DrugInfoSys

Thymosin alpha one

Drug #2174

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). <br>Thymosin is a synthetic version of a naturally occurring hormone that circulates inside your thymus. Thymosin alpha-1 is an injectable synthetic hormone that is being studied for hepatitis B, lung and neck cancer, and as an immune-modulator in AIDS. Results from a very small Italian trial suggest that thymosin in combination with an anti-retroviral and low dose alpha-interferon may result in increased T cells. <BR>Thymosin alpha 1 has not been approved by FDA for general use in the United States although It has been approved in other countries.

Primary Characteristics

It is of Synthetic origin and belongs to Polypeptide.

It belongs to Immune Modifiers pharmacological group on the basis of mechanism of action. It is also classified under Hormones .

Non-proprietary name: Thymosin alpha one · pH: 6.8.

Molecular structure of Thymosin alpha one

Pharmacokinetics

Elimination: plasma half-life is 2.1 hours, renal excretion is 30% to 60%.

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Indications

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

Contraindications

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

Dosage

Thymosin alpha one's dosage details are as follows:

DoseSingle DoseFrequencyRouteInstructions
Adult Dosage
1 mg1 mgIM,SCtwice a week. (This dose is used in clinical trials for HIV/AIDS.)
1 – 1.6 mgSCTwice 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.
Paediatric Dosage (20kg)
No data.
Neonatal Dosage (3kg)
No data.

Drug Interactions

1 interaction

Always consult your physician for the change of dose regimen or an alternative drug of choice that may strictly be required.

Side Effects

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

Warnings / Precautions

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.<br>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.

Available Brands

None recorded.

Storage Conditions

Thymosin alpha one should be stored Inj.

Drug Classification

  1. 1.6.5.2Antiretroviral drugs
  2. 2.8.1Immunomodulators