Entecavir Monohydrate 1mg (Baraclude®)
Highly Specialised Drugs Program Declaration Form*
| NOTE: This declaration form is for PBS-subsidised entecavir monohydrate 1mg tablets, there is a different indication and declaration form for PBS-subsidised entecavir monohydrate 0.5mg tablets. |
| Patient's Name: | ____________________________________ |
| Medical Record Number: | ____________________________________ |
| Medicare Number: | ____________________________________ |
I certify that the above patient meets the Pharmaceutical Benefits Advisory Committee's criteria for funding under Section 100 of the National Health Act, 1953.
| NOTE: PBS-subsidised entecavir monohydrate must be used as monotherapy. |
| NOTE: Patients should have undergone a liver biopsy at some point since initial diagnosis to obtain histological evidence of chronic hepatitis. |
Criteria
Patients with chronic hepatitis B who have failed lamivudine therapy and who satisfy all of the following criteria:
- (a) Repeatedly elevated serum ALT levels while on concurrent antihepadnaviral therapy of greater than or equal to 6 months duration in conjunction with documented chronic hepatitis B infection;
or
(b)Repeatedly elevated HBV DNA levels one log greater than the nadir value or failure to achieve a one log reduction in HBV DNA within 3 months, whilst on previous antihepadnaviral therapy except in patients with evidence of poor compliance; - Female patients of child-bearing age are not pregnant, not breast-feeding, and are using an effective form of contraception.
Persons with Child's class B or C cirrhosis (ascites, variceal bleeding, encephalopathy, albumin less than 30 g per L, bilirubin greater than 30 micromoles per L) should have their treatment discussed with a transplant unit prior to initiating therapy.
Specialist Prescriber
| Signature: | ____________________________________ |
| Name: | ____________________________________ |
| Date: | ____________________________________ |
*To be completed by the specialist initiating drug treatment, and retained by the hospital Pharmacy Department.
July 2008