Merck 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). (See Selected
Safety Information below.)
“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.
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