THIS INFORMATION IS ADDRESSED TO HEALTHCARE PROFESSIONALS WHO TAKE CARE OF PATIENTS TREATED WITH QIZENDAY®
(Biotin 100 mg, hard capsules).

(Educational material as agreed in the risk minimisation plan)



THERAPEUTIC INDICATION OF QIZENDAY

QIZENDAY is indicated in adults for the treatment of progressive multiple sclerosis (primary or secondary).


WARNING

Some laboratory tests may potentially be distorted by QIZENDAY.

Biotin may interfere with some immunoassay methods that use a biotinylated reagent i.e. based on a biotin/streptavidin interaction (including tests that could be required in an emergency situation). Please refer to the list of parameters below (non-exhaustive). Interference may also occur with some tissue pathology examinations.

Depending on the method used, results can be falsely low (e.g. sandwich immunoassays) or falsely high (e.g. competitive immunoassays). This may lead to misdiagnosis.

Learn more about biotin interference with :

Sandwich Immunoassays Competitive Immunoassays

Information to the physician prescribing/interpreting a laboratory test

Check with the laboratory if biotin interferes with the assay method used for this laboratory test.

The laboratory should be informed of the potential interferences between biotin and immunoassays.

Remind the patient to carry and transmit their card to any healthcare professional they see.

Information to the healthcare professionals from the laboratory

Check if biotin interferes with the assay method used for this laboratory tests.

If biotin interferes with the assay method used for this laboratory test, the test should be repeated using an assay not subject to interference by biotin.
TREATMENT WITH QIZENDAY MAY INTERFERE WITH SOME LABORATORY TESTS
(non-exhaustive list)

ANAEMIA
EPO
Ferritin
Folate
Vitamin B12

CARDIOLOGY
BNP
CK-MB
D-Dimer
Myoglobin
NT-proBNP
Troponin I
Troponin T

ENDOCRINOLOGY
ACTH
AMH
Androstenedione
Cortisol
C-Peptide
DHEA-s
Estradiol
Estriol, unconj.
FSH, LH
HbA1c
HCG
hGH
IGF-1
IGFBP-3
Inhibin A
Insulin
PAPP-A
PlGF
Progesterone
Prolactin
SHBG
Testosterone
Anti TG
Anti TPO
Anti-TSHr
Calcitonin
T3, FT3
T4, FT4
TBG
Tg
TSH
T-Uptake

ONCOLOGY
ACE
AFP
β-microglobuline
BR 27.29
CA 125
CA 15-3
CA 19.9
CA 72-4
Cyfra 21-1
HE4
HER-2/neu
Gastrin
NSE
PAP
ProGRP
PSA
S100
sFlt-1
TPS

BONE METABOLISM
Anti-CCP
Beta cross Laps
Osteocalcin
PTH
P1NP
Pyrilinks-D
Vitamin D

SEPSIS / INFLAMMATION
C1 inhibitor
C3, C4
CRP
IgA, IgE, IgG, IgM
IL6, IL8, IL10
LBP
Prealbumin
Procalcitonin
TNF-α
Transferrin

INFECTIOUS DISEASES
Ag HBe
Ag HBs
Anti-HAV
Anti-HBc
Anti-HBc IgM
Anti-Hbe
Anti-HBs
Anti-HCV 2
Anti-HIV 1/2
C. Difficile Toxin A&B
CMV IgG, IgM
H. Pylori IgG
Herpes I & II IgG
HIV Ag p24
HIV Ag Confirm.
HIV Combo
HSV-1/2 IgG
Rubella IgG, IgM
Syphilis
Toxo Avidity
Toxo IgG, IgM

THERAPEUTIC DRUGS
Carbamazepine
Ciclosporine
Digitoxine
Digoxine
Gentamicin
Lidocaine
Lithium
Mycophenolate
Phenobarbital
Phenytoin
Procainamide
Sirolimus
Sodium Valproate
Tacrolimus
Theophylline
Tobramycin
Vancomycine

LIVER FIBROSIS
Hyaluronic acid
PIIINP
TIMP-1

DRUGS OF ABUSE/ TOXICOLOGY
6-Acetylmorphine
Acetaminophen
Amphetamines
Barbiturates
Benzodiazepines
Caffeine
Cannabinoids
Cocaine metabolite
Ecstasy
Methadone
Methadone metabolites, EDPP
Methaqualone
Methotrexate
Opiates
Phencyclidine
Propoxyphene
Salicylate
Tricyclic antidepressants


For further information on this product, please refer to EMA Website

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions the national reporting system listed in Appendix V.


Please note that the information you will find in this website is for healthcare professionals who take care of patients treated with Qizenday®.

If you are a patient, this website contains important information for any healthcare professionals you may consult. Some laboratory tests may potentially be affected by using this medicine, including some that may be used in emergency situation. Therefore, you must always carry the card provided with the Qizenday leaflet and show it to any healthcare professional you see.

OK
UDI: COM-010-001
Last update:13/07/2017