Drug Interaction:
Methotrexate
For the treatment of RA, SIMPONI should be used with methotrexate (MTX)
Since the presence or absence of concomitant MTX did not appear
to influence the efficacy or safety of SIMPONI in the treatment of PsA or AS,
it can be used with or MTX in the treatment of PsA and AS.
Indication:
Proprietary Name- Simponi
Established Name - Golimumab - Tumor Necrosis Factor (TNF) blockers
Applicant- Centocor Ortho Biotech INC.
Indication-
Treat moderately to severely active rhematoid arthiritis(RA)
Dosage-
Approved by FDA on 24-4-2010 (Ref- FDA approved List- 2010)
Adverse Reaction:
Most common adverse reactions (incidence)o 5%): upper respiratory tract infection,
nasopharyngitis
Contra-Indications:
CONTRAINDICATIONS
None
WARNINGS AND PRECAUTIONS
Serious Infections - Do not start SIMPONI during an active infection.
If an infection develops, monitor carefully, and stop SIMONI if infection
becomes serious
Invasive fungal infections - For patients who develop a systemic illness
on SIMONI, consider empiric antifungal therapy for those who reside
in or travel to regions where mycoses are endemic
Hepatitis B reactivation - Monitor HBVcarrers during and several months
after therapy. If reactivation occurs, stop SIMPONI and begin anti-viral therapy .
Malignancies - The incidence of lymphoma was seen more often than in
the general U.S. population. Cases of other malignancies have been observed
among patients receiving TNF-blockers
Heart failure - Worsening, or new onset, may occur. Stop SIMPONI if
new or worsening symptoms occur
Demyelinating disease, exacerbation or new onset, may occur
Hypersensitivity Reactions - Serious systemic hypersensitivity reactions
including anaphylaxis may occur
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
SIMPONI is a tumor necrosis factor (TN) blocker indicated for the treatment of:
Moderately to severely active Rheumatoid Arthritis (RA) in adults, in
combination with methotrexate
Active Psoriatic Aithritis (PsA) in adults, alone or in combination with
methotrexate
Active Ankylosing Spondylitis in adults (AS)
DOSAGE AND ADMINISTRATION .
Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis
50 mg administered by subcutaneous injection once a month.
DOSAGE FORMS AND STRENGTHS
50 mg/O.5 mL in a single dose prefilled auto injector
50 mg/0.5 mL in a single dose prefilled syringe
Patient Information:
Patient Counseling
1.Patients should be advised of the potential benefits and risks of SIMPONI.
2.Physicians should instruct their patients to read the Medication Guide
before starting SIMPONI therapy and to read it each time the prescription
is renewed.
3.Infections
Inform patients that SIMPONI may lower the ability of their immune system
to fight infections.
4.Instruct the patient of the importance of contacting their doctor if they develop
any symptoms of infection, including tuberculosis, invasive fungal infections,
and hepatitis B reactivation.
5. Patients should be counseled about the risk of lymphoma and other malignancies
while receiving SlMPONI.
6. Allergic Reactions
Advise latex-sensitive patients that the needle cover on the prefilled syringe
as well as the prefilled 857 syringe in the prefilled SmartJect autoinjector contains
dry natural rubber (a derivative of latex).
Pharmacology/ Pharmacokinetics:
Mechanism of Action
Golimumab is a human monoclonal antibody that binds to both the soluble and
transmembrane human TNFa. This interaction prevents the binding ofTNFa to its
receptors,bioactive forms of thereby inhibiting the biological activity of
TNFa (a cytokine protein).
Pharmacokinetics
Following subcutaneous administration of SIMPONI to healthy subjects and patients
with active RA, the median time to reach maximum serum concentrations (Tmax)
ranged from 2 to 6 days.
A subcutaneous injection of 50 mg SIMPONI to healthy subjects produced
a mean maximum serum concentration (Cmax) of approximately 2.5 ¡.g/mL.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category B . There are no adequate and well-controlled studies of
SIMPONI in Pregnant women. Because animal reproduction and developmental
studies human response, it is not known whether SIMPONI can cause fetal harm
when administered to a pregnant woman or can affect reproduction capacity.
SIMPONI should be used during pregnancy only if clearly needed
Nursing Mothers
SIMPONI is excreted in human milk or absorbed systemically after
Because many drugs and immunoglobulins are excreted in human milk,
a decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to
the mother.
Pediatric Use
Safety and effectiveness of SIMPONI in pediatric patients in less than
than 18 years of age have not been established.
Geriatric
In clinical trials,there were no overall differences in SAEs, serious 503 infections,
and AEs in SIMPONI-treated patients ages 65 or older compared
with younger SIMPONI treated patients.
Because there is a higher incidence of infections in the geriatric population
in general, caution should be used.in treating geriatric patients with SIMPONI.
Manufacturer Details