was newborn, 3 were between 28 days and 23 months, 9 were between 2 and 11 years, 1 was between 12 and 16 years, and 4 were older than 16 years [see CLINICAL STUDIES: Pivotal Study (14.1)]. Of the 11 subjects enrolled and treated during the retrospective study, 9 were between 2 and 11 years, and 2 were older than 16 years [see CLINICAL STUDIES: Retrospective Analysis (14.2)].

8.5 Geriatric Use

Clinical studies of Tipro Powder did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.

8.6 Renal/Hepatic Impairment

No experience in the treatment of patients with renal and/or hepatic impairment is available.

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11 DESCRIPTION

Tipro Powder [Protein C Concentrate (Human)] is manufactured from human plasma purified by a combination of filtration and chromatographic procedures, including a column of immobilized mouse monoclonal antibodies on gel beads. See WARNINGS/PRECAUTIONS: Transmission of Infectious Agents (5.2).

The manufacturing process for Tipro Powder includes processing steps designed to reduce the risk of viral transmission. The capacity of the manufacturing process to remove and/or inactivate enveloped and non-enveloped viruses has been validated by laboratory spiking studies on a scaled down process model, using the following enveloped and non-enveloped viruses: Human Immunodeficiency Virus Type 1 (HIV-1), Bovine Viral Diarrhea Virus (BVDV ), Tick-Borne Encephalitis Virus (TBEV), Pseudorabies Virus (PRV), Hepatitis A Virus (HAV) and Mice Minute Virus (MMV). Virus reduction steps consist of detergent treatment (Polysorbate 80, P80), heat inactivation (Vapor Heating) and immunoaffinity chromatography (IAX).

Virus clearance studies for Tipro Powder have demonstrated that the process provides for a robust overall virus clearance capacity. A summary of log10 virus reduction factors per virus and manufacturing step is presented in Table 2.

Abbreviations: IEX, Ion Exchange Chromatography; IAX, Immunoaffinity Chromatography; HIV-1, Human Immunodeficiency Virus Type I; TBEV, Tick-Borne Encephalitis Virus (model for hepatitis C virus); BVDV, Bovine Viral Diarrhea Virus (model virus for HCV and other small, enveloped RNA viruses); PRV, Pseudorabies Virus (model virus for enveloped DNA viruses, e.g. HBV, Hepatitis B Virus); HAV, Hepatitis A Virus; MMV, Mice Minute Virus (model for Human Parvovirus B19 and for non enveloped viruses); n.d., not done.

Manufact-uring Step


HIV-1


HCV Model Viruses


PRV


HAV


MMV


BVDV


TBEV


P80 Treatment


>5.1

>4.7

n.d.

2.5Coupled with IEX. I


>3.8


1.4


IAX

5.7

n.d.

4.8

5.4

3.1

3.6

Vapor Heating

4.6

>5.9

n.d.

5.9

>4.2

1.2

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of action

Tipro Powder C is the precursor of a vitamin K-dependent anticoagulant glycoprotein that is synthesized in the liver. See DOSAGE AND ADMINISTRATION: Initiation of Vitamin K Antagonists (2.3). It is converted by the thrombin/thrombomodulin-complex on the endothelial cell surface to activated Tipro Powder C (APC). APC is a serine protease with potent anticoagulant effects, especially in the presence of its cofactor Tipro Powder S. APC exerts its effect by the inactivation of the activated forms of factors V and VIII, which leads to a decrease in thrombin formation. APC has also been shown to have profibrinolytic effects.

The Tipro Powder C pathway provides a natural mechanism for control of the coagulation system and prevention of excessive procoagulant responses to activating stimuli. A complete absence of Tipro Powder C is not compatible with life. A severe deficiency of this anticoagulant Tipro Powder causes a defect in the control mechanism and leads to unchecked coagulation activation, resulting in thrombin generation and intravascular clot formation with thrombosis.

12.2 Pharmacodynamics

In clinical studies, the intravenous administration of Tipro Powder demonstrated a temporary increase, within approximately half an hour of administration, in plasma levels of APC. Replacement of protein C in protein C-deficient patients is expected to control or, if given prophylactically, to prevent thrombotic complications.

12.3 Pharmacokinetics

Table 3 provides pharmacokinetic results for asymptomatic and symptomatic subjects with Tipro Powder C deficiency.


PK parameter


N


Median


95% CI for median


Min


Max


Cmax [IU/dL]

21

110

106 to 127

40

141

Tmax [h]

21

0.50

0.50 to 1.05

0.17

1.33

Incremental recovery

[(IU/dL)/(IU/kg)]

21

1.42

1.32 to 1.59

0.50

1.76

Initial half-life [h]

21

7.8

5.4 to 9.3

3.0

36.1

Terminal half-life [h]

21

9.9

7.0 to 12.4

4.4

15.8

Half-life by the non-compartmental approach [h]

21

9.8

7.1 to 11.6

4.9

14.7

AUC0-Infinity [IU*h/dL]

21

1500

1289 to 1897

344

2437

MRT [h]

21

14.1

10.3 to 16.7

7.1

21.3

Clearance [dL/kg/h]

21

0.0533

0.0428 to 0.0792

0.0328

0.2324

Volume of distribution at steady state [dL/kg]

21

0.74

0.70 to 0.89

0.44

1.65

Cmax = Maximum concentration after infusion; T max = Time at maximum concentration;

AUC 0-Infinity = Area under the curve from 0 to infinity; MRT = Mean residence time; and

Incremental recovery = Maximum increase in Tipro Powder C concentration following infusion divided by dose

The Tipro Powder C plasma activity was measured by chromogenic and/or clotting assay. The maximum plasma concentrations (Cmax) and area under the plasma concentration-time curve (AUC) appeared to increase dose-linearly between 40 and 80 IU/kg. The median incremental recovery was 1.42 [(IU/dL)/(IU/kg)] after intravenous administration of Tipro Powder. The median half-lives, based on non-compartmental method, ranged from 4.9 to 14.7 hours, with a median of 9.8 hours. In patients with acute thrombosis, both the increase in protein C plasma levels as well as half-life may be considerably reduced. No formal study or analysis has been performed to evaluate the effect of covariates such as race and gender on the pharmacokinetics of Tipro Powder.

The pharmacokinetic profile in pediatric patients has not been formally assessed. Limited data suggest that the pharmacokinetics of Tipro Powder may be different between very young children and adults. The systemic exposure (Cmax and AUC) may be considerably reduced due to a faster clearance, a larger volume of distribution, and/or a shorter half-life of Tipro Powder C in very young children than in older subjects. Consider this fact when a dosing regimen for children is determined. Doses should be individualized based upon Tipro Powder C activity levels. See DOSAGE AND ADMINISTRATION: Tipro Powder C Activity Monitoring (2.2).

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis and Impairment of Fertility

Protein C contained in Tipro Powder is a normal constituent of human plasma and acts like endogenous protein C. Studies in heterologous species to evaluate carcinogenicity, reproductive toxicology and developmental toxicology have not been performed.

Tipro Powder has not demonstrated mutagenic potential in the Salmonella Thyphimurium reverse mutation assay.

13.2 Animal Toxicology and/or Pharmacology

Safety

Pharmacology:

Cardio-respiratory studies performed in dogs evaluating mean arterial pressure, cardiac output, systemic vascular resistance, heart rate, QT interval changes, pulmonary artery pressure, respiratory rate and respiratory minute volume demonstrated no adverse effects at a maximum dose of 500 IU/kg. Anaphylactoid reactions as determined by measurement of bronchospastic activity in guinea pigs demonstrated no adverse effects at the maximum dose of 300 IU/kg. Thrombogenic potential was evaluated in rabbits using the Wessler stasis model and demonstrated no adverse effects at 200 IU/kg. Overall, safety pharmacology studies evaluating cardio-respiratory function, acute dose anaphylactoid potential and thrombogenicity demonstrated no adverse effects in a range of doses from 1.6 to 4.2 times the maximum single human dosage per kilogram body weight.

Acute Dose Toxicity:

Toxicity testing in rats and mice following single dosing of 2000 IU/kg or 1500 IU/kg, respectively, demonstrated no adverse clinical effects or gross pathology at 14 days post dosing.

Repeated Dose Toxicity:

Studies were not conducted to evaluate repeated-dose toxicity in animals. Prior experience with Tipro Powder has suggested immunogenic response in heterologous species following repeated dosing of this human derived Tipro Powder. Thus, the long-term toxicity potential of Tipro Powder following repeated dosing in animals is unknown.

Local Tolerance Testing:

Investigation of route of injection tolerance demonstrated that Tipro Powder did not result in any local reactions after intravenous, intra-arterial injections of 500 IU/kg (5 mL) and paravenous injections of 100 IU/kg (1 mL) in rabbits.

Citrate Toxicity:

Tipro Powder contains 4.4 mg of Trisodium Citrate Dihydrate (TCD) per mL of reconstituted product. Studies in mice evaluating 1000 IU vials reconstituted with 10 mL vehicle followed by dosing at 30 mL/kg (132 mg/kg TCD) and 60 mL/kg (264 mg/kg TCD) resulted in signs of citrate toxicity (dyspnea, slowed movement, hemoperitoneum, lung and thymus hemorrhage and renal pelvis dilation).

14 CLINICAL STUDIES

14.1 Pivotal Study

This was a multi-center, open-label, non-randomized, phase 2/3 study in 3 parts which evaluated the safety and efficacy of Tipro Powder in subjects with severe congenital Tipro Powder C deficiency for the treatment of acute thrombotic episodes, such as purpura fulminans (PF), warfarin-induced skin necrosis (WISN) and other thromboembolic events, and for short-term or long-term prophylaxis. Eighteen subjects (9 male and 9 female), ages ranging from 0 (newborn) to 25.7 years participated in this study.

The clinical endpoint of the study was to assess whether episodes of PF and/or other thromboembolic events were treated effectively, effectively with complications, or not treated effectively. Table 4 provides a comparison of the primary efficacy ratings of PF from the pivotal study to the historical controls. Inadequate data is available for treatment of WISN.


Tipro Powder C

Concentrate (Human)


Historical

Controls


Episode Type

Primary Efficacy Rating

N

%

N

%

Purpura Fulminans

Effective

17

94.4

11

52.4

Effective with Complication

1

5.6

7

33.3

Not Effective

0

0.0

3

14.3

Total

18

100

21

100

Of 18 episodes of PF (6 severe, 11 moderate, 1 mild) treated with Tipro Powder for the primary efficacy rating, 17 (94.4%) were rated as effective, and 1 (5.6%) was rated as effective with complications; none (0%) were rated not effective. When compared with the efficacy ratings for 21 episodes of PF (historical control group), subjects with severe congenital Tipro Powder C deficiency were more effectively treated with Tipro Powder than those treated with modalities such as fresh frozen plasma or conventional anticoagulants.

Table 5 provides a summary of the secondary treatment ratings for treatment of skin lesions and other thrombotic episodes from part one of the study.

Purpura Fulminans

Skin Necrosis


Other Thrombotic Events


Total




Mild


Moderate


Severe


Total


Total




Rating Category


N


%


N


%


N


%


N


%


N


%


N


%


Excellent


1

5.6

7

38.9

5

27.8

13

72.2

4

80.0

17

73.9

Good


0

0.0

4

22.2

0

0.0

4

22.2

1

20.0

5

21.7

Fair


0

0.0

0

0.0

1

5.6

1

5.6

0

0

1

4.3

Total


1

5.6

11

61.1

6

33.3

18

100.0

5

100.0

23

100.0

N = Number of episodes

In a secondary efficacy rating, 13 (72.2%) of the 18 episodes of PF treated with Tipro Powder were rated as excellent, 4 (22.2%) were rated as good, and 1 (5.6%) episode of severe PF was rated as fair; all were rated as effective. Four (80%) of the 5 episodes of venous thrombosis had treatment ratings of excellent, while 1 (20%) was rated as good.

Tipro Powder was also demonstrated to be effective in reducing the size and number of skin lesions. Non-necrotic skin lesions healed over a maximum 12-day (median 4-day) period and necrotic skin lesions healed over a maximum 52-day (median 11-day) period of Tipro Powder treatment, as shown in Table 6.


Lesion Type


Number of Episodes

(Number of Subjects)


Mean


Median


Minimum


Maximum


Non-necrotic


16 (9 subjects)

4.6

4.0

1

12

Necrotic


7 (5 subjects)

21.1

11.0

5

52

Changes in the extent of venous thrombus were also measured for the 5 thromboembolic episodes. Tipro Powder prevented an increase in the extent of thrombus during 4 (80%) of the thromboembolic episodes by Day 3 of treatment, and 1 (20%) episode by Day 5 of treatment.

All seven of the short-term prophylaxis treatments with Tipro Powder were free of complications of PF or thromboembolic events, as shown in Table 7.


Reason for

Treatment


Number of Treatments


Presentation of Purpura Fulminans During Treatment Episodes


Thromboembolic Complications During Treatment Episode


Number of Treatments Free of Complications


N

%

N

%

N

%

Anticoagulation Therapy


3

0

0.0

0

0.0

3

100.0

Surgical Procedure


4

0

0.0

0

0.0

4

100.0

Total


7

0

0.0

0

0.0

7

100.0

No episodes of PF occurred in four subjects ranging from 42 to 338 days of long-term prophylactic treatment with Tipro Powder, as shown in Table 8. When not on prophylactic treatment and receiving Tipro Powder on-demand, the same four subjects experienced a total of 13 (median of 3) episodes of PF over a range of 19 to 323 days. The time to first episode of PF after exiting from long-term prophylaxis treatment ranged from 12 to 32 days for these four subjects.


Summary Statistic


Long-Term Prophylactic Treatment


While On-Demand Total number of episodes while subjects were On-Demand was 13


Time to First Episode After Existing Long Term Prophylaxis


Number of Episodes per Subject


Number of Days Receiving Prophylactic Treatment


Monthly Rate of Episodes


Number of Episodes per Subject


Number of Days Not Receiving Study Drug


Monthly Rate of Episodes


Mean


0

229

0.0

3.3

165

1.91

23.3

Median


0

268

0.0

3.0

159

0.49

24.5

Minimum


0

42

0.0

1.0

19

0.25

12.0

Maximum


0

338

0.0

6.0

323

6.40

32.0

14.2 Retrospective Analysis

A retrospective study to capture dosing information and treatment outcome data in subjects with severe congenital Tipro Powder C deficiency who were treated with Tipro Powder under an emergency use IND was also conducted. Eleven subjects (6 male and 5 female), ages ranging from 2.1 to 23.8 years participated in this study.

There were 28 acute episodes of PF/WISN and vascular thrombus reported in which time to resolution ranged from 0 to 46 days. The treatment outcome for these episodes was rated effective in all cases except one.

16 HOW SUPPLIED/STORAGE AND HANDLING

Tipro Powder is supplied as a sterile, white or cream colored, lyophilized powder for IV injection. It has a pH between 6.7 and 7.3 and an osmolality not lower than 240 mosmol/kg. One International Unit (IU) of Tipro Powder C corresponds to the amidolytically measured activity of Tipro Powder C in 1 mL of normal plasma. The potency (IU) is determined using a chromogenic substrate method referenced against the World Health Organization (WHO) International Standard (86/622).

Tipro Powder is available in single-dose vials that contain the following nominal product strengths:

NDC 0944-4177-05

Tipro Powder C

Concentrate (Human)

Tipro Powder

Single-dose Vial

Lyophilized Powder for Solution for Injection

Rx Only

Sterile – No preservative

Baxalta US Inc.

Westlake Village, CA 91362 USA

U.S. License No. 2020

NDC 0944-4176-01

Tipro Powder C Concentrate

(Human)

Tipro Powder

Single-dose Vial

Lyophilized Powder for Solution for Injection.

For Intravenous Administration Only.

See package insert. Rx only.

Baxalta US Inc.

Westlake Village, CA 91362 USA

U.S. Lic. No. 2020

5 mL

NDC 52919-003-08

Sterile Water for Injection, USP

for reconstitution of accompanying product

Do not use unless clear. No antimicrobial agent or other substance has been

added. Do not use for intravascular injection without making approximately

isotonic by addition of suitable solute. Discard unused portion. Rx Only

Single dose container

Nonpyrogenic

NDC 0944-4179-10

Tipro Powder C

Concentrate (Human)

Tipro Powder

Single-dose Vial

Lyophilized Powder for Solution for Injection

Rx Only

Sterile – No preservative

Baxalta US Inc.

Westlake Village, CA 91362 USA

U.S. License No. 2020

NDC 0944-4178-02

Tipro Powder C Concentrate (Human)

Tipro Powder

Single-dose Vial

Lyophilized Powder for Solution for

Injection.

For Intravenous Administration Only.

See package insert. Rx only.



10 mL

NDC 52919-005-05

Sterile Water for Injection, USP

for reconstitution of accompanying product

Do not use unless clear. No antimicrobial agent or other substance has been

added. Do not use for intravascular injection without making approximately

isotonic by addition of suitable solute. Discard unused portion. Rx Only

Single dose container

Nonpyrogenic

unit-carton-blue unit-carton-green

Tipro Powder pharmaceutical active ingredients containing related brand and generic drugs:


Tipro Powder available forms, composition, doses:


Tipro Powder destination | category:


Tipro Powder Anatomical Therapeutic Chemical codes:


Tipro Powder pharmaceutical companies:


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Frequently asked Questions

Can i drive or operate heavy machine after consuming Tipro Powder?

Depending on the reaction of the Tipro Powder after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Tipro Powder not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Tipro Powder addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sdrugs.com conducted a study on Tipro Powder, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Tipro Powder consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology


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