Consumer medicine information

1. Why am I taking EDURANT?

EDURANT contains the active ingredient rilpivirine. EDURANT in combination with other HIV medicines is used to treat adults who are infected by HIV and who have not used other anti-HIV medicines before.
For more information, see Section 1. Why am I taking EDURANT? in the full CMI.

2. What should I know before I take EDURANT?

Do not use if you have ever had an allergic reaction to EDURANT or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you are 65 years or older, or have problems with your liver, or symptoms of infection or inflammation. Tell your doctor if you take any other medicines.
Tell your doctor if you are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I take EDURANT? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with EDURANT 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 take EDURANT?

• The usual dose of EDURANT is one tablet taken once daily with a meal.

5. What should I know while taking EDURANT?

6. Are there any side effects?

The most common side effects you may experience include: stomach pain, nausea, vomiting, depression, sleep disorders, decreased appetite, tiredness, changes in your routine liver tests, headache, dizziness and rash.
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

Rilpivirine.

2 Qualitative and Quantitative Composition

Edurant (rilpivirine) is available as 25 mg film-coated tablets. Each tablet contains rilpivirine hydrochloride equivalent to 25 mg rilpivirine.
Excipients with known effect. Edurant tablets also contain lactose monohydrate. For a full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Edurant 25 mg tablets are white to off-white, film coated, round, biconvex, tablets of 6.4 mm, debossed with "TMC" on one side and "25" on the other side.

4 Clinical Particulars

4.9 Overdose

There is no specific antidote for overdose with Edurant. Human experience of overdose with rilpivirine is limited. Treatment of overdose with rilpivirine consists of general supportive measures including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient. Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.
It is advisable to contact the Poison Information Centre (telephone 131126) for advice on the management of overdose.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Rilpivirine has tested negative in the in vitro Ames reverse mutation assay and in vitro clastogenicity mouse lymphoma assay, tested in the absence and presence of a metabolic activation system. Rilpivirine did not induce chromosomal damage in the in vivo micronucleus test in mice.
Carcinogenicity. Rilpivirine was evaluated for carcinogenic potential by oral gavage administration to mice and rats up to 104 weeks. Daily doses of 20, 60 and 160 mg/kg/day were administered to mice and doses of 40, 200, 500 and 1500 mg/kg/day were administered to rats. An increase in the incidences of hepatocellular adenomas and carcinomas was observed in mice and rats. An increase in the incidences of follicular cell adenomas and/or carcinomas in the thyroid gland was observed in rats. Administration of rilpivirine did not cause a statistically significant increase in the incidence of any other benign or malignant neoplasm in mice or rats. The observed hepatocellular findings in mice and rats are considered to be rodent specific, associated with liver enzyme induction. A similar mechanism does not exist in humans; hence, these tumors are not relevant for humans. The follicular cell findings are considered to be rat specific, associated with increased clearance of thyroxine and are not considered to be relevant for humans. At the lowest tested doses in the carcinogenicity studies, the systemic exposures (based on AUC) to rilpivirine were 21-fold (mice) and 3-fold (rats), relative to those observed in humans at the recommended dose (25 mg q.d.).

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSRILHYD.gif CAS number. CAS No.: 700361-47-3.
Molecular formula: C₂₂H₁₈N₆.HCl.
Molecular weight: 402.88.
The chemical name of rilpivirine is 4-[[4-[[4-[(E)-2-cyanoethenyl]-2, 6-dimethylphenyl] amino-2pyrimidinyl] amino] benzonitrile monohydrochloride.
Rilpivirine hydrochloride is a white to off-white powder. Rilpivirine hydrochloride is practically insoluble in water over a wide pH range, its pKa is 5.6 (pyrimidine moiety) and log P between 1-octanol and a phosphate solution (pH 7.0) is 4.86 (at 21°C).

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/EDURANST.gif