Immune System MHRA alerts

Question 1

Which immunosuppressants must be prescribed and dispensed by brand name?

Answer 1

Ciclosporin and tacrolimus

Question 2

For the different brands of tacrolimus, how does the frequency of administration differ?

Answer 2

Adoport, Prograf, Capexion, Tacni and Vivadex are immediate-release capsules (BD)

Advagraf is a prolonged-release capsule that is taken OD in the morning.

Modigraf granules are used to prepare an immediate-release oral suspension which is taken BD.

Question 3

Patients taking belimumab for systemic lupus erythematous may experience which neurological side effects?

Answer 3

Clinical trials show an increased risk of depression, suicidal ideation or behaviour, or self-injury in patients

Question 4

What is the current guidance regarding male patients taking mycophenolate?

Answer 4

Clinical evidence does not indicate an increased risk of malformations or miscarriage in pregnancies where the father was taking mycophenolate medicines, however mycophenolate mofetil and mycophenolic acid are genotoxic and a risk cannot be fully excluded.

Question 5

How should pregnancy be excluded in female of child-bearing potential before treatment?

Answer 5

2 pregnancy tests 8–10 days apart are recommended.

Women should use at least 1 method of effective contraception before and during treatment, and for 6 weeks after discontinuation.

2 methods of effective contraception are preferred.

Question 6

After discontinuation of MMF treatment, how long should male patients and their female partners continue to use contraception?

Answer 6

During treatment and 90 days after

Question 7

In female patients, how long should contraception be continued?

Answer 7

6 weeks

Question 8

Fingolimod is a treatment used for multiple sclerosis. What could happen if treatment is stopped or switched?

Answer 8

Rebound syndrome

Question 9

What significant cardiac contraindications are associated with fingolimod?

Answer 9

Persistent bradycardia, which can increase the risk of serious cardiac arrhythmias.
Heart block

Question 10

Which cancers can Fingolimod increase the risk of?

Answer 10

Skin cancers and lymphoma.

As well as, fatal fungal infections and reports of progressive multifocal leukoencephalopathy.

Question 11

What is the contraception advice associated with Fingolimod?

Answer 11

Females of childbearing potential must use effective contraception during, and for 2 months after stopping, treatment.

Question 12

What key monitoring should be carried out with Fingolimod? Why is this necessary?

Answer 12

Liver function tests including serum bilirubin should be performed before starting and during treatment at months 1, 3, 6, 9, and 12, then periodically thereafter until 2 months after discontinuation.

Due to the risk of serious liver injury and herpes meningoencephalitis

Question 13

How should methotrexate be taken?

Answer 13

ONCE weekly

Question 14

What strength of methotrexate tablets should be dispensed? What should be included on the label?

Answer 14

Only one strength of methotrexate tablet (usually 2.5mg) is prescribed and dispensed.

The prescription and the dispensing label clearly show the dose and frequency of methotrexate administration

Question 15

Methotrexate can cause serious side effects of three main organ systems. What are these and what signs should patients look out for?

Answer 15

1. Pulmonary e.g. shortness of breath
2. Liver toxicity e.g. nausea and vomiting, abdominal discomfort and dark urine
3. Blood disorders e.g. sore throat, bruising and mouth ulcers

Question 16

What new measures have been introduced to ensure methotrexate is taken safely?

Answer 16

• Patient alert card (record day of the week, info about signs of overdose)
• The product information and packaging of all methotrexate products for once-weekly dosing will carry a warning about the dosing schedule and the consequences of dosing errors.
• The outer package warning will also include a space for the dispenser to write the day of the week for intake
• On dispensing the pharmacist should transcribe the defined day of the week for intake
  onto the patient card provided within the pack and on the outer packaging. The pharmacist
  should show the patient card to the patient/carer, reiterate the once weekly dosing
  schedule and the other elements described on the patient card.

Question 17

Which route of administration should vinca alkaloids be given by? Which route should be avoided and why?

Answer 17

INTRAVENOUS ONLY.

Intrathecal can lead to severe neurotoxicity, which is usually fatal.

Question 18

How are vinca alkaloids package to promote correct administration?

Answer 18

The NPSA have advised that adult and teenage patients treated in adult or adolescent unit should receive their vinca alkaloid dose in a 50ml minibag.

Teenagers and children treated in a child unit may receive their vinca alkaloid dose in a syringe.

Question 19

Name some key points of the safe handling of cytotoxics guidelines.

Answer 19

• Trained personnel should reconstitute cytotoxics
• Reconstitution should be carried out in designated pharmacy areas
• Protective clothing (including gloves, gowns, and masks) should be worn
• The eyes should be protected and means of first aid should be specified
• Pregnant staff should avoid exposure to cytotoxic drugs (all females of child-bearing age should be informed of the reproductive hazard)
• Use local procedures for dealing with spillages and safe disposal of waste material, including syringes, containers, and absorbent material
• Staff exposure to cytotoxic drugs should be monitored

Question 20

Name some of the key points of the safe systems of cancer chemotherapy.

Answer 20

• Cytotoxic drugs for the treatment of cancer should be given as part of a wider pathway of care coordinated by a multidisciplinary team
• Cytotoxic drugs should be prescribed, dispensed, and administered only in the context of a written protocol or treatment plan
• Injectable cytotoxic drugs should only be dispensed if they are prepared for administration
• Oral cytotoxic medicines should be dispensed with clear directions for use

Question 21

How should the prescribing of oral chemo be carried out compared to parenteral?

Answer 21

Should be carried out the same.

Question 22

What guidance should be available to non-specialists who prescribe on-going chemotherapy regimes?

Answer 22

Non-specialists who prescribe or administer on-going oral cytotoxic medication should have access to written protocols and treatment plans, including guidance on the monitoring and treatment of toxicity

Question 23

What key stages should be followed in the dispensing of cytotoxics?

Answer 23

• Staff dispensing oral cytotoxic medicines should confirm that the prescribed dose is appropriate for the patient.
• Patients should have written information that includes details of the intended oral anti-cancer regimen, the treatment plan, and arrangements for monitoring, taken from the original protocol from the initiating hospital.
• Staff dispensing oral cytotoxic medicines should also have access to this information, and to advice from an experienced cancer pharmacist in the initiating hospital.

Question 24

Irinotecan can cause what serious CV side effects?

Answer 24

Reports of serious and fatal thromboembolic events