REMSIMA Infusion
Infliximab
100mg
Hikma Pharmaceuticals
| Pack size | 10ml Vial |
|---|---|
| Dispensing mode | POM |
| Source | JORDAN |
| Agent | ALPHAMED DRUG STORE |
| Retail Price | 1801.50 AED |
Indications
REMSIMA Infusion is used for:
Crohn's disease, Rheumatoid arthritis, Ulcerative colitis, Ankylosing spondylitis, Psoriatic arthritis, Plaque psoriasis
Adult Dose
Intravenous
Crohn's disease
Adult: Initially, 5 mg/kg by infusion over at least 2 hr, repeated at 2 wk after 1st infusion. No further doses should be given if there is no response after 2 doses. Responders: Maintenance: 5 mg/kg at 6 wk after initial dose then 8 wkly thereafter. May be re-administered w/in 16 wk after last infusion if signs/symptoms recur.
Rheumatoid arthritis
Adult: In combination w/ methotrexate: Initially, 3 mg/kg by infusion over at least 2 hr, repeated at 2 wk and 6 wk after 1st infusion then 8 wkly thereafter. May increase dose in increments of 1.5 mg/kg to a max of 7.5 mg/kg 8 wkly if patient has inadequate response or loses response over a period of 12 wk. Alternatively, 3 mg/kg 4 wkly. May be re-administered w/in 16 wk after last infusion if signs/symptoms recur.
Fistulising Crohn's disease
Adult: Initially, 5 mg/kg by infusion over at least 2 hr, repeated at 2 wk and 6 wk after 1st infusion. No further doses should be given if there is no response after 3 doses. Responders: Maintenance: 5 mg/kg 8 wkly. Re-admin: 5 mg/kg if signs/symptoms recur, followed by 5 mg/kg 8 wkly.
Ankylosing spondylitis
Adult: Initially, 5 mg/kg, repeated at 2 wk and 6 wk, then 6-8 wkly thereafter. Stop treatment if there is no response after 2 doses.
Ulcerative colitis
Adult: Initially, 5 mg/kg by infusion over at least 2 hr, repeated at 2 wk and 6 wk after 1st infusion then 8 wkly thereafter. No further doses should be given if there is no response after 3 doses.
Psoriatic arthritis; Plaque psoriasis
Adult: Initially, 5 mg/kg by infusion over at least 2 hr, repeated at 2 wk and 6 wk, then 8 wkly thereafter. Stop treatment if there is no response after 12 wk for psoriatic arthritis and after 14 wk for plaque psoriaris.
Child Dose
Intravenous
Crohn's disease
Child: 6-17 yr Initially, 5 mg/kg by infusion over at least 2 hr, repeated at 2 wk and 6 wk after 1st infusion then 8 wkly thereafter.
Ulcerative colitis
Child: 6-17 yr Initially, 5 mg/kg by infusion over 2 hr, repeated at 2 wk and 6 wk after 1st infusion then 8 wkly thereafter.
Renal Dose
Administration
Contra Indications
Patient w/ TB or other severe infections (e.g. sepsis, abscesses, opportunistic infections), moderate or severe heart failure (NYHA class III or IV).
Precautions
Patient w/ mild heart failure (NYHA class I or II), history of blood dyscrasias, chronic or recurrent infection. Childn. Pregnancy and lactation. Patient Counselling This drug may cause dizziness, if affected, do not drive or operate machinery. Monitoring Parameters Monitor for signs and/or symptoms of infection, hypersensitivity reaction, lupus-like syndrome, heart failure, malignancy. Monitor vital signs every 2-10 min if reaction is noted during infusion. Perform hepatitis B virus screening prior to and hepatitis B virus carriers during and several mth after therapy; CBC w/ differential, LFTs.
Pregnancy-Lactation
Pregnancy
It is not known whether therapy can cause fetal harm when administered to pregnant woman or can affect reproduction capacity; administer therapy to a pregnant woman only if clearly needed
As with other IgG antibodies, drug crosses placenta; drug has been detected in serum of infants up to 6 months following birth; consequently, these infants may be at increased risk of infection, including disseminated infection which can become fatal; >6 month waiting period following birth recommended before administration of live vaccines (eg, BCG vaccine or other live vaccines, such as the rotavirus vaccine) to these infants; cases of agranulocytosis in infants exposed in utero also reported
Animal data
No evidence of maternal toxicity, embryotoxicity or teratogenicity observed in a developmental toxicity study conducted in mice using an analogous antibody that selectively inhibits the functional activity of mouse TNF alpha
Lactation
Not known whether drug excreted in human milk or absorbed systemically after ingestion; because many drugs and immunoglobulins are excreted in human milk, and potential for adverse reactions in nursing infants, women should not breastfeed their infants while on therapy; a decision should be made whether to discontinue nursing or discontinue drug, taking into account importance of drug to mother
There are no data on effects of infliximab products on milk production
Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for an infliximab product and any potential adverse effects on breastfed infant from infliximab products or from underlying maternal condition
Interactions
Increased risk of serious infection and neutropenia w/ anakinra or abatacept. Risk of clinical infections, including disseminated infections w/ concurrent admin of live vaccines.
Adverse Effects
Side effects of Infliximab :
Mechanism of Action
Infliximab is a chimeric monoclonal antibody which binds w/ high affinity to the soluble and transmembrane forms of tumour necrosis factor-α (TNF-α) thereby inhibiting binding of TNF-α to its receptors.
Note
REMSIMA 100mg Infusion manufactured by Hikma Pharmaceuticals. Its generic name is Infliximab. REMSIMA is availble in United Arab Emirates.
Farmaco UAE drug index information on REMSIMA Infusion is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.