- AVONEX PEN®
- The new AVONEX PEN (AVONEX 30mcg/0.5mL solution for injection) is the first intramuscular (IM) autoinjector for chronic use, designed to enhance the self-injection process for patients receiving AVONEX therapy.
- A new dose titration regimen, facilitated by the AVOSTARTGRIP titration devices, provides patients with the option to gradually increase the dose of AVONEX at treatment initiation to reduce the incidence and severity of flu-like symptoms that patients may experience with therapy.
These product enhancements offer the potential for a more tolerable initiation and an easier injection process compared to the AVONEX Prefilled Syringe.
“It is our priority to continue to improve our existing treatments like
AVONEX, which patients have relied on to effectively treat their MS
since it was approved in the U.S in 1996,” said
AVONEX PEN is the first IM autoinjector approved in MS treatment. It was
designed to enhance the self-injection process and features a
substantially smaller needle than the AVONEX Prefilled Syringe.
“One of the key aspects of treating MS is helping patients manage their
treatment in order to get the most out of their therapy,” said Peter B.
Wade, M.D., medical director at the Joyce D. and
The recently-approved AVONEX titration schedule can be facilitated by
the AVOSTARTGRIP kit, a set of three devices that work with the AVONEX
Prefilled Syringe to administer the appropriate amount of medicine
needed to titrate up to a full dose of AVONEX over the course of three
weeks. The
Patients who are new to AVONEX treatment have the option to initiate therapy with the AVOSTARTGRIP titration kit; once patients have completed the titration regimen, treatment can be continued with AVONEX PEN or other approved dosing options.
AVONEX PEN is available from the same pharmacies patients currently fill their AVONEX Prefilled Syringe prescriptions. Patients and healthcare providers who would like more information about AVONEX PEN or the AVOSTARTGRIP titration kit can visit www.avonex.com.
About AVONEX PEN
AVONEX PEN is the first single-use, once-a-week, fully integrated IM autoinjector for MS. It is designed for use with AVONEX treatment in patients with relapsing forms of MS. AVONEX PEN integrates the currently approved AVONEX Prefilled Syringe and incorporates a smaller needle (25 gauge, 5/8 inch), which is thinner and 50 percent shorter than the standard AVONEX Prefilled Syringe needle.
Additional features of AVONEX PEN include: a protective injector shield that conceals the needle prior to injection; automated needle insertion and medication delivery; and a diameter and length designed to stabilize AVONEX PEN during the injection procedure. In addition, AVONEX PEN incorporates a safety lock, which helps prevent injection error and a display window that confirms complete delivery of the medication.
The efficacy and safety of AVONEX PEN was evaluated in an open-label, multicenter, Phase 3b study (n=70). Efficacy was assessed through objective and subjective assessments of key aspects of patients’ use of AVONEX PEN.
About Titration
The AVONEX label provides physicians and patients with a clinically-supported schedule for gradually escalating the dose of AVONEX at the start of therapy, which has been shown to reduce the incidence and severity of flu-like symptoms that can occur with AVONEX treatment. In an eight-week, healthy-volunteer, randomized, Phase 1 study (n=234), a three-week titration period at the initiation of AVONEX treatment reduced the incidence (Odds Ratio: 0.18) of flu-like symptoms versus no titration four to six hours post-injection. It also reduced the severity of flu-like symptoms by 76 percent versus no titration four to six hours post-injection.
Titration with AVONEX can be facilitated by the AVOSTARTGRIP kit, a set of three devices that work with the AVONEX Prefilled Syringe to administer three titrated doses of AVONEX over a three-week period: 7.5mcg, 15mcg and 22.5mcg. The full dose should be administered at week four.
A titration regimen should only be considered for patients initiating AVONEX therapy. Once patients have completed the titration regimen, treatment can be continued with AVONEX PEN or other administration options.
AVOSTARTGRIP titration kits are provided free of charge to patients who
initiate treatment with AVONEX. For more information about services
About AVONEX
AVONEX is one of the most prescribed treatments for relapsing forms of MS worldwide. AVONEX is indicated for the treatment of patients with relapsing forms of MS to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with MS in whom efficacy has been demonstrated include patients who have experienced a first clinical episode and have MRI features consistent with MS.
Symptoms of depression, suicidal ideation, or psychosis, and cases of suicide, have been reported with increased frequency with patients receiving AVONEX. Severe hepatic injury, including cases of hepatic failure has been reported rarely in patients. Rare cases of anaphylaxis have been reported. While beta interferons do not have any known direct cardiac toxicity, cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition. Decreased peripheral blood counts have been reported from postmarketing experience. Seizures have been reported in patients using AVONEX, including patients with no prior history of seizure. Autoimmune disorders of multiple target organs have been reported. Routine periodic blood chemistry, hematology, liver function, and thyroid function tests are recommended. There are no adequate and well-controlled studies in pregnant women. AVONEX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The most common side effects associated with AVONEX treatment are flu-like symptoms, including chills, fever, myalgia, and asthenia.
For additional important safety information, and the complete
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Source:
MEDIA CONTACT:
Biogen Idec
Kate Niazi-Sai,
+1-781-464-3260
or
INVESTOR CONTACT:
Biogen Idec
Ben
Strain, +1-781-464-2442
