EXELA Pharma Sciences, LLC Receives Approval for NIPRIDE® RTU, (sodium nitroprusside) in 0.9% sodium chloride injection, 10mg / 50mL (200 mcg/mL), the First Ready to Use 200 mcg/mL sodium nitroprusside injection.

EXELA Pharma Sciences, LLC Receives Approval for NIPRIDE® RTU, (sodium nitroprusside) in 0.9% sodium chloride injection, 10mg / 50mL (200 mcg/mL), the First Ready to Use 200 mcg/mL sodium nitroprusside injection.

Lenoir, NC February 9, 2018 – Exela Pharma Sciences, LLC (“Exela”) today announced that it received FDA approval for NIPRIDE® RTU (sodium nitroprusside) in 0.9% sodium chloride injection, 10mg/50mL (200 mcg/mL) as a supplement to the currently marketed NIPRIDE® RTU 50mg/100mL.

NIPRIDE® RTU (sodium nitroprusside) is indicated for the immediate reduction of blood pressure of adult and pediatric patients. NIPRIDE® RTU is also indicated for producing controlled hypotension to reduce bleeding during surgery. NIPRIDE® RTU is also indicated for the treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure,  peripheral vascular resistance and mean arterial blood pressure. NIPRIDE® RTU carries a boxed warning. Please see safety information below and additional important safety information in the full prescribing information.

Exela’s NIPRIDE® RTU 50mg/100mL (500 mcg/mL) was the first sodium nitroprusside sterile injectable product available in a ready to use formulation.  Based on clinician feedback, Exela has introduced this new lower strength form in order to help reduce waste and lower cost of therapy. Ready to use sterile formulations, where available, have generally been recommended by the Joint Commission, American Society of Health System Pharmacists (ASHP), and the Institute for Safe Medication Practices.1 Ready to use formulations have been shown to eliminate costs, save time and reduce effort for the institution. Exela’s NIPRIDE® RTU 50mg has been available in a ready to use 100mL amber vial containing 0.9% sodium chloride and is stable for 24 months from manufacturing. NIPRIDE® RTU 10mg will be available also in a ready to use format in a 50mL amber vial containing 0.9% sodium chloride and is stable for 24 months from manufacturing. NIPRIDE® RTU should be stored in the carton until use, but requires no shrouding of the vial during administration. Therefore, health systems can keep NIPRIDE® RTU readily available in the pharmacy, in automated dispensing cabinets or on the floor and use it as needed.  Provided the seal on the vial is not punctured and the vial is kept in the carton that it is distributed in, the product can be returned to the pharmacy for storage and use up to the expiration date on the vial.

“Exela is pleased to announce the addition of NIPRIDE® RTU 10mg/50mL (200 mcg/mL) to our NIPRIDE® RTU  family of ready to use formulations of sodium nitroprusside in 0.9% sodium chloride injection.” said Dr. Phanesh Koneru, CEO and President, Exela. “This new strength was in response to clinician requests for lower concentrations and volumes to treat pediatric patients and to help cut down on cost and waste.  Developing injectable products that improve patient and provider experiences is an important goal for Exela.  I thank all of our Exela employees that worked tirelessly to make this product a reality, and continue to help create and secure high paying US manufacturing jobs in our North Carolina facilities.”

“NIPRIDE® RTU 10mg/50mL (200 mcg/mL) is a ready to use product that was designed with the convenience of the healthcare provider in mind. We are very pleased to offer differentiated value-added product such as NIPRIDE® RTU 10mg/50mL (200 mcg/mL),” said Mark Hartman, Chief Commercial Officer for Exela. “This new product is a direct result of Exela’s core value of listening to the needs of healthcare practitioners and responding quickly. This is consistent with our commitment to serve the institutional practitioners with products that meet their professional and patient needs.” Launch of NIPRIDE® RTU 10mg/50mL (200 mcg/mL) to hospitals will begin at the end of February.

About NIPRIDE® RTU Injection – Please see full Prescribing Information

INDICATIONS AND USAGE

  • For the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises.
  • For induction and maintenance of controlled hypotension in adults and children during surgery, to reduce bleeding.
  • For the treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance, and mean arterial blood pressure.

IMPORTANT SAFETY INFORMATION
WARNING: (A) EXCESSIVE HYPOTENSION; (B) CYANIDE TOXICITY
(A) Sodium Nitroprusside can cause precipitous decreases in blood pressure which can lead to irreversible ischemic injuries or death. Use only with continuous blood pressure monitoring. (2.2, 5.1)
(B) Sodium nitroprusside metabolism produces dose-related cyanide, which can be lethal. A patient’s ability to buffer cyanide will be exceeded in less than one hour at the maximum dose rate (10 mcg/kg/min); limit infusion at the maximum rate to as short a duration as possible (5.2).

CONTRAINDICATIONS – should not be used

  • in the treatment of diseases with compensatory hypertension.
  • in patients with inadequate cerebral circulation or in moribund patients (A.S.A. Class 5E) coming to emergency surgery.
  • in patients with congenital (Leber’s) optic atrophy or with tobacco amblyopia.
  • for the treatment of acute heart failure associated with reduced peripheral vascular resistance.
  • with sildenafil, tadalafil, vardenifil, or riociguat.

WARNINGS

  • Sodium nitroprusside can cause severe hypotension. See PI for further details.
  • Infusions above 2 mcg/kg/min generate cyanide ion (CN¯) faster than the body can normally dispose of it. At the maximum recommended rate of 10 mcg/kg/min, patient’s ability to buffer CN-will be exceeded in less than 1 hour. Patients with hepatic dysfunction are more susceptible to cyanide toxicity.
  • Most of the cyanide produced during metabolism of sodium nitroprusside is eliminated as thiocyanate, which is mildly neurotoxic (tinnitus, miosis, hyperreflexia) at serum levels of 1 mmol/L (60 mg/L) and life-threatening when levels reach ~200 mg/L. Plasma thiocyanate levels should be routinely monitored in patients with normal renal function when cumulative sodium nitroprusside doses exceed 7 mg/kg/day.  Limit the mean infusion rate to less than 3 mcg/kg/min in patients with eGFR <30 mL/min/1.73 m2, and to 1 mcg/kg/min in anuric patients.
  • Infusions cause dose-dependent conversion of hemoglobin to methemoglobin, which can impair oxygen release from red blood cells in tissue capillaries. See PI for further details.

PRECAUTIONS

  • Can cause increases in intracranial pressure.
  • Patients with hepatic dysfunction are more susceptible to cyanide toxicity.
  • If possible, correct pre-existing anemia and hypovolemia prior to administration.
  • Use during pregnancy only when there is no appropriate alternative for a particular patient as cyanide toxicity may be fatal to the fetus.
  • No information about the presence of sodium nitroprusside in human milk, the effects on the breastfed infant, or the effects on milk production.

ADVERSE REACTIONS

  • Include: bradycardia, electrocardiographic changes, tachycardia, rash, hypothyroidism, ileus, decreased platelet aggregation, flushing, increased intracranial pressure, venous streaking and irritation at the infusion site.

OVERDOSAGE

Overdosage can manifest as excessive hypotension, cyanide toxicity, or thiocyanate toxicity. To treat cyanide toxicity, discontinue sodium nitroprusside; administer sodium nitrite to convert as much hemoglobin into methemoglobin as the patient can safely tolerate; and then infuse sodium thiosulfate to convert the cyanide into thiocyanate. Hemodialysis is ineffective in removal of cyanide, but it will eliminate most thiocyanate.

You are encouraged to report negative side effects of prescription drugs to the FDA. Call 1-800-FDA-1088 or Visit www.fda.gov/medwatch.

About Exela Pharma Sciences

Exela Pharma Sciences, a fast-growing specialty pharmaceutical company, focuses on developing, manufacturing and marketing proprietary and generic injectable and sterile ophthalmic products with the healthcare provider and patient in mind. Our goal is to deliver high quality, affordable products that make a difference in people’s lives and meet the needs of the healthcare providers that treat them. Built from a strong Research and Development, Regulatory and Quality foundation, Exela is focused on delivering excellence in Quality, Reliability and Affordability. Established in 2005 by a former Pharmacist, Exela is headquartered in Lenoir, N.C. Please visit www.exelapharma.com to learn more.

1.American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health Syst Pharm. 2013;70(18):1619-1630, Institute for Safe Medication Practices. Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for SAFE Preparation of Sterile Compounds. http://www.ismp.org/tools/guidelines/IVSummit/IVCGuidelines.pdf. Accessed February 26, 2016

For more information, contact Mark Hartman at mhartman@exela.us