Mallinckrodt Announces U.S. FDA Approval of OFIRMEV® IV Bag Presentation

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Mallinckrodt Pharmaceuticals

Nov 08, 2016, 07:35 ET

CHESTERFIELD, United Kingdom, Nov. 8, 2016 /PRNewswire/ -- Mallinckrodt Pharmaceuticals (NYSE: MNK), a leading global specialty pharmaceutical company, announced today the U.S. Food and Drug Administration (FDA) has approved a Prior Approval Supplement for OFIRMEV® (acetaminophen) injection available in an intravenous (IV) bag presentation, which will provide health care providers an additional delivery option.

The Prior Approval Supplement to the approved OFIRMEV New Drug Application included the addition of a new container closure and manufacturer. The polypropylene bags will be manufactured by Fresenius Kabi. Mallinckrodt anticipates product availability in the second quarter of 2017.

ABOUT OFIRMEV (Acetaminophen) Injection
OFIRMEV (acetaminophen) injection is the first and only intravenous (IV) formulation of acetaminophen to be approved and currently marketed in the United States. The U.S. Food and Drug Administration approved OFIRMEV in November 2010. OFIRMEV is available to hospitals and outpatient and ambulatory surgical centers across the U.S.

INDICATIONS AND USAGE
OFIRMEV (acetaminophen) Injection is indicated for the management of mild to moderate pain, management of moderate to severe pain with adjunctive opioid analgesics, and reduction of fever.

IMPORTANT RISK INFORMATION

WARNING: RISK OF MEDICATION ERRORS AND HEPATOTOXICITY

 

Take care when prescribing, preparing, and administering OFIRMEV Injection to avoid dosing errors which could result in accidental overdose and death. In particular, be careful to ensure that:     

  • the dose in milligrams (mg) and milliliters (mL) is not confused;
  • the dosing is based on weight for patients under 50 kg;
  • infusion pumps are properly programmed; and
  • the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.

OFIRMEV contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the recommended maximum daily limits, and often involve more than one acetaminophen-containing product.

CONTRAINDICATIONS

  • Acetaminophen is contraindicated in patients with:
  • known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation.
  • severe hepatic impairment or severe active liver disease.

WARNINGS AND PRECAUTIONS

  • Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of liver failure and death. Do not exceed the maximum recommended daily dose of acetaminophen. The maximum recommended daily dose of acetaminophen includes all routes of acetaminophen administration and all acetaminophen-containing products administered, including combination products. Dosing errors could result in accidental overdose and death.
  • Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, alcoholism, chronic malnutrition, severe hypovolemia (e.g., due to dehydration or blood loss), or severe renal impairment (creatinine clearance ≤ 30 mL/min).
  • Rarely, acetaminophen may cause serious skin reactions such as acute generalized exanthematous pustulosis (AGEP), Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal.
  • Hypersensitivity and anaphylaxis associated with the use of acetaminophen have been reported. Clinical signs included swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, and pruritus.
  • The antipyretic effects of OFIRMEV may mask fever.

ADVERSE REACTIONS

  • Serious adverse reactions may include hepatic injury, serious skin reactions, allergy and hypersensitivity, and anaphylaxis.
  • Common adverse reactions in adults include nausea, vomiting, headache, and insomnia. Common adverse reactions in pediatric patients include nausea, vomiting, constipation, pruritus, agitation, and atelectasis.

USE IN SPECIFIC POPULATIONS

  • Pregnancy Category C. OFIRMEV should be given to a pregnant woman only if clearly needed.
  • Breastfeeding: While studies with OFIRMEV have not been conducted, acetaminophen is secreted in human milk in small quantities after oral administration.
  • Pediatric Use: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients < 2 years of age.

For additional Important Risk Information, including complete boxed warning, see Full Prescribing Information.

ABOUT MALLINCKRODT
Mallinckrodt is a global business that develops, manufactures, markets and distributes specialty pharmaceutical and biopharmaceutical products and therapies, as well as nuclear imaging products. Areas of focus include autoimmune and rare diseases in specialty areas like neurology, rheumatology, nephrology, pulmonology and ophthalmology; immunotherapy and neonatal respiratory critical care therapies; analgesics and hemostasis products; and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing; and the Nuclear Imaging segment includes nuclear imaging agents. To learn more about Mallinckrodt, visit www.mallinckrodt.com.

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Contacts:

Investor Relations
Coleman N. Lannum, CFA
Senior Vice President, Investor Strategy and IRO
314-654-6649
[email protected]

Daniel J. Speciale, CPA
Director, Investor Relations
314-654-3638
[email protected]

Media
Rhonda Sciarra
Senior Manager, Communications
314-654-8618
[email protected]

Meredith Fischer
Chief Public Affairs Officer
314-654-3318
[email protected]

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SOURCE Mallinckrodt Pharmaceuticals