Tremfya 100mg/Ml Injection
Guselkumab
100mg/ml
JANSSEN CILAG INTERNATIONAL N.V.
| Pack size | 1 Pre-Filled Syringe (1ml) |
|---|---|
| Dispensing mode | POM |
| Source | BELGIUM |
| Agent | CITY MEDICAL STORE |
| Retail Price | 11561.50 AED |
Indications
Tremfya 100mg/Ml Injection is used for:
Moderate to severe, plaque psoriasis, in adults who are candidates for systemic therapy.
Adult Dose
Plaque Psoriasis
Indicated for moderate-to-severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy
100 mg SC at Week 0, Week 4, and q8Weeks thereafter
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Administration
SC Preparation
Remove from refrigerator; allow syringe to reach room temperature (~30 min) before removing syringe cap
Preservative free; visually inspect syringe for any particulates or discoloration prior to administration
SC Administration
For SC use only; inject full amount (1 mL)
Do not inject areas where skin is tender, bruised, red, hard, thick, scaly, or affected by psoriasis
Contra Indications
Serious hypersensitivity. Clinically important active infections (eg, active TB).
Precautions
Discontinue use in case of serious hypersensitivity reactions. Increased risk of infection. Evaluate for TB prior to treatment initiation. Monitor for signs & symptoms of active TB during & after treatment. Concurrent use w/ live vaccines. Withhold treatment for at least 12 wk after last dose prior to live viral or bacterial vaccination; treatment can be resumed 2 wk after vaccination. Women of childbearing potential should use effective methods of contraception during & for at least 12 wk after treatment. Pregnancy & lactation. Elderly >65 yr. Childn & adolescent <18 yr.
Pregnancy-Lactation
Pregnancy
No available data on use in pregnant women to inform a drug-associated risk of adverse developmental outcomes
Human IgG antibodies are known to cross the placental barrier; therefore, guselkumab may be transmitted from the mother to the developing fetus
Animal studies
In a combined embryofetal development and prenatal and postnatal development study, no adverse developmental effects were observed in infants born to pregnant monkeys after SC administration during organogenesis through parturition at doses up to 30 times the maximum recommended human dose (MRHD)
Neonatal deaths were observed at 6-to 30-times the MRHD
Lactation
Unknown if distributed in human breast milk; maternal IgG is known to be present in human milk
Guselkumab was not detected in the milk of lactating cynomolgus monkeys
Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition
Interactions
Concomitant use w/ immunosuppresants (eg, biologics) or phototherapy.
Adverse Effects
Side effects of Guselkumab :
>10%
Infections (23%)
Upper respiratory tract infections (14.3%)
1-10%
Headache (4.6%)
Injection site reactions (4.5%)
Arthralgia (2.7%)
Elevated liver enzymes (2.6%)
Diarrhea (1.6%)
Gastroenteritis (1.3%)
Tinea infections (1.1%)
Herpes simplex infections (1.1%)
Mechanism of Action
Monoclonal antibody (IgG1-lambda) that inhibits IL-23 by selectively binding to p19 subunit of IL-23; IL-23 is a natural cytokine associated with inflammatory and immune responses; guselkumab inhibits the proinflammatory actions of IL-23, thereby decreasing cytokine and chemokine release.
Note
Tremfya 100mg/Ml 100mg/ml Injection manufactured by JANSSEN CILAG INTERNATIONAL N.V.. Its generic name is Guselkumab. Tremfya 100mg/Ml is availble in United Arab Emirates.
Farmaco UAE drug index information on Tremfya 100mg/Ml Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.