Mavenclad® (cladribine)

The active ingredient of Mavenclad® is cladribine. It is used for the treatment of patients with relapsing remitting MS to reduce inflammation in the nervous system caused by MS. In MS, the immune system mistakenly attacks the protective layer around the nerve cells, called myelin. This causes inflammation and damage which stops the nervous system working properly. By reducing the number of destructive immune cells in circulation, Mavenclad® may slow down or stop the immune attack.

Mavenclad® has been shown to result in fewer relapses, less disease activity in the brain and less progression of disability.

Mavenclad® is administered in two treatment courses over two years. Each treatment course consists of two treatment weeks. For a treatment week, you will be prescribed to take one or two tablets, once a day for 4-5 days.

There is no Mavenclad® treatment between the two courses.

Dosage of Mavenclad® is dependent on your weight. Your doctor will decide the number of tablets per day (1 or 2) and number of treatment days (4 or 5) depending on your body weight. You may need to take the same number of tablets each day or some days you might take two tablets and then only one tablet on the following days.

No further Mavenclad® treatment is required in years 3 and 4. Re-initiation of therapy after 4 years has not been studied.

Mavenclad® helps most people with MS, but may have side effects in some people. All medications have side effects. It is important to notify your health professional if you experience any side effects or are feeling unwell.

A common side effect of Mavenclad® is a reduction in the number of a type of white blood cell known as lymphocytes. Reduced lymphocytes may increase your risk of getting an infection, particularly viral infections.

Other common side effects include cold sores, shingles, skin rashes and a reduced neutrophil count (a common type of white blood cell important to fighting off infections). Symptoms of shingles include a ‘band’ of severe pain and blistering rash, typically on one side of the upper body or the face, burning, tingling, numbness or itchiness of the skin in the affected area and feeling generally unwell or fever in the early stages of infection. Tell your doctor immediately if you get symptoms of shingles.

Your neurologist will assist you to assess the risks and the expected benefit of treatment with Mavenclad® prior to starting therapy and over the course of treatment. Your health professional can provide comprehensive information on the use of Mavenclad®, including precautions and side effects.

Mavenclad® interferes with DNA synthesis and suspected to cause or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage.

Pregnancy should be avoided during treatment and for at least 6 months after the last dose.

Men being treated should take precautions to prevent pregnancy of their partner.

If you are currently pregnant or trying to become pregnant, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.

It is not known if Mavenclad® is excreted in human milk. Because many medications are excreted in human milk and there is no published experience with cladribine during breastfeeding, it should be avoided during breastfeeding.

If you are currently breastfeeding, please discuss your individual circumstances and treatment options with your neurologist or healthcare team.

Mavenclad® has been approved by the Therapeutic Goods Administration (TGA) for the treatment of patients with relapsing remitting MS and is available through the Pharmaceutical Benefits Scheme (PBS). Your neurologist will need to obtain an authority to prescribe the medication for you.

For details of the criteria required to receive a prescription for Mavenclad® treatment through the PBS, please visit the official PBS website at: https://www.pbs.gov.au/medicine/item/11603Q-11604R-11611D-4326Q-7225G

You will need to click on the red Authority Required (STREAMLINED) link.

If you are eligible for medications through the PBS, you will need to pay a contribution fee each time your prescription is dispensed. The Federal Government pays for the remaining cost. The amount of the contribution fee depends upon whether or not you have a pension or concession card. The amount of this fee is set each year by the Federal Government.

Further information about the PBS, your entitlements and details regarding the PBS safety net (which protects patients and their families requiring a large number of PBS items) is available through the Medicare Australia website at: www.medicare.gov.au

If you are not eligible for Mavenclad® through the PBS, for example if you are a visitor from overseas, your neurologist may write a private prescription. In this instance you will have to pay the full cost to the pharmacy that dispenses your medication. You will need to request a quote from your pharmacist for the price of any medication which is not subsidised by the PBS.