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Rx Item-Avonex 30Mcg .5ml Kit 4 by Biogen Refrigerated

NDC No.59627-0222-05 UPC/GTIN No.3-59627-22205-1 MPN 22205 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical TherapisBiogenOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Avonex 30Mcg .5ml Kit 4 by Biogen Refrigerated

$8906.04$8004.99

NDC No.59627-0222-05 UPC/GTIN No.3-59627-22205-1 MPN 22205 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX Item. Rx Item No.Rx400642 Avonex 30Mcg/.5ml Kit 4 by Biogen Item No.3400642 NDC No.59627022205 UPC No.359627222051 Other Name Interferon Beta-1A Im Therapeutic Code 922000 Therapeutic Class Immunomodulatory

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AVONEX- interferon beta-1a
Biogen Idec MA Inc.
DESCRIPTION
AVONEX is 166 amino acid glycoprotein with molecular weight of approximately 22,500 daltons. It is produced by recombinant DNA technology using genetically engineered Chinese Hamster Ovary cells into which the human interferon beta gene has been introduced. The amino acid sequence of AVONEX is identical to that of natural human interferon beta.
Mechanism of Action
The mechanism of action by which AVONEX exerts its effects in patients with multiple sclerosis is unknown.
INDICATIONS AND USAGE
AVONEX (interferon beta-1a) is indicated for the treatment of patients with relapsing forms of multiple sclerosis to slow the accumulation of physical disability and decrease the frequency of clinical exacerbations. Patients with multiple sclerosis in whom efficacy has been demonstrated include patients who have experienced first clinical episode and have MRI features consistent with multiple sclerosis.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing info.
AVONEX is administered intramuscularly.
The recommended dose is 30 micrograms once week. To reduce the incidence and severity of flu-like symptoms that may occur when initiating AVONEX therapy at dose of 30 micrograms, AVONEX may be started at dose of 7.5 micrograms and the dose may be increased by 7.5 micrograms each week for the next three weeks until the recommended dose of 30 micrograms is achieved
An AVOSTARTGRIP kit containing titration devices can be used for titration and is to be used only with AVONEX Prefilled Syringes.

1 Dosed once week, intramuscularly


AVONEX Dose1
Recommended Dose
Week 1
7.5 micrograms
1/4 dose
Week 2
15 micrograms
1/2 dose
Week 3
22.5 micrograms
3/4 dose
Week 4+
30 micrograms
full dose
2.2 Important Administration Instructions (All Dosage Forms)
All AVONEX dosage forms are single-use (injection of reconstituted solution, prefilled syringe, and prefilled autoinjector). See Patient?s Instructions for Use for complete administration instructions.
The first AVONEX injection should be performed under the supervision of an appropriately qualified health care professional. If patients or caregivers are to administer AVONEX, train them in the proper intramuscular injection technique and assess their ability to inject intramuscularly to ensure the proper administration of AVONEX.
Advise patients and caregivers to:
rotate sites for intramuscular injections with each injection to minimize the likelihood of injection site reactions
NOT inject into an area of the body where the skin is irritated, reddened, bruised, infected or scarred in any way
Check the injection site after hours for redness, swelling, or tenderness
Contact their doctor or nurse if they have skin reaction and it does not clear up in few days
A 25 gauge, 1? needle for intramuscular injection with AVONEX prefilled syringe or injection of reconstituted solution may be substituted for the 23 gauge, ?? needle by the healthcare provider, if deemed appropriate. 25 gauge, 5/8? needle specific to the prefilled autoinjector is supplied with the AVONEX PEN Administration Dose Pack. DO NOT use any other needle with the autoinjector.
Use safe disposal procedures for needles and syringes. Do not re-use needles, syringes, prefilled syringes, or autoinjectors. Following the administration of each titrated dose, discard any remaining product.
2.3 Premedication for Flu-like Symptoms
Concurrent use of analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms associated with AVONEX use.
DOSAGE FORMS AND STRENGTHS
For injection: 30 micrograms lyophilized powder in single-use vial
Injection: 30 micrograms per 0.5 mL solution in single-use prefilled syringe
Injection: 30 micrograms per 0.5 mL solution in single-use prefilled autoinjector
4 CONTRAINDICATIONS
AVONEX is contraindicated in patients with history of hypersensitivity to natural or recombinant interferon beta, or any other component of the formulation [see Warnings and Precautions ].
The lyophilized vial formulation of AVONEX is contraindicated in patients with history of hypersensitivity to albumin (human).
5 WARNINGS AND PRECAUTIONS
5.1 Depression, Suicide, and Psychotic Disorders
Patients treated with AVONEX and their caregivers should be advised to report immediately any symptoms of depression, suicidal ideation, and/or psychosis to their prescribing physicians. If patient develops depression or other severe psychiatric symptoms, cessation of AVONEX therapy should be considered.
5.2 Hepatic Injury
Severe hepatic injury, including cases of hepatic failure, has been reported rarely in patients taking AVONEX. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge with AVONEX. In some cases, these events have occurred in the presence of other drugs that have been associated with hepatic injury. The potential risk of AVONEX used in combination with known hepatotoxic drugs or other products (e.g., alcohol) should be considered prior to starting AVONEX, or before starting hepatotoxic drugs. Patients should be monitored for signs of hepatic injur
5.3 Anaphylaxis and Other Allergic-Reactions
Anaphylaxis has been reported as rare complication of AVONEX use. Other allergic reactions have included dyspnea, orolingual edema, skin rash and urticaria. Discontinue AVONEX if anaphylaxis or other allergic reactions occur.
5.4 Congestive Heart Failure
Patients with pre-existing congestive heart failure should be monitored for worsening of their cardiac condition during initiation of and continued treatment with AVONEX. While beta interferons do not have any known direct cardiac toxicity, during the post-marketing period cases of congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure have been reported in patients without known predisposition to these events, and without other etiologies being established. In some cases, these events have been temporally related to the administration of AVONEX. In some of these instances recurrence upon rechallenge was observed.
5.5 Decreased Peripheral Blood Counts
Decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia, have been reported from postmarketing experience in AVONEX-treated patients
Seizures
Seizures have been temporally associated with the use of beta interferons in clinical trials and postmarketing safety surveillance. In the two placebo-controlled studies in multiple sclerosis patients receiving AVONEX experienced seizures, while no seizures occurred in the placebo group.
5.7 Autoimmune Disorders
Post-marketing reports of autoimmune disorders of multiple target organs in AVONEX-treated patients included idiopathic thrombocytopenia, hyper- and hypothyroidism, and rare cases of autoimmune hepatitis. If AVONEX-treated patients develop new autoimmune disorder, consider stopping the therapy.
Laboratory Tests
In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts, and blood chemistries, including liver function tests, are recommended during AVONEX therap
Pregnancy
Pregnancy Category C
HOW SUPPLIED/STORAGE AND HANDLING
16.1 AVONEX Lyophilized Powder Vial
A vial of AVONEX is supplied as lyophilized powder in single-use vial containing 33 micrograms (6.6 million international units) of interferon beta-1a; 16.5 mg Albumin (Human), USP; 6.4 mg Sodium Chloride, USP; 6.3 mg Dibasic Sodium Phosphate, USP; and 1.3 mg Monobasic Sodium Phosphate, USP, and is preservative-free. Diluent is supplied in single-use vial (Sterile Water for Injection, USP).
AVONEX lyophilized vials are available in the following package configuration (NDC 59627-001-03): package containing four Administration Dose Packs (each containing one vial of AVONEX, one 10 mL diluent vial, two alcohol wipes, one gauze pad, one mL syringe, one MICRO PIN? vial access pin, one 23 gauge, 1? inch needle, and one adhesive bandage).
Vials of AVONEX should be stored in 2?C to 8?C (36?F to 46?F) refrigerator. Should refrigeration be unavailable, vials of AVONEX can be stored at 25?C (77?F) for period of up to 30 days. DO NOT EXPOSE TO HIGH TEMPERATURES. DO NOT FREEZE. Protect from light. Do not use beyond the expiration date stamped on the vial. Following reconstitution, it is recommended the product be used as soon as possible within hours stored at 2?C to 8?C (36?F to 46?F). DO NOT FREEZE RECONSTITUTED AVONEX.
16.2 AVONEX Single-Use Prefilled Syringe
A prefilled syringe of AVONEX is supplied as sterile liquid albumin-free formulation containing 30 micrograms of interferon beta-1a, 0.79 mg Sodium Acetate Trihydrate, USP; 0.25 mg Glacial Acetic Acid, USP; 15.8 mg Arginine Hydrochloride, USP; and 0.025 mg Polysorbate 20 in Water for Injection, USP. Each prefilled glass syringe contains 0.5 mL for Intramuscular injection.
AVONEX prefilled syringes are available in the following package configuration (NDC 59627-002-05): package containing four Administration Dose Packs (each containing one single-use syringe of AVONEX and one 23 gauge, 1? inch needle), and recloseable accessory pouch containing alcohol wipes, gauze pads, and adhesive bandages.
AVONEX in prefilled syringes should be stored in 2?C to 8?C (36?F to 46?F) refrigerator. Once removed from the refrigerator, AVONEX in prefilled syringe should be allowed to warm to room temperature (about 30 minutes). Do not use external heat sources such as hot water to warm AVONEX in prefilled syringe. Should refrigeration be unavailable, AVONEX in prefilled syringe can be stored at 25?C (77?F) for period up to days. Once the product is removed from the refrigerator, it must not be stored above 25?C (77?F). If the product has been exposed to conditions other than those recommended, DISCARD THE PRODUCT and DO NOT USE. DO NOT EXPOSE TO HIGH TEMPERATURES. DO NOT FREEZE. Protect from light. Do not use beyond the expiration date stamped on the syringe.



NDC No.59627-0222-05 UPC/GTIN No.3-59627-22205-1 MPN 22205 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapis
Avonex 30Mcg .5ml Kit 4 by Biogen Refrig
NDC No.59627-0222-05 UPC/GTIN No.3-59627-22205-1 MPN 22205 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapis

Biogen
AmericanPharmaWholesale.com
Biogen

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
INTERFERON BETA-1A INTRAM
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

Want to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.com
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.
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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.