The FDA has recently announced the approval of a new drug used to treat relapsing multiple sclerosis. Manufacturer Biogen Idec Inc. announced their peg interferon beta-1a injection, known as Plegridy, received approval as a treatment option for relapsing forms of MS.
By attaching a polyethylene glycol molecule to the interferon beta-1a, it extends the medication’s half life, thus allowing patients to go longer between doses. Their product has a dosing schedule of once every two weeks, while the other two interferon beta-1a products on the market must be administered one to three times a week.
The product labeling suggests the medication be administered in 125 µg every two weeks, by injection, starting with the third dose, on day 29. The first dose should be 63 µg, and on day 15, the second dose should be 94 µg. Acceptable injection sites include the: back of the upper arm, abdomen, and thigh.
Random placebo controlled clinical studies showed more than 40% of patients experienced: redness/rash at the injection site, fever, headache, and flu-like symptoms as a side effect of using the medication. To combat these side effects, it’s recommended to administer either an antipyretic or an analgesic, or both, on days when injections are given.
Patients with a history of hypersensitivity to either natural or recombinant interferon or peginterferon products should not use this medication. The clinical trials excluded patients who have progressive forms of MS.
Patients who use this medication may experience liver problems. Those with existing liver problems should be closely monitored, as it is possible the medication will worsen liver problems. It is also possible patients who use this therapy will experience depression and suicidal thoughts. Regular blood testing will be required to monitor liver function. Patients who experience yellowing of the skin or eyes should seek medical attention right away.
Plegridy will be available in both injector pens and syringes, filled with 0.5 mL of the solution. Starter packs will contain two pens or syringes for administering the doses on day 1 and day 15. Regular packs will be available for administering additional doses, each containing two pens or syringes.
Pharmacies should store the medication in its original packaging, closed, in a refrigerator at 2–8 °C (36°F to 46°F). Storage, for up to 30 days, is allowed at temperatures between 2 and 25°C (36°F to 77°F). Before using, remove the pen or syringe from the refrigerator and allow it to warm to room temperature on its own. Do not attempt to warm the medication.
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