Consumer medicine information

1. Why am I using VEMLIDY?

VEMLIDY contains the active ingredient tenofovir alafenamide. VEMLIDY is used for the treatment of chronic (long-lasting) hepatitis B virus (HBV) in adults.
For more information, see Section 1. Why am I using VEMLIDY? in the full CMI.

2. What should I know before I use VEMLIDY?

Do not use if you have ever had an allergic reaction to VEMLIDY or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use VEMLIDY? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with VEMLIDY and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use VEMLIDY?

• The usual dose is one VEMLIDY tablet orally, once daily.

5. What should I know while using VEMLIDY?

6. Are there any side effects?

The most common side effect of VEMLIDY is nausea.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Vemlidy (tenofovir alafenamide 25 mg).
The active substance in Vemlidy tablets is tenofovir alafenamide.

2 Qualitative and Quantitative Composition

Vemlidy is available as tablets. Each Vemlidy tablet contains 25 mg of tenofovir alafenamide (equivalent to 28 mg of tenofovir alafenamide fumarate). Vemlidy tablets are yellow, round, film-coated, debossed with "GSI" on one side and "25" on the other side of the tablet. Contains lactose. For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Vemlidy tablets are yellow, round, film-coated, debossed with "GSI" on one side and "25" on the other side.

4 Clinical Particulars

4.9 Overdose

If overdose occurs the patient must be monitored for evidence of toxicity. Treatment of overdose with Vemlidy consists of general supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient.
Limited clinical experience is available at doses higher than the therapeutic dose of tenofovir alafenamide. A dose of 120 mg tenofovir alafenamide (4.8 times the dose in Vemlidy) was administered once daily for 28 days to 10 patients with chronic hepatitis B; no serious adverse reactions were reported. The effects of higher doses are unknown. Tenofovir is efficiently removed by haemodialysis with an extraction coefficient of approximately 54%.
For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia) and 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Tenofovir alafenamide was not genotoxic in the reverse mutation bacterial test (Ames test), mouse lymphoma or rat micronucleus assays.
Carcinogenicity. Because there is a lower tenofovir exposure in rats and mice after tenofovir alafenamide administration compared to tenofovir disoproxil fumarate, carcinogenicity studies were conducted only with tenofovir disoproxil fumarate. Long-term oral carcinogenicity studies of tenofovir disoproxil fumarate in mice and rats were carried out at exposures up to approximately 10 times (mice) and 4 times (rats) those observed in humans at the 300 mg therapeutic dose of tenofovir disoproxil fumarate for chronic hepatitis B. The tenofovir exposure in these studies was approximately 167 times (mice) and 5 times (rat) those observed in humans after administration of Vemlidy treatment. At the high dose in female mice, liver adenomas were increased at tenofovir exposures of 10 times (300 mg tenofovir disoproxil fumarate) and 167 times (for Vemlidy) greater than the tenofovir exposures in humans. In rats, the study was negative for carcinogenic findings.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure. Tenofovir alafenamide fumarate is the drug substance. The chemical name of tenofovir alafenamide fumarate is L-alanine, N-[(S)- [[(1R)-2-(6-amino-9H-purin-9-yl)-1- methylethoxy]methyl] phenoxyphosphinyl]-, 1-methylethyl ester, (2E)-2-butenedioate (2:1).
It has a empirical formula of C₂₁H₂₉O₅N₆P.½(C₄H₄O₄) and a formula weight of 534.50. It has the following structural formula:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTENALA.gif Tenofovir alafenamide fumarate is a white to off-white or tan powder with a solubility of 4.7 mg per mL in water at 20°C.
CAS number. CAS registry number for tenofovir alafenamide: 379270-37-8.
CAS registry number for tenofovir alafenamide fumarate: 1392275-56-7.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes

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