FDA Approves Merck’s Noxafil (posaconazole) Injection

WHITEHOUSE STATION, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved Noxafil (posaconazole) injection (18 mg/ mL), a new formulation of Noxafil for intravenous (IV) use. Merck’s antifungal agent is also marketed as Noxafil (100 mg) delayed-release tablets and Noxafil (40 mg/mL) oral suspension. Noxafil injection, delayed-release tablets and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy. Noxafil injection is indicated in patients 18 years of age and older. Noxafil delayed-release tablets and oral suspension are indicated in patients 13 years of age and older. With this approval, Merck now provides an IV formulation and two oral formulations of Noxafil for prophylaxis against invasive Aspergillus and Candida infections in high-risk patients.

Noxafil should not be administered to persons allergic to posaconazole or other azole antifungal medicines. The administration of Noxafil with sirolimus, pimozide, quinidine, atorvastatin, lovastatin, simvastatin and ergot alkaloids must be avoided. When administered with Noxafil, some drugs such as cyclosporine and tacrolimus required dosage adjustments and frequent monitoring of their levels in the blood as serious side effects in the kidney (nephrotoxicity) or brain (leukoencephalopathy) including deaths have been reported in patients with increased cyclosporine or tacrolimus blood levels. Noxafil should be administered with caution to patients who may develop an irregular heart rhythm as Noxafil has been shown to prolong the QT interval and cases of potentially fatal irregular heart rhythm (torsades de pointes) have been reported in patients taking Noxafil (posaconazole).

“Merck is pleased to add Noxafil injection to the Noxafil family of products. The availability of a Noxafil formulation for intravenous administration is particularly important for those patients who may benefit from or require intravenous therapy, or who, for a variety of reasons, might not be able to take an oral formulation. In addition, patients have the possibility to start on Noxafil injection and transition to oral Noxafil,” said Dr. Nicholas Kartsonis, executive director, Infectious Disease, Merck Research Laboratories.

Noxafil injection offers patients once-daily maintenance dosing following a twice-daily loading dose on the first day of Noxafil therapy. Noxafil injection is administered with a loading dose of 300 mg (one 300 mg vial) twice a day on the first day of Noxafil therapy, then 300 mg (one 300 mg vial) once a day thereafter. Once combined with a mixture of intravenous solution (150 mL of 5% dextrose in water or sodium chloride 0.9%), Noxafil injection should be immediately administered through an in-line filter. Administer Noxafil through a central venous line by slow IV infusion over approximately 90 minutes. If not used immediately, the solution can be stored up to 24 hours refrigerated at 2-8 degrees C (36-46 degrees F). Coadministration of drugs that can decrease the plasma concentration of posaconazole should generally be avoided unless the benefit outweighs the risk. If such drugs are necessary, patients should be monitored closely for breakthrough fungal infections.

In clinical trials, the adverse reactions reported for Noxafil IV injection were generally similar in type to that reported in trials of Noxafil oral suspension. The most frequently reported adverse reactions with an onset during the posaconazole intravenous phase of dosing 300 mg once-daily therapy were diarrhea (32%), hypokalemia (22%), fever (21%) and nausea (19%).

Noxafil injection is expected to be available at wholesalers in mid-April.

About Merck

Today's Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside of the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit www.merck.com and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Merck’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of Merck patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2013 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov).

Please see Prescribing Information for Noxafil (posaconazole) IV injection, delayed-release tablets and oral suspension at http://www.spfiles.com/piNoxafil.pdf and Patient Information for Noxafil at http://www.spfiles.com/ppiNoxafil.pdf.

Noxafil® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, N.J., USA.

Source: Merck & Co., Inc.

Posted: March 2014

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Noxafil (posaconazole) FDA Approval History

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