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TITRATION SCHEDULING ACCORDING TO CLINICAL EXPERIENCE

Start your patient at a dose of 1.25 ng/kg/min. Titrate up in 1.25 ng/kg/min increments per week to achieve a dose that improves PAH symptoms while minimizing excessive pharmacologic effects of Remodulin (ie, headache, nausea, emesis, restlessness, anxiety, and infusion site pain or reaction).1

  • In the pivotal, randomized, controlled studies of SC Remodulin, the mean dose at week 12 was 9.3 ng/kg/min1
  • Dose adjustments can be made as frequently as tolerated1
Initiate First 4 Weeks After Week 4
Initiate
Remodulin at
1.25 ng/kg/min
(or 0.625 ng/kg/min
if not tolerated)1
Increase in
increments of
1.25 ng/kg/min
per week1
Increase in
increments of
2.5 ng/kg/min
per week1

Titrate slowly in patients with hepatic or renal insufficiency. These patients will likely be exposed to greater systemic concentrations than patients with normal hepatic or renal function.1

If inhibitors or inducers of CYP2C8 are added or withdrawn, you should also adjust treatment doses. Co-administration of Remodulin with a CYP2C8 inhibitor increases exposure to treprostinil and with an inducer decreases exposure to treprostinil.1

Real-World Dosing Experience2

Real-world dosing experience over 24 months

Real-world dosing should be interpreted with appropriate caution. Time points are subject to patient attrition or discontinuation from treatment

Data Source and Methodology2

  • Based on the data of 2066 patients as of January 2020
  • Includes patients that started treatment on Remodulin and only one Remodulin route of therapy
  • Median dose per month is calculated using Specialty Pharmacy dosing data for patients receiving Remodulin through a single route of therapy between Jan 2005-Jan 2020
  • Excludes patients with no dose
66
ng/kg/min

Average dose in real-world use of Remodulin2

Based on Specialty Pharmacy shipment data during January 2020. Dose data reported in Specialty Pharmacy shipments only. Limited to unique quarterly patients with dosing data.

Initiating dosing with Remodulin

To help ensure a successful start on Remodulin:

Set expectations for the patient

Complete the Patient Referral Form and submit documentation with desired titration schedule

Take advantage of United Therapeutics’ support resources for patients

Partner with Specialty Pharmacies for dosing schedule adjustments and patient follow-up protocol

Calculating SC (undiluted) Remodulin Infusion rate1*:

SUBCUTANEOUS
INFUSION RATE (mL/hr)
=
DOSE (ng/kg/min) x WEIGHT (kg) x 0.00006
REMODULIN VIAL STRENGTH (mg/mL)

*Undiluted Remodulin can also be used for IV administration in the CADD-MS® 3 pump along with appropriate anticoagulation.

Conversion factor of 0.00006 = 60 min/hour x 0.000001 mg/ng.

Calculating Amount of IV (diluted) Remodulin Injection1:

Step 1: Calculate Diluted Remodulin Concentration (mg/mL)

DOSE (ng/kg/min) x WEIGHT (kg) x 0.00006
IV INFUSION RATE (mL/hr)

Step 2: Calculate Amount of Remodulin Injection (mL)

DILUTED REMODULIN IV CONCENTRATION (mg/mL) As calculated in Step 1
REMODULIN VIAL STRENGTH (mg/mL)
x
TOTAL VOLUME OF DILUTED REMODULIN SOLUTION IN RESERVOIR (mL)

The calculated volume of Remodulin Injection is then added to the reservoir along with the sufficient volume of diluent to achieve the desired total volume in the reservoir.

Remodulin open-label extension study1

Population Duration Dosing Safety
860 patients 1.6 years mean
duration of therapy
(max 4.6 years)
29% of patients
achieved a dose of ≥40 ng/kg/min
(max 290 ng/kg/min)
Similar safety profile to that of the 12-week placebo-controlled studies except for the following adverse drug reactions, which occurred in ≥3% of patients:
  • Anorexia
  • Vomiting
  • Infusion site infection
  • Asthenia
  • Abdominal pain

IV=intravenous; PAH=pulmonary arterial hypertension; SC=subcutaneous.

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Specific Populations

Indication

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

REMISIhcpOct19

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit www.remodulin.com or call Customer Service Line at 1-877-UNITHER (1-877-864-8437).

Important Safety Information

Warnings and Precautions

Adverse Reactions

Drug Interactions

Specific Populations

Indication

Remodulin is a prostacyclin vasodilator indicated for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) to diminish symptoms associated with exercise. Studies establishing effectiveness included patients with NYHA Functional Class II-IV symptoms and etiologies of idiopathic or heritable PAH (58%), PAH associated with congenital systemic-to-pulmonary shunts (23%), or PAH associated with connective tissue diseases (19%).

In patients with PAH requiring transition from epoprostenol, Remodulin is indicated to diminish the rate of clinical deterioration. Consider the risks and benefits of each drug prior to transition.

REMISIhcpOct19

Please see accompanying Full Prescribing Information for Remodulin.

For additional information, visit www.remodulin.com or call Customer Service Line at 1-877-UNITHER (1-877-864-8437).

References: 1. Remodulin [package insert]. Research Triangle Park, NC: United Therapeutics Corporation; 2018. 2. Data on file. United Therapeutics Corporation. Research Triangle Park, NC.