ZADAXIN
THYMOSIN ALPHA 1 (THYMALFASIN) · by GETZ
Composition
Inj: Purified sterile lyophilized injection of zadaxin 1.6mg/ml and1.0 ml of sterile water for Injection
Indications & Dosage
Monotherapy or in combination with interferon for the treatment of chronic hepatitis B, In combination with interferon for the treatment of chronic hepatitis C: BY SC INJ: Adult: 1.6 mg (900 g/m2) injection twice a week for 6 to 12 months (consult product literature). Patients (weighing less than 40 kg): 40g/kg (consult product literature). Adjuvant therapy in non-small cell lung carcinoma, malignant melanoma, hepatocellular carcinoma, breast cancer, non-Hodgkins lymphoma, colorectal cancer, head and neck cancer, leukemias, pancreatic carcinoma, and renal cell carcinoma: BY SC INJ: Adult: 1.6 mg (900 g/m2) injection for 6 months or between chemotherapy cycles for the duration of treatment (consult product literature).
Administration
To be administered as subcutaneous injection and should not be given intravenously. It should be reconstituted with the diluent provided of 1.0 ml sterile water for Injection, immediately prior to use.
Stability
Store between 2 and 8C (36 to 46 F). Reconstituted should be used immediately.
Precautions
Renal impairment; reduce dose, advanced liver disease due to Hepatitis B, pancreatitis. Initiate treatment under specialist supervision, caution in children, elderly, it should be considered contraindicated in patients who are being deliberately immunosuppressed, such as organ transplant patients, unless the potential benefits of the therapy clearly outweigh the potential risks
Pregnancy
Avoid unless the potential benefits outweigh the risks
Lactation
Caution advised, avoid
Side Effects
Alopecia, local discomfort at the injection site, erythema, transient muscle atrophy, polyarthralgia combined with hand edema, and rash