Immualpha inj. (Thymosin alpha 1)
Product classification: General medication
1.6 mg (900 µg/m²) thymosin alpha 1 per vial
1.0 ml of Sterile Water
Lyophilized Thymosin alpha 1 per vial and Sterile Water
Supplemental treatment for influenza vaccination in elderly patients with impaired immune functions.
900µg/m² (1 vial) is intended for subcutaneous or intramuscular injection twice a week for 4 weeks after vaccination.
It should be reconsitituted with 1.0 ml of Sterile Water provided for injection, immediately prior to use.
1 vial (Diluent) X 2
Sealed container, 2°and 8°C, keep out of direct sunlight
1. Do not administer to the next patient.
1) Person who has a history of hypersensitivity in this drug and its ingredients
2) Patients who intentionally degrade immune funtions such as organ trasplants (This medicine promotes immune function).
2. Abnormal reaction
This medicine is generally drug-tolerant. A clinical study involving more than 990 patients showed no clinical significant side effects caused by cyomosine alpha 1, but a reduction in the heat and transitory of the injection site in a study using other prescribed drug contained cyomosine alpha 1 drug other than this drug. These symptoms were observed in patients with specific manufacturing units but were eliminated when replaced by new units.
In a single dose determination study, one patient who was administered 2.4 mg/㎡ doses was found to have a fever and two patients with 4.8 and 9.6 mg/㎡ doses to have nausea when compared with the recommended dose of 0.9 mg/㎡.
Even if this drug may temporarily increases the ALT numerical value in blood by more than twice from the reference value, administration should be continued with the drug unless signs of liver damage are observed. There are also rare red spots, temporary muscle hypertrophy, and multiple joint pain that occur, such as local symptoms of the injection site and swelling of the hands in low-frequency due to adverse reactions. For a review in S. Korea, back pain was once reported in a survey of 602 people over the past 6 year
3. General caution
During the period of administration of this drug, liver function tests (serum ALT, albumin and bilirubin measurements) are performed on a regular basis
4. Drug interactions
Care should be taken when combined with other immunomodulators and should not be mixed with other drugs.
5. Administration to pregnant women and nursing mothers
Animal testing did not report any fatal flaws in the embryo caused by the drug's administration, but since the effects of reproductive ability or hazards were unkown to pregenant women (Pregnancy Category C) only when the benefits of the drug exceeds its risks the drug is administered. Moreover, it is unknown whether the drug is trasffered to the milk, so care should be taken when administering it to breast-feeding women.
6. Administration to children
Safety and effectiveness have not been established for patients under the age of 18
There are no reported instances of deliberate or accidental overdosage in humans. Animal testing studies showed no adverse reactions in a single dose up to 20 mg/kg and in repeated doses up to 6 mg/kg/day for 13 weeks, which were highest doses studied. The highest single dose tested in animals represents 800-times the clinical dose. There was no adverse reaction in humans if 16 mg was administered twice a week for 4 weeks
8. Further information
1) Carcinogenecity test was not conducted by this drug.
2) Lyophilized thymosin alpha 1 should be immediately reconstituted the provided diluent prior to use.