AVONEX PACKAGE INSERT PDF

1. Package leaflet: Information for the user. AVONEX 30 micrograms/ ml solution for Injection. (Interferon beta-1a). Pre-filled syringe. Read all of this leaflet. Package leaflet: Information for the user. AVONEX 30 micrograms/ml solution for injection in pre-filled pen. (Interferon beta-1a). Pre-filled pen. Read all of this. Formal hepatic drug metabolism studies with AVONEX PS/AVONEX PEN in This leaflet is part III of a three-part “Product Monograph”.

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Send the page ” ” to a friend, relative, colleague or yourself. We do not record any personal information entered above. The indicated dose is based on data suggesting that early initiation of interferon beta-1a therapy delays the onset of clinically definite Knsert in high-risk patients who have recently experienced a demyelinating event but do not yet have clinical MS.

If a dose is missed, it should be given as soon as possible. The regular schedule may then be packabe, but do not give 2 injections within 2 days of each other. As an alternative, to reduce the incidence and severity of flu-like symptoms, treatment may be initiated with an IM dose of 7.

Doses of 60 mcg IM once weekly do not provide any packqge benefits versus the 30 mcg dose. Titrate patients to the full dose over a 4-week period using the Rebif titration pack, which contains 6 doses of 8. If the goal dose is 22 mcg, in weeks 1 to 2 administer 4. Inserg the goal dose is 44 mcg, in weeks 1 to 2 administer 8.

The 2-year, placebo-controlled PRISMS trial has shown that Rebif 22 mcg or 44 mcg subcutaneously 3 times weekly significantly reduces the number of relapses, delays disability progression, and reduces disease activity and burden as measured by MRI.

All patients got either of the 2 interferon beta-1a doses for the next 4 years; patients who had originally received placebo were randomized to one of the 2 interferon beta-1a dose groups late treatment group.

A long-term follow-up assessment was conducted at year 7 or 8 from the original PRISMS trial; data were available for of the patients and of the were still taking interferon beta-1a subcutaneously 3 times weekly. As compared with data from patients who got late treatment, patients who received interferon beta-1a initially had lower expanded disability status scale progression, relapse rate, and T2 disease burden up to 8 years later; the benefit was greater with the higher interferon beta-1a dose.

Guidelines recommend the use of a peginterferon product plus ribavirin as part of a combination regimen depending on patient factors and genotype. In contrast, none of the placebo recipients and Significantly more patients with a HCV genotype 1 who got both interferon beta-1a and ribavirin had a SVR 37 of 80 as compared with interferon beta-1a monotherapy recipients 19 of In another study, a negative HCV RNA 24 weeks after therapy cessation was obtained in 11 of 51 patients who got 22 mcg subcutaneously daily for 24 weeks and in 14 of 51 patients who also got ribavirin 1, mg PO daily for weight less than 70 kg and 1, mg PO daily for weight 70 kg or more.

Use with caution in patients with hepatic disease. Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed. Immediately discontinue Rebif if jaundice or other symptoms of liver dysfunction appear.

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The dose may be slowly increased once the enzyme concentrations have normalized. Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed. For storage information, see specific product information within the How Supplied section.

Variations in dosage exist among different interferon beta-1a products; these products are not equivalent. Therefore, do not use different interferon beta-1a products in a single treatment regimen.

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Visually inspect parenteral products for particulate matter and discoloration prior to administration whenever solution and container permit. The Rebif liquid is clear to slightly yellow. Do not use if it is cloudy, discolored, or has particles. Interferon beta-1a Avonex 30 mcg is equivalent to 6 million International Units. Premedication with acetaminophen or ibuprofen and administration of interferon beta-1a at bedtime may lessen the severity insrrt flu-like symptoms.

Patients may self-inject only if their physician determines that it is appropriate, and with medical follow-up, and after proper training in packaeg injection technique.

The first avobex should be performed under the supervision of an appropriately qualified health care professional. Refer to the Patient Medication Guide for detailed instructions for preparing and giving a dose. Wash hands prior to handling Dose Pack contents. Remove 1 Administration Dose Pack from refrigerator about 30 minutes svonex to use to warm to room temperature. Do not use external heat sources such as hot water psckage warm.

Do not inject into an area of the body where skin is ijsert, reddened, bruised, infected, or scarred in any way. Use the alcohol wipe to clean the skin at the injection site you choose and allow it to dry prior to injection. After the injection, use gauze pad to apply pressure for a few seconds or rub gently in a circular motion. The injection site should be checked after 2 hours for redness, edema, or tenderness.

Instruct patients to contact their health care provider if a skin reaction occurs that does not resolve in a few days. If a dose is missed, administer it as soon as possible. Continue the regular schedule but do not give 2 injections within 2 days of each other.

Injection sites should be rotated with each administration to minimize iinsert likelihood of injection site reactions. All products are for single-use only. Do not re-use needles, syringes, pre-filled syringes, titration devices, or autoinjectors. Dispose of used vials, needles, syringes, or titration devices in a puncture-resistant container and discard appropriately.

The manufacturer of Avonex offers free training on intramuscular injection administration pacmage patients and their health care partners. Contact MS ActiveSource for more information —— Indert and Administration of Avonex lyophilized powder: Use appropriate aseptic technique for preparation of solution. Rapid addition of the diluent may cause foaming, making it difficult to withdraw the solution.

Gently swirl the vial to aid in dissolution; do not shake. Discard if the reconstituted product contains particulate matter or is discolored. Withdraw 1 ml of reconstituted solution into a syringe.

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Attach the sterile jnsert, and pull the protective cover straight off the needle; do not twist the cover off. Inject intramuscularly at a 90 degree angle into the thigh or upper arm.

Use within 6 hours of reconstitution; store reconstituted solution at 2—8 degrees C 36—46 degrees F ; do NOT freeze. Discard any unused solution. Both drug and diluent vials are single-use only. Administration pavkage Avonex pre-filled syringe: Hold the syringe so the cap is facing down and the 0.

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Be sure the amount of liquid in the syringe is the pakcage or very close to the 0. If the correct amount of liquid is not in the syringe, do not use it and call the pharmacist. Hold syringe upright so that the rubber cap faces up. Remove the cap by bending it at a 90 degree angle until it snaps free. Attach the needle by pressing it ijsert the syringe and turning pacoage clockwise until it locks in place. Be careful not to push the plunger while attaching the needle.

Pull the protective cover straight off the needle; do not twist the cover off. If self-injecting, rotate between thighs. With help from another person, may rotate between thighs and upper arms. Store at 2—8 degrees C 36—46 degrees F. If refrigeration is unavailable, may store at 77 degrees F or less for up to 7 days. After removal from refrigerator, do not store product above 25 degrees C. If the product has avonexx exposed to conditions other than recommended, discard the product and do not use.

Packzge not expose to high temperatures. Administration of Avonex pre-filled syringe using the Avostartgrip titration kit: The dose may be titrated over 3 weeks using the titration kit. A titration device will only allow the administration of a fraction of the full zvonex contents. Select the appropriate titration device for the weekly dose.

Place the device on a flat surface with the door open. Position the prefilled syringe over the device. The syringe needle should point toward the narrow end of the device, and the plunger should point toward the thick end of the device that has a “collar”.

Push the syringe down into the device until both ends snap into place. Close the door over the syringe; a snap sound will occur when the door is closed correctly. Do not re-open the door.

Be sure to push the plunger all the way down until touches the collar. Administration of Avonex pre-filled autoinjector: Ensure tamper-evident cap has isert been removed or is loose. Then grasp the cap and bend it at a 90 degree angle until it snaps off.

Pull off the sterile foil from the needle cover. Hold the Avonex Pen with the glass syringe tip pointing up. Press the needle onto the glass syringe tip.

Gently turn the needle clockwise until firmly attached. Do not remove plastic cover from the needle. Hold Pen with one hand and using other hand, hold onto the injector shield grooved area tightly and quickly pull up on the injector shield until the injector shield covers the needle all the way.

The plastic needle cover will pop off after the injector shield has been fully extended. When the injector shield is extended the right way, there will be a small blue rectangular area next to the oval medication display window.