Tysabri Infusion
Natalizumab
300mg/15ml
BIOGEN IDEC DENMARK MANUFACTURING ApS
| Pack size | 15ml Glass Vial |
|---|---|
| Dispensing mode | POM |
| Source | DENMARK |
| Agent | CITY MEDICAL STORE |
| Retail Price | 10737.00 AED |
Indications
Tysabri Infusion is used for:
Multiple Sclerosis, Crohn's Disease
Adult Dose
Intravenous
Relapsing-remitting multiple sclerosis
Adult: As monotherapy: 300 mg via infusion over 1 hour once every 4 weeks. Discontinue use if no progress is shown after 6 months of treatment.
Crohn's disease
Adult: Moderate to severe, refractory cases: 300 mg via infusion over 1 hour once every 4 weeks. Discontinue use if no progress is shown within 12 weeks upon initiation of treatment.
Child Dose
Renal Dose
Administration
IV Preparation
Concentrate is a colorless opalescent solution
Visually inspect for particulate matter or discoloration - do not use if either present
Withdraw 15 mL from the vial and dilute in 100 mL 0.9% NaCl; no other diluent should be used
Gently invert to mix - do not shake
Make sure no particulate matter is present
After dilution, use immediately or within 8 hr (keep refrigerated at 2-8°C)
If refrigerated, warm before using
Do not freeze
IV Administration
Infuse over 1 hr
After infusion is complete flush with 0.9% NaCl
Do not coadminister any other drugs either through Y-site or dissolved in same solution
Observe patients during infusion and for 1 hr after infusion is complete
Promptly discontinue infusion upon any signs or symptoms consistent with a hypersensitivity-type reaction
Use of filtration devices during administration has not been evaluated
Other medications should not be injected into infusion set side ports or mixed with natalizumab
Contra Indications
Patient with or with history of progressive multifocal leukoencephalopathy (PML), active malignancies (except cutaneous basal cell carcinoma), active infection. Immunocompromised patients. Concomitant use of immunosuppressants, immunomodulator, antineoplastics, and TNF-α inhibitors.
Precautions
Patient with chronic infections, history of recurring infections and/or underlying conditions that may predispose them to develop infections, presence of anti-JCV antibodies. Hepatic impairment. Pregnancy and lactation.
Pregnancy-Lactation
Pregnancy
There are no adequate data on the developmental risk associated with use in pregnant women
Animal data
In animal studies, administration of natalizumab during pregnancy produced fetal immunologic and hematologic effects in monkeys at doses similar to the human dose and reduced offspring survival in guinea pigs at doses greater than the human dose
Doses were not maternally toxic but produced the expected pharmacological effects in maternal animals
Lactation
Natalizumab has been detected in human milk
No data available on the effects of this exposure on the breastfed infant or the effects of the drug on milk production
Interactions
Potentially Fatal: Increased risk of opportunistic infections with immunosuppressants (e.g. 6-mercaptopurine, azathioprine, ciclosporin, methotrexate), immunomodulators (e.g. interferon beta or glatiramer), antineoplastics, and TNF-α inhibitors.
Adverse Effects
Side effects of Natalizumab :
>10%
Fatigue (10%)
Diarrhea (10%)
Urinary urgency/frequency (9%)
Sinusitis (8%)
Vaginal infections (8%)
Arthralgia (8%)
Cough (3-7%)
Viral infection (7%)
Dermatitis (7%)
Pharyngolaryngeal pain (6%)
Peripheral edema (6%)
Rash (6%)
Dysmenorrhea (2-6%)
Vertigo (6%)
Dyspepsia (5%)
Abnormal liver function test (5%)
Irregular menstruation (5%)
Urinary incontinence (4%)
Toothache (4%)
Pruritus (4%)
Lower abdominal pain (4%)
Constipation (4%)
Vaginal infections (4%)
Limb injury (3%)
Viral infections (3%)
Urinary tract infections (3%)
Flatulence (3%)
Skin laceration (2%)
Aphthous stomatitis (2%)
Amenorrhea (2%)
Ovarian cyst (2%)
Somnolence (2%)
Acute hypersensitivity reactions (2%)
Thermal burn (1%)
Dry skin (1%)
Tremor (1%)
Night sweats (1%)
Mechanism of Action
Natalizumab is a recombinant humanised monoclonal antibody that selectively binds to the alpha-4 integrin molecules. It prevents the migration of leucocytes into the CNS and the gut, thus reducing frequency of relapse, inflammation, and demyelination.
Note
Tysabri 300mg/15ml Infusion manufactured by BIOGEN IDEC DENMARK MANUFACTURING ApS. Its generic name is Natalizumab. Tysabri is availble in United Arab Emirates.
Farmaco UAE drug index information on Tysabri Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.