Drug Interaction:
Myleosuppressive agents - because of possibility of interferon beta -1a to cause neutropenia, and lymphoma proper monitoring is required if administered concomittantly with mylosuppressive agents
Indication:
Multiple sclerosis
Patent Expiry Date of drugs (Ref - IDMA Publication)
Chemical Category Manufacturer/ US Patent
Ingredient- Marketer Expiration Date
Interferon Biopharmaceutical Berlex Labs 07-07-2007
beta-1b
Adverse Reaction:
Most serious adverse reactions were depression, suicidal ideation
Most commonly reported adverse reactions were-
asthenia, flu -like symptoms, headache, injection site reactions, lymphoma, and pain
Adverse reactions-
Cardiovascular - vasodilation 2%
CNS - asthenia 20%, depression 15%, dizziness 12% headache 50%
Dermatologic - alpoecia 4%
GI - abdominal pain 6%
Contra-Indications:
Hypersensitivity to components in the formulation
Precautions/ warnings
Chronic progressive MS multiple sclerosis - safety and efficacy of interferon beta in chronic MS have not been evaluated
Depression - use with caution in patients suffering from depression, or mood disorders.
Suicidal attempts are known to occur. Advice patients to report any symptoms of depression
Injection site necrosis - has been reported
Anaphylaxis- anaphylaxis has been reported as a rare complicationof interferon beta use
Decreased peripheral blood counts - decreased peripheral blood counts in all cell lines, including rare pancytopenia and thrombocytopenia have been reported
Special risk patients- excercise caution when administering interferon beta -1a to patients with pre-existing seizure disorders. Seizures have been associated with the use of beta interferons
Cardiac disease - closely monitor ptients with cardiac disease such as angina, CHF or arrhythmias, for worsening of their condition during treatment taking interferon beta
Hepatic function impairment - Very rarely, severe liver dysfunction leading to hepatic failure requiring liver transplant has been reported rarely in patients
Photosensitivity - caution patients to take protective measures against exposure to sun light or ultraviolet light
Pregnancy - no adequate and well documented studies in pregnant women. Weigh the potential benefit against potential hazards to the fetus before taking interferon beta
Lactation- It is not known whether interferon beta is excreted in breast milk. Decide whether to discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother
Children- safety and efficacy in children younger than 18 years of have not established
Dosages/ Overdosage Etc:
Indication-
Multiple sclerosis
Dosage-
Dosages shown to be safe are 22 and 44 mcg injected subcutaneously 3 time per week.
Administer if possible at the same time preferably in the late afternoon or evening on the same
day 3 times, ( Monday, Wednesday , Friday ) at least 48 hrs apart ech week.
Generally start patients at 20% of the prescribed dose 3 times per and increased over a
4-week period to the targeted dose either 22 or 44mcg 3 times per week
Patient Information:
1. Instruction for self -injection technique - instruct patients in the use of aspectic technique when administering interferon beta . Give appropiate instruction for reconstitution of the product and self injection
2. Caution patients not to change the dosage or the schedule of administration without consulting doctor
3. Disposal - caution patients against the re-use of needles or syringes and instruct them in
safe disposal procedures
4. Injection site reactions- injection site reactions may occurat least one time during therapy. In general these are transient and do not require discontinuationof the therapy
5. Flu-like symptoms- are common following initiation of therapy. Symptoms of flu syndrome are most prominent at the initiation of therapy and decrease in frequency with continued therapy
6. Depression/suicide - caution patients to report depression or suicidal ideation
7. Abortifacient potential - advice patients about the abortificient potential
8. Photosentiivity - advice patients to avoid prolonged exposure to sun light or ultraviolet light since interferon beta may cause photosentivity
Pregnancy and lactation:
Pregnancy -
No adequate and well documented studies in pregnant women. Weigh the potential
benefit against potential hazards to the fetus before taking interferon beta
Lactation-
It is not known whether interferon beta is excreted in breast milk. Decide whether to
discontinue nursing or discontinue the drug taking into account the importance of the drug to the mother
Children-
Safety and efficacy in children younger than 18 years of have not established