Contrave (Bupropion + Naltrexone) – Patient Information for Australia
Basic Product Information
| International Non-Proprietary Name (INN) | Bupropion hydrochloride and Naltrexone hydrochloride |
|---|---|
| Brand Name (Australia) | Contrave |
| ATC Code | A08AA62 |
| Available Forms & Strengths | Extended-release tablets: 8 mg naltrexone + 90 mg bupropion per tablet |
| Manufacturer | iNova Pharmaceuticals (Australia) Pty Ltd |
| Prescription Status | Prescription only (Schedule 4: Prescription Medicine) |
Mechanism of Action
- Simple Explanation (Patients): Contrave works in your brain to help reduce appetite and cravings, making it easier to control eating and help with weight loss, when used alongside a healthy diet and exercise plan.
- Specialist/Clinical Explanation: Contrave combines bupropion (a norepinephrine and dopamine reuptake inhibitor) with naltrexone (an opioid receptor antagonist). Together, they modulate the activity of hypothalamic appetite-regulating pathways and the mesolimbic dopaminergic pathway, addressing reward-driven eating behaviours and cravings, thereby supporting sustained weight reduction.
Pharmacokinetics
- Absorption: Both active ingredients are absorbed orally, reaching peak concentrations in 1–4 hours (bupropion) and 2–8 hours (naltrexone).
- Metabolism: Bupropion undergoes hepatic metabolism primarily by CYP2B6, while naltrexone is metabolised to 6-β-naltrexol via non-CYP pathways.
- Elimination: Bupropion and its metabolites are eliminated mainly via urine; naltrexone is excreted via both urine and faeces.
- Duration of Action: Once-daily dosing supports steady blood levels, helping control appetite throughout the day.
Use in Everyday Life and Best Practices
Contrave is used as part of a comprehensive weight management programme for adults who are overweight (BMI ≥27 kg/m²) with weight-related conditions (such as type 2 diabetes, high blood pressure, or cholesterol), or obese (BMI ≥30 kg/m²). Treatment should always be combined with a reduced-calorie diet and increased physical activity, as recommended by Australian clinical guidelines.
- Typical dosing for adults: Contrave is usually started at a low dose, gradually increased over 4 weeks to minimise side effects.
- How to take: Swallow tablets whole with water. Do not crush, split, or chew. Take at the same time(s) each day for best results.
- Medical supervision: Your GP or accredited weight-management clinic team will monitor your progress and manage any side effects or medication adjustments.
Dosing in the Morning vs Evening
- Morning Dosing: Usually preferred. Reduces the risk of insomnia, as bupropion can cause difficulty sleeping if taken late.
- Evening Dosing: Generally avoided. Taking Contrave at night may lead to disturbed sleep, which can impact energy and wellbeing.
- Tips: Take doses with breakfast and lunch or as directed by your healthcare provider. Stick to a routine to help develop healthy habits and avoid missed doses.
Taking with Food or on an Empty Stomach
- With Food: Contrave should be taken with food to minimise the chance of stomach upset and to optimise drug absorption.
- On an Empty Stomach: Not recommended, as it increases the risk of side effects and may reduce effectiveness.
- Dietary Context (Australia): A typical balanced meal including whole grains, fruits, and lean proteins is suitable when taking your dose. Avoid high-fat meals, as these may increase drug levels and risk of side effects.
Interaction Warnings
| Interacting Substance | Potential Effect / Risk | Advice |
|---|---|---|
| Alcohol | Increased risk of seizures | Avoid or limit alcohol intake |
| Opioid medicines (e.g. codeine, morphine) | Reduced effectiveness of pain relief; possible withdrawal symptoms | Do not use with opioids |
| MAOIs (monoamine oxidase inhibitors) | Risk of serious drug reaction (hypertensive crisis) | Do not use within 14 days of MAOIs |
| Some antidepressants (SSRIs, tricyclics) | Possible additive effects or interactions | Inform prescriber about all mental health medications |
| Anti-seizure medications | Risk of reduced seizure threshold | Use with caution under specialist advice |
| CYP2B6 inhibitors/inducers | May alter bupropion levels | GP may need to adjust the dose |
| Saint John’s Wort, other herbal supplements | May reduce effectiveness or increase side effects | Avoid or discuss with pharmacist |
Indications
| Type | Detail / Criteria |
|---|---|
| Official (PBS-Listed) |
|
| Off-label (specialist or individual cases) |
|
Dosing According to Clinical Indications
| Population | Initial Dose | Titration | Maintenance Dose | Maximum Dose |
|---|---|---|---|---|
| Adults (18–64 years) | 1 tab (8 mg/90 mg) once daily in week 1 | Increase by 1 tab weekly, up to 2 tabs twice daily by week 4 | 2 tabs (8 mg/90 mg each) in the morning, 2 tabs in the evening | 32 mg naltrexone/360 mg bupropion daily (4 tabs) |
| Elderly (≥65 years) | Same as adults, but titrate more conservatively | Monitor closely for side effects and adjust as advised by doctor | – | – |
| Adolescents (under 18 years) | Not recommended due to insufficient safety and efficacy data | |||
| Hepatic/renal impairment | Dose adjustments or avoidance may be necessary; requires specialist monitoring | |||
Safety Profile / Side Effects
| Frequency | Side Effect | Notes/Warnings |
|---|---|---|
| Very Common (≥10%) | Nausea, headache, constipation | Often improve after first few weeks |
| Common (1–10%) | Insomnia, dry mouth, dizziness, anxiety, vomiting, increased sweating | May persist; contact doctor if troublesome |
| Uncommon (0.1–1%) | Increased blood pressure, palpitations, mood changes | Monitor, seek advice if noticed |
| Rare (<0.1%) | Seizures, severe allergic reactions (rash, swelling), suicidal thoughts/behaviour | Seek urgent medical help |
- Warnings: Not for use if you have uncontrolled hypertension, seizure disorders, severe hepatic impairment, or are pregnant or breastfeeding.
- Regular doctor checks: Required for blood pressure, mental health, and progress assessments.
Guidelines for Proper Use (Australia-Specific Advice)
- Provide your pharmacist and doctor with a complete medication list to check for interactions.
- Store Contrave at room temperature (below 30°C), away from moisture and direct sunlight.
- Keep out of reach of children and pets.
- Never share your medication, even with others trying to lose weight, as there are strict medical criteria and monitoring is required.
- If you miss a dose, skip it and continue as normal – do not double up doses.
- Ensure regular GP reviews (at least every 3–6 months) to assess effectiveness and check for side effects; therapy may be discontinued if at least 5% weight reduction is not achieved after 16 weeks.
- Support is available through Australian obesity management programs and accredited health professionals.
Alternative Treatment Options in Australia
- Orlistat (Xenical):
- Blocks fat absorption, can cause oily stools and gastrointestinal side effects
- Over-the-counter availability for some indications
- Liraglutide (Saxenda):
- Injectable GLP-1 agonist, helps control appetite
- May cause nausea, vomiting, available by prescription
- Semaglutide (Wegovy/Ozempic):
- Once-weekly injection, GLP-1 receptor agonist, high weight loss efficacy
- Emerging access in Australia; higher price and supply limitations
- Phentermine:
- Appetite suppressant, recommended for short-term use under close supervision
- Potential for insomnia, increased blood pressure, dependency
- Non-pharmacological therapies:
- Australian Dietary Guidelines, physical activity, behavioural therapy
- First-line for all patients before considering medication
Each option has unique profile of benefits and risks—discuss with your doctor to choose the most suitable approach for your circumstances.
Legal, Registration, and Reimbursement Status in Australia
- Therapeutic Goods Administration (TGA): Contrave is registered for weight management in Australia under AUST R 239301.
- Pharmaceutical Benefits Scheme (PBS): Contrave is listed for eligible adults, with restricted benefits according to current national guidelines. Out-of-pocket costs may apply.
- Prescription Requirements: Schedule 4 medication – valid script from a registered prescriber required.
- Supply controls: Some states and territories may require notification or approval for weight loss prescribing—consult your pharmacist or GP for regional details.
Latest Research and Clinical Guidance (2022–2025)
- 2022–2024 Clinical Guidelines: The Australian Obesity Management Guidelines (RACGP, 2022 update) endorse Contrave as a second-line treatment for adults whose weight loss goals cannot be met through diet and lifestyle modification alone.
- Recent studies (JAMA, 2023; Aust Prescriber, 2022): Evidence shows Contrave can lead to greater weight loss compared to placebo, particularly in combination with structured support, but is most effective when adherence and monitoring are optimised.
- Safety Review (TGA, 2024): Ongoing post-marketing surveillance reaffirms an acceptable safety profile; risk management focuses on seizures, psychiatric side effects, and blood pressure monitoring.
- International Consensus (Obesity Reviews, 2024): Contrave is considered part of a multi-modal treatment pathway for high-risk patients not responding to non-pharmacological interventions.
Availability and Delivery
| Pack Size | Typical Days Supply | Indicative Retail Price* (AUD) | Delivery Times (Business Days) |
|---|---|---|---|
| 112 tablets | 28 days (max dose) | $220–$280 (varies by pharmacy, PBS discounts may apply) | Sydney: 1–2 days Melbourne: 2–3 days Brisbane: 2–4 days Perth: 3–5 days Adelaide: 2–4 days Regional/rural: 3–7 days |
*Prices and delivery times indicative, subject to change. Contact your pharmacy for current quotes and availability.
FAQ – Common Patient Questions
- Do I need to follow a special diet while taking Contrave?
Yes, Contrave is most effective when combined with a reduced-calorie, balanced diet and regular physical activity. Your doctor or dietitian can help create a plan suited to your needs. - How quickly will I start to lose weight?
Most patients begin to see weight loss within the first 4–8 weeks. Your doctor will review your results; at least 5% weight loss at 16 weeks is typically expected to continue the therapy. - What should I do if I miss a dose?
Skip the missed dose and resume your usual schedule—do not take an extra tablet to make up for it. If you have any concerns, speak to your pharmacist or doctor. - Can I keep taking Contrave long-term?
Contrave can be used long-term under regular medical review, provided it remains effective and no side effects or risks arise. Your doctor will periodically review your progress and need for ongoing therapy. - Who should NOT take Contrave?
Contrave is not suitable for people with uncontrolled high blood pressure, seizure disorders, current opioid use, severe liver/kidney disease, or if pregnant or breastfeeding. Tell your prescriber about your full medical history.
