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If inhibitors or inducers of CYP2C8 are added or withdrawn, you should also adjust treatment doses.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 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
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*:
INFUSION RATE (mL/hr)
*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)
Step 2: Calculate Amount of Remodulin Injection (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:
|
IV=intravenous; PAH=pulmonary arterial hypertension; SC=subcutaneous.