Alemtuzumab intravenous infusion for adults

Who can administer

May be administered by registered competent doctor or nurse/midwife

Important information

• Very expensive product: take care when preparing to avoid wastage
• Pre-treatment: patients should be pre-treated with corticosteroids immediately prior to administration of alemtuzumab. - see under dose for further information
• Post-treatment antimicrobial prophylaxis required: see further information
• Not routinely stocked in GUH- ordered on Consultant request
• Facilities to manage hypersensitivity or anaphylaxis should be available
• Important: see 'Monitoring requirements' below
• Patients must receive the Package leaflet, the Patient Alert Card and the Patient Guide BEFORE STARTING TREATMENT
• Consider delaying treatment in patients with active infection, until the infection is fully controlled
• In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded in the medical notes

Available preparations

Lemtrada 12mg in 1.2ml vial

Reconstitution

Already in solution

Dilute further prior to administration

Infusion fluids

Sodium chloride 0.9% or Glucose 5%

Methods of intravenous administration

Intermittent intravenous infusion

• Gloves, protective eyewear and a mask should be worn by those handling this drug ^{(ref 1)}
• Do not shake the vials prior to use
• Add 12mg (1.2ml) injection solution to 100ml infusion fluid
• Invert the bag gently to mix the solution
• Administer over a period of approximately 4 hours
• Needs light protection during administration
• Once infusion is complete, it is important to ensure residual drug in the giving set is flushed through- attach a 50ml bag of Sodium chloride 0.9% and run at the previously tolerated flow rate

Dose in adults

Pre-treatment

• Patients should be pre-treated with corticosteroids immediately prior to administration on each of the first three days of any treatment course
• Suggested dose: Methylprednisolone 1g IV daily just before alemtuzumab Days 1-3 only
• Consider antihistamine and/or antipyretics if necessary

Alemtuzumab dose

• Initial treatment course: 12mg daily for five consecutive days (60mg total dose)
• Second treatment course (12 months after initial treatment course) 12mg daily for three consecutive days (36mg total dose)
• Further treatment courses may be considered at least 12 months later- see SPC

Post-treatment

• Patients should be given oral prophylaxis for herpes infections, starting on the first day of each treatment course and continuing for at least one month after
• Suggested dose: Aciclovir 200mg bd po
• Patients should be given co-trimoxazole 960mg three times per week for one month after each cycle of alemtuzumab (i.e. same schedule as aciclovir) ^{(ref 2)}

Monitoring

• Infusion associated reactions (IARs): Observe for IARs during and for two hours after infusion is finished. IARs may occur despite pre-treatment
• If an IAR occurs, provide the appropriate symptomatic treatment, as needed. If the infusion is not well tolerated, the infusion time may be increased. If severe IARs occur, immediate discontinuation of the infusion should be considered. Refer to Q-Pulse CLN-NM-0118 for further information.
• The following monitoring requirements have been recently recommended ^{(ref 3)}
  • Vital signs should be monitored before and during the intravenous infusion. If clinically significant changes are observed, discontinuation of infusion and additional monitoring, including ECG, should be considered
  • Monitor LFTs. If patients develop signs of liver damage, unexplained liver enzyme elevations or symptoms suggestive of hepatic dysfunction (e.g. unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice or dark urine), alemtuzumab should only be re-administered following careful consideration.
  • Patients who develop signs of pathological immune activation should be evaluated immediately, and a diagnosis of haemophagocytic lymphohistiocytosis considered. Symptoms of immune activation may occur up to 4 years after the start of treatment.

Monitor	Details
Urinalysis with microscopy	Prior to initiation of treatment and at monthly intervals for 48 MONTHS after the last infusion
Serum creatinine	Prior to initiation of treatment and at monthly intervals for 48 MONTHS after the last infusion
FBC (platelets particularly)	Monitor FBC Platelet count should be obtained immediately after infusion on Days 3 and 5 of the first infusion course, as well as immediately after infusion on Day 3 of any subsequent course. Clinically significant thrombocytopenia needs to be followed until resolution. Referral to a haematologist for management should be considered.
Liver function tests	Prior to initiation of treatment and at monthly intervals for 48 MONTHS after the last infusion
Thyroid function tests	Prior to initiation of treatment and at THREE monthly intervals for 48 MONTHS after the last infusion

Storage

• Store between 2 and 8⁰C
• Do not freeze
• Pharmacy to store in fridge, individually by patient name and date ordered

References

SPC 10/04/2024
1: Clinical Oncology Society of Australia. Position statement: safe handling of monoclonal antibodies in healthcare settings September 2013
2: Guidance on the prevention of Listeria infection after alemtuzumab treatment of multiple sclerosis.  Alasdair Coles 15th May 2017
3. EMA, April 12th 2019. Use of multiple sclerosis medicine Lemtrada restricted while EMA review is ongoing

Therapeutic classification

Monoclonal antibody