treprostinil sodium

treprostinil sodium

Remodulin

Pharmacologic class: Synthetic prostacyclin analog

Therapeutic class: Antiplatelet agent, vasodilator

Pregnancy risk category B

Action

Dilates pulmonary and systemic arterial vascular beds, reducing right and left ventricular afterload and increasing cardiac output and stroke volume. Also inhibits platelet aggregation.

Availability

Injection: 1 mg/ml, 2.5 mg/ml, 5 mg/ml, 10 mg/ml

⊘Indications and dosages

➣ To diminish exercise-induced symptoms of pulmonary artery hypertension (PAH) in patients with NYHA class II-IV symptoms

Adults: Initially, 1.25 ng/kg/minute by continuous subcutaneous infusion; if initial dose isn't tolerated, reduce infusion rate to 0.625 ng/kg/minute. For maintenance, may increase infusion rate in increments of no more than 1.25 ng/kg/minute q week for first 4 weeks, then in increments of no more than 2.5 ng/kg/minute q week, if needed. Maximum dosage is 40 ng/kg/minute.

Dosage adjustment

• Hepatic insufficiency

Contraindications

• Hypersensitivity to drug, its components, or structurally related compounds

Precautions

Use cautiously in:
• renal disease
• history of hepatic disease
• elderly patients
• pregnant or breastfeeding patients
• children.

Administration

☞ Give first dose in setting where resuscitation equipment is available and other health care personnel can assist if an emergency arises.
• Administer by continuous subcutaneous infusion through subcutaneous catheter with infusion pump made specifically for subcutaneous infusions.
• Expect to adjust dosage for first 6 to 12 weeks as prescriber balances symptom improvement against adverse reactions.
☞ Don't stop infusion abruptly (may worsen pah).

Route	Onset	Peak	Duration
Subcut.	Unknown	Unknown	Unknown

Adverse reactions

CNS: dizziness, headache, anxiety, restlessness

CV: vasodilation, edema, hypotension

EENT: jaw pain

GI: nausea, vomiting, diarrhea

Skin: rash, pruritus

Other: infusion site pain or reaction (such as erythema, rash, induration)

Interactions

Drug-drug. Anticoagulants: increased risk of bleeding

Antihypertensives, diuretics, other vasodilators: increased risk of hypotension

Vitamin A: increased risk of bleeding

Drug-herbs. Alfalfa, anise, arnica, astragalus, bilberry, black currant seed oil, bladderwrack, bogbean, boldo (with fenugreek), borage oil, buchu, capsaicin, cat's claw, celery, chaparral, chincona bark, clove oil, dandelion, dong quai, evening primrose oil, fenugreek, feverfew, garlic, ginger, ginkgo, guggul, papaya extract, red clover, rhubarb, safflower oil, skullcap, tan-shen: increased risk of bleeding

Patient monitoring

☞ Especially after first dose, watch closely for severe vasodilation leading to chest pain and hypotension. These signs and symptoms call for emergency measures.
☞ Monitor vital signs. Assess carefully for indications of right ventricular failure.
• Assess neurologic status. Institute safety measures as needed to prevent injury.
☞ Watch for infusion site reaction.

Patient teaching

• Tell patient drug is a long-term measure to control PAH and requires a commitment to maintain infusion system.
☞ Instruct patient to immediately report signs and symptoms of infusion site reaction (such as redness, rash, and hardened tissue).
• Teach patient which symptoms reflect underlying disease and which may reflect adverse reactions that he should report.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and herbs mentioned above.