Thymosin alpha one
Thymosin alpha one Information

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Thymosin alpha one

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About Thymosin alpha one

Thymosin alpha-1 (TA1) is an investigational drug in Phase II trials for the treatment of chronic hepatitis B and in Phase III trials for the treatment of chronic hepatitis C. Phase II trials for hepatocellular carcinoma, malignant melanoma, and drug-resistant tuberculosis were scheduled to begin in fall 2000 (R. Koh, SciClone Pharmaceuticals, personal communication, 2000 May 5). TA1 has been granted orphan drug status for the treatment of chronic hepatitis B, HIV, hepatocellular carcinoma, and DiGeorge's syndrome with immune defects. (Di George's syndrome is a congenital birth defect that leads to hypoplasia or aplasia of the thymus and parathyroid glands, cardiac defects, and immune system dysfunction).

Indications

Thymosin alpha one is primarily indicated in conditions like AIDS, Chronic hepatitis B infection, DiGeorge's syndrome, Hepatitis C, Lung cancer, Malignant melanoma.

Contraindication

Thymosin alpha one is contraindicated in conditions like Hypersensitivity to any component of product.

Side Effects

The signs and symptoms that are produced after the acute overdosage of Thymosin alpha one include Nausea, Vomiting, fatigue, Muscle aches, Fever, Neutropenia.

Warnings

Thymosin comes as two doses in one small bottle. Once mixed with sterile water, the SECOND dose must be taken with TWO DAYS, or the drug will become too weak to be useful.TA1(Thymosin Alpha 1) is classified as being in pregnancy category C. Teratogenicity studies in both mice and rabbits have not demonstrated any difference when comparing TA1-treated and control animals. However, there are no data on TA1 in pregnant or nursing women. It is recommended that caution be exercised when administering the drug to nursing mothers.

High Risk Groups

Drug should not be given to Pregnant Mothers.If prescribing authority justifies the benefits of the drug against the possible damages he/she should reevaluate them and consult the reference material and previous studies.

Dosage

Thymosin alpha one Dosage for Adults

Dose 1 mg
Single Dose 1 (1)
Frequency As recommended.
Route IM,SC
Note: twice a week. (This dose is used in clinical trials for HIV/AIDS.)
Dose 1 to 1.6 mg
Single Dose 1.3 (1.3)
Frequency As recommended.
Route SC
Note: Twice a week either as monotherapy or in combination with interferon, in the treatment of chronic hepatitis B and C. When patients weigh less than 40 kg, TA1 should be given at a dose of 40 µg/kg. Once mixed, thymosin is only stable for two days. Suggested dosing schedule: Monday-Thursday or Tuesday-Friday. Keep it refrigerated at all times.

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