Lemtrada® (alemtuzumab)

Lemtrada® is the brand name for alemtuzumab in Australia. Lemtrada® is a monoclonal antibody that targets a protein (CD52) abundant on T and B cells. Circulating T and B cells are thought to be responsible for the damaging inflammatory process in MS. Lemtrada® works by depleting the circulating T and B cells after each treatment, to reduce the impact of MS.

Lemtrada® is not recommended for patients with inactive disease or those who are stable on their current therapy.

In clinical trials, Lemtrada® has been shown to reduce the frequency of and delay the progression of disability in some people when compared to interferon beta treatment.

Lemtrada® is given by intravenous infusion over two treatment courses. For the first treatment course you will receive one infusion per day on 5 consecutive days. One year later you will receive one infusion per day on 3 consecutive days.

Lemtrada® infusions are usually administered in a hospital under the supervision of a neurologist. Each infusion takes approximately 4 to 6 hours.

Lemtrada® 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.

Potential side effects of Lemtrada® treatment include infusion-associated reactions, infections and development of autoimmune conditions.

Infusion-associated reactions, such as headache, rash, fever and nausea, are common and occur at the time of the infusion or within 24 hours after the infusion. Most infusion reactions are mild. To minimise the risk of these side effects, medications are given prior to infusion of Lemtrada® and you will be monitored during and after the infusion so that any reactions can be managed.

Lemtrada® increases your risk of getting infections. Infections are usually mild or moderate in severity but in some cases can be serious. You may have an increased chance of getting an infection caused by the bacteria Listeria. It is recommended to avoid food that might be a source of Listeria if you are being treated with Lemtrada®.

Lemtrada® can increase your risk of developing certain auto-immune conditions. These include thyroid disorders (overactive or underactive thyroid), immune thrombocytopenic purpura (a bleeding disorder, also called ITP) and, rarely, kidney disorders. These autoimmune conditions can develop many years after Lemtrada® treatment and can be very serious if left undiagnosed and untreated. You will need to undergo regular (monthly) blood testing from before treatment starts and for four years after your last infusion to ensure that these conditions can be detected early and treated promptly.

Your health professional can provide comprehensive information on the use of Lemtrada®, including precautions and side effects.

There are no adequate and well-controlled studies of Lemtrada in pregnant women. Lemtrada should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Lemtrada® may cross the placental barrier as well and thus potentially pose a risk to the fetus. It is not known whether Lemtrada can cause fetal harm when administered to pregnant women or whether it can affect reproductive capacity. Lemtrada® crosses the placenta in laboratory models.

Women of childbearing potential should use effective contraceptive measures when receiving a course of treatment with Lemtrada® and for 4 months following that course of treatment.

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

No information is available on the clinical use of Lemtrada® during breastfeeding. Lemtrada® is a large protein molecule, so the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant’s gastrointestinal tract. Until more data becomes available, Lemtrada® should be used with caution or avoided during breastfeeding, especially while nursing a newborn or preterm infant.

The manufacturer recommends that breastfeeding be discontinued during Lemtrada® therapy and for 4 months following the last infusion of each treatment course.

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

Lemtrada® has been approved by the Therapeutic Goods Administration (TGA) and is available through the Pharmaceutical Benefits Scheme (PBS). Please discuss with your neurologist whether Lemtrada® is the right treatment for you.

Lemtrada® is listed on the PBS under the Highly Specialised Drugs Program, which means there are restrictions on where it can be prescribed and dispensed. Generally, the clinic where you have Lemtrada® infused will take care of your prescription and order the medication for you.

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 Lemtrada® 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.