A1, A2, B, C1, C2, D, E, F, G-H, I-K, L, M, N, O, P1, P2, Q-R, S, T, U-V, W-Z

Remodulin Indications, Dosage, Storage, Stability - Treprostinil sodium

INDICATIONS

AND USAGE

Remodulin^TMis indicated as a continuous subcutaneous infusion for the treatment of pulmonary arterial hypertension in patients with NYHA Class II-IV symptoms (see CLINICAL PHARMACOLOGY: Clinical Effects) to diminish symptoms associated with exercise.

DOSAGE AND ADMINISTRATION

Remodulin™ is supplied in 20 mL vials in concentrations of 1.0 mg/mL, 2.5 mg/mL, 5.0 mg/mL and 10.0 mg/mL. Remodulin is meant to be administered without further dilution.

Initial Dose

Remodulin is administered by continuous subcutaneous infusion. The infusion rate is initiated at 1.25 ng/kg/min. If this initial dose cannot be tolerated, the infusion rate should be reduced to 0.625 ng/kg/min.

Dosage Adjustments

The goal of chronic dosage adjustments is to establish a dose at which PAH symptoms are improved, while minimizing excessive pharmacological effects of Remodulin (headache, nausea, emesis, restlessness, anxiety and infusion site pain or reaction).

The infusion rate should be increased in increments of no more than 1.25 ng/kg/min per week for the first four weeks and then no more than 2.5 ng/kg/min per week for the remaining duration of infusion, depending on clinical response. There is little experience with doses >40 ng/kg/min. Abrupt cessation of infusion should be avoided (see PRECAUTIONS).

Administration

Remodulin is administered by continuous subcutaneous infusion, via a self-inserted subcutaneous catheter, using an infusion pump designed for subcutaneous drug delivery. To avoid potential interruptions in drug delivery, the patient must have immediate access to a backup infusion pump and subcutaneous infusion sets. The ambulatory infusion pump used to administer Remodulin should: (1) be small and lightweight, (2) be adjustable to approximately 0.002 mL/hr, (3) have occlusion/no delivery, low battery, programming error and motor malfunction alarms, (4) have delivery accuracy of �6% or better and (5) be positive pressure driven. The reservoir should be made of polyvinyl chloride, polypropylene or glass.

Infusion rates are calculated using the following formula.

Infusion Rate (mL/hr) = Dose (ng/kg/min) x Weight (kg) x [0.00006/Remodulin dosage strength concentration (mg/mL)]

Tables 4 through 7 provide Remodulin infusion delivery rates for doses up to 100 ng/kg/min, based on patient weight, drug delivery rate and concentration. These tables may be used to select the most appropriate concentration and infusion rate for Remodulin. No dilution is necessary.

Table 4 1.0 mg/mL Concentration of Remodulin^TMPump Infusion Rate Setting (mL/hr) for 1.0 mg/mL Remodulin Patient Weight (kg)

Dose (ng/kg/min)	25	30	35	40	45	50	55	60	65	70	75	80	85	90	95	100
1.25	0.002	0.002	0.003	0.003	0.003	0.004	0.004	0.005	0.005	0.005	0.006	0.006	0.006	0.007	0.007	0.008
2.5	0.004	0.005	0.005	0.006	0.007	0.008	0.008	0.009	0.010	0.011	0.011	0.012	0.013	0.014	0.014	0.015
3.75	0.006	0.007	0.008	0.009	0.010	0.011	0.012	0.014	0.015	0.016	0.017	0.018	0.019	0.020	0.021	0.023
5	0.008	0.009	0.011	0.012	0.014	0.015	0.017	0.018	0.020	0.021	0.023	0.024	0.026	0.027	0.029	0.030
6.25	0.009	0.011	0.013	0.015	0.017	0.019	0.021	0.023	0.024	0.026	0.028	0.030	0.032	0.034	0.036	0.038
7.5	0.011	0.014	0.016	0.018	0.020	0.023	0.025	0.027	0.029	0.032	0.034	0.036	0.038	0.041	0.043	0.045
8.75	0.013	0.016	0.018	0.021	0.024	0.026	0.029	0.032	0.034	0.037	0.039	0.042	0.045	0.047	0.050	0.053
10	0.015	0.018	0.021	0.024	0.027	0.030	0.033	0.036	0.039	0.042	0.045	0.048	0.051	0.054	0.057	0.060
11.25	0.017	0.020	0.024	0.027	0.030	0.034	0.037	0.041	0.044	0.047	0.051	0.054	0.057	0.061	0.064	0.068
12.5	0.019	0.023	0.026	0.030	0.034	0.038	0.041	0.045	0.049	0.053	0.056	0.060	0.064	0.068	0.071	0.075
13.75	0.021	0.025	0.029	0.033	0.037	0.041	0.045	0.050	0.054	0.058	0.062	0.066	0.070	0.074	0.078	0.083
15	0.023	0.027	0.032	0.036	0.041	0.045	0.050	0.054	0.059	0.063	0.068	0.072	0.077	0.081	0.086	0.090
16.25	0.024	0.029	0.034	0.039	0.044	0.049	0.054	0.059	0.063	0.068	0.073	0.078	0.083	0.088	0.093	0.098
17.5	0.026	0.032	0.037	0.042	0.047	0.053	0.058	0.063	0.068	0.074	0.079	0.084	0.089	0.095	0.100	0.105
18.75	0.028	0.034	0.039	0.045	0.051	0.056	0.062	0.068	0.073	0.079	0.084	0.090	0.096	0.101	0.107	0.113
20	0.030	0.036	0.042	0.048	0.054	0.060	0.066	0.072	0.078	0.084	0.090	0.096	0.102	0.108	0.114	0.120
21.25	0.032	0.038	0.045	0.051	0.057	0.064	0.070	0.077	0.083	0.089	0.096	0.102	0.108	0.115	0.121	0.128
22.5	0.034	0.041	0.047	0.054	0.061	0.068	0.074	0.081	0.088	0.095	0.101	0.108	0.115	0.122	0.128	0.135
23.75	0.036	0.043	0.050	0.057	0.064	0.071	0.078	0.086	0.093	0.100	0.107	0.114	0.121	0.128	0.135	0.143
25	0.038	0.045	0.053	0.060	0.068	0.075	0.083	0.090	0.098	0.105	0.113	0.120	0.128	0.135	0.143	0.150
27.5	0.041	0.050	0.058	0.066	0.074	0.083	0.091	0.099	0.107	0.116	0.124	0.132	0.140	0.149	0.157	0.165
30	0.045	0.054	0.063	0.072	0.081	0.090	0.099	0.108	0.117	0.126	0.135	0.144	0.153	0.162	0.171	0.180
32.5	0.049	0.059	0.068	0.078	0.088	0.098	0.107	0.117	0.127	0.137	0.146	0.156	0.166	0.176	0.185	0.195
35	0.053	0.063	0.074	0.084	0.095	0.105	0.116	0.126	0.137	0.147	0.158	0.168	0.179	0.189	0.200	0.210
37.5	0.056	0.068	0.079	0.090	0.101	0.113	0.124	0.135	0.146	0.158	0.169	0.180	0.191	0.203	0.214	0.225
40	0.060	0.072	0.084	0.096	0.108	0.120	0.132	0.144	0.156	0.168	0.180	0.192	0.204	0.216	0.228	0.240
42.5	0.064	0.077	0.089	0.102	0.115	0.128	0.140	0.153	0.166	0.179	0.191	0.204	0.217	0.230	0.242	0.255

The infusion rate for 1.0 mg/mL can be calculated using the following formula: Patient weight (kg) x dose (ng/kg/min) 0.00006.

Table 5 2.5 mg/mL Concentration of Remodulin^TMPump Infusion Rate Setting (mL/hr) for 2.5 mg/mL Remodulin Patient Weight (kg)

Dose (ng/kg/min)	25	30	35	40	45	50	55	60	65	70	75	80	85	90	95	100
5	0.003	0.004	0.004	0.005	0.005	0.006	0.007	0.007	0.008	0.008	0.009	0.010	0.010	0.011	0.011	0.012
6.25	0.004	0.005	0.005	0.006	0.007	0.008	0.008	0.009	0.010	0.011	0.011	0.012	0.013	0.014	0.014	0.015
7.5	0.005	0.005	0.006	0.007	0.008	0.009	0.010	0.011	0.012	0.013	0.014	0.014	0.015	0.016	0.017	0.018
8.75	0.005	0.006	0.007	0.008	0.009	0.011	0.012	0.013	0.014	0.015	0.016	0.017	0.018	0.019	0.020	0.021
10	0.006	0.007	0.008	0.010	0.011	0.012	0.013	0.014	0.016	0.017	0.018	0.019	0.020	0.022	0.023	0.024
11.25	0.007	0.008	0.009	0.011	0.012	0.014	0.015	0.016	0.018	0.019	0.020	0.022	0.023	0.024	0.026	0.027
12.5	0.008	0.009	0.011	0.012	0.014	0.015	0.017	0.018	0.020	0.021	0.023	0.024	0.026	0.027	0.029	0.030
13.75	0.008	0.010	0.012	0.013	0.015	0.017	0.018	0.020	0.021	0.023	0.025	0.026	0.028	0.030	0.031	0.033
15	0.009	0.011	0.013	0.014	0.016	0.018	0.020	0.022	0.023	0.025	0.027	0.029	0.031	0.032	0.034	0.036
16.25	0.010	0.012	0.014	0.016	0.018	0.020	0.021	0.023	0.025	0.027	0.029	0.031	0.033	0.035	0.037	0.039
17.5	0.011	0.013	0.015	0.017	0.019	0.021	0.023	0.025	0.027	0.029	0.032	0.034	0.036	0.038	0.040	0.042
18.75	0.011	0.014	0.016	0.018	0.020	0.023	0.025	0.027	0.029	0.032	0.034	0.036	0.038	0.041	0.043	0.045
20	0.012	0.014	0.017	0.019	0.022	0.024	0.026	0.029	0.031	0.034	0.036	0.038	0.041	0.043	0.046	0.048
21.25	0.013	0.015	0.018	0.020	0.023	0.026	0.028	0.031	0.033	0.036	0.038	0.041	0.043	0.046	0.048	0.051
22.5	0.014	0.016	0.019	0.022	0.024	0.027	0.030	0.032	0.035	0.038	0.041	0.043	0.046	0.049	0.051	0.054
23.75	0.014	0.017	0.020	0.023	0.026	0.029	0.031	0.034	0.037	0.040	0.043	0.046	0.048	0.051	0.054	0.057
25	0.015	0.018	0.021	0.024	0.027	0.030	0.033	0.036	0.039	0.042	0.045	0.048	0.051	0.054	0.057	0.060
27.5	0.017	0.020	0.023	0.026	0.030	0.033	0.036	0.040	0.043	0.046	0.050	0.053	0.056	0.059	0.063	0.066
30	0.018	0.022	0.025	0.029	0.032	0.036	0.040	0.043	0.047	0.050	0.054	0.058	0.061	0.065	0.068	0.072
32.5	0.020	0.023	0.027	0.031	0.035	0.039	0.043	0.047	0.051	0.055	0.059	0.062	0.066	0.070	0.074	0.078
35	0.021	0.025	0.029	0.034	0.038	0.042	0.046	0.050	0.055	0.059	0.063	0.067	0.071	0.076	0.080	0.084
37.5	0.023	0.027	0.032	0.036	0.041	0.045	0.050	0.054	0.059	0.063	0.068	0.072	0.077	0.081	0.086	0.090
40	0.024	0.029	0.034	0.038	0.043	0.048	0.053	0.058	0.062	0.067	0.072	0.077	0.082	0.086	0.091	0.096
42.5	0.026	0.031	0.036	0.041	0.046	0.051	0.056	0.061	0.066	0.071	0.077	0.082	0.087	0.092	0.097	0.102

The infusion rate for 2.5 mg/mL can be calculated using the following formula: Patient weight (kg) x dose (ng/kg/min) x 0.000024.

Table 6 5.0 mg/mL Concentration of Remodulin^TMPump Infusion Rate Setting (mL/hr) for 5.0 mg/mL Remodulin Patient Weight (kg)

Dose (ng/kg/min)	25	35	40	45	50	55	60	65	70	75	80	85	90	95	100
10	0.003	0.004	0.005	0.005	0.006	0.007	0.007	0.008	0.008	0.009	0.010	0.010	0.011	0.011	0.012
12.5	0.004	0.005	0.006	0.007	0.008	0.008	0.009	0.010	0.011	0.011	0.012	0.013	0.014	0.014	0.015
15	0.005	0.006	0.007	0.008	0.009	0.010	0.011	0.012	0.013	0.014	0.014	0.015	0.016	0.017	0.018
17.5	0.005	0.007	0.008	0.009	0.011	0.012	0.013	0.014	0.015	0.016	0.017	0.018	0.019	0.020	0.021
20	0.006	0.008	0.010	0.011	0.012	0.013	0.014	0.016	0.017	0.018	0.019	0.020	0.022	0.023	0.024
22.5	0.007	0.009	0.011	0.012	0.014	0.015	0.016	0.018	0.019	0.020	0.022	0.023	0.024	0.026	0.027
25	0.008	0.011	0.012	0.014	0.015	0.017	0.018	0.020	0.021	0.023	0.024	0.026	0.027	0.029	0.030
27.5	0.008	0.012	0.013	0.015	0.017	0.018	0.020	0.021	0.023	0.025	0.026	0.028	0.030	0.031	0.033
30	0.009	0.013	0.014	0.016	0.018	0.020	0.022	0.023	0.025	0.027	0.029	0.031	0.032	0.034	0.036
32.5	0.010	0.014	0.016	0.018	0.020	0.021	0.023	0.025	0.027	0.029	0.031	0.033	0.035	0.037	0.039
35	0.011	0.015	0.017	0.019	0.021	0.023	0.025	0.027	0.029	0.032	0.034	0.036	0.038	0.040	0.042
37.5	0.011	0.016	0.018	0.020	0.023	0.025	0.027	0.029	0.032	0.034	0.036	0.038	0.041	0.043	0.045
40	0.012	0.017	0.019	0.022	0.024	0.026	0.029	0.031	0.034	0.036	0.038	0.041	0.043	0.046	0.048
42.5	0.013	0.018	0.020	0.023	0.026	0.028	0.031	0.033	0.036	0.038	0.041	0.043	0.046	0.048	0.051
45	0.014	0.019	0.022	0.024	0.027	0.030	0.032	0.035	0.038	0.041	0.043	0.046	0.049	0.051	0.054
47.5	0.014	0.020	0.023	0.026	0.029	0.031	0.034	0.037	0.040	0.043	0.046	0.048	0.051	0.054	0.057
50	0.015	0.021	0.024	0.027	0.030	0.033	0.036	0.039	0.042	0.045	0.048	0.051	0.054	0.057	0.060
55	0.017	0.023	0.026	0.030	0.033	0.036	0.040	0.043	0.046	0.050	0.053	0.056	0.059	0.063	0.066
60	0.018	0.025	0.029	0.032	0.036	0.040	0.043	0.047	0.050	0.054	0.058	0.061	0.065	0.068	0.072
65	0.020	0.027	0.031	0.035	0.039	0.043	0.047	0.051	0.055	0.059	0.062	0.066	0.070	0.074	0.078
70	0.021	0.029	0.034	0.038	0.042	0.046	0.050	0.055	0.059	0.063	0.067	0.071	0.076	0.080	0.084
75	0.023	0.032	0.036	0.041	0.045	0.050	0.054	0.059	0.063	0.068	0.072	0.077	0.081	0.086	0.090
80	0.024	0.034	0.038	0.043	0.048	0.053	0.058	0.062	0.067	0.072	0.077	0.082	0.086	0.091	0.096

The infusion rate for the 5 mg/mL concentration can be calculated by using the following formula: Patient weight (kg) x dose (ng/kg/min) x 0.000012.

Table 7 10.0 mg/mL Concentration of Remodulin^TMPump Infusion Rate Setting (mL/hr) for 10.0 mg/mL Remodulin Patient Weight (kg)

Dose (ng/kg/min)	35	40	45	50	55	60	65	70	75	80	85	90	95	100
50	0.011	0.012	0.014	0.015	0.017	0.018	0.020	0.021	0.023	0.024	0.026	0.027	0.029	0.030
55	0.012	0.013	0.015	0.017	0.018	0.020	0.021	0.023	0.025	0.026	0.028	0.030	0.031	0.033
60	0.013	0.014	0.016	0.018	0.020	0.022	0.023	0.025	0.027	0.029	0.031	0.032	0.034	0.036
65	0.014	0.016	0.018	0.020	0.021	0.023	0.025	0.027	0.029	0.031	0.033	0.035	0.037	0.039
70	0.015	0.017	0.019	0.021	0.023	0.025	0.027	0.029	0.032	0.034	0.036	0.038	0.040	0.042
75	0.016	0.018	0.020	0.023	0.025	0.027	0.029	0.032	0.034	0.036	0.038	0.041	0.043	0.045
80	0.017	0.019	0.022	0.024	0.026	0.029	0.031	0.034	0.036	0.038	0.041	0.043	0.046	0.048
85	0.018	0.020	0.023	0.026	0.028	0.031	0.033	0.036	0.038	0.041	0.043	0.046	0.048	0.051
90	0.019	0.022	0.024	0.027	0.030	0.032	0.035	0.038	0.041	0.043	0.046	0.049	0.051	0.054
95	0.020	0.023	0.026	0.029	0.031	0.034	0.037	0.040	0.043	0.046	0.048	0.051	0.054	0.057
100	0.021	0.024	0.027	0.030	0.033	0.036	0.039	0.042	0.045	0.048	0.051	0.054	0.057	0.060

The infusion rate for the 10 mg/mL concentration can be calculated by using the following formula: Patient weight (kg) x dose (ng/kg/min) x 0.000006

HOW SUPPLIED

Remodulin™ is supplied in 20 mL multi-use vials at concentrations of 1.0 mg/mL, 2.5 mg/mL, 5.0 mg/mL, and 10.0 mg/mL treprostinil, as sterile solutions in water for injection, individually packaged in a carton. Each mL contains treprostinil sodium equivalent to 1.0 mg/mL, 2.5 mg/mL, 5.0 mg/mL, or 10.0 mg/mL treprostinil. Unopened vials of Remodulin are stable until the date indicated when stored at 15 to 25�C (59 to 77�F). Store at 25�C (77�F), with excursions permitted to 15-30�C (59-86�F) [see USP Controlled Room Temperature].

During use, a single reservoir (syringe) of Remodulin can be administered up to 72 hours at 37�C. A single vial of Remodulin should be used for no more than 14 days after the initial introduction into the vial.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. If either particulate matter or discoloration is noted, Remodulin should not be administered.

20-mL vial containing treprostinil sodium equivalent to 1.0 mg treprostinil per mL, carton of

1 (NDC 66302-101-01).

20-mL vial containing treprostinil sodium equivalent to 2.5 mg treprostinil per mL, carton of

1 (NDC 66302-102-01).

20-mL vial containing treprostinil sodium equivalent to 5.0 mg treprostinil per mL, carton of

1 (NDC 66302-105-01).

20-mL vial containing treprostinil sodium equivalent to 10.0 mg treprostinil per mL, carton of

1 (NDC 66302-110-01).

US Patent No. 5,153,222 (Use Patent)

United Therapeutics Corp.

Research Triangle Park, NC 27709

REMODULIN

manufactured by: Baxter Pharmaceutical Solutions LLC , Bloomington, IN 47403

For United Therapeutics Corp. Research Triangle Park, NC 27709 , March 2002

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