This is the text extract for SA0997 – Tenofovir, browse documents here.

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Ministry of Health Phone 0800 243 666 APPLICANT (stamp or sticker acceptable)

APPLICATION FOR WAIVER OF RULE BY SPECIAL AUTHORITY

Page 1

Form SA0997

September 2010

PATIENT NHI: ...................................................... REFERRER Reg No: ............................................

Reg No: ................................................................ First Names: ......................................................... First Names: ......................................................... Name: ................................................................... Surname: .............................................................. Surname: .............................................................. Address: ............................................................... DOB: ..................................................................... Address: ............................................................... ............................................................................... Address: ............................................................... ............................................................................... ............................................................................... ............................................................................... ............................................................................... Fax Number: ......................................................... ............................................................................... Fax Number: .........................................................

Tenofovir

INITIAL APPLICATION - Drug-Resistant Chronic Hepatitis B Applications only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid for 1 year. Prerequisites (tick boxes where appropriate)

and and

u u

Patient has confirmed Hepatitis B infection (HBsAg positive for more than 6 months) Patient has had previous lamivudine, adefovir or entecavir therapy

Documented drug resistance, defined as both: and

u u u u u

ALT greater than upper limit of normal; or ≥ Metavir Stage F3 HBV DNA greater than 20,000 IU/mL or increased ≥ 10 fold over nadir

and Hepatitis B virus resistant to lamivudine with detection of M204I/V mutation Hepatitis B virus resistant to adefovir with detection of A181T/V or N236T mutation Hepatitis B virus resistant to entecavir with detection of I169T, L180M T184S/A/I/L/G/C/M, S202C/G/I, M204V or M250I/V mutation

or or

RENEWAL - Drug-Resistant Chronic Hepatitis B Current approval Number (if known):............................................................... Applications only from a gastroenterologist, infectious disease specialist or general physician. Approvals valid for 2 years. Prerequisites (tick box where appropriate)

u

The treatment remains appropriate and the patient is benefiting from treatment

Note: • Tenofovir disoproxil fumarate should be stopped 6 months following HBeAg seroconversion for patients who were HBeAg positive prior to commencing Tenofovir disoproxil fumarate. • The recommended dose of Tenofovir disoproxil fumarate for the treatment of hepatitis B is 300 mg once daily. • In patients with renal insufficiency (calculated creatinine clearance less than 50ml/min), Tenofovir disoproxil fumarate dose should be reduced in accordance with the approved Medsafe datasheet guidelines. • Tenofovir disoproxil fumarate is not approved for use in children.

I confirm the above details are correct and that in signing this form I understand I may be audited. Signed: .............................................................................. Date: ...............................................

Post application to Ministry of Health, Private Bag 3015, Wanganui – Fax: 0800 100 131