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Drug overview for REMODULIN (treprostinil sodium):
Generic name: TREPROSTINIL SODIUM (treh-PRAW-steh-nil)
Drug class: Pulmonary Antihypertensive Agents - Prostacyclin-type
Therapeutic class: Cardiovascular Therapy Agents
Treprostinil and treprostinil diolamine, synthetic analogs of prostacyclin, are vasodilators.
No enhanced Uses information available for this drug.
Generic name: TREPROSTINIL SODIUM (treh-PRAW-steh-nil)
Drug class: Pulmonary Antihypertensive Agents - Prostacyclin-type
Therapeutic class: Cardiovascular Therapy Agents
Treprostinil and treprostinil diolamine, synthetic analogs of prostacyclin, are vasodilators.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for REMODULIN (treprostinil sodium) have been approved by the FDA:
Indications:
Pulmonary arterial hypertension
Professional Synonyms:
Hypertensive pulmonary arterial disease
Pulmonary hypertensive arterial disease
Indications:
Pulmonary arterial hypertension
Professional Synonyms:
Hypertensive pulmonary arterial disease
Pulmonary hypertensive arterial disease
The following dosing information is available for REMODULIN (treprostinil sodium):
For the treatment of pulmonary arterial hypertension (PAH; WHO group 1) to reduce symptoms associated with exercise, the recommended initial adult dosage of treprostinil is 1.25 ng/kg per minute by continuous subcutaneous or IV infusion. If this initial dosage is not tolerated, the infusion rate should be decreased to 0.625
ng/kg per minute. Dosage should be titrated to achieve symptomatic improvement while minimizing adverse effects (e.g., infusion site reactions or pain, headache, nausea, vomiting, restlessness, anxiety). The infusion rate should be increased in increments of 1.25
ng/kg per minute at weekly intervals for the first 4 weeks and then 2.5 ng/kg per minute at weekly intervals for the remaining duration of infusion, depending on clinical response. More frequent dosage adjustments may be attempted if tolerated.
Several months may be required to identify the optimal dosage in an individual patient.
Abrupt withdrawal or sudden large reductions in dosage of treprostinil may result in worsening of pulmonary hypertension symptoms and should be avoided. If therapy is interrupted for brief periods (e.g., a few hours), treprostinil may be restarted at the same dosage; longer periods of interruption may require retitration of therapy.
When patients are transitioned from an external infusion pump to an implantable IV infusion pump, the initial dose of treprostinil should be the same as the current dose the patient is receiving at the time of transition.
When converting patients from IV epoprostenol to parenteral treprostinil therapy, the manufacturer recommends that treprostinil be initiated at a dosage equal to 10% of the current epoprostenol dosage; dosage of treprostinil should then be gradually increased while simultaneously decreasing the dosage of epoprostenol. The following titration protocol is recommended by the manufacturer:
Step Epoprostenol Dosage Treprostinil Dosage 1 Unchanged 10% of starting epoprostenol dosage 2 80% of starting 30% of starting epoprostenol dosage epoprostenol dosage 3 60% of starting 50% of starting epoprostenol dosage epoprostenol dosage 4 40% of starting 70% of starting epoprostenol dosage epoprostenol dosage 5 20% of starting 90% of starting epoprostenol dosage epoprostenol dosage 6 5% of starting 110% of starting epoprostenol dosage epoprostenol dosage 7 0 110% of starting epoprostenol dosage + additional 5-10% increments as needed
Treprostinil dosage should be titrated according to individual requirements to a dosage that will allow for withdrawal of epoprostenol therapy while balancing symptoms of PAH and prostacyclin-related adverse effects. Any increase in PAH symptoms that occurs during the transition should be managed initially by increasing the dosage of treprostinil, and any adverse effects related to excess prostacyclin (e.g., facial flushing, headache, jaw pain) should be managed initially by decreasing the epoprostenol dosage. Other transition protocols have been used successfully to convert patients from epoprostenol to treprostinil therapy, including a rapid transition method in which the drug reservoir containing IV epoprostenol is switched directly with one containing IV treprostinil.
Although data are limited, patients who transition from epoprostenol to IV treprostinil appear to require higher average dosages of treprostinil (in some cases, at least double) to maintain the same clinical benefits.
The recommended initial dosage of orally inhaled treprostinil solution is 18 mcg (3 inhalations) per treatment session. If this initial dosage is not tolerated, dosage should be reduced to 1 or 2 inhalations per treatment session, then subsequently increased to 3 breaths as tolerated. A total of 4 treatment sessions should be administered daily, spaced equally apart at intervals of approximately 4 hours during waking hours.
Dosage of orally inhaled treprostinil solution should be further increased by 3 inhalations per treatment session every 1-2 weeks until the target maintenance dosage of 9-12 inhalations per treatment session, 4 times daily. Patients who are unable to reach the target dosage due to adverse effects should be maintained on the highest possible tolerated dosage. If a treatment session is missed or interrupted, therapy should be resumed as soon as possible at the usual dosage.
The recommended initial dosage of orally inhaled treprostinil powder is one 16-mcg cartridge per treatment session, 4 times daily. Increase dosage by an additional 16 mcg per treatment session at intervals of approximately 1 to 2 weeks to reach the maintenance dosage. The target maintenance dosage is usually 48 mcg to 64 mcg per session.
If titration is not tolerated, continue treatment at the highest tolerated dose. If a scheduled treatment session is missed, resume therapy as soon as possible at the usual dosage.
Dosage for transition from treprostinil oral inhalation solution to the inhalation powder: For patients transitioning from orally inhaled treprostinil solution to the orally inhaled treprostinil powder, the following regimens provide similar exposure.
Treprostinil Oral Inhalation Powder Treprostinil Oral Inhalation (Tyvaso DPI) Cartridge Strength Solution (Tyvaso) Number of Breaths 16 mcg <=5 (<=30 mcg) 32 mcg 6 to 7 (36 to 42 mcg) 48 mcg 8 to 10 (48 to 60 mcg) 64 mcg 11 to 12 (66 to 72 mcg)
Dosage of treprostinil diolamine is expressed in terms of treprostinil.
The recommended initial oral dosage of treprostinil in adults is 0.25 mg twice daily (taken approximately every 12 hours) or 0.125 mg 3 times daily (taken approximately every 8 hours) as extended-release tablets.
Dosage should be increased in recommended increments of 0.25 or 0.5 mg twice daily or 0.125
mg 3 times daily no more frequently than every 3-4 days until the highest tolerated dosage is achieved. A slower titration should be considered for patients not tolerating such increases. The appropriate maintenance dosage of oral treprostinil is determined by patient tolerability.
If intolerable adverse effects occur, dosage should be decreased in increments of 0.125 mg 3 times daily or 0.25 mg twice daily.
Abrupt discontinuance of treprostinil therapy should be avoided.
When used concomitantly with potent inhibitors of cytochrome P-450 (CYP) 2C8 (e.g., gemfibrozil), oral treprostinil should be initiated at a dosage of 0.125 mg twice daily and increased in increments of 0.125 mg twice daily not more frequently than every 3-4 days as tolerated.
When transitioning from parenteral to oral treprostinil therapy, the manufacturer recommends decreasing the dosage of subcutaneous or IV treprostinil while simultaneously increasing the dosage of oral treprostinil. Dosage of parenteral treprostinil may be reduced up to 30 ng/kg per minute per day and dosage of oral treprostinil may be simultaneously increased up to 6 mg per day (administered as 2 mg 3 times daily) if tolerated. The following equation can be used to estimate a target dose of oral treprostinil using the patient's current parenteral treprostinil dose:
Temporary infusion of subcutaneous or IV treprostinil may be considered in the event of a planned, short-term interruption of oral treprostinil therapy in patients who are unable to take oral medications. The following formula can be used to calculate a comparable dose of parenteral treprostinil using the patient's current dose of oral treprostinil:
The recommended initial dosage of orally inhaled treprostinil solution is 18 mcg (3 breaths) per treatment session. If this initial dosage is not tolerated, dosage should be reduced to 1 or 2 breaths per treatment session, then subsequently increased to 3 breaths as tolerated. Dosage of orally inhaled treprostinil solution should be further increased by 3 breaths per treatment session every 1-2 weeks until the target maintenance dosage of 9-12 breaths per treatment session, 4 times daily, is achieved.
Patients who are unable to reach the target dosage due to adverse effects should be maintained on the highest possible tolerated dosage. If a treatment session is missed or interrupted, therapy should be resumed as soon as possible at the usual dosage.
The recommended initial dosage of orally inhaled treprostinil powder is one 16 mcg cartridge per treatment session, 4 times daily. To reach maintenance dosage, increase dosage of orally inhaled treprostinil powder by an additional 16 mcg per treatment session at intervals of approximately 1 to 2 weeks. The target maintenance dosage is usually 48 mcg to 64 mcg per session.
If titration is not tolerated, continue orally inhaled treprostinil powder at the highest tolerated dose. If a scheduled treatment session is missed, resume therapy as soon as possible at the usual dosage.
Dosage for transition from treprostinil oral inhalation solution to the inhalation powder: For patients transitioning from orally inhaled treprostinil solution to orally inhaled treprostinil powder, the following dosage regimens provide similar exposure.
Treprostinil Oral Inhalation Powder Treprostinil Oral Inhalation (Tyvaso DPI) Cartridge Strength Solution (Tyvaso) Number of Breaths 16 mcg <=5 (<=30 mcg) 32 mcg 6 to 7 (36 to 42 mcg) 48 mcg 8 to 10 (48 to 60 mcg) 64 mcg 11 to 12 (66 to 72 mcg)
ng/kg per minute. Dosage should be titrated to achieve symptomatic improvement while minimizing adverse effects (e.g., infusion site reactions or pain, headache, nausea, vomiting, restlessness, anxiety). The infusion rate should be increased in increments of 1.25
ng/kg per minute at weekly intervals for the first 4 weeks and then 2.5 ng/kg per minute at weekly intervals for the remaining duration of infusion, depending on clinical response. More frequent dosage adjustments may be attempted if tolerated.
Several months may be required to identify the optimal dosage in an individual patient.
Abrupt withdrawal or sudden large reductions in dosage of treprostinil may result in worsening of pulmonary hypertension symptoms and should be avoided. If therapy is interrupted for brief periods (e.g., a few hours), treprostinil may be restarted at the same dosage; longer periods of interruption may require retitration of therapy.
When patients are transitioned from an external infusion pump to an implantable IV infusion pump, the initial dose of treprostinil should be the same as the current dose the patient is receiving at the time of transition.
When converting patients from IV epoprostenol to parenteral treprostinil therapy, the manufacturer recommends that treprostinil be initiated at a dosage equal to 10% of the current epoprostenol dosage; dosage of treprostinil should then be gradually increased while simultaneously decreasing the dosage of epoprostenol. The following titration protocol is recommended by the manufacturer:
Step Epoprostenol Dosage Treprostinil Dosage 1 Unchanged 10% of starting epoprostenol dosage 2 80% of starting 30% of starting epoprostenol dosage epoprostenol dosage 3 60% of starting 50% of starting epoprostenol dosage epoprostenol dosage 4 40% of starting 70% of starting epoprostenol dosage epoprostenol dosage 5 20% of starting 90% of starting epoprostenol dosage epoprostenol dosage 6 5% of starting 110% of starting epoprostenol dosage epoprostenol dosage 7 0 110% of starting epoprostenol dosage + additional 5-10% increments as needed
Treprostinil dosage should be titrated according to individual requirements to a dosage that will allow for withdrawal of epoprostenol therapy while balancing symptoms of PAH and prostacyclin-related adverse effects. Any increase in PAH symptoms that occurs during the transition should be managed initially by increasing the dosage of treprostinil, and any adverse effects related to excess prostacyclin (e.g., facial flushing, headache, jaw pain) should be managed initially by decreasing the epoprostenol dosage. Other transition protocols have been used successfully to convert patients from epoprostenol to treprostinil therapy, including a rapid transition method in which the drug reservoir containing IV epoprostenol is switched directly with one containing IV treprostinil.
Although data are limited, patients who transition from epoprostenol to IV treprostinil appear to require higher average dosages of treprostinil (in some cases, at least double) to maintain the same clinical benefits.
The recommended initial dosage of orally inhaled treprostinil solution is 18 mcg (3 inhalations) per treatment session. If this initial dosage is not tolerated, dosage should be reduced to 1 or 2 inhalations per treatment session, then subsequently increased to 3 breaths as tolerated. A total of 4 treatment sessions should be administered daily, spaced equally apart at intervals of approximately 4 hours during waking hours.
Dosage of orally inhaled treprostinil solution should be further increased by 3 inhalations per treatment session every 1-2 weeks until the target maintenance dosage of 9-12 inhalations per treatment session, 4 times daily. Patients who are unable to reach the target dosage due to adverse effects should be maintained on the highest possible tolerated dosage. If a treatment session is missed or interrupted, therapy should be resumed as soon as possible at the usual dosage.
The recommended initial dosage of orally inhaled treprostinil powder is one 16-mcg cartridge per treatment session, 4 times daily. Increase dosage by an additional 16 mcg per treatment session at intervals of approximately 1 to 2 weeks to reach the maintenance dosage. The target maintenance dosage is usually 48 mcg to 64 mcg per session.
If titration is not tolerated, continue treatment at the highest tolerated dose. If a scheduled treatment session is missed, resume therapy as soon as possible at the usual dosage.
Dosage for transition from treprostinil oral inhalation solution to the inhalation powder: For patients transitioning from orally inhaled treprostinil solution to the orally inhaled treprostinil powder, the following regimens provide similar exposure.
Treprostinil Oral Inhalation Powder Treprostinil Oral Inhalation (Tyvaso DPI) Cartridge Strength Solution (Tyvaso) Number of Breaths 16 mcg <=5 (<=30 mcg) 32 mcg 6 to 7 (36 to 42 mcg) 48 mcg 8 to 10 (48 to 60 mcg) 64 mcg 11 to 12 (66 to 72 mcg)
Dosage of treprostinil diolamine is expressed in terms of treprostinil.
The recommended initial oral dosage of treprostinil in adults is 0.25 mg twice daily (taken approximately every 12 hours) or 0.125 mg 3 times daily (taken approximately every 8 hours) as extended-release tablets.
Dosage should be increased in recommended increments of 0.25 or 0.5 mg twice daily or 0.125
mg 3 times daily no more frequently than every 3-4 days until the highest tolerated dosage is achieved. A slower titration should be considered for patients not tolerating such increases. The appropriate maintenance dosage of oral treprostinil is determined by patient tolerability.
If intolerable adverse effects occur, dosage should be decreased in increments of 0.125 mg 3 times daily or 0.25 mg twice daily.
Abrupt discontinuance of treprostinil therapy should be avoided.
When used concomitantly with potent inhibitors of cytochrome P-450 (CYP) 2C8 (e.g., gemfibrozil), oral treprostinil should be initiated at a dosage of 0.125 mg twice daily and increased in increments of 0.125 mg twice daily not more frequently than every 3-4 days as tolerated.
When transitioning from parenteral to oral treprostinil therapy, the manufacturer recommends decreasing the dosage of subcutaneous or IV treprostinil while simultaneously increasing the dosage of oral treprostinil. Dosage of parenteral treprostinil may be reduced up to 30 ng/kg per minute per day and dosage of oral treprostinil may be simultaneously increased up to 6 mg per day (administered as 2 mg 3 times daily) if tolerated. The following equation can be used to estimate a target dose of oral treprostinil using the patient's current parenteral treprostinil dose:
Temporary infusion of subcutaneous or IV treprostinil may be considered in the event of a planned, short-term interruption of oral treprostinil therapy in patients who are unable to take oral medications. The following formula can be used to calculate a comparable dose of parenteral treprostinil using the patient's current dose of oral treprostinil:
The recommended initial dosage of orally inhaled treprostinil solution is 18 mcg (3 breaths) per treatment session. If this initial dosage is not tolerated, dosage should be reduced to 1 or 2 breaths per treatment session, then subsequently increased to 3 breaths as tolerated. Dosage of orally inhaled treprostinil solution should be further increased by 3 breaths per treatment session every 1-2 weeks until the target maintenance dosage of 9-12 breaths per treatment session, 4 times daily, is achieved.
Patients who are unable to reach the target dosage due to adverse effects should be maintained on the highest possible tolerated dosage. If a treatment session is missed or interrupted, therapy should be resumed as soon as possible at the usual dosage.
The recommended initial dosage of orally inhaled treprostinil powder is one 16 mcg cartridge per treatment session, 4 times daily. To reach maintenance dosage, increase dosage of orally inhaled treprostinil powder by an additional 16 mcg per treatment session at intervals of approximately 1 to 2 weeks. The target maintenance dosage is usually 48 mcg to 64 mcg per session.
If titration is not tolerated, continue orally inhaled treprostinil powder at the highest tolerated dose. If a scheduled treatment session is missed, resume therapy as soon as possible at the usual dosage.
Dosage for transition from treprostinil oral inhalation solution to the inhalation powder: For patients transitioning from orally inhaled treprostinil solution to orally inhaled treprostinil powder, the following dosage regimens provide similar exposure.
Treprostinil Oral Inhalation Powder Treprostinil Oral Inhalation (Tyvaso DPI) Cartridge Strength Solution (Tyvaso) Number of Breaths 16 mcg <=5 (<=30 mcg) 32 mcg 6 to 7 (36 to 42 mcg) 48 mcg 8 to 10 (48 to 60 mcg) 64 mcg 11 to 12 (66 to 72 mcg)
Treprostinil is administered parenterally (by continuous subcutaneous or IV infusion) using a controlled-infusion device. Treprostinil also is available as an inhalation solution that is administered by oral inhalation using the Tyvaso(R) Inhalation System or as a dry powder formulation for oral inhalation using the Tyvaso DPI(R) inhaler. Treprostinil diolamine is administered orally as extended-release tablets (Orenitram(R)).
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| REMODULIN 1 MG/ML VIAL | Maintenance | Adults infuse 1.25 nanogram/kg/minute via subcutaneous infusion pump by cont subcutan infusi route |
| REMODULIN 2.5 MG/ML VIAL | Maintenance | Adults infuse 1.25 nanogram/kg/minute via subcutaneous infusion pump by cont subcutan infusi route |
| REMODULIN 5 MG/ML VIAL | Maintenance | Adults infuse 1.25 nanogram/kg/minute via subcutaneous infusion pump by cont subcutan infusi route |
| REMODULIN 10 MG/ML VIAL | Maintenance | Adults infuse 1.25 nanogram/kg/minute via subcutaneous infusion pump by cont subcutan infusi route |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| TREPROSTINIL 20 MG/20 ML VIAL | Maintenance | Adults infuse 1.25 nanogram/kg/minute via subcutaneous infusion pump by contsubcutan infusi route |
| TREPROSTINIL 50 MG/20 ML VIAL | Maintenance | Adults infuse 1.25 nanogram/kg/minute via subcutaneous infusion pump by contsubcutan infusi route |
| TREPROSTINIL 100 MG/20 ML VIAL | Maintenance | Adults infuse 1.25 nanogram/kg/minute via subcutaneous infusion pump by contsubcutan infusi route |
| TREPROSTINIL 200 MG/20 ML VIAL | Maintenance | Adults infuse 1.25 nanogram/kg/minute via subcutaneous infusion pump by contsubcutan infusi route |
The following drug interaction information is available for REMODULIN (treprostinil sodium):
There are 0 contraindications.
There are 0 severe interactions.
There are 3 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Treprostinil/Strong CYP2C8 Inhibitors SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Strong CYP2C8 inhibitors may inhibit the metabolism of treprostinil.(1) CLINICAL EFFECTS: Concurrent use of a strong CYP2C8 inhibitor may increase levels and effects of treprostinil, including severe headache, nausea, diarrhea, and hypotension.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: When initiating oral treprostinil in patient maintained on a strong CYP2C8 inhibitor, the initial dose should be 0.125 mg twice daily, with dosage increases limited to 0.125 mg twice daily every 3 to 4 days.(1) When initiating a strong CYP2C8 inhibitor in patients maintained on oral treprostinil, consider halving the dose of oral treprostinil.(1) Since it is unknown how strong CYP2C8 inhibitors will affect treprostinil administered intravenously or via inhalation, it would be prudent to initiate and titrate treprostinil doses cautiously in patients maintained on CYP2C8 inhibitors and monitor patients maintained on treprostinil in whom CYP2C8 inhibitors are discontinued. DISCUSSION: Concurrent use of a strong CYP2C8 inhibitor (gemfibrozil, 600 mg twice daily for 4 days) doubled the maximum concentration (Cmax) and area-under-curve (AUC) of treprostinil (1 mg).(1) The extent to which intravenous(2) and inhaled treprostinil(3) would be affected by a CYP2C8 inhibitor is unknown. Strong inhibitors of CYP2C8 includes gemfibrozil.(4,5) |
GEMFIBROZIL, LOPID |
| Tizanidine/Selected Antihypertensives SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Tizanidine is an alpha-2 agonist. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and tizanidine may result in hypotension.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. The risk of hypotension may be decreased by careful titration of tizanidine dosages and monitoring for hypotension prior to dose advancement. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Severe hypotension has been reported following the addition of tizanidine to existing lisinopril therapy.(2-4) |
TIZANIDINE HCL, ZANAFLEX |
| Apomorphine/Selected Antihypertensives and Vasodilators SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Apomorphine causes dose-dependent decreases in blood pressure. Concurrent use with antihypertensive agents may result in additive effects on blood pressure.(1) CLINICAL EFFECTS: Concurrent use of antihypertensives and apomorphine may result in orthostatic hypotension with or without dizziness, nausea, or syncope.(1) PREDISPOSING FACTORS: The risk of orthostatic hypotension may be increased during dose escalation of apomorphine and in patients with renal or hepatic impairment.(1) PATIENT MANAGEMENT: Patients receiving concurrent therapy should be monitored for hypotension. Counsel patients about the risk of orthostatic hypotension.(1) DISCUSSION: Healthy volunteers who took sublingual nitroglycerin (0.4 mg) concomitantly with apomorphine experienced a mean largest decrease in supine systolic blood pressure (SBP) of 9.7 mm Hg and in supine diastolic blood pressure (DBP) of 9.3 mm Hg, and a mean largest decrease in standing SBP and DBP of 14.3 mm Hg and 13.5 mm Hg, respectively. The maximum decrease in SBP and DBP was 65 mm Hg and 43 mm Hg, respectively. When apomorphine was taken alone, the mean largest decrease in supine SBP and DBP was 6.1 mm Hg and 7.3 mm Hg, respectively, and in standing SBP and DBP was 6.7 mm Hg and 8.4 mm Hg, respectively.(1) |
APOKYN, APOMORPHINE HCL, ONAPGO |
The following contraindication information is available for REMODULIN (treprostinil sodium):
Drug contraindication overview.
*The manufacturer states that there are no known contraindications to the use of parenteral or orally inhaled treprostinil. *Oral treprostinil is contraindicated in patients with severe hepatic impairment (Child-Pugh class C).
*The manufacturer states that there are no known contraindications to the use of parenteral or orally inhaled treprostinil. *Oral treprostinil is contraindicated in patients with severe hepatic impairment (Child-Pugh class C).
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Disease of liver |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
There are 2 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Hypotension |
| Increased risk of bleeding |
The following adverse reaction information is available for REMODULIN (treprostinil sodium):
Adverse reaction overview.
Infusion site pain and reactions (excluding bleeding/bruising but including reactions such as erythema, induration, and rash) are the most common adverse effects reported in patients receiving subcutaneous infusions of treprostinil; in some cases, these reactions may be severe or require discontinuance of the drug. Adverse effects attributed specifically to the IV route of administration of treprostinil include arm swelling, paresthesias, hematoma, and pain. Headache, diarrhea, nausea, rash, jaw pain, and vasodilation are other common adverse effects frequently reported in clinical trials of patients receiving either subcutaneous or IV treprostinil.
Common adverse effects associated with orally inhaled treprostinil solution include cough, throat irritation, headache, GI effects, muscle pain, jaw pain, bone pain, flushing, and syncope. Common adverse effects associated with orally inhaled treprostinil powder include cough, headache, shortness of breath, and nausea. Common adverse effects associated with oral treprostinil include headache, diarrhea, nausea, flushing, jaw pain, extremity pain, hypokalemia, and abdominal discomfort.
Infusion site pain and reactions (excluding bleeding/bruising but including reactions such as erythema, induration, and rash) are the most common adverse effects reported in patients receiving subcutaneous infusions of treprostinil; in some cases, these reactions may be severe or require discontinuance of the drug. Adverse effects attributed specifically to the IV route of administration of treprostinil include arm swelling, paresthesias, hematoma, and pain. Headache, diarrhea, nausea, rash, jaw pain, and vasodilation are other common adverse effects frequently reported in clinical trials of patients receiving either subcutaneous or IV treprostinil.
Common adverse effects associated with orally inhaled treprostinil solution include cough, throat irritation, headache, GI effects, muscle pain, jaw pain, bone pain, flushing, and syncope. Common adverse effects associated with orally inhaled treprostinil powder include cough, headache, shortness of breath, and nausea. Common adverse effects associated with oral treprostinil include headache, diarrhea, nausea, flushing, jaw pain, extremity pain, hypokalemia, and abdominal discomfort.
There are 6 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Edema Erythema Hypotension Injection site sequelae |
None. |
| Rare/Very Rare |
|---|
|
Thrombocytopenic disorder Thrombophlebitis |
There are 19 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Diarrhea Dizziness Headache disorder Jaw pain Nausea Pruritus of skin Skin rash |
Anorexia General weakness Vasodilation of blood vessels Vomiting |
| Rare/Very Rare |
|---|
|
Arthralgia Bone pain Cellulitis Maculopapular rash Muscle spasm Myalgia Pain in extremities |
The following precautions are available for REMODULIN (treprostinil sodium):
Safety and efficacy of parenteral treprostinil have not been established in children <=16 years of age. Clinical studies of parenteral treprostinil did not include sufficient numbers of patients 16 years of age and younger to determine whether pediatric patients respond differently than adults. In general, dosage should be titrated carefully in pediatric patients. Safety and efficacy of oral or orally inhaled treprostinil have not been established in pediatric patients younger than 18 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
There are limited case reports of the use of treprostinil in pregnant women and this is insufficient to evaluate the risk associated with adverse developmental outcomes. Consideration also must be given to the risks to the mother and the fetus associated with PAH. In studies in rats, no adverse reproductive and developmental effects were seen at dosages about 123 and 48 times the human exposure. In rabbits, external fetal and soft tissue malformations and skeletal malformations were observed at dosages about 7 and 5 times the human exposure.
It is not known whether treprostinil is distributed into milk, the effects on the breastfed infant, or the effects on milk production.
Clinical studies of parenteral treprostinil did not include sufficient numbers of patients >=65 years of age to determine whether geriatric patients respond differently than younger patients. In clinical studies of orally inhaled treprostinil solution in patients with PAH and PH-ILD, 47.8% of the patients were >=65 years of age.
The treatment effects and safety profile observed in geriatric patients were similar to younger patients. Clinical studies of oral treprostinil in patients >=65 years of age demonstrated slightly higher absolute and relative adverse event rates compared to younger patients. In general, dosage should be selected carefully in geriatric patients. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly should be considered.
The treatment effects and safety profile observed in geriatric patients were similar to younger patients. Clinical studies of oral treprostinil in patients >=65 years of age demonstrated slightly higher absolute and relative adverse event rates compared to younger patients. In general, dosage should be selected carefully in geriatric patients. The greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly should be considered.
The following prioritized warning is available for REMODULIN (treprostinil sodium):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for REMODULIN (treprostinil sodium)'s list of indications:
| Pulmonary arterial hypertension | |
| I27.0 | Primary pulmonary hypertension |
| I27.21 | Secondary pulmonary arterial hypertension |
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