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 reconstituted with 1.0 ml of sterile water provided for injection, immediately prior to use.
1 vial (Diluent) X 2
Sealed container, between 2°and 8°C, keep out of direct sunlight.
1. Do not administer to the following patients
1) Person who has a history of hypersensitivity in this drug and its ingredients.
2) Patients who intentionally degrade immune functions such as organ transplants (This medicine promotes immune function).
2. Abnormal reaction
This medicine is generally drug-tolerant. A clinical study involving more than 990 patients showed no clinically significant side effects caused by thymosin alpha 1, but a reduction in the heat and transitory of the injection site in a study using other prescribed drugs containing thymosin alpha 1 drug other than this drug. These symptoms were observed in patients with specific manufacturing units but were eliminated when they were 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 had nausea when compared with the recommended dose of 0.9 mg/㎡.
Even if this drug may temporarily increase the ALT numerical value in the blood by more than twice the reference value, administration should be continued with the drug unless signs of liver damage are observed. There may also be rare red spots, temporary muscle hypertrophy, and multiple joint pains, such as local symptoms of the injection site and swelling of the hands in low-frequency due to adverse reactions. In the survey conducted with 602 people in Korea, back pain was once reported over the past 6 years.
3. General caution
During the period of administration of this drug, liver function tests (serum ALT, albumin, and bilirubin measurements) should be
performed on a regular basis.
4. Drug interactions
Carefully 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 unknown to pregnant women (Pregnancy Category C) only when the benefits of the drug exceeded its risks, the drug was administered. Moreover, it is unknown whether the drug is transferred to the milk, so it should be administered carefully 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 cases of deliberate or accidental overdosage in humans. Animal testing studies showed no adverse reactions to a single dose up to 20 mg/kg and in repeated doses up to 6 mg/kg/day for 13 weeks, which were the highest doses studied. The highest single dose tested in animals represents 800-times the clinical dose. There were no adverse reactions in humans when 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.