Method for reducing flu-like symptoms associated with intramuscular administration of interferon using a fast titration escalating dosing regimen

Abstract

The present invention provides a method for treating multiple sclerosis (MS), and for reducing flu-like symptoms associated with administration of an interferon to a patient with MS. The method involves intramuscularly administering the interferon to the MS patient according to an escalating dosing regimen in weeks 1 to 3, and a full therapeutically effective dose of interferon in week 4. In one embodiment of the invention, the escalating dosing regimen comprises administering one quarter of the therapeutically effective dose in week 1, half of the therapeutically effective dose in week 2, and three-quarters of the therapeutically effective dose in week 3. Also provided are titration packages for enabling compliance with a regimen of changing dosage of an interferon over a period of time.

1 . A method of titrating a dose of interferon-β-1a in a dosage titration regimen in a patient suffering from multiple sclerosis, the method comprising providing a titration package for titrating the dosage of interferon-β-1a weekly up to a full dosage of 30 μg of interferon-β-1a to the patient in week four so as to reduce the severity of flu-like symptoms associated with treating a patient having multiple sclerosis with intramuscularly administered interferon-β-1a, the method comprising:
 titrating the interferon-β-1a dosage in weeks one through three using a titration package comprising interferon-β-1a and delivery devices for once a week intramuscular administration to a patient having multiple sclerosis according to a first titration schedule comprising: 
 a) a first delivery device for intramuscularly administering 7.5 μg of interferon-β-1a to the patient in week one; 
 b) a second delivery device for intramuscularly administering 15 μg of interferon-β1a to the patient in week two; and 
 c) a third delivery device for intramuscularly administering 22.5 μg of interferon-β-1a to the patient in week three; 
 intramuscularly administering 30 μg of interferon-β-1a to the patient in week four and thereafter. 
 
     
     
         2 . The method of  claim 1 , further comprising providing vials containing the interferon-β-1a in lyophilized form. 
     
     
         3 . The method of  claim 2 , further comprising providing a vial adapter and the delivery devices are syringes pre-filled with a diluent for said lyophilized interferon-β-1a. 
     
     
         4 . The method of  claim 1 , wherein the delivery devices are pre-filled syringes containing correct dosages of interferon-β-1a in liquid form. 
     
     
         5 . The method of  claim 1 , wherein the delivery device comprises an auto-injector. 
     
     
         6 . The method of  claim 1 , wherein the delivery device is needle-free. 
     
     
         7 . The method of  claim 1 , wherein the delivery device is a pen. 
     
     
         8 . The method of  claim 1 , further comprising a needle stick prevention device. 
     
     
         9 . The method of  claim 1 , wherein the needle-stick prevention device comprises a needle shield. 
     
     
         10 . The method of  claim 9 , wherein the shield is activated manually by the patient. 
     
     
         11 . The method of  claim 9 , wherein the shield is automated. 
     
     
         12 . The method of  claim 11 , wherein the automated shield is activated by the patient. 
     
     
         13 . The method of  claim 11 , wherein the needle is automatically shielded without any action by the patient. 
     
     
         14 . The method of  claim 11 , wherein the needle is shielded without any action by the patient. 
     
     
         15 . The method of  claim 1 , wherein the package further comprises a dose-limiting titration device. 
     
     
         16 . The method of  claim 1 , further comprising administering an analgesic, a steroid, or anti-inflammatory drug, or a mixture thereof. 
     
     
         17 . The method of  claim 16 , wherein the drug is an analgesic. 
     
     
         18 . The method of  claim 16 , wherein the drug is a non-steroidal anti-inflammatory agent. 
     
     
         19 . The method of  claim 16 , wherein the drug is acetaminophen. 
     
     
         20 . The method of  claim 16 , wherein the drug is ibuprofen.