Buvidal

What is Buvidal used for?

This medicine is used as maintenance treatment for opioid dependence in patients who are also receiving medical, social and psychological support. It contains the active substance buprenorphine. Buprenorphine acts as a substitute for opioids and it helps withdrawal from opioids over a period of time. This medicine is available only with a doctor’s prescription.

 

You must not receive Buvidal if you have an allergy to or are:

• any medicine containing buprenorphine
• pregnant
• breast-feeding

 

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue or other parts of the body
• rash, itching or hives on the skin

 

You must not receive Buvidal if you are under 16 years of age:

• Safety and effectiveness in children younger than 16 years has not been established.

 

You must not receive Buvidal if you have serious medical problems:

• with your liver
• with your breathing such as asthma
• if you are intoxicated due to alcohol or have delirium tremens (the ‘shakes’ and hallucinations)

 

What it looks like

Buvidal is a modified release solution for injection. Each pre-filled syringe contains a yellowish to yellow clear liquid. The following pack sizes are available: Pre-filled syringes containing, 64 mg/0.18 mL, 96 mg/0.27 mL, and 128 mg/0.36 mL solution for injection. Each pack contains 1 pre-filled syringe with stopper, needle, needle shield, safety device and 1 plunger rod.

 

Before you receive it Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes. Tell your doctor if you have or have had any of the following medical conditions:

• any kidney disease
• liver problems such as hepatitis
• low blood pressure
• recently suffered a head injury or brain disease
• a urinary disorder (especially linked to enlarged prostate in men)
• thyroid problems
• an adrenocortical disorder (e.g. Addison’s disease)
• gall bladder problems
• problems with excess alcohol use
• history of seizures

 

How much you will be given

Your doctor will determine the best dose for you. During your treatment, the doctor may adjust the dose, depending on how you respond to the medicine.

 

How it will be given

Buvidal is given by a healthcare professional as an injection under the skin (subcutaneously) in the buttock, thigh, abdomen or upper arm. When it will be given.

 

Before starting treatment with Buvidal

You will need to be stabilised on treatment for opioid dependence on buprenorphine before you are given Buvidal maintenance treatment. If you have not been stabilised, then you will need to receive sublingual buprenorphine or buprenorphine/naloxone for at least seven days before treatment with Buvidal commences.

 

Starting treatment with Buvidal

Once you are stabilised on sublingual buprenorphine or buprenorphine/naloxone, you can start receiving Buvidal the day after your last dose of the sublingual treatment. Your doctor will prescribe the correct starting dose of Buvidal for you.

 

Side Effects

• difficulty sleeping
• headache
• sleepiness
• upset stomach including, nausea, vomiting and diarrhoea or constipation
• redness, soreness, swelling or itching at the Buvidal Monthly injection site
• dizziness, feeling off balance
• dry mouth
• swelling of the legs and arms
• respiratory infection
• pain when urinating
• pain in joints,
• anxiety
• hives, rash, itching

 

Other side effects which may occur are:

• strong or irregular heart beat
• abnormal vision
• upset stomach including stomach pain, wind, indigestion
• malaise, yawning
• flushing
• dizziness or fainting when standing up
• tremor
• flu like symptoms, such as chills, fever, sore throat, coughing, runny nose, watery eyes and sweating
• shortness of breath, enlarged or sore lymph nodes
• pain in the abdomen, back, and muscles, leg cramps, chest pain, neck pain, menstrual pain, muscle weakness
• headache-migraine
• decreased appetite
• depression, abnormal thinking, agitation, nervousness, anger, hallucinations

 

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

 

Other side effects not listed above may also occur in some people. Some of these side effects such as liver problems can only be found when your doctor does tests from time to time to check your progress

 

Important things to be aware of while you are receiving this medicine:

 

Breathing problems

Some people have died from the reduced ability to breathe (respiratory depression) because they took a similar medicine also containing buprenorphine, together with central nervous system depressants such as benzodiazepines, gabapentinoids, alcohol or other opioids.

 

Drowsiness

This medicine may cause drowsiness especially when taken with alcohol or other central nervous system depressants such as benzodiazepines, tranquilisers, sedatives, gabapentinoids or hypnotics. Dependence This medicine can cause dependence.

 

Liver damage

Liver damage has been reported after taking buprenorphine, especially when the medicine is misused. This could also be due to viral infections (chronic hepatitis C), alcohol abuse, anorexia or use of other medicines with the ability to harm your liver. Regular blood tests may be conducted by your doctor to monitor the condition of your liver. Tell your doctor if you have any liver problems before you start treatment with Buvidal Monthly.

 

Blood pressure

This product may cause your blood pressure to drop suddenly, causing you to feel dizzy, if you get up too quickly from sitting or lying down.

 

Athletes

Athletes should be aware that this medicine may cause a positive reaction to “anti-doping” tests.

 

Elderly

The safety and effectiveness in patients over 65 years of age has not been established.

 

Diagnosis of unrelated medical conditions

This medicine may mask pain symptoms that could assist in the diagnosis of some diseases. Do not forget to advise your doctor if you are being given this medicine.

 

What is Buvidal?

Buvidal contains buprenorphine within a long acting injection, meaning you only have to take the medication monthly. It releases the medication into your blood stream throughout the month, helping to prevent cravings and withdrawal.

 

How will Buvidal help me?

Being prescribed Buvidal monthly helps reduce the withdrawal and cravings that opioid dependence brings. It also gets rid of the burden of daily medication pick ups – helping to break the cycle.

 

Buvidal is designed so that stable therapeutic levels of buprenorphine are maintained  within your blood stream throughout the month.

 

Why do I only need to take Buvidal monthly?

When injected, Buvidal is converted into a gel like substance in the body which releases buprenorphine as the gel breaks down over the month.

 

How is Buvidal taken?

Buvidal is injected under the skin by one of our nurses. It can be injected into your abdomen, buttock, thigh or upper arm. You may experience some pain during the injection, but this doesn’t usually last long.

 

When can I start Buvidal?

Already taking Buprenorphine: You can be switched straight into Buvidal.

 

Never taken Buprenorphine: You’ll be started on a small dose of Buprenorphine orally to ensure that your body doesn’t have any negative reactions to it.

 

Taking methadone: We must reduce your methadone dose to 30mg per day or less before starting on Buvidal. This is to lower the risk of having more sudden or severe withdrawal symptoms.

 

You will also need to be an mild-moderate withdrawal before starting on Buvidal.

 

What if I miss a dose?

If you miss a dose, we will work quickly to get you rebooked onto a new clinic. We run several Buvidal clinics each week.

 

What if I want to stop Buvidal?

Speak to the nurse and your keyworker if you wish to stop your treatment – stopping on your own can cause severe withdrawal.

 

Can I take any other medications at the same time?

Some medications can increase the side effects of Buvidal. It’s important that you let us know if you are on any other medications. It’s also important to tell your GP before starting any other medications.

 

What are the side effects of Buvidal?

The most common side effects are:

– insomnia

– headaches

– nausea

– sweating

– pain

– drug withdrawal syndrome

 

It’s important to maintain regular contact with your keyworker during your Buvidal treatment so that we can support you and track any side effects.